# Final Comment Response Document for the Regulatory

Determination for

Perchlorate (Categorized Public Comments)Office of Water (4607M)

EPA 815-R-10- 005 January 2011 http://water.epa.gov/drink/EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page i 

### Table of Contents

1. I NTRODUCTION AND O VERVIEW ............................................................................................ 1

2. A PPARENT M ASS M AILING C AMPAIGNS .................................................................................. 4

Apparent Mass Mailing #1 - Physicians for Social Responsibility ....................................................... 4

Apparent Mass Mailing #2 - Physicians for Social Responsibility ....................................................... 4

Apparent Mass Mailing #3 Group Unidentified .........

.......................................................................... . 5

Apparent Mass Mailing #4 - Natural Resources Defe nse Council...................................................... 6
Apparent Mass Mailing #5 - Clean Water Fund/Clean Water Action ............................................... 7

Apparent Mass Mailing #6 - Earth Just ice ...................................................................................... ........ 7
Apparent Mass Mailing #7 – Group Unidentified .......

......................................................................... 8

Apparent Mass Mailing #8 - Food and Water Watch .... ....................................................................... 8

Apparent Mass Mailing #9 - Group Unidentified ......

........................................................................... 9

Apparent Mass Mailing #10 - Group Unidentified ......

......................................................................... 9

Apparent Mass Mailing #11 - Food an d Water Watch ....................................................................... 10

3. C OMMENTS AND EPA R ESPONSES BY C OMMENT C ODE ...................................................... 12

EPA Comment Code: 1000 General Comments ............ ..................................................................... 12

EPA Comment Code: 1100 SDWA requirements and the CCL and Regulatory Determinations process ........................................................................................................ .......... 19

EPA Comment Code: 1300 Length of the co mment period following the October 2008

FR Notice ..................................................................................................................... .................... 26

EPA Comment Code: 1500 EPA's handlin g of comments on the October 2008 FR

Notice ........................................................................................................................ ........................ 45

EPA Comment Code: 1600 Length of the co mment period following August 2009 FR

Notice ........................................................................................................................ ........................ 47

EPA Comment Code: 2000 Perchlorate Health Effects ..................................................................... 51

EPA Comment Code: 2100 NAS (NRC) revi ew of perchlorate health effects and

reference dose ................................................................................................................ .................. 62

EPA Comment Code: 2110 Regulatory determination based upon the already-established

RfD ........................................................................................................................... ...................... 103

EPA Comment Code: 2150 EPA's decision not to seek further input from the NRC on issues related to perchlorate ................................................................................................. ....... 109

EPA Comment Code: 2200 Use of NHANES biomonitoring data for health effects

evaluation .................................................................................................................... ................... 119

EPA Comment Code: 2300 Use of PBPK models from Clewell et al (2007) and Merrill et al (2005) to evaluate health effects ....................................................................................... .. 178

EPA Comment Code: 2400 Use of EPA’s PBPK mode l to evaluate health effects ................... 182

EPA Comment Code: 2410 Use of PBPK model to select life-stage-specific HRLs .................. 213

EPA Comment Code: 2420 Suggestions for alternative ways to use the PBPK model to inform the regulatory determination ..................

........................................................................ 217EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page ii EPA Comment Code: 2500 Other health effects studies, models, and data for EPA to consider (besides NAS/NRC report, NHANES biomonitoring data, and PBPK models already evaluated) ..................................................................................................... ....... 221

EPA Comment Code: 2600 Comments on expanding scope of risk assessment to include other goitrogens and/or dietary iodide de ficiency ..................................................... 275

EPA Comment Code: 3000 Perchlorate Occurrence in Drinking Water...................................... 305

EPA Comment Code: 3100 UCMR 1 occurrence analysis .............................................................. 309

EPA Comment Code: 3120 UCMR 1 stat istical methodology and nationally representative sample of small systems ............... ...................................................................... 32 5

EPA Comment Code: 3140 UCMR 1 entry- point-level estimation of perchlorate

exposure ...................................................................................................................... ................... 327

EPA Comment Code: 3150 Potential use of a Bayesian model to estimate number of PWSs and population served at a range of thresholds ............................................................ 330

EPA Comment Code: 3160 Use of Census data to estimate populations that are in the sensitive life stage .......................................................................................................... ............... 338

EPA Comment Code: 3170 Accounting for variation of perchlorate levels in public water systems over time ....................................................................................................... ........ 342

EPA Comment Code: 3200 Supplemental drinking water occurrence data from

California and Massachusetts .................................................................................................. .... 347

EPA Comment Code: 3300 Other drinking water occurrence studies, models, and data for EPA to consider (besides UCMR 1 and California and Massachusetts data already evaluated) ............................................................................................................ .............. 350

EPA Comment Code: 4000 Evaluation of Pe rchlorate Exposure from Sources Other than Drinking Water ........................................................................................................... ......... 367

EPA Comment Code: 4110 Dietary studies – FDA’ s 2005-2006 total dietary study (TDS) ...... 371

EPA Comment Code: 4130 Dietary studies -- ot her studies, models, and data (besides FDA’s 2005-2006 TDS, and 2003-2005 exploratory data) ..................................................... 375

EPA Comment Code: 4210 Biomonitoring -- urinary data from the 2001-2002 NHANES study, and EPA/CDC’s NHANES-UCMR analysis ........................................... 382

EPA Comment Code: 4220 Biomonitoring -- breast milk studies discussed in the notice ........ 390

EPA Comment Code: 4230 Biomonitoring -- other biomonitoring studies, models, and data for EPA to consider (other than NHANES and breast milk studies discussed in the notice) ................................................................................................................ .................. 395

EPA Comment Code: 4300 Other perchlorate exposure studies, models, and data for EPA to consider (other than drinking water, diet, and biomonitoring) ............................... 397

EPA Comment Code: 5000 SDWA Criteria ...................................................................................... 399

EPA Comment Code: 5100 SDWA Criterion #1 – EPA’s determination that perchlorate may have adverse effects on the health of persons ................................................................. 403

EPA Comment Code: 5200 SDWA Criterion #2 – EPA’s determination that perchlorate occurs infrequently at levels of health concer n in public water systems .............................. 406

EPA Comment Code: 5210 Derivation of the RSC ......................................................................... 412

EPA Comment Code: 5220 Derivation of the HRL ........................................................................ 419EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page iii EPA Comment Code: 5225 Use of alternative HRLs specific to sensitive life stages, as described in Table 2 of the August 2009 FR notice. ............................................................... 448

EPA Comment Code: 5230 Calculation of fr equency of exposure above the HRL among

pregnant women ................................................................................................................ ........... 483

EPA Comment Code: 5240 Consideration of other sensitive subpopulations (e.g., infants, children, and persons with iodine deficiency or thyroid disorders) when establishing the HRL .......................................................................................................... .......... 485

EPA Comment Code: 5300 SDWA Criterion #3 – EPA’s determination that regulating perchlorate with a NPDWR would not represent a meaningful opportunity to reduce health risks for persons served by public water systems ............................................ 504

EPA Comment Code: 6000 EPA Actions ......................................................................................... 52 4

EPA Comment Code: 6100 EPA’s preliminary dete rmination not to regulate perchlorate ....... 525

EPA Comment Code: 6110 Comments urging EPA not to regulate perchlorate ....................... 527

EPA Comment Code: 6120 Comments urging EPA to regulate perchlorate .............................. 564

EPA Comment Code: 6125 Comments critical of preliminary determination (in the October 2008 FR Notice) specific to Washington Post article ........................................... 1004

EPA Comment Code: 6130 Miscellaneous comments on the preliminary determination not to regulate (in the October 2008 FR Notice) .. ................................................................ 1006

EPA Comment Code: 6140 Additional new literature and information for EPA to consider when making a regulatory determination ................................................................ 1020

EPA Comment Code: 6200 Comments related to EPA’ s health advisory ................................. 1037

EPA Comment Code: 6210 Need for EPA to provide additional support to States and

water systems ................................................................................................................. .............. 1042
EPA Comment Code: 6300 EPA's intention to revise guidance on clean-up levels (preliminary remediation goals) ............................................................................................... . 1046

EPA Comment Code: 6310 Clean up as a solution ........................................................................ 1049

EPA Comment Code: 6400 EPA's decision to subject updated PBPK model to peer review during comment period (in the October 2008 FR Notice) ..................................... 1051

EPA Comment Code: 6500 Comments on alternative ri sk reduction approaches .................... 1057

EPA Comment Code: 7000 Miscellaneous Comments .... ............................................................. 1063
EPA Comment Code: 7100 N/A May 2007 Comments ............................................................... 1086

A

PPENDIX 1

– C OMPLETE L IST OF EPA C OMMENT C ODES ..................................................1097



### List of Exhibits

Exhibit 1: Public Submissions by Category Type ......

.......................................................................... ......... 3EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1 of 1099 

## 1. Introduction and Overview

Background The U.S. Environmental Protection Agency (EPA or The Agency) is required by the Safe Drinking Water Act (SDWA), as amended in 1996, to pu blish a list of contaminants (Drinking Water Contaminant Candidate List, or CCL) that are know n or anticipated to occur in public water systems, and which may require regulation under the SDWA. The CCL 2 was published in a Federal Register Notice (FR Notice) on February 24, 2005 (7 0 FR 9071). The Agency is also required to make Regulatory Determinations on at least five of the CCL contaminants following publication. EPA published preliminary regulatory determinations for 11 of 51 total contaminants from CCL 2 on May 1, 2007 (72 FR 24016). In the 2007 notice, perchlorate was not part of the list of 11 contaminants, however, the Agency asked for new information and data related to perchlorate. Subsequently, EPA made a final regulatory determi nation not to regulate the 11 of the contaminants identified in the May 1, 2007 Federal Register notice. Responses to public comment regarding these 11 contaminants were answered as part of the final regulatory determination process and posted to www.regulations.gov (refer to document ID EPA-HQ-OW-2007-0068-0178).

The Agency deferred responding to comments on pe rchlorate, and issued a separate preliminary determination not to regulate perchlorate on Octo ber 17, 2008 (73 FR 66895), followed by an additional public comment period. In a third Federal Register notice, issued on August 19, 2009 (74 FR 41883), EPA requested new information and da ta via public comment. The purpose of issuing

the notice was to obtain comments on additional a pproaches to analyzing data related to EPA’s regulatory determination. EPA wanted to ensure consideration of all the potential options for evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate through a national primary drinking water rule.

This final comment response document presents the comments and responses for all three comment periods. Approximately 39,000 public su bmissions (in the form of letters, apparent mass mailing campaigns, e-mails, and/or postings to www.regulations.gov) were received by EPA. All original public submissions can be found in their respective docket locations; at www.regulations.gov, under Docket ID EPA–HQ–O W–2007–0068 for the May 2007 notice; EPA– HQ–OW–2008–0692 for the October 2008 notice; and EPA–HQ–OW–2009–0297 for the August

2009 notice.

EPA’s Categorization of Public Co mments and Document Organization

Within the 3 Federal Register notices related to perchlorate, EPA sought public comment on a number of topics, including: regulatory determination; the approach EPA used to make its determination;
new data and information; and seve ral other issues specific to the individual FR notices. To address and respond to the public comments that were re ceived, EPA developed a list of numerically ordered topics (referred to as “EPA Comment Codes”) that were likely to be addressed by commenters (typically based on the outlines of the draft FR notices). Not all of the EPA Comment Codes were addressed by commenters. The comple te list of EPA Comment Codes is provided in Appendix 1, including notation for co des that did not receive comments.

To organize and track public submissions, EPA assi gned a document identification (ID) number . These “document IDs” were assigned to give each public submission a unique identifier, and to tie

each submission to the docket for the Federal Register notice it was submitted under, or to identify itEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 2 of 1099 as the representative letter from an apparent mass mailing campaign (see discussion below regarding mass mailing campaigns).

Each public submission was read by EPA, and, where appropriate, was subdivided into “comment sections,” or distinct issue areas, based on topica l breaks within the submission. EPA grouped these comment sections (hereinafter referred to as “com ments”) and assigned a five digit EPA comment identification (ID) number or “comment ID.” Comments that were similar in topic were then grouped together into a corresponding EPA Comment Code. Each EPA Comment Code was assigned a four digit reference number.

Apparent Mass Mailing Campaigns – Section 2 EPA received more than 37,000 public submissions from 11 apparent mass mailing campaigns. EPA read each submission and determined if it was part of a campaign. Only one representative letter (the first letter that was received) from each campaign is included in this response to comment document. The representative letters from each campai gn appear in their entirety in Section 2 of this report. Each individual letter is presented in the or der in which it was originally written, separated into its individual comments ( i.e. , at topical breaking points), with each comment followed by the associated EPA response (see explanation on the next page regarding cross referencing of responses, and response to comment codes). Each comment from a campaign also appears in Section 3, under its assigned EPA Comment Code.

Comments and Responses by Comment Code – Section 3 Section 3 presents the public comments and EPA’ s responses. These are organized first by EPA Comment Code, ( i.e. , the topical subsections within Section 3); then within each Comment Code, comments are organized numerically by EPA Comme nt ID. Readers can first find the comment code for topics they are interested in, and then find responses to specific Comment IDs for individual comments. The commenter name, organiza tion, and document ID are also given for each comment. Any comment can be read as it appears wi thin the commenter’s original letter, e-mail, or posting by searching on the associated Document ID on www.regulations.gov (see explanation of
Document IDs in the introduction to this section, “EPA’s Categorization of Public Comments and Document Organization”). The Document ID can al so be used to find additional information, such as tables or figures, which may be included with in the context of comment s or attachments in the commenter’s original submission.

Cross Referencing of Responses In many cases, several commenters addressed the same or similar issues. For these comments, EPA has cross referenced responses to avoid redundancy and to ensure consistency. Responses are cross referenced by providing the pertinent EPA Comment ID, along with the EPA Comment Code

where the EPA Comment ID is located. As noted above, Section 3 is organized first by EPA Comment Code (the subsections within the chapter), then numerically by EPA Comment ID.

Response to Comment Code Many comments received by EPA addressed similar topics, and were thus grouped under the same
EPA Comment Code. In several of these cases, th e same response was appropriate for multiple comments, and EPA developed a “Response to Comme nt Code” which appears at the beginning of each EPA Comment Code section. Responses to in dividual comments may point the reader to the appropriate Response to Comment Code.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 3 of 1099 Who Submitted Comments Because EPA received approximately 39,000 public submissions it is not practical to list all commenters and the topics they commented on. However, in reviewing commenter submissions and profiles, EPA binned commenter s into 12 categories to provide a broad characterization of
interested stakeholders. Exhibit 1, below, lists commenter category, and the number of comments received within each category.

Exhibit 1: Public Submissions by Category Type

Category Type Number of Public

Submissions

Academia / Professional Societies (i ncluding: university departments, professors (even if writing on their own behalf)) 10

Consultants 19

Drinking Water Organizations 19

Drinking Water Systems 7

Environmental Groups 44

Federal Government 4

Individual Manufacturers/Companies 2

Industry Groups 14

Local Government 6

States 31

Worker & Public Health Groups 9

Private Citizen and Anonymous Commenters Approximately 38,800

1. Original documents can be found in the docket at http://www.regulations.gov , under Docket EPA–HQ–OW–2007–0068 for the May 2007 FR; EPA–HQ–OW–2008–0692 for the October 2008 FR ; and EPA–HQ–OW–2009–0297 for the August 2009 FR. 2. A complete list of the EPA Comment Codes and their descriptions can be found in Appendix 1.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

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## 2. Apparent Mass Mailing Campaigns

Apparent Mass Mailing #1 - Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19687

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-20 08-0692): Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinki ng water is unacceptable. Perchlorate is found in drinking water in 35 states, and according to the EPA’s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.

Response: See response to comment code 6120.

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19688

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.



### Apparent Mass Mailing #2 - Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19689

EPA Comment Code: 6120

Comment: The Environmental Protection Agency (EPA), supposedly protecting us against harmful chemicals in our air, water and food, has formally refused to set a drinki ng- water standard for perchlorate, a chemical in rocket fuel that has be en linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19690EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 5 of 1099 EPA Comment Code: 5220

Comment: The maximum safe level for perchlorate in drinking water is now 15 times higher than

what the EPA declared safe in 2002. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water

in 35 states in the U.S.

Response: See response to comment 1987 3 under comment code 5220.

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19691

EPA Comment Code: 6120

Comment: The Senate Environment and Public Works Committee has endorsed legislation requiring the EPA to set a federal standard for perc hlorate and to monitor levels of the chemical in tap water. Please regulate perchlorate in our dr inking water: Your current decision is harmful to public health.

Response: See response to comment code 6120.



### Apparent Mass Mailing #3 Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-0561

EPA Comment ID: 19964

EPA Comment Code: 1300

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period I am writing to express my concern regarding the EPA's failure to regula te perchlorate, as well as the proposed reference level, which fails to protect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children. EPA has spent a number of years researching perchlorate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and th roughful public response. We cannot afford to have this decision rushed through, in the last da ys of the current administration, and leaving those communities that face the greatest risk without enou gh time to comment. It takes time for public and community groups to evaluate EPA's findings, re view the ever-changing scientific literature, and prepare comments. I therefore request that th e EPA extend the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 6 of 1099 

### Apparent Mass Mailing #4 - Natur al Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20016

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460 Dear Administrator Johnson and EPA staff, I urge you to set a drinking water standa rd for perchlorate that will protect pregnant women and babies nationwide. Perchlorate poses a risk for pregnant women, newborns and young children by interfering with thyroid hormone, which is critical for optimal development of the brain and nervous system. Perchlorate is found in drinking wa ter in at least 26 states, and 20-40 million people could be exposed to this chemical. Several states ha ve set drinking water standards or guidelines for this chemical, but these standards vary widely, so it is critical for the EPA to set a national standard

that is based on the best available science and th at will protect public heal th. The EPA's own staff scientists have determined that your decision not to regulate perchlorate places some infants and young children above safe levels of exposure. The EPA's current draft scientific analysis should undergo independent scientific peer review and should be used as the basis for the regulation.

Response: The Agency believes that further review by the Na tional Research Council would unnecessarily delay regulatory decision making for perchlorate. Therefor e, EPA is not, at present, planning to request additional NRC review of issues related to perchlor ate. Instead, EPA issued a notice in August of 2009 seeking comments on a broad range of alterna tive approaches to the interpretation of the

scientific data relevant to a regulatory determination for perchlorate in drinking water.

EPA has determined to regulate perchlorate in dr inking water. See response to comment code 6120.

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20017

EPA Comment Code: 5300

Comment: All Americans deserve healthy and clean dr inking water. The EPA should not finalize this decision until the scientific review is compl ete and should make decisions that are consistent with the agency's own scientists. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity for health risk reduction."

Response: See response to comment code 5300.

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20018

EPA Comment Code: 6120

Comment: Again, I urge you to reverse your decision an d to set a national drinking water standard for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 7 of 1099 Response: See response to comment code 6120.



### Apparent Mass Mailing #5 - Clea n Water Fund/Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-0689

EPA Comment ID: 20019

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. * perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; * a national primary drinking water regulation would provide a meaningful opportunity to protect public health. Additional Facts * Perchlorate is a harmful chemical used in rocket fuel, flares, and explosives. * Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. * Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills. * EPA agrees that perchlorate has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Response: See response to comment code 6120.



### Apparent Mass Mailing #6 - Earth Justice

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20884

EPA Comment Code: 6120

Comment: Administrator Stephen L. Johnson 1101 A EPA Headquarters 1200 Pennsylvania Avenue, NW, Ariel Rios Building Washington, DC 20460 Subject: Protect Our Drinking Water

From Perchlorate Contamination Dear Administrato r Johnson, I am writing to urge you reverse EPA's preliminary regulatory determination and s et a protective drinking water standard for perchlorate as required by the Safe Drinking Water Act. Perchlorate contamination in our food and water supplies is too widespread, and its toxic effects too well known, for continued inaction on this problem.

Response: See response to comment code 6120.

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20885

EPA Comment Code: 5240

Comment: Many experts disagree with your assessment th at drinking water with 15 parts per billion of perchlorate is safe and acceptable. Scientis ts from the California Environmental ProtectionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 8 of 1099 Agency and the Massachusetts Department of Envi ronmental Protection have set stricter standards to will ensure that the most vulnerable populations -- pregnant women, infants, and small children -- are protected from the adverse impacts of perchlorate.

Response: See response to comment code 5220.

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20886

EPA Comment Code: 4000

Comment: EPA's analysis fails to consider that th e combination of food and drinking water exposure to perchlorate in the U.S. population exceed s the reference dose set by EPA. Nor does it incorporate the more protective methodology behind the recent state regulatory actions. These flaws must be remedied for the sake of the millions of U.S. families exposed to dangerous levels of perchlorate contamination.

Response: EPA considers the combination of food and drinking water through the relative source contribution (RSC). The RSC is the percentage of the reference dose remaining for drinking water after other sources of exposure to perchlorate have been considered (e.g., food). See the August 2009 Federal Register notice (41887) for a detailed discussion of RSC derivation.

Regarding the comment about incorporating methodologies behind recent state regulatory actions, States use different methodologies or assumptions to derive their own standard based on their unique exposure scenarios. EPA has used the best available peer reviewed science in making this regulatory determination.



### Apparent Mass Mailing #7 – Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-1518

EPA Comment ID: 20705

EPA Comment Code: 6120

Comment: I understand the dangers of perchlorate an d ask you to keep the testing requirement intact for our public drinking water supplies. Re moval of the testing requirement would eliminate detection of perchlorate in the case of accidental or intentional c ontamination of drinking water supplies, such as the Tewksbury Massachusetts contamination in 2004.

Response: See response to comment code 6120.



### Apparent Mass Mailing #8 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2008-0692-1805

EPA Comment ID: 20883EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 9 of 1099 EPA Comment Code: 6120

Comment: Dear Administrator Johnson, I am writing to urge you to reconsider EPA's preliminary determination not to regulate perchlorate in drin king water. Perchlorate has been found in the drinking water supply of 35 states and the Dist rict of Columbia. Widesp read human exposure to perchlorate was confirmed by the Center for Di sease Control’s NHANES study, which found that 100 percent of the 2,820 randomly selected study part icipants had detectable levels of perchlorate in their urine. The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroi d gland’s iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive effects for those affected. EPA’s failure to regulate perchlorate in drinking water places consumers - especially children and pregnant women - at risk. In response to this misguided determination, EPA’s own Children’s Health Protection Advisory Committee has drafted a letter expressing its concern with EPA’s decision not to regulate perc hlorate. Members of th e committee claim that EPA rushed a decision on perchlorate without taking time to consider all the latest peer-reviewed studies. Given the vital importance of fetal central nervo us development not only for long-term health and development of children, but also for the viability of fetuses, why would EPA rush to a decision? Unfortunately, the only conclusion we can draw is that EPA has issued this determination to avoid strapping the Department of Defense with costs to clean up near military bases, missile testing sites and chemical plants. While millions of consumers’ health is jeopardized, it seems the budget concerns of the Pentagon or White House are drivin g EPA’s decision. This determination is clearly another instance of a regulatory agency shirking its responsibility to pro tect the American public. Instead of fulfilling its obligations under the SDWA, EPA has once again folded to pressure.

Response: See response to comment code 6120.



### Apparent Mass Mailing #9 - Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-2366

EPA Comment ID: 29116

EPA Comment Code: 6120

Comment: Water Docket, EPA, Mailcode 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460 To Whom It May Concern: I urge you to re verse your decision and set a federal limit for perchlorate in drinking water. Perchlorate is a na tionwide problem and has health impacts at lower levels than previously thought. Please protect public health, especially infants and children, by regulating perchlorate.

Response: Please see the response to comment code 6120.



### Apparent Mass Mailing #10 - Group UnidentifiedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 10 of 1099 EPA Document ID: EPA–HQ–OW–2009–0297-0039

EPA Comment ID: 28365

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billi on for perchlorate. perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. a national pr imary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 6120.



### Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA–HQ–OW–2009–0297-0526

EPA Comment ID: 28614

EPA Comment Code: 6120

Comment: Administrator Jackson USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 September 18, 2009 Dear Administrator Jackson, I am writing, on behalf of Food and Water Watch, to ur ge you to make a national primary drinking water rule for perchlorate. Perchlorate has been found in the drinking water supply of 35 states and the District of Columbia. Widespread human exposure to perchlorate was confirmed by the Center for Disease Control's NHANES study, which found that 100 percent of the 2,820 randomly selected study participants had detectable levels of perchlorate in their urine. And according to your request for comment notice, dated August 5, 2009, the nu mber of people served by water contaminated with high levels of perchlorate ranges between 53.4 and 16.8 million people.

Response: See response to comment code 6120.

EPA Document ID: EPA–HQ–OW–2009–0297-0526

EPA Comment ID: 28615

EPA Comment Code: 2150

Comment: Your decision to not request additional NRC re view of issues relating to perchlorate is ill advised. Additional NRC research may better elucidate the health e ffect and exposure risk we presently face. Moreover, NRC research may provid e better guidance in making a final regulatory determination, especially in determining the best health reference level (HRL).

Response: Please see the response to comment ID 28822 under comment code 2150.

EPA Document ID: EPA–HQ–OW–2009–0297-0526

EPA Comment ID: 28616

EPA Comment Code: 5225EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 11 of 1099 Comment: As suggested by previous commenter's, I believe that the Agency's proposed HRL, of 15 micrograms/Liter, is too high. The alternative HRLs presented in Table 2 of your request for comment notice, dated August 5, 2009, do not use the most appropriate data. The data in Table 2 uses mean ingestion rates from the CSFII. The CSFII is already several years out of date.

Response: Regarding the Agency's proposed HRL of 15 ug/L being too high, see response to comment code 5220. Regarding use of CSFII data, EPA believes that it is the best peer reviewed

science that is available.

EPA Document ID: EPA–HQ–OW–2009–0297-0526

EPA Comment ID: 28617

EPA Comment Code: 3170

Comment: You also request comment on how the Agency should account for variation of perchlorate levels over time in public water syst ems. This is simple: the Agency should act with extreme precaution.

Response: See response to comment code 6120.

EPA Document ID: EPA–HQ–OW–2009–0297-0526

EPA Comment ID: 28618

EPA Comment Code: 6120

Comment: The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroid glands iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive effects for those affected. EPA's failure to regulate perchlorate in drinking water places consumers, especially children and pregnant women, at risk. We urge the EPA to consider the regulation of perchlorate as an opportunity to protect our waterways and make our drinking water safe for all.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 12 of 1099 

## 3. Comments and EPA Responses by Comment Code

EPA Comment Code: 1000 General Comments

Individual Comments

Commenter Name: Julie L. Heckman Commenter Organization: American Pyrotechnics Association (APA)

EPA Document ID: EPA-HQ-OW-2009-0297-0522

EPA Comment ID: 28489

EPA Comment Code: 1000

Comment: Please see the attached comments of the American Pyrotechnics Association.

Attachment

September 18, 2009

EPA Docket Center (Water Do cket) U.S. Environmental Prote ction Agency EPA West Building
1301 Constitution Ave., N.W., Room: 3334, Mail Code: 2822T Washington, DC 20004

Re: Drinking Water: Perchlorate Supplemental Reques t for Comments, 74 Fed. Reg. 41883 (Aug. 19, 2009); Docket ID No. EPA-HQ-O W-2007-0297; RIN 2040-AF08

Dear Sir or Madam:

These comments are submitted on behalf of the Am erican Pyrotechnics Association ("APA"), in response to the above-referenced Notice and Supplemental Request for Comments ("Notice") appearing in the Federal Register on Wednesday, August 19, 2009. We appr eciate the opportunity to provide the Agency with these comments.

Interest of the APA

The APA is the principal safety and trade associ ation of the fireworks industry representing manufacturers, importers, distributors, retailers, supp liers, and professional public display firms. The APA has over 240 member companies. Along with their subsidiaries, APA member companies are responsible for 90 percent of the fireworks manufactured, imported, distributed and displayed in the

U.S.

The fireworks industry is predominately comprised of small family businesses that together, on one day each year, serve almost all of the nation an d its citizens with the very special honor of celebrating this country's most patriotic of holidays, Independence Day, the Fourth of July. This is a responsibility entrusted to us by the founders themselves.

Response: No response is necessary to the info rmation provided by the commenter.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 13 of 1099 Commenter Name: Julie L. Heckman Commenter Organization: American Pyrotechnics Association (APA)

EPA Document ID: EPA-HQ-OW-2009-0297-0522

EPA Comment ID: 28491

EPA Comment Code: 1000

Comment: Perchlorate has recently been used in fireworks because it is essential to the formula to cause the fireworks compositions to burn properly. The perchlorate formulas replaced chlorate formulas, which were less stable and highly fricti on sensitive, in order to provide a much safer product. The perchlorate formulas are designed so that the perchlorate is consumed during combustion. Efforts to replace perchlorate contin ue, but the technology for a safe, equally effective substitute is still developing.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0649

EPA Comment ID: 28494

EPA Comment Code: 1000

Comment: October 7, 2009

U.S. Environmental Protection Agency Mailcode 2822T 1200 Pennsylvania Ave., NW. Washington,

DC 20460

Subject: Docket ID No. EPA-HQ-OW-0297

Reference: Drinking Water: Perchlorate Supplemen tal Request for Comments (Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices

This letter is submitted to correct and clarify comments provided by the Nevada Division of Environmental Protection (NDEP) dated Septembe r 16, 2009 in response to the referenced "Supplemental Request for Comments" noticed by the U.S. Environmental Protection Agency (EPA) in the August 19, 20 09 Federal Register; Docket ID No. EPA-HQ-OW-2009-0297.

The modifications to our earlier submittal con cern the description of analytical methods and detection limits associated with perchlorate data collected and reported by the Metropolitan Water District (MWD) of Southern California for the Whitsett Intake. The NDEP is providing these corrections even though these corrections do not change the NDEP's analyses or recommendations provided in our original submittal.

The necessary corrections relate to several dates and a reporting limit that were provided on page 16 of 22 within the referenced submittal. Specifically , following submittal of initial comments by the
NDEP, it came to our attention that:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 14 of 1099 * A change from a reporting limit of 4 ug/L to 2 ug/L occurred early than was referenced; * A change from EPA Method 314 to EPA Method 331 occurred earlier than was referenced; * A change from EPA Method 331 to EPA Method 332 occurred earlier than was referenced; and * The MWD is being provided a 0.1 ug/L reporting lim it for EPA Method 331 and EPA Method 332.

A corrected page 16 of 22 to the September 16, 20 09 NDEP submittal is attached to this letter to serve as an errata replacement page to our earlier submittal. Track change mode was used to provided clarity and transparency related to this re vision. Please use the provided errata to update your records. Additionally, please contact the un dersigned should you wish to discuss these data

further.

The NDEP appreciates this opportunity to provide th e EPA with helpful information to enable the EPA to make a thoughtful and credible decision regarding whether there is a meaningful opportunity for health risk reduction to persons served by public water systems through promulgating a national drinking water rule for perchlorate.

Sincerely, Tom Porta, Deputy Administrator Ne vada Division of Environmental Protection

Tp/tjc cc Jennifer Carr, P.E., CE M, Chief, Bureau of Safe Drinki ng Water, Nevada Division of
Environmental Protection, 901 S. Stewart Street, Suite 4001, Carson City, NV 89701-5249 Darrel Osterhoudt, Regulatory Affairs Mana ger, Association of State Drin king Water Administrators, 1401 Wilson Blvd., Suite 1225, Arlington, VA 22209 Kay Brothers, Deputy General Manager, SNWA Engineering/Ops, Southern Nevada Water Authori ty, 100 City Parkway, Suite 700, Las Vegas, NV 89106 Dr. Mic Stewart, Manager, Water Quality Se ction, Metropolitan Water District of Southern California, 700 North Alameda Street, Los Angeles, CA 90012 Marie Pearthree, Assistant General Manager, Central Arizona Water Conservation Dist rict, PO Box 43020, Phoenix, AZ 85080-3020 Brenda Pohlmann, Environmental Programs Ma nager, City of Henderson, PO Box 95050, Henderson, NV 89009 Susan Crowley, Tronox, LLC, PO Box 55, Henderson, NV 89009 Jeff Gibson, AMPAC, 3883Howard Hughes Parkway, Suite 70, Las Vegas, Nevada 89109

Attachment [See PDF docket ID EPA-HQ-OW-20 09-0297-0649; this corrects docket ID EPAHQ-OW-2009-0297-0638]

Response: No response is necessary to the information provided by the commenter and the errata

sheet.

Commenter Name: Anthony Russo Commenter Organization: Chemistry Council of New Jersey (CCNJ)

EPA Document ID: EPA-HQ-OW-2009-0297-0673

EPA Comment ID: 28691

EPA Comment Code: 1000

Comment: An arbitrarily low standard for perchlorate could result in misdirected regulatory action against any and all low level contaminants in our water supply and the negative public health impacts

that will follow from that.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 15 of 1099 CCNJ appreciates this opportunity to comment. We believe that the scientific evaluation of perchlorate has become quite complica ted over the past few years and that there is still the need for study and debate. We hope that CPA w ill carefully consider our comments.

Sincerely, Anthony Russo Director of Regulatory Affairs CCNJ

Response: Please see the response to comment code 6120.

Commenter Name: Janice Dunn Commenter Organization: California Space Authority (CSA)

EPA Document ID: EPA-HQ-OW-2009-0297-0671

EPA Comment ID: 28692

EPA Comment Code: 1000

Comment: October 6, 2009

Ms. Lisa P, Jackson Administrator U.S. En vironmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: EPA-HQ-OW-2009-0297, "Drinking Water: Perchlorate - Supplemental Request for Comments," 74 FR 159:41883, 19 August 2009

Dear Ms. Jackson:

The California Space Authority (CSA) is a nonprofit corporation representing the commercial, civil, and national defense/homeland security interests of California's diverse space enterprise community. Therefore, we feel compelled to share our con cern regarding the Environmental Protection Agency (EPA) request for public comment s regarding data related to EPA's perchlorate regulatory determination (the Notice; U.S. EPA, 2009b).

Earlier this year, President Obama issued a broad directive that would guarantee scientific integrity in all federal policy making. We strongly support this policy standard. CSA believes that additional approaches proposed by EPA which support a possibl e regulatory determination are consistent with

this directive.

There is a substantial body of scientific eviden ce related to the health risks associated with perchlorate. Five decades of sc ientific investigation, includin g a landmark National Academy of Sciences (NAS) review, result in a clear and consistent conclusion: low levels of perchlorate are not dangerous to public health.

CSA respectfully requests that the EPA support sound public policy which protects human health

and is based on solid science standards.

Sincerely, Janice Dunn Deputy Director

Response: Please see the response to comment code 6120.

Commenter Name: Robert E. BrackettEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 16 of 1099 Commenter Organization: Grocery Manufacturers Association (GMA)

EPA Document ID: EPA-HQ-OW-2009-0297-0413

EPA Comment ID: 28705

EPA Comment Code: 1000

Comment: GMA appreciates the opportunity to provid e comments on the public notice regarding alternative approaches to the interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking water.

Attachment

September 18, 2009

Water Docket Environmental Protection Agency Ma ilcode 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: Docket No. EPA-HQ-OW-2009-0297, "Drinkin g Water: Perchlorate - Supplemental Request for Comments," 74 FR 159:41883, 19 August 2009

Dear Sir/Madam:

The Grocery Manufacturers Association (GMA) repr esents the world's leading food, beverage and consumer products companies. The Associati on promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence. The GMA board of directors is comprised of chief

executive officers from the Association's member companies. The $2.1 trillion food, beverage and consumer packaged goods industry employs 14 m illion workers, and contributes over $1 trillion in added value to the nation's economy.

GMA appreciates this opportunity to provide co mments on the above referenced public notice regarding alternative approaches to the interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking water.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28826

EPA Comment Code: 1000

Comment: AMWA's comments are presented in two parts. The first part focuses on several areas where AMWA requests clarification or makes reco mmendations including: EPA's alternative HRL analysis, review of this analysis and the PBPK model by the National Academies National Research Council, EPA's population estimates, the Inspector General (IG) report, the significance of the reference dose (RfD) being set at a no observed effect level (NOEL) rather than a no observed adverse effect level (NOAEL), and the science surro unding perchlorate. The second part of theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 17 of 1099 letter provides responses to three issues where EPA specifically requested comment in the Federal Register (FR) notice.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 29080

EPA Comment Code: 1000

Comment: Is perchlorate known to occur or is there a substantial likelihood that perchlorate occurs at a frequency and at a level of public health concern in public water systems?

Perchlorate is not known or likely to occur in pub lic water systems with high enough frequency nor does it occur at levels of public health concern. The NHANES studies and breast milk biomonitoring studies, notwithstanding their lim itations, reveal that the US population is not exposed to levels of perchlorate that could cause an adverse effect, even when all exposure sources -

in food and water - are considered.

In the NHANES results, Americans 6 years and older had a 50th percentile dose of perchlorate at the time of sampling equivalent to 2.2 ppb in drinking water. (Blount, 2006) This dose is less than 10 percent of the conservative NOEL level that is the basis of EPA's RfD and 7,000 times lower than the NOAEL. Less than 0.004% of the population has the potential for exposure to perchlorate above the RfD. (Blount, 2006) By all standard regulatory benchmarks EPA uses to determine acceptable incremental potential population risk fr om drinking water expos ure, total perchlorate exposure has not required regulation. If total ex posure does not present a meaningful risk for regulatory purposes, it follows that the risk from exposure to perchlorate in drinking water only is

even smaller.

The sole effect of setting a drinking water standa rd would be to reduce this already insignificant fraction. Rarely does EPA have both toxicology and exposure measures of such high quality. This evidence shows that drinking water is not a sign ificant source of perchlorate for the population.

The nationally-representative Unregulated Contam inant Monitoring Rule 1 results show that perchlorate does not occur frequently or at levels of public health concern in public water systems. The process for collecting data on unregulated cont aminants in large and small water systems has been well established and relied upon by EPA for pa st Contaminant Candidate List (CCL) regulatory determinations. The UCMR is the most complete source of information on contaminant occurrence in the nation's drinking water sources. The use of UCMR sampling data for regulatory

determinations has been well established.

Response: EPA has determined that perchlorate occurs or there is a substantial likelihood that perchlorate will occur with a frequency and at leve ls of health concern in public water systems. Therefore, EPA has determined to regulate perchlor ate in drinking water. See response to comment

code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 18 of 1099 EPA disagrees with the interpretation of the NHANES studies and breast milk monitoring revealing that the US population is not exposed to levels of perchlorate that could cause an adverse effect. The NHANES studies did not measure exposure in infants and children under the age of 6. In light of the discussion presented in the final regulatory determination notice and the information available at this time, EPA believes that a NPDWR for pe rchlorate could reduce perchlorate exposures to levels below the potential alternative HRLs.

EPA disagrees with the statement that the UCMR 1 results show that perchlorate does not occur frequently or at levels of public health concer n in public water systems. EPA believes that the UCMR 1 is the best available data on the frequency and level of perchlorate occurrence in public water systems nationally. UCMR 1 indicated that 5.1 to 16.6 million people are served by PWSs, for which we have data, that have detected perchlorate at levels above the potential health levels.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 19 of 1099 

### EPA Comment Code: 1100 SDWA require ments and the CCL and Regulatory Determinations process

Individual Comments

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Administrators (ASDWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0169

EPA Comment ID: 20285

EPA Comment Code: 1100

Comment: States are also very interested in the contaminants for which a decision has not yet been proposed but where EPA shared information in th e notice on the status of its analysis of these chemicals. Contaminants in this category includ e MTBE and perchlorate. ASDWA appreciates the

fact that EPA chose to share extensive information on these contaminants in the notice, since some of these contaminants are "hot" topics in many st ates. Even if regulatory decisions are not yet made, states need to know the current status to help them deal with public water systems where these contaminants have been found. ASDWA encourag es EPA to continue to provide information on the status of their regulatory deliberations especi ally for contaminants like MTBE and perchlorate where there has been significant public and legisl ative interest. ASDWA and individual states are ready to assist and provide input to EPA's decision making at any time. We offer the following specific observations about perchlorate, metolachlor, and MTBE .

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Administrators (ASDWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0169

EPA Comment ID: 20287

EPA Comment Code: 1100

Comment: National regulations covering a contaminant that may be a very localized problem need to be considered very carefully. They must be suppor ted by scientific data. If further information is needed on the sources of human exposure, states urge the Agency to consider such additional documentation before a regulatory determination is made. If analysis of additional data does support regulation, states do not believe there is adequate justification for establishing a new national drinking water standard. Under such circumstances, its primary impact would be to add more water quality monitoring without necessarily enhancing pub lic health protection. If an MCL is eventually developed based on somewhat localized occurrence patterns, we would encourage the Agency to consider requiring targeted monitoring, based on pr eliminary initial rounds of monitoring, rather than uniform monitoring across the board.

Response: EPA intends to develop monitoring requireme nts for perchlorate as part of a proposed National Primary Drinking Water Regulation.

Commenter Name: D. DaleyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 20 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1625

EPA Comment ID: 20564

EPA Comment Code: 1100

Comment: Please include perchlorate on the EPA's Contaminant Candidate List. I am concerned with the potential health risks to all living things fr om exposure to perchlorate, especially in drinking water. By leaving this contaminant on the EPA's Contaminant Candidate List, it will be given attention needed to control it's use and disposal properly and safely to prevent significant future pollution problems to the environment. As a licen sed professional engin eer with the State of Connecticut, I urge you to reverse the EPA's decision to remove this dangerous contaminant from the CCL and place it back on the CCL as it should be there. Please help keep this dangerous chemical out of our drinking water.

Response: EPA included perchlorate on the first, second, and third Contaminant Candidate Lists that were published in the Federal Register on Marc h 2, 1998 (63 FR 10273), February 24, 2005 (70 FR 9071), and October 8, 2009 ( 74 FR 51850), respectively. EPA has decided to regulate perchlorate in drinking water. See respons e to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20940

EPA Comment Code: 1100

Comment: Furthermore, section 1412(b)(3)(A) of the SD WA requires that the EPA Administrator, when making a decision based on science, shall use "the best available peer-reviewed science and supporting studies conducted in accordance with so und and objective scientific practices."[FN27: 42 U.S.C. [section] 300g-1(b)(3)(A) (Westlaw 2008).] However, according to EPA's Science Advisory Board (SAB), EPA's preliminary determination not to regulate perchlorate "relies on the use of a dosimetric model which is now undergoing letter peer review."[FN28: Letter from Dr. Deborah L. Swackhammer, Chair, EPA Science Advisory Bo ard, and Dr. Joan Rose, Chair, EPA Science Advisory Board, Drinking Water Committee, to EP A Administrator Stephen L. Johnson, at 1 (Nov. 5,2008).] Yet EPA plans to make a final determina tion whether to regulate perchlorate by December 2008.[FN29: 73 Fed. Reg. at 60281.] Conseque ntly, the SAB has expressed concern that the soundness of the dosimetric model "will not be publicly vetted."[FN30: Letter from Dr. Swackhammer & Dr. Rose, at 1.] The SAB stresses the importance of such peer review: "The quality

of the scientific foundation for EPA's decisions depends on peer review, which brings a variety of scientific perspectives to bear on critical components of EPA's decisions. Where science

assessments have been conducted with the benefit of external scrutiny, the end products have been better able to support the policy making process."[FN31: Id. at 2.7] It is critical, therefore, that EPA make the determination whether to regulate perchlor ate with the benefit of fully peer-reviewed, and publicly- scrutinized scientific analysis. Failure of EPA to do so would be arbitrary and capricious and not in accordance with the requirements of the SDWA.

Thank you for your consideration of these comments.

Ron Curry Cabinet SecretaryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 21 of 1099 cc:Governor Bill Richardson Sarah Cottrell, Office of the Governor Attorney General Gary King Stephen R. Farris, Office of the Attorney General

Response: Administrator Stephen Johnson replied to the SAB on January 9, 2009. The letter is available in EPA’s docket ID No. EPA-HQ-OW-2009 -0297 for this notice. EPA agrees with the

commenter that it is critical th at EPA make the determination whether to regulate perchlorate with the benefit of fully peer-reviewed scientific analys is, which is available to the public. This comment was received prior to EPA's peer-review process for the PBPK (dosimetric) model, which has now been completed. EPA has made this determination based on a consideration of the best available peer reviewed science and data collected in accord ance with accepted methods related to perchlorate occurrence in drinking water, the presence of perchl orate in foods, and the potential health effects of exposure to perchlorate.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20983

EPA Comment Code: 1100

Comment: BACKGROUND

In 1974, Congress enacted the federal Safe Drinking Water Act (SDWA) to protect the public health from contaminated drinking water supplies by regu lating public drinking water systems. The SDWA was amended in 1986 and 1994, and requires EPA, in ter alia, to publish national primary drinking water regulations, which must include both non-enforceable, health-based Maximum Contaminant Level Goals (MCLGs) and enforceable Maximum Contaminant Levels (MCLs).[FN7: 42 U.S.C. §300g-1(a)(1).] The MCLG must be set "at the le vel at which no known or anticipated adverse effects on the health of persons occur and which a llows for an adequate margin of safety."[FN8: 42 U.S.C. §300g-1(b)(4)(A).] In contrast, the MCL, th e maximum level of a regulated contaminant that any particular covered public water system may deliver to any user, must be set "as close to the maximum contaminant level goal as is feasible." [FN9: 42 U.S.C. §300g-1(b)(4) (B).] SDWA requires EPA to set a national primary drinking water standa rd when it determines for a contaminant that:

(i) the contaminant may have an adverse effect on the health of persons; (ii) the contaminant is

known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public heal th concern; and (iii) in the sole judgment of the Administrator, regulation of such contaminant pr esents a meaningful opportunity for health risk reduction for persons served by public water sy stems.[FN10: 42 U.S.C. §300g-1(b) (1)(A).]

SDWA also requires EPA to establish a "contaminant candidate list" (CCL) identifying a list of contaminants, not yet regulated by the Agency, which are known or anticipated to occur in drinking water and which may require regulation.[FN11: 42 U.S.C. §300g-1(b)(1)(B). ] Every five years, EPA must determine whether or not to regulate five of the contaminants that appear on the CCL.[FN12: Id.] In March, 1998, EPA's first CCL included perc hlorate, but the Agency did not choose to make any determination about whether to regulate the c ontaminant. In February, 2005, EPA announcedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 22 of 1099 its second CCL, CCL2, on which perchlorate appeared again. As a result of its status as a candidate contaminant, EPA subsequently announced this preliminary determination on perchlorate.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Gregg Grunenfelder Commenter Organization: National Drinking Water Advisory Council (NDWAC)

EPA Document ID: EPA-HQ-OW-2008-0692-2010

EPA Comment ID: 21008

EPA Comment Code: 1100

Comment: November 26, 2008

Mr. Stephen L. Johnson Administrator U.S. En vironmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington D.C. 20460

Dear Administrator Johnson:

In follow-up to EPA’s October 10, 2008 prelimin ary regulatory determination for perchlorate in drinking water, the National Drinking Water Advisory Council (NDWAC) would like to again convey to EPA the necessity for more thorough health effects research to support Safe Drinking Water Act (SDWA) related regulations. While NDWAC members do not have a consensus position to relay on the perchlorate decision itself, th e members fully support the need for a strong, scientifically valid basis upon which to make such decisions.

On June 24, 2008, the NDWAC expressed to you our recommendation for a holistic drinking water research plan that includes the needed health e ffects research for Contaminant Candidate List (CCL) contaminants. The NDWAC strongly supports the CCL process and recommends that EPA consider a refocus of research priorities in order to ensure sound health effects data are available in a timely fashion to better inform future CCL decisi on-making processes. The availability of this type of information will become increasingly important as issues such as pharmaceuticals and personal care products in drinking water contin ue to be of concern to the public.

Under the provisions of the SDWA the nation look s to EPA to set drinking water standards which are protective of the public’s health. When adequate health effects research information is lacking, important regulatory determinations can be cont roversial and potentially misguided. Lacking EPA leadership on standard setting, states can be pressed into making independent regulatory determinations. In the case of perchlorate, at least two different drinking water standards have already been set by California and Massachusetts. In addition, Congress may also be compelled to by-pass the CCL process when inadequate health e ffects data results in controversial regulatory

determinations.

Thank you for your consideration of this key r ecommendation on research needs. If you have any questions, please contact Veronica Blette, Desi gnated Federal Officer for the NDWAC, at (202)

564-4094.

Sincerely, Gregg Grunenfelder Chair National Drinking Water Advisory CouncilEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 23 of 1099 cc: Benjamin H. Grumbles, Assistant Admini strator for Water George Gray, Assistant Administrator for Research and Development Cynt hia C. Dougherty, Dir ector,Office of Ground Water and Drinking Water Ephraim King, Dir ector, Office of Science and Technology Kevin Teichman, Deputy Assistant Administrator for Research and Development EPA Docket ID No. EPA-HQ-OW-2008-0692

Response: EPA agrees that thorough health effects research can improve regulatory decisionmaking. We will continue to work with the NDWAC and other advisory groups to identify research

needs for future decisions.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21103

EPA Comment Code: 1100

Comment: Finally, should a final determination be made not to establish a NPDWR for perchlorate, EPA should also make clear that it s final determination also removes perchlorate from

the CCL3 list. Based on EPA's careful consideration of the scientific evidence, it has fully evaluated perchlorate and met its requirements under the la w. Continued consideration of perchlorate would siphon resources away from the long list of other substances and microbes on the CCL3.

X. References

American Water Works Association, 2008). Nationa l Cost Implications of a Potential Perchlorate Regulation, Jul. 2008, at 31).

Amitai Y, Winston G, Sack J, Wasser J, Lewis M, Bl ount BC, Valentin-Blasini L, Fisher N, Israeli A, Leventhal A. 2007. Gestational exposure to high pe rchlorate concentrations in drinking waer and neonatal thyroxine levels. Thyroid 17:843-850.

Blount BC, Valentin-Blasini L, Osterloh JD, Maul din JP, Pirkle JL. 2007. Perchlorate exposure of the US population, 2001-2002. J Expo Sc i Environ Epidemiol. 17(4):400-7.

Braverman LE, Pearce EN, He X, Pino S, Seeley M, Beck B, Magnani B, Blount BC, Firek A. 2006. Effects of six months of daily low-dose perc hlorate exposure on thyroid function in healthy volunteers. J Clin Endocrinol Metab. 91(7):2721-4. Epub 2006 Apr 24.

Clewell RA, Merrill EA, Gearhart JM, Robinson PJ, Sterner TR, Mattie DR, Clewell HJ 3rd. 2007. Perchlorate and radioiodide kinetics across life stag es in the human: using PBPK models to predict dosimetry and thyroid inhibition and sensitive subpopulations based on developmental stage. J

Toxicol Environ Health A 70:408-28.

Greer MA, Goodman G, Pleus RC, Greer SE. 2002 . Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 110(9):927-37 . Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 24 of 1099 Merrill EA, Clewell RA, Robinson PJ , Jarabek AM, Gearhart JM, Sterner TR, Fisher JW. 2005.

PBPK Model for Radioactive Iodide and Perchlorate Kinetics and Perchlorate-Induced Inhibition of Iodide Uptake in Humans, Toxi cological Sciences 83:25-43.

Murray CW, Egan SK, Kim H, Beru N, Bolger PM. 2008. US Food and Drug Administration's Total Diet Study: Dietary intake of perchlora te and iodine. J Expo Sci Environ Epidemiol.

National Research Council of the National Academ ies (NAS). 2005. Health Implications of Perchlorate Ingestion. Committee to Assess the Health Implications of Perchlorate Ingestion, Board on Environmental Studies and Toxicology, Division on Earth and Life Studies. Washington, D.C.:

The National Academies Press.

Tellez RT, Chacon PM, Abarca CR, Blount BC, Va n Landingham CB, Crump KS, Gibbs JP. 2005. Longterm environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal pe riod. Thyroid. 15(9):963-975.

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28793

EPA Comment Code: 1100

Comment: REGULATORY BACKGROUND

In 1974, Congress enacted the federal Safe Drinking Water Act (SDWA) to protect the public health from contaminated drinking water supplies by regu lating public drinking water systems. The SDWA was amended in 1986 and 1994, and requires EPA, in ter alia, to publish national primary drinking water regulations, which must include both non-enforceable, health-based Maximum Contaminant Level Goals (MCLGs) and enforceable Maximum Contaminant Levels (MCLs).[FN7: 42 U.S.C. [Sec] 300g-1(a)(1).] The MCLG must be set "at th e level at which no known or anticipated adverse effects on the health of persons occur and which a llows for an adequate margin of safety."[FN8: 42 U.S.C. [Sec]300g-1(b)(4)(A).] In contrast, the MC L, the maximum level of a regulated contaminant that any particular covered public water system may deliver to any user, must be set "as close to the maximum contaminant level goal as is feasib le."[FN9: 42 U.S.C. [Sec]300g-1(b)(4)(B).] SDWA requires EPA to set a national primary drinking water standard when it determines for a

contaminant that:

(i) the contaminant may have an adverse effect on the health of persons; (ii) the contaminant is

known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public heal th concern; and (iii) in the sole judgment of the Administrator, regulation of such contaminant pr esents a meaningful opportunity for health risk reduction for persons served by public water sy stems.[FN10: 42 U.S.C. [Sec] 300g-1(b)(1)(A).]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 25 of 1099 SDWA also requires EPA to establish a "contaminant candidate list" (CCL) identifying a list of contaminants, not yet regulated by the Agency, which are known or anticipated to occur in drinking water and which may require regulation.[FN11: 42 U.S.C. [Sec]300g-1(b)(1)(B).] Every five years, EPA must determine whether or not to regulate fi ve of the contaminants that appear on the CCL.[FN12: Id.]

In March, 1998, EPA's first CCL included perchl orate, but the Agency did not choose to make any determination about whether to regulate the cont aminant. In February, 2005, EPA announced its second CCL, CCL2, on which perchlorate appeared ag ain. As a result of its status as a candidate contaminant, EPA subsequently announced its pre liminary determination not to regulate perchlorate
in October, 2008.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28833

EPA Comment Code: 1100

Comment: Consideration For Future Regulations

The current regulatory framework in place in the US puts the burden on the government to show that a chemical is unsafe and must be regulated. Th is is a very slow process, which takes many years or even decades and often is done only after the presence of the specific chemical and its impacts have become well known. More importantly, the current process also lacks any incentive for chemical manufacturers to support source water pro tection, or to consider or disclose negative impacts of their products on human health and the natural environment and control the contaminants at generation points, which often would be much more economical than treating them at downstream water plants.

The issue is becoming a critical one as new analytical methods can detect ever- increasing contaminants of emerging concern at parts per trillion and below, and as potential treatment to remove them could significantly add to the financia l burden of water utilities, their energy needs and greenhouse gas emissions.

These concerns can be resolved effectively and eco nomically by a regulatory paradigm shift to put the lead responsibility where it belongs, i.e. on the generators of the contaminants. While it is not possible to address perchlorate in this way, in lig ht of the new administration's reanalysis of the science of perchlorate, AMWA encourages this admi nistration to also consider taking another look at how we can protect watersheds and drinking wa ter quality by addressing preventable problems caused by the generators of chemicals and man-made sources of pollution.

Response: Please see response to comment code 7000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 26 of 1099 

### EPA Comment Code: 1300 Length of the comment period following the

October 2008 FR Notice

Response to Comment Code 1300: A number of commenters reque sted that EPA extend the 30 day comment period for the Agency's preliminary regulatory determination for perchlorate (73 FR 60262, October 10, 2008). In response to these comments, EPA extended the comment period until November 28, 2008, which provided commenters wi th 49 days to prepare comments. EPA received comment letters from over 37,000 individuals/ or ganizations on the October 2008 Federal Register

Notice.

Individual Comments

Commenter Name: Jennifer Sass, PhD Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2008-0692-0322

EPA Comment ID: 19810

EPA Comment Code: 1300

Comment: Document ID: EPA-HQ-OW-2008-0692-EP A-HQ-OW-2008-0692-0322 Last Name: Sass, PhD First Name: Jennifer Title: Organiza tion: Natural Resources Defense Council (NRDC) City: State: Zip Code: Phone Number: Fax Number: Country Code: Email Address: Current Category Code: 302

Comment:

October 17, 2008

Docket identification (ID): EPA-HQ-OW-2008-006 92 Preliminary Regulatory Determination on

Perchlorate

Re: Request for extension of comment period.

The October 10, 2008 Federal; Register noti ce announcing EPA.s preliminary regulatory determination on perchlorate opened the public co mment period for 30 days, with comments due by November 10, 2008. Given the importance of the science on perchlorate and the exposure data, the Natural Resources Defense Council (NRDC) re spectfully requests a 60-day extension of the public comment period to January 10, 2008 (that is, 90 days from the October 10, 2008 notice).

Response: See the response to comment code 1300.

Commenter Name: Jennifer Sass, PhD Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2008-0692-0322

EPA Comment ID: 19813

EPA Comment Code: 1300EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 27 of 1099 Comment: Council (NRDC) respectfully requests a 60-day extension of the public comment period to January 10, 2008 (that is, 90 days from the October 10, 2008 notice).

EPA.s preliminary regulatory determination not to set a regulatory standard for perchlorate in drinking water could put 20 - 40 million people at ri sk for perchlorate toxicity, including infants, toddlers and pregnant women. A prop osal with such far-reaching public health implications deserves careful and thorough comments with adequate time to review and respond to EPA.s analysis.

Part of EPA.s preliminary determination relies on pe rchlorate monitoring data from the Unregulated Contaminant Monitoring Rule. The large amount of occurrence data collected over five years from almost 4000 public water systems will require additional time for NR DC and other stakeholders to review and assess, especially in light of the impor tance EPA placed on these data in the preliminary

determinations.

NRDC plans to submit public comments on this proposed determination, and a thoughtful and detailed technical response will require more than th e 30 days that has been allotted by EPA. We respectfully request the comment period be extended by 60 days.

Response: See response to comment code 1300.

Commenter Name: Anila Jacob, M.D., M.P.H. Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-0466

EPA Comment ID: 19894

EPA Comment Code: 1300

Comment: October 22, 2008

Eric Burneson Office of Ground Water and Drin king Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC

20460

Re: Request for extension of comment period for Docket Identification (ID): EPA- HQ-OW- 2008- 0692- Preliminary Regulatory Determination on Perchlorate

Dear Mr. Burneson:

EPA announced it's preliminary regulatory deter mination on perchlorate in the Federal Register notice dated October 10, 2008 and opened a publ ic comment period for 30 days, with comments due by November 10, 2008. Given the far- re aching public health implications ofEPA's determination, the Environmental Working Group (EWG) plans to thoroughly review EPA's

document and submit comments. The document that EPA has produced is 80 pages long and highly technical and EWG respectfully requests that the comment period be extended by 60 days, so comments will be due 90 days from the October 10, 2008 notice.

Response: See response to comment code 1300.

Commenter Name: Anila Jacob, M.D., M.P.H.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 28 of 1099 Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-0466

EPA Comment ID: 19895

EPA Comment Code: 1300

Comment: Perchlorate contamination of drinking water potentially affects 20 to 40 million US. residents and EPA's preliminary regulatory determination not to regulate perchlorate has serious health implication for these millions of peopl e. A thorough and detailed response to EPA's determination will require EWG scientists to pore qver EPA's document line by line in order to effectively make our argument for stringent re gulation of perchlorate in drinking water. As advocates for public health, EWG has a responsib ility to submit the strongest document to EPA

that we can and we feel that an ex tension of the public comment period by 60 days will allow us to

do that.

Thank you for your consideration. Best regards, Anila Jacob, M.D., M.P.H. Senior Scientist Environmental Working Group

Response: See the response to comment code 1300.

Commenter Name: Apparent Mass Mailing #3 Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-0561

EPA Comment ID: 19964

EPA Comment Code: 1300

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

I am writing to express my concern regarding the EPA's failure to regulate perchlorate, as well as the proposed reference level, which fails to pro tect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children.

EPA has spent a number of years researching perchl orate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and throughful public response.

We cannot afford to have this decision rushed through, in the last days of the current administration, and leaving those communities that face the greatest risk without enough time to

comment.

It takes time for public and community groups to evaluate EPA's findings, review the ever-changing scientific literature, and prepare comments.

I therefore request that the EPA extend the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 29 of 1099 Commenter Name: Apparent Mass Mailing #3 Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-0561

EPA Comment ID: 19964

EPA Comment Code: 1300

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

I am writing to express my concern regarding the EPA's failure to regulate perchlorate, as well as the proposed reference level, which fails to pro tect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children.

EPA has spent a number of years researching perchl orate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and throughful public response.

We cannot afford to have this decision rushed through, in the last days of the current administration, and leaving those communities that face the greatest risk without enough time to

comment.

It takes time for public and community groups to evaluate EPA's findings, review the ever-changing scientific literature, and prepare comments.

I therefore request that the EPA extend the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Response: No reponse necessary, duplicate comment entry.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0585

EPA Comment ID: 19968

EPA Comment Code: 1300

Comment: time to comment should be extended. i want very much to hear what environmental working group comments. i trust them more than my own government agencies. and certainly more than profiteers.

Response: See the response to comment code 1300.

Commenter Name: S. Quezada Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0596

EPA Comment ID: 19971

EPA Comment Code: 1300

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment periodEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 30 of 1099 Americans cannot afford to have a final determina tion on Perchlorate's safety rushed through in light of the high scientific controversy surrounding the matter. Therefore, I request an extension of public comments from 30 days to 90 days. This action by the EPA would be appropriate and prudent given the high scientific and academic controversy over the matter. Even the mere appearance of "rushing" is in appropriate and s hould be dispelled by providing Americans the opportunity to fully evaluate and meaningfully comment on the EPA's proposed perchlorate

determination.

The EPA has spent a number of years researching perchlorate and developing its conclusions. To now turn around and provide the American public 30 days for public comment on a complex matter is both unfair and questionable and certainly not aimed at obtaining "public comment."

Sincerely,

S. Quezada

416 Ridgeview Ave

Iowa City, Iowa 52246

Response: See the response to comment code 1300.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0629

EPA Comment ID: 19980

EPA Comment Code: 1300

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

To Whom It May Concern:

It is clear that the issue of how/whether to regula te perchlorate is not a simply resolved one. Please extend the comment period on the October 10, 2008 Preliminary Regulatory Determination on Perchlorate to at least 90 days, so that as many entities with views and knowledge of the subject as possible may have a chance to be heard. The benefits of extending seem certain to outweigh any negatives that might be involved in doing so.

Response: See the response to comment code 1300.

Commenter Name: N Henry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0637

EPA Comment ID: 19984

EPA Comment Code: 1300EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 31 of 1099 Comment: Please extend the comment period regarding perchlorate regulation. The quality of our water supply and health of our nation are serious matters, which require appropriate deliberation and

evaluation.

Thank you.

Response: See the response to comment code 1300.

Commenter Name: Lenny Siegel Commenter Organization: Center for Public Environmental Oversight

EPA Document ID: EPA-HQ-OW-2008-0692-0642

EPA Comment ID: 19985

EPA Comment Code: 1300

Comment: Attachments

EPA-HQ-OW-2008-0692-0642.1 Co mment attachment submitted by Lenny Siegel, Executive Director, Center for Public Environmental Oversight

Eric Burneson Office of Ground Water and Drinki ng Water Standards and Risk Management U.S. Environmental Protection Agency

REF: Docket ID# EPA- HQ-OW-2008-0068

Dear Sir:

I am concerned that EPA’s failure to regulate perchlorate, as well as its unprotective proposed health reference level, will adversely affect the he alth and development of hundreds of thousands, perhaps millions of American children. It has take n EPA years, with its extensive resources, to come to its conclusions. Its findings are complex and cont roversial. We cannot afford to have this decision rushed out the door, in the waning days of th e current administration, without giving impacted

communities sufficient time to comment.

Organizations that advocate for public health and environmental protection have few people with the expertise, resources, and time to evalua te EPA’s findings, review continuously emerging scientific literature, and prepare comments. I therefore call upon EPA to extend the 30-day comment period on its October 10, 2008 Prelimin ary Regulatory Determination on Perchlorate to 90 days.

Sincerely,

(submitted electronically)

Lenny Siegel Executive Director

Cc: EPA Administrator Stephen JohnsonEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 32 of 1099 Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Health Scientist, Environmental Defense Fund PUBLIC

EPA Document ID: EPA-HQ-OW-2008-0692-0649

EPA Comment ID: 19992

EPA Comment Code: 1300

Comment: October 27, 2008

Mr. Eric Burneson Office of Ground Water and Dr inking Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC20460 Re: Request for extension of comment period for Docket Identification (ID): EPA- HQOW-2008- 0692- Preliminary Regula tory Determination on Perchlorate

Dear Mr. Burneson:

On October 10, 2008, EPA published a Federal Re gister notice announcing the opening of a 30-day comment period on its preliminary regulatory d etermination on perchlorate. We have concerns regarding the proposed regulatory determination, in particular the unprecedented use of a pharmacodynamic model to justify the exceedance of the reference dose and we believe this introduces complexity into the evaluation of the standard that merits more than just 30 days for judicious scientifically-sound public comment. We therefore request that the comment period be extended by 60 days, so comments will be due 90 days from the October 10, 2008 notice, on January
10, 2009.

Thank you for considering this request.

Sincerely, Caroline Baier-Anderson, Ph.D. Health Scientist

Response: See the response to comment code 1300.

Commenter Name: Luis Olmedo Vélez Commenter Organization: Comité Cívico del Valle, Inc.

EPA Document ID: EPA-HQ-OW-2008-0692-0652

EPA Comment ID: 19995

EPA Comment Code: 1300

Comment: Among profit and non-profit organizations th at take environmental issues seriously, there are only several people who are qualified to measure and evaluate EPA’S findings and conclusions. Therefore, a 30-day comment period is far too short a time period to take action against any rulings that may be detrimental to th e water supply. We ask that the EPA extend the preliminary regulatory determination date to 90-days.

Sincerely,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 33 of 1099 Luis Olmedo Vélez Executive Director Comité Cívi co del Valle, Inc. Center for Health Education, Prevention and Advocacy

Response: See the response to comment code 1300.

Commenter Name: Steven Brittle Commenter Organization: Don't Waste Arizona

EPA Document ID: EPA-HQ-OW-2008-0692-0653

EPA Comment ID: 19996

EPA Comment Code: 1300

Comment: October 26, 2008

Eric Burneson Office of Ground Water and Drinki ng Water Standards and Risk Management U.S. Environmental Protection Agency Ariel Rios Buildin g 1200 Pennsylvania Avenue, N. W. Mail Code: 4607M Washington, DC 20460

Dear Sir:

Don’t Waste Arizona (DWAZ) is a non-profit en vironmental organization especially concerned

about toxics issues.

DWAZ is concerned that EPA's failure to regulate perchlorate, as well as its unprotective proposed health reference level, will adversely affect the he alth and development of hundreds of thousands, perhaps millions of American children, including those in Arizona. It has taken EPA years, with its
extensive resources, to come to its conclusions. Its findings are complex and controversial. We

cannot afford to have this decision rushed out the door, in the waning days of the current administration, without giving impacted co mmunities sufficient time to comment.

Organizations that advocate for public health and environmental protection have few people with the expertise, resources, and time to evalua te EPA's findings, review continuously emerging scientific literature, and prepare comments. DWAZ therefore calls upon EPA to extend the 30-day comment period on its October 10, 2008 Prelimin ary Regulatory Determination on Perchlorate to 90 days.

Sincerely,

Stephen M Brittle President Don’ t Waste Arizona 6205 South 12th Street Phoenix, AZ 85042 602-

268-6110

Cc: EPA Administrator Stephen Johnson

Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0682EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 34 of 1099 EPA Comment ID: 20023

EPA Comment Code: 1300

Comment: I request the comment period be extended for 90 days to give those a chance to review the information and offer their voice about it. re. the regulatory determination on PERCHLORATE......epa -hq--ow-2008-0692

Response: See the response to comment code 1300.

Commenter Name: Luis Olmedo Vélez Commenter Organization: Comité Cívico del Valle, Inc., Center for Health Education, Prevention and Advocacy

EPA Document ID: EPA-HQ-OW-2008-0692-0736

EPA Comment ID: 20048

EPA Comment Code: 1300

Comment: Among profit and non-profit organizations th at take environmental issues seriously, there are only several people who are qualified to measure and evaluate EPA’S findings and conclusions. Therefore, a 30-day comment period is far too short a time period to take action against any rulings that may be detrimental to th e water supply. We ask that the EPA extend the preliminary regulatory determination date to 90-days.

Sincerely,

Luis Olmedo Vélez Executive Director Comité Cívi co del Valle, Inc. Center for Health Education, Prevention and Advocacy

Response: See the response to comment code 1300.

Commenter Name: Lynn and Paul Thorp and Schwartz Commenter Organization: Clean Water Action (CWA)

EPA Document ID: EPA-HQ-OW-2008-0692-0750

EPA Comment ID: 20056

EPA Comment Code: 1300

Comment: October 28, 2008 Eric Burneson U.S. En vironmental Protection Agency Arid Rios Building 120o Pennsylvania Ave. NW Washin gton DC 20460 Re: Request for Extension of Comment Period for Preliminary Regulatory Dete rmination on Perchlorate Public Noticed October to, 2008 at 73 Fed. Reg. 60262 Docket Id entification (ID): EPA-HQ-OW-2008-00692

Dear Mr. Burneson: On behalf of our more than 1.2 million members, we request an extension of the public comment period for the Preliminary Regu latory Determination on Perchlorate of at least 60 days beyond the November to deadline, for a total extension of not less than qo days to January to, 2009. The proposed Preliminary Regulatory D etermination on Perchlorate raises complex issues which require more time to be sufficiently reviewed. Furthermore, the Determination makes conclusions which contradict those made by several states, such as Massachusetts and New Jersey,

which have reviewed the same issue and have set a drinking water standard for percblorate. The Determination raises serious implications for human health. These include the exposure toEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 35 of 1099 perchlorate by millions of Americans in their food and the adverse effects of perchlorate exposure to those most at risk, including infants, toddlers, and pregnant women. Additional time will enable us to analyze and make informed comments regardin g the Preliminary Determination. Please make this letter part of the comment record for the Preliminary Determination. Thank you for your attention to this request.

Sincerely,

Lyn Thorp National Campaign Coordinator Ext. 109

Paul Schwartz National Policy Coordinator Ext. 105

CC: Stephen Johnson, Administrator, US Environm ental Protection Agency [Via First Class Mail and Fax 202-501-1450]

Response: See the response to comment code 1300.

Commenter Name: Robin Mark Freeman Commenter Organization: Merritt College

EPA Document ID: EPA-HQ-OW-2008-0692-0662

EPA Comment ID: 20237

EPA Comment Code: 1300

Comment: Organizations that advocate for public he alth and environmental protection have few people with the expertise, resources, and time to evaluate EPA's findings, review continuously emerging scientific literature, and prepare comments. We therefore call upon EPA to extend the 30- day comment period on its October 10, 2008 Prel iminary Regulatory Determination on Perchlorate to 90 days.

Sincerely, Prof. Robin Mark Freeman, Co-Director Institute for Sustainable Policy Studies Merritt College, Oakland , CA

Cc: EPA Administrator Stephen Johnson

Response: See the response to comment code 1300.

Commenter Name: Tatjana and Jeremy Thomas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0669

EPA Comment ID: 20243

EPA Comment Code: 1300

Comment: Water Docket Environmental Protection Ag ency Mailcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 36 of 1099 Docket Identification (ID) Number: EPA- HQ-OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

I am writing to express my concern regarding the EPA's failure to regulate perchlorate, as well as the proposed reference level, which fails to protect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children.

EPA has spent a number of years researching perchl orate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and throughful public response.

We cannot afford to have this decision rushed through, in the last days of the current administration, and leaving those communities that face the greatest risk without enough time to

comment.

It takes time for public and community groups to evaluate EPA's findings, review the ever-changing scientific literature, and prepare comments.

I therefore request that the Sincerely, EPA exten d the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Sincerely,

Tatjana Thomas

Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).

Commenter Name: D. Manzullo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0676

EPA Comment ID: 20250

EPA Comment Code: 1300

Comment: Allow more time for all the appropriate researchers and scientists to comment on the harm these chemicals are doing to humans, living creatures and plant life!

Response: See the response to comment code 1300.

Commenter Name: S. Smolen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0679

EPA Comment ID: 20255

EPA Comment Code: 1300

Comment: Because the decision of whether or not to implement a national maximum contaminant level is so important and far reaching, I respectf ully request that the EPA extend the comment period to 90+ days (an additional 60 days past th e current deadline of November 10th) in order toEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 37 of 1099 allow groups wishing to submit comments on the d ecision sufficient time to review and respond to the evidence supporting the EPA's position.

Sincerely,

Stephanie Smolen Former San Gabriel Valley resident EPA Region 9, Superfund Areas 1 & 2,

California EPA ID#’s CAD980677355 & CAD980818512 respectively

Response: See the response to comment code 1300.

Commenter Name: Kathy M. Kinsey Commenter Organization: Maryland Department of the Environment

EPA Document ID: EPA-HQ-OW-2008-0692-1421

EPA Comment ID: 20426

EPA Comment Code: 1300

Comment: Kathy M. Kinsey Senior Policy Advisor Mary land Department of the Environment 410- 537-3897 kkinsey@mde.state.md.us Re: Docket ID No. EPA-HQ-OW-2008-0692 Comments on
Perchlorate Determination November 7, 2008

The Maryland Department of the Environment ("Department") submits the following comments on EPA's preliminary regulatory determination on perchlorate.

Request for Extension of the Public Comment Period

As a preliminary matter, the Department request s that EPA extend the public comment period. EPA's preliminary determination not to set a regulato ry standard for perchlorate in drinking water has serious public health implications for the millions of people potentially exposed to perchlorate through public drinking water systems. EPA's d etermination was based on an analysis of highly complex data and an unprecedented application of published models with adjustments that have not undergone peer review. A thorough and thoughtf ul review of EPA's analysis and preliminary determination requires more than the 30 days curre ntly allotted by EPA. The Department, therefore, requests that EPA extend the public comment period by a minimum of 60 days beyond the current November 10, 2008 deadline for submitting comments.

Response: See the response to comment code 1300.

Commenter Name: Kathy M. Kinsey Commenter Organization: Maryland Department of the Environment

EPA Document ID: EPA-HQ-OW-2008-0692-1421

EPA Comment ID: 20429

EPA Comment Code: 1300

Comment: For the foregoing reasons, the Departme nt urges EPA to both extend the public comment period on its preliminary determination by an additional 60 days beyond the current
November 10, 2008 deadline, and set a federal drinking water standard for perchlorate.

Response: See the response to comment code 1300.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 38 of 1099 Commenter Name: Vicky and Bll Clary Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0622

EPA Comment ID: 20465

EPA Comment Code: 1300

Comment: EPA has spent a number of years resear ching perchlorate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and throughful public response.

We cannot afford to have this decision rushed through, in the last days of the current administration, and leaving those communities that face the greatest risk without enough time to comment. Every American affected should have a voi ce in this issue and it shouldn't be decided by the military or pushed through before we are all given a chance to comment or even to become aware of the problem.

It takes time for public and community groups to evaluate EPA's findings, review the ever-changing scientific literature, and prepare comments.

I therefore request that the EPA extend the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Sincerely,

Vicky and Bll Clary

Response: See the response to comment code 1300.

Commenter Name: Nancy Yoke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0621

EPA Comment ID: 20560

EPA Comment Code: 1300

Comment: I am writing to express my concern regarding the EPA's failure to regulate perchlorate, as well as the proposed reference level, which fails to protect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children.

EPA has spent a number of years researching perchl orate and developing its conclusions - which are considered highly controversial and complex. They require, therefore, the time for measured and throughful public response.

We cannot afford to have this decision rushed through, in the last days of the current administration, and leaving those communities that face the greatest risk without enough time to

comment.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 39 of 1099 It takes time for public and community groups to evaluate EPA's findings, review the ever-changing scientific literature, and prepare comments.

I therefore request that the EPA extend the 30-day comment period on its October 10, 2008 Preliminary Regulatory Determination on Perchlorate to 90 days.

Sincerely,

Nancy Yoke

Response: See the response to comment code 1300. EP A plans to initiate the process of proposing a national primary drinking water regulation for pe rchlorate (see response to comment code 6120).

Commenter Name: Caroline Baier-Anderson Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1534

EPA Comment ID: 20637

EPA Comment Code: 1300

Comment: November 13, 2008

Mr. Eric Burneson Office of Ground Water and Dr inking Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC

20460

Re: Second request for extension of comment period for Preliminary Regulatory Determination on Perchlorate, Docket ID EPA-HQ-OW-2008-0692

Dear Mr. Burneson:

On October 10, 2008, EPA published a Federal Re gister notice announcing the opening of a 30-day comment period on its preliminary regulatory determination on perchlorate and on October 27th we submitted to the docket a letter requesting that th e comment period be extended for 60 days (EPAHQ- OW-2008-0692-0649). On November 7, EDF was notified by telephone that the comment period has been extended only 18 days, until November 28, 2008, but that the notice for this

extension would not be entered into the Federal Re gister until Wednesday, November 12, two days

after the initial deadline for comments.

We believe that this extension is inadequate, for the following reasons:

1. As noted in our previous letter, the Preliminary Regulatory Determination on Perchlorate is based on the virtually unprecedented use of a pharmacodyn amic model developed by industry to justify

the exceedance of the reference dose. This model and its novel application introduce significant complexity into the evaluation of the standard, which merits more than just 30 days for judicious scientifically-sound public comment.

2. Providing only an 18-day extension to this comm ent period is far shorter than and hence not consistent with other extensions EPA has granted. For example:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 40 of 1099 * Three extensions were made to th e comment period for the "Draft Li st of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act", consisting of 60 days, 45 days, and 42 days, for a total of 147 days (EPA-HQ-OPPT2004-0109; FRL-8346-5).

* The comment period for the re-registration of Chloropicrin, Dazomet, Metam Sodium/Potassium, and Methyl Bromide was extended for 45 days (EPA-HQ- OPP-2008-0518; FRL-8380-5).

* The comment period for the "Proposed Rule for Standards of Performance for Portland Cement Plants" was also extended by 45 days (E PA-HQ-OAR-2008-0260; FRL-8703-2).

3. Since presumably you could only contact those commenters whom you knew or anticipated were planning to submit comments, the failure to post the notice of the extension in a timely manner placed any commenters not known to you at a significant disadvantage. (An incorrect docket number published in the initial notice also likely serves to further confuse and delay commenters.)

We therefore reiterate our request that the commen t period be extended by at least 60 days, with comments due no earlier than 90 days from the October 10, 2008 notice, or January 10, 2009. We consider this request to be both reasonable and justified by the complexity of and importance of the decision. It is also more in line with other extensions the Agency has granted.

We request a reply at your earliest convenience.

Thank you again for your consideration.

Sincerely,

Caroline Baier-Anderson, Ph.D. Health Scientist

Response: EPA considered this request for a second extension beyond the revised November 28, 2008 extension but concluded that a further extension beyond the 49 days provided was not needed for commenters to consider the information in the 1 page Federal Register Notice and would unnecessarily delay decision making.

Commenter Name: Deborah Swackhamer Commenter Organization: Science Advisory Board

EPA Document ID: EPA-HQ-OW-2008-0692-1749

EPA Comment ID: 20660

EPA Comment Code: 1300

Comment: As you know, the SAB operates under the requirements of the Federal Advisory Committee Act for advance notice of public meeting s. Therefore, the SAB will not be able to provide you with our comments regarding the scientific basis of this determination in time to meet the Agency’s deadline of November 10, 2008. Acco rdingly, the SAB urges the Agency to consider extending the public comment period thereby a llowing us to provide comments for the Agency’s consideration in making the final regulatory deter mination on perchlorate. Thank you in advance for your consideration.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 41 of 1099 Sincerely,

/Signed/ Dr. Deborah L. Swackhamer, Chair Science Advisory Board

/Signed/ Dr. Joan Rose, Chair SAB Drinking Water Committee

cc: Marcus Peacock, Deputy Administrator Ben Grumbl es, Assistant Administrator, Office of Water Cynthia Dougherty, Office of Water

Response: Administrator Stephen Johnson replied to the SAB on January 9, 2009. The letter is

available in EPA’s docket ID No. EP A-HQ-OW-2009-0297 for this notice

Commenter Name: S. Quezada Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1840

EPA Comment ID: 20729

EPA Comment Code: 1300

Comment: October 24, 2008 Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460

Docket Identification (ID) Number: EPA- HQ-OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

Americans cannot afford to have a final determina tion on perchlorate's safety rushed through in light of the high scientific controversy surrounding the matter. Therefore, I request an extension of public comments from 30 days to 90 days. This extension would be appropriate and prudent given the high scientific and academic controversy over the matter. Even the mere appearance of "rushing" to a final determination is inappropriate and should be dispelled by providing Americans the opportunity to fully evaluate and meaningfully comment on the EPA's proposed action.

The EPA has spent a number of years researching perchlorate and developing its conclusions. To now, turn around and provide the American public 30 days for public comment on a complex matter is both unfair and questionable as to whet her the EPA truly seeks to obtain the public's comments (to which the EPA must articulate a ra tional response in its final adoption of any perchlorate's final determination).

Sincerely, S. Quezada 416 Ridgevi ew Ave Iowa City, Iowa 52246

Response: See the response to comment code 1300.

Commenter Name: Andrew E. Stevenson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1878

EPA Comment ID: 20766

EPA Comment Code: 1300EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 42 of 1099 Comment: Please extend the public comment for this important environmental issue, in order to give the citizens of our country time to weigh in on this.

Sincerely yours, Andrew E. Stevenson 311-A Ea st Bellefonte Ave. Alexandria, VA 22301

Response: See the response to comment code 1300.

Commenter Name: Mary Moore Commenter Organization: Lindon Park Neighborhood Association (LPNA)

EPA Document ID: EPA-HQ-OW-2008-0692-2002

EPA Comment ID: 20833

EPA Comment Code: 1300

Comment: U.S. Environmental Protection Agency O ffice of Water Docket (Mail Code: 2822T) 1200 Pennsylvania Ave., NW Washington, DC 20460

Ref: Docket EPA-HQ-OW-2008-068 Drinking Water: Preliminar y Regulatory Determination on

Perchlorate

To Whom It May Concern:

The Lindon Park Neighborhood Association (LPNA) respectfully requests that EPA extend the public comment period for 60 days to allow sufficient time for a thorough review of the documents used by EPA in reaching the preliminary determi nation not to issue a national primary drinking water regulation.

Response: See the response to comment code 1300.

Commenter Name: D'Lanie Blaze Commenter Organization: TheAeroSpace

EPA Document ID: EPA-HQ-OW-2008-0692-0641

EPA Comment ID: 20892

EPA Comment Code: 1300

Comment: It the EPA is indeed motivated by an ethica l commitment to safety, it will recognize the error in this decision. It will also facilitate pub lic awareness and extend an obvious invitation to take part in this process, recognizing that 90+ days is required for the public to exercise this right in an informed capacity.

Sincerely,

D'Lanie Blaze Mission Control : TheAeroSpace IGNITE YOUR INTELLECT : CONNECT!

http://www.TheAeroSpace.org

Links of Interest : SSFLEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 43 of 1099 http://www.ACMELA.org http://www.Rocketdyn eArchives.com http://www.dtsc-ssfl.com/ http://www.CleanUpRocketdyne.org h ttp://www.CommitteeToBridgeTheGap.org

Response: See the response to comment code 1300.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20918

EPA Comment Code: 1300

Comment: In light of the extremely short initial public comment period of 30 days and the complexity of the EPA assessment, EWG and other environmental groups requested a 60- day extension of the comment period. On November 10th, EPA granted an 18-day extension to the initial comment period. EWG respectfully requests that the 60- day extension that we had initially requested be granted to allow for a more thorough review of EPA’s assessment.

Response: See the response to comment code 1300.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20930

EPA Comment Code: 1300

Comment: November 26, 2008

Stephen L. Johnson Administrator United Sta tes Environmental Protection Agency c/o Water Docket Mailcode 2822T 1200 Pennsylvani a, N.W. Washington, D.C. 20460

Re:Comments on Preliminary Regulatory Determi nation on Perchlorate Docket ID No. EPA-HQOW-2008-0692

Dear Administrator Johnson:

By this letter I am submitting the comments of the New Mexico Environment Department on the Preliminary Determination on Perchlorate that the United States Environmental Protection Agency (EPA) issued on October 3, 2008. 73 Fed. Reg. 60262 (Oct.10, 2008). Although EPA initially requested comments by November 10, 2008, the ag ency subsequently extended the comment period through November 28, 2008. 73 Fed. Reg. 6689 5 (Nov. 12, 2008). The Environment Department appreciates the opportunity to comment on this impor tant regulatory decision, and the extension of

time to submit these comments.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 44 of 1099 EPA Comment ID: 21091

EPA Comment Code: 1300

Comment: II. The EPA Should Publish its Fina l Determination as Soon as Possible

In the Federal Register notice, EPA has set a timeline for public comment, a final decision, and the possible decision to set a Health Advisory (HA). EP A's timeline for a final determination is wise for two principal reasons. First, the 45-day period provides ample time for the public to review EPA

documents and submit comments as EPA has offere d substantial opportunities for public comment on this matter. EPA previously provided a 60-day public comment period on the Contaminant Candidate List 2 (CCL) preliminary regulatory d eterminations for 11 chemicals issued May 1, 2007 via publication in the Federal Register as well as on its website.[FN1: 72 Fed. Reg. 24016 (2007) (published May 1, 2007).] In that publication, EPA also extended the opportunity to the public to comment on perchlorate. The PSG and other orga nizations commented extensively on that notice. EPA, indicating it was not issuing a determination at that time, discussed th e various scientific and technical data being reviewed and considered by the agency, including the National Academy of Sciences (NAS) report, the Unregulated Contaminan t Monitoring Rule 1 (UCMR) occurrence data, and options to use data to establish the rela tive source contribution (RSC). The agency also identified options for potential methodologies that could be employed to make a determination, including the option of using the NHANES and UCMR 1 data. EPA has selected that approach as its basis for its preliminary determination. Thus EP A has offered the public multiple opportunities for public comment, more than most substances on the CCL for which EPA has made a

determination.

Response: See the response to comment code 1300.

Commenter Name: Teresa Jordan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2086

EPA Comment ID: 21109

EPA Comment Code: 1300

Comment: Mr. Grumbles and Mr. Burneson, I thank the USEPA, and persons who may have made the request, for extending the public comment peri od. I had not written sooner because I have had my hands full adressing: California State Water Resources Control Board water issues, the Los Angeles Regional Water Quality Control Board's Ba sin Plan Triennial Review, the California 2009 Water Plan Update (Initial, Working, and Pre-Ad ministrative Draft Plans for the South Coast Hydrologic Region-Ventura and Los Angeles Countie s), and Alaska's Seafood Processors general

NPDES Permit.

Sincerely,

Mrs. Teresa Jordan

[see attachments Docket ID EP A-HQ-OW-208-0692-2086]

Response: No response necessary to the information provided by the commenter.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 45 of 1099 

### EPA Comment Code: 1500 EPA's handling of comments on the October 2008

FR Notice

Individual Comments

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28858

EPA Comment Code: 1500

Comment: Docket ID No. EPA-HQ-OW-2009-0297 Drin king Water: Perchlorate Supplemental Request for Comments. U.S. Envi ronmental Protection Agency.

The Massachusetts Department of Environmental Protection Office of Research and Standards is pleased to provide the attached comments regarding the U.S. Environmental Protection Agency's (EPA) decision to reconsider its approach to anal yzing scientific data re lated to perchlorate in drinking water. The Wednesday, August 19, 20 09 Federal Register announcement includes a summary of the major comments EPA received regarding its October 10, 2008 preliminary regulatory determination to not regulate perchlorat e in drinking water. This includes comments on why the proposed 15 ppb health advisory is not protective of children's health. These comments provide a strong basis for EPA's appropriate decision to consider a broader range of alternatives for interpreting the health data, the level of health c oncern, the frequency of occurrence of perchlorate in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard. The Commonwealth of Massachusetts' Department of Environmental Protection (MassDEP) is pleased to provide comments on seve ral of the issues that are the focus of this Federal Register announcement and is available to further consult with you or answer any questions you may have on our comments. Our comments ar e organized by issues described in specific sections of the Federal Register and are detailed in the attachment. Thank you.

Attachment

September 17, 2009

Docket ID No. EPA-HQ-OW-2009-02 97 Drinking Water: Perchlorate Supplemental Request for Comments U.S. Environmental Protection Agency

We highly commend the U.S. Environmental Pro tection Agency's (EPA) decision to reconsider its approach to analyzing scientific data related to perchlorate in drinking water. The Wednesday, August 19, 2009 Federal Register announcement in cludes a summary of the major comments EPA received regarding its October 10, 2008 prelimin ary regulatory determination to not regulate perchlorate in drinking water. This includes co mments on why the proposed 15 ppb health advisory is not protective of children's health. These comm ents provide a strong basis for EPA's appropriate decision to consider a broader range of alternative s for interpreting the health data, the level of health concern, the frequency of occurrence of perchlorate in drinking water, and the opportunity for health risk reduction through a national primar y drinking water standard. The Commonwealth ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 46 of 1099 Massachusetts' Department of Environmental Protection (MassDEP) is pleased to provide

comments on several of the issues that are the foc us of this Federal Register announcement and is available to further consult with you or answer any questions you may have on our comments. Our comments are organized by issues described in specific sections of the Federal Register.

Response: No response is necessary to the info rmation provided by the commenter.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 47 of 1099 

### EPA Comment Code: 1600 Length of th e comment period following August

2009 FR Notice

Response to Comment Code 1600: A number of commenters requested an extension to EPA's 30 day comment period on the Agency 's August 19, 2009 Federal Register Notice (74 FR 41883, August 19, 2009). In response to these request s, the Agency extended the comment period until October 8, 2009, thereby providing commenters with 51 days to review the information contained in the Federal Register Notice and prepare comme nts. EPA received comment letters from over 6,000 individuals and organizations on the Aug ust 19, 2009 Federal Register Notice.

Individual Comments

Commenter Name: David L. Thomas Commenter Organization: National Sorghum Producers

EPA Document ID: EPA-HQ-OW-2009-0297-0336

EPA Comment ID: 28447

EPA Comment Code: 1600

Comment: September 14, 2009

Eric Burneson Office of Ground Water and Drin king Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC

20460

Re: Request for extension of comment period fo r Docket Identification (ID) EPA- HQ-OW-2008- 0692-Perchlorate Supplementa l Request for Comments

Dear Mr. Burneson,

In the Federal Register on August 19, 2009, EP A published a notice seeking comments under a 30 day public comment period on "additional approaches available for analyzing data related to EPA's perchlorate regulatory determination."

The sorghum industry has been using the chemical perchlorate for many years. It is essential to producers because it aids in the dry down process and allows crops to be harvested properly without

additional moisture.

Even though perchlorate is naturally occurring, EP A states in the August 19, 2009 Federal Register

notice that the "additional alternatives under consideration could result in health reference levels

which are much lower than the level identified in the October 2008 notice."

Since the public comments collected under this Federal register could have serious affects on sorghum producers, the National Sorghum Produ cers asks that EPA establish the appropriate science based methodology before proceeding with a regulatory determination. EPA has raised a number of complicated scientific issues in th is Federal Register notice that will impact ourEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 48 of 1099 producers. On their behalf, we are requesting that the comment period be extended by 60 days to allow for a more thorough analysis of the issues raised.

Thank you for your consideration.

Sincerely, David L. Thomas

Response: See response to comment code 1600.

Commenter Name: Larry Cummings Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2009-0297-0417

EPA Comment ID: 28471

EPA Comment Code: 1600

Comment: The Perchlorate Study Group acknowledges that EPA has placed a notice on their website granting a 15-day extension to the co mment period for Docket EPA-HQ- OW-2009-0297 and intends to submit detailed comments by the conclusion of the extension.

September 18, 2009

U.S. Environmental Protection Agency O ffice of Water Docket (Mailcode 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Comments in Response to EPA Drinking Water: Perchlorate Supplemental Request for Comments [EPA-HQ-OW-2009-0297]

The Perchlorate Study Group (PSG) acknowledges that EPA has posted on its website a statement that the comment period for Docket EPA-HQ-OW- 2009-0297 has been extended for a period of 15 days. This action will allow us to submit more detailed responses to the questions that have been raised in the August 19 "Drinking Water: Perc hlorate Supplemental Request for Comments" for EPA's consideration. We look forward to receiving formal notice of this action next week and will submit our comments by the 15-day closing date prov ided in the Federal Register notice announcing the extension of the comment period.

We welcome the opportunity to meet wi th EPA staff to explain our position in greater detail. Please feel free to contact me at 3883 Howard Hughes Parkway, Suite 700, Las Vegas, NV 89169.

Sincerely, Larry Cummings Chairman Perchlorate Study Group

Response: No response necessary to the information provided by the commenter.

Commenter Name: Stephen Haterius Commenter Organization: The National Association of State Departments of Agriculture (NASDA)

EPA Document ID: EPA-HQ-OW-2009-0297-0500

EPA Comment ID: 28484

EPA Comment Code: 1600EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 49 of 1099 Comment: Please see the attached letter to Assi stant Administrator Silva from the National Association of State Departments of Agricultur e requesting a 30-day extension of the comment period in response to EPA's supplemental request for comments on perchlorate.

Attachment

September 18, 2009

The Honorable Peter S. Silva Assistant Administrator for Water U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Perchlorate Supplemental Request for Comme nts (Docket ID No. EPA-HQ- OW-2009-0297)

Dear Assistant Administrator Silva:

The National Association of State Departments of Agriculture (NASDA) respectfully requests a 30- day extension of the public comment period for the supplemental request for comments on perchlorate so that state regulators, as well as impacted sectors of our nation’s agriculture economy, have an appropriate opportunity to review the a pproach EPA has taken in its evaluation of perchlorate.

NASDA represents the commissioners, secretaries, and directors of the state departments of agriculture in all fifty states and four U.S. terri tories. NASDA'S members are responsible for a wide range of public health programs from food safety to combating the spread of disease. Moreover, as co-regulators with EPA, NASDA’s members ar e the lead state agencies responsible for administering, implementing and enforcing the laws regulating the production, labeling, distribution, sale, use and disposal of pesticides. This br oad range of responsibilities gives our members a significant basis of relevant expertise in respond ing to the request for comment in the August 19, 2009 Federal Register.

We are concerned that the approaches EPA describe d in the August 19, 2009 Federal Register are a significant departure from the traditional met hods by which EPA has analyzed scientific and technical data. Previous opportunities for public comment on the traditional approaches for analyzing data related to perchlorate have allowed for comments periods of up to 60 days. In light of this, and because the approaches detailed in the Aug ust 19, 2009 Federal Register differ significantly from those used for perchlorate and other Contam inant Candidates, an additional 30 days is

necessary.

Response: See response to comment code 1600.

Commenter Name: Stephen Haterius Commenter Organization: National Association of State De partments of Agriculture (NASDA)

EPA Document ID: EPA-HQ-OW-2009-0297-0664

EPA Comment ID: 28547

EPA Comment Code: 1600

Comment: October 8, 2009EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 50 of 1099 Water Docket U.S. Environmental Protection Agen cy Mailcode: 2922T 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Perchlorate Supplemental Request for Comme nts (Docket ID No. EPA-HQ-OW-2009-0297)

Dir Sir/Madam:

The National Association of State Department s of Agriculture (NASDA) represents the
commissioners, secretaries, and directors of the state de partments of agriculture in all fifty states and four U.S. territories. NASDA'S members are responsib le for a wide range of public health programs from food safety to combating the spread of disease. Moreover, as co-regulators with the Environmental Protection Agency (EPA), NASD A's members are the lead state agencies responsible for administering, implementing and enforcing the laws regulating the production, labeling, distribution, sale, use and disposal of pesticides.

This broad range of responsibilities gives our member s a significant basis of relevant expertise in responding to EPA's August 19, 2009 request for comment on alternative appr oaches to interpreting data related to EPA's earlier regulatory deter mination for perchlorate in drinking water. The comments NASDA is submitting today are in tended to supplement comments submitted on September 18, 2009 in which NASDA requested addi tional time to review the approaches outlined by EPA.

Response: No response necessary to the information provided by the commenter.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 51 of 1099 

### EPA Comment Code: 2000 Perc hlorate Health Effects

Response to Comment Code 2000: EPA used the January 2005 National Research Council (NRC) study “Health Implications of Perchlorate Ingestion, ” a review of the state of the science regarding potential adverse health effects of perchlorate ex posure and mode of action for perchlorate toxicity (NRC, 2005) in developing this regulatory determination. The NRC recommended that EPA use

data from the Greer et al. (2002) human clinical study as the basis for deriving a reference dose for perchlorate (NRC, 2005). Although the NRC committee concluded that hypothyroidism is the first adverse effect in the continuum of effects of pe rchlorate exposure, NRC recommended that “the most health-protective and scientifically valid a pproach” was to base the perchlorate RfD on the inhibition of iodide uptake by the thyroid, wh ich the NRC considered a non-adverse effect (NRC, 2005). The NRC recommended that EPA apply an in traspecies uncertainty factor of 10 to the no observed effect level (NOEL) 1 , to account for differences in sensitivity between the healthy adults in

the Greer et al., (2002) study and the most sensitive popu lation, fetuses of pregnant women who might have hypothyroidism or iodide deficiency. They viewed this as conservative and protective of health given that the NOEL is based on a non-ad verse effect (iodide uptake inhibition), which precedes the adverse effect in a continuum of po ssible effects of perchlorate exposure. The NRC also noted that “any decrease (in thyroid hormone) is potentially more likely to have adverse effects in sensitive populations (people with thyroid diso rders, pregnant women, fetuses, and infants). EPA’s Integrated Risk Information System (IRIS) adopted the NRC’s recommendations resulting in

an RfD of 0.7 μ g/kg/day (USEPA, 2005b).

Individual Comments

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0469

EPA Comment ID: 19898

EPA Comment Code: 2000

Comment: I think you should regulate perchlorate in dr inking water unless you know the following:

1. That perchlorate and thiocyanate don't have a sy nergistic effect within the thyroid by virtue of perchlorate inhibiting the conversion of thiocyanate to sulfate within the thyroid. Such an effect would increase the level of toxic sulfite in the thyroid. EPA chemist Ed Urbanski told me the EPA considered molybdenum co-factor enzymes, and pe rhaps subunits of those enzymes (sulfite oxidase

is a subunit of nitrate reductas e) to be perchlorate targets.

2. That adhesion of perchlorate to albumin and similar proteins in the blood and skin, which occurs

in the blood before inhibition of the sodium io dide symporter and continues in the skin after perchlorate is cleared from the blood and thyroid, never forms a hapten that triggers an autoimmune reaction similar to iododerma and bromoderma. This seemed pertinent to Burleson's skin contact

1 No observed effect level (NOEL) - an exposure level at wh ich there are no statistically or biologically significant increases in the frequency or severity of any effect be tween the exposed population an d its appropriate control.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 52 of 1099 sensitivity data in the 2002 external peer review, but there was no discussion of these traits of chaotropic salts in the EPA evaluation.

3. That perchlorate doesn't inhibit the effectiveness of defensin at its positively-charged 6-cysteine structure. Such an effect may help explain the ap lastic anemia reported from medicinal doses of perchlorate by promoting infection by B-19 parvov irus. B-19 parvovirus is also associated with thyroid autoimmunity and thyroid cancer.

4. That pendrin is not the primary means of excreting perchlorate from the kidneys. If pendrin is the primary means of excreting perchlorate, then persons in a state of acidosis or low blood bicarbonate would retain perchlorate and be more vulnerable to its effects. Premature infants, infants with diarrhea, smokers, and adults with poorly managed diabetes in particular fit in this category of patient.

5. That extra-thyroidal sodium iodide symporter in the salivary glands, bronchial epithelium, gastric mucosa,and elsewhere in the body is not more sensit ive to perchlorate than thyroidal sodium iodidesymporter in the thyroid that is upregulated by TSH. Interference with proper function of nonthyroidal NIS may promote increased nitrosation in the gastric fluid, insufficient thiocyanate supply for myeloperoxidase, and gastrin imbalance. The function of NIS in the gastrointestinal tract was totally ignored in the EPA's decision not to regulate -- not a single GI tract specialist was consulted.

Response: EPA agrees with the commenter that the Agency should regulate perchlorate. On August 19, 2009, EPA published a Federal Re gister notice requesting supplemental public comments on its preliminary determination not to re gulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this Aug ust 19, 2009 Federal Register notice, EPA requested comments on additional interpretation of data on th e level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard. EPA has c onsidered and discusses in this Federal Register

notice the results of current scientific literature on potential adverse biological effects, in the process of evaluating the adverse human health effects of perchlorate. The Agency analyzed the additional
information, and EPA has determined that a na tional primary drinking water regulation for perchlorate would present a meaningful opportunity fo r health risk reduction for persons served by public water systems.

Commenter Name: M. Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0937

EPA Comment ID: 20148

EPA Comment Code: 2000

Comment: Please review your decision regarding perc hlorate regulation in water. The extremely high oxidizing potential of perchlorates produ ces radical species in water which have been determined as causing health problems - hydroxyl radicals, oxychlorides and the potential to form

tri- and bi- halomethanes. The harsh effects of even low concentrations of highly oxidizing reactive species on organic tissues has not been fully studie d and evaluated, yet their typical impacts have been determined to mutate and react to damage biological life forms.

Response: Please see the response to comment ID 19898 under comment code 2000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 53 of 1099 Commenter Name: Gail Charnley Commenter Organization: HealthRisk Strategies

EPA Document ID: EPA-HQ-OW-2008-0692-1073

EPA Comment ID: 20205

EPA Comment Code: 2000

Comment: RE: Docket ID No. EPA-HQ-OW-2008-006 8 Comments on the US Environmental Protection Agency’s Preliminary Regulatory Deter mination on Perchlorate November 5, 2008

Thank you for the opportunity to comment on the USEPA Office of Water’s Preliminary Regulatory Determination on Perchlorate. My comme nts address the relative sensitivities of the mammary and thyroid glands to the iodine-uptak e- inhibiting effects of perchlorate and the implications that difference has for perchlorate’s re ference dose (RfD). In short, scientific evidence indicates that the thyroid gland is 10 times more sensitive to the effects of perchlorate than the mammary gland; the 10X uncertainty factor currently incorporated into the RfD is thus protective not only of pregnant women but of nursing infants as well.

EPA’s current RfD for perchlorate is, of course, ba sed on perchlorate’s ability to inhibit the thyroid gland’s uptake of iodide by competing for the sodium (Na+)/iodide (I?) symporter (NIS), the protein responsible for transporting iodide into the thyroid gland for the purpose of synthesizing thyroid hormones. Because iodide uptake does not constitute an adverse effect itself, its choice as the basis for the RfD is health-protective. Insufficient iodide can result ultimately in changes in thyroid hormone levels, although normally such ch anges are compensated for. Insufficient thyroid hormone levels can impair normal fetal growth and development. Although studies have not specifically demonstrated adverse effects in child ren attributable to perchlorate,(1) the adverse

effects of insufficient iodide are well known.

Because the perchlorate RfD was based on a study pe rformed using healthy adults, it incorporates a 10X uncertainty factor to protect the most sensitiv e population the fetuses of pregnant women who might have hypothyroidism or iodide deficiency.(1) Iodide deficiency among pregnant women in the US is apparently not uncommon.(2)

Recent concern about the adequacy of perchlora te’s RfD has focused on the results of studies demonstrating the presence of perchlorate in human m ilk at higher concentrations than in serum,(3) potentially posing a disproportionate risk to nursing infants. Although higher concentrations of milk perchlorate have not been associated with reduced milk iodide concentrations,(3) its presence in milk has led some to suggest that an additional un certainty factor of 10 is needed to protect nursing infants.(4) An additional uncertainty factor of 10 is unnecessary, however, because the current RfD already protects nursing infants.

The current RfD protects nursing in fants because the potency of perchlorate as an iodide uptake inhibitor has been shown to be ten times weaker for the mammary gland than for the thyroid gland.(5,6) In other words, it would take ten times as much perchlorate exposure to inhibit mammary iodide uptake to the same extent as thyroid iodide uptake. There are two possible explanations for the difference: the mammary NIS is simply different and less easily inhibited compared to the thyroid NIS, or there are two mechanisms by which the mammary gland takes up iodide and the non-NIS mechanism compensates in pa rt for the NIS when the latter is inhibited.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 54 of 1099 There is no evidence supporting or refuting the firs t explanation but there is evidence supporting the second.(6)

The second mechanism by which the mammary gland obtains iodide is through the pendrin-iodide transporter.(7) When thyroid iodide uptake is inhibi ted, serum levels increase significantly, making more iodide available to the mammary gland (or placenta) and allowing the non-NIS mammary gland processes to help protect th e newborn against inhibition.(8)

Thus because the mammary gland is ten times less sensitive to iodide uptake inhibition by perchlorate compared to the thyroid gland due to the presence of an iodide uptake mechanism that is not only unaffected by perchlorate but compensates for its effects, the current perchlorate RfD of 0.7 Âμg/kg/day is adequate to protect nursing n ewborns and an additional uncertainty factor is not

needed.

I would be happy to provide further information upon request.

CITATIONS

(1) National Academy of Sciences/National Rese arch Council (2005). Health Implications of Perchlorate Ingestion. National Academy Press. Washington, DC

(2) Caldwell KL, Jones R, Hollowell JG (2005). Ur inary iodine concentration: United States.

National Health And Nutrition Ex amination Survey 2001-2002.

Thyroid 15:692-699

(3) Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin- Blasini L, Braverman LE (2007). Breast milk iodine and perc hlorate concentrations in lactating Boston-area women. Journal of Clinical Endocrinology an d Metabolism 92:1673-1677; Kirk AB, Dyke JV, Martin CF, Dasgupta PK (2007). Temporal patterns in perchlorate, thiocyanate, and iodide excretion in human milk. Environmental Health Perspectives 115:182-186

(4) Ginsberg GL, Hattis DB, Zoeller RT, Rice DC (2007). Evaluation of the U.S. EPA/OSWER Preliminary Remediation Goal (PRG) for perchlor ate in groundwater: Focus on exposure to nursing

infants. Environmental Health Perspectives 115:361-369

(5) Tonacchera M, Pinchera A, Dimida A, Ferrarini E, Agretti P, Vitti P, Santini F, Crump K, Gibbs J (2004). Relative potencies and additivity of perc hlorate,thiocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the human sodium iodide symporter. Thyroid 14:1012- 1019; De Groef B, Decallonne BR, Van der Geyten S, Darras VM, Bouillon R (2006). Perchlorate versus other environmental sodium/iodide symporte r inhibitors: potential thyroid-related health effects. European Journal of Endocrinology 155:17-25

(6) Potter GD, Tong W, Chaikoff IL (1959). The m etabolism of 131I-labeled iodine, thyroxine, and triiodothyronine in the mammary gland of the lactati ng rat. Journal of Biological Chemistry 234:350- 355; Dasgupta PK, Kirk AB, Dyke JV, Ohira S-I (2008). Intake of iodine and perchlorate and excretion in human milk. Environmental Science & Technology 42:8115-8121EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 55 of 1099 (7) Rillema JA, Hill MA (2003). Prolactin regulation of the pendrin-iodide transporter in the mammary gland. American Journal of Physiolo gy, Endocrinology, & Metabolism 284:E25-E28

(8) Clewell RA, Merrill EA, Gearhart JM, Robinson PJ, Sterner TR, Mattie DR, Clewell HJ (2007). Perchlorate and radioiodide kinetics across life stag es in the human: Using PBPK models to predict dosimetry and thyroid inhibition and sensitiv e subpopulations based on developmental stage. Journal of Toxicology and Environmental Health, Part A 70:408-428

Response: Please see the response to comment ID 28863 under comment code 2110 and response

to comment code 2000.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20943

EPA Comment Code: 2000

Comment: Perchlorate Poses a Significant Risk to Human Health

The principle mode of action of perchlorate has be en well-characterized: perchlorate blocks iodide uptake in the thyroid by the sodium (Na+)-iodide (I-) symporter (NIS), an ion channel initially identified as the mechanisms of iodide uptake in the basal membrane of thyroid follicular cells (Stanbury and Wyngaarden 1952; Wyngaarden et al. 1952), which is necessary for thyroid hormone synthesis. The selectivity of perchlorate for the sodi um-iodide symporter (NIS) is as much as 30-fold greater than for iodide (Tonaccher a et al. 2004) suggesting that lo w concentrations of perchlorate can out-compete iodide for uptake into the thyroid.

Significant inhibition of iodide uptake results in decreased production of iodine-rich thyroid hormones triiodothyronine (T3) and thyroxine (T4) . Thyroid hormone production is regulated by a negative feedback system referred to as the hypothalamic-pituitary-thyroid axis. The thyroid produces T4 and T3; the pituitary gland produces thyroid stimulating hormone (TSH); and the hypothalamus produces thyrotrophic-releasing horm one (TRH). Cells in both the hypothalamus and pituitary gland respond to low levels of circul ating T4 and T3; the hypothalamus stimulates the pituitary gland through TRH to produce TSH, whic h then prompts the thyroid to produce T4 and T3. Circulating plasma proteins can bind T4 and T3 , serving as a reservoir. When thyroid production levels are low the output of TRH and TSH increase.

Response: EPA agrees that perchlorate may pose an adverse risk to human health, as discussed in more detail in the preamble announcing the final determination. Also, see response to comment

code 2000.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21017

EPA Comment Code: 2000

Comment: P.O. Box 13222 Sacramento, CA95813 December 12, 2008EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 56 of 1099 Dr. Melanie Marty, Chair Children’s Health Pr otection Advisory Committee Air Toxicology and Epidemiology Branch Office of Environmental He alth Hazard Assessment 1515 Clay Street Suite
1600 Oakland, CA 94612

Dr. Marty:

On behalf of the Perchlorate Study Group (PSG) I am writing in response to your November 3 letter to US EPA Administrator Steven Johnson re garding the Agency’s preliminary determination on perchlorate. To be more specific, I’m writing in the hopes of addressing the various concerns you have raised and providing some additiona l perspective for your consideration.

First, a little about the PSG. As manufacturers an d users of perchlorate, the PSG is committed to ensuring the best available science is provided in public debate and applied in the subsequent setting of regulatory standards. The member companies of the PSG include Aerojet, American Pacific (AMPAC), Alliant Techsystems (ATK), and Tronox.

By providing funding for scientif ic studies without interposition on the design, execution, or results for more than ten years, the PSG has worked cooperatively and effectively with the US Environmental Protection Agency (EPA) and other fe deral agencies, state governments, and water

purveyors to:

* increase scientific and medical understanding of perchlorate’s possible effects on human health;
and,

* assess the level of perchlorate in drinking water that is not expected to cause adverse effects even in the most sensitive population.

We read your November 3 letter with great interest. In that letter, you raised several concerns with the scientific foundation of EPA’s preliminary determination and questioned whether EPA gave

sufficient consideration to the health effects of perchlorate on sensitive populations other than pregnant women and their fetuses.

As you are aware, EPA has been studying the heal th effects of perchlorate for more than 15 years releasing their first guidance document in 1992. Few chemicals have been the subject of such extensive research and so many peer- reviewed pu blished studies. One of the unique scientific aspects of perchlorate is that we have a comprehe nsive understanding of how it affects the body. Due to its previous medical use and knowledge of the mechanism of action reduces uncertainty compared to most environmental chemicals. After several studies, draft risk assessments, guidance

document revisions-- as well as an extensive an d comprehensive review by the National Academy of Sciences (NAS), Agency for Toxic Substances and Disease Registry (ATSDR), and subsequent studies which have confirmed the NAS perchlora te panel’s conclusions-- EPA is well positioned to

issue its determination.

Response: EPA agrees that it has considered all releva nt and best available science in making the final determination to regulate perchlorate. Also, see response to comment code 2000.

Commenter Name: Michael GirardEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 57 of 1099 Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21019

EPA Comment Code: 2000

Comment: 2. Your letter asserts that EPA’s decision does not take into account that the developing brain is sensitive to small decreases in thyroid hor mone levels and that neonates have diminished stores of thyroid hormone relative to adults.

No references to support your position are provided in your letter. Thus it is difficult to assess the literature you may have used to support your stat ement. Nevertheless, there are some points to consider. First, thyroid hormones and pituit ary hormones have normal and common temporal variability for a number of reasons (i.e., circadian rhythms, ambient temperature, etc.) Small changes in thyroid hormones are unlikely to cause long-term effects. To be adverse, changes due to chemical agents would have to be of a sustained, clinically significant magnitude over a period of time.

Second, a very small number of scientists have argu ed that the infant has less storage of iodine or thyroid hormone than the adult which would make the infant more vulnerable than the pregnant woman or its fetus. However, the RfD is based on no inhibition of iodide uptake, a non adverse and fully reversible effect. The half-life of perchlora te is short (approximately 8 hours) and it does not bioaccumulate. Basing an RfD that cautiously prev ents the first step in the biochemical pathway would prevent any downstream event from occurring. Thus any differences between adults and children are not likely to be a factor since the first step, inhibition of IUI, is prevented. Moreover, in its assessment of perchlorate and the identifica tion of the most sensitive population, the NAS considered all the relevant literature, including t hose reporting the storage an d half life of thyroidal parameters. With their review, the NAS made the assessment that in pregnant women, infants and children, and people who have a low iodide intake or pre-existing thyroid dysfunction, the dose required to cause a decrease in thyroid hormone production may be lower. However, a dose that does not inhibit thyroid iodide uptake will not a ffect thyroid function, even in subjects with an abnormal thyroid gland or a very low iodide intake. (NAS, 2005)

Response: Please see the response to comment ID 21063 under comment code 4220 and response

to comment ID 19898 under comment code 2000.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21055

EPA Comment Code: 2000

Comment: The EPA's National Center for Environmenta l Assessment (NCEA) prepared draft risk assessments for perchlorate in 1998 and 2002 . The proposed reference doses (RfD) were 0.0009 mg/kg-day in 1998 and 0.00003 mg/kg-day in 2002. Using EPA's conventional (or default)
conversion factors, these reference doses translated to drinking water values of 32 and 1 ppb, respectively. Both reference doses proposed by EP A/NCEA were based on the results of animal studies. In 2002, EPA/NCEA interpreted these stud ies as showing adverse effects in the pups of rats exposed during pregnancy to a perchlorate dose as low as 0.01 mg/kg-day (U.S. EPA, 2002).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 58 of 1099 Public comments on the 2002 draft risk assessment raised serious concerns about the validity of using these animal studies for human health risk assessment (U.S. EPA, 2003). The EPA, NRCA, and the Departments of Energy and Defense jointly sponsored a review of the underlying science by

the NRC.

Response: EPA’s determination to regulate perchlora te is based upon the National Research Council’s 2005 (NRC, 2005) recommendation to use data from a human clinical study (Greer et al. 2002) as a basis for the human health risk assessmen t, and as a basis for the current RfD. On August 19, 2009, EPA published a FR Notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (FR Vol. 74, No. 159, p. 41883). In this August 19, 2009 FR Notice, EPA requested comm ents on additional interpretation of data on the level of human health concern, perchlorate fre quency of occurrence in drinking water, and the opportunity for health risk reduction through a nati onal primary drinking water standard. EPA has

considered and discusses in the FR Notice the hu man health effects of perchlorate. The Agency analyzed the additional information received, and EPA has determined that perchlorate meets the criteria for regulating a contaminant in drinki ng water under Section 1412(b)(1)(A) of SDWA. See
comment code 5000, 510 0, 5200 and 5300 for further discussion of the criteria for a regulatory determination and EPA’s decision to regulate perc hlorate. Greer MA, Goodman G, Pleus RC, Greer SE. Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in hu mans. Environ Health Perspect. 2002 Sep;110(9):927- 37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732. National Research Council (NRC). 2005. Health Implications of Perchlora te Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, Ja nuary, 2005, Washington, D.C. 276 p.

Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28542

EPA Comment Code: 2000

Comment: A 1 ppb or lower MCL is supported by the most recent comprehensive studies, and these should be central to EPA's analysis. The in dustry-supported Greer study, which serves as the basis for EPA's current reference dose consisted of a 14-day study of 37 healthy adults. In more recent years, Blount et al analyzed a nationally representative sample of 2299 U.S. residents, and they have documented anti-thyroid effects in a large population of women exposed to perchlorate at concentrations far lower than levels previously shown to have such effects. This study and subsequent data clearly justify promul gation of a more protective MCL.

Response: On October 10, 2008, EPA published a FR Notice requesting public comments on its preliminary determination not to regulate perchlor ate in drinking water (FR Vol. 73, No. 198, p. 60266). EPA has considered and discusses in the FR Notice the results of the Greer et al. (2002), and Blount et al. (2006) studies, in the proce ss of evaluating the adverse health effects of perchlorate. The Blount et al. (2006) study investig ated adverse effects of perchlorate exposure with women with urinary iodine below 100 ug/L, and revealed adverse thyroid hormone effects in women whose urinary iodine was below 100 ug/L, which is suggestive of a partial study population iodine deficiency status. EPA published additional analyses of these and other studies in August
2009. In this final determination, EPA evaluated the best available peer-reviewed science, and theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 59 of 1099 Agency has determined to regulate perchlorate in dr inking water. An appropriate level for regulation has not yet been determined.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.

Greer MA, Goodman G, Pleus RC, Greer SE. He alth effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9) :927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28877

EPA Comment Code: 2000

Comment: In the Notice EPA describes alternative inter pretations of health and exposure data for perchlorate that may impact EPA's final regulato ry determination for perchlorate. EPA seeks

comments on these alternatives in three areas:

* interpretation of physiologically-based pharmacokinetic (PBPK) modeling;

* derivation of alternative health reference levels (HRLs) based on body weight and water consumption rates for sensitive life stages; and

* use of data on perchlorate occurrence in drinking water.

To provide context for these comments, several points regarding the availability of scientific data on perchlorate are important. First, substantial research and evaluation of the potential health effects of perchlorate have been conducted. The scientific li terature represents more than five decades of scientific inquiry. Since EPA began evaluating perc hlorate in the early 1990s, scientists from government, industry, and academia have made im portant contributions to reducing uncertainties about the risks of perchlorate to public health (see footnote 4). In response to EPA's request for comment on its preliminary determination, Inter tox reviewed the existing data (Intertox, 2008).[FN4: These comments were in response to the EPA FR notice Drinking Water: Preliminary Regulatory Determination on Perchlorate (U.S. EPA, 2008a).] Briefly, these data include:

* the 2005 NRC assessment of perchlorate and update of key studies that have been added to the
scientific literature;

* at least twelve animal toxicological studies conducted between 1997 and 2002, all using EPA protocols, including pharmacokinetic, subchronic, developmental, and immunotoxicology studies, and a multigenerational reproductive study, c onducted using a range of doses, and evaluated independently by EPA;EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 60 of 1099 * several clinical and occupational exposure studies in humans and a number of epidemiologic and ecological studies between 1997 and 2002, some in occupational settings and some in populations exposed to perchlorate via the community drinking-water supply; and

* additional studies conducted since 2002, adding to the scientific literature.

Other agencies, e.g., the ATSDR (2008), have also conducted rigorous reviews of the scientific literature regarding the potential for adverse heal th effects from perchlorate exposure and have determined that doses equivalent to the current RfD are health protective.

Second, a no observed effect level (NOEL) has been identified for perchlorate exposure in humans. At the lowest dose of Greer et al. (2002) (the basis of the perchlorate RfD), there was no statistical difference in iodide uptake inhibition (IUI), a nonadv erse effect, for subjects before and after a dose of 0.007 mg/kg-d (245 ppb assuming default bod y weight and drinking water intake).[FN5: The actual variable measured in Greer et al. (2002) wa s radioactive iodide uptake or RAIU.] As the NRC (2005) states with emphasis, "Inhibition of iodide uptake by the thyroid clearly is not an adverse
effect; however if it does not occur, there is no progression to adverse health effects." Use of a NOEL is more conservative than EPA's common approach using the no observable adverse effect level (NOAEL) or the lowest observabl e adverse effect level (LOAEL).

Third, perchlorate is water soluble, has a half lif e in humans of approximately eight hours, and does not bioaccumulate. Because perchlorate has a sh ort half life, some have questioned whether exposure to perchlorate might cause an acute eff ect. Toxicologically speaking, "acute" describes effects seen after one high dose or an exposur e of less than 24 hours. No published study has demonstrated an effect after one exposure to perchl orate at environmental levels. The dose required for acute effects would require therapeutic levels; the medical literature reports that doses from 200 mg to over 1 gram given on a daily basis (the equi valent of 100,000 to 500,000 ppb in drinking water using standard EPA default assumpt ions[FN6: 1g = 1,000 mg; Drinki ng Water Equivalent for 1,000 mg perchlorate / 2 L of water per day = 500 mg /L or 500 ppm or 500,000 ppb; Drinking Water Equivalent for 200 mg would be 100 ppm or 100,00 0 ppb.]) are necessary to cause side effects (e.g., nausea and gastrointestinal upset at lower doses to aplastic anemia and agranulocytosis at daily doses of one gram or more) in 5 to 18 percent of study populations (NRC, 2005; Barzilai and Sheinfeld, 1966). At exposures lasting several weeks to m onths (more commonly termed "subchronic"), the scientific literature does not demonstrate any evid ence of adverse effect. Thyroxine (T4) has a half life of 6-8 days and must be sufficiently depleted for developmental effects to occur. A single perchlorate dose in excess of 1 gram per day woul d most likely cause some frank toxicity, but based
on the science to date, will not decrease serum th yroid hormone levels without daily exposure for

weeks.

Fourth, the NRC's recommendation to base the RfD on a NOEL was conservative and health protective, as this dose is lower than any dose at which adverse effects may occur. To derive the RfD, the NOEL was divided by an uncertainty factor (UF) of 10 to account for the most sensitive individuals in a population, the hypothyroid or iodine-deficient pregnant women and their developing fetuses. The NRC committee stated that using a NOEL as the point of departure (POD) is a more conservative and health protective appr oach than EPA's customary approach of using the adverse effect (NRC, 2005). For example, the use of the threshold for IUI as a POD is more conservative and health protective than using changes in thyroid hormones (also a precursor to possible adverse effects) or an adverse effect such as hypothyroidism.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 61 of 1099 Perchlorate's reversible inhibition of the NIS is do cumented in many experiments, both in vivo and

in vitro. This interaction exhibits the standard sigmoidal dose-response curve in toxicology and pharmacology-as dose increases, so does the respon se. There is no scientific evidence to suggest that low doses of perchlorate will cause any other effect. Perchlorate competi tively inhibits iodide uptake; it neither mimics a hormone nor directly stimulates a response.

Response: See response to comment code 2000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 62 of 1099 

### EPA Comment Code: 2100 NAS (NRC) review of perchlorate health effects

and reference dose

Response to Comment Code 2100: On October 10, 2008, EPA published a Federal Register notice presenting the Agency’s preliminary regula tory determination for perchlorate and supporting
rational for this determination, in accordance with the Safe Drinking Water Act (SDWA) (Federal Register Vol. 73, No. 198, p. 60262). In this October 10, 2008 Federal Register notice, EPA determined that a national primary drinking wa ter regulation (NPDWR) for perchlorate would not present a meaningful opportunity for health risk reduction for persons served by public water systems. In 2003, the National Research Council (N RC) of the National Acad emy of Sciences (NAS) was asked by EPA to assess the current state of th e sciences regarding potential adverse effects of perchlorate exposure in human and animals, and to determine whether EPA’s prior perchlorate risk assessment findings were consistent with current sc ientific evidence. In a NRC 2005 review of the state of the sciences regarding potential perchl orate adverse health effects and mode-of-action (“Health Implications of Perchlorate Ingesti on”, NRC 2005), the NRC recommended that data from the Greer et al. (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD)(NRC 2005). From this Greer et al. (2002) human clinical study, the statistical no observed effect level (NOEL) for the perchlora te-induced inhibition of thyroid iodide uptake was determined to be 7.0 ug/kg, which corresponded to an iodide uptake inhibition of 1.8 %. The NRC concluded that the most health protective an d scientifically valid approach to deriving a reference dose for perchlorate was to base the perc hlorate RfD on the inhibition of iodide uptake by the thyroid, and that iodide uptake inhibition, though not an adverse effect per se, is the most appropriate precursor event, and would precede an y more severe adverse health effects of perchlorate exposure in humans. The NRC recommended basing the RfD on a precursor to an adverse effect rather than an adverse effect pe r se. The precursor event precedes a downstream adverse effect in the dose response continuum. In this case, NRC used prevention of iodide uptake inhibition, a precursor to adverse thyroid effects, to establish a level at which no adverse effects would be anticipated in exposed populations. This approach is consistent with the Agency’s policy on the use of precursor events when appropriate in establishing the critical effect upon which an RfD is based (U.S. EPA, 2002). The NRC recommen ded that EPA apply an uncertainty factor of 10 to this NOEL of 7.0 ug/kg for the perchlorate- induced inhibition of thyroid iodide uptake, to account for differences in sensitivity between healthy adults and the most sensitive sub-population, consisting of fetuses of pregnant women who migh t have hypothyroidism or iodide deficiency. The NRC viewed the recommended uncertainty factor of 10 as conservative and protective of health, given that the NOEL is based on a non-adverse ef fect (iodide uptake inhibition) which precedes the adverse effect in a continuum of possible adverse biological effects of perchlorate exposure. NRC recommended that using a non-adverse effect that is upstream of the adverse effect represents a more conservative, health-protective approach to the risk assessment for perchlorate, noting that the purpose of the 10-fold uncertainty factor is to protect sensitive subpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposure. EPA has adopted the NRC’s recommendations in its “Integrated Risk Informatio n System” (IRIS) (USEPA 2005), resulting in an RfD of 0.7 ug/kg/day, which was derived by a pplying a 10-fold (10x) uncertainty factor to the NOEL of 7.0 ug/kg/day.

EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. EPA notes that the data underlying the definition of iodide uptake inhibition as a precursor effect and the re lationship of iodide uptake inhibition to theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 63 of 1099 continuum of adverse outcomes reflects an understanding of effects in adults; it may not reflect the relationship of the precursor event to adverse outc omes in neonates and infants, who may not have iodide stores sufficient to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a pr ecursor event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 levels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (Greer et al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[ T]he minimal prolonged decrease in thyroid hormone production that would be associated wi th adverse health effects is not known; any decrease is potentially more likely to have adve rse effects in sensitive populations (people with thyroid disorders, pregnant women, fetuses, and in fants) but data are not available to determine the magnitude of the decrease needed to cause adverse effects in those populations.”

Individual Comments

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20418

EPA Comment Code: 2100

Comment: We note that the RfD itself is uncertain an d is not necessarily a health protective benchmark. It is based upon a limited clinical st udy of short duration and small sample size not representative of the variability in the huma n population (Greer, et al., 2002). When a larger epidemiologic study was conducted by CDC, signif icant correlations were found between increasing perchlorate exposure and decreasing thyroid horm one levels in the subpopulation of women with low iodide intake, which the CDC NHANES data show constitutes 31% of all women (Blount, et al 2006). The exposure levels associated with anti - thyroid effects in these women were below the perchlorate RfD. These findings cast doubt on the protectiveness of the RfD, and make it especially important that no group exceed this health benchmark.

Response: See response to comment ID 28936 under comment code 2100

.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20439

EPA Comment Code: 2100

Comment: Exposure

In addition to occurrence, the evaluation criteria in the SDWA also consider whether contamination is occurring at levels "of public health" concer n and whether regulation of the contaminant would meaningfully reduce potential health risks. AWWA would like to acknowledge and compliment the

National Research Council for the extensive assessmen t of risk that resulted in setting the oral Reference Dose (RfD) at 7x10-4 mg /kg-day. In consideration of the SDWA criteria, it should be emphasized that the RfD represents a No Ob served Effect Level (NOEL) versus the more traditional No ObservedAdverse Effect Level (N OAEL). As discussed by Crawford-Brown et.al.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 64 of 1099 (2006) and in the proposed decision, a NOAEL is by definition equal to or higher than a NOEL

wherethe effect used to establish the NOEL is a precursor to the adverse effect of interest in establishing a NOAEL. The NRC's use of a precursor to an adverse effect (iodine uptake inhibition) in establishing a threshold for exposure repr esents a "more conservative, health-protective approach". This assures the protection of the sensitive subpopulation (iodide-deficient pregnant women and their fetuses) and mitigates the need for additional uncertainty factors to be applied.

Response: EPA does not agree that use of precursor effect alters the need for uncertainty factors. Uncertainty factors are applied to respond to speci fic aspects of uncertainty in some aspect of the health assessment, regardless of the nature of the endpoint used. Examples include intraspecies or interspecies variability, data gaps, or discrepancie s in time course of the study compared to the anticipated effect/exposure profile in the pub lic. Also, see response to comment code 2100.

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20454

EPA Comment Code: 2100

Comment: Perchlorate interferes with iodide uptake an d affects the release of thyroid hormones. Appropriate levels of thyroid hormones are critic al to the development of the brain and other organs, making the fetus and newborn infant partic ularly sensitive to perchlorate toxicity. Maternal exposure to elevated levels of perchlorate has been linked to mild, in some cases severe and irreversible, neurological outcomes in infants. Perchlorate is but one more contaminant along with mercury, PCBs, PBDEs, and lead that ad versely impact the developing brain.

Washington Department of Health and Oregon De partment of Human Services, Public Health

Division believe that the 10-fold uncertainty factor used by EPA to derive a Reference Dose (RfD), and its subsequent use to formulate a health ba sed drinking water level, is insufficient.

We believe that due to the data gaps in the limi ted studies available for perchlorate that a higher uncertainty factor is warranted. Back in 2002, EP A more appropriately utilized a higher uncertainty factor in the agency’s assessment of perchlorate, as did the state of Massachusetts in their in-depth risk assessment of perchlorate. Exposure estimates based on a more protective RfD indicate that, at any one time, as many as 210,000 pregnant wome n in the US are exposed to unsafe levels of perchlorate. This view of risk could well influen ce the conclusion as to whether or not a national regulation of percholorate in drinking water pr esents a meaningful opportunity to protect public

health.

As state regulators, we strive to evaluate chemical hazards in a consistent manner. If EPA had used its standard risk assessment methodology, their find ings of the hazards of perchlorate in drinking water would have been significantly different. We recommend that EPA reconsider its evaluation since there is no obvious scientific reason for using the different methodology which led to this preliminary determination.

We support the scientific approach reflected in the enclosed information prepared by the Washington Department of Health, and ask that EPA carefully consider it as your agencyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 65 of 1099 determines the appropriate next step. Further, if we can provide any further information regarding this important public health issue, please c ontact us, Gregg Grunenfelder, Washington State Department of Health, (360.236.3 050) or Gail Shibley, Oregon Sta te Department of Human Health Services (971.673.0400).

Sincerely,

Gregg Grunenfelder, Assistant Secretary Washin gton State Department of Health Division of

Environmental Health

Gail R. Shibley, Administrator Oregon State Department of Human Services Office of

Environmental Public Health

Response: Please see response to comment ID 28818 under comment code 2100.

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20455

EPA Comment Code: 2100

Comment: Enclosure

November 10, 2008 Docket ID No. EPA-HQ-O W-2008-0692 Comments on EPA’s Preliminary Regulatory Determination for Perchlorate Prepared by Washington State Department of Health

On October 10, 2008, the US Environmental Prot ection Agency (EPA) placed an action notice on the Federal Register [FN1: EPA 2008. Fact Sh eet: Preliminary Regulatory Determination for

Perchlorate. Office of Water. United States Environmental Protection Agency. EPA 815-F-08-009. October 2008.],[FN2: Federal Regi ster: October 10, 2008 (Volume 73, Number 198). Notices. Page 60262-60282. From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCOD:fr10oc08-66].] relating to preliminar y regulatory determination for perchlorate in accordance with the federal Safe Drinking Water A ct. The agency determined that a national primary drinking water regulation for perchlorate would not present "a meaningful opportunity for health risk reduction for persons served by public wa ter systems." EPA will make a final regulatory determination for perchlorate after considering pu blic comments and information provided during the 30-day comment period ending November 10, 2008. EPA intends on publishing its final regulatory determination in December 2008 to provid e state and local public health officials with

technical information that can be used to address local contamination.

Perchlorate (ClO4) is a naturally occurring inor ganic compound that can also be manufactured. Ammonium perchlorate (NH4ClO4), is a salt used as an oxidizer in rocket propellants and

fireworks. It has also been found in certain fertilizer s, and was used in the past as a medicine to treat hyperthyroidism (overactive thyroid) in humans. Perchlorate salts are ionic and dissociate completely when dissolved in water. The soluble anion ClO4 has been found in groundwater in many states where testing has occurred. To date, it is not clear to what extent pe rchlorate is found in groundwater across the United States, because it has not been widely studied. In the northwest, lowEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 66 of 1099 levels of perchlorate have been found in groundwater in some tested areas of eastern Washington and Oregon.

Perchlorate interferes with the thyroid’s ability to take in iodide. The thyroid needs iodide to produce certain hormones that are necessary for numerous body functions. If the thyroid is unable to produce enough of these hormones, a conditi on known as hypothyroidism (underactive thyroid disease) may result. Thus, perchlorate exposure ha s the potential to result in hypothyroidism.

All people are susceptible to perchlorate’s effects on the thyroid (decreased iodide uptake), but pregnant women, infants, children, and people with low iodide intake in the diet, or pre-existing thyroid problems may be more sus ceptible. Hypothyroidism, if untreated, can lead to numerous health effects including, fatigue, muscle aches, unexplained weight-gain, depression, and many other symptoms. Moreover, hypothyroidism in pregnant women (developing fetuses), infants, and children can lead to impaired mental and physical development. Maternal exposure to elevated levels of perchlorate has been linked to mild, and in some cases severe and irreversible neurological

outcomes in infants. Similar adverse outcomes to th e developing fetus have been documented with exposure to mercury, PCBs, PBDEs, and lead.

In the absence of federal regulatory standards on perchlorate, several states have developed Reference Doses (RfD) or safe doses that are use d to derive safe drinking water guidance or standards. Most notably are recent efforts by EPA [FN3: EPA 2002. Perchlorate environmental contamination: toxicological review and risk chara cterization. External Review Draft. United States Environmental Protection Agency. Office of Rese arch and Development. NCEA-1-0503. January 16, 2002.], California [FN4: Ting D, Howd RA, Fan AM, and Alexeeff GV. 2006. Development of a Health-Protective Drinking Water Level for Perchlor ate. Environmental Health Perspectives (114)6: 881-86.],[FN5: California Environmental Protection Agency. 2004. Office of Environmental Health

Hazard Assessement. Public Health Goals for Che micals in Drinking Water: Perchlorate. March 2004.], New Jersey [FN6: New Jersey Department of Environmental Protection 2005. New Jersey Drinking Water Quality Institute. Maximum Contaminant Level Recommendation for Perchlorate. October 7, 2005.], Massachusetts [FN7: Massachus etts Department of Environmental Protection. 2006. Office of Research and Standards. Update to "Perchlorate Toxicological Profile and Health Assessment". March 2006.], and the National Resear ch Council of the National Academy of Science (NAS) [FN8: National Academy of Sciences. 2005. Health Implication of Perchlorate Ingestion. National Academies Press. Washington D.C. Available at URL: http://www.nap.edu/catalog.php?record_id=11202].

EPA conducted the initial draft toxicological review of perchlorate in 2002, resulting in a proposed RfD of 0.00003 mg/kg/day based primarily on studies that identified neurodevelopmental deficits in rat pups [FN9: Argus 2001. Hormone, thyroid, and ne urohistological effects of oral (drinking water) exposure to ammonium perchlorate in pregnant and lactating rats and in fetuses and nursing pups exposed to ammonium perchlorate during gest ation or via maternal milk. Argus Research
Laboratories, Inc. Horsham, PA. Protocol no. ARGUS 1416-003. Cited in EPA 2002.]. These deficits were linked to maternal exposure to perchlor ate. Subsequent to this assessment, California, New Jersey, the NAS, and Massachusetts reviewed the health implications of perchlorate, and each proposed an alternative reference dose of 0.0 004, 0.0007, 0.0007, and 0.00003 mg/kg/day, respectively. This is based primarily on a study on humans conducted by Greer et al. published in 2002. A summary of perchlorate reference doses deve loped by the various agencies is presented in

Table 1.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 67 of 1099 [Table 1. Comparison of Perchlorate Reference Do ses (RfD) Developed by Other Agencies - see PDF Docket ID EPA-HQ-OW-2008-0692-1259]

In the Greer et al. [FN10: Greer MA, Goodman, F, Pleus RC, and Greer SE. 2002. Health Effects

Assessment for Environmental Perchlorate Contamin ation: The Dose Response for Inhibition for Thyroid Radioiodine Uptake in Humans. Environm ental Health Perspectives (110)9: 927-37.] study cited by four of the five agencies, 37 human subjects were split into four exposure groups and administered oral doses of perchlorate at 0.007 (7 subjects), 0.02 (10 subjects), 0.1 (10 subjects), and 0.5 (10 subjects) mg/kg/day. Signifi cant decreases in iodide uptake were found in the three highest exposure groups. Iodide uptake was not significantl y reduced in the lowest exposed group, but four of the seven subjects in this group experienced inhibited iodide uptake. The RfD proposed by NAS was accepted by EPA and added to its integrated risk information system (IRIS) in 2005.

Much debate was generated following EPA’s pos ting of the RfD in IRIS, most notably in commentary submitted to the journal Environmenta l Health Perspectives by Ginsberg and Rice [FN11: Ginsberg G and Rice D. 2005. The NAS Pe rchlorate Review: Questions Remain about the Perchlorate RfD. Environmental Health Perspective s (115)3: 361-69.]. The authors argued that the RfD was not adequately protective of human health for the following reasons:

1. The NAS report described the level of lowest ex posure from Greer et al. as a no observed effect level (NOEL). However, there was actually an effect at that level although not statistically significant largely due to small size of study population (four of seven subjects showed a slight decrease in iodide uptake).

2. Reduced iodide uptake was not considered an adverse effect. However, it is a precursor to an adverse effect (hypothyroidism). Therefore, additional safety factors are necessary when extrapolating from the point of departure to the RfD.

3. Consideration of data uncertainty was insufficien t because the Greer, et al. study reflected only a 14-day exposure to healthy adults and no addi tional safety factors were considered to protect sensitive subpopulations. For example, the potential for greater toxicity to breastfeeding newborns

was not considered.

Response: EPA believes that the RfD recommended by the NAS remains appropriate, as discussed in the other responses to comments in this section (comment code 2100); however, EPA will be continue to evaluate scientific studies of perchl orate health effects as the Agency develops the National Primary Drinking Water Regulation for perchlorate.

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20458

EPA Comment Code: 2100

Comment: The Department of Health’s Conclusions:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 68 of 1099 There is consensus among agencies that the Greer et al. study is appropriate for deriving the RfD, but there is not consensus with regard to developing drinking water maximum contaminant levels (MCLs) or action levels. One of the key differences results from how the point of departure is viewed [i.e., No observed effect level (NOEL) or lowest observed adverse effect level (LOAEL)], or

whether a benchmark dose should be used to derive the RfD. Defining the point of departure as a NOEL or LOAEL has implications when it come s to applying appropriate safety factors to the point of departure to derive the RfD.

Based on a review of existing literature, the Depa rtment of Health has identified the following concerns with EPA’s perchlorate action level:

* EPA’s RfD, which is the basis for the health refere nce level, may not be protective of public health with a reasonable margin of safety.

Response: Please see response to comment code 2100 for a discussion of the RfD. See Response to

comment code 5220 for a discussion of alternative Health Reference Levels. EPA will continue to refine its analyses for purposes of proposing an MCL and MCLG. EPA plans to seek comment on the proposed national drinking water regulation pur suant to the requirements of the Safe Drinking

Water Act.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20630

EPA Comment Code: 2100

Comment: We also found critical errors in the selection, design and interpretation of the studies that were included in docket ID No. EPA-HQ-OW- 2008-0692. The irrelevant studies should be dropped from the docket, the flawed interpretation s of the remaining studies should be corrected,

and the conclusions drawn revised.

Several studies reported in docket ID No. EPA- HQ-OW-2008-0692 are either inappropriate for inclusion, or erred in their design or interpretation. Most significant in this regard is the population that was emphasized by the EPA in citing the NA S report of 2005 (NRC, 2005): pregnant adults. EPA provided no scientific justification for this emphasis. Moreover, the emphasis on the pregnant adult illustrates the mistake of public health reco mmendations by persons who are not at significant risk. As we’ve noted above: "the adult thyroid sy stem appears capable of significant compensation for low thyroid hormone levels, and the consequences of low thyroid hormone are likely to be

reversible."

Response: EPA respectfully disagrees with the commenter . It is also noted that the commenter does not specify which studies she is critical of. In a NRC 2005 review of th e state of the sciences regarding potential perchlorate adverse health eff ects and mode-of-action (“Health Implications of Perchlorate Ingestion”, NRC (2005)), the NRC reco mmended that data from the Greer et al. (2002) human clinical study be used as the basis for de riving a perchlorate reference dose (RfD) (NRC 2005). From this Greer et al. (2 002) human clinical study, the statistical no observed effect level (NOEL) for the perchlorate-induced inhibition of thyroid iodide uptake was determined to be 7.0 ug/kg, which corresponded to an iodide uptake inhibition of 1.8%. The NRC concluded that theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 69 of 1099 most health protective and scientifically valid appr oach to deriving a reference dose for perchlorate was to base the perchlorate RfD on the inhibition of iodide uptake by the thyroid, and that iodide uptake inhibition, though not an adverse effect pe r se, is the most appropriate precursor event, and would precede any more severe adverse health e ffects of perchlorate exposure in humans. The NRC recommended basing the RfD on a precursor to an adverse effect rather than an adverse effect per se. The precursor event precedes a downstream adverse effect in the dose response continuum. In this case, NRC used prevention of iodide uptake inhi bition, a precursor to adverse thyroid effects, to

establish a level at which no adverse effects wo uld be anticipated in exposed populations. This approach is consistent with the Agency’s policy on the use of precursor events when appropriate in establishing the critical effect upon which an RfD is based (U.S. EPA, 2002). The NRC recommended that EPA apply an uncertainty facto r of 10 to this NOEL of 7.0 ug/kg for the perchlorate-induced inhibition of thyroid iodide up take, to account for differences in sensitivity between healthy adults and the most sensitive sub -population, consisting of fetuses of pregnant women who might have hypothyroidism or iodide deficiency. Iodide uptake inhibition has been

identified in the literature as an area of c oncern in connection with increasing the risk of neurodevelopmental impairment in fetuses of high-risk mothers. The NRC viewed the recommended uncertainty factor of 10 as conserva tive and protective of health, given that the NOEL is based on a non-adverse effect (iodide upta ke inhibition) which precedes the adverse effect in a continuum of possible adverse biological e ffects of perchlorate exposure. NRC recommended that using a non-adverse effect that is upstream of the adverse effect represents a more conservative, health-protective approach to the risk assessment for perchlorate, noting that the purpose of the 10- fold uncertainty factor is to protect sensitive su bpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposur e. EPA has adopted the NRC’s recommendations in its “Integrated Risk Information System” (IRIS) (USEPA, 2005), resulting in an RfD of 0.7 ug/kg/day, which was derived by applying a 10-f old (10x) uncertainty factor to the NOEL of 7.0 ug/kg/day. Greer MA, Goodman G, Pleus RC , Greer SE. Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 20 02 Sep;110(9):927-37. National Research Council (NRC). 2005. Health Implications of Perchlora te Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2002. A review of the reference dose and reference concentration processes. Risk Assessment Forum, Washington, DC; EPA/630/P–02/0002F. USEPA. 20 05. ‘‘Integrated Risk Information System (IRIS), Perchlorate and Perchlor ate Salts.’’ February 2005.

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20641

EPA Comment Code: 2100

Comment: Our primary concern is related to the Rf D EPA used to estimate Health Reference

Level. Our comments follow three lines of evaluation:

1. Critically important data on pregnant women and their offspring have become available since the time of the development of the EPA RfD in 2005 (EPA, 2008), which necessitate a reconsideration of the existing value. This reconsideration is consistent with recommendations of the NAS (2005) on page 69 of its report.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 70 of 1099 2. The excellent relative source contribution eval uation of EPA, based on well supported and clearly
described work of the FDA, necessitates a rethinki ng of the EPA’s RfD, since the subjects in Greer et al. (2002) on which it was based undoubtedly had unmeasured perchlorate in their food.

3. The 2005 NAS "RfD" does not follo w the existing EPA RfD method.

All three of these arguments are more fully di scussed below. We also offer a commentary on the Blount et al. (2007) that may have some bearing on this federal action (Attachment A). Note, while a reanalysis of the RfD will not have an effect on th e regulatory conclusion discussed in this Federal Register notice, it will have an effect on the Heal th Advisory that EPA derives, which will be used by States for their regulation of perchlorate.

Response: See response to comment ID 20957 under comment code 2100 for a discussion of adjusting the Greer study to account for perchl orate which may have been in subjects’ food. EPA supports the review and evaluation of additi onal new data regarding the health effects of perchlorate. However EPA respectf ully disagrees with the commenter regarding the NRC (2005)
recommendations for the RfD, as discussed below. EPA will continue to evaluate scientific studies of perchlorate health effects as part of the perchlorate rulemaking

The EPA “Integrated Risk Information System” (I RIS) employs EPA’s standard risk assessment methodology. The RfD, which is derived from the NOEL, is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral ex posure to the human population that is likely to be without an appreciable risk of deleterious eff ects during a lifetime. The RfD, based on the assumption that thresholds exist for certain toxic e ffects of chemicals, represents the drinking water perchlorate exposure plus an incremental additiona l exposure of perchlorate from either water or food which could trigger iodine uptake inhibi tion, with a 10X safety factor applied. The NRC recommended that data from the Greer et al. (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD) (NRC 2005), and also noted that the results of this study were supported by those of other human studies. From this Greer et al. (2002) human clinical study, the statistical no observed effect level (NOEL) fo r the perchlorate-induced inhibition of thyroid iodide uptake was determined to be 7.0 ug/kg (a corresponding iodide uptake inhibition of 1.8%). The NRC concluded that the most health protective and scientifically valid approach was to base the perchlorate RfD on the precursor even t of inhibition of iodide uptake by the thyroid. This approach is consistent with the Agency’ s policy on the use of precursor events when appropriate in establishing the critical effect upon which an RfD is based (U.S. EPA, 2002). The NRC recommended that EPA apply an uncertainty factor of 10 to this NOEL of 7.0 ug/kg to account for differences in sensitivity between healthy adults and the most sensitive sub-population (fetuses of pregnant women who might have hypothyroidism or iodide deficiency). Iodide uptake inhibition due to perchlorate exposure has been identified as an area of concern in connection with increasing the risk of neurodevelopmental impairment in f etuses of high-risk mothers. The NRC viewed the recommended uncertainty factor of 10 as conserva tive and protective of health. NRC recommended that using a non-adverse effect that is upstream of the adverse effect represents a more conservative, health-protective approach to the risk assessment for perchlorate, noting that the purpose of the 10- fold uncertainty factor is to protect sensitive su bpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposur e. EPA has adopted the NRC’s recommendations in its “Integrated Risk Information System” (USEPA, 2005), resulting in an RfD of 0.7 ug/kg/day, which was derived by applying a 10-fold uncerta inty factor to the NOEL of 7.0 ug/kg/day. EPAEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 71 of 1099 used the best available peer-reviewed science, and the Agency has determined to regulate perchlorate in drinking water.

Greer MA, Goodman G, Pleus RC, Greer SE. Envir on Health Perspect. 2002 Sep;110(9):927-37. National Research Council (NRC). 2005. Health Im plications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2002. A review of the refere nce dose and reference concentration processes. Risk Assessment Forum, Washington, DC; EPA/630/P–02/0002F. USEPA. 2005. "Integrated Risk Information System (IRIS), Perchlorate an d Perchlorate Salts." February 2005.

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20642

EPA Comment Code: 2100

Comment: Availability of New Data

Critically important data on pregnant women and their offspring have become available since the time of the development of the 2005 EPA’s Refere nce Dose (RfD) (EPA, 2008), which necessitate a reconsideration of the existing value.

For example, although the NAS recommended that th e Greer et al (2002) be used as the basis of the RfD, the NAS also recognized that new, useful data were under development:

"On the basis of the iodide-inhibition analyses , the additional comparisons, and a review of information on urinary iodide excretion, the committee concluded that the data from Chile could be considered in the evaluation of the U.S. experience with perchlorate in drinking water." (NAS, 2005, page 69)

The data to which NAS referred was published prior to the NAS report as Crump et al. (2000), and after the NAS report as Tellez et al. (2005), the abstract of which reads:

"We have conducted a longitudinal epidemiologic st udy among pregnant women from three cities in northern Chile: Taltal with 114 ug/L, Chañaral with 6 ug/L, and Antofagasta with 0.5 ug/L perchlorate in the public drinking water. We tested the hypothesis that long-term exposure to perchlorate at these levels may cause a situati on analogous to iodine deficiency, thus causing increases in thyrotropin (TSH) and thyroglobulin (T g) levels and decreased levels of free thyroxine (FT4), in either the mother during the early stages of gestation or the neonate at birth, or in the fetus cause growth retardation. We found no increases in Tg or TSH and no decreases in FT4 among either the women during early pregnancy (16.1 +/- 4.1 weeks), late pregnancy (32.4 +/- 3.0 weeks), or the neonates at birth related to perchlorate in drinking water. Neonatal birth weight, length, and

head circumference were not diffe rent among the three cities and were consistent with current U.S. norms. Therefore, perchlorate in drinking water at 114 ug/L did not cause changes in neonatal thyroid function or fetal growth retardation. Median urinary iodine among the entire cohort was 269 ug/L, intermediate between that of pregnant wome n in the United States at National Health and Nutrition Examination Survey (NHANES) I and at NHANES III and consistent with current World Health Organization (WHO) recommendations. Median breast milk iodine was not decreasedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 72 of 1099 in the cities with detectable perc hlorate. Analysis of maternal urin ary perchlorate excretion indicates an additional dietary source of perc hlorate." (Tellez et al., 2005)

In addition, EPA has discussed other data relevant to deriving an updated RfD in this Federal Register notice, including Amitai et al., 2007, Blount et al., 2006b (see a separate discussion of Blount in Attachment A), and the studies disc ussing PBPK models (Merrill et al., 2005; Clewell et al., 2007).

Contribution of Perchlorate in Food to Total Exposure

As EPA discussed in this Federal Register notice, the US population is being exposed to perchlorate through both food and water. Based on EPA’s exce llent relative source contribution evaluation (Table 6), the dose of perchlorate from food co uld range from 0.075 ug/kg-day (median dose) to 0.167 ug/kg-day (90th percentile dose) and accoun t for 24% of total perchlorate exposure for the general population.

This information may necessitate a rethinking of the 2005 RfD based on Greer et al. (2002). Since these investigators did not measure perchlorate in the food of the human subjects, it is likely the total perchlorate dose received by the subjects wa s higher than the drinking water dose of 0.007 mg/kg-day that was used as the point of departure for the RfD. This same consideration might also be appropriate for RfDs based on other human studies.

The 2005 NAS "RfD" does not follow the existing EPA RfD method.

While we agree that perchlorate causes adverse eff ects in the manner described by EPA, and that EPA based its Reference Dose (RfD) principally on the work of the NAS/NRC (2005), and further that the NRC (2005) provided an insightful and c onclusive discussion of perchlorate science, it is exceedingly clear that NRC did not use accepted ri sk assessment methods, nor EPA methods, to develop a reference dose. NRC conc luded that hypothyroidism would be the first observed adverse effect, or critical effect (Faustman, and Omenn. 20 01; EPA, 2008), and that the dose level at which this effect would likely first be observed (the no observed adverse effect level, or NOAEL) in healthy adults is 0.4 mg/kg-day. This choi ce might be appropriate basis of the RfD.

Yet, NRC selected the lowest of several precursors to this lowest adverse effect, the threshold of iodine uptake inhibition, as the starting point fo r its reference dose (RfD), because it was "more health protective". As NRC clearly stated, this e ffect of itself does not result in any harm, and the dose at which it occurs is approximately 100 times lower than the NOAEL of the first adverse effect. Moreover, this choice of lowest precursor is not consistent with EPA guidelines.

Specifically, NRC ignores two principles that govern calculating RfDs: 1. To identify an intake that

"reduces hazard to a minimum and at the same ti me allows use of [necessary] chemicals ((Faustman, and Omenn. 2001)," and 2. To base RfDs on an ad verse effect (Lehman and Fitzhugh, 1954), or an adverse effect or its precursor (Barne s and Dourson, 1988; EPA, 2002).

That is, the definition of critical effect by EPA sp ecifies an adverse effect or its precursor---singular- --meaning the penultimate precursor when several are available. Thus, the RfD has been, and must continue to be, the largest intake that can be re asonably certain to cause no injury to the wholeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 73 of 1099 population. Otherwise, there is no reason not to c hoose lower precursors for any RfDs, resulting in RfDs that solely depend on how many precursor effects have been monitored.

The practice of focusing on the first adverse e ffect, or its known precursor, in dose response assessment, is based on decades of experience in the United States, Canada, and Europe. This practice allows us to draw conclusions about public health in the absence of observable data and in the presence of scientific uncertainty. The a ccepted process for developing RfDs (Barnes and Dourson, 1988) suggests two possible approaches to developing an RfD from the perchlorate data.

The first would be to use the NOAEL of the crit ical effect from an adult population and apply uncertainty factors to account for sensitive populations and for lack of precision in defining this NOAEL. The second approach would be to use a NOAEL from a sensitive population.

Following this second approach, a standard RfD of 0.002 mg/kg-day has been described that is adequately health-protective (Strawson et al., 2004). This RfD may be suitably upgraded with the use of the newer epidemiology studies, as described briefly above.

Using a non-standard RfD process in regulating chem icals, such as that suggested by NAS (2005) for perchlorate, is not consistent with accepted EPA methods for developing such values. EPA’s acceptance of this non-standard RfD undermines its good dose response assessment work in other

programs.

Response: Please see the response to comment ID 20641 under comment code 2100, and the response to comment code 2100.

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20644

EPA Comment Code: 2100

Comment: However, we also recommend that EPA update its RfD prior to publishing a Health Advisory for the following reasons:

Additional important data on pregnant women and th eir offspring have become available since the time of the development of the EPA's RfD in 2005, which necessitate a reconsideration of the existing value. This reconsideration is consisten t with recommendations of the NAS (2005) in its

report.

The excellent relative source contribution evalua tion of EPA, based on we ll supported and clearly
described work of the FDA, necessitates a rethinki ng of the any RfD, since the underlying studies may not have measured perchlorate in the food of the human subjects.

The 2005 "RfD" of the NAS does not follow the existing EPA method.

Additional information is provided in the attached document.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 74 of 1099 Commentary on "Drinking Water: Preliminary Regu latory Determination on Perchlorate" Docket ID No. EPA-HQ-OW-2008-0068 Michael L. Dours on, Ph.D., DABT, ATS Joan Strawson, M.S., M.T.S.C., J.D. Toxicology Excelle nce for Risk Assessment (TERA)

The opinions expressed in this text are those of the authors for the purpose of protecting public health. These authors' opinions do not necessa rily represent the views of the sponsors.

Response: See response to comment ID 20641 under response code 2100.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20646

EPA Comment Code: 2100

Comment: III (A)(1 and 2), pp 60266-60268. The NRC (2 005) review of the Greer et al. (2002) study is discussed. EPA notes that the lowest do se of 7 ug/kg-day in the Greer et al. study corresponds to a statistical NOEL, and suggests that an uncertainty factor of 10 from the lowest dose is adequate to derive a health- protective level of 0.7 ug/kg-day, to account for human variability, as recommended by the NTP review panel. However, OEHHA would like to point out

that the data also allow calculation of the lower confidence limit on a benchmark dose level for inhibition of iodide uptake. Using the lower 95% confidence limit of a 5% benchmark dose for inhibition of iodide uptake, OEHHA calculated a BMDL of 3.7 ug/kg- day, using EPA BMDS software (OEHHA, 2004). Although the low number of subjects (37) in the Greer et al. study cannot provide an accurate estimate of true human variability, it seems to us that using the available data in this calculation is a more reasonable way to account for the uncertainty in the data than just dividing the NOEL by 10. Our approach in fact follows the recommendations of EPA as to when BMD modeling should be applied.

It should also be noted that a sensitive populati on (women who consume low iodide levels) has been identified (Blount et al., 2006), and this populati on was excluded from the study of Greer et al. (2002). An apparent additional iodide inhibitory effect was noted by Steinmaus et al. (2007) in women who smoke (and consume low iodine). We therefore recommend that either the BMDL of 3.7 ug/kg-day be utilized for the calculation, or th at an extra 3-fold uncertainty factor be utilized in the EPA NOEL/UF approach to account for th e missing sensitive subpopulation and to help account for the known variability.

Because the NRC panel did not have access to the da ta of Blount et al. (2006), relying on the NRC conclusions without specific acknowledgement that that approach does not address the sensitive population issues seems inappropriate.

Response: See response to comment ID 20641 under comment code 2100. EPA agrees with the commenter’s suggestions regarding the review and evaluation of additional new data regarding the health effects of perchlorate, and will do so as part of the perchlorate regulatory process.

Commenter Name: Brie Brigham Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 75 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1436

EPA Comment ID: 20895

EPA Comment Code: 2100

Comment: The EPA has set an official reference dose of .0007 mg/kg/day of perchlorate, which is not expected to cause adverse health effects in humans. The EPA then converted this reference dose into a drinking water equivalent level of 24.5 ppb by assuming a person weighs 154 pounds and consumes 68 ounces of drinking water per day over a lifetime. Based on these conversions, the drinking water equivalent level for infants should be 4.35 ppb. The EPA as sumes that a perchlorate contamination level of 15 ppb is safe. However, this level more than triples the level assumed safe

for infants.

Response: The NRC (2005) identified "the fet us of pregnant women who might have hypothyroidism or iodide deficiency" as "the most sensitive population," but also identified infants and developing children as additional "sensitive populations." Infants and young children have greater exposure to contaminants in food and water because of greater consumption of food and water on a per unit body weight basis. See res ponse to comment code 5220 for a discussion of

alternative Health Reference Levels. National Resear ch Council (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276 p.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20900

EPA Comment Code: 2100

Comment: Compounding these problems, the CIIT relied heavily on a flawed, industry-funded study (the Greer study) when creating the computer model (Greer et al. 2002) - the problems with the Greer study have been documented in the published scientific literature and by the Massachusetts Department of Environmental Pro tection (Ginsberg and Rice 2005, MassDEP 2006).

Response: EPA believes that the Greer study, selected by the NRC as the basis for the RFD, represents the best available study for derivi ng a RfD. See response to comment code 2100.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20911

EPA Comment Code: 2100

Comment: The PBPK model relies heavily on industry-f unded Greer study: The CIIT generated PBPK model uses data from the Greer study, whic h showed a dose-dependent decrease in iodine uptake (RAIU) by the thyroid gland with increasi ng perchlorate ingestion (Greer et al. 2002). This study included only 37 participants who were divided into several study groups and administered different doses of perchlorate for 14 days; the re searchers determined that 0.007 mg/kg/day was the no observed effect level (NOEL) for perchlorate. The results from this study were used by the National Academy of Sciences (NAS) in setting the reference dose fo r perchlorate of 0.7 ug/kg/day.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 76 of 1099 However, the Greer study results and assumptions drawn from these results have been questioned in a peer-reviewed article that was published in Environmental Health Perspectives in 2005 (Ginsberg and Rice 2005). Two toxicologists, one from the Connecticut Department of Public Health and the other from the Maine Bureau of Health, conducted an analysis of the raw data from the Greer study and concluded that the "Individual re sults of Greer et al. point to an effect in four of the seven individuals tested at the lowest dose (0 .007 mg/kg/day), indicating that this dose is an effect level." In other words, while Greer et al. and the NAS both concluded that 0.007 mg/kg/day is a NOEL, closer analysis of the data reveals th at several of the 7 study subjects in this group experienced effects at this dose, thereby invalidating 0.007 mg/kg/day as a NOEL.

The Massachusetts Department of Environmental Protection (Mass DEP), which has set the most stringent drinking water standard for perchlora te nationally, had the following observations about the Greer study:

"MassDEP has concerns about the lowest dose in the Greer study being a no-effect level based on the facts that: due to the small number of subjects in the lowest dose group, there is low power to detect a statistically significant effect; averaging of group responses obscures positive individual inhibition; a non- statistically significant IUI (iod ine uptake inhibition) effect was observed at the lowest dose tested; and, good low dose corr oborating data is lacking" (MassDEP 2006).

In light of these valid criticisms of the Greer study, it is unclear why EPA chose to rely so heavily on the PBPK model that incorporates data from this study while essentially ignoring much more

relevant data from the CDC.

Response: Blount et al., (2006) found that perchlorate exposure was a statistically significant predictor of thyroid hormones in women, but not in men. Their observations that adverse thyroid hormone effects were found in women whose urinary iodine was below 100 ug/L is suggestive of a partial study population iodine deficiency status. Blount et al. (2006) also noted several limitations of their study. Since their study was cross-sectional in design, it also cannot be concluded whether or not the association between perchlorate and thyroid hormone levels is causal, or is mediated by some other correlate of both. Blount et al., (2007) found that almost all participants in the same 2001-2002 NHANES survey, including the participan ts in their 2006 study, had urinary levels of perchlorate corresponding to estimated dose leve ls that are below the RfD of 0.7 ug/kg/day.

The NRC recommended that data from the Greer et al . (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD ) (NRC 2005), and also noted that the results of this study were supported by those of other huma n studies. From this Greer et al. (2002) human clinical study, the statistical no observed effect le vel (NOEL) for the perchlorate-induced inhibition of thyroid iodide uptake was determined to be 7. 0 ug/kg (a corresponding iodide uptake inhibition of 1.8%). The NRC recommended that EPA apply an uncertainty fa ctor of 10 to this NOEL of 7.0 ug/kg for the perchlorate-induced inhibition of thyr oid iodide uptake, to account for differences in sensitivity between healthy adults and the most sens itive sub-population, consisting of fetuses of pregnant women who might have hypothyroidism or iodide deficiency.

EPA evaluated the published PBPK models (Clewe ll et al., 2007, and Merrill et al., 2005) and used them to further explore the relationship between wa ter concentrations and iodide uptake inhibition in different subpopulations (USEPA, 2008). However , EPA did not rely on this PBPK analysis for determining the HRL. Rather, the HRL of 15 μg/l was calculated directly from the RfD to protectEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 77 of 1099 the most sensitive subpopulation, the fetuses of pregnant women, using high end exposure assumptions. EPA thus applied the adjusted mode l to the HRL of 15 μg/l to determine the predicted percent RAIU inhibition (USEPA, 2008), and found that the 2.2 percent inhibition level for 7-day old bottle fed infants is comparable to the 1.8 percent inhibition level that the NRC identified as a no effect level in healthy adults and recommended as the point of departure for calculating the RfD (NRC, 2005). So, the modeling essentially agrees with the original NRC conclusions, and yielded results comparable to or below the 1.8 percent no effect inhibition level from the Greer (2002) study.

EPA used the best available peer-reviewed science, and the Agency has determined to regulate perchlorate in drinking water.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasi ni L, Caldwell KL. Environ Health Perspect. 2006 Dec;114(12):1865-71. Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. J Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7. Cl ewell RA, Merrill EA, Gearhart JM, Robinson PJ, Sterner TR, Mattie DR, Clewell HJ 3rd. J Toxico l Environ Health A. 200 7 Mar 1;70(5):408-28. Greer MA, Goodman G, Pleus RC, Greer SE. Envir on Health Perspect. 2002 Sep;110(9):927-37. Merrill EA, Clewell RA, Robinson PJ, Jarabek AM, Gearhart JM, Sterner TR, Fisher JW. Toxicol Sci. 2005 Jan;83(1):25-43. National Research Council (NRC ). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on En vironmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2008. Inhibition of the Sodium-Iodide Symporter By Perchlorate: An Evaluation of Lifestage Sensitiv ity Using Physiologically Based Pharmacokinetic (PBPK) Modeling. U.S. Environmental Pr otection Agency, Washington, D.C., 2009.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20945

EPA Comment Code: 2100

Comment: The EPA Reference Dose is not Adequa tely Protective of Human Health

The EPA Reference Dose is based on a Limited Study

The EPA Reference Dose for perchlorate is based on data from Greer et al. (2002) that observed the inhibition of radioiodide uptake. Ginsberg and Rice (2005) identified several problems with the Greer study that suggest the need for a reevaluation of the value that serves as the foundation for regulatory decision- making:

* Several individuals in the low dose group appear to demonstrate a response to perchlorate that is not evident in the reported mean. In analyzing this study, the National Academy of Sciences used the average response, and the significant variability in the response likely diminished the impact (e.g., as a result of reduced statistical po wer) of those showing a response.

* Ginsberg and Rice also point out that the apparent non-significant response resulted in the NAS characterizing the dose as a NOAEL, rather than a LOAEL. In their paper Ginsberg and Rice suggest an alternative interpretation that "[t]he data of Greer et al. (2002) point toward a more sensitive subgroup, which in this case represents more than half of the test group but is not evidentEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 78 of 1099 in the group mean analysis due to the variable nature of the response." If this is indeed the case then we can expect that there will be a wide range of susceptibility to perchlorate effects in the larger population.

Response: See response to comment ID 20641 under comment code 2100.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20957

EPA Comment Code: 2100

Comment: 2. The very particular case of perchlorate: Total effective perchlorate NOEL and RfD

-These food and drinking water perchlorate back ground levels are now known also for the U.S. population.

-These food and drinking water perchlorate background level are very low

-Therefore adding the background perchlorate level to the Greer (nominal) NOEL does not significantly increase the effective NOEL (from 7.0 to 7.04 ug/kg-day)

-However what significantly increases the nominal NOEL is the also known equivalent perchlorate background level caused by nitrate and thiocyanate and which results in an effective perchlorate equivalent NOEL of 12.8 ug/kg- day instead of 7 ug/kg-day.

Response: EPA believes that the Greer study as design ed and interpreted by the authors is the appropriate interpretation. Addition of a correction for other sources would significantly bias the results. This is especially true given that the mea sured change in RAIU was a change relative to the start of the study, not an unco rrected measure. The use of the st art of study measure effectively corrected for any background levels that existed on a subject by subject basis. Also, see response to

comment code 2100.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20963

EPA Comment Code: 2100

Comment: The NRC RfD on itself was based on the Greer et al., 2002(1) critical study.

NRC believed that the Greer study cohort that had been administered the perchlorate dose-response doses, was, in terms of competitive iodine upta ke inhibition caused by perchlorate (and, we suppose, by goitrogens in general), representative for the adult US population excluding the more sensitive subpopulations (The RfD took into account these subpopulations by applying an uncertainty factor, UF).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 79 of 1099 Conversely if this cohort would not have been repr esentative for this (general) segment of the US population, the Greer study outcome wouldn’t have been so either and therefore the resulting RfD couldn’t have been assumed to be health protective for the US population either.

To our knowledge no argument has emerged that pu t in doubt the representativeness of the Greer

cohort.

Response: EPA agrees.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20965

EPA Comment Code: 2100

Comment: The Greer study is a type 3 s et-up (see section 1.3 below).

EPA asserts that it was applying a "default" RSC to estimate its former recommended DWEL (Drinking Water Equivalent Level) of 24.5 ppb issu ed in 2005 and based on the Greer study . With all due respect, EPA rather found that the RSC was not applicable for the reasons explained before. Indeed arriving at a 24.5 ppb DWEL from the RfD of 0.70ug/kg-day implies a RSC equal to 1 according to above equation with BW= 70 kg and DW =2l/day.

1.3. The Greer trial set-up

The Greer study cohort, in order to determine do se-response effects, received several oral doses of perchlorate.

Those doses were in addition to their background pe rchlorate levels originating from DW and food background sources.

The Greer trial was thus a type 3 set-up.

In fact the real NOEL for perchlorate alone (NOE L2) was not 0.7ug/kg-day as generally assumed but 0.7ug/kg-day plus the background from food + water. Thus in fact the 0.7ug/kg-day Greer NOEL (NOEL1) was an approximate or nominal level.

Establishing DW maximum contaminant levels ba sed on trials where the contaminant is already consciously present in the background are not frequent but precedents do exist.

* The MCL of 2 ppm for barium was based on Wone s R.G et al, Lack of Effect of Drinking Water
Barium on Cardiovascular Risk Factors, Environm ental Health Perspectives Volume 85, 1990, a critical human study, analogue to the Greer 2002.

We quote from Massachusetts Department of Environmental Protection:

http://www.mass.gov/dep/water/drinking/standards /barium.htm: "The MCLG is based on the RfD (presented below) derived from the Wones et al., study. It assumes that a 70 kg adult ingests 2EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 80 of 1099 L/day of water. Since this value is based on a huma n study that considers contributions from food
and air, no relative source contribution wa s applied for drinking water exposures"

* Also the nitrate MCL of 10 ppm N (as nitrate) was based on 2 critical human studies:

-Bosch H et al., (1950). Methemoglobinemia and Mi nnesota well supplies. Journal of the American
Water Works Association 42:161-70, 1950 and

-Walton G (1951). Survey of literature relating to infant Methemoglobinemia due to nitrate contaminated water. Am. J. Public Health 41:986-9 6, 1951. There the RSC was considered as "not applicable" i.e. equal to 1.The RSC was not applicable because it did not have sense to apply it.

* The same reasoning went into the Cal. PHG (P ublic Health Goal) for fluorine: with an RSC = 100% followed by this

Comment: "OEHHA assumes that the populations unde r study exhibited comparable dietary and hygiene exposures to fluoride. Therefore, the rela tive source contribution factor is 100% to account for equal exposure of study populations to fluori de from sources other than drinking water (http://oehha.ca.gov/water/phg/pdf/fluor_c.pdf)

This is the same as saying that the study cohor t was representative for the California population and that therefore the average background, which already contained fluorine, should have been so too.

Response: No response is necessary to the informat ion provided by the commenter. Also, see response to comment code 2100.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20967

EPA Comment Code: 2100

Comment: B. The other goitrogens that are part of the background should be taken into account.

Most of the time, each contaminant has its own mode of action different from others or on different

moments.

This is not the case for NIS (Sodium Iodine Symporter) related inhibitors of iodine uptake such as nitrate, perchlorate and thiocyanate which are comp etitive inhibitors with simultaneous joint effects (4).

Once again, to our knowledge this is the first time that background data are available also for the other goitrogens .This would allow to calcula te an even more refined NOEL (NOEL4) and a corresponding HRL i.e. HRL4

In the Blount study those goitrogens were controlled for and evaluated when testing the relationship of perchlorate with T4 and TSH thyroid hormone s. Average urinary(U) th iocyanate and nitrate levels were 1.2 (1.08-1.33 at 95% CI) and 38 mg/l (35.9-40.3 at 95% CI) respectively which, whenEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 81 of 1099 applying the relative potencies compared with perchlorate of 1/15 and 1/240(2) respectively, translated into 80 and 158 ug /L respectively.

80 ug /L U thiocyanate corresponds with about 2. 8 ug/kg-day cyanide dietar y uptake, applying the same regression as for perchlorate and assumin g a 40% urinary recovery from cyanide and thioglucosides, the precursors of thiocyanate (5, 6).

158 ug /L U nitrate corresponds with about 3.0 ug/k g-day nitrate dietary uptake, applying the same regression as for perchlorate and assuming a 75 % urinary recovery (7, 8).

The total average perchlorate equivalent background is therefore estimated at 0.04 + 2.8 + 3.0 =5.8 ug/kg-day.

This comes down to trial set-up type 3 instead that the DW perchlorate BG plus the perchlorate equivalent BG should be added to the RfD and with RSC =1 since all contributors are now captured in the effective total equivalent NOEL (= NOEL4) and RfD (=RfD4) as shown in the following equations and fig.4 :

NOEL4= NOEL1 dose +FBG+ DWBG + PEBG.

RfD4= NOEL4/UF= NOEL4/10

HRL4 = [(RfD3 +PEBG) Ã— BW)/DWI] Ã— RSC= [(RfD4) Ã— BW)/DWI] x 1

Fig. 4: NOEL based on dose-response trial with pe rchlorate food background and with drinking water background: perchlorate equivalent ba ckground. [see PDF Docket ID EPA-HQ- OW-2008- 0692-1798]

So the background levels of the other 2 goitro gens are substantially more relevant than the perchlorate back ground level itself.

This increases the effective perchlorate equivale nt NOEL (NOEL4) to 7 ug/kg-day +5.8 ug/kg-day = 12.8 ug/kg-day which would have lead to a to tal goitrogen RfD4 of 1.28 ug/kg-day and a DW HRL4 of 44.8 ppb for perchlorate and nitrate/240 tog ether (Thiocyanate in DW is negligible in the absence of a point source contamination).

Indeed when applying an RSC =1, BW= 70kg an d DWI = 2 l/day, the HRL equation becomes:

HRL4 = [(RfD4 Ã— BW)/DWI] Ã— RSC = 44.8 ppb =45 ppb

So the perchlorate equivalent effect due to the ot her 2 goitrogens has a much larger impact on the final optimal HRL (HRL4) than the perchlorate background itself but has not been taken into

consideration.

Response: While EPA acknowledges that nitrate and th iocyanate have the same mode of action as perchlorate, and that the effects of combined expo sure to perchlorate, nitrate, and thiocyanate are
additive, EPA does not believe there are sufficient scientific data currently available to assess and

characterize the combined risk of these contam inants. EPA has committed to a drinking waterEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 82 of 1099 strategy that outlines four principles to expand public health protection for drinking water. One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchlorate should be further delayed. Therefore, EPA intends to develop a proposed rule for perchlorate. At such time as a NPDWR is promulgated, EPA is required to review and revise, as appropriate, its dr inking water standards at least every six years. Any revision must at least maintain or improve public health protection. When there are sufficient

scientific data to assess the cumulative risks of perchlorate and other contaminants, EPA will review this information to evaluate whether any new or revised NPDWRs are appropriate.

Commenter Name: Commenter Organization: Ag Council et al

EPA Document ID: EPA-HQ-OW-2008-0692-1987

EPA Comment ID: 20975

EPA Comment Code: 2100

Comment: The NAS Study is the Most Comprehensive Sc ientific Review on the Health Effects of

Perchlorate to Date.

We support EPA's decision to rely on the recommen dations of the NAS perchlorate review panel in deriving a reference dose (RfD). From our pe rspective, the NAS panel conducted a thorough scientific inquiry of the available health effects literature in a highly professional and independent manner. The Panel's 2005 recommendations, based upon the best science then available, continue to be validated by new scientific studies on perchlora te health effects and exposures. It is critically important to bear in mind that the NAS panel view s the perchlorate RfD as providing a large margin of safety because it is based on a No-Obser ved-Effect-Level (NOEL) as opposed to EPA's traditional approach of deriving the RfD from a No-Observed-Adverse-Effect-Level (NOAEL). The NOEL is a precursor effect (inhibition of iodine uptake by the thyroid) to an actual adverse effect (hypothyroidism). The RfD also incorporates a 10-fold safety factor to account for variability in the human population. For these reasons, the NA S views the RfD as highly health protective, even for sensitive subpopulations.

Response: See response to comment code 2100.
Greer MA, Goodman G, Pleus RC, Greer SE. He alth effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9):927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732. National Research Cou ncil (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20984

EPA Comment Code: 2100

Comment: A reference dose (RfD) is an estimate of the daily exposure to an agent over a full lifetime that is "likely to be without an appreci able risk of deleterious effects" for the humanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 83 of 1099 population, including sensitive subgroups.[FN13: EP A Integrated Risk Information System (IRIS) Glossary of terms. http://www.epa.gov/ncea/iris/help_gloss.htm#r] In 2005, the National Research Council (NRC) of the National Academy of Sciences recommended an RfD for daily intake of perchlorate that it considered to be an acceptable level of exposure of 0.7 ug/kg/day.[FN14: NRC. 2005. Health Implications of Perchlorate Ingestion. National Research

Council of the National Academies. National Acad emies Press, Washington, D.C.] EPA adopted this RfD and posted on its public database, the Integrated Risk Information System (IRIS) in February 2005.[FN15: EPA IRIS assessment of perchlorate. http://www.epa.gov/NCEA/iris/subst/1007.htm]

Response: No response is necessary to the informat ion provided by the commenter. Also, see response to comment code 2100.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20986

EPA Comment Code: 2100

Comment: The RfD for perchlorate and perchlorate salt s of 0.7 ug/kg body weight/day is based on a human volunteer study, Greer et al, 2002.[FN16 : Greer, M.A., Goodman, G., Pleuss, R.C., Greer, S.E. 2002. Health effect assessment for environmental perchlorate contamination: The dose response for inhibition of thyroidal radioiodide uptake in humans. Environ. Health Perspect. 110:927-937.] The RfD is for oral exposure, incl uding food and water, and is based on radioactive iodide uptake inhibition (RAIU) in the thyroid as the critical effect. The IRIS assessment of perchlorate explains that "The point of departur e is based on a non-statistically significant mean 1.8% (standard error of the mean 8.3%) decline in RAIU in healthy adults following two weeks exposure to a daily perchlorate dose of 0.007 mg/k g/day. An intraspecies uncertainty factor of 10 is applied to protect the most sensitive population, the fetuses of pregnant women who might have hypothyroidism or iodide deficiency. Dose is given as perchlorate anion."[FN17: EPA. IRIS database. Perchlorate and perchlorate salts. http ://www.epa.gov/ncea/iris/subst/1007.htm#revhis]

Response: No response is necessary to the informat ion provided by the commenter. Also, see response to comment code 2100.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20987

EPA Comment Code: 2100

Comment: The RfD adopted by EPA has been widely crit icized as inadequately protective by state scientific experts[FN18: Ginsberg G and D Rice. The NAS perchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] an d by EPA's own Children's Health Protection Advisory Committee,[FN19: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/PerEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 84 of 1099 chlorateLetter.pdf] and no longer reflects the best available data.[FN20: EN Pearce, AM. Leung, BC
Blount, HR Bazrafshan, X He, S Pino, L Valentin -Blasini, and LE Braverman, 2007. Breast milk iodine and perchlorate concentrations in lactating Boston-area women. J Clin Endocrinol Metab. 92(5):1673-7.] [FN21: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] However, even when basing it s decision upon this unacceptably high RfD, EPA's preliminary determination not to regulate perchlorate would still expose hundreds of thousands of children and infants to unsafe levels of perchlorate.

Response: EPA respectfully disagrees with the commen ter. See response to comment code 2100.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20994

EPA Comment Code: 2100

Comment: D. EPA relies on the RfD based on the comparatively weak Greer et al study to

determine the HRL

In simple terms, the HRL is the maximum tolerable am ount of perchlorate that could be in drinking water, considering that perchlorate is also in f ood, and still keep daily consumption levels from exceeding the RfD. The HRL was calculated as follows: For all populations, including pregnant women, EPA determined that the RfD is 0.7 ug/kg /day. This value is posted on the IRIS database based on recommendations from a committee of the National Academies. EPA reports that for pregnant women, exposure to perchlorate from f ood is 0.263 ug/kg/day at the 90th percentile (based on data from a national food survey), repres enting nearly 38% of the RfD, thus leaving an RSC (relative source contribution) for water of 62 % (FR at 60276). This is equivalent to 0.437 ug/kg/day from water, assuming an average body weigh t of 70 kg, and a daily water consumption of 2 L (90th percentile adult water consumption). That is, 0.437 ug x 70 kg body wt. = 30.6 ug perchlorate in 2 L (the daily consumption amoun t). This is 15 ug/L, or 15 ppb, the HRL.

Because the dose-response relationship used to dete rmine the RfD is derived exclusively from the Greer et al study, the HRL also is dependent on the Greer et al study to determine the maximum allowable level of drinking water contamination.

The Greer et al study [FN34: Greer MA, G Good man, RC Pleus, and SE Greer. 2002. Health effects assessment for environmental perchlorate contamination: the dose- response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.] reported on study results from intentional dosing of a small population (N=37) of healthy men and women, for only two weeks, and the study lack ed measurements of iodine stat us that is now known to be a critical variable. Other serious problems with the Greer study included the fact that the low dose group contained only seven participants including only six women. Use of these limited data to calculate a regulatory trigger level has been wide ly criticized as inade quate by state scientific experts[FN35: Ginsberg G and D Rice. The NAS pe rchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] and by EP A's own Children’s Health Protection AdvisoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 85 of 1099 Committee,[FN36: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] and no longer reflects the best available data.[FN37: EN Pearce, AM. Leung, BC
Blount, HR Bazrafshan, X He, S Pino, L Valentin -Blasini, and LE Braverman, 2007. Breast milk iodine and perchlorate concentrations in lactating Boston-area women. J Clin Endocrinol Metab. 92(5):1673-7.][FN38: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] Despite these limitations, careful analysis of the Greer data reveal clear evidence of perchlorate toxicity in the low-dose group; th ree subjects showed no perchlorate effect, but four subjects in the low-dose group had a measurable decrease in iodide uptake commensurate with perchlorate exposure.[FN39: For a complete analys is of the NAS review of perchlorate, see: Ginsberg G and D Rice. The NAS perchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117- 9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] Because the study authors relie d on averaged data rather than individual data, the more sensitive individuals in the study group were obscured

The short duration of the Greer study, only 14 days, creates considerable uncertainty that the cumulative effect of longer-ter m exposure are accounted for. A study in rats found greater perchlorate toxicity to the thyroid from 90- day exposure than from 14-day exposure (Springborn Laboratories 1998), suggesting that cumulative exposure may cause significant systemic injury that is not detectable in a short-term study. Although one longer-term (six month) human study with 13 volunteers has been promoted by industry as indi cating that humans adapt to long-term exposure (Braverman et al. 2006[FN40: Braverman LE, EN Pearce, X He, S Pino, M Seeley, B Beck, B Magnani, BC Blount, and A Firek. 2006. Effects of six months of daily low-dose perchlorate exposure on thyroid function in healthy volunteers. J Clin Endocrinol Metab. Jul; 91(7):2721-4. Epub 2006 Apr 24.]) this study was unlikely to have adequate statistical power to detect an effect, especially given the particular vulnerability for so me populations. The Blount (2006) study showed that some people are much more vulnerable to perchlorate toxicity than the average population; women are more sensitive than men, iodine-deficient women are more sensitive than iodinesufficient women, and iodine-deficient women with TSH levels on the high end of the normal range

are even more sensitive than other iodine-deficie nt women.[FN41: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perc hlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.] Other human studies suffer fr om the same limitations. For example, a study of chronically perchlorate-exposed pregnant wo men in Chile[FN42: Tellez RT, PM Chacón, CR Abarca, BC Blount, CB Van Landingham, KS Cr ump and JP Gibbs. 2005. Long-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal period. Thyroid 15(9):963-975.] that also failed to find an effect of perchlorate exposure had only three iodine- deficient female subjects out of 183.

Response: Regarding this comment encouraging EPA to review additional data to support the perchlorate regulatory determination, EPA will contin ue to rely on the best available science as it proceeds through the rulemaking process.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 86 of 1099 Please see the response to comment ID 20987 under comment code 2100, and the response to

comment code 2100 for a discussion of the RfD. Pl ease see the response to comment code 5220 for

a discussion of alternative Health Reference Levels.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20999

EPA Comment Code: 2100

Comment: EPA tries to support its conclusions that the HRL is safe by avoiding referring to the RfD, and instead referring to the level of inhibi tion of RAIU on which the NRC report (NRC, 2005) based its recommended RfD.[FN54: 73 Fed. Reg. at 60277.] EPA cannot pretend that its own RfD does not exist, and shift its evaluation of accep table exposure estimates to a discrete biological endpoint.

Response: Please see the response to comment code 52 20 for a discussion of alternative Health Reference Levels. Please see the response to comment ID 20987 under comment code 2100, and the response to comment code 2100.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21022

EPA Comment Code: 2100

Comment: 5. Your letter also raises concerns with th e Greer et al. study, stating that the RfD is uncertain and not necessarily a health protective benchmark because Greer was a short-term study with a small sample size.

The NAS perchlorate panel addressed this very i ssue at length in their comprehensive report, pointing out that there were four doses across 37 subjects. Second, the panel concluded that since the point of departure is based upon IUI- a short- term event- any chronic effects "would have no greater effect" than any short term effects that may occur (NAS, 2005). Importantly, the NAS also

noted that it did not examine Greer in isolation. The NAS noted that the findings in Greer are supported by other clinical studies, occupational and environmental epidemiological studies, and studies of long-term perchlorate administration to patients with hyperthyroidism. ATSDR reviewed all the literature in its 2008 toxicology document and still agrees that Greer et al. (2002) is the best study to determine a point of departure for a toxicity guideline value.

Response: Please see response to comment code 2100.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21056

EPA Comment Code: 2100EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 87 of 1099 Comment: [Text Box: On basing an RfD on a no effect level for a non adverse effect, the NRC states: "Inhibition of iodide uptake by the thyroid cl early is not an adverse effect; however if it does not occur, there is no progression to adverse health effects."]

For this current regulatory determination, EPA has the benefit of a rigorous and independent peer

review of the available science. These include th e study by the NRC and more recently the Agency for Toxic Substances and Disease Registry, an agen cy of the Department of Human Health Services (ATSDR, 2008).

In 2005, the NRC perchlorate panel reached a consensus and recommended an RfD of 0.0007 mg/kg per day. The NRC panel comprised 15 leadin g scientists and physicians with wide-ranging expertise necessary to evaluate all aspects of the available science related to perchlorate. The NRC process occurred over a 15- month time period, providing ample time for the panel to review studies and consider oral testimony and written co mments prior to issuing its conclusions and recommendations. As part of this process, the NRC panel performed an exhaustive review of the wide body of available animal and human studies as well as other scientif ic data relevant to understanding the health effects of perchlorate. The NRC panel noted that "emphasis was given to

studies with the soundest scientific methods to dr aw conclusions regarding the effects of perchlorate exposure" (NRC, 2005).

The charge to the Committee was to "critically ev aluate the scientific literature, including both human and animal data, and...assess the key stud ies underlying EPA's 2002 Draft Toxicological

Review and Risk Characterization for Perchlorate in terms of quality, reliability, and relevance to draw conclusions about the health implications of exposure to low levels of perchlorate in drinking

water." As stated in the NRC Committee Report, "EPA has been criticized that it did not appropriately consider all the relevant data for it s assessments and that it based its conclusions on flawed scientific studies" (NRC, 2005).

The NRC independently evaluated the science which was published in the report Health Implications of Perchlorate Ingestion (2005). Th e NRC report recommended an RfD of 0.7 ug/kg-d based on a No Observed Effect Level (NOEL), or th e dose at which no effects occur, adverse or otherwise (NRC, 2005). One of the critical studies th at served as the basis for this RfD was the study by Greer et al. (2002) which demonstrated that there was no inhibition of iodide uptake by the thyroid at a dose of 7 ug/kg-d. Importantly, the NRC did not examine Greer in isolation. According to the NRC report, the findings in Greer are supported by other clinical studies, occupational and environmental epidemiologic studies, and studies of long-term perchlorate administration to patients with hyperthyroidism.

Further, the NRC states with emphasis, "Inhibition of iodide uptake by the thyroid clearly is not an
adverse effect; however if it does not occur, ther e is no progression to adverse health effects." The committee views its recommendation to use [IUI] by th e thyroid as the basis of the perchlorate risk assessment to be the most health-protective an d scientifically valid approach (NRC, 2005).

[Text Box: After review all scientific data, includin g studies since the release of the NRC perchlorate review, ATSDR has adopted the EPA's chronic RfD recommended by the EPA (2005) for the chronic MRL"]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 88 of 1099 In using a NOEL, the NRC committee was conservative as this dose is already lower than any dose in which adverse effects occur; a safety factor of 10 is further applied to the already conservative

NOEL to account for the most sensitive individual s in a population, in this case, hypothyroid or iodine- deficient pregnant women and their developi ng fetuses. The NRC pane l stated that using a NOEL as the point of departure is a more conserva tive and health- protective approach than EPA's customary approach of using the adverse effect (NRC , 2005). Thus, for example, the use of IUI as a point of departure is a more cautious health pro tective approach than using changes in thyroid hormones (a precursor to possible adverse e ffects) or to some adverse effect such as hypothyroidism.

The panel also took time to differentiate betw een a NOAEL and a NOEL, finding that there was confusion between the two and stating that the NO AEL is based upon an adverse effect, whereas the NOEL is based upon a nonadverse effect (N RC, 2005). With the incorporation of an uncertainty factor of 10, the RfD recommended by th e NRC was many times lower than the point at which adverse effects occur. It should be noted that the NRCNRC report concluded that no other uncertainty factors were necessary. Specifically on the issue of adequacy of database, the NRC concluded that the database contained sufficient studies from which to determine an RfD, finding

that the database contained both human and animal data from which to evaluate IUI. The NRC also concluded that no LOAEL to NOAEL conversion factor was required, since the point of departure was the NOEL, again, a more conservative approach . Some have also argued that the Greer study was of short duration and have argued for a subchr onic to chronic extrapolation. On that issue, the NRC concluded that since the point of departure is based upon IUI-a short- term event-any chronic effects "would have no greater effect" than any short term effects that may occur. (NRC, 2005).

The EPA has based its RfD for perchlorate and Integrated Risk Information System (IRIS) summary on the NRC report.

Response: No response is necessary to the informat ion provided by the commenter. Also, see response to comment code 2100.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21059

EPA Comment Code: 2100

Comment: It should be noted that the RfD aims to protect the most sensitive individuals within a population (i.e., pregnant women and their fetuses). Wh ile some have argued that the infant or child is the more sensitive individual in the population; the experts of the Perchlorate NRC committee, EPA, ATSDR, OEHHA, and others, disagree. In addi tion, no reliable scientific data at relevant environmental exposures for this change in sensitive population has been put forward. One of the central considerations in these arguments is the di sregard of dose and exposure. Any chemical at a

sufficient dose will cause an adverse effect.

[Text Box: Studies published since the NRC repor t in 2005 add to an already well-developed database, adding more studies that are consistent to previous analyses and reducing uncertainty. Thus, the science supports EPA's decision that the current RfD for perchlorate is both conservative and health protective to even the most sensitive individuals.]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 89 of 1099 However, dose is a foundational tenant of the standard medical sciences (e.g., toxicology, endocrinology, pharmacology, etc.). Dose consid eration is an absolute foundation of the risk assessment process by all recognized authoritative bodies.

Response: See response to comment code 2100.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21067

EPA Comment Code: 2100

Comment: First, as stated above, ATSDR (2008) reviewed this study in their assessment and did not feel that it merited any special consideration over other studies in the well developed perchlorate literature database. They state that their decision ". ..was made after a careful evaluation of the NRC report and of studies that have been published af ter the NRC (2005) report. The results from newer studies do not change the bottom-line recommendation" (ATSDR, 2008).

Response: No response is necessary to the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21094

EPA Comment Code: 2100

Comment: EPA has provided sufficient support for its findings under the SDWA. To take the statutory criteria in turn:

May perchlorate have an adverse effect on the health of persons?

Everything - including water itself - may cause an ad verse effect if the dose is sufficiently high. The plain meaning of the first criterion relates to the dose of the contaminant at levels which people are likely to be exposed to through drinking water.

The scientific literature is clear that perchlorate will not cause adverse effects at the concentrations under review here. The NAS report declares,

An important point is that inhibition of thyroid iodide uptake is the only effect that has been consistently documented in humans exposed to pe rchlorate. The continuum of possible effects of iodide-uptake inhibition caused by perchlora te exposure is only proposed and has not been demonstrated in humans (with the exception that in patients with hyperthyroidism doses of 200 mg daily or higher may reduce thyroid secretion). More importantly, the outcomes at the end of the continuum are not inevitable consequences of thyroid exposure.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 90 of 1099 In other words, except for its deliberate medical use, perchlorate has never been shown to have
caused adverse effects in humans. Moreover, the NA S also concluded that perchlorate is not likely to be a carcinogen.

In addition to the NAS conclusions, subsequent studies indicate perchlorate has not been

demonstrated to have an adverse effect on the health of persons at environmentally relevant levels (Blount et al., 2006). The weight-of-evidence suggest s that adverse effects do not occur following chronic exposures to perchlorate at doses much greater than the RfD (Tellez et al., 2005; Amitai et al., 2006; Braverman et al., 2006).

Response: EPA’s final determination to regulate perchlor ate is based upon the National Research Council’s 2005 (NRC, 2005) recommendation to use data from a human clinical study (Greer et al. 2002) as a basis for the human health risk assessm ent, and as a basis for the RfD. On August 19, 2009, EPA published a FR Notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (FR Vol. 74, No. 159, p. 41883). In this August 19, 2009 FR Notice, EPA requested comm ents on additional interpretation of data on the level of human health concern, perchlorate fre quency of occurrence in drinking water, and the opportunity for health risk reduction through a nati onal primary drinking water standard. EPA has

considered and discusses in the FR Notice the resu lts of current scientific literature on potential adverse biochemical effects, in the process of ev aluating the adverse human health effects of perchlorate. See response to comment code 2100.

Greer MA, Goodman G, Pleus RC, Greer SE. He alth effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9):927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732. National Research Cou ncil (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp.

Commenter Name: Ellen Blaschinski, M.B.A., R.S. Commenter Organization: Regulatory Services Branch, Connecticut Department of Public Health

EPA Document ID: EPA-HQ-OW-2008-0692-2091

EPA Comment ID: 21114

EPA Comment Code: 2100

Comment: November 21, 2008 Water Docket Environmental Protection Agency Mailcode 2822T 1200 Pennsylvania Ave, NW Washington DC 20 460 Re: Docket 1D No. EPA-HQ-OW-2008-0692

The Connecticut Department of Public Health appreciates this opportunity to comment on the Agency's Preliminary Regulatory Determination fo r Perchlorate dated Oct 10, 2008. We have been following perchlorate closely because of its to xic properties and widespread occurrence in the human environment, particularly in food and wa ter supplies impacted by local sources. It appears that risks from perchlorate in drinking water coul d be appreciable during the perinatal period in cases where iodine intake is marginal. This concern comes from the CDC study showing that perchlorate body burden is correlated with decrea sed thyroid hormone levels in the 31% of US women with low iodide intake (Blount et al. Envi ron Health Perspect 114:1865, 2006). Given the sensitive relationship between thyroid hormone and brain development, it is critical that the perinatal period be adequately protected from agents which can interfere with thyroid hormoneEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 91 of 1099 production. Therefore, regulting perchlorate in drinking water represents a meaningful opportunity for EPA to safeguard public health by setti ng a health-protective Maximum Contaminant Level (MCL) and then by requiring water supplies to regularly rest for this analyte.

Response: Please see the response to comment ID 20975 under comment code 2100.

Commenter Name: John P Gibbs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28550

EPA Comment Code: 2100

Comment: My comments are in the attached file.

John P Gibbs, MD 300 Fischer Store Road Wimberley,TX 78676 phone 512/847-2748 cell: 512/667-0625 email jpgibbs@hughes.net

ENVIRONMENTAL PROTECTION AGENCY OFFICE OF WATER [EPA-HQ-OW-2009- 0297; FRL-8943-9], RIN 2040-AF08 Drinking Wa ter: Perchlorate, Supplemental Request for Comments Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices

Water Docket, EPA Docket Center (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. (202) 566-2426.

Dear Sirs,

I appreciate the opportunity to comment on the Un ited States Environmental Protection Agency (U.S. EPA) Office Water regarding its request for supplemental comments. I have been very active with the perchlorate issue over the past 11 years.

John P. Gibbs, MD PO Box 2 948, 300 Fischer Store Road Wi mberley, Texas 78676 Phone: 512-
847-2748, cell 512-667-0625 Em ail: jpgibbs@hughes.net

1) The 2005 NAS REPORT

Perchlorate is one of the most well-studied chem icals with detailed information on the mechanism of action, dose-response, and health effects. Th e 2005 NAS report was a comprehensive review of the science. The animal and human studies that have been published since the NAS report reduce the uncertainty and reinforce the NAS panel's finding that there will not be any adverse health effects from perchlorate at environmentally-relevant concentrations

In using a NOEL, the NAS committee deemed its appr oach as conservative and health protective as this dose is already lower than any dose in which adverse effects occur. Furthermore, a safety factor of 10 is applied to the NOEL to account for the mo st sensitive individuals in a population, in this case, hypothyroid or iodine-deficient pregnant wo men and their developing fetuses. The NAS panel stated that "the NOEL value from Greer et al. (200 2) is a health- protective and conservative point of departure is supported by...extensive human and animal data that demonstrate that there will be no progression to adverse effects if no i nhibition of iodide uptake occurs"EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 92 of 1099 Response: For the reasons provided in the preliminary and final determinations, EPA has found that perchlorate may have an adverse effect on hu man health. Also, see response to comment code

2100.

Commenter Name: John P Gibbs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28554

EPA Comment Code: 2100

Comment: 5) CONCLUSIONS

The 2005 NAS report remains the most credible and complete assessment on potential toxicity of perchlorate from environmental sources. All scient ific reports issued after the NAS report (with the exception of Blount et al 2006) support that the RfD recommended by the NAS is protective for sensitive subpopulations. Setting an MCL for perchl orate in drinking water below 15 or 24 ug/L does not provide meaningful opportuni ty for improving public health.

Response: EPA has considered the results of current scientific literature on potential adverse biological effects, in the process of evaluating th e adverse human health effects of perchlorate. The Agency analyzed the additional information, an d EPA has determined that a national primary drinking water regulation for perchlorate would present a meaningful opportunity for health risk reduction for persons served by public water systems, and that regulation of perchlorate in drinking water due to occurrence and health implications is warranted. EPA will continue to evaluate all of the available science related to perchlorate as the Agency develops a National Primary Drinking Water Regulation for perchlorate. See respons e to comment code 5220 for a discussion of

alternative Health Reference Levels.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28678

EPA Comment Code: 2100

Comment: The NAS Report Remains the Most Comprehensive Scientific Review on the Health

Effects of Perchlorate to Date.

The National Academy of Sciences conducted a thorough inquiry of the perchlorate health effects literature in a highly professional and independ ent manner. The Panel's 2005 recommendations, based upon the best science available, continue to be validated by new scientific studies on perchlorate health effects and exposures. It is crit ically important to bear in mind that the NAS panel views its recommended perchlorate reference do se (RfD) as providing a large margin of safety

because it is based on a No-Observed-Effect-Level (NOEL) -- inhibition of iodine uptake by the thyroid - rather than the traditional approach of starting from a No-Obs erved-Adverse-Effect-Level (NOAEL). The NOEL is the level below which exposur e to a substance fails to elicit any biological response at all, and in the case of perchlorate is orders of magnitude below the levels at whichEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 93 of 1099 adverse effects may occur. The NAS perchlorate panel further reduced this NOEL by a factor of 10 to account for variations in human response, lead ing them to conclude that their recommended RfD is highly health protective, even for sensitive subpopulations.

Further downward adjustment of the RfD base d on body weight and water consumption rates at various life stages, as contempla ted in EPA's proposed alternative health reference levels, is needlessly duplicative and provides no additiona l health protection for any population. Moreover, EPA has not presented any scientific evidence indica ting why its current perchlorate health reference level (15 ppb), which is based on the most sens itive sub-population (the pregnant woman/fetus), and which incorporates a ten-fold safety factor to account for variability in human response, is inadequate.

Response: See response to comment code 5220 for a discussion of alternative Health Reference

Levels.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28695

EPA Comment Code: 2100

Comment: The NRC perchlorate panel (2005) and th e EPA agreed that the most susceptible population are "the fetuses of pregnant wome n who might have hypothyroidism or iodide deficiency" but also identified infants and developing children as additional "sensitive populations." Epidemiological data shows that at perchlora te exposures above and below the EPA's Reference Dose (RfD) for perchlorate, no adverse health effects were documented in adults and children exposed chronically to perchlorate via drinking water (Crump and Gibbs 2005; Tellez, Chacon et al. 2005; Amitai, Winston et al. 2007).

Response: See response to comment code 2100 and today’s Federal Register notice for a discussion of EPA’s finding of possible adverse health effects.

Commenter Name: Robert E. Brackett Commenter Organization: Grocery Manufacturers Association (GMA)

EPA Document ID: EPA-HQ-OW-2009-0297-0413

EPA Comment ID: 28707

EPA Comment Code: 2100

Comment: Second, EPA must make it clear to the public that the starting point for determining the Reference Dose (RfD), a safe daily exposure level fo r perchlorate, is a biological effect that is not itself harmful, and does not indicate any harm will occur. In 2005, an expert panel of the National Research Council (NRC) reviewed the evidence and determined a reference dose (RfD) for perchlorate based on a No Observed Effect Leve l (NOEL) in a study in human subjects. The NOEL is the lowest observed dose at which no biolog ically significant changes are observed, and it is a lower does than the customary starting poi nt for an RfD, the No Observed Adverse Effect Level (NOAEL), the dose at which no adverse effects are observed. Humans and animals have built-in, compensatory mechanisms that assure th eir survival over a wide range of complex and continually changing challenges. Biological chan ges that are part of these normal compensatoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 94 of 1099 mechanisms are considered adaptive, not adverse. The NRC experts specifically articulated that extra measure of protection inherent in their use of the NOEL. In addition, they used a safety factor of 10 to account for any variations in sensitivity within the population potentially at risk, hypothyroid or iodine deficient pregnant women and developing fetuses. The NRC approach assures that, even if the sensitive population were to experience an exposur e as high as the RfD there is a high degree of

confidence that no adverse effects will occur.

Response: EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. EPA notes that the data underlying the definition of iodide uptake inhibition as a precursor effect and th e relationship of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in adults; it may not reflect the relationship of the precursor event to adverse outc omes in neonates and infants, who may not have iodide stores sufficient to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a pr ecursor event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 levels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (Greer et al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[ T]he minimal prolonged decrease in thyroid hormone production that would be associated wi th adverse health effects is not known; any decrease is potentially more likely to have adve rse effects in sensitive populations (people with thyroid disorders, pregnant women, fetuses, and in fants) but data are not available to determine the magnitude of the decrease needed to ca use adverse effects in those populations.”

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28740

EPA Comment Code: 2100

Comment: Moreover, a 1 ppb or lower MCL is supported by the most recent comprehensive
studies, and these should be central to EPA’s an alysis. The industry-supported Greer study, which

serves as the basis for EPA’s current reference do se as well as California's current 6 ppb standard, consisted of a 14-day study of 37 healthy adults. In more recent years, Blount et al analyzed a nationally representative sample of 2299 U.S. re sidents, and they have documented anti- thyroid effects in a large population of women exposed to perchlorate at concentrations far lower than levels previously shown to have such effects. Th is study and subsequent data clearly justify promulgation of an even more protective MCL. It should be noted that California's Office of Environmental Health Hazard Assessment is in the process of reevaluating its Public Health Goal,

on which the state MCL is based.

Response: See response to comment code 5220 for a discussion of alternative Health Reference Levels and response to comment code ID 28936 un der comment code 2100 for a discussion of the Blount et al study. EPA will conduct further anal ysis in developing a proposed MCL and MCLG for perchlorate.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28794EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 95 of 1099 EPA Comment Code: 2100

Comment: A reference dose (RfD) is an estimate of the daily exposure to an agent over a full lifetime that is "likely to be without an appreci able risk of deleterious effects" for the human population, including sensitive subgroups.[FN13: EP A Integrated Risk Information System (IRIS) Glossary of terms. http://www.epa.gov/ncea/i ris/help_gloss.htm#r] The RfD is not an enforceable regulatory standard; it can be used with exposure information to set clean up levels. In 2005, the National Research Council (NRC) of the National Academies of Science recommended an RfD for daily intake of perchlorate that it consid ered to be an acceptable level of exposure of 0.7 ug/kg/day.[FN14: NRC. 2005. Health Implications of Perchlorate Ingestion. National Research

Council of the National Academies. National Acad emies Press, Washington, D.C.] EPA adopted this RfD and posted on its public database, the Integrated Risk Information System (IRIS) in February 2005.[FN15: EPA IRIS assessment of perchlorate. http://www.epa.gov/NCEA/iris/subst/1007.htm] Wh ile IRIS values are not regulations per se, they are used by both state and federal regulators and by the international community for a range of environmental health regulation and management purposes. For example, the information can be used in combination with exposure data to set clea nup levels at hazardous waste sites, or to set exposure standards for air, water, soil, and food. Thus, the accuracy, credibility, and timeliness of IRIS assessments have real world consequences for human health.

In simple terms, the HRL is the maximum contamin ation level of perchlorate that could be in drinking water, and still keep daily human consumption levels from exceeding the RfD of 0.7 ug/kg/day. It is not an enforceable standard. EP A reports that for pregnant women, exposure to perchlorate from food is 0.263 ug /kg/day at the 90th percentile (b ased on data from a national food survey), representing nearly 38% of the RfD, th us leaving an RSC (Relative Source Contribution) for water of 62%.[FN16: 73 Fed Reg at 60276] This is equivalent to 0.437 ug/kg/day from water, assuming an average body weight of 70 kg, and a da ily water consumption of 2 L (90th percentile adult water consumption). That is, 0.437 ug x 70 kg body wt. = 30.6 ug perchlorate in 2 liters (the daily consumption amount). This is 15 ug/L, or 15 ppb, the originally proposed HRL.

The RfD for perchlorate and perchlorate salts of 0.7 ug/kg body weight/day is based on a human volunteer study, Greer et al, 2002.[FN17: Greer, M. A., Goodman, G., Pleuss, R.C., Greer, S.E. 2002. Health effect assessment for environmental perc hlorate contamination: The dose response for inhibition of thyroidal radioiodide uptake in humans. Environ. Health Perspect. 110:927-937. Docket HQ- OW-2009-0297 NRDC supplemental comme nts on perchlorate] The RfD is for oral exposure, including food and water, and is based on radioactive iodide uptake inhibition (RAIU) in the thyroid as the critical effect. The IRIS assessm ent of perchlorate explains that "The point of departure is based on a non- statistically signific ant mean 1.8% (standard error of the mean 8.3%) decline in RAIU in healthy adults following two weeks exposure to a daily perchlorate dose of 0.7 ug/kg/day. An intraspecies uncertainty factor of 10 is applied to protect the most sensitive population, the fetuses of pregnant women who migh t have hypothyroidism or iodide deficiency. Dose is given as perchlorate anion."[FN18: EPA. IRIS database. Perchlorate and perchlorate salts. http://www.epa.gov/ncea/iris/subst/1007.htm#revhis]

The RfD adopted by EPA has been widely criticized as inadequately protective by state scientific experts[FN19: Ginsberg G and D Rice. The NAS pe rchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] and by EP A's own Children's Health Protection AdvisoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 96 of 1099 Committee,[FN20: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] and no longer reflects the best available data.[FN21: EN Pearce, AM. Leung, BC
Blount, HR Bazrafshan, X He, S Pino, L Valentin -Blasini, and LE Braverman, 2007. Breast milk iodine and perchlorate concentrations in lactating Boston-area women. J Clin Endocrinol Metab. 92(5):1673-7.] [FN22: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/conten t/perchlorateletter.htm /$file/PerchlorateLetter .pdf]

Response: Please see the response to comment ID 28818 under comment code 2100.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28818

EPA Comment Code: 2100

Comment: Acronyms: BAF: Background Adjusting Factor BW: Body weight of an adult (70Kg) DW: Drinking-Water DWL: Daily Drinking-Wa ter Consumption in litres (2 l) GREER_NOEL: Greer 2002 NOEL(7ug/kg -day) NAS: National Ac ademy of Sciences NOEL: Non Adverse Effect

Level MCL: Maximum Contaminant Level OIG: EPA's Office of Inspection General PEC: Perchlorate Equivalent Concentration PEC-NOEL : Perchlorate Equivalent Concentration NOEL PEC-PHG : Perchlorate Equivalent Concentration PHG PHG: Public Health Goal RfD: Reference

dose RSC: Relative Source Contribution SPEC: Se rum Perchlorate Equivalent Concentration RAIU: Radioactive Iodine Uptake TGL: Total Urinary Go itrogen Load expressed in PEC: [Perchlorate] + [nitrate/150] + [thiocyanate/8.8] TH: thyroid Hormone UF: Uncertainty Factor UPEC: Urinary Perchlorate Equivalent Concentration

Executive Summary

In evaluating the risks posed by perchlorate and th e value of regulation through establishment of an MCL, EPA is relying on information derived from a flawed analysis of the impacts of perchlorate exposure. There are two primary factors that ha ve significantly impacted the perchlorate risk assessment, and could explain the omissions and contradictions mentioned further below.

First, the NOEL (Non Observed Effect Level) fo und in the Greer 2002 study from which the perchlorate RfD is derived, did not take into acco unt existing background effect. The root of this omission could lie in the fact that a qualitative observational study, which takes into account background levels and is by far the most common human epidemiological study used in evaluating exposure risks to humans, was not performed or re lied on in analyzing the impact of perchlorate in this instance. Instead, the Greer study was an experimental study on humans, which did not take into account background effects and thus signific antly overstates the impact of perchlorate on human health. Therefore, the NOEL found by the Greer study is not accurate, and should not be relied upon to either regulate perchlorate or establish an RfD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 97 of 1099 Response: EPA respectfully disagrees with the commen ter. The RfD, which is derived from the NOEL, is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population that is likely to be without an appreciable risk of deleterious effects during a lifetime. The RfD, based on the as sumption that thresholds exist for certain toxic effects of chemicals, represents the drinking water perchlorate exposure plus an incremental additional exposure of perchlorate from either wa ter or food which could trigger iodine uptake inhibition, with a 10X safety factor applied. The NRC recommended that data from the Greer et al. (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD) (NRC 2005), and also noted that the results of this study were supported by those of other human studies. From this Greer et al. (2002) human clin ical study, the statisti cal no observed effect level (NOEL) for the perchlorate-induced inhibition of thyroid iodide uptake was determined to be 7.0 ug/kg (a corresponding iodide uptake inhibition of 1.8%). The NRC concluded that the most health protective and scientifically valid approach to deri ving a reference dose for perchlorate was to base the perchlorate RfD on the precursor event of inhi bition of iodide uptake by the thyroid, which would precede any more severe adverse health eff ects of perchlorate exposure in humans. In this case, the NRC used a precursor to adverse thyroid effects to establish a level at which no adverse effects would be anticipated in exposed populations. This approach is consistent with the Agency’s policy on the use of precursor events when appropria te in establishing the critical effect upon which an RfD is based (U.S. EPA, 2002). The NRC reco mmended that EPA apply an uncertainty factor of 10 to this NOEL of 7.0 ug/kg fo r the perchlorate-induced inhibition of thyroid iodide uptake, to account for differences in sensitivity between healthy adults and the most sensitive sub-population (fetuses of pregnant women who might have hy pothyroidism or iodide deficiency). The NRC viewed the recommended uncertainty factor of 10 as conservative and protective of health, given that the NOEL is based on a non-adverse effect (i odide uptake inhibition). NRC recommended that using a non-adverse effect that is upstream of th e adverse effect represents a more conservative, health-protective approach to the risk assessment for perchlorate, noting that the purpose of the 10- fold uncertainty factor is to protect sensitive su bpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposur e. EPA has adopted the NRC’s recommendations in its “Integrated Risk Information System” (USEPA, 2005), resulting in an RfD of 0.7 ug/kg/day, which was derived by applying a 10-fold uncerta inty factor to the NOEL of 7.0 ug/kg/day. EPA used the best available peer-reviewed science, and the Agency has determined to regulate perchlorate in drinking water. EPA will continue to evaluate scie ntific studies of perchlorate health effects as part of the perchlorate rulemaking process. Gr eer MA, Goodman G, Pleus RC, Greer SE. Environ Health Perspect. 2002 Sep;110(9):927-37. Nati onal Research Council (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2002. A review of the reference dose and reference concentration processes. Risk Assessment Forum, Washington, DC; EPA/630/P–02/0002F. USEPA. 2005. ‘‘Integrated Risk Information System (IRIS), Perchlorate and Perchlorate Salts.’’ February 2005.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28820

EPA Comment Code: 2100

Comment: 1.1. IntroductionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 98 of 1099 The perchlorate NAS (National Academy of Scienc es) RfD (Reference Dose) of 0.7ug//kg-day is based on the Greer 2002 dose response experiment al clinical study[FN1: Greer MA, Goodman G,
Pleus RC, Greer SE, 2002. Health Effects Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodine Uptake in Humans. Environ. Health Perspective, 110(9):927-937.] . However the NOEL (Non Observed Effect Level) found in the Greer experimental longitudinal stud y did not take into account existing background
effects, and therefore the Greer NOEL is not an a ccurate reflection of the NOEL for perchlorate.

NAS did not add this background level to the Gree r NOEL level in its evaluation of perchlorate. Similarly, EPA’s OIG did not do so in its Decem ber 2008 study [FN2: Office of Inspector General Scientific Analysis of Perchlorate, Assign ment No. 2008-0010, D ecember 30, 2008.]. The consequences of this omission are significant as discussed below.

Response: Please see the response to comment ID 28818 under comment code 2100.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28896

EPA Comment Code: 2100

Comment: As a reminder, Intertox provided comments to these studies in a 2008 submission; these comments are located in the EPA docket (Intertox, 2008). Intertox also provided comments to the Draft OIG report (Intertox, 2009). Nonetheless, these studies are summarized below. EPA has also posted several additional documents to the docket that require additional context.

A. The 2009 FR Notice Docket

The EPA Docket for this Notice (Docket ID No. EPA-HQ-OW-2009-0297) in cludes a number of documents including a commentary that provides cr iticism of the NRC expert panel's conclusions on perchlorate, but does not provide new scient ific data from which to base a regulatory determination (Ginsberg and Rice, 2005). To pr ovide a transparent compendium of available information, if the Agency provides or uses any co mmentaries, it should consider all commentaries. For example, a response to Ginsberg and Rice (2005) was published in the same journal. This response was co-authored by the NRC perchlorate panel chair and three other members from the 18-member panel and provides point-by-point scien ce based rebuttals to why the Ginsberg and Rice(2005) assertions are incorrect. The response authors conclude by stating that the NRCrecommended RfD "provides a wide margin of saf ety for all subjects of all ages" (Johnston, et al., 2005). We request that EPA add this response to the docket.

Response: EPA will continue to evaluate the best availa ble science related to perchlorate as the Agency develops a National Primary Drinking Wa ter Regulation for perchlorate. The Johnson, et. al., commentary has been revi ewed by EPA and added to the docket. Also, see response to

comment code 2100.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 99 of 1099 EPA Comment ID: 28901

EPA Comment Code: 2100

Comment: Greer et al. (2002)

As noted above and briefly reiterated here, th e mechanism of action (MOA) of perchlorate in humans is the inhibition of iodide uptake (IUI). The MOA has been reviewed by numerous authoritative bodies (NRC, EPA, ATSDR, etc.) who ha ve concluded that it is not adverse. Iodide uptake is mediated by the NIS in the thyroid follic ular cell. Greer et al. found a level where there was no statistical change in IUI and therefor e, no downstream effects were possible.

That IUI is not adverse has been well-documen ted by NRC, EPA, New Jersey, California, and ATSDR. Much is documented about exposures to pe rchlorate at environmentally relevant doses up to therapeutic doses, the amount of IUI these dose s cause, and the lack of downstream effects with environmentally relevant doses. For example, many studies demonstrate a statistically significant IUI, but no change in thyroid hormones for weeks or months (Greer et al., 2002; Braverman et al., 2005; Lawrence et al., 2000 and 2001; etc.). More over, the literature regarding perchlorate at therapeutic doses demonstrates the effect of IUI and changes in hormones. The NRC committee members unanimously stated that transient changes in thyroid hormones are not adverse and prolonged changes in thyroid hormones must occur for a person to become hypothyroid.

Some have argued that the study population of the Greer Study was too small to exhibit statistical significance of small changes in IUI particularly wi th the variability reported. It is important to note that decisions regarding statistical power and sa mple size were conducted a priori, in accordance with standard experimental design. These were stat ed and agreed upon by the researchers and EPA. The questions by some about variability have been raised a posteriori, after the results are known. Based on all the information available when the experiment was designed, the sample sizes in the Greer Study were sufficient. Notabl y, with a dose of 0.02 mg/kg- d, a 16% IUI (24-hr value) was statistically significant.

Regarding the variability of the low dose group, IUI from "background" (as noted above in Figure 3) perchlorate, nitrate, thiocyanate, and other agen ts found in the diet and drinking water were not controlled. This likely explains a significant proportion of daily interpersonal RAIU changes. Furthermore, 1) variability in RAIU for the low do se group was not different from RAIU for other dose groups, 2) all volunteers had normal baseline RAIU values when compared to the literature, and 3) when baseline RAIU is low, small absolute changes will appear large as relative RAIU, which is a mathematical, not physiologic, phenomenon.

In a dose-response study, one dose group should not be taken in isolation. The best way to evaluate the low-dose variability in RAIU is to examine all data generated by the study. Simple inspection of the data show a decrease in RAIU change with increasing dose-IUI occurred in a classic and unequivocal dose- response manner. Additiona lly, the No Effect Level (NEL) using linear regression of all relevant RAIU clinical data was 6 ug/kg-d for 24 hours, which was similar the NOEL of 7 ug/kg-d. Considering the data from La wrence et al. (2001) which demonstrated a higher dose of perchlorate (approximately 40 ug/kg-d assuming 3 mg/d for a 70 kg person) with a nonstatistically significant decrease in RAIU (as we ll as no corresponding change in thyroid hormones) strengthens this understanding.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 100 of 1099 Response: See response to comment code 2100. EPA will continue to evaluate all of the available science related to perchlorate as the Agency develo ps a National Primary Drinking Water Regulation for perchlorate.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28936

EPA Comment Code: 2100

Comment: EWG urges the agency to take the results from this CDC study into account and revise the current RfD to reflect these findings. In written responses to questions for the record from the House Committee on Energy and Commerce dated from 2007 (attached), Dr. James Pirkle, Deputy

Director for Science at the National Center for En vironmental Health and coauthor of the study, had the following comments regarding the study resul ts: "We do not think confirmatory analysis is necessary to validate Blount's analysis of th e NHANES data. Although we understand that conclusions of causality can rarely be drawn base d upon a single study, when viewed within the
context of the available clinical literature, the findings of the Blount study are consistent with causality" (Attached). In addition, an independent analysis of the NHANES data by scientists who

work for California's Office of Environmental Health Hazard Assessment confirmed CDC's findings (Steinmaus et al 2007). Given the issues wi th the data in the Greer study and the strengths of the Blount study, the agency should place grea ter weight on the results from the Blount study in

its determination.

Response: In the October 10, 2008 FR Notice reques ting public comments on its preliminary determination not to regulate perchlorate in drin king water (FR Vol. 73, No. 198, p. 60266), EPA

considered and discusses the results of the Greer et al. (2002), and Blount et al. (2006, 2007) studies, in the process of evaluating the adverse health eff ects of perchlorate. Blount et al., (2006) published a study in the journal “Environmental Health Perspectives” examining the relationship between urinary levels of perchlorate and blood serum levels of TSH and total T4 in 2,299 men and women (ages 12 years and older) who participated in CDC’s 2001–2002 NHANES. Blount et al. (2006) evaluated perchlorate along with a number of cova riates known or likely to be associated with thyroid hormone levels, to assess the relationshi p between perchlorate and these hormones. The Blount et al. (2006) study found that perchlorate ex posure was a statistically significant predictor of thyroid hormones in women, but not in men. For women with urinary iodide levels less than 100 ug/L, the researchers found that urinary perchlorate was associated with a decrease in T4 levels and an increase in TSH levels. For women with urinary iodide levels greater than or equal to 100 ug/L, the researchers found that perchlorate was a si gnificant positive predictor of TSH, but not a predictor of T4. Their observations that advers e thyroid hormone effects were found in women whose urinary iodine was below 100 ug/L is su ggestive of a partial study population iodine deficiency status. Blount et al. (2006) noted severa l limitations of their study and recommended that their findings be affirmed in other large studie s focusing on women with low urine iodide levels. Since their study was cross-sectional in design, it also cannot be concluded whether or not the association between perchlorate and thyroid hormone le vels is causal, or is mediated by some other correlate of both, although the relationship between urine perchlorate and total TSH and T4 levels persisted after statistical adjustments for some additional covariates known to predict thyroid

hormone levels. EPA has evaluated this data as part of the regulatory determination EPA willEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 101 of 1099 continue to evaluate new scientific information on the health effects of pe rchlorate as the Agency develops the proposed perchlorate drinking water regulation.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.

Blount BC, Valentin-Blasini L, Osterloh JD, Mauldi n JP, Pirkle JL. Perchlor ate exposure of the US Population, 2001-2002. J Expo Sci Environ Epidemio l. 2007 Jul;17(4):400-7. Epub 2006 Oct 18.

Greer MA, Goodman G, Pleus RC, Greer SE. He alth effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9):927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 29079

EPA Comment Code: 2100

Comment: EPA's preliminary determination includes impreci se language that bears clarification:

Perchlorate interacts with the sodium iodide symporter, reducing iodine uptake into the thyroid gland and, at sufficiently high doses, the amount of T4 produced and available for release into circulation. Sustained changes in thyroid hormone secretion can result in hypothyroidism. (p. 60275; emphasis added)

[Text Box: The NAS concluded that perchlorate will not cause adverse effects under consideration in this determination. The NAS findings are consis tent, as well as the overwhelming majority of the large body of available peer-rev iewed science on perchlorate.]

The "sufficiently high doses" that EPA refers to are orders of magnitude higher, approximately 0.4 mg/kg-d (approximately 19,000 ppb)[FN2: See, NA S, at 171-172 (pdf version) ("...a sustained exposure at more than 0.4 mg/kg per day would most likely be required to cause a sufficience decline in iodide uptake and thyroid hormone pr oduction to result in adverse health effects in

normal adults. That estimate is based on clinical studies and studies of long-term treatment of patients who had hyperthyroidism.]. These levels have never been reported in public drinking water systems. According to the NAS report, even these le vels do not inevitably lead to adverse effects.

The NAS independently evaluated the science and its conclusions and recommendations are published in the report Health Implications of Perchlorate Ingestion (2005). The NAS report recommended an RfD of 0.7 ug/kg-d based on a No Observed Effect Level (NOEL), or the dose at which no effects occur, adverse or otherwise (NAS, 2 005). One of the critical studies that served as the basis for this RfD was the study by Greer et al. (2002) which demonstrated that there was no inhibition of iodide uptake by the thyroid at a do se of 7 ug/kg-d. Some have argued that the low dose group contained only seven subjects; however the NAS correctly dismissed this assertion, pointing out that there were four doses provid ed across 37 subjects. Importantly, the NAS alsoEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 102 of 1099 noted that it did not examine Greer in isolation. According to the NAS report, the findings in Greer are supported by other clinical studies, occupati onal and environmental epidemiologic studies, and studies of long-term perchlorate administra tion to patients with hyperthyroidism.

Further, the NAS states with emphasis,

"Inhibition of iodide uptake by the thyroid clearly is not an adverse effect; however if it does not occur, there is no progression to adverse heal th effects." The committee views its recommendation to use [IUI] by the thyroid as the basis of the pe rchlorate risk assessment to be the most healthprotective and scientifically valid approach (NAS, 2005).

In using a NOEL, the NAS committee adopted a not ably conservative, health- protective approach. This dose is already lower than any dose in which adverse effects occur; an additional safety factor of 10 is applied to the already conservative NOEL . The NAS was acting to ensure protection for the most sensitive individuals in a population, in this case, hypothyroid or iodine- deficient pregnant women and their developing fetuses. Importantly , the NAS panel did consider other sensitive populations besides pregnant women and their fetuse s. They also considered the potential effect on infants, developing children, people who have compromised thyroid function, and people who are iodide-deficient. The NAS panel stated that using a NOEL as the point of departure is a more conservative and health-protective approach than EPA's customary approach of using the adverse effect (NAS, 2005).

The NAS panel also took time to distinguish between a No Observable Adverse Effect Level (NOAEL) from a NOEL. The experts observed that there was confusion between the two and clarified that the NOAEL is based upon an advers e effect, whereas the NOEL is based upon a dose at which no effect occurs, adverse or otherwise. (NAS, 2005).

EPA adopted the RfD recommended by the NAS and confirmed that it was conservatively based on the NOEL, not the NOAEL. EPA should clarify its finding as to the potential adverse effects of perchlorate to bring the final determination into a lignment with its own NAS-based reference dose.

In sum: perchlorate will not cause adverse effects at levels under consideration in this determination.

This conclusion reflects the best available scient ific findings, including the NAS report and the overwhelming majority of the large body of ava ilable peer-reviewed science on perchlorate.

Response: Please see the response to comment ID 21094 under comment code 2100.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 103 of 1099 

### EPA Comment Code: 2110 Regulatorydetermination based upon the alreadyestablished RfD

Individual Comments

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment (TERA)

EPA Document ID: EPA-HQ-OW-2009-0297-0637

EPA Comment ID: 28493

EPA Comment Code: 2110

Comment: Our primary concerns relate to the current EPA RfD of 0.0007 mg/kg-day found on EPA's Integrated Risk Information System (IRIS), sin ce new data have shown this value to be out of

date.

Concern: EPA acknowledges in its Federal Register not ice that critically important data on pregnant women and their offspring have become available since the time of the development of the EPA RfD in 2005 (EPA, 2008), but then fails to cite a prospective epidemiology study by Tellez et al. (2005) that analyzed the results of differing pe rchlorate exposures in pregnant mothers and their newborns. As a basis of an RfD, Tellez et al. (2005) is superior to the study used as the basis of the current RfD, that is Greer et al. (2002), since the Tellez et al. (2005) study is on the sensitive populations of interest (pregnant women and their babi es). As a basis of an RfD, Tellez et al. (2005) is vastly superior to the ecological epidemiology study of Blount et al. (2006, 2007), since Tellez et al. (2005) measured perchlorate exposure in the in dividuals on which the effects of concern were

monitored.

Recommendation: EPA needs to reconsideration it s existing RfD on the basis of the Tellez et al. (2005) epidemiology study in pregnant women and their babies. This reconsideration is consistent with recommendations of the NAS (2 005) on page 69 of its report.

Concern: NAS (2005, pages 9 and 112) admits that it did not follow EPA's traditional RfD method when it developed their value. Since EPA adopted the NAS RfD, the inescapable conclusion is that

EPA did not follow it own RfD method either. Mo re importantly, lack of adherence to EPA’s methods will encourage others to do so as well, resulting in a potpourri of values with little resemblance to those that already exist on EPA's Integrated Risk Information System (IRIS) or

elsewhere.

Recommendation: Recalculate the existing perc hlorate RfD using EPA's published methods.

See the attached file for details. Reviewed usingdevelopmental reserve. [See PDF Docket ID EPAHQ-OW-2009-0297-0637; Note that this attachment is identical to Docket ID EPA-HQ-OW-2008- 0692-1562; responses to this comment are pr ovided through Docket ID EPA-HQ-OW-2008-0692- 1562.]

Response: See response to comment ID 28863 under comment code 2110.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 104 of 1099 EPA will consider the best available peer reviewed data in developing an NPDWR for perchlorate, including the data from the Tellez study.

Commenter Name: Jonathan Borak Commenter Organization: Yale School of Medicine

EPA Document ID: EPA-HQ-OW-2009-0297-0209

EPA Comment ID: 28506

EPA Comment Code: 2110

Comment: My submitted comments are contained in the attachment. Thank you for this opportunity to contribute to the Agency's efforts.

Jonathan Borak, MD, DABT, FACP, FACOEM

Attachment

September 16, 2009

Water Docket Environmental Protection Agency Ma ilcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2009-0297

Dear Sir or Madam:

At the request of the Perchlorate Study Group, I am writing as a physician and toxicologist in response to your request for comments (Fed Reg 74:41883, 08/19/09) regarding EPA's perchlorate regulatory determination. By way of introduction, I am Clinical Professor of Epidemiology and
Medicine at Yale School of Medicine, Director of the Yale University Interdisciplinary Risk Assessment Forum, and a faculty member of the Yale Occupational and Environmental Medicine Program. I serve as Co-Chair of the Council on Sc ientific Affairs of the American College of Occupational and Environmental Medicine (ACO EM), was Editor and Course Director of the

ACOEM Core Curriculum in Environmental Medicine , and served as a founding member of EPA's National Advisory Committee to Develop Acute Exposure Guideline Levels for Hazardous

Substances.

1.) First and foremost, I support the Agency's decision to base its regulatory decision upon the current RfD, and not upon the findings of st udies published since 2005 (Fed Reg 74:41892, 08/19/09). Over the past several years, much a ttention has been given to findings reported by Blount et al. (1), who analyzed data from th e CDC's 2001-2002 NHANES study and performed additional analyses on NHANES urine samples.

Response: The Agency believes that the current RfD is a ppropriate for purposes of this regulatory

determination.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 105 of 1099 EPA Comment ID: 28745

EPA Comment Code: 2110

Comment: 2. The findings of several studies conducted since 2005 suggest that the EPA- adopted reference dose of 0.7 ug/kg-day is a conservative and health-protective reference dose that has a 10- fold uncertainty factor applied to the point of depa rture to account for differences between healthy adults and the most sensitive population: f etuses of pregnant women who might have hypothyroidism or iodide deficiency. Consequent ly, additional non-standard adjustments appear unnecessary because the health of the most se nsitive sub-population (fetuses and neonates) has already been considered. Application of an appr opriately calculated relative source contribution (RSC) term, as was conducted during developmen t of the December 2008 Health Advisory (HA), appears adequate and appropriate.

Response: EPA believes that the RfD indicated by the NAS is appropriate. EPA has not yet determined how best to develop the MCLG for pe rchlorate. EPA plans to seek comments on its development of its proposed regulation, incl uding the MCLG, as required by the SDWA.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28863

EPA Comment Code: 2110

Comment: 5) Although the HRL of 2 ppb recommended above is numerically similar to the maximum contaminant level adopted by MassDEP an d protective of the sensitive segment of the population, the RfDs used by the two agencies as th e bases to derive the drinking water levels are

different. MassDEP concluded that the National Re search Council's (NRC) RfD is not protective of public health (Zewdie et al. 2009). Although uncer tain, the EPA's modified PBPK analysis presented in Table 1 for a 7-day-old healthy infant supports this position. In this analysis, the infant gets about 3 times the maternal dose through breast milk at the dose equal to the point-of-departure (POD) in

the NRC RfD derivation. This translates to a 7- day infant receiving about 20 ug/kg/day (0.02 mg/kg/d) dose of perchlorate through breast milk from a mother ingesting 7 ug/kg/day. This dose level is equivalent to the exposure level that resulted in significant inhibition (17 %) of iodide uptake in healthy adults in the Greer et al. (2002) study, suggesting that the factor of 10 applied to the POD by the NRC to protect sensitive individuals is insufficient. An additional uncertainty factor is required to extrapolate from LOAEL to NOAEL as 0.02 mg/kg/day is an effect level. Efforts to determine populations at risk based on the NRC Rf D will yield significant underestimates of those at risk. MassDEP can support EPA's decision to not re-evaluate the NRC RfD at this time, if EPA adopts an HRL of 2 ppb or lower.

Response: With regards to conclusions of the NRC panel on the effects of perchlorate exposure, EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. The NRC (2005) identified "the fetus of pregnant women who might have hypothyroidism or iodide deficiency" as "the most sensitive population," but also identified infants and developing children as additional "sensitive populations." It is important to consider that the source of the perchlorate in breast milk is probably due to a much greater extent to the greater prevalence of perchlorate in food, than due to comparatively lesser prevalence of perchlorate in drinking water. The NRC recommend ed that EPA apply an uncertainty factor of 10EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 106 of 1099 to the NOEL of 7.0 ug/kg for the perchlorate-in duced inhibition of thyroid iodide uptake, to account for differences in sensitivity between healthy adults and the most sensitive sub-population, consisting of fetuses of pregnant women who mi ght have hypothyroidism or iodide deficiency. Iodide uptake inhibition has been identified in the literature as an area of concern in connection with increasing the risk of neurodevelopmental impair ment in fetuses of high-risk mothers. The NRC viewed the recommended uncertainty factor of 10 as conservative and protective of health, given

that the NOEL is based on a non-adverse effect (iodide uptake inhibition) which precedes the adverse effect in a continuum of possible adverse biological effects of perchlorate exposure. NRC recommended that using a non-adverse effect that is upstream of the adverse effect represents a more conservative, health-protective approach to the risk assessment for perchlorate, noting that the purpose of the 10-fold uncertainty factor is to protect sensitive subpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposure. EPA has adopted the NRC’s recommendations in its “Integrated Risk Informatio n System” (IRIS) (USEPA 2005), resulting in an RfD of 0.7 ug/kg/day, which was derived by a pplying a 10-fold (10x) uncertainty factor to the NOEL of 7.0 ug/kg/day. EPA used the best avai lable peer-reviewed science, and the Agency has determined to regulate perchlorate in drinking water. EPA will be reevaluating this issue as part of the perchlorate rulemaking. Greer MA, Goodman G, Pleus RC, Greer SE. Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9):927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732 . National Research Council (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2005. "Integrated Risk Information System (IRIS), Perchlorate and Perc hlorate Salts." February 2005. Available on the Internet at: http:// www.epa.gov/iris/subst/1007.htm.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28895

EPA Comment Code: 2110

Comment: III. OTHER COMMENTS

In Section IV of the Notice, EPA discusses its consideration of studies published since EPA adopted the NRC RfD for perchl orate. The Notice states:

EPA's preliminary regulatory determination is ba sed on NRC's (NRC, 2005) recommendation to use data from the Greer et al. (2002) study as the ba sis for the perchlorate RfD/risk assessment. Since the publication of the NRC report, researchers have investigated perchlorate occurrence in humans by analyzing for perchlorate in urine and breast milk-such biomonitoring data has the potential to better inform EPA's analysis of exposure to perc hlorate through food and water and to provide insight into the possible interactions of other physi ologic conditions (e.g., iodine deficiency) with perchlorate ingestion. EPA's preliminary regulato ry determination described the consideration of these studies, many of which were published after the NRC report (including, but not limited to, Blount et al. (2006 and 2007), Steinmaus et al. (2007), and Amitai et al. (2007)).

EPA's conclusion to this section is:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 107 of 1099 EPA agrees that additional important data have become available since the RfD was derived in 2005.
However, EPA has evaluated the new data and has decided to make the regulatory determination based upon the current RfD.

The weight-of-scientific evidence supports this EPA conclusion.

Response: EPA believes that the RfD indicated by the NR C is appropriate. As discussed in this FR
notice, EPA has decided the model does not directl y bear on the current decision regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28927

EPA Comment Code: 2110

Comment: - EPA must modify the RfD that is the basis for its standard setting to include a substantial body of peer-reviewed science publis hed since 2002, including two large, high quality epidemiologic studies from the CDC (Blount et al 20 06a, Blount et al 2006b). In addition to these new studies, peer reviewed analyses of the study that forms the basis for the current RfD (Greer 2002) have revealed fatal flaws with this work. A study with such fundamental and well-documented shortcomings cannot be used as the basis to determi ne national safety standards for exposure to this potent thyroid toxin.

Response: See response to comment ID 28863 under comment code 2110.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 29077

EPA Comment Code: 2110

Comment: EPA is justified in making a regulatory determination based upon the current Reference Dose (RfD), which includes a 10-fold uncertainty factor (UF) to account for sensitive life stages; further reductions for sensitive life stages are duplic ative and not scientifically justified. Importantly, authoritative bodies concur that the RfD is based on a No Observed Effect Level (NOEL), which is a more conservative approach than EPA's tradit ional use of a No Observed Adverse Effect Level (NOAEL). In establishing the threshold for IUI-which is defined by the National Academy of Sciences as a nonadverse effect-as the point of de parture, EPA has already ensured that downstream adverse effects due to perchlorate (which to date have not been reported in humans exposed to perchlorate at environmental levels) will not o ccur (NRC, 2005). Since much information regarding the perchlorate mechanism of action is known, EPA should use PBPK modeling based on the best

science rather than the estimations in the alternative HRL calculations.

Response: EPA believes that the RfD indicated by the NR C is appropriate. As discussed in this FR
notice, EPA has decided the model does not directl y bear on the current decision regarding the needEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 108 of 1099 for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 109 of 1099 

### EPA Comment Code: 2150 EPA's decision not to seek further input from the NRC on issues related to perchlorate

Response to Comment Code 2150: On October 10, 2008, EPA published a Federal Register notice presenting the Agency’s preliminary regula tory determination for perchlorate and supporting
rational for this determination, in accordance with the Safe Drinking Water Act (SDWA) (Federal Register Vol. 73, No. 198, p. 60262). In this October 10, 2008 Federal Register notice, EPA determined that a national primary drinking wa ter regulation (NPDWR) for perchlorate would not present a meaningful opportunity for health risk reduction for persons served by public water systems. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Register notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, the opportunity for health risk reduction through a national primary drinking water standard, and also requested comment on whether further review by the NRC would be warranted. In Janu ary of 2009, EPA announced that the Agency planned to seek additional input from the National Research Council (NRC) on perchlorate. The NRC previously studied perchlorate health implicat ions from March, 2003 until they issued their report in January, 2005 (NRC 2005). EPA has comp iled and evaluated additional scientific studies relevant to perchlorate health effects and expo sure available in the scientific literature since publication of the 2005 NRC report. EPA also ha s obtained peer review and public comment on the Agency’s analysis of a number of these studies. The Agency currently believes that further review by the NRC would unnecessarily delay regulatory deci sion making for perchlorate. EPA also notes in this August 19, 2009 Federal Register notice that if the Agency were to make a final determination to regulate perchlorate, the Agency, in accordance wi th the SDWA, would seek review by the Science Advisory Board prior to proposal of any maximum contaminant level goal and national primary drinking water rule. Therefore, EPA is not, at pres ent, planning to request additional NRC review of issues related to perchlorate.

Individual Comments

Commenter Name: Julie L. Heckman Commenter Organization: American Pyrotechnics Association (APA)

EPA Document ID: EPA-HQ-OW-2009-0297-0522

EPA Comment ID: 28492

EPA Comment Code: 2150

Comment: EPA's Commitment to Use Sound Science

In January of this year, EPA announced that it would reevaluate the science regarding perchlorate's potential health effects, with particular emphasis on evaluating the effects of perchlorate exposure on infants and young children. The Agency further announced that it planned to seek additional advice from the National Research Council ("NRC") on perchlorate before making a final

determination. Since the time NRC last issued its January 2005 report on perchlorate,[FN1: National Research Council, Health Implications of Perchl orate Ingestion, National Academies Press, Board on Environmental Studies and Toxicology (January 2005). Subsequently in 2005, EPA adopted theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 110 of 1099 NRC recommended reference dose of 0.0007 mg/kg pe r day, which translates to a drinking water equivalent level of 24.5 ppb ("DWEL"). In Ja nuary 2006 EPA's Superfund office issued guidance adopting the NRC reference dose and DWEL of 24.5 ppb as the recommended value to be considered as the preliminary remediation goal to guide perchlorate assessment and cleanup at Superfund sites. In January 2007, EPA reported that it had collected sufficient occurrence data, and that further monitoring was not needed for the Agency to make a regulatory determination. 72 Fed. Reg. 367 (January 4, 2007). In October of 2008 , EPA announced a preliminary determination not to regulate perchlorate, noting that less than 1% of water systems have perchlorate levels above the health reference level. EPA concluded that perchl orate failed to meet two regulatory criteria (i.e., that a contaminant occur frequently at levels of health concern, and that establishing a national drinking water standard would provide a "meanin gful opportunity for health risk reduction"). Then, in January 2009, EPA announced that it was replac ing the perchlorate preliminary remediation goal of 24.5 ppb with an interim health advisory, establishing a nonenforceable concentration of contaminants in drinking water at which no adverse health effects are expected to occur, of 15 ppb. In the face of this uncertainty and regulatory histor y, debate over the science of perchlorate health risks has continued.] EPA has compiled and evalua ted additional scientific studies relevant to perchlorate health effects and ex posure that were not available to the NRC. However, in its August
19, 2009 Notice, EPA announced that it would, in fact, not seek further review by the NRC because it believed such review would "unnecessarily delay" regulatory decision making for perchlorate.

Concerns about protection of human health and the environment must always be in the fore front of our thinking, but to do so properly, sound scienc e should not be sacrificed in the interest of mere expediency. The APA firmly believes that EPA sh ould ask the NRC to review the new information

to assist EPA with its determinati on. EPA has spent years assessing perchlorate's health effects and

occurrence to determine whether a national standard is warranted.[FN2: Under the Safe Drinking Water Act ("SDWA"), [Sec] 1412, to regulate a cont aminant in drinking water, EPA must determine that it meets three criteria: (1) The contaminant may have an adverse effect on human health, (2) the

contaminant is known to occur or there is a substan tial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern, and (3) regulation of such contaminant presents a meaningful opportunity fo r health risk reduction for persons served by public water systems. These legal criteria are prem ised on the use and application of sound science.] In the interest of obtaining the best available sc ientific information and advice, a comprehensive NRC review should be preferred.[FN3: The Notice specifically requested comment upon whether further review by the NRC is warranted, 74 Fed. Re g. 41884, and noted that if the Agency were to make a final decision to regulate perchlorate, it would seek review by the Science Advisory Board ("SAB") prior to proposal of any maximum contam inant level goal and national primary drinking water rule. Id. However, the statutorily require d review by the SAB under section 1412 of the SDWA to comment prior to setting the levels of a maximum contaminant level goal and national primary drinking water regulation, should not be a substitute for the timely scientific review of the NRC prior to the Agency's predicate decision ma king responsibility under the SDWA on whether regulation is warranted in the first place. Rigorous application of scientific review and sound science principles, especially by outside independent entities, should inform each statutorily- required regulatory step and decision, not only the final one. Indeed, it is the first step that has been the most controversial and it is that process of reevalua tion in which the Agency is currently engaged.]

EPA has, itself, recognized the significant scie ntific complexity involved here. "The public comments EPA received pursuant to the October 10, 2008, notice of preliminary regulatory determination and from the peer review of the supporting documents underscore the complexity ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 111 of 1099 the scientific issues regarding the regulatory d etermination for perchlorate in drinking water." 74 Fed. Reg. 41884. Given that complexity, thorough review, analysis, and input from all available sources, including the NRC, should be sought to ensure full Agency consideration of the latest and best available science and thinking.

EPA's website addressing "Using Sound Science" re iterates the importance of thorough scientific

review:

We depend upon sound science to do our work. Scient ific information is especially important in the development of regulations. Whether we are devel oping a standard to protect the public from a newly recognized risk or defining monitoring requirements to gauge how well an environmental control is working, we incorporate the most currentand credible scientific information into our regulation development process. . . . EPA relies, to the extent possible, on information that has undergone thorough peer review. During peer revi ew, qualified, independent experts provide critical

assessments to ensure that activities are technica lly supportable, competent ly performed, properly documented, and consistent with established quality criteria.... We also regularly solicit outside expertise from the National Research Council, other federal agencies with related responsibilities, and other scientific organizations.[FN4: Using Sound Science, available at: http://www.epa.gov/lawsregs/brochure/science.html]

This Administration has reaffirmed the federal government's commitment to the principles of scientific integrity and the incorporation of full an d open scientific review in all its policy-making functions. On March 9, 2009, the President issued his Memorandum on Scientific Integrity, directed

to the heads of executive de partments.[FN5: Available at: http://www.whitehouse.gov/the_press_office/ Memorandum-for-the-Heads-of- ExecutiveDepartments-and-Agencies-3-9-09/), published at 74 Fed. Reg. 10671 (March 11, 2009).] The

President stated:

"science and the scientific process must inform an d guide decisions of my Administration on a wide range of issues, including improvement of public health [and] protection of the environment."

He charged the Director of the Office of Science and Technology Policy with "the responsibility for ensuring the highest level of integrity in all asp ects of the executive branch's involvement with scientific and technological processes." As the President further emphasized:

The public must be able to trust the science and scientific process informing public policy decisions. Political officials should not suppress or alter scie ntific or technological findings and conclusions. If scientific and technological information is develope d and used by the Federal Government, it should ordinarily be made available to the public. To the extent permitted by law, there should be transparency in the preparation, identification, an d use of scientific and technological information in policymaking.

In response to the March 9 Presidential Memorand um on Scientific Integrity, we understand that EPA's Office the Science Advisor ("OSA") has been working with the White House Office of Science and Technology Policy ("OSTP") to devel op recommendations for the President and with EPA's Science Policy Council to establis h the EPA position on the topic. See http://www.epa.gov/osa/scientific_integri ty.htm. As the OSA has explained:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 112 of 1099 The role and use of science at EPA are determined by the nature of scientific information and how it fits within the context of Ag ency decision-making. Scientific info rmation--whether it comes from EPA, other agencies, academia, the regulated comm unity, or other sources-- always includes some degree of uncertainty and is subject to varying inter pretations. For example, assessments of risks to humans from exposure to chemicals are often base d on tests in which laboratory animals are given high doses of a chemical. Effects seen in the an imals may or may not appear in humans, who are typically exposed to much lower doses and whos e bodies may metabolize the chemicals differently. In addition, there are often different scientifically justifiable ways to conduct risk assessments, and the method chosen by the assessor can si gnificantly impact the risk estimate.

Scientific knowledge is not only uncertain, but also dynamic. Through research that is designed to reduce uncertainties, our understanding increases and, as a result, we change our assumptions about the impacts of environmental problems an d how they should be addressed....

Science does not drive EPA's policy and regulatory decisions, but rather, along with other relevant factors, informs and supports those decisions. Im plementation costs and technological feasibility, local autonomy versus federal control, and justice and equity--all of which impact our quality of life and standard of living--are among the considerations that need to be factored into EPA's decisions without compromising scientific integrity, the Ag ency's mission, or statutory mandates. The impacts
or limitations of these non-science factors, as we ll as the current state-of-the-science, will influence how scientific considerations are brought to bear on a particular environmental problem facing the Agency.[FN6: See http://www.epa.gov/osa/osa.htm.]

Administrator Jackson recently testified in front of the U.S. Senate Committee on Environment and Public Works on "Scientific Integrity and Transp arency Reforms at the Environmental Protection Agency" on June 9, 2009,[FN7: Available at: http:// www.epa.gov/ocir/hearings/.] that "[t]he public health and environmental laws that Congress has enacted depend on rigorous adherence to the best

available science... While the laws that EPA im plements leave room for policy judgments, the scientific findings on which of these judgments ar e based should be arrived at independently using well-established scientific methods, including peer review, to assure rigor, accuracy, and impartiality." In her testimony, Administrator Jackson acknowledg ed that, "Environmental science is complex and multi-faceted, and able scientists may not always agree on what methodologies should be employed or how studies should be interpreted. I am committed to fostering a culture of robust scientific debate and discussion within the Agency, recognizing that in the end senior scientists must take responsibility for resolving differences of opinions using established science policies and their best professional judgment."

APA respects and supports the Agency's paramoun t obligation to protect water quality and public health. We respectfully ask that the Agency take it s own commitment to use sound science, as well

as the directive of the White House to observe the highest principles of scientific-integrity, into

account as it decides whether to ask the NRC or others to perform additional scientific review on the admittedly complex questions surrounding perchlorate. EPA has sought these additional comments from the public in "an effort to ensure consideration of all the potential options for evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate through a national primary drinking water rule." 74 Fed. Reg. 41883. No less so should EPA again seek the widely respected expertise, comments an d advice of the NRC on this most difficult of public health issues, especially where that NRC review has proved so beneficial in the very recentEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 113 of 1099 past to a full and robust consideration of the scie ntific data and uncertainties that must inform sound public health policy.

Because the science and policy judgments underl ying your decision-making for regulating perchlorate in drinking water are extraordinarily complex and will impact not only public health but
also the environment and our businesses, full consideration of all available scientific information as well as all available peer review of that informati on, is clearly warranted. Please reconsider your decision not to seek further review by the NRC of all the critical studies, data, and risk analyses in this important process, so that EPA may have the benefit of the most rigorous and complete analysis of the available scientific data on whic h to deliberate and act. To ensure that this commitment to scientific integrity be met, while EPA could simply look at the same information again and ask the public if it has any new though ts on how to interpret that information, we would respectfully suggest EPA request, as it originally intended to do,[FN8: See Congressional Research Service, CRS Report to Congress, Perchlorate Con tamination of Drinking Water: Regulatory Issues and Legislative Actions, August t, 2009, p. 5.] that the NRC study and provide to EPA an evaluation of impacts to infants and young children from pe rchlorate and evaluate the more recent studies, EPA's use of models, and its derivation of th e 15 ppb health reference level, as well.

Thank you for your consideration of our comments and our request that the Agency take advantage of the full panoply of available means to incorporate rigorous scientific review into your process for reevaluating the risks, and the EPA's proposed addi tional approaches to analyzing the data, related to EPA's perchlorate determination. EPA should r eceive benefit of further NRC analysis of the

latest data which will ensure that the Administra tion's commitment and mandate to use of sound science in policy- making is fulfilled.

Respectfully submitted, Julie L. Heckman Executi ve Director cc: Administrator Lisa Jackson

Assistant Administrator for Water

Response: EPA is committed to the application of sound science and the principles of scientific integrity in its decision-making. The proposed path fo rward is designed to ensure adherence to both. See response to comment ID 28835 under comment code 2150.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528

EPA Comment ID: 28516

EPA Comment Code: 2150

Comment: Finally, we wish to discourage EPA from again referring the perchlorate assessment to the National Research Council (of the National Academies of Sciences) for further review. The last time (2005) the NRC reviewed perchlorate, it ov erstepped its charge and recommended a reference dose. This usurped EPA's authority and made it difficu lt for the public to comment at a key phase in the regulatory process. Furthermore, NRC commi ttees meet a handful of times over many months. A referral would delay the process withou t a great deal of additional review.

Response: See response to comment code 2150 an d comment ID 28822 under comment code

2150.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 114 of 1099 Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28609

EPA Comment Code: 2150

Comment: Your decision to not request additional NRC re view of issues relating to perchlorate is ill advised. Additional NRC research may better elucidate the health e ffect and exposure risk we presently face. Moreover, NRC research may provid e better guidance in making a final regulatory determination, especially in determining th e best health reference level (HRL).

Response: See response to comment ID 28822 under comment code 2150.

Commenter Name: Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28615

EPA Comment Code: 2150

Comment: Your decision to not request additional NRC re view of issues relating to perchlorate is ill advised. Additional NRC research may better elucidate the health e ffect and exposure risk we presently face. Moreover, NRC research may provid e better guidance in making a final regulatory determination, especially in determining th e best health reference level (HRL).

Response: Please see the response to comment ID 28822 under comment code 2150.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28741

EPA Comment Code: 2150

Comment: Finally, we wish to discourage EPA from again referring the perchlorate assessment to the National Research Council (of the National Acad emies of Sciences) for further review. A referral would delay the process without a gr eat deal of additional benefit.

Response: See response to comment code 2150 and comment ID 28822 under comment code

2150.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28797

EPA Comment Code: 2150

Comment: HISTORY OF DELAY

EPA had evidence in the 1980's that perchlora te was leaching from military dumpsites into groundwater, as documented in a 1985 interagen cy letter from EPA to the Centers for DiseaseEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 115 of 1099 Control and Prevention (CDC) reporting on levels as high as 300-800 ppb "potentially affecting 32,000 to 42,000 households."[FN24: As documen ted in: Sass J. U.S. Department of Defense and White House working together to avoid cleanup and liability for perchlorate pollution. Int J Occup Environ Health. 2004. Jul-Sep;10(3):330-4.] EPA se t a provisional RfD of 0.0001 mg/kg/day in 1992; this would have been equivalent to an MCL of 3.5 ppb in water, presuming an adult average body weight and daily water consumption, and pr esuming no other sources of perchlorate.[FN25: As documented in: Sass J. U.S. Department of Defense and White House working together to avoid cleanup and liability for perchlorate pollution. Int J Occup Environ Health. 2004. Jul- Sep;10(3):330- 4.] It has been 17 years since that provisional RfD, and in that time the science supporting that RfD has grown significantly stronger, along with pub lic concern and Agency interest. Moreover, the RfD now finalized is 0.7 ug/kg/day, not dramatically different from the provisional RfD 17 years ago, given the extremely lengthy delay.

EPA's progress on this assessment has been extensive ly and repeatedly reviewed by the interagency panel that was created in 1998 as a partnership be tween EPA, the U.S. Department of Defense , and other federal agencies to review perchlorate issues.

In 2002, EPA issued an External Re view Draft that recommended a lim it of 1 ppb in drinking water.
This was sent to the NRC for review in 2004, which resulted in the recommended oral RfD of 0.0007 mg/kg/day, adopted by EPA in 2005.

REQUEST FOR COMMENT ON NRC REVIEW

NRDC Response: Further Review by NRC Not Warranted

After over 17 years of accumulated science (d ocumented above), two EPA toxicological reviews (1998, 2002), and a lengthy NRC review (2004), it is past time for EPA to take effective regulatory action to protect people's health by preventing ex posure to perchlorate. Therefore, NRDC supports the Agency's belief that further review by the NRC would create an unnecessary delay without adding anything to the scientific rigor of the Agency's determination.

NRDC would likely support the Agency if it requested a review by its Scientific Advisory Board, since it would be more rapid and less costly th an an NAS review, while providing scientific oversight.

Response: See the response to comment ID 28822 under comment code 2150.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28822

EPA Comment Code: 2150

Comment: Given these significant concerns, EPA should also move forward with its alternative proposal to seek additional input from the Nation al Research Council of the NAS, regarding the health impacts of (synthetic and natural) perchlor ate, and should specifically request input regarding the issues presented in these comments, includin g the problems associated with the Greer NOEL

and the RfD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 116 of 1099 Response: The NRC previously studied perchlorate health implications from March, 2003 until they issued their report in January, 2005 (NRC, 2005). EPA has compiled and evaluated additional scientific studies relevant to perchlorate health effects and exposure available in the scientific literature since publication of the 2005 NRC report. EPA also has obtained peer review and public comment on the Agency’s analysis of a number of these studies. The Agency currently believes that further review by the NRC would unnecessarily de lay regulatory decision making for perchlorate. EPA also notes in this August 19, 2009 Federal Re gister notice that if the Agency were to make a final determination to regulate perchlorate, the Ag ency, in accordance with the SDWA, would seek review by the Science Advisory Board prior to pro posal of any maximum contaminant level goal and national primary drinking water rule. Therefore, EPA is not, at present, planning to request additional NRC review of issues related to perchlorate.

National Research Council (NRC). 2005. Health Im plications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28828

EPA Comment Code: 2150

Comment: Review By NAS. In the October 10, 2008 Fe deral Register notice (73 FR 60262) EPA

stated that it would send its review of the sc ience surrounding perchlorate again to the NAS. AMWA still believes the analysis should go to NA S for review although the association's reasons have shifted in light of the agency's new analysis of alternative HRLs. Specifically, AMWA believes a review by NAS of EPA's new analysis and methodology explained in this NODA for determining alternative HRLs is judicious because this analysis is the first time the agency has applied its 2005 Guidance. It is also prudent as EPA is asking for comment on using the PBPK model for evaluating the relative sensitivity of the various life stag es to perchlorate exposure in drinking water.

AMWA recommends that EPA send both the revised PBPK model as well as the analysis used to

derive alternative HRLs to NAS for review because the potential precedent that will be set if these analyses are used in rulemaking have signific ant ramifications for how policy is developed. Particularly where endocrine disrupting compou nds are concerned, the impacts of particular chemicals on children's development must be pr operly characterized and modeled. Specifically, AMWA recommends that an NAS review panel be fo rmed to address the questions posed in section
A.4 of 74 FR 41886. In addition, NAS should be asked to determine the merits of the alternative approaches for calculating HRLs detailed in section B.3 (74 FR 41887-41889) and specifically with regard to EPA's request for co mments in B.4 (74 FR 41889).

AMWA has additional comments related to the NA S review later in this comment letter where EPA's specific requests for comment are identified.

Response: See the response to comment ID 28822 under comment code 2150.

Commenter Name: Diane VanDe HeiEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 117 of 1099 Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28834

EPA Comment Code: 2150

Comment: Part II: Specific EPA requests for comment

74 FR 41884: "EPA requests co mment upon whether further revi ew by [the National Research Council] NRC is warranted. EPA also notes that if the Agency were to make a final determination to regulate perchlorate the agency would seek review by the SAB prior to proposal of any MCLG or national primary drinking water rule."

Response: In previous comments, AMWA suggested that EPA send its review of the perchlorate science to NAS for review by 2011 (or sooner if the agency so desires) . As expressed earlier in this comment letter, AMWA still believes the analysis should go to NAS for review although the association's reasons have shifted in light of the agency's new analysis of alternative HRLs.

AMWA disagrees with EPA that another review by NAS/NRC could slow the process. Previous NAS/NRC panels have finished their work in short time spans and EPA could convene a panel concurrent with the development of a perchl orate regulation, should the agency make a determination to regulate perchlorate.

EPA states in the NODA that it will have the Sc ience Advisory Board (SAB) review any regulatory determination made prior to proposal of the re gulation. This is required in Section 1412 of the SDWA and AMWA agrees that this is a good and appropriate course of action. However, a SAB review would likely focus on the entire perchlorate regulatory proposal rather than specific components of the proposal.

As a result, AMWA believes that a focused NAS/ NRC review of the alternative HRL analysis that

used EPA's 2005 Guidance as well as the 2008 Child-Specific Exposure Factors Handbook is necessary because of the broad potential policy imp lications for OGWDW and the analysis of future regulations. In addition, the mission of the NAS, in particular NRC, "is to improve government decision-making and public policy, increase pub lic education and understanding, and promote the acquisition and dissemination of knowledge in matt ers involving science, engineering, technology, and health. The institution takes this charge seriously and works to inform policies and actions that have the power to improve the lives of pe ople in the U.S. and around the world." (http://sites.nationalacademies.org/NRC/index.htm)

A NAS/NRC panel should be selected with expertise in mind to address the questions put forward in the FR notice. The new analysis to determi ne HRLs, as well as the agency's additional consideration for using the PBPK model, should also be peer reviewed by experts who are well versed in modeling.

Response: See the response to comment ID 28822 under comment code 2150. The SAB will consider all aspects of the NPDWR, includin g the scientific evaluations underlying it.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 118 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28835

EPA Comment Code: 2150

Comment: Should EPA decide not to seek review by NAS, AMWA strongly recommends that EPA include in the charge to SAB the requests for comment surrounding the alternative HRLs analysis found in this NODA (Section A. 4 of 74 FR 41886). In addition, NAS should be asked to determine the merits of the alternative approaches for calculating HRLs detailed in section B. 3 (74 FR 41887-41889) and specifically with regard to EPA's request for comments in B.4 (74 FR 41889). AMWA also strongly recommends that EPA provide at least six months for SAB to review the alternative HRL analysis and PBPK model as it relates to this analysis. EPA should also take care to ensure that there are sufficient reviewers with the proper expertise for the task.

Response: See response to comment ID 28822 under comment code 2150. EPA will ensure that the charge to the SAB and the composition of the panel are appropriate for the review of the entire scientific underpinnings of the NPDWR.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28859

EPA Comment Code: 2150

Comment: Section II: Background

MassDEP supports EPA's opinion that further revi ew by the National Research Council (NRC) will delay regulatory decision-making and supports EPA's current plan to publish alternative approaches to interpreting the data on perchlorate and to consider public comments towards making a regulatory decision on perchlorate in drinking water.

Response: EPA agrees with the commenter as disc ussed in the response to comment ID 28822 under comment code 2150. Also, see response to comment code 2150.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 119 of 1099 

### EPA Comment Code: 2200 Use of NHANES biomonitoring data for health

effects evaluation

Response to Comment Code 2200: After a report prepared by the NRC (National Research Council) on “Health Implications of Perchlorate In gestion” (NRC 2005) was released, several papers were published that investigated whether biomonitori ng data associated with the National Health and Nutrition Examination Survey (NHANES) could be used to discern if there was a relationship between perchlorate levels in the body and thyroid function. Blount et al., (2007) published a study examining the relationship between urinary levels of perchlorate and blood serum levels of TSH and total T4 in 2,299 men and women (ages 12 years and older) who particip ated in CDC’s 2001–2002 NHANES. Blount et al. (2007) evaluated perchlora te along with a number of covariates known or likely to be associated with T4 or TSH levels to assess the relationship between perchlorate and
these hormones, and the influence of other factors on this relationship, including gender, age, race/ethnicity, body mass index, serum albumin, se rum cotinine (a marker of nicotine exposure), estimated total caloric intake, pregnancy status, post-menopausal status, premenarche status, serum C-reactive protein, hours fasting before sample collection, urinary thiocyanate, urinary nitrate, and use of selected medications. The Blount et al. (2 007) study found that perchlorate exposure was a statistically significant predictor of thyroid hormone s (T4) in women with urinary iodine levels <100 ug/l, but not in men. Blount et al. (2007) noted several limitations of their study and recommended that their findings be affirmed in at least one more large study focusing on women with low urine iodide levels. Since their study was cross-sectional in design, it also cannot be concluded whether or not the association between perchlorate and thyroid hormone levels is causal, or is mediated by some other correlate of both, although the relationship between urine perchlorate and total TSH and T4 levels persisted after statistical adjustment s for some additional covariates known to predict thyroid hormone levels (e.g., total kilocalorie in take, estrogen use, and serum C-reactive protein levels). An additional paper by Blount et al., (2006), found that almost all participants in the NHANES survey, including the participants in this first group, had urinary levels of perchlorate corresponding to estimated dose levels that are below the RfD of 0.7 μ g/kg/day.

The Blount et al. (2006) study suggested that perchlorate could be a surrogate for another unrecognized determinant of thyroid function, sin ce there are other chemical s, including nitrate and thiocyanate, which can affect thyroid function. Stei nmaus et al., (2007) further analyzed the data from NHANES 2001–2002 to assess the impact of smoking, cotinine and thiocyanate on the relationship between urinary perchlorate and blood serum T4 and TSH. Thiocyanate affects the thyroid by the same mechanism as perchlorate (comp etitive inhibition of iodide uptake). Steinmaus et al. (2007) analyzed the NHANES data to determine whether smoking status (smoker or nonsmoker), serum thiocyanate, or serum cotinine were better predictors of T4 and TSH changes than perchlorate, or if the effects reflected the combined effects of perchlorate and thiocyanate.

These authors found no association between either perchlorate or T4, and smoking, cotinine, or thiocyanate in men or in women with urinary iodine levels >100 μ g/l. In addition, Steinmaus et al. (2007) found no association between cotinine and T4 or TSH in women with iodine levels <100

μ g/l. However, in women with urinary iodine levels <100 μ g/l, they found that an association between urinary perchlorate and decreased serum T4 was stronger in smokers than in non-smokers, and stronger in those with high urinary thiocyanate levels than in those with low urinary thiocyanate levels. The authors concluded that for these low-iodine women, the results suggest that at commonly occurring perchlorate exposure levels, thiocyanate in tobacco smoke and perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 120 of 1099 interact in affecting thyroid function, and that ag ents other than tobacco smoke might cause similar interactions (Steimaus et al., 2007).

Individual Comments

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20629

EPA Comment Code: 2200

Comment: The analyses that form the basis of do cket ID No. EPA-HQ-OW-2008-0692, entitled "Drinking Water: Preliminary Regulatory Determina tion on Perchlorate" err significantly in the omission of critically relevant data sources. At a minimum, a critical ev aluation of Blount et al (2006a) should be incorporated into the docket and the conclusions drawn therein should be revised accordingly.

Another key data source that was omitted from consideration by the EPA is the relationship between perchlorate exposure and thyroid function iden tified by Blount et al. (Blount et al., 2006a). Blount et al., (2006a) results are consistent with a causal relationship between perchlorate exposure and thyroid function as follows:

a. The strength of the relationship between urin ary perchlorate and serum total T4 and serum TSH was greater in women with low urinary iodide (>100 ug/L).

b. The strength of the relationship between urin ary perchlorate and serum total T4 and serum TSH was greater in women who smoked (Steinmaus et al., 2007).

c. Significant relationships with other ions know n to affect iodide uptake were not observed.

d. Given the known variability in urinary perchlorate levels (Blount et al., 2006b) and in T4 and TSH levels (Andersen et al., 2002; Andersen et al., 2003) , a very large sample size would be required to identify these relationships.

EPA cites the NAS report of 2005 (NRC, 2005) as indicating that epidemiological studies cannot identify a causal relationship between perchlora te exposure and thyroid function. However, the CDC study of 2006 represents a verification th at known and predicted relationships between perchlorate exposure and thyroid function are occu rring at environmental levels of perchlorate exposure in the human population. EPA must consid er the statistical power of the CDC study to identify relationships of interest. These findings, furthermore, indicate that the high-dose, shortterm studies of Greer and others do not provide rele vant information about the life-time low-dose exposure to perchlorate. Therefore, in the absence of a rational alternative to epidemiological studies to identify such relationships of interest in humans, EPA must employ the best available science - that of the Blount study.

Response: See response to comment ID 29078 under comment code 2200.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 121 of 1099 Commenter Name: Rebecca Downey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1888

EPA Comment ID: 20772

EPA Comment Code: 2200

Comment: The EPA is choosing to ignore and dismiss several scientific studies, including thise
from the CDC, that show that Perchlorate can ca use serious thyroid disruption in women, children, developing fetuses and newborns. This is especi ally concerning in the unborn and newborn, as thyroid disruption effects brain development, that can lead to mental deficiences.

Response: EPA has found that perchlorate may have an adverse effect on human health. EPA intends to develop a proposed NPDWR for perchlora te and will consider the best available, peer reviewed data as we develop the proposed NPDWR.

Commenter Name: Lenny Siegel Commenter Organization: Center for Public Environmental Oversight

EPA Document ID: EPA-HQ-OW-2008-0692-2019

EPA Comment ID: 20854

EPA Comment Code: 2200

Comment: More important, though it draws upon the wo rk of the Centers for Disease Control to profile perchlorate exposures in the population, it dismisses one of its key findings: In 2006 Blount et al found that women with low iodide levels (over a third of the female population) experience decreased thyroid functions at low perchlorate exposures characteristic of much of the U.S. population. That effect could seriously impair the development of fetuses carried by such women.

But EPA states that Blount did not establish a causal relationship. That is, other factors-such as exposure to nitrates or thiocyanate, might be influe ncing thyroid function. It wrote, "It is also not known whether the association between perchlor ate and thyroid hormone levels is causal or mediated by some other correlate of both."

That is, EPA recognizes that there is a major threat to public health, but it refuses to take action

because there is a chance that the association between perchlorate and decreased thyroid function might be caused by another. unknown chemical compound. Yet EPA promis es no action to track down and investigate that mysterious cause. This is unconscionable!

Response: See response to comment ID 29078 under comment code 2200

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20901

EPA Comment Code: 2200EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 122 of 1099 Comment: Even with the errors and bias that the use of the CIIT computer model injects into EPA’s assessment, EPA still concludes that up to 2 million people may be consuming drinking water that exceeds the HRL, including tens of thousand s of infants and young children. The agency then dismisses these impacts as not significant enough to justify setting a drinking water standard for perchlorate. If EPA had used CDC’s real world da ta in it’s assessment instead of the flawed computer model, a much higher number of infants, children, and women of childbearing age would

be found to be at risk.

Response: See response to comment ID 28608 under comment code 2200. Also, see response to

comment ID 20903 in comment code 2200 and response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20903

EPA Comment Code: 2200

Comment: Introduction:

In this assessment, EPA relies primarily on a phy siologically-based pharmacokinetic (PBPK) model to estimate risks to different populations from pe rchlorate contamination of drinking water. This approach is somewhat suspect to begin with becaus e it is based on a computer model, rather than on the wealth of data from human studies on pe rchlorate. Recent large, well-conducted human studies on perchlorate have revealed that exposure to this thyroid toxin is widespread among the U.S. population and that women with lower iodine le vels are a particularly vulnerable group, in addition to breast-fed infants and young children.

Response: Several commenters supported the use of the PBPK model to inform the regulatory determination only if the significant limitations of the current model are addressed. For example, the inability of the model to reflect iodide nutritional status was cited by commenters and three of four peer reviewers as an important limitation (USEPA, 2008d). Also, several commenters stated that the risks to breast-fed infants and young children ar e not adequately addressed by the model. They challenged that the modeling analysis is based on average weight infants and healthy adults, while the sensitive life stages for perchlorate include premature infants and hypothyroid women.

After further consideration of the peer review and public comments, EPA concludes that the PBPK modeling analysis, in the context of the perchlorat e regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman.

The model also allows for the estimation of the co ncentration of perchlorate in breast milk (thus breast-fed infant exposure) at various maternal pe rchlorate exposure levels. However, because of the stated limitations, EPA has decided the model does not directly bear on the current decision regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 123 of 1099 Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20909

EPA Comment Code: 2200

Comment: Background

Recent research from the CDC and the Food an d Drug Administration (FDA) provide strong evidence that perchlorate exposure among the U.S. population presents potential health threats that justify strong protective measures by public heal th agencies. The most compelling findings from recent research from government agencies and academic scientists are summarized below:

* CDC tested 2,820 U.S. residents (a ges 6 an older) in a nationally representative sample and found detectable levels of perchlorate in the urine of every person tested (Blount et al. 2006a);

* Urinary perchlorate levels in children ages 6 to 11 were 1.6 times higher than levels in adults (Blount et al. 2006a);

* CDC scientists analyzed both perchlorate and th yroid hormone levels in more that 1,000 U.S. women and found that in the one third of women with lower iodine levels, perchlorate exposure far below EPA RfD of 0.7 ug/kg/day wa s associated with significant changes in thyroid hormone levels (Blount et al. 2006b);

* Using CDC data, an EWG analysis found that 2 million women of childbearing age may be at risk for abnormal thyroid hormone levels during pregnancy (EWG 2006);

* CDC and academic scientists have tested a co mbined 118 samples of U.S. breast milk in 4 different studies and have found perchlorate in every sample tested (Dasgupta et al. 2008, Kirk et al. 2005, Kirk et al. 2007, Pearce et al. 2007);

* Breast milk studies suggest that a significant number of breast fed infants may be exposed to perchlorate at levels that exceed the EPA RfD of 0.7 ug/kg/day (Dasgupta et al. 2008, Kirk et al. 2005, Kirk et al. 2007, Pearce et al. 2007);

* FDA scientists found perchlorate in three quar ters of nearly 300 commonly consumed foods and beverages; young children are exposed to perchl orate doses that fall between 50 to 56% of EPA’s RfD from food alone and could easily exceed EPA’ s RfD with additional drinking water exposures (Murray et al. 2008);

* A recent study from scientists at the Universi ty of Texas found that breast tissue concentrates perchlorate at 3 times the rate of iodine (Dasgupta et al. 2008).

This body of data from a number of respected sources including CDC, FDA, and academic scientists provides compelling evidence that esta blishes widespread exposure to perchlorate among the U.S. population and toxicity in a vulnerable population (women with lower iodine levels). The findings of widespread food contamination are es pecially concerning for young children, who eat more food and drink more water per unit of body weight when compared to adults.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 124 of 1099 EPA’s decision not to regulate perchlorate in drinki ng water in the face of such compelling facts is irresponsible and indefensible given the strength of the evidence for stringent regulation. In fact, EPA reached its decision by using flawed models an d methodology; following are some of the most glaring reasons that this assessment is inadequate.

Response: EPA agrees that perchlorate occurs at a fre quency and at levels of public concern in public water systems and intends to develop an NPDWR for perchlorate.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20912

EPA Comment Code: 2200

Comment: EPA relies on flawed computer model while downplaying significance of human data: As noted above, EPA relies heavily on a deeply flawed computer model that predicts RAIU inhibition at various levels of perchlorate cont amination of drinking water. The dependence on such a computer model would be more understandab le were there not comprehensive human data on perchlorate exposure and toxicity. However, in the last two years, government agencies like CDC and FDA, as well as prominent academic scientists , have published studies establishing widespread perchlorate exposure among the U.S. population, wi th especially high exposures among breast-fed infants and young children, and evidence of toxicity among women with lower iodine levels.

CDC published a ground breaking study in 2006 showing that current perchlorate exposures are associated with significant effects on thyroid hor mone levels in women with low urinary iodine levels. EPA deliberately downplays the significance of these findings, noting that CDC findings are contradicted by another study: "Results from st udies of the effects of perchlorate exposure on hormone levels have been mixed. One recent study did not identify any effects of perchlorate on blood serum hormones (Amitai et al. 2007), while another study (Blount et al. 2006b) did identify such effects" (EPA 2008).

However, when the Amitai et al. study is reviewed, it is clear that the results of this study do not
contradict the results from Blount et al.; in fa ct, the study authors themselves note, "Based on differences in iodine intake and life stages for th e two studies, our findings do not contradict those of Blount et al." (Amitai et al. 2007). Yet, EPA main tains that the results from Amitai et al. provide evidence to doubt CDC results although the two st udies are completely different and the CDC study is the only one to have established unique vuln erability to perchlorate among women with lower urinary iodine levels. By raising doubts about the validity of CDC findings, despite no scientific justification, EPA is able to downplay the signific ance of these findings to justify excluding them in

their assessment.

Response: See response to comment ID 20909 under comment code 2200. Also see responses to comment IDs 29078 regarding the Blount et al. st udy and 20903 regarding PBPK modeling under

comment code 2200.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 125 of 1099 Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20946

EPA Comment Code: 2200

Comment: CDC Studies Reveal Relationships between Perchlorate Exposure and Thyroid Hormones that Make Biological Sense

CDC researchers evaluated the relationship between urinary levels of perchlorate (which was found in every individual tested and at significantly higher levels in children, and serum levels of TSH and total T4 in 2,299 men and women, >=12 years of age, participating in the CDC-sponsored National Health and Nutrition Examination Survey (NHANE S) during 2001-2002 (Blount et al. 2006, 2007). This study found that:

* All individuals tested were exposed to perchlorat e. * Children had significantly higher levels of perchlorate exposure, * For all women >=12 years of age, multiple regression analysis found urinary perchlorate to be a significant predictor of serum TSH and a significant predictor of serum T4. * For women with urinary iodine < 100 ug/L, multiple regression analysis found perchlorate to be a significant predictor (p < 0.0001) of T4 with a coefficient for log perchlorate of -0.8917. * Perchlorate was also a significant predictor (p = 0. 0010) of log TSH with a coefficient of 0.1230.

Hence, the results of the Blount study more closely reflect our understanding of the biological and toxicological processes pertaining to thyroid homeostasis, both in terms of thyroid hormone variability and the role of iodine. The researchers c onclude that "[i]ncreased urinary perchlorate was

associated with increased TSH and decreased T4 fo r women with urinary iodine levels < 100 ug/L, a group possibly more susceptible to competitive inhi bition of thyroid iodine uptake by perchlorate. The statistically significant associations of ur inary perchlorate with decreased serum T4 and increased serum TSH were consistent with comp etitive inhibition of iodide uptake."

The Blount study also validates findings of previo us CDC study that 36 % of women in the National Health and Nutrition Examination Survey (NHANE S), 2001-2002, had low iodine intake (< 100 ug/L urinary iodine) (Caldwell et al. 2005) , which translates to approximately 43 million US women (Pirkle 2007).

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20948

EPA Comment Code: 2200

Comment: EPA Fails to Recognize the Importance of Iodine and Individual Variability

On page 60268 of the Federal Register Notice, EP A suggests that a study by Amitai et al. (2007) provides information that contradicts the findings of the Blount study, stating that measured T4EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 126 of 1099 values were not associated with perchlorate levels , despite the fact that the perchlorate levels were much higher than in the CDC study. Amitai et al . directly address this comparison, asserting that because of differences in the study population betw een the Amitai and Blount studies, the studies are not contradictory:

"A previous study of pregnant women in the coas tal areas of Israel indicates iodine sufficiency (urinary iodine median=143 ug=L, mean=130 ug =L) based on World Health Organization (WHO) criteria. Another important difference between the cu rrent work and the Blount et al.'s study is the study population: we examined thyroid function in neonates, while Blount et al. studied adults and

adolescents. Based on differences in iodine intake an d life stage for the two studies, our findings do not contradict those of Blount et al." (emphasis added) (Amitai et al. page 848).

Another earlier study evaluating high levels of exposure to perchlorate (the Chilean study) also involved a population that was iodine sufficient (T ellez et al. 2005). Taken together these studies indicate they iodine sufficiency is a critical componen t of resistance to perchlorate effects. With over 1/3 of US women demonstrating insufficient iodine intake, iodine status must be considered as an important characteristic of the exposed population.

EPA's failure to appropriately account for both in dividual variability and iodine status ignores important biological and toxicological considerat ions and has contributed to the selection of a reference dose that is not adequately protective of sensitive subpopulations.

We strongly recommend that the CDC data analyzed in the study by Blount et al. 2006 and Blount et al. 2007 be used as the basis for the derivation of a new reference dose. One option would be to estimate perchlorate dose from urinary perchlora te using an equation developed by Mage et al 2004 and applied by Blount et al. 2007. EPA could then estimate benchmark doses of perchlorate associated with benchmark responses for abnormally low T4 serum concentrations and abnormally high serum TSH concentrations in women with low urinary iodine excretion. EPA could use the BMD low (representing the lower limit of a one- sided 95% confidence interval), which more accurately reflects the statistical power inherent in the study design than the NOAEL (or NOEL, or LOEL for that matter), and more efficiently utiliz es the dose-response data while being less sensitive to the spacing of doses. An uncertainty factor ma y be necessary to ensure the protection of the fetus and neonate. There are likely to be other approaches to data analysis that accounts for sensitive subpopulations, including individual variability, io dine status and windows of vulnerability and we encourage EPA to re-evaluate these options.

Response: See response to comment ID 29078 under comment code 2200. EPA accounts for individual variability by incorporation of an intras pecies uncertainty factor in the derivation of the

RfD.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20970

EPA Comment Code: 2200

Comment: This value could be further checked against the NHANES data:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 127 of 1099 The effective perchlorate equivalent NOEL (NOE L3) as explained before is 7.04 + 5.8 = 12.8 ug/kg-day. This, as explained before, leads to a ne w RfD of 1.28 ug/kg-day applying the same UF of

10.

The background of the other 2 goitrogens repr esents 40% of NOEL3 (5.8/12.8= 0.4) (and the perchlorate background 0.3%).

Therefore the RfD for perchlorate alone for th e general population would be 1.28x 0.6 = 0.77 ug/kg-day and the HRL would be 27 ppb.

This is very close to the 26.7 ppb assigned above as HRL for perchlorate alone in the perchloratenitrate cup if the nitrate HRL would also be subject to an UF of 10 and it is also close to the current EPA DWEL of 24.5 ppb.

In any case it would not have much sense as a pu blic health policy and in particular in terms of thyroid protection to try to arrive at the most accurate DW HRL for perchlorate and leave the nitrate MCL at such levels that this effort would be completely nullified.

Therefore it should be recommended to set a joint HRL of 45 ppb perchlorate equivalent for nitrate and perchlorate combined.

Response: See response to comment ID 29078 under comment code 2200. EPA cannot comment on a value for combined nitrate and perchlorate because that has not been peer reviewed.

Commenter Name: Commenter Organization: Ag Council et al

EPA Document ID: EPA-HQ-OW-2008-0692-1987

EPA Comment ID: 20978

EPA Comment Code: 2200

Comment: The Blount (2006) Analysis of Perchlor ate Data has Several Limitations and EPA Should not Rely on its Conclusions to Make Regulatory Decisions.

The argument has been made that the Blount (2006b) results, which show a slight correlation between perchlorate in urine and changes in thyroid hormone levels in women with sub-optimal iodine levels, should be given considerable weight by EPA in making its regulatory determination for perchlorate. This work has several limitations which necessarily impede its use in drawing conclusions regarding the health effects of perchl orate, particularly for purposes of regulatory decision making. Chief among these is the fact th at Blount (2006b) does not establish direct causation, only an association between two independ ent data sets. A number of intervening factors could cause or contribute to the reported decrease in thyroid hormone levels. Moreover, the Blount (2006b) results conflict with the overwhelming bod y of scientific evidence showing no effect on the thyroid at environmentally relevant levels. Dr. Bl ount himself has acknowledged the limitations of his results. Similar concerns have been raised by independent organizations such as the American Thyroid Association.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 128 of 1099 The California agricultural industry appreciates US EPA's consideration of our comments on its preliminary regulatory determination for perchlor ate. We remain committed to working with US EPA, FDA and individual states to preserve the safety of our products and their contribution to balanced, heallthy diets.

Sincerely,

Ag Council California Citrus Mutual California Co tton Ginners and Growers Association California

Farm Bureau Federation California Grain and Feed Association California Grape and Tree Fruit League Grower-Shipper Association of Central California Grower-Shipper Association of Santa Barbara and San Luis Obispo Counties Imperial Valley Vegetable Grower Association Ventura County Agricultural Association Western Grower s Western Plant Health Association Western United Dairymen

Cc: Benjamin Grumbles, Assistant Administrator, U.S. EPA Office of Water Nega Beru, Director, U.S. FDA Office of Plant Dairy Foods and Bevera ges Charles F. Conner, Deputy Secretary, U.S. Department of Agriculture

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21024

EPA Comment Code: 2200

Comment: 7. Next, your letter raises the issue of the NHANES 2001-2002 survey results and the Blount et al. 2006b study.

It is important to note that the results of the NHANES survey reveal that the US population is not exposed to levels of perchlorate that could cause an adverse effect, even when all exposure sources -

in food and water - are considered. There has be en considerable discussion over the role of the Blount study in the regulatory decision-making process. Those who support its use point to the specific finding that perchlorate levels were a negati ve predictor of total T4 and a positive predictor of TSH in women with urinary iodide less than 100 μg/L. While the findings of the study are interesting, the specific finding at issue is not ab le to determine causation and is simply based upon an association between two variables. The study di rectly conflicts with the large number of studies that have shown no effect at environmental levels. Government agencies and private organizations, including the Agency for Toxic Substances and Dise ase Registry, the American Thyroid Association and the Toxicology Excellence for Risk Assessmen t (TERA), have identified several limitations concerns with the Blount study. As a result they recommend that based on its status as solely an associational study and as well as the numerous lim itations, it should not be used in regulatory decision-making.

ATSDR (2008) reviewed the Blount et al. (2006b) st udy in their assessment. ATSDR did not believe that it merited any special consideration over other studies in the well developed perchlorate literature database. They stated that their decision "...was made after a careful evaluation of the NRCEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 129 of 1099 report and of studies that have been published af ter the NRC (2005) report. The results from newer studies do not change the bottom-line recommendation" (ATSDR, 2008).

The lead author, Dr. Benjamin Blount, has acknowle dged several limitations with the study and that its results require validation. At an NAS workshop on risk assessment considerations for thyroid active compounds [FN5: National Research Cou ncil Fifth Workshop of the Standing Committee on Risk Analysis Issues and Reviews, Risk Assessmen t Considerations for Interpretation of Bioassay Data and Human Biomonitoring Data for Thyroid-A ctive Compounds: Issues of Variability, Critical Reproductive-Developmental Periods, and Cro ss-Species Comparisons, May 15-16, 2008.], Dr. Blount reviewed the results of this study and id entified several limitations with the study:

* due to other missing data, perchlorate coul d be a surrogate for an unknown variable;

* the study is only a cross-sectional association, recognizing that it does not establish a direct causation between perchlorate levels and thyroid hormone levels;

* although this study looked at total T4, free T4 is a better measure, and

* the study was based upon a weak iodine assess ment. [FN6: Ben Blount, Biomonitoring Data on Thyroid-Active Compounds: Database and Issues Regarding Variability and Interpretation, presented at NAS workshop in note 1 above, May 15, 2008.]

8. Please see the attached copy of our comment s recently submitted to the EPA docket for a more extensive discussion regarding concerns and limitations of the Blount study and its inappropriate use for regulatory decision-making.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21038

EPA Comment Code: 2200

Comment: RE: Docket ID No. EPAHQ- OW-2008-00 68 Comments on the US Environmental Protection Agency’s Preliminary Regulatory Deter mination on Perchlorate November 28, 2008

I am submitting these comments unanimously since I am employed in an organisation that may not consider these comments acceptable.

Thank you for the opportunity to comment on the USEPA Office of Water’s Preliminary Regulatory Determination on Perchlorate.

Comment subject

EPA refers to the Blount et al., (2006b) study and EPA mentions that in that study other covariates were evaluated besides perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 130 of 1099 Of those covariates only 2 were substances that, just as perchlorate, have a potential effect on TSH and T4 levels i.e. nitrate and thiocyanate.

EPA also mentioned that "The researchers state that perchlorate could be a surrogate for another unrecognized determinant of thyroid function".

We would like to comment on the fact that a multit ude of other substances exist in the environment that can affect the level of those thyroid horm ones and that most probably perchlorate is the surrogate, the marker for this pool of substances and nothing else.

Summary

More than 2 years after the publication of the Blou nt et al., (2006b) study there exist still doubts and EPA seems to confirm this, that the very low levels of perchlorate, in contrast to the body of literature, would be the cause of the observed thyroid hormone level change.

The following reasoning should eliminate this doubt.

1. Circumstantial evidence

1.1. The effect level found in the Blount study at 10 ,000 times or 4 orders of magnitude lower than consistently found hitherto in the body of literature is unlikely.

1.2. If it still would be seen as likely, then cons equently the current EPA HRL should be divided by 10,000 from 24.5 ppb to 0.002 ppb and even to 0.00 02 ppb if an additional UF (uncertainty factor) on top of the NRC UF of 10 would be applied (as ha s been suggested by some, justified or not ).

1.3. Iodine uptake inhibition precedes any adverse health effect of perchlorate exposure including TH (thyroid hormone; here T4 and/or TSH) level ch ange so perchlorate cannot have an effect on TH when there is no iodine uptake inhibition in the first place. Evidence from the NHANES data on which the Blount study was based shows that ov erall, most probably iodine inhibition did not

exist.

1.4. The relationship of 2 other well known iodine uptake inhibitors with TH.

1.4.1. Their "unexpected" relationships Thiocyanate and nitrate show relationships with TH and iodine in an "unexpected" direction and contrary to the perchlorate relationship with TH and iodine which was in the "expected" direction (and then only for iodine insufficient women; the direction was "unexpected" as well for iodine sufficient women).

If those would be assumed to be causal as well - and they should be if the relationship with perchlorate is assumed as such- then the competitive uptake inhibition mechanism as we know it should be discarded and dietary increase of iodine should always be discouraged. The same should be said also regarding the relationship of perchlor ate with TH for iodine sufficient women. We have not heard those proposals.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 131 of 1099 1.4.2. Their strength level The other 2 goitrogens, thiocyanate and nitrate, with the same mode of action as perchlorate do not show this "expected" re lationship even though their equivalent levels are 28 and 56 times higher respectively.

Conclusion of 1.4.: If all other re lationships found are considered highly implausible(in the opposite direction of what should be "expected ") to be causal, what can be the justification to single out one as causal because it seems to fit the "expectations" and explain away all the other relationships as "unclear" since they do not fit those expectations?

2. The number and probability of possible alternative causes

2.1. Why should those possible alternative causes have been considered with priority? Since it was shown that iodine levels overall were probably not relevant we should not look for something that affects NIS (and therefore potentially but only indi rectly TH levels) but something that affects TH levels directly.

It is surprising that EPA does not raise this i ssue but limits itself to mentioning nitrate and thiocyanate. If the Blount et al. study were about iodine uptake inhibition effect then this would have been justified. But it was not.

It was about the downstream effect, the effect on TH.

2.2. Covariates that have not been taken into cons ideration in the study and should have been so with priority.

There are many widespread contaminants that are goitrogenic with effects on TH levels via mechanisms unrelated to iodine uptake such as organohalogens and other dioxin-like compounds which are ubiquitous and include many pesticides as well.

They act thru different mechanisms.

Only PCBs already include 209 congeners that vary based on the number and positions of chlorine

atoms.

Other substances such as Bisphenol-A , methylme rcury are believed to be goitrogenic, even halogens like bromide or fluorine added in drin king water (besides chlorine) or their reaction products. Added to these should be natural goitro genic substances such as isoflavones, genistein, resveratrol, silymarin and linuron.

Data on some were available in the same 2001-20 02 NHANES database from which perchlorate, iodine and the other 2 NIS goitrogens were extracted.

Many studies including several EPA sponsored studie s deal with those other goitrogens; some even include perchlorate in parallel.

The question should then be asked: why were those goitrogens not controlled for or at least referred to as possible causes?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 132 of 1099 2.3. The level found compared with the effect level

The known threshold effect level on THs of organo halogens such as PCBs and other dioxin-like

substances and their levels in the NHANES 2001-200 2 database have been found to be in the same range and some showed a relationship with THs as well.

This is in stark contrast with the 4 orders of magnitude difference for th e corresponding levels of perchlorate in the Blount study.

3. What then could be the link between perchlor ate and those known endocrine disruptors?

The most obvious and most widely spread common link is chlorine.

On one hand it has been shown that chlorine ba sed disinfectants such as those found in drinking water (DW) oxidize to perchlorate as a disinfection by-product (DBP).

This is for example the reason why Massachusetts doubled its MCL from 1 to 2 ppb.

This oxidation is significant as it corresponds to ab out 1/3 of the average daily intake of perchlorate according to the Blount study (from the NHANES data).

Bleach is used ubiquitously as for example in water purification stations, paper mills, drinking water and for many other applications.

Other potential sources of perchlorate as a DBP ar e other chlorine derivates such as chlorine gas

and chloramine.

On the other hand other DBPs originate from th e reaction of chlorine based disinfectants with organic matter (waste) to form organochlorides.

There are 2 DBP pathways that link perchlora te and those other goitrogenic substances with

chlorine:

DBP road 1: Bleach/Cl2/Cl-/chloramine ->ClO-3 ->ClO-4

DBP road 2: (in presence of organic (C) material):

Bleach/ Cl2/Cl-/ chloramine ->phenols ->organochlorides/dioxins

So chlorine is one example of the link between ve ry low levels of perchlorate and TH affecting

substances.

Since organo-chlorinated compounds are ubiquitous and since we find around 1/3 of the total dietary perchlorate where we find organo-chlorina ted compounds and since many of those have been shown to affect TH levels it is to be expected that low levels of perchlorate are associated with TH levels as found in the Blount study.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 133 of 1099 Yet assigning cause to this association would be against all common sense as overwhelming circumstantial evidence points in another direction.

Perchlorate seems to be rather a marker, a witn ess, a messenger of the presence of ubiquitous goitrogenic contamination caused by the net effect of hundreds of substances (see also next section).

4. Would this be the final answer: organochlorides are the sole cause of the (slight) TH changes? Probably not.

There seems to be a ubiquitous contaminant pool in which there are all kinds of goitrogenic substances acting thru all kind of mechanisms that influence TH levels and thyroid function. Somehow they could be all linked together.

So it seems plausible that perchlorate is a ma rker of this ubiquitous pool of thyroid function affecting contaminants which means that the more perchlorate is found (outside from the point source contaminations of course) the more goitrogenic the pool will be via the chlorine and halogen link and therefore the more goitrogenic effect on THs will be seen.

5. Conclusion

The answer to the question of what caused the Thyr oid hormone changes in the Blount study is: all of the above except perchlorate as seen at those very low levels.

It may be felt as politically rewarding to look fo r a simple explanation but, from what precedes such a simplistic and irrational interpretation would certa inly not lead to effective health protective measures. On the contrary it would lead to a feel good situation with only illusory effects.

A careful analysis should precede any sweeping sta tements like those we are s eeing in some media. We hear a lot about holistic approaches in he alth risk assessment but not many practical applications. This may be one of them.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21039

EPA Comment Code: 2200

Comment: In trying to establish a HRL (Health Reference Level) for drinking water, EPA seems to be torn between the 2005 NRC RfD (reference dose) [see reference 1], referred to as "NRC RfD " hereafter, and a subsequent study [see reference 2], referred to as "Blount" hereafter, that, on first sight, appears to undermine this very RfD.

This study showed a relationship between extremel y low levels of perchlorate and TH (thyroid hormone; here T4 and/or TSH) levels.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 134 of 1099 As a result this relationship has been considered by many as a cause effect relationship suggesting (adverse) effects at a level of perchlorate much lo wer than that of the NRC RfD, which itself is based on the body of literature.

All kind of erudite and highly complex reviews came out during the following 2 years either supporting or weakening the perceived c onsequences of this new finding.

Did all this bring us today one step closer to an explanation of this significant contradiction? No, it

did not.

Yet it is abundantly clear that there is an evident overall fallacy that has not been exposed. EPA rightly points out, as many have done before, that a cross- sectional study, such as the Blount study

can show associations but cannot decide causes.

The main reason is that it does not allow cont rol for non quantified (measured) covariates or for quantified covariates that were not considered relevant but that should have been.

In order to evaluate the likelihood of this hypothetical cause-effect relationship the following 3 aspects should be appraised:

1. The presence of circumstantial evidence i.e. a co llection of facts that, when considered together would conclude in favour or against the hypothesis.

2. The number and probability of possible alternative causes.

3. The link of these alternative causes with the hypothetical cause.

Let’s see how those 3 obvious criteria work out.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21040

EPA Comment Code: 2200

Comment: 1. Circumstantial evidence

1.1. The 4 orders of magnitude difference in leve ls From Blount ( NHANES 2001-2002) data and regression curves, the average urinary level of 2.84 u, which is found to be related to thyroid hormone (TH) change, is equivalent to an oral perchlorate dose of approximately 0.00004mg/kgday.

This is 100 times lower than the dose of 0.004 mg/kg-day that was found to be without effect not even on iodide uptake [see reference 1] and which led to the NRC RfD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 135 of 1099 Further this dose of 0.004 mg/kg-day on itself is about 100 times smaller than 0.5mg/kg-day, the dose found to have no effect on TH [see reference 1].

So, in stark contradiction to what was found in th e body of the literature, the Blount study would suggest, if the relationship perchlorate /TH would be seen as causal, that perchlorate is 10,000 more potent than formerly found.

[see figure in PDF docket ID EPA-HQ-OW-2008-0692-1990]

The following illustrates the effect of 4 orders of magnitude: A dose of perchlorate used to treat Graves disease (excess thyroid function) and whic h was known since decennia to be effective at about 700 mg/day or 10 mg/kg-da y would all of a sudden be eff ective at 0.001mg/kg-day, a dose that is not only 10,000 times lower than prescribed but also 500 times lower than the dose that only may start to have the intended e ffect but on euthyroid people instead (0 .5 mg/kg- day). At that time would it have been likely that a 10,000 times overdose would have been recommended during several decades knowing that the side effects fi nally caused this remedy to be pulled from the market? This is highly improbable to say the least.

Another image for the most tenacious readers: To make it more visually comprehensible for their readers, the NRC RfD of 0.0007 mg /l has often been expressed in the media as "a couple of drops in an Olympic seized swimming pool".

The 10,000 times lower dose would then mean that about 9900 swimming pools of that size should be first build in the U.S. before it would be possi ble to further dilute those same couple of drops to this level since there are only a bout 100 of those pools existing..

In any case if this first massive conflict would st ill not be considered relevant or convincing (for reasons that then should be explained however) and the extremely low leve l causal effect would still be seen as probable then at least the consequences should be consistent which leads us to the

second circumstantial evidence:

Response: EPA cannot comment on the calculations by the commenter that have not been peer

reviewed.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21041

EPA Comment Code: 2200

Comment: 1.2. The new MCL that should be recommended accordingly

This means the RfD and the corresponding MCL (or HRL) should be lowered accordingly and not from 24.5 ppb to, say, 1 ppb (half the Massachusett s MCL, the lowest state MCL) but to 0.24 or 0.024 ppt (if applying an UF of 10 or 100 respectively) or 0.0002 / 0.00002 ppb.

We have not heard this claim. If this causal relationship would nevertheless exist then this corresponding low level should be suggested as an MCL or HRL. Yet the lowest MCL we have seenEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 136 of 1099 proposed in relation to this "new finding" was only about 10-50 times lower than the NRC RfD. This shows that even the most enthusiastic believers don’t really belief in it.

When it is too bad to believe, it probably isn’t.

Besides, since perchlorate is, just as nitrate, also naturally found in many drinking water wells in the US, particularly in the west and centre of the country at levels about 1000 to 10,000 times higher(between 0.1 and 1 ppb) than this "new" level, one wonders then what effect should this have

on the TH status of the millions of people in those areas if such much lower levels would have an effect already.

Response: See response to comment ID 20772 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21042

EPA Comment Code: 2200

Comment: 1.3. A downstream effect implies an upstream effect

Adding even more to this discrepancy was th e fact that the NRC RfD was based on an effect upstream from the Blount study effect.

Indeed since iodine uptake inhibition precedes an y adverse health effect of perchlorate exposure including TH level change [see reference 1], perchlorate cannot have an effect on TH when there is no iodine uptake inhibition in the first place. This is the essence of the iodine uptake inhibition mechanism leading to a (potential) effect on TH levels.

Unfortunately information about possible Iodine uptake inhibition into the thyroid at such low levels, while highly improbable as shown above, was not available from the NHANES data on which the Blount study was based. - Yet what we do know from those data is that there exists a strong relationship between those low levels of urin ary (U) perchlorate and U iodine: for an increase of 1 ug/l U perchlorate, the U iodi ne levels increase linearly with about 30 ug/l all the way from the first to the ninth decile. So, even if perchlorate would have had a potential effect at such low levels it should have been more than compensated by the iodine association as this is what should be expected from a competitive uptake mechanism and because of the fact that the perchlorate inhibitive potency in relation to iodine is known to be around 1/30 based on in vitro studies [see reference 3] or 1/3 in a recent publication based on a in vivo study [see reference 4].

The scatter plot below [see reference 5] illustrates the strong relationship, all the way to the 9th percentile, of very low U perchlorate with U io dine in the U.S. population (NHANES 2001-2002)

controlled for THs.

[see figure in PDF docket ID EPA-HQ-OW-2008-0692-1990]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 137 of 1099 There may be even an explanation for this: perchl orate and iodine are both naturally present in all soils and low levels of perchlorate [see reference 6] and iodine are continuously formed in the atmosphere (just as the other halogens including io dine [see reference 7] and nitrate by the way). The complete disappearance of the relationship in th e 9th percentile could be explained as the appearance of the higher level but less diffuse cont aminant point sources of perchlorate on top of this natural background.

- Further the same NHANES data show that U iodine is not related with (serum) TH [see reference 8] which implies that the TH level changes observe d seem to be caused by something that does not have anything to do with iodine levels and therefor e with iodine uptake inhibition. If the TH levels found are independent from iodine U levels and th erefore from the levels present in the diet then the downstream TH changes cannot be caused by an iodine uptake inhibitor such as perchlorate. If that still would be the case then iodine supplements should not be recommended for iodine insufficient individuals; again this does not have any sense.

This association unfortunately was not discussed in the Blount paper as the population was split in 2 groups based on their U iodine levels (this confirms that the mind was set on iodine uptake inhibition and not on any other mechanism, see next section).

Response: See response to comment ID 29078 under comment code 2200 regarding the Blount et al. study. As discussed in the final determination, EPA believes that perchlorate may have an adverse

effect on human health.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21043

EPA Comment Code: 2200

Comment: What other circumstantial evidence we have?

What about some other covariates?

1.4. Covariates that have been taken into consideration in the Blount study

1.4.1. Relationships of other goitrogens with THs

To be consistent, if the relationship of perchlora te with TH would be considered causal without any supportive evidence then the relationship of the other goitrogens with the same effect on iodide uptake and TH levels should be considered causal as well.

1.4.1.1. Now in this study it was also found that increased levels of thiocyanate were significantly associated with decreased thyroid activity i.e. an unexpected opposite association compared with perchlorate’s association. Would that then mean that if this study were about investigating thiocyanate’s effect on TH (i.e. not focused on perchlorate) it would have to be concluded that it was now a remedy instead of a goitrogen and th at for example consuming cassava would now beEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 138 of 1099 good for fighting goitre? Since the opposite is known, this is further strong circumstantial evidence against the causal association.

1.4.1.2. Also nitrate, also a known goitrogen with effect on iodine uptake and therefore, tested (controlled for) as a covariant as well, was significantly associated with T4 levels but only for women with iodine levels considered as sufficient ( =100 ug/l ) and not for those with levels considered as insufficient. Isn’t that contrary to the known mechan ism associated with goitrogens as iodine uptake inhibitors? Or how can it be explained that su fficient becomes now insufficient and insufficient

becomes now sufficient?

Again the question can be raised: if this were ins tead a study on the goitrogenic effects of nitrate wouldn’t this association, if causal, preclude io dine supplements as a remedy and therefore also preclude iodine as a remedy against perchlorate an d thiocyanate? We have not heard this and that would be unlikely and thus further undermines the causal hypothesis.

1.4.1.3. This would then also be in direct conf lict with the recommendations we have seen in relation with this study in that iodine insufficient individuals should increase the dietary intake of iodine to compensate for the alleged perchlorate effects.

1.4.1.4. Moreover the fact that perchlorate was a ssociated with T4 also for U iodine sufficient women all the way to the highest levels (besides for iodine insufficient women) would lead to the

same contradiction.

1.4.1.5. Most or all of the above statistically signif icant relationships could only be plausibly causal if the currently generally accepted knowledge abou t iodine and NIS (Sodium Iodine Symporter) goitrogens in association with the thyroid would be rejected.

We have not found any author bringing forward this new hypothesis about the mechanism related to

NIS either.

This overwhelming direct and indi rect evidence that the above relationships with other goitrogens could not be causal implies once again that attrib uting a cause-effect aspect to the perchlorate TH relationship because it happens to be in the "expected" direction, is arbitrary and unreasonable.

Or said in other words, if all other relationships found are considered highly implausible to be causal, what can be the justification to single out one as causal because it seems to fit the "expectations" and explain away all the other relationships as "unclear" [see reference 2] since they do not fit those expectations?

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21044

EPA Comment Code: 2200

Comment: 1.4.2. Levels of other goitrogens compared to perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 139 of 1099 1.4.2.1. Thiocyanate compared to perchlorate The average U level of the goitrogen thiocyanate is 1,200 ug/l which, after applying a potency equivalency of 1/15 [see reference 2,3], translates into 80 ug/l perchlorate equivalency or 28 times more th an the average perchlorate level of 2.8 ug/l.

If 28 times more perchlorate equivalent does not show an association in the "expected" direction how could it be explained that 28 times less does?

1.4.2.2. Nitrate compared to perchl orate The average U level of the goitrogen nitrate is 38,000 ug/l which, after applying a potency equivalency of 1/ 2402, 3, translates into 158 ug/l perchlorate equivalency or 56 times more than the av erage perchlorate level of 2.8 ug/l.

If 56 times more perchlorate equivalent does not show an association in the "expected" direction as

there is interaction with iodine levels but in the "wrong" direction, how could it be explained that 56

times less does?

It should be noted that the perchlorate potency comp ared to iodine has recently shown to be much weaker in vivo than in vitro yet the relative potency of the goitrogens compared to each other has been shown to remain unchanged [see reference 4].

Conclusion: Circumstantial evidence overwhelmi ngly concludes against the hypothesis.

Response: EPA does not believe that sufficient data ex ist to permit comparison of the relative potency of perchlorate to other goitrogens, or to permit the conduct of a cumulative risk assessment. See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21045

EPA Comment Code: 2200

Comment: 2. The number and probability of possible alternative causes

2.1. Why should those possible alternative causes have been considered with priority?

Above we have discussed the goitrogens that have the same mode of acti on as perchlorate i.e. inhibition of iodine uptake thru NIS (sodium iodide symporter).

There exist many other goitrogenic substances (which in effect are also goitrogens as they lead to the same endpoints) that have a different mode of action not related to iodine.

The Blount study is about possible effects on TH s of substances present in the population sample.

So all known substances that affect TH levels should have been statistically tested and controlled for as well and not only those that act through the same mechanism as perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 140 of 1099 Since as shown iodine levels are probably not relevant we should not look in the first place for something else that affects NIS function (and ther efore potentially but only indirectly TH levels) but something that affects TH levels directly.

EPA’s current RfD for perchlorate is based on perc hlorate’s ability to inhibit the thyroid gland’s uptake of iodide by competing for the sodium (Na+)/iodide (I-) symporter (NIS), the protein responsible for transporting iodide into the thyr oid gland for the purpose of synthesizing thyroid

hormones.

So it is surprising that EPA does not raise this issue but limits itself to mentioning nitrate and thiocyanate. If the Blount et al. study were about iodine uptake inhibition effect then this would have been justified. But it was not. It was about the downstream effect, the effect on TH.

Yet in the Blount study it was assumed that iodine uptake inhibition was the upstream effect so much so that, as said, the population had been split into 2 groups, iodine deficient and iodine sufficient. As noted before, this only added more inconsistencies as it exposed additional "unexpected" relationships which should have been seen as an additional warning that something

was amiss.

Hence substances that have a direct effect on TH s hould have been tested with priority instead.

Response: See response to comment ID 21044 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21046

EPA Comment Code: 2200

Comment: 2.2. Covariates that have not been taken into consideration in the study and should have been so with priority

We quote from the January 2008 Thyroid jour nal: "Toxicological models and limited epidemiological studies have indicated that ma ny organohalogen aromatic compounds, including dioxins, polychlorinated biphenyls (PCBs), and polybrominated diphenyl ethers (PBDEs), may be classified as â€ ̃â€ ̃endocrine disruptors, as they ha ve the potential to alter normal thyroid function." "Because environmental exposures rarely occur singly , it is often difficult to disentangle a single exposure from other cooccurring environmental ex posures and conditions that may confer risks upon children. Therefore, there is often the poten tial for confounding, in which both the exposure and the outcome under investigation are related to a third factor that may distort the observed exposure-disease relationship." "In epidemiologic st udies, it is critically important to identify, measure, and control for such confounders."

As mentioned, there are many widespread contam inants that are goitrogens with effects on TH levels via mechanisms unrelated to iodine uptake.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 141 of 1099 Some can be expressed as TEQ’s (total toxic equivalents) and include the known endocrine disruptors such as PCBs (polychlorinated bipheny ls), PCDDs (polychlorinated dibenzo-pdioxins), PCDFs (polychlorinated dibenzofurans) besides PCDFs, PBDEs (polybrominated diphenyl ethers), DDE (dichlorodiphenyldichloroethylene) TCDDs (tetrachlorodibenzo-pdioxin), TBBPAs (Tetrabromobisphenol A), degradation products of DDT such as HCB (Hexachlorobenzene), etc. [see reference 9, 10 ,11]

Most of them have a structure resembling thyroid hormones [see reference 12].

They act thru different mechanisms [see reference 13].

PCBs include 209 congeners that vary based on the number and positions of chlorine atoms. Compared with estrogens and antiandrogens, thyroi d-disrupting chemicals are the least well studied endocrine disruptors (ED). It is therefore not sur prising that few mixture studies exist using this kind of agents.

Further many other substances with completely diffe rent structures are known goitrogens in the sense that they also affect directly or indirectly TH levels (see section 4).

Question: Why weren’t these substances tested and controlled for as covariates to evaluate the independence of the perchlorate relationship, the more so that the data on some, such as PCBs and other dioxin-like substances, including those conc erning pesticides, were available as they were

included in the same 2001-2002 NHANES database from which perchlorate, iodine, the other 2 NIS goitrogens and other 12 tes ted covariates were extracted?

here were other hints that pointed to a different direction: While NHANES 2001-2002 THs levels do not reflect urinary iodine concentrations [s ee reference 5], serum PCBs, p,p'-DDE and HCB predict Thyroid Hormone Levels [see reference 14 ] and some do so in NHANES 2001-2002 as well [see reference 15] Also co variants such as smoking status which were associated with thiocyanate in the Blount study and follow-up studies [see reference 16] could just as well be linked to organohalogens as cause since tobacco contains organohalogen pesticides that are organohalogen based or transformed in such substances during burning [see reference 17].

Also why doesn’t EPA itself refer here to those crit ical covariates as they did in the EPA coauthored document: Moving Upstream: Evaluating Adve rse Upstream Endpoints for Improved Risk Assessment and Decision-Making, EHP, 2008 and other EPA studies? [see reference 18, 19, 20].

Also reference [see reference 12] that dealt with perchlorate and PCBs as EDs together was research sponsored by an EPA grant.

Why would for example investigating the effects on TH levels of a certain pesticide in soya without controlling for say isoflavones (see further below) or vice versa not be acceptable and why would it be in the case of perchlorate, particularly at such extremely low levels.

Response: The hypothesis tested for in the Blount stud y was that there was a relationship between perchlorate and a limited number of other goitroge ns, iodide status, and TSH/T4 concentration in the samples evaluated. The additional analyses noted by the commenter are beyond the scope of theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 142 of 1099 Blount study. EPA relies upon the best available peer reviewed data. See response to comment ID

21049 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21047

EPA Comment Code: 2200

Comment: 2.3. The level found compared with the effect level

The known threshold effect level on THs of organo halogens such as PCBs and other dioxin like substances that has an effect on THs has been found to be in the range of 0.1 to 10 ug /l serum depending on the substance [see reference 21].

The levels of those substances found in NHANES 20 01-2002 is in this range and, as mentioned, a relationship of some with THs was found as well [see reference 15].

This is in stark contrast with the 4 orders of magnitude difference between the effect level of perchlorate on THs known from the body of the li terature and the perchlorate levels that were related with THS found in the Blount study.

This is illustrated by some scatter plots [see reference 5]:

Scatterplot 1 and 2: the sum of 24 PCBs [see reference 5] has a similar relation with TSH as does perchlorate and for the same range of concentrations (The PCBs are concentrated at the left because of the detection limit). The 2 relationships are statistically significant.

[see figures in PDF docket ID EPA-HQ-OW-2008-0692-1990]

Response: EPA cannot evaluate calculations presented by the commenter that have not been peer

reviewed.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21048

EPA Comment Code: 2200

Comment: 3. What then could be the link between perchlorate and those known endocrine disruptor.

The most obvious and most widely spread common lin k is chlorine. On one hand it has been shown

that chlorine based disinfectants such as those foun d in drinking water (DW) oxidize to perchlorate as a disinfection by-product (DBP).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 143 of 1099 This is for example the reason why Massachusetts doubled its MCL from 1 to 2 ppb because otherwise chlorination of DW and swimming pools with for example bleach would have to be

curtailed.

Is this oxidation of perchlorate from bleach (h ypochlorite and hypochlorous acid) significant in comparison with daily intake of perchlorate?

According to the Blount study (from the NHANES data) the average urinary perchlorate level in the population is 2.84ug/l which is roughly equivalent to an oral dose of 0.04 ug/kg-day. This corresponds with drinking water of 1.4 ppb. Ma ssachusetts’ MCL was based on data that showed that about 0, 5 ppb perchlorate originated from bleach alone [see reference 22].

Therefore about 1/3 of the average daily intake of perchlorate would be due to bleach oxidation

alone which is substantial and which shows that chlorine could be a significant source of perchlorate.

Bleach is used ubiquitously as for example in water purification stations, paper mills, drinking water and for many other applications.

Other potential sources of perchlorate as a DBP ar e other chlorine derivates such as chlorine gas

and chloramine.

On the other hand other DBPs originate from th e reaction of chlorine based disinfectants with organic matter (waste) to form or ganochlorides [see reference 23].

What could be one of the possible pathways that link perchlorate to organochlorides such as PCBs

via chlorine?

According to EPA the building block for organoc hlorides is chlorophenol and chlorophenols are produced from the organic matter found in used wa ter when it reacts with chlorinated disinfectants [see reference 24] (phenol is benzene with a hydr oxyl group and PCBs are basically 2 chlorinated benzene rings).

Those DBPs are found back in the drinking water leaving the water purification plants just as perchlorate when no special perchlorate removing devices are used which is the case most of the time in areas where only low levels are found.

So this is one example of the link between very low levels of perchlorate and TH affecting

substances: chlorine based disinfectants such as blea ch, Cl2 and chloramines evolve to perchlorate on one side and to phenols, PCBS and other orga nochlorides including dioxin-like compounds on

the other side.

[Chloramines, besides being an added disinfectant, can also be formed as a reaction product of bleach with ammonia, itself amply pr esent in used water [see ref 25]].

Response: EPA discussed the potential for perchlorate to be introduced into drinking water as part of the May 1, 2007 FR Notice. However, the source of perchlorate contamination is not a key factor in the determination under SDWA to regulate a c ontaminant. The presence of perchlorate inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 144 of 1099 disinfectants will be a factor eval uated by EPA as part of the tr eatment and technology evaluation for the proposed NPDWR for perchlorate.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21049

EPA Comment Code: 2200

Comment: Summary of chapter 3

DBP road 1: Bleach/Cl2/Cl-/chloramine ->ClO-3 ->ClO-4

DBP road 2: (in presence of organic (C) material):

Bleach/ Cl2/Cl-/ chloramine ->phenols ->organochlorides/dioxins

Since organo- chlorinated compounds are ubiquitous and since we find at least 1/3 of the total dietary perchlorate where we find organo-chlorina ted compounds and since many of those have been shown to affect TH levels it is to be expected that low levels of perchlorate are associated with TH levels as found in the Blount et al study.

Yet assigning cause to this association would be against all common sense as overwhelming

circumstantial evidence shows in another direction.

Perchlorate seems to be rather a marker, a witn ess, a messenger of the presence of ubiquitous goitrogenic contamination caused by the net effect of hundreds of substances (see also next section).

This alternative explanation would on the same time eliminate any and all contradictions as listed

from section 1.1. to 1.4.2.2 above.

Response: EPA does not believe there are sufficient scientific data currently available to assess and characterize the combined risk of goitrogenic co mpounds. EPA has committed to a drinking water strategy that outlines four principles to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchl orate should be further delayed. Therefore, EPA intends to develop a proposed rule for perchlora te. At such time as a NP DWR is promulgated, EPA is required to review and revise, as appropriate, its drinking water standards at least every six years. Any revision must at least maintain or improve public health protection. When there are sufficient

scientific data to assess the cumulative risks of perchlorate and other contaminants, EPA will review this information to evaluate whether any revisions of NPDWRs are appropriate.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21050EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 145 of 1099 EPA Comment Code: 2200

Comment: 4. Would this be the final answer: organochlorides are the sole cause of the (slight) TH changes?

Probably not.

The fact that in the NHANES 2001-2002 database organochlorides are cross- sectionally associated with THs and, contrary to perchlorate, at levels that are consistent with known effect levels and, contrary to perchlorate, that this does not occasion related inconsistencies if the relationship would
be seen as cause effect, still does not mean it is so.

What we only can say at this point is that the chance that those contaminants are at least partially the cause is much higher than for perchlorate.

There seems to be a ubiquitous contaminant pool in which there are all kinds of goitrogens acting with all kind of mechanisms that influence TH levels and thyroid function.

Somehow they could be all linked together.

Following an example of such a link:

When bromides are used as disinfectant also or ganobromides are formed [see reference 21].

When bromine and chlorine is involved, halogenated furanones can be produced in drinking water by the reaction of naturally occurring organic matt er and bromide with the disinfectant chlorine and

chloramine. Research on their concentrations in drin king water is at an early stage and they are not regulated by EPA: http://pubs.acs.org/cen/news/86/i13/8613news7.html

[Clarification: A furanone is a furan where the H is substituted with Cl, becoming polychlorinated furanones or polychlorinated dibenzofuranones. A fu ran is short for dibenzofuran; a chlorinated dibenzofuran is a PCB with a furan ring in the middle]

So the halogen bromine can join the second pathway for chlorine: Bleach/Cl2/ Cl2/Cl-/
chloramine, bromides ->furanones or phenols ->organohalogens/dioxins

This can be illustrated again thru NHANES data plots:

Scatterplot 3 and 4 [see reference 5]: the organobr omide PDE (polybrominated diphenyl ethers) has a similar relation with TSH as does perchlorate and for the same range of concentrations. The 2 relationships are statistically significant. Thus organochlorides, organobromides and perchlorate seems to be related with each other within the goitrogenic pool.

[see figures in PDF docket ID EPA-HQ-OW-2008-0692-1990]

Some components of this goitrogenic contaminan t pool have a stimulatory or agonistic effect, others an inhibitory or antagonistic effect [see refe rence 26, 27]. Some do not have any effect at all at

environmental doses.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 146 of 1099 This may explain why in cross sectional studies as those based on the NHANES data base the effect of the sum of some PCBs apparently is not always greater than each individual effect as would be expected [see reference 28] as each individual PCB on itself can be linked to other non identified and quantified goitrogens i.e. (once again) not controlled for covariates with opposite effects.

As mentioned, already there exist 209 known congeners of PCBs alone. They vary based on the number and positions of chlorine atoms but also on their effect (strength and direction).

Many have not even been studied on their goitrogenic effect.

Even different groups of chemicals with different mechanism could have synergetic or antagonistic effects [see reference 29].

Others may be linked to each other in certain environments and not in others.

Going back to the example above: Polychlorinated Biphenyls (PCBs) and Polybrominated Diphenyl Ethers (PBDEs) (both also called polyhalogenated phenolic compounds) may have a cumulative

effect where bromine and chlorine based disinfecta nts are used (for example for swimming pools) and end up as DBPs (disinfection byproducts) in drinking water after having gone thru the purification plant. This link could not exist in places where one of both is not used.

Other goitrogenic phenols, such as Bisphenol A, linked itself to polyvinylchloride (PVC) such as used in waterpipes, may be linked to this chloride and halogen pool. On the other side completely different types of goitrogens, even natural ones, could be linked indirectly to the pool as well: for example organohalogen based pesticides may be present in very low amounts in soybeans but the goitrogenic effect could instead be primarily due to the isoflavones naturally present in soymilk [see reference 30] or the thiocyanates present in rape or broccoli or other natural goitrogens such as genistein, resveratrol, silymarin, linuron [see reference 24].

Also fluorine is considered a goitrogen [see refere nce 31]. So, adding fluorine in salt for dental purposes could partially neutralise the effect of a dded iodine. Adding fluori ne, another halogen, in drinking water, which is also common, would th en on itself be linked to perchlorate and the organohalogen DBPs.

Further fluorine is a major constituent of phosphate fertilizers [see reference 32] and is taken up by the crop so it could, just as the goitrogenic pesticides and isoflavones, be part of the goitrogenic pool as well. Also iodine itself, the fourth halogen, is used as a disinfectant.

Other factors, even the most unexpected (birth delivery mode) may confound the effects [see reference 33].

So it seems plausible that perchlorate is a marker , but only marker, of this ubiquitous pool of thyroid function affecting contaminants which means that th e more perchlorate is found (outside from the point source contaminations of course) the more goitrogenic the pool will be via the chlorine and halogen link and therefore the more goitrogenic effect on THs will be seen.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 147 of 1099 The answer to the question of what caused the Thyr oid hormone changes in the Blount study is: all of the above except perchlorate as seen at those very low levels.

Response: See response to comment ID 21049 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1990

EPA Comment ID: 21051

EPA Comment Code: 2200

Comment: It may be felt as politically rewarding to l ook for a simple explanation but, from what precedes, such a simplistic and irrational interpretation would certainly not lead to effective health protective measures. On the contrary it would lead to a feel good situation with only illusory effects.

A careful analysis should precede any sweeping statem ents like those we are seei ng in the media. We hear a lot about holistic approaches in health ri sk assessment but not many practical applications. This may be one of them.

______________________________________________ 1 National Academy of Sciences/National Research Council. Health Imp lications of Perchlorate Ingestion. National Academy Press. Washington, DC. 2005.

2 Benjamin C. Blount, James L. Pirkle, John D. Osterloh, Liza Valentin-Blasini, and Kathleen L. Caldwell. Urinary Perchlorate and Thyroid Horm one Levels in Adolescent and Adult Men and Women Living in the United States. Environmen tal Health Perspectives. December 2006, Volume
114, Number 12.

3 Tonacchera M., Pinchera A., Dimida A., Ferrarini E., Agretti P., Vitti P., Santini F., Crump K., Gibbs J. Relative Potencies and additivity of perc hlorate, thiocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the hu man sodium iodide symporter. Thyroid 14: 1012-

1019. 2004.

De Groef B., Decallonne BR., Van der Geyten S., Darras VM., Bouillon R. Perchlorate versus other environmental sodium/iodide symporter inhibitors : potential thyroid-related health effects. European Journal of Endocri nology. 2006, 155: 17-25.

4 Dasgupta PK., Kirk AB, Dyke JV, Ohira S-I. In take of iodine and perchlorate and excretion in

human milk. Environmental Science & Technology. 2008, 42: 8115-8121.

5 Charnley G. Perchlorate: Overview of Risks and Regulation. Food and Chemical Toxicology. 2008. Some graphs shown above and related to this study were obtained from the Statistical Department of the Catholic Un iversity of Leuven, Belgium.

6 Dasgupta PK, Martinelango PK, Jackson WA, An derson TA, Tian K, Tock RW, et al. The origin of naturally occurring perchlorate: the role of atmospheric processes. Environ Sci Technol. 2005.

39:1569-1575.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 148 of 1099 7 KÃ1⁄4pper F.C., Carpenter L. J., McFiggans G. B.,. Palmer C. J., Waite T. J., Boneberg E.-M.,
Woitsch S., Weiller M., Abela R., Grolimund D., Potin P., Butler A., Luther G. W., Kroneck P. M. H., Meyer-Klaucke W., Feitersm M. C.. Iodide accumulation provides kelp with an inorganic antioxidant impacting atmospheric chemistry. Th e National Academy of Sciences of the USA.

Environmental Sciences. 2008.

Baker A. R, Tunnicliffe C. Jickells T. D. Iodine speciation and deposition fluxes from the marine atmosphere. Journal of geophysical research. ISSN 0148-0227. 2001.

Von Glasow R. Seaweed, Iodine, New Particles an d Atmospheric Chemistry - The Current State of Play. Institute of Environmental Physics, Im Ne uenheimer Feld 229, University of Heidelberg, 69120 Heidelberg, Germany. Email: roland .von.glasow@iup.uni-heidelberg. 2005.

8 Soldin OP, Tractenberg RE, Pezzullo JC. Do thyroxine and thyroid-stimulating hormone levels reflect urinary iodine concentrations? Therap eutic Drug Monitoring. 2005, 27: 178-185.

9 Brucker-Davis F. Effects of environmental synt hetic chemicals on thyroid function.Thyroid. 1998,

8: 827-826.

10 McLanahan ED Campbell JL Jr, Ferguson DC , Harmon B, Hedge JM, Crofton KM; Mattie DR, Braverman L, Keys DA, Mumtaz M, Fisher JW. Low-dose effect of ammonium perchlorate on the hypothalamic-pituitary-thyroid (HPT) axis of adult male rats pretreated wi th PCB 126. Toxicological
Sciences. 2007, 97: 308-317.

11 Tallsness CE, Kuriyama SN, Sterner-Kock A, Schni tker P. Grande SW, Shakibaei M., Andrade A,
Grote K, Chahoud I. In utero and lactational ex posures to low doses of polybrominated diphenyl ether-47 alter the reproductive system and thyroi d gland of female rat offspring. Environmental Health Perspectives (in press/online). 2007.

12 Zoeller R.T., Presentation (year unknown) : Low-Dose Effects of Thyroid Toxicants on Neurodevelopment , year unknown) , fund ed by US EPA grant nr.RD83213701.

13 Wataru Miyazaki, Toshiharu Iwasaki, Akira Ta keshita, Chiharu Tohyama, Noriyuki Koibuchi. Identification of the Functional Domain of Thyroid Hormone Receptor Responsible for Polychlorinated Biphenyl-Mediated Suppression of Its Action In Vitro. Environmental Health Perspectives. September 2008, Volume 116, Number 9.

Chris E. Talsness, Sergio N. Kuriyama, Anja Sterner-Kock, Petra Sc hnitker, Simone Wichert Grande, Mehdi Shakibaei, Anderson Andrade, Konstanze Grote, Ibrahim Chahoud. Utero and Lactational Exposures to Low Doses of Polybromina ted Diphenyl Ether-47 Alter the Reproductive System and Thyroid Gland of Female Rat Offspr ing. Environmental Health Perspectives. March 2008, Volume 116, Number 3.

Andreas Kortenkamp. Ten Years of Mixing Coc ktails: A Review of Combination Effects of Endocrine-Disrupting Chemicals. Environmenta l Health Perspectives. December 2007. Volume
115, Number S-1.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 149 of 1099 14 John D. Meeker, Larisa Altshul, Russ Hauser. Serum PCBs, p,p'-DDE and HCB predict Thyroid

Hormone Levels in Men. Environ Re s. 2007 June; 104(2): 296-304.

15 Mary E. Turyk, Henry A. An derson, Victoria W. Persky. Relationships of Thyroid Hormones with Polychlorinated Biphenyls, Dioxins, Furans, and DDE in Adults. Environmental Health Perspectives. August 2007, Volume 115, Number 8.

16 Craig Steinmaus, Mark D. Miller, Robert Howd. Impact of Smoking and Thiocyanate on Perchlorate and Thyroid Hormone Associations in the 2001-2002 National Health and Nutrition Examination Survey. Environmental Health Perspecti ves. September 2007, Volume 115, Number 9.

17 Julie B. Herbstman, Andreas SjÃ¶din, Benjam in J. Apelberg, Frank R. Witter, Donald G. Patterson Jr., Rolf U. Halden, Richard S. Jones, A nnie Park, Yalin Zhang, Jochen Heidler5 Larry L. Needham, Lynn R. Goldman. Determinants of Prenatal Exposure to Polychlorinated Biphenyls (PCBs) and Polybrominated Diphenyl Ethers (P BDEs) in an Urban Population. Environmental Health Perspectives. December 2007, Volume 115, Number 12.

18 Tracey J. Woodruff, Lauren Zeise, Daniel A. Ax elrad, Kathryn Z. Guyton, Sarah Janssen, Mark Miller, Gregory G. Miller, Jackie M. Schwartz, George Alexeeff, Henry Anderson, Linda Birnbaum, Frederic Bois, Vincent James Cogliano, Kevin Crofton, Susan Y. Euling, Paul M.D. Foster, Dori R. Germolec, Earl Gray, Dale B. Hattis, Amy D. Kyle, Robert W. Luebke, Michael I. Luster, Chris Portier, Deborah C. Rice, Gina Solomon, John Va ndenberg, R. Thomas Zoeller. Meeting Report: Moving Upstream-Evaluating Adverse Upstream End Points for Improved Risk Assessment and Decision-Making. November 2008. Environmental Health Perspectives Volume 116, Number 11.

19 US Environmental Protection Agency (US EPA) . Exposure and Human Health Reassessment of 2,3,7,8- Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds National Academy Sciences (NAS) Review Draft. National Center fo r Environmental Assessment. Office of Research and Development. Washingt on, DC. 2004. Page 14

20 US Environmental Protection Agency (US EPA). Framework for Cumulative Risk Assessment. EPA/630/P- 02/001F. National Center for Envi ronmental Assessment. Office of Research and Development. Washington, DC. 2003a. Available at http://cfpub.epa.gov/ncea/raf/recordisplay.cfm?deid=54944

21 Johan Maervoet, Griet Vermeir, Adrian Covac i, Nicolas Van Larebeke, Gudrun Koppen, Greet Schoeters, Vera Nelen, Willy Baeyens, Paul Sche pens, Maria K. Viaene. Association of Thyroid Hormone Concentrations with Levels of Organochlorine Compounds in Cord Blood of Neonates. Environmental Health Perspectives. Decem ber 2007, Volume 115, Number 12.

Jonathan Chevrier, Brenda Eskenazi, Asa Bradma n, Laura Fenster, Dana B. Barr. Associations between Prenatal Exposure to Polychlorinated Biphenyls and Neonatal Thyroid-Stimulating Hormone Levels in a Mexican-American Populati on, Salinas Valley, California. Environmental Health Perspectives. October 2007. Volume 115, Number 10.

Lawrence M. Schell, Mia V. Gallo, Melinda Denha m, Julia Ravenscroft, Anthony P. DeCaprio, David O. Carpenter. Relationship of Thyroid Hormone Levels to Levels f PolychlorinatedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 150 of 1099 Biphenyls, Lead, p,pÂ ́- DDE, and Other Toxicant s in Akwesasne Mohawk Youth. Environmental Health Perspectives. June 2008, Volume 116, Number 6

Lesa L. Aylward, Julie E. Goodman, Gail Charnl ey, Lorenz R. Rhomberg. A Margin- of-Exposure Approach to Assessment of Noncancer Risks of Dioxins Based on Human Exposure and Response Data. Environmental Health Perspectives. October 2008. Volume 116, Number 10.

June-Soo Park, Linda Linderholm, M. Judith Charles , Maria Athanasiadou, Jan Petrik, Anton Kocan, Beata Drobna, Tomas Trnovec, Ã...ke Bergman, Irva Hertz- Picciotto. Polychlorinated Biphenyls and Their Hydroxylated Metabolites (OH- PCBs) in Pregnant Women from Eastern Slovakia. Environmental Health Perspectives Volume. January 2007, 115, Number 1.

22 Massachusetts Department of Environmental Proctection. Perchlorate: Draft Toxicological

Profile and Health Assessment. 2004.

23 Gary A. Boorman, Vicki Dellarco, June K. Dunnick, Robert E. Chapin, Sid Hunter, Fred
Hauchman, Hank Gardner, Mike Cox, and Robert C. Sills. Drinking Water Disinfection Byproducts: Review and Approach to Toxicity Evaluation. En vironmental Health Perspectives Supplements, February 199, Volume 107, Number S1.

24 Environmental Protection Agency, EPA/60 0/P-03/002F).An Inventory of Sources and Environmental Releases of Dioxin-Like Compounds in the United States for the Years 1987, 1995 and 2000. Federal Register: December 1, 2006 (Volume 71, Number 231)] Page 69564-69565]

Glinda S. Cooper, Samantha Jones. Pentachloroph enol and Cancer Risk: Focusing the Lens on Specific Chlorophenols and Contaminants. National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington, DC, USA. Received 16 November 2007; accepted 10 April 2008.

25 John Tibbetts. What's in the Water: The Disinfectant Dilemma. Environmental Health Perspectives. Volume 103, Number 1, January 1995. http://content.nejm.org/cgi/content/extract/341/11/848-a http://www.erj.ersjournals.com/cgi/content/full/19/5/790

26 Cornelia Schmutzler, Inka Gotthardt, Peter J. Hofmann, Branislav Radovic, Gabor Kovacs, Luise Stemmler, Inga Nobis, Anja Bacinski, Birgit Me ntrup, Petra Ambrugger, Annette GrÃ1⁄4ters, Ludwik
K. Malendowicz, Julie Christoffel, Hubertus Jarry, Dana SeidlovÃ -Wuttke, Wolfgang Wuttke, Josef KÃ¶hrle. Endocrine Disruptors and the Thyroid Glandâ€”A Combined in Vitro and in Vivo
Analysis of Potential New Biomarkers. Environmental Health Perspectives. December 2007,
Volume 115, Number S-1.

27 http://www.ourstolenfuture.org/Basics/chemlist.htm

28 Kevin M Crofton, Elena S Craft, Joan M He dge, Chris Gennings, Jane E Simmons, Richard A Carchman, W Hans Carter Jr, Michael J Devito. Thyroid-hormone- disrupting chemicals: evidence for dose-dependent additivity or synergism. Neurotoxicology Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 151 of 1099 Environmental Protection Agency, Research Triang le Park, North Carolina, USA. Environ Health Perspect. 2005 Nov ;113 (11):154 9-54 16263510 (P,S,G,E,B)

29 Andreas Kortenkamp. Ten Years of Mixing Cocktails: A Review of Combination Effects of Endocrine-Disrupting Chemicals. Environmenta l Health Perspectives, December 2007, Volume
115, Number S-1.

30 Daniel R. Doerge, Daniel M. Sheehan. Goitroge nic and Estrogenic Activity of Soy Isoflavones. Environmental Health Perspectives Supplements. June 2002, Volume 110, Number S3.

31 Fluoride in Drinking Water: A Scientif ic Review of EPA's Standards (NAS, 2006) http://www.iicph.org/docs/water-reg-20060830.htm http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=476957

32 http://fluoridealert.org/phosphate/overview.htm#2

33 Julie B. Herbstman, Andreas SjÃ¶din, Benjamin J. Apelberg, Frank R. Witter, Rolf U. Halden, Donald G. Patterson Jr., Susan R. Panny, Larry L. Needham, and Lynn R. Goldman. Birth Delivery Mode Modifies the Associations between Prenatal Polychlorinated Biphenyl (PCB) and Polybrominated Diphenyl Ether (PBDE) and Neon atal Thyroid Hormone Levels. Environmental Health Perspectives. October 2008, Volume 116, Number 10.

Response: See response to comment code 2200. SDWA requires EPA to rely upon the best available peer reviewed science in establishing a NPDWR.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21066

EPA Comment Code: 2200

Comment: iv. Blount et al. (2006; cited at Blount et al., 2006b in the EPA Notification)

Using the NHANES 2001-2002 data set and a cr oss-sectional study design, this study reports measurement of urinary perchlorate, urinary iodide , serum TSH, and serum total T4 levels in men and women over the age of 12. Th e 2001-2002 NHANES data provide the largest group of subjects to date from which sampling data can be derived. The authors report that perchlorate levels were

not associated with total T4 or TSH levels in me n, but were a negative predictor of total T4 and a positive predictor of TSH in women with urinary iodine less than 100 ug/L. They report that in women with urinary iodine greater than 100 ug/L , urinary perchlorate was a positive predictor of TSH, but not associated with T4. The significance of evaluating women with urinary iodide less than 100 ug/L is based on the WHO statement that a medi an urinary iodine concentration for the entire population, based on spot samples of less than 100 ug/L is indicative of overall iodine deficiency for that population (WHO 2004).

This study has drawn a great deal of attention as it appears-to the averag e audience-to demonstrate an "effect" of perchlorate, albeit at exposures be low those which cause any measurable inhibition ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 152 of 1099 iodide uptake. However, there are a number of consid erations that should be noted that to better understand the significance of the data reported.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21068

EPA Comment Code: 2200

Comment: Second, it is important to understand what the methods inherent to scientific research are. For example, knowing what is meant by "sta tistical significance and "clinical significance." A "statistically significant" difference simply means it is unlikely that there is a difference between two variables (e.g., numbers) that is due to chance. Wi th a well designed experimental study, statistical significance can be extremely important. However, stat istical significance is also a function of sample size, variability in the variables measured, etc. Stat istical significance does not necessarily mean the difference is large, important, or biologically sign ificant. However, for biological data, we are keenly interested if something is statistically significant is it also clinically significant, that is is there change in the variable or parameter that is large enough to affect a clinical or medical condition (e.g., development of hypothyroidism). Blount et al., 2006 report statistically significant variables, but do not report any variables with clinical significance.

This type of study conducted by Blount and his colleagues cannot determine causation, only association between the variables studied (Wartenberg and Buckler, 2001). If important variables are missing, then spurious conclusions can be made. Thus, without a full set of variables measured, including a consistent urinary iodide measurement, any association should be examined carefully for reliability.

Furthermore, perchlorate did not actually lower (or was even associated with) thyroid hormones outside the normal range of values. Even if it had, the NRC committee does not think that "...transient changes in serum thyroid hormones or TSH concentrations are adverse health effects; they are simply biochemical changes that might precede adverse effects" (NRC, 2005).

The study was considered by ATSDR; however, ATSDR states, "limitations of the study acknowledged by the investigators include those common to cross-sectional analyses, the assumption that urinary perchlorate correlate with levels in the thyroid stroma and tissue, and the

measurement of total T4 rather than free T4" (ATSDR, 2008).

Third, any study must have careful consideration for the parameters and variables that are measured or available. The purpose of NHANES is designed to collect information about the health and diet of people in the United States. It is a survey for a broad range of possible diseases related to diet and health. While it obtains parameters for thyroid function, those parameters fall far short of the parameters needed to clearly understand thyroid health. For example, ther e were only two measures of thyroid function (total T4 and TSH) in the NHANES dataset used in this study; NHANES currently uses spot urine samples for iodide status wh ich are neither the preferred, nor most reliable, measure of urinary iodide (Barr et al. 2005); th ere was lack of normalization for the dilution of individual urine samples using urinary creatinine levels; and due to restraints of the NHANESEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 153 of 1099 database, the authors were not able to note the in cidence of autoimmune thyroiditis, the most common thyroid disorder in the U.S., which causes changes in serum T4, T3, and TSH

concentrations due to errant immune mechanis ms attacking the thyroid gland (NRC, 2005). A complete assessment produced by Intertox is attach ed as Appendix A. In the appendix, there is a more thorough discussion regarding the use of spot urine testing, confounders, and use of the

available NHANES variables to drawn conclusions.

This study did not present urinary measures nor malized to creatinine. The concentration of
dissolved substances in urine, such as iodide, ma y vary between individuals or between samples from

the same individual. Normalization with creatinine is not a perfect method, but is commonly used to account for this variability (Furnee et al. 1994).

Response: No response is required for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21069

EPA Comment Code: 2200

Comment: At a recent symposium on perchlorate held in conjunction with the annual Society of Toxicology (SOT) meeting in Seattle, Lamm et al. (2 008) presented their initial reanalysis of the NHANES dataset used by Blount et al. with an adjustment for urinary creatinine. Lamm et al.

considered a subset of women from the Blount et al. study who were of childbearing age (15-44 years old; the Blount et al. study group included all women over the age of 12) as well as the interaction of thiocyanate and nitrate, both in urin e. They found there was no significant association between perchlorate and total T4, even for women wi th urinary iodide less than 92 ug/g (Figure 2). They did find a significant association for women wi th urinary iodide greater than 163.7 ug/L for both perchlorate and thiocyanate.

[Figure 1. Urinary Reanalysis Results of th e NHANES Data - See PDF Docket ID EPA-HQ-OW2008-0692-1855]

Response: No response is required to the inform ation provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21071

EPA Comment Code: 2200

Comment: The American Thyroid Association (ATA) issue d a public health st atement cautioning against the paper's use in making decisions on regu lating perchlorate. The ATA noted that "serum thyroxine was measured as total thyroxine rather than as free thyroxine, the most frequently used clinical measurement and the physiologically availabl e form of thyroxine. Thyroid autoantibodies, an important confounder in thyroid physiology, have not yet been measured. These have an especially high prevalence in women and may have contribu ted to the reported correlations. The presence ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 154 of 1099 potentially confounding pharmaceutical and medica l factors, such as estrogen use or autoimmune thyroid disease, was not used as a basis for ex clusion from the analysis. Inclusion of laboratory results from multiple laboratories may need to be more carefully considered. The reason that perchlorate, but no other measured goitrogen stud ied, influenced thyroid function at low urinary levels of iodine is not explained. The developm ent of further laboratory information is necessary before the implications of the findings can be understood. The issues raised are important and additional study to resolve them should be pursued" (ATA, 2006).

Fourth, not only were the thyroid hormone values within normal clinical ranges, but urinary perchlorate levels as a surrogate for dose demons trate that these perchlorate exposures are well

below the threshold for zero inhibition of iodide uptake, a non-adverse effect. Exposures that are below the threshold for iodine uptake inhibition are below the NOEL for perchlorate and are not adverse (NRC, 2005; Greer et al., 2002).

Finally, taken from the premise that science is incremental and knowledge builds collectively over time, concerns raised by scientists related to the Blount et al. study should be considered an opportunity for further study. According to Dr. Be njamin Blount, a new study will be conducted using a new data set, NHANES 2007, and will includ e obtaining data for eight variables of thyroid function (total T4, free T4, total T3, free T3, thyroid globulin, anti-thyroid peroxidase, anti-thyroid globulin, and TSH).[FN5: Personal Communication between Dr. Richard Pleus and Dr. Benjamin Blount. September 22, 2008.] Furthermore, recogniz ing that urinary spot iodine or single point iodine measures are not a good indicator of iodine status, a different approach is being considered.

We believe more research should be conducted to better understand the results of this study.

Response: No response is needed to the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21072

EPA Comment Code: 2200

Comment: Steinmaus et al. (2007) used the same data set as Blount et al. to assess the correlation between smoking, thiocyanate and urinary perchlorate, and thyroid hormone levels. Using the same NHANES data set, it is not surprising that many of the same results were noted. Many of the same methodological issues reported for Blount et al. apply to this study. As in Blount et al., they did not find any interaction between perchlorate and smoking and TSH or total T4 in women with urinary iodine levels greater than or equal to 100 ug/L or in men. They did conclude that in women with urinary iodine less than 100 ug/L, perchlorate increa sed the risk of lower total T4 and greater TSH, just as was reported in the Blount et al. study. This association was stronger when the woman was also a smoker or had high urinary thiocyanate levels.

Both Blount et al. and Steinmaus et al. (2007) s how an association between exposures to low, environmentally-relevant levels of perchlorate an d non-adverse reductions in thyroid hormones that remain within the normal ranges. However, these st udies contradict the wide body of direct studies showing no effect even at low levels. These studies ar e valuable in that they test a large population; however, neither study shows that exposure to perc hlorate at environmentally relevant doses causes an adverse health effect, even in a sensitive population.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 155 of 1099 Response: See response to comment ID 29078 under comment code 2200. As discussed in the final perchlorate regulatory determination and el sewhere in the response to comments document, EPA believes that perchlorate may have an adverse effect on the health of persons.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21073

EPA Comment Code: 2200

Comment: v. Blount et al. (2007)

Blount and colleagues used the NHANES urinary perc hlorate data to estimate the total daily dose for adults. These data were adjusted for creatini ne. The estimated 95th percentile dose was 0.234 ug/kg-day with a confidence interva l of 0.202 - 0.268 ug/kg-d. They also reported that perchlorate was measurable in all of the samples they tested and the urinary levels were higher in children compared to adults. The estimated doses reported here were lower than the RfD and below the level of inhibition of iodide uptake. The NRC states that "...inhibition of iodide uptake by the thyroid clearly is not an adverse effect; however if it do es not occur, there is not progression to adverse health effects" (NRC, 2005).

Response: No response is necessary to the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21080

EPA Comment Code: 2200

Comment: APPENDIX A

Review of Blount BC, Pirkle JL, Osterloh JD , Valentin-Blasini L, Caldwell KL. 2006.

Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in

the United States. Environmental He alth Perspectives 114(12):1865-71.

A number of scientific issues related to the expe rimental design of the NHANES dataset and the Blount et al. (2006) analysis make drawing meaningf ul conclusions from the data extremely difficult. Many of these issues are discussed below, although this list is not exhaustive.

In their paper, Blount et al. (2006) examined th e relationship between urinary levels of perchlorate and serum levels of thyroid stimulating hormone (TSH) and total thyroxine (T4) in men and women, aged 12 and older, participating in the NHANES during 2001-2002. They made the following primary observations:

* Perchlorate was not a significant predicto r of total T4 or TSH levels in men.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 156 of 1099 * For women with spot urinary iodine concentrat ions < 100 ug/L, perchlorate was a significant negative predictor of total T4 (p < 0.0001) and a positive predictor of TSH (p = 0.001).

* For women with urinary iodine >= 100 ug/L, perc hlorate was a significant positive predictor of TSH (p = 0.025), but not total T4 (p = 0.550).

To assess the reliability of these conclusions, we reviewed the Blount et al. (2006) paper and the NHANES 2001-2002 dataset (CDC 2006) used by the authors. We reviewed the same variables reported in the paper and several dozen other variable s not reported in the paper but reported in the

NHANES 2001-2002 dataset.

The data collected by NHANES is a survey and not a true epidemiological or clinical study. In epidemiological and clinical studies, effort is made to design the study to control for all variables except the variables in question. Surveys are not de signed in this manner-their purpose is to collect data from a large number of people over a period of time. NHANES is designed to assess the health and nutritional status of adults and children in the United States (U.S.), combining interviews and physical examinations. It is a major program of th e National Center for Health Statistics (NCHS), which is part of the Centers for Disease Control and Prevention (CDC) of the U.S. Public Health Service, and has the responsibility for producing vital health statistics for the nation (CDC, 2006).

NHANES 2001-2002 was designed to continue the collection of information about the health and diet of people in the U.S. that was begun with ear lier surveys to fulfill specific goals. These include estimating the number and per cent of persons in the general U.S. population and designated subgroups with selected diseases and risk factors; monitoring trends in the prevalence, awareness,
treatment, and control of select diseases; monitori ng trends in risk behaviors and environmental exposures; studying the relationship between diet, nutrition, and health; and exploring emerging public health issues.

Response: No response is needed for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21081

EPA Comment Code: 2200

Comment: Key components to designing a thyroid study

When conducting a thyroid study, a number of k ey variables should be considered that are not necessarily included when collecting data for a survey such as NHANES. For instance, thyroid hormone and TSH levels can vary substantially during the day. Free T4 (not total T4, which was measured in NHANES) is the most important th yroid parameter for assessing hypothyroidism. Because hypothyroidism is most commonly cause d by one's own immune system, parameters used to assess this effect (including serum antibodies to thyroglobulin and thyroid peroxidase) should also be measured (but were not in the NHANES study). In general, the use of NHANES data to draw conclusions regarding exposures is controversial beca use of "...the utility of these data to address anEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 157 of 1099 existing public health concern, including investigat ion of etiology, instead of undertaking a study that includes original data collection" (Wartenberg and Buckler, 2001).

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21082

EPA Comment Code: 2200

Comment: Study variables of concern

We were able to confirm the dataset Blount et al. (2006) used in the paper and generally replicate the statistical results obtained by Blount et al. This a llows us to examine the experimental design of the study with more confidence. Based on our review, we observed several key variables that caused us to question the conclusions presented in the Blount et al. paper. These variables are summarized below.[FN10: This evaluation is primarily based on the sample of 1,111 women aged 12 and older (i.e., the "study group"), described by Blount et al., from whom urine samples for perchlorate and serum thyroid hormone/TSH concentrations were measured, and excluding those who had a reported history of thyroid disease, were taking thyroid medications or a small subset of other thyroid- active drugs, or had extr eme (high) levels of TSH or extreme (low) levels of T4. It should also be noted that total T4 measurements were performed at two separate laboratories which may have introduced some bias.]

Relying upon the urinary iodide measurements for classification of study subjects into "low" or "high" iodine groups is not scientifically appropriate.

* Urinary iodine concentrations in the study gr oup ranged from 6 to 136,161 ug/L. The geometric mean was 127 ug/L (SE = 5.4) and the 5th and 95 th percentiles were 22 and 568 ug/L, respectively. Our findings for this group are consistent with the summary of urinary iodine measurements in NHANES 2001-2002 published by the CDC (Caldwe ll et al., 2005). If taken at face value as representative of chronic iodine nutrition, the u pper limits of these measurements likely exceed safe levels and should be a source of some alarm for the CDC. For example, elevated TSH levels and hypothyroidism have been associated with daily iodine intakes in excess of 750 ug/day by adults (NAS 2001). However, these measurements were take n in spot samples and are thus not necessarily

indicative of an individual's iodine status.

* Urinary creatinine concentrations were highly va riable from subject to subject (range 9 to 774 ng/mL), indicating significant differences in sample dilution and, likely, urinary output.

* The WHO has stated that a me dian urinary iodine concentrat ion within a population, based on spot samples of <100 ug/L is indicative of iodine deficiency within the population (WHO, 2004). The median urinary iodine concentration for the study population evaluated by Blount et al. (n =1,111) is 133 ug/L. Thus, assuming that iodine deficiency exists within this population is inappropriate- the WHO criteria ar e not meant to diagnose iodine de ficiency in individuals (Borak, 2005). Conversely, the best way to establish indivi dual urinary excretion of iodine (or any urinaryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 158 of 1099 analyte) is to collect 24-hour samples (Bourdoux, 1998). However, without a reliable measure or indicator or iodine status, comparison s make suing this measure could be spurious.

* Figure 1A illustrates the variability in urinary iodi ne concentrations in the Blount et al. dataset.

[Figure 1A: Variability of Urinary Iodine from Bl ount et al. (2006) - See PDF Docket ID EPA-HQOW-2008-0692-1855]

Response: See response to comment ID 29078 under comment code 2200. EPA does not have

sufficient information to evaluate th e WHO criteria for iodide status.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21083

EPA Comment Code: 2200

Comment: 1. Characteristics of individual members of the study group vary widely. Because many of these variables could impact overall subject health and, potentially, thyroid hormone or TSH levels, it is impossible to establish causality based on this dataset. The following is a sample of some of these variables-many others, both reported in and not reported in the dataset, could potentially impact thyroid measurements.

* NHANES is a survey designed to assess the health and nutritional status of adults and children in the U.S. It is not a controlled epidemiological stud y. Up to 3,400+ different variables are reported in the online NHANES 2001-2002 dataset in association with specific study subjects. The potential for spurious associations between variables is significant.

* 48% of those who responded were active smok ers (42% reported smoking "everyday" and 6% "some days"; only 301 subjects out of 1,111 study su bjects had a reported response to this question). 21% of smokers reported smoking 15 or more ciga rettes per day. Smoking status of study subjects under 18 years of age (29% of all study subjects ) was not reported due to privacy concerns. In addition, 21% of study subjects reported living in a home with a smoker. Smoking is a known source of thiocyanate and other goitrogens. In smokers, cyanide from cigarette smoking is likely the most important source of SCN- in the body (Tonacchera et al., 2004). Ingbar (2000) states that thiocyanate as well as the pyridine components of cigarette smoke are likely a cause of lower T4 and T3 levels in serum of heavy smokers. Smoking and thiocyanate were found to be significant in a later analysis of the same data (Steinmaus et al., 2007).

* 105 reported being pregnant at the time of the ex amination. Pregnancy is known to have an effect on thyroid economy with significant changes in iodine metabolism and serum thyroid binding proteins (Lazarus, 2005a; 2005b).

* Although Blount et al. excluded subjects who wer e taking thyroid medications (e.g., levothyroxine) or certain other thyroid active agents (e.g., pr opylthiouracil or methimazole), subjects taking any other kind of drug were included. 43% of study subjects reported taking at least one prescription drug within the month preceding their examination interview. This includes subjects takingEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 159 of 1099 medications known to directly aff ect the thyroid including lithium, amiodarone, and carbamazepine. Many drugs affect tests of thyroid function throug h alterations in the synt hesis, transport, and metabolism of thyroid hormones, as well as via influences on thyrotrophin (TSH) synthesis and secretion. Despite effects on circulating thyroid hormone and TSH levels, few drugs result in important changes in clinical thyroid state, but difficulty in interpretation of thyroid function tests often results. Commonly prescribed drugs incl uding anticonvulsants, non-steroidal antiinflammatory drugs, steroid hormones and heparin may result in abnormal thyroid function tests in the absence of clinical features of thyroid dysfun ction. In contrast, lithium and iodine containing drugs, including radiographic contrast agents an d amiodarone, may result rarely in overt thyroid disease (Davies and Franklyn 1991; Gittoes an d Franklyn 1995; Wenzel 1996; Daminet and Ferguson 2003).

* Many reported having one of a number of speci fic potentially severe medical conditions; however, only a limited list of conditions was reported. For example, 14 reported having had heart failure, 3 had a current liver condition, 71 had current or past cancer, 13 had been told at some time they have weak or failing kidneys, and an unreported number (due to privacy concerns, presumably) had hepatitis C. Kidney failure is known to causes al terations in thyroid hormone metabolism known as nonthyroidal illness syndrome (Rosolowska-Huszcz et al., 2005). Hepatitis C patients on interferon therapy were found to be more susceptible to auto immune thyroid diseases (Muratori et al., 2005).

* 4% of adult study subjects are underweight (per CDC guidelines, BMI <18.5), 20% are obese (BMI >=30 and <40), and 4% are morbidly obese (BMI >= 40). Associations between body weight and thyroid hormone and TSH levels have been reported in obese and morbidly obese individuals (Sari et al., 2003; Michalaki et al., 2006).

* Many report other types of exposures. 16% of st udy subjects reported using pesticides within their home during the previous month. A small number of women (16) reported using cocaine or other street drugs within the previous year, with one repo rting using a drug on a total of 200 days during the previous year- because of the nature of this inform ation, it could be assumed that this statistic is 28 underreported. Illicit drug use status for subjects under age 18 was not reported. Associations between pesticide exposure and changes in thyroid hormone/TSH levels have been reported in some animal studies (Beard and Rawlings 1999; Jeon g et al., 2006). T4 levels have been shown to decrease in rats following amphetamine ad ministration (Budziszewska et al., 1996).

* 66% of study subjects reported regularly (five or more times per month) consuming dark leafy green vegetables. Among these, consumption amount varied widely (up to 91 times per month). 48% reported consuming cooked dried beans or peas five or more times per month. Dark green vegetables from the Brassica family (e.g., broccoli, kale) are known to contain high concentrations of both thiocyanate and nitrate, two agents known to cause iodide uptake inhibition (IUI) by the thyroid in the same way as perchlorate. Legumes ar e also known to contain high concentrations of

nitrates.

* 46% of study subjects reported taking dietary supplements during the month preceding their examination interview. 2% (22 subjects) admitted taking a dietary supplement during the fasting period. There is evidence that dietary supplements can affect thyr oid function. For example, shortterm dietary supplementation with kelp (high in iodine) significantly increases both basal and poststimulation TSH (Clark et al., 2003).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 160 of 1099 * NHANES 2001-2002 does not report on consumpt ion of soy or soy products. Soy consumption has been associated with development of goiter an d an increase in TSH levels in humans (Doerge and Sheehan, 2002). Soy products are heavily ma rketed to women as healthful, including such products as soy milk, tofu, energy bars and dr inks, and meat substitutes. Soy isoflavones (e.g., genistein and daidzein) can also be measured in biological samples such as serum, to give an approximation of soy intake levels.

* Several other important study variables, includ ing location and time of year when samples were collected, were not reported due to privacy concerns . Seasonally-related changes in thyroid hormone concentrations have been shown in adults, with high er T3 and T4 values seen in winter months, and a tendency to a greater TSH response to TSH-rele asing hormone (TRH) was noted at this time (Harrop et al., 1985). These changes could reflect a centrally-mediated response of the hypothalamic-pituitary-thyroid axis to environmen tal temperature (Harrop et al. 1985). Significant annual, four-monthly and biannual rhythms were d etected in serum TSH in adults, with the lowest detected in spring. A significant annual rhythm was detected in T3, with lower values in spring and summer than in the other seasons. The peak-trough di fferences in the yearly variation expressed as a percentage of the mean were 29.1% and 8.2% fo r TSH and T3, respectively (Maes et al., 1997).

Response: No response is needed for information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21084

EPA Comment Code: 2200

Comment: 2. The "spot" urine and serum samples cannot be relied upon to establish chronic exposure levels or conditions. Spot samples are known to be inherently variable due to variations in urine volume and intake of exogenous compounds, and, in this population, fasting times varied widely between individuals and a substantial percen tage of participants did not comply with study fasting requirements.

* For chemicals with a short biological half-life (e. g., perchlorate, iodine), concentrations in spot urine samples are known to be highly variable between samples, due to within- and between-day variations in urine volume and intake of exoge nous compounds (Barr et al., 2005). Factors shown to influence concentrations include fasting time, time of day, nature of the last meal, sample dilution, collection method, preservation method, sample interferences, and analytical method (Rasmussen et al., 1999). Urinary iodine concentrations in 24-hou r samples vary up to three fold from one day to another. This suggests that a single sample is insufficient to determine long-term iodine status (Rasmussen et al., 1999). Population iodine excr etion estimates require 100 to 500 spot urine samples for each group or subgroup and fewer than 10 urine samples in an individual may be misleading (Anderson et al., 2008).

* Serum and urine samples were collected at ei ther "morning" (46%), "afternoon" (36%), or "evening" (18%) examination sessions. Specific sample time of day is not given. In humans, serum TSH concentrations are at their maximum at night, shortly before sleep, about 50-100% greater than the morning low (Fisher, 1996). Early morning values are greater than later morning values (Surks et al., 2005). TSH is secreted in pulses, with eight to fourteen pulses occurring in 24 hours. SleepEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 161 of 1099 deprivation, strenuous exercise, or working during night or evening shifts accentuate the rhythms (Surks et al., 2005).

* Fasting times were highly variable. Subjects appoin ted to a morning session were asked to fast for 9 hours while subjects appointed to an afternoon or evening session or a home exam session were asked to fast for 6 hours. However, the protocol sta tes the "greater goal [is] completing as many components as possible within the time constraint s of the session with phlebotomy as the highest priority component." Reported length of fast rang ed from 0 to 63 hours, with a mean and 50th percentile of 10.3 hours and 5th and 95th percentiles of 1.7 hours and 19 hours, respectively. For the morning, afternoon, and evening sessions, 8%, 13% and 24%, respectively, did not meet the fasting requirement.

* About 2% (22/1111) admitted taking a dietary supplement during the pre-blood and urine collection fasting period. There is evidence that di etary supplements can affect thyroid function. For example, short-term dietary supplem entation with kelp (high in iodine) significantly increases both basal and poststimulation TSH (Clark et al., 2003).

* Study participants were allowed to consume diet so da, black coffee or tea with saccharine or Equal since "these have no affect on study analytes." (Protoco l p. 4-32). It is relatively clear that sugar

substitutes such as those used in diet sodas do not have a significant impact on thyroid function.
However, the evidence for a lack of effect with caffeine is less clear. Studies in rats have shown that injection of caffeine results in a decrease in serum TSH followed by a subsequent decrease in serum T3 and T4 (Spindel et al., 1980). However, no e ffect on thyroid parameters were found in men (TSH and T3) or Syrian hamsters (TSH, T4, and T3) (Spindel et al., 1984; Bartsch et al., 1996).

* Figure 2A illustrates the variability in the fa sting times. Though no direct correlation between urinary iodine (and perchlorate) measures and fasting times is seen, it is unclear whether fasting time,

exclusive of all of the other variables 30 inherent in this dataset, could have affected urinary

concentrations in a well-controlled dataset.

[Figure 2A: Variability of Fasting Times from NHANES 2001-2002 - See PDF Docket ID EPAHQ-OW-2008-0692-1855]

Response: No response is needed for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21085

EPA Comment Code: 2200

Comment: 3. The observed differences in perchlorate are that thyroid response between men and women are not explained, which could be due to another unexplained variable. Comparable differences have not been observed in previous st udies of perchlorate exposure (e.g., Greer et al., 2002; Braverman et al., 2006; Crump et al., 2000). Missing database variables make it difficult to exclude other possible causes of the observe d differences between men and women.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 162 of 1099 * Thyroid autoantibodies are not measured in NH ANES 2001-2002. Women are known to be about 2.7 times more likely to acquire an autoimmune disease than men (Jacobson et al., 1997), and to have a greater incidence of thyroid autoimmuni ty (Chiovato et al., 1993 ). Thyroid autoantibody levels have been shown to be positively correlated with TSH levels in humans (Hollowell et al., 2002; O'Leary et al., 2006; Hoogendoorn et al.,2006). In analysis of data from NHANES III, a significant association between female gender an d elevated serum TSH levels disappeared when controlled for TPOAb (Hollowell et al., 2002).

* The NHANES dataset does not include a variable directly characterizing time since last pregnancy; this value can be approximated based on reported "age at last live birth" and current age. Using this, about 7.5% of women not currently pregnant repor ted being pregnant within the previous 2 years. The possibility that postpartum thyroiditis affli cted some of these women cannot be excluded. Postpartum thyroiditis, a syndrome of transi ent or permanent thyroid dysfunction caused by autoimmune inflammation of the thyroid, occurs fr equently in the first year after delivery, with a prevalence of about 5-7% (Muller et al., 2001). In about 25-30% of these women, the condition progresses to permanent hypothyroidism (Lazarus, 2005b).

* Figures 3A and 4A depict the variability in the NHANES data set and the nominal changes noted in thyroid hormones.

[Figure 3A: Variability of Perchlorate in NHAN ES Data Set - See PDF Docket ID EPA-HQ-OW2008-0692-1855]

[Figure 4A: Variability of Perchlorate and Chang es in Thyroid Horomones - See PDF Docket ID EPA-HQ-OW-2008-0692-1855]

Response: No response is needed for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21086

EPA Comment Code: 2200

Comment: 4. Spot urine concentrations of nitrate and thiocyanate, two other inhibitors of iodide uptake into the thyroid, were highly variable am ong study subjects. Since perchlorate, nitrate, and thiocyanate all act through the same mechanism of action (iodide uptake inhibition (IUI) at the thyroid), evaluation of correlations between expos ure to iodide uptake inhibitors and thyroid hormone or TSH concentrations should take into account combined exposures to all three anions.

* Perchlorate equivalent concentrations of nitrate, thiocyanate, and perchlorate in urine in the study population (calculated assuming that nitrate is 1/240 as potent and thiocyanate is 1/15 as potent as perchlorate; Tonacchera et al., 2004) ranged from 3.7 to 3329 ug/L. On average, for any given subject, perchlorate comprised about 1% of th e total perchlorate equivalent concentration (geometric means are 2.8 and 270 ug/L for perchl orate and perchlorate equivalent concentration, respectively). One would expect to see thyroid e ffects of nitrate or thiocyanate before seeing perchlorate effects; however, Blount et al. (2006) re port no reliable associations between urine levels of nitrate and thiocyanate and serum total T4 or TSH.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 163 of 1099 * No correlation between perchlorate equivalent c oncentration and serum total T4 or serum TSH is apparent. Perchlorate equivalent concentration was not a significant predictor of total T4 (p=0.43, coefficient -0.00011) or TSH (p=0.25, coeffici ent -0.00023). Conceivably, the same problems inherent in relying upon spot urine samples as indicators of longer term iodine intake would affect the reliability of spot urine samples for perchlorate, nitrate, and thiocyanate.

Response: No response required for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21087

EPA Comment Code: 2200

Comment: Missing Data

Some of the key data related to this study were not accessible in the time fr ame of this project. For instance, the analytical quality assurance/quality co ntrol data is available for review through the National Center for Health Statistics (NCHS), but NCHS requires reviewers to request an appointment and travel to their location to revi ew the data. Other data would need to be obtained under the Freedom of Information Act (FOIA). K ey data that could be obtained through these mechanisms might include exact times of blood sa mples and urine samples, the sequence of sample collection, QA/QC of the analyses, analytical logbook s, and other notes from the survey. These are critical pieces of information that could be use ful to characterize the dataset and examine the significance of associations.

Response: No response is needed for the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21088

EPA Comment Code: 2200

Comment: Summary

If one considered this as a pilot study which woul d be consistent with the stated intended use, then the appropriate and logical next step would be to address a number of these concerns with an enhanced experimental design. For example, adding critical thyroid function variables (e.g., free T4, anti-TPO), 24-hour urine collections, and better control of medications will provide a more appropriate study design.

Response: No response is necessary to the information provided by the commenter.

Commenter Name: Steve Lamm Commenter Organization: Consultants in Epidemiology and Occupational Health, LLC (CEOH)

EPA Document ID: EPA-HQ-OW-2009-0297-0654EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 164 of 1099 EPA Comment ID: 28486

EPA Comment Code: 2200

Comment: Attached are our comments on perchlorate (1 0-08-09). The cited references will be submitted separately.

October 8, 2009

Eric Burneson Office of Ground Water and Drin king Water Standards and Risk Management Division Environmental Protection Agency

Re: Docket ID No. EPA-HQ-OW-2009-0297

Comments on Scientific Literature on Public Health levels of concern of perchlorate in drinking

water

EPA is considering whether to specifically regulate the level of perchlorate in drinking water and needs to consider the potential adverse effect on hu man health, the frequency and level of exposure, and whether regulation of the contaminant repres ents a meaningful opportunity for reducing public health risks. EPA states that it is particularly concerned about the fetus of the iodine-deficient pregnant mother, infants, and developing children."

I review below the literature on the question as to whether the Blount et al. (2006) analysis demonstrates a risk from background perchlorate exposures on "the fetus of the iodine-deficient pregnant mother, infants, and developing ch ildren?" I conclude that it does not.

Lamm et al. (2007, under review) demonstrate that th e primary Blount finding on perchlorate effect on thyroxine level at low iodine level is dependent on the definition of low iodine as low urinary iodine (<100UG/l) on a single sample. It is not fo und when creatinine-adjusted urinary iodine level is used as the metric for defining low iodine. Thus, the primary finding is dependent on analytic

method and not robust to reasona ble variants of definition.

Pearce et al.(2007, 2008 under review) demonstrate th at maternal thyroid function is not adversely affected by background levels of perchlorate among first trimester pregnant women from mild or moderate iodine deficient populations or with low urine iodine levels (< 100 ug/L).

Review of published literature is consistent with findings of studies pending publication. Replication of the Blount et al. (2006) type analysis will be possible with the NHANES 2007-2008 dataset.

Regulatory assessment should not be considered independent of these findings. My presentations below provide the bases for the above statements.

Two major issues that I do not deal with here but th at must be recognized is (1) that the biological effect proposed by the Blount et al. (2006) analysis is at an exposure level one to two orders of magnitude below that at which effects of perchlor ate exposure have been observed and (2) that the issue of iodine adequacy for preg nant women and their offspring in the United states is important, complex, and appropriate for discussion elsewhere.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 165 of 1099 Is there a negative association between perchl orate and thyroxine with low iodine status?

Blount et al. (2006) is the only report that suggests th at there is a biological effect from perchlorate at general US population exposure levels. They ha ve analyzed data from NHANES 2001-2002 and report that women with low urine iodine levels have reduced total thyroxine (tT4) levels associated with increasing levels of urinary perchlorate, i. e., a negative association between urine perchlorate level and serum total thyroxine level among women with urinary iodine level < 100 ug/L. Steinmaus et al. (2007) further indicates that this finding is confounded by smoking.

The Blount et al. (2006) analysis has been interpret ed as indicating that the children of women with low iodine status may be at increased risk of neurodevelopment deficit associated with their perchlorate exposure. This is an over-interpretation.

(1) There is no accepted measure for iodine stat us of an individual within a population. The reference point of 100 ug/L (or 100 ug/g creatini ne) refers a population, not an individual. A low urine iodine level in a single urine sample does not equate to a finding of low iodine status.

The usual measure of iodine status is 24-h urinary iodine excretion, and the NHANES datasets do not give that metric. Historically, the 24-h urinar y iodine excretion for an individual has been

estimated from the urine iodine to urine creatini ne ratio (e.g., Rasmussen 1999). This metric could

be calculated from the NHANES dataset but is no t included in the Blount et al. (2006) analysis. Even that would be a point estimate and not repres ent the general iodine status of the individual but only the iodine throughput status of that day. Andersen et al. (2001) have shown that single low measurements of iodine level on one day do not de monstrate as an average a low iodine level over multiple specimens over a long period of time (one year).

Laurberg et al. (2007) should get particular attention as it deals with many of the issues confronting EPA on perchlorate and has been developed indepe ndent of any perchlorate issues. They succinctly summarize the Andersen et al. (2001) paper as demonstrating that "in a group of people, the distribution of average iodine concentrations in several samples from the same subjects is much narrower than the distribution of values from single spot samples from the same people." They observe that "Only the median or average can be used to classify iodine intake." They conclude that "the concentration of iodine in a spot or casua l urine sample cannot be used to diagnose iodine deficiency in an individual."

(2) The Blount et al. (2006) analysis has not analyzed separately these relationships for women of child-bearing age (WCBA, ages 15-44), which would be the relevant population with respect to protecting fetal health.

An analysis of the NHANES 2001-2002 data set for women of child-bearing age using iodine/creatinine as the metric of iodine exposur e has examine the relationship of total thyroxine (tT4) with regarding to an association with urinar y levels of perchlorate (and the other two iodineuptake inhibitors, thiocyanate and nitrate) for those with low, medium, and high iodine/creatinine (Lamm et al., 2007). Lamm et al. (2007) has been pu blished in abstract form and is currently under review for peerreview publication.

Lamm et al. (2007) demonstrated that "the negati ve association of serum thyroxine and urinary perchlorate found for WCBA with low iodine defi ned by UI (ug I/L urine) was not found for thoseEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 166 of 1099 with low iodine defined by UICr (ug I/g creatinine)." Their analyses, in contrast, found such an association for WCBA with high iodine/creatinine.

This is not the place to discuss which of these two an alyses are "right", but rather to observe that the Blount finding was highly dependent upon the specif ic metric used to classify low iodine. The lack of robustness with respect to the definition of low iodine suggests that the analytic results are method dependent, rather than a reflection of underl ying biology. In this case, it is premature to serve as a basis for regulatory decision-making.

It should be noted that the Lamm et al. (2007 and 2010 pending) analysis of the NHANES 2001- 2002 data set demonstrated that a negative asso ciation between serum thyroxine level and urinary thiocyanate level was found in WCBA with high iodine level rather than low iodine level, a finding consistent with a similar analysis of the NHANES III dataset (Vanderver et al., 2007). The replication of this finding in a second NHANES da taset is noteworthy. The Vanderver et al (2007) study further uses as its endpoint metric not the serum thyroxine leve l but the prevalence of hypothyroxinemia, which may be a better metric of outcome.

While the NHANES III dataset did not contain me asurements of perchlorate, the NHANES 2007- 2008 dataset that is currently being released does. The NHANES 2007-2008 dataset will be appropriate for examining these analytic issues. An alyses of the NHANES 2001-2002 dataset does

not resolve them.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Jonathan Borak Commenter Organization: Yale School of Medicine

EPA Document ID: EPA-HQ-OW-2009-0297-0209

EPA Comment ID: 28507

EPA Comment Code: 2200

Comment: 2). A related, but different issue involves the use of spot urine testing to diagnose

individuals as "low iodine intake" or "iodine deficient". I raise this concern for three reasons:

1). The Blount et al. and Steinmaus et al. analyses found significant effects principally in women with spot urine iodine levels <100 ug/L, not in those with spot iodine levels >=100 pg/L. However that 100 ug/L cut-off level is derived from a WHO/U NICEF/ICIDD criterion for determining iodine sufficiency in populations, not individuals.

2). There is a general consensus that "impacts of perchlorate exposure will vary depending upon an individual's iodine sufficiency" (15). Thus, predi cting the adverse effects of perchlorate exposure requires knowledge of individuals' iodine sufficiency.

Response: See reponse to comment IDs 29078 and 28531 under comment code 2200.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 167 of 1099 EPA Comment ID: 28515

EPA Comment Code: 2200

Comment: Moreover, a 1 ppb or lower MCL is supported by the most recent comprehensive studies, and these should be central to EPA's an alysis. The industry-supported Greer study, which

serves as the basis for EPA's current reference do se as well as California's current 6 ppb standard, consisted of a 14-day study of 37 healthy adults. In more recent years, Blount et al analyzed a nationally representative sample of 2299 U.S. re sidents, and they have documented anti- thyroid effects in a large population of women exposed to perchlorate at concentrations far lower than levels previously shown to have such effects. Th is study and subsequent data clearly justify promulgation of an even more protective MCL. It should be noted that California's Office of Environmental Health Hazard Assessment is in the process of reevaluating its Public Health Goal,

on which the state MCL is based.

Response: EPA intends to determine the value for the MCLG in developing a proposed NPDWR with consideration of the best available, peer reviewed science. A value for the MCLG has not yet

been determined.

Commenter Name: Richard T. Kloos Commenter Organization: American Thyroid Association (ATA)

EPA Document ID: EPA-HQ-OW-2009-0297-0635

EPA Comment ID: 28531

EPA Comment Code: 2200

Comment: Of great concern to us is the fact that wome n with low iodine status appear to be at particular risk of perchlorate effects. The study of Blount et al. demonstrated that among the 36% of women with urinary iodine values <100 ug/L in the NHANES 2001-2002 data set, there was a significant positive correlation between urinar y perchlorate concentrations and serum TSH (p=0.001) and an inverse correlation between urin ary perchlorate concentrations and serum T4 values (p<0.0001).12 Among women with urinary iodine values >100 μg/L, there was a positive association between urinary perchl orate concentrations and serum TSH (p=0.025), but there was no association between urinary perchlorate concen trations and serum T4 values. There were no significant associations between urinary perchlorat e concentrations and thyroid function values in men irrespective of iodine intake. Therefore, if th e results of this study are correct, the population at highest risk for adverse effects of environmenta l perchlorate exposure is women with low dietary

iodine intake.

Response: EPA agrees that promoting iodide nutrition is good public health policy and may have a positive influence in reducing the iodide uptake inhibition effects associated with exposure to perchlorate. However, the Agency does not think it is appropriate to rely on the promotion of iodide nutrition in this case, especially since thes e activities are outside of EPA’s SDWA authority. While the health concerns associated with perchlor ate may be addressed through other means, it is the Administrator’s judgment that a standard limiting perchlorate in drinking water can reduce health risk, particularly to fetuses, infants and children.

Commenter Name: John P GibbsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 168 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28553

EPA Comment Code: 2200

Comment: 4) THE USE OF THE NHANES DATA AS A POINT OF DEPARTURE

The NHANES 2001-2002 epidemiological urinary data are from a single un-timed spot urinalysis and can vary due to dilution or concentration of th e urine (i.e., due to an individual’s hydration status). A common technique to eliminate this variation in the spot urinalysis is to normalize the iodide urine concentration against creatinine resulti ng in the analysis expressing iodide excretion as ug of iodide/g of creatinine (i.e., ug/g creatini ne) instead of ug of iodide/L of urine. Lamm has successfully repeated Blount’s statistical analys is of the NHANES 2001-2002 epidemiological data only when his analysis measures UIC as ug/L (Lamm 2007). However, when Lamm 2007 repeats the statistical analysis using only women of childbe aring age (ages 15-44 years) and UIC measured as ug/g creatinine, the statistical significance of the relationship between decreasing tT4 with increasing perchlorate exposure in women with low UIC is lost. The statistical significance of this relationship should be present regardless if the analysis expr esses UIC in ug/L or ug/g of creatinine. This inconsistency suggests that the relationship betwee n tT4 and perchlorate reported in the Blount analysis might be an artifact in the NHANES data set. The figures below show significant scatter in the perchlorate vs T4 and TSH correlations from the NHANES datset and cast considerable doubt on the clinical significance of any statistical sign ificant findings reported by Blount et al 2006.

[Figure. Gender groups - Perchlorate vs T4 - see PDF docket ID EPA- HQ- OW-2009-0297-0636]

Additionally, studies among pregnant women do not demonstrate a correlation between urine perchlorate and thyroid function, A cohort of 789 pregnant women (i.e., 396 from Cardiff, Wales; 311 from Turin, Italy; and 82 from Dublin, Irel and) with perchlorate exposure levels shows no association between urinary perchlorate levels and fr ee T4 levels in the pregnant women as a group or in the subgroup of pregnant women with UIC <= 100 ug/L (Pearce 2007). . A cohort of 230 pregnant women (i.e., 128 from Los Angeles, Ca lifornia; 102 from Cordoba, Argentina) with low perchlorate exposure levels predicted by the Blount analysis to induce a reduction of tT4 shows no association between urinary perchlorate levels and fr ee T4 levels in the pregnant women as a group or in the subgroup of pregnant women with UIC <= 100 ug/L (Pearce 2008). From the 2005 Tellez cohort study (Tellez 2005) in three Chilean cities, a reanalysis of the data identified 16 of the pregnant women had UIC <= 100 ug/L (Gibbs 2008 ). The reanalysis shows no association between urinary perchlorate levels and free T4 levels in this subset of pregnant women with UIC <= 100 ug/L.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28561

EPA Comment Code: 2200EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 169 of 1099 Comment: The Blount et. al. studies were useful in demonstrating that although perchlorate exposure is widespread (through diet), the revi ew of the NHANES data clearly indicated that thyroid hormone levels measured in the study were clinically normal, even in the presence of perchlorate and other goitrogens such as nitrate and thiocyanate. The Blount et. al. 2006 study did show, however, that iodine nutrition is a significant concern, especially for women of childbearing age. The conclusions concerning associations purpor ted in Blount et. al. 2006 are problematic as the

authors failed to use consistent models to derive th eir findings across age, sex, ethnic and other key
variables. Furthermore, it is hard to lend cr edence to associations between thyroid hormones and perchlorate exposure that are negative in one ca se for women with low urinary iodine excretion while being positive for other women. As a continuous variable, one might expect to see a more or less negative value between the groups, but not a complete change in the direction of the slope for a well-defined biological process. The statistical sign ificance reported by the authors may be a result of the iodine level instead of the perchlorate level, as low iodine would result in elevated TSH and reduced T4 levels, while higher (i.e. sufficient) iodi ne levels would not be expected to result in a statistical association between thyroid hormone levels and iodine or perchlorate, as demonstrated in the study.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28608

EPA Comment Code: 2200

Comment: Perchlorate has been found in the drinking water supply of 35 states and the District of Columbia. Widespread human exposure to perchlor ate was confirmed by the Center for Disease Control's NHANES study, which found that 100 percent of the 2,820 randomly selected study participants had detectable levels of perchlorate in their urine. And according to your request for comment notice, dated August 5, 2009, the number of people served by water contaminated with high levels of perchlorate ranges b etween 53.4 and 16.8 million people.

Response: Under the first Unregulated Contaminant Monitoring Rule (UCMR 1). EPA collected and analyzed drinking water occurrence data fo r perchlorate from 3,865 PWSs between 2001 and 2005 under the UCMR 1. The minimum reporting level (MRL) for perchlorate under the UCMR 1

was 4 μ g/L. EPA found that 160 (approximately 4.1 pe rcent) of the 3,865 PWSs that sampled and reported had at least 1 analytical detection of perc hlorate (in at least 1 sampling point) at levels greater than or equal to the MRL of 4 μ g/L. These 160 PWSs are located in 26 States and 2 territories. Of these 160 PWSs, 8 are systems serv ing 10,000 or fewer people and 152 are systems serving more than 10,000 people. These 160 system s reported 637 detections of perchlorate at levels greater than or equal to 4 μ g/L, which is approximately 11.3 percent of the 5,629 samples collected by these 160 PWSs and approximately 1.9 percent of the 34,331 samples collected by all 3,865 PWSs. The average concentration of perchlora te for those samples with positive detections for perchlorate was 9.85 μ g/L and the median concentration was 6.40 μ g/L.

Table 1 in the final regulatory determination presents the number and percentage of PWSs that reported perchlorate at levels exceeding various threshold concentrations.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 170 of 1099 Table 2 of today’s notice presen ts EPA’s estimates of the population served by PWSs that were monitored under UCMR 1 for which the highest reported perchlorate concentration was greater

than the thresholds identified in Table 1. These population estimates are for people at all life stages. EPA has determined that a NPDWR for perchlora te could reduce perchlorate exposures for these populations to levels below the potential alternative HR Ls that EPA has identified as levels of public health concerns for purposes of this determina tion, and that such exposure reductions present a meaningful opportunity for the reduction of heal th risks for persons served by PWSs.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28682

EPA Comment Code: 2200

Comment: U.S. EPA uses the US Centers for Diseas e Control and Prevention's National Health and Nutrition Examination Survey (NHANES) biom onitoring dataset in concert with the FDA TDS dataset to estimate the relative proportional intake of perchlorate from both food and water sources. The NHANES data provide the best av ailable measure of actual human exposure to perchlorate from all sources, including food and water, using urinary perchlorate concentrations from a large U.S. population cohort. The overall ex posure to perchlorate from all sources based on the NHANES data is below any meaningful level of concern identified in the available scientific literature. Thus, as a fraction of total exposure, in take of perchlorate from food alone must be well below any meaningful level of concern. FDA's TDS and food sampling data, which provides an approximation of human exposure to perchlora te from food, validates this conclusion.

Recent Epidemiological Data, Including the Blount (2006) Analysis of NHANES Data, Should Not Be Used as a Basis for a New Perchlorate Regulatory Determination.

The undersigned groups support EPA's decision to base its perchlorate regulatory determination on the NAS RfD. Some have argued that the Blount (2006b) results, which show a slight correlation between perchlorate in urine and changes in thyroid hormone levels in women with sub-optimal iodine levels, should be given considerable weigh t in EPA's review of its preliminary regulatory determination. In fact, the Blount analysis has seve ral limitations which necessarily impede its use in drawing conclusions regarding the health effects of perchlorate, particularly for purposes of risk assessment and regulatory decision making. Chief am ong these is the fact that Blount (2006b) does not establish direct causation, only an association between two independent data sets. A number of intervening factors could cause or contribute to the reported decrease in thyroid hormone levels, including methodological issues such as the use of relevant measures of thyroid function (total T4 versus free T4) and appropriate biomonitoring data (24 hour urine versus spot urine samples). Second, even if changes in thyroid hormone levels were considered adverse (they are not), the changes identified in Blount (2006b) were not outs ide the normal ranges for thyroid hormone levels. Third, estimated perchlorate doses based on the urinary concentrations were below the level that can trigger inhibition of iodide uptake, the non-advers e precursor effect that is the basis of the NAS

NOEL.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 171 of 1099 The Blount (2006b) results conflict with the overwh elming body of scientific evidence showing that perchlorate has no effect on the thyroid at envir onmentally relevant levels. Similar concerns have been raised by independent organizations such as the American Thyroid Association[FN2: The American Thyroid Association in 2007 concluded that the CDC study findings were "intriguing," but limited in their application to the setting of exposure standards. (http://www.thyroid.org/professionals/publicati ons/statements/06_12_13_ perchlorate.html).], and a key member of the NAS perchlorate panel has indicated that the NAS RfD remains sufficiently health protective[FN3: In April 20 07 - after publication of the CDC study - NAS panelist Dr. Robert Utiger, senior physician with th e Harvard Institutes of Medicine, testified before Congress and stated: "I continue to believe that a reference dose of 0.007 mg/kg/day (24.5 ppb) is quite adequate."].

Response: EPA disagrees that the overwhelming body of scientific evidence shows that perchlorate has no effect on the thyroid at environmentally re levant levels. See response to comment ID 29078

under comment code 2200.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28717

EPA Comment Code: 2200

Comment: If the association between perchlorate and th yroid hormone levels was causal, as is sometimes inferred from the Blount study, then logically the effects of thiocyanate and nitrate observed by Blount in connection with those same hormones should also be viewed as causal. If that were so, it would then appear that thiocyanate has all of a sudden become a remedy against goitrogens instead of a goitrogen itself, and nitra te would only act as a goitrogen when iodine levels were sufficient. That of course would be very sur prising, and would be inconsistent with years of scientific observations and studies regarding thes e substances. As discussed in greater detail below, we have reviewed the information presented in the Blount study regarding perchlorate, and the full range of substances in the same NHANES 20 01-2002 database, and have concluded that perchlorate is not the cause of observed TH impacts, but is simply a marker for other thyroid affecting substances.

1. The four orders of magnitude difference between the adverse effect levels found in the two most cited recent studies in relation to perchlora te, the Greer study and the Blount study

In stark contrast to all previous studies, the results of the Blount study suggest that if the relationship between perchlorate and thyroid hormone s is causal, perchlorate is about 10,000 times more potent than previously found. It is simply not plausible that all other studies would have missed this surprising outcome, particularly in view of the fact that perchlorate was and still is used as a drug in the treatment of thyroid disorders.

From Blount (NHANES 2001-2002) data and regression curves, th e average urinary level of 2.84 ug/L, which is found to be related to thyroid hor mone (TH) change, is equivalent to an oral perchlorate dose of approximately 0.00004mg/kg - day[FN2: Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL, 2006a. Perchlor ate Exposure of the U.S. Population, 2001-2002.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 172 of 1099 Journal of Exposure Science and Environmental Epidemiology, 1-8.]. This is 100 times lower than the dose of 0.004 mg/kg-day that was found in th e Greer study to be without effect not even on iodide uptake and which led to the NAS RfD ba sed on a (slightly higher) NOEL of 0.007 mg/kgday. Further this dose of 0.004 mg/kg-day on itse lf is about 100 times smaller than 0.5mg/kg-day, the dose found to have no effect on THs[FN3: NAS 2005, Health Implications of Perchlorate Ingestion, The National Academies Press, Washington, DC, 2005.]. So, in stark contrast to what has been found in the body of the literature, the conclusions of the Blount study would suggest that perchlorate is about 10,000 times more potent than measured in previous studies as illustrated in fig.
3, below.

Fig. 3 [see PDF docket ID EPA-HQ-OW-2009-0297-0647]

The NAS RfD of 0.0007 mg/l has often been expresse d in the media as "a couple of drops in an Olympic seized swimming pool" to make it more visually comprehensible. We could push this metaphor a bit further: the 10,000 times lower dose would then mean that the level represents a couple drops in 10,000 Olympic sized swimming pool s. If the effect of perchlorate were indeed so strong, the resulting drinking water public heal th goal (PHG) would be well below 25/100 ppb and closer to 25/10,000 ppb or 0.0025 ppb which is at least 2 orders of magnitude below the mean natural perchlorate background in drinking water.

Finally, if the causal interpretation of the results of the Blount study are to be believed, the downstream TH adverse effect level of 0.00004 mg /kg-day would be 2 orders of magnitude lower than the upstream iodine uptake inhibition non- effect level. This is in itself contradictory, since according to NAS "a perchlorate dose that does not inhibit thyroid iodide uptake will not affect thyroid function" (ref. 2 above) and thus cannot affect TH levels.

A sudden four order of magnitude difference in eff ect level attributed to a well studied substance is extremely improbable. It is instead far more likely that the study’s interpretations regarding the impact of low doses of perchlorate are inaccurate and should not be relied upon as a basis for regulation.

2. The cause of the TH changes in the Blount et al. study: is it another substance or an environmental pool of substances?

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28897

EPA Comment Code: 2200

Comment: B. Recent Studies Listed in the 2009 FR Notice

The Notice states that EPA has evaluated addi tional data made available since the 2005 RfD determination. In response to comments suggesting that other studies, particularly Blount et al. (2006), be used for defining a regulatory standa rd, EPA noted that new studies have provided important information to the scientific literature, but that it has "decided to make the regulatoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 173 of 1099 determination based upon the current RfD." The papers EPA listed are summarized below. Based on these data, Greer et al. (2002) continues to provid e the best scientific information to be used as the basis for EPA's perchlorate RfD risk assessment.

Most of these comments have been presented by Intertox in the past. Where appropriate, however, these summaries are updated with new information.

Blount et al. (2006)

Using the NHANES 2001-2002 data set and a cr oss-sectional study design, Blount et al. (2006) report measurement of urinary perchlorate, urinary iodide, serum TSH, and serum total T4 levels in men and women over the age of 12. The 2001-200 2 NHANES data provide the largest group of subjects to date from which sampling data can be derived. The authors report that perchlorate levels

were not associated with total T4 or TSH levels in men, but were a negative predictor of total T4 and a positive predictor of TSH in women with urinary iodine less than 100 ug/L. They report that in women with urinary iodine greater than 100 ug /L, urinary perchlorate was a positive predictor of TSH, but not associated with T4. The significance of evaluating women with urinary iodide less than 100 ug/L is based on the World Health Organizati on (WHO) statement that a median urinary iodine concentration for the entire population, based on spot samples of less than 100 ug/L, is indicative of overall iodine deficiency for that population (WHO, 2004).

This study has drawn a great deal of attention as it may be misinterpreted to demonstrate an "effect" of perchlorate, albeit at exposures below t hose that cause measurable IUI. A number of
considerations, however, should be noted to better understand the significance of the data reported.

First, as stated above, ATSDR (2008) reviewed th is study in their assessment and did not feel it merited any special consideration over other stud ies in the well developed perchlorate literature

database. It states that its decision "...was made after a careful evaluation of the NRC report and of studies that have been published after the NRC (200 5) report. The results from newer studies do not change the bottom-line recommendation" (ATSDR, 2008).

Second, it is important to interpret the results of scientific research based on what is known about the biological system. For example, there is a diffe rence between "statistical significance and "clinical significance." A "statistically significant" differe nce simply means it is unlikely that a difference between two variables (e.g., measurements) is due to chance. With a well designed experiment, statistical significance can be extremely important. Because statistical significance is also a function of sample size, variability in the variables measured , etc., the finding of statistical significance does not necessarily mean the difference is large, important , or biologically significant. For biological data, it is important to understand whether something that is statistically significant is also clinically significant; that is, whether a change in a variable or parameter is large enough to affect a clinical or medical condition (e.g., development of hypothyro idism). Blount et al. (2006) report statistically significant relationships for some variables, but do not report any variables with clinical significance,

such as free T4.

The type of study conducted by Blount and co lleagues (i.e., a cross-sectional study) cannot determine causation, only associat ion between the variables studie d (Wartenberg and Buckler, 2001). If important variables are missing, then spurious conclusions can be made. Thus, without a full setEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 174 of 1099 of thyroid-specific variables measured, including re peated 24-hour urinary iodide measurement, any association should be examined carefully for reliability.

Furthermore, perchlorate did not actually lower (nor was it associated with) thyroid hormone levels outside the normal range of values. Assuming that it had, the NRC committee does not think that "...transient changes in serum thyroid hormones or TSH concentrations are adverse health effects; they are simply biochemical changes that might precede adverse effects" (NRC, 2005). For each individual in the NHANES study, a single spot urin e sample and a single plasma sample for analysis of thyroid hormones and other parameters were collected. These data do not provide more than a "snapshot" or transient assessment of these individuals.

Regarding Blount et al. (2006), ATSDR states, " limitations of the study acknowledged by the investigators include those common to cross-sectional analyses, the assumption that urinary perchlorate correlate with levels in the thyroid st roma and tissue, and the measurement of total T4 rather than free T4" (ATSDR, 2008).

Third, any study must have careful consideration for the parameters and variables that are measured or available and how these variables relate to the outcome of interest. NHANES is designed to collect a broad range of data about the health an d diet of people in the United States. NHANES collected data on some parameters relevant to thyroid function, but these parameters fall short of providing sufficient information needed to clearl y understand thyroid health. Only two clinical measures of thyroid function were taken (total se rum T4 and TSH). Missing where free T4, thyroid binding globulin (TBG), and T3 among others. Iodi ne status was reported on the basis of spot urine samples, which are neither the preferred, nor most reliable, measure of urinary iodide (Barr et al., 2005). Further, NHANES did not collect data on the incidence of autoimmune thyroiditis, the most common thyroid disorder in the U.S., which causes changes in serum T4, T3, and TSH

concentrations due to errant immune mechanisms attacking the thyroid gland, called Hashimoto's thyroiditis (NRC, 2005). Intertox (2008) provides a more thorough discussion regarding the use of spot urine testing, confounders, and use of the av ailable NHANES variables to draw conclusions.

This study did not present urinary measures norma lized to creatinine, although creatinine was included as a variable in the regression analysis. The concentration of dissolved substances in urine, such as iodide, may vary between individuals or between samples from the same individual based on

water intake. Normalization with creatinine is me ant to normalize for dilution, not variability due to differences in exposure. It is not a perfect method, but is commonly used to account for this dilution (Furnee et al., 1994). Normalization may have been particularly useful in dividing the women up in to those with urinary iodide less than and greater than 100 ug/L.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28899

EPA Comment Code: 2200EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 175 of 1099 Comment: Fourth, not only were the thyroid hormone va lues within normal clinical ranges, but urinary perchlorate levels as a surrogate for dose demonstrate that these perchlorate exposures are

well below the threshold for zero inhibition of io dide uptake, a nonadverse effect. Exposures that are below the threshold for iodine uptake inhibition are below the NOEL for perchlorate and are not adverse (NRC, 2005; Greer et al., 2002).

Finally, based on the premise that science is incremental and knowledge builds collectively over time, concerns raised by scientists related to the Blount et al. (2006) study should be considered an opportunity for further study. Furthermore, recogniz ing that urinary spot iodine or single point iodine measures are not a good indicator of iodine status, a different approach is being considered by Dr. Blount. More research should be conducted to better understand the results of this study.

Response: See response to comment ID 29078 under comment code 2200.

Commenter Name: Jonathan Borak Commenter Organization: Yale School of Medicine

EPA Document ID: EPA-HQ-OW-2009-0297-0209

EPA Comment ID: 29078

EPA Comment Code: 2200

Comment: The key findings of the Blount study are well known:

1) Measures of thyroid function (T4 and TSH) were significantly associated with urinary perchlorate
levels in women, but not men;

2) T4 levels were negatively associated with urin ary perchlorate levels in women with spot urine iodine levels <100 ug/L, but not >=100 ug/L . TSH levels were positively associated with perchlorate in both groups of women;

3) Urinary thiocyanate levels were negatively associated with TSH in women with spot urine iodine levels >=100 ug/L, but there was no association in those with <100 ug/L. Urinary thiocyanate levels were not significantly associated with T4 in women with spot urine iodine levels <100 ug/L or >=100 ug/L;

4) Urinary nitrate levels were negatively associated with T4 in women with spot urine iodine levels >=100 ug/L, but not in those with levels <100 ug/L . Urinary nitrate levels were not significantly associated with TSH in women with spot urin e iodine levels <100 ug/L or >=100 ug/L.

The Blount perchlorate findings are provocative, an d at first seem biologically plausible. But when all study findings are viewed together, their pattern is inconsistent with what is generally accepted to be the basic physiology of the Sodium/Iodide Symporter (NIS).

Three principal anions, perchlorate, thiocyanate and nitrate (along with other 'lesser' anions) exert qualitatively similar effects upon the thyroid, i.e., th ey competitively inhibit iodine uptake by the NIS (2-5). The NIS effects of these molecules have been shown repeatedly to be similar in direction and additive in magnitude, and their quantitative re lationships have been well characterized (6-12).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 176 of 1099 Accordingly, it is reasonable to expect that the effects on iodine uptake of increasing exposure to perchlorate, thiocyanate and nitrate would be dir ectionally similar and quantitatively predictable.

That viewpoint is widely held by EPA scientis ts and others. Consider, for example, the views expressed in the recent report of the EPA's Office of Inspector General (OIG) (13):

"... the human body is exposed to all three NIS inhibitors concurrently and the resulting effect on the uptake of iodide by the thyroid is cumulative and indistinguishable from each other ..."

"The three NIS inhibitors (thiocyanate, nitrate, and perchlorate) exceed EPA's 'mode of action' requirement by sharing the same 'mechanism of to xicity' (i.e., simple competitive interaction) by inhibiting the uptake of iodide at the NIS..."

Likewise, Blount et al. agree that thiocyanate, nitr ate, and perchlorate share activity as competitive inhibitors of iodine uptake (1):

"the ability of NIS to transport adequate amounts of iodide depends on the relative concentrations of these competing anions".

Steinmaus et al. also concur (14):

"High doses of perchlorate have been shown to co mpetitively inhibit iodide uptake in the thyroid gland ... other agents, including nitrate in food an d water and thiocyanate in food or from tobacco smoke also affect the thyroid by the same mechanism."

De Groef et al., in consideration of expected ha lf-lives and exposure levels of these anions, concluded that the anti-thyroid effect of perchlorate was similar to, but substantially smaller than the respective effects of thiocyanate and nitrate (12):

"perchlorate accounts for less than 10% of possibl e thyroidal effects resulting from the exposure from drinking water; in food, its share is even negligible."

The inconsistencies in the Blount data are shown in the following table, which indicates the direction of expected effects on T4 and TSH levels re sulting from increased ex posure to perchlorate, thiocyanate or nitrate, and the effects on T4 and TS H levels observed in various groups as reported by Blount et al. No consistent pattern of effects is seen, and observed effects are not all consistent with expected.

Expected Effects and Reported Significant Effects on T4 and TSH from Increasing Exposure to Perchlorate, Thiocyanate and Nitrate [see table in PDF docket ID EPA-HQ-OW-2009-0297-0209]

Also surprising is the general absence of effects attributable to thiocyanate and nitrate. As emphasized in the OIG analysis, "typical human exposures" to thiocyanate and nitrate should have induced "substantially more NIS inhibition" than that caused by 13 ug/day perchlorate exposure, the 95th percentile exposure level in the Blount study (13).

Blount et al. recognized that such results were surprising:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 177 of 1099 "unexpected based on a mechanism of NIS inhibition. The explanation for this is unclear"(1).

Although various hypothetical and speculative explanations were proposed for such apparent inconsistency, I am not aware that any has actually been validated.

Steinmaus et al., in their re-analysis of the NHANES and Blount data, evaluated the impact of urinary thiocyanate levels on the associations between urinary perchlorate and thyroid function noted by Blount et al. (14). Like Blount, they found no significant effects in males and no significant effects in women with urinary iodine levels >=100 ug/L. And also like Blount, they recognized and could not explain the inconsistencies of their re sults. They could not explain the observed genderspecificity:

"We do not know why the effects we id entified were seen only in women".

Similarly, they could not explain the absence of e ffects for nitrate, which "requires investigation beyond the scope of this paper". Finally, they co uld not explain the absen ce of perchlorate- and thiocyanate-related effects in women with spot urine iodine levels >=100 ug/L.

It is not known whether the inconsistent results reported in Blount and Steinmaus reflect yet-to-beelucidated physiological relationships, heretofore un recognized sources of confounding, or just 'bad luck' that adversely impacted the composition of the study cohort. Whichever, it is apparent that these data are not adequate to serve as the basis for regulatory rule making. There are too many inexplicable scientific uncertainties that can only be addressed by hypothetical and speculative thinking. Moreover, it is unlikely that reanalys is of the 2001-2002 NHANES data and Blount analyses can resolve these concerns, nor can the Steinmaus et al. analysis be used to validate the Blount et al study, as emphasized in the OIG report (13):

"the Steinmaus analysis does not corroborate the Blount analysis because both studies use the same

NHANES 2001-2002 data set."

In summary, the Blount et al. and Steinmaus et al. studies are provocative and useful as the bases for hypothesis generating. They are not, however, adequa te for hypothesis testing and their conclusions remain too speculative and uncertain to provide a sound basis for regulation.

Response: EPA has evaluated the Blount and Steinmaus papers as well as the OIG report cited by

the commenter. EPA has determined that these stud ies and report are informative, but the Agency believes the recommendations of the NRC represent the best available peer reviewed science on which to base a regulatory determination. EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. See further discussion of the RfD in today’s Federal Register notice. With respect to effects of nitrate and thiocyanate, data do not exist at this time to permit a quantitati ve assessment of potential cumulative effects of perchlorate and other compounds that impact th e sodium iodide symporter. However, EPA has committed to a drinking water strategy that outlin es four principles to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchlorate should be further delayed. Therefore, EPA intends to deve lop a proposed rule for perchlorate. EPA will continue to analyze the best available sc ience in developing the proposed rule.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 178 of 1099 

### EPA Comment Code: 2300 Use of PBPK mode ls from Clewell et al (2007) and Merrill et al (2005) to ev aluate health effects

Response to Comment Code 2300: EPA reviewed, modified, and applied the perchlorate Physiologically-Based Pharmacokinetic (PBPK) mo dels, which were originally developed by Merrill et al. (2005) for adults and Clewell et al. (2007) for ot her life stages, to estimate the iodide uptake inhibition in the thyroid for each life-stage (73 FR 60262; USEPA 2008a). Estimated ingestion rates were then used to estimate the internal dose and resulting iodide uptake inhibition for several life stages, including susceptible populations (e.g., pregna nt women and their fetuses, as well as breastfed and bottle-fed infants).

In the August 2009 notice, EPA stated that it was re-evaluating how best to incorporate the PBPK modeling analysis into its evaluation of perchlor ate — if at all. The Agency sought comments on ways to use the PBPK modeling analysis to inform the regulatory determination.

Several commenters supported the use of the PBPK model to inform the regulatory determination only if the significant limitations of the current model are addressed. For example, the inability of the model to reflect iodide nutritional status was cited by commenters and three of four peer reviewers as an important limitation (USEPA, 2008d) . Also, several commenters stated that the risks to breast-fed infants and young children are not adequately addressed by the model. They challenged that the modeling analysis is based on average weight infants and healthy adults, while the sensitive life stages for perchlorate include prem ature infants and hypothyroid women.

After further consideration of the peer review and public comments, EPA concludes that the PBPK modeling analysis, in the context of the perchlorat e regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman.

The model also allows for the estimation of the co ncentration of perchlorate in breast milk (thus breast-fed infant exposure) at various maternal pe rchlorate exposure levels. However, because of the stated limitations, EPA has decided the model does not directly bear on the current decision regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.

Individual Comments

Commenter Name: Rebecca Downey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1888

EPA Comment ID: 20773

EPA Comment Code: 2300

Comment: This decision has been based in large part on an unvetted, industry funded computer model. Any studies of this kind are highly suspect and must be verified by proper scientific studies.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. This model has been extensively vetted, with publication of theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 179 of 1099 perchlorate specific model (Clewell et al. 2007) in a reputable journal. In addition, EPA has subjected the modified model to peer review and revised the model in accordance with peer

reviewer recommendations.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20899

EPA Comment Code: 2300

Comment: Instead of using state of the art science and human bio-monitoring data from the Centers For Disease Control and Prevention (CDC) to assess risks, the agency employs a highly questionable, non-peer reviewed computer model deve loped by the discredited industry front group, the Chemical Industry Institute of Toxicology (C IIT). The choice to use a model instead of real
world data was done for one reason, to make the ri sks from perchlorate look smaller than they really are. The model did achieve that result, but even th is faulty analysis did not completely exonerate this potent thyroid toxin. In the end, this computer model predicts that 30,000 pregnant women would be exposed to perchlorate in drinking water at leve ls that exceed EPA’s health reference level (HRL) of 15 ppb at any given time (EPA 2008).

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. EPA acknowledges the Blount et al (CDC) analysis of effects of perchlorate on the thyroid status of women with low urinary iodide. However, the applicability of the analysis is limited by deficiencies noted by the authors. See response to comment code ID 28515

under comment code 2200.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20904

EPA Comment Code: 2300

Comment: Other noteworthy errors and flaws in th is assessment include the following:

* The physiologically-based PBPK model that EPA uses in their assessment was designed by researchers who work for the CIIT, an industry funded research organization with a history of providing assessments to EPA that favor industry interests;

* The PBPK model that EPA uses in their assessm ent relies heavily on the flawed, industry-funded Greer study;

* EPA essentially ignores data from large, we ll-conducted human studies in favor of a PBPK computer model;

Response: See response to comment code 2300 for a discussion of PBPK modeling in and considerations in this regulatory determination. EPA acknowledges the Blount et al. analysis of effects of perchlorate on the thyroid status of women with low urinary iodide. However, the applicability of the analysis isEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 180 of 1099 limited by deficiencies noted by the authors. See response to comment ID 28515 under comment

code 2200. See also response to comment ID 20899 under comment code 2300.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20910

EPA Comment Code: 2300

Comment: EPA relies on PBPK model that was designed by industry-funded group: EPA relies heavily on the PBPK model in their assessment; this model was designed in part by scientists who work for the CIIT, which is an industry-funded organization that is sponsored by corporations such as 3M, BASF, Dow, and ExxonMobil and trade gr oups such as the American Chemistry Council

and the American Petroleum Institute.

The CIIT has a history of conducting assessments that result in outcomes that favor industry. In a 2008 report, the Government Accountability Offi ce (GAO) notes that the CIIT developed a risk assessment for formaldehyde that was 2,400 time s less stringent than a previous Integrated Risk Information System (IRIS) estimate (GAO 2008). The GAO report goes on to note "The decision to use the CIIT assessment in the plywood national emissions standard was controversial, and

officials in EPA’s National Center for Environm ental Assessment said the center identified numerous problems with the CIIT estimate" (GAO 2008).

In 2004 the CIIT also published a model for the contaminant trichloroethylene (TCE) that proposed

cancer risk values for TCE inhalation that were 300 times less protective than EPA's 2001 proposed values (Clewell et al. 2004). Leading EPA researchers subsequently published a critique of the CIIT's work, stating that their literature review did not pr esent a "sufficiently current, complete, accurate, and transparent review of the pertinent literature," and concluding that the resulting model had not been adequately described or validated (Caldwell et al . 2006). EPA scientists also noted that the CIIT had failed to disclose their funding for the TCE mo del, and inappropriately implied that it had been funded by EPA.

In addition, EPA itself has noted errors in the CIIT PBPK model used in the perchlorate assessment, explaining in thei r report, "EPA evaluated the PBPK model code provided by the model authors and found minor errors in mathematical equations and computer code, as well as some inconsistencies between model code files" (EPA 2008). It is unclear why EPA relies so heavily on the CIIT generated PBPK model when the CIIT has a history of conducting industry friendly assessments, as with the formaldehyde example, and there are clear errors in the perchlorate model, as acknowledged by EPA.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. As the commenter notes, EPA modified the model of Clewell et al. (2007) to correct minor mathematical errors and to expand the capabilities to reflect additional life stages. This work was conducted with the consent and support of the model developers. The model was previously peer reviewed and published in a reputable journal.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 181 of 1099 EPA does not believe that CIIT’s work on formaldehyde or TCE is relevant to the perchlorate

assessment.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 182 of 1099 

### EPA Comment Code: 2400 Use of EPA’s PBPK model to evaluate health

effects

Individual Comments

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20417

EPA Comment Code: 2400

Comment: The Agency justifies the high MRL [sic] by a pharmacokinetic model that simulates iodine uptake inhibition in the human fetus and newborn based upon experimental data in rat pups. While the model has been validated in adult humans and rat pups, it has not been validated in infants and children. As we described in the CHPAC 2006 letter, use of the rat data to project pharmacolcinetics to human newborns is uncertain given the well known differences in the rate of development of clearance mechanisms between rodents and humans. The modeling performed by the Agency does not remove the clear concern for elevated neonatal exposure to perchlorate, well in excess of the RfD. This also represents an unorthodox use of pharmacokinetic modeling in regulatory risk assessment because once an RfD is established, it is inappropriate to use additional modeling to justify exceeding the RfD.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20433

EPA Comment Code: 2400

Comment: 4. The PBPK Model is Uncertain Especially for Iodine Insufficient Women. Instead of using the standard approach of comparing estimated doses to the RfD to determine safe drinking water levels, EPA is instead relying on physiolog ically-based pharmacokinetic (PBPK) modeling to predict IUI. MassDEP believes that the PBPK mo deling has a number of limitations and may be less reliable. For example, the PBPK modeling does not adequately address effects in iodide insufficient populations and is very uncertain wi th respect to predicted breast milk perchlorate concentrations, effects on neonates and impacts duri ng early fetal development. Empirical data on these issues is sparse, limiting model construction and evaluation. More robust uncertainty analysis and evaluation of model outputs is needed.

5. EPA Needs to Better Assess and Present PBPK Model Uncertainties. Since EPA relies heavily on the outputs of the PBPK model to predict brea st milk perchlorate levels, a more thorough presentation of the model, model uncertainties an d its outputs, in particular for breast milk perchlorate concentrations and neonatal exposures under differing maternal exposure scenarios is needed. This information should be provided to the public for review and comment, in addition to aEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 183 of 1099 scientific peer review session. These are uncertain because the PBPK model relied on rat data for several key parameters that influence breast milk perchlorate concentrations. Furthermore, the model was only evaluated against limited human data derived from populations in Chile (Tellez et al., 2005).

6. US Data Indicates the PBPK Model May Unde restimate Breast Milk Perchlorate. Due to differences in dietary iodide intake rates, which are likely to be much higher in Chile, as well as other factors, breast milk data from US populations with lower levels of iodine intake, such as from the Boston study (Pearce et al., 2007), should also be used for model evaluation. Based on the Pearce et al., study, MassDEP is concerned that the model may significantly underestimate perchlorate breast
milk concentrations in US women. Table 1, co mpiled by MassDEP, compares observed perchlorate and iodide concentrations in breast milk and perchlorate in urine from the Chilean and Boston study populations. These data are consistent with higher dietary iodide intake levels in the Chilean populations compared to the Boston area. The US data also exhibits a higher breast milk to urine perchlorate concentration ratio compared to those observed in the Chilean study groups - a factor of 4 for the Boston data vs. a range of only 0.33 to 2 for the Chilean populations. This suggests that the Boston women, perhaps due to lower iodide inta ke, may have partitioned a greater fraction of perchlorate dose into breast milk than predicted by the model. This would result in even higher neonatal exposures than predicted by EPA at a maternal drinking water concentration of 15 ug/L, which as noted above, already exceeds the RfD.

[Table 1. Lactational Perchlorate and Iodide levels in Urine and Breast Milk - see PDF Docket ID EPA-HQ-OW-2008-0692-1422]

7. The PBPK Model is Deficient for Early Developm ental Periods. Emerging data now indicate that thyroid hormone deficiency during early gestation causes neuronal toxicity (Sinah et al., 2008). The EPA has acknowledged that the lack of biological information during early fetal development limits the applicability of the PBPK modeling of the fetus and thus can not make meaningful predictions regarding early fetal IUI.

8. The PBPK Model Does Not Consider Other Potential Mechanisms of Toxicity. Additionally, the model only addresses iodide uptake inhibition. Howev er, perchlorate not only inhibits iodide uptake but also promotes the discharge of endogenous iodide, which is not addressed in EPA’s assessment. The thyroid gland possesses two kinds of iodide. The first is the iodide which is accumulated into the thyroid by an active transport mechanism, th e so-called "transported iodide". The second source is the iodothyronins which are derived by hydrol ysis from thyroglobulin and rapidly deiodinated within the gland to yield the so- called "endogenous iodide". It is believed that both iodide sources are used within the thyroid gland for the synthesi s of hormones. Rosenberg et al., 1961; Isaacs et al., 1966; Greer et al., 1969 showed that perchlorate di scharged endogenous iodide in animals, and Burgi et al.(1974) confirmed this phenomenon to occur in humans. Wolff (1974) has attempted to propose mechanisms by which perchlorate accomplishes the discharge of stored thyroidal iodide, but how this process affects thyrocytes upon short- and long -term exposure is not well understood and is not covered by the PKPB modeling.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Jeanne HerbEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 184 of 1099 Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20448

EPA Comment Code: 2400

Comment: Proposed HRL of 15 ug/L for Perchlorate

In 2006, USEPA adopted an IRIS Reference Dose (RfD) of 0.7 ug/kg/day for perchlorate, based on the advice of the National Research Council (NRC) Committee to Assess the Health Implications of Perchlorate Ingestion (2005), whic h had been assembled at the request of USEPA.

The proposed Health Reference Level (HRL) for perc hlorate of 15 ug/L was derived using exposure assumptions for a pregnant woman/fetus exposed to the RfD of 0.7 ug/k g/day with a Relative Source Contribution (RSC) factor of 0.6. In developi ng this HRL, USEPA assumed that the fetus is the most sensitive subpopulation, more sensitive than the infant, so that the infant can be safely exposed to much higher doses than the fetus. Af ter deriving the HRL of 15 ug/L based on exposure of the pregnant woman/fetus, a physiologically -based pharmacokinetic (PBPK) model was used to evaluate the dose reaching the thyroid and to esti mate effects on the inhibition of thyroidal iodine uptake in sensitive subpopulations exposed to 15 ug/L of perchlorate.

Insufficient information has been provided to the public about the details of the PBPK model to allow for the necessary evaluation of this approa ch. The proposal states that USEPA modified the published PBPK model to reflect the decreased urinary clearance of young infants and for other reasons, but the citation for this information (USEPA, 2008b) does not provide a document that is available to the public. Additionally, USEPA states that the modifications it has made to the published model have not yet been peer reviewed, and that this peer review will take place prior to finalizing the proposal. We believe that the results of the peer review should be available as part of the USEPA proposal, so that the public can consider the conclusions of the peer review as to the appropriateness of the appr oach used by USEPA.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. The modifications to the Clewell (2007) model were peer reviewed and found to be sound. The peer review report can be found on EPA’s website at http://water.epa.gov/drink/contaminants/unregul ated/perchlorate.cfm. The major reservation expressed centers on attempting to use the model beyond its capabilities.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20450

EPA Comment Code: 2400

Comment: Another matter of concern is the assumption th at a 2.2% decrease in iodide uptake in 7- day old infants can be regarded as a No Eff ect Level (73 Fed. Reg. 60278 (October 10, 2008)) by extrapolation from the NRC panel’s conclusi ons. The NRC based the conclusion that a 1.8%

decrease was a No Effect Level on data from norma l healthy adults. Additionally, the 1.8% decrease

was considered to be within the normal variation expected in an experimental measurement, which differs in concept from a prediction of a decrease of any magnitude by a model. Although iodideEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 185 of 1099 uptake by the thyroid in healthy infants functions at a level similar to adults, this assumption that a decrease of 2.2% is inconsequential does not pr ovide the level of protection that is usually extended to clearly sensitive subpopulations. Critically, infa nts do not achieve complete maturity of thyroid function until 1-2 months postnatally, display a shorter thyroxine half-life, and do not have the same degree of thyroid reserve capacity as healthy ad ults (Brown et al., 2004; van den Hove et al., 1999; Zoeller and Rice, 2004). While most infants with se vere thyroid problems are identified within a few days after birth, premature infants, infants with su bclinical hypothyroidism or with low iodine intake are not represented by the average healthy infant considered by the PBPK model. Furthermore, the predictions for perchlorate exposure and decreases in iodide uptake are only averages for the group considered, normal healthy infants, and the range that could be predicted by the model due to differences in pharmacokinetic and pharmacodynamic factors is not given.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20647

EPA Comment Code: 2400

Comment: III (A)(3), pp 60268-9. The elegant PBPK mode l of Clewell et al. (2007) represents a significant advance in understanding potential perchlorate effects on the human maternal/fetal unit, and the maternal to infant passage of perchlorate and iodide through mother’s milk. However, some of the parameters in this model are inadequately understood and documented. The adaptations utilized by EPA (U.S. EPA, 2008) appear to impr ove the model, but we are concerned that it may not sufficiently address fetal and infant iodide/p erchlorate ratios and potential effects on thyroid hormone regulation. We believe that more revi ew of the model and its interpretation are needed, especially considering potential inhibition of f etal iodide uptake in mothers with low iodide consumption (i.e., maternal/fetal variation).

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20650

EPA Comment Code: 2400

Comment: IV (B)(5), pp 60277-9. PBPK modeling. Critical parameters such as relative transport of iodide and perchlorate across the placenta and upta ke into fetal thyroid are not yet available. We therefore would judge these calculations and conclusions very cautiously.

For estimation of infant’s exposure to formula on p. 60279, the EPA has referred to their new

evaluation of the data from the 1994-96 an d 1998 Continuing Survey of Food Intakes byEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 186 of 1099 Individuals, by Kahn and Stralka, which was recen tly published online in the Journal of Exposure Science and Environmental Epidemiology. We note that the values cited from this source are less than we have been using, based on EPA (2004), but we have not had the opportunity to compare the evaluations and strength of conclusions in detail.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20654

EPA Comment Code: 2400

Comment: Third, in particular, the PBPK model referenced in the letter has already been extensively peer-reviewed. Furthermore, the EPA is conducting an independent external letter peer review of a draft report prepared by EPA’s Office of Research and Development titled, Inhibition of the Sodium-Iodide Symporter by Perchlorate: An Evaluation of Lifestage Sensitivity Using Physiologically-based Pharmacokinetic (PBPK) Mode ling. This review is expected to be completed shortly. The underlying model and its expansions are already the subject of four peer-reviewed, published scientific articles.[FN5: Rebecca A. Clewell et al., The Use of Physiologically-Based Models to Integrate Diverse Data Sets and Reduce Uncertainty in the Prediction of Perchlorate and Iodide Kinetics Across Life Stages and Species, Toxicol. Ind. Health, 2001, 210-222; Rebecca A. Clewell et al., Predicting Fetal Perchlorate Dose and Inhibition of Iodide Kinetics During Gestation: A Physiologically-Based Pharmacokinetic Analysis of Perchlorate and Iodide Kinetics, 2003,
Toxicol. Sci., 2003, 235-55; Elaine A. Merrill et al., PBPK Model for Radioactive Iodide and

Perchlorate Kinetics and Perchlorate-Induced Inhibi tion of Iodide Uptake in Humans, Toxicol. Sci.,
2005, 25-43; Rebecca A. Clewell et al., Perchlorate and Radioiodide and Kinetics Across Life Stages in the Human: Using PBPK Models to Predict Dosimetry and Thyroid Inhibition and Sensitive Subpopulations Based on Developmental Stage, J. Toxicol. Envtl Health, 2007, 408-28.] Significantly, the NAS panel endorsed it as "the be st available approach" for determining effects in sensitive subpopulations where experimentation is impossible. While we are not aware of the particular changes EPA staff made to the PBPK mo del for use in the preliminary determination, the Federal Register notice provides an estimate of pr edicted changes in iodine uptake inhibition (IUI) in sensitive subpopulations that do not differ signif icantly from the published findings in Clewell et al. (2007). The results of this modeling estimate th at certain sensitive populations (although not the most sensitive population, which are pregnant wo men and their fetuses) may have exposures in excess of the RfD. However, these groups would ha ve minimal IUI at environmental doses. These conclusions are important enough to state again: even at doses greater than the reference dose, sensitive subgroups within the population may have minimal changes in their IUIs. The magnitudes of these changes are small enough to be attributable to normal fluctuations, possibly from diet. As noted by the NAS review, unless there is a sustained and significant change in IUI, adverse effects from perchlorate will not occur.[FN6: See Note 1.]

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Caroline Baier-Anderson, PhDEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 187 of 1099 Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20950

EPA Comment Code: 2400

Comment: A major concern is that the application of the PBPK model after the establishment of an RfD is a novel concept that must be thoroughly vetted prior to using in the regulatory setting. EPA should convene a peer review process to evalua te this novel use of a PBPK model, not just for use in developing a health advisory level for perc hlorate, but its use in the general sense. Such deviations from the standard risk-based approaches must be thoroughly evaluated, with recommended applications and limitations clearly identified.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20968

EPA Comment Code: 2400

Comment: EPA seems to aim to limit uncertainties as mu ch as is possible by taking into account

the latest available evidence such as the NHANES data and make use of sophisticated models such

as the FDA TDS and the PBPK models. This is laudable.

Response: EPA has assessed the available scientific in formation on health effects and exposure to perchlorate. See response to comment code 23 00 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20997

EPA Comment Code: 2400

Comment: 3. EPA ignores fails to adequately consider evidence that the proposed HRL is not safe

Although EPA's scientific staff issued a rigorous review of the PBPK model and its findings, the Agency has ignored the most important conclusions of the report, that infants and young children will have a perchlorate intake that exceeds the Rf D. Instead, the preliminary determination seems to suggest that the PBPK model results support the Ag ency's proposed HRL. This is not the case.

A. The PBPK model provides evidence that at the proposed HRL, infants and young children will have a perchlorate intake that exceeds the reference dose.

The EPA scientific staff conducted a rigorous eval uation of the application of the physiologicallybased pharmacokinetic (PBPK) model, particularly as it applies to sensitive life-stages.[FN49: EPA Office of Research and Developmen t. Inhibition of the sodium-iodide symporter by perchlorate: AnEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 188 of 1099 evaluation of lifestage sensitivity using physiol ogically-based pharmacokinetic (PBPK) modeling. Preliminary Draft. October 2, 2008. EPA/60 0/R-08/106A. Docket ID No. EPA-HQ-OW-2008- 0692-0076.] On October 2, 2008, EPA issued the report, which identifies some very troubling findings, including evidence that consuming water that was contaminated at the HRL of 15 ug/L would lead to bottle-fed infants exceeding the reference dose by 5-fold and young children exceeding the reference dose by 2.8-fold, based on average food contamination rates, average body weights, and 90th percentile water consumption rates for each age group (Staff Report, Table 4).[FN50: EPA Office of Research and Development. Inhibition of the sodium-iodide symporter by perchlorate: An evaluation of lifestage sensit ivity using physiologically-based pharmacokinetic (PBPK) modeling. Preliminary Draft. October 2, 2008. EPA/600/R-08/106A. Docket ID No. EPA-HQ-OW-2008-0692-0076.] Specifically, the st aff report found that the PBPK model predicted the perchlorate intake (ug/kg-day) from average food consumption, and 90th percentile water consumption held to 15 ug/L perchlorate as shown in Table 1. The table also identifies the magnitude by which the RfD is exceeded at the proposed HRL.

[Table 1: Perchlorate intake at a Health Refere nce Level of 15 ug/L - see PDF Docket ID EPAHQ-OW-2008-0692-????]

These values were also reported in the Federal Re gister notice, Table 8.[FN51: 73 Fed. Reg. at 62078.] Note that the overwhelming majority of pe rchlorate for these age groups is coming from water or breast milk, and not from solid food. These data, generated from the PBPK model predictions, provide substantial scientific support for the conclusion that infants (both breast- and bottle-fed) and young children would exceed the reference dose if their dietary water were contaminated with perchlorate at the HRL.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21001

EPA Comment Code: 2400

Comment: B. PBPK model supports an uncertainty factor of at least 15-fold

EPA normally uses a 10-fold default uncertainty factor to adjust for variations among individuals, called the intraspecies factor, when the Agency la cks adequate data to calculate intra-individual variability. EPA used this 10X intraspecies factor for its perchlorate hazard assessment on its IRIS database: "An intraspecies uncertainty factor of 10 is applied to protect the most sensitive population, the fetuses of pregnant women w ho might have hypothyroidism or iodide deficiency."[FN58: EPA. IRIS database. Perchlorate and perchlorate salts. http://www.epa.gov/ncea/iris/subst/1007.htm#re vhis] The Agency has adopted the practice of describing the default 10-fold intraspecies factor as being comprised of the product of two 3-fold factors, one for pharmacokinetic variability, and th e other for pharmacodynamic variability.[FN59: US EPA. Office of the Science Advisor: Staff Pape r, Risk Assessment Principles & Practices. Page 69, Section 4.3.2. EPA/100-B-04/001. March, 2004 . http://www.epa.gov/osa/pdfs/ratffinal.pdf] Pharmacokinetics describes the way that a compou nd such as perchlorate moves through the body,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 189 of 1099 including its absorption, distribution, metabolis m and excretion. In contrast, pharmacodynamics describes what the compound does in the body, including depressing, stimulating, irritating, or killing cells or systems.

According to the IRIS glossary of terms, a PBPK model estimates the dose of a compound to a target organ or tissue by calculating the rate of ab sorption in the body, the distribution among target organs, the metabolism of the compound, an d the excretion of the compound.[FN60: IRIS Glossary. Physiologically Based Pharmacokinetic (PBPK) Model. http://www.epa.gov/ncea/iris/help_gloss.htm#p] In other words, the PBPK model, by definition and design, estimates the pharmacokinetics of a compound.

The data from EPA's staff report however, shows that EPA's reliance on a default uncertainty factor of 10 underestimates the variability between fetuses and adults. The Executive Summary of the staff report states that "at a perchlorate dose of 7 ug/kg-day [the RfD], the percent RAIU inhibition predicted by the model for the near -term fetus is 5-fold greater than the average adult...The same analysis predicts percent RAIU inhibition approx imately 1-2 fold higher for the breast-fed and bottle-fed infant (7-60 days) than for the average adult."[FN61: See EPA Staff Paper, Table 3; see also 73 Fed. Reg. 60278.] More specifically, for perchlorate, the variability between a near-term fetus (40 weeks gestation) and an adult is 5.3-fo ld, Therefore, the PBPK model supports a pharmacokinetic adjustment factor of at least 5-fold.

The Agency has no information from the PBPK mo del, or from other data, to develop an intraspecies uncertainty factor for pharmacodynamic variability, particularly between adults and sensitive lifestages. Therefore, EPA should reta in a 3-fold default factor for pharmacodynamic uncertainty, consistent with its current practice.

Using the data from the PBPK model to support a pharmacokinetic intraspecies variability factor of 5, and the lack of pharmacodynamic data to support a default factor of 3, then the total intraspecies uncertainty factor should be (5 x 3) 15-fold, whic h is consistent with EPA policy and practices, and is supported by the available data.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. The modeled estimates of alternative HRLs reflect only pharmacokinetics and do not consider uncertainty due to pharmacodynamics. Pharmacodynamics is dose description of the dose-dependent effect of a chemicals on the target organ. Pharmacodynamics may vary by life

stage.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21020

EPA Comment Code: 2400

Comment: 3. Your letter also raises a concern that the PBPK model has been only validated in adult humans and rat pups, not in infants and children, adding that use of rat data to project pharmacokinetics to human newborns is uncertain given the differences in the rate of development

of clearance mechanisms between rodents and humans.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 190 of 1099 PBPK modeling is the best method today to address sensitive populations when testing is not possible or ethical. In fact, the PBPK model refere nced has already been extensively peer reviewed, including via modeling conducted on sensitive populations.

To be specific, the underlying model and its ex pansions are the subject of four peer-reviewed, published scientific articles [FN1: Rebecca A. Clewell et al., The Use of Physiologically-Based Models to Integrate Diverse Data Sets and Reduce Uncertainty in the Prediction of Perchlorate and Iodide Kinetics Across Life Stages and Species, Toxicol. Ind. Health, 2001, 210-222; Rebecca A. Clewell et al., Predicting Fetal Perchlorate Dose and Inhibition of Iodide Kinetics During Gestation: A Physiologically-Based Pharmacokinetic Analysis of Perchlorate and Iodide Kinetics, 2003,
Toxicol. Sci., 2003, 235-55; Elaine A. Merrill et al., PBPK Model for Radioactive Iodide and

Perchlorate Kinetics and Perchlorate-Induced Inhibi tion of Iodide Uptake in Humans, Toxicol. Sci.,
2005, 25-43; Rebecca A. Clewell et al., Perchlorate and Radioiodide and Kinetics Across Life Stages in the Human: Using PBPK Models to Predict Dosimetry and Thyroid Inhibition and Sensitive Subpopulations Based on Developmental Stage, J. Toxicol. Envtl Health, 2007, 408-28.]. Further, EPA is conducting an independent external letter peer review of a draft report prepared by EPA’s Office of Research and Development titled, I nhibition of the Sodium-Iodide Symporter by Perchlorate: An Evaluation of Lifestage Sensitiv ity Using Physiologically-based Pharmacokinetic (PBPK) Modeling. This review is expected to be completed shortly.

While we are not aware of the particular changes EP A staff made to the PBPK model for use in the preliminary determination, the Federal Register noti ce provides an estimate of predicted changes in iodine uptake inhibition (IUI) in sensitive subpopula tions that do not differ significantly from the published findings in Clewell et al. (2007). The resul ts of this modeling estimate that certain sensitive populations (although not the most sensitive popu lation, which are pregnant women and their fetuses) may have exposures in excess of the RfD.

However, these groups would have no significant i nhibition of IUI at environmental doses. These conclusions are important enough to state again: even at doses greater than the reference dose, sensitive subgroups within the population may have minimal changes in their IUIs. The magnitudes of these changes are small enough to be attributable to normal fluctuations, possibly from diet. The critical study chosen by the NAS to base its r ecommended RfD on, Greer et al. (2002) reported no IUI (1.8% ± 8.3) which was determined not to inhibit the first effect - a non adverse, fully reversible

biochemical reaction - in the cascade of bioche mical events. The PBPK modeling estimated that infants may have IUI as great as 2.2% at this dose, however, this value is well within normal variability and does not suggest that perchlorate is causing any inhibition of IUI that is different from Greer et al. (2002) and is supportive of ot her similar information re garding the affinity of perchlorate to the NIS.

As noted by the NAS review, unless there is a sust ained and significant change in IUI, adverse effects from perchlorate will not occur.[FN2: Nationa l Academy of Sciences, Health Implications of Perchlorate Ingestion, 2005, at 165 (pdf version).]

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. EPA agrees that the modifications to the Clewell (2007) model were peer reviewed and found to be sound. The peer review report can be found on EPA’s website at http://water.epa.gov/drink/contamin ants/unregulated/perchlorate.cfm.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 191 of 1099 Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21021

EPA Comment Code: 2400

Comment: 4. Also concerning PBPK Modeling, your l etter suggests that EPA’s application of the PBPK modeling is "unorthodox" in regulatory risk assessment because it should not be used to
exceed an established RfD. However, EPA’s use of the modeling is not used to exceed the RfD in
this case, but rather to validate the benchmark of 15 ug/L as the HRL, and supports the point that the HRL derived by the Agency is even more health protective than the already conservative NASbased RfD that has been adopted by EPA. EP A policy has been to use PBPK modeling for determining human equivalent exposures (HEEs) and adjusting default uncertainty factors [FN3:
U.S. EPA Risk Assessment Forum, A Review of the Reference Dose and Reference Concentration Process, December 2002.] Significantly, the NAS pe rchlorate panel agreed with EPA in finding PBPK modeling is "the best available approach" in determining effects in sensitive populations where experimentation is impossible (NAS, 20 05) [FN4: The NAS panel also concluded the following: "By applying factors for life-stage differen ces (such as pregnant or lactating female rat vs. adult male rat) and for species differences (such as adult rat vs. adult human or pregnant or lactating rat vs. pregnant or lactating human), one ca n constrain PBPK simulations by using known physiologic measures and biochemical constant s to estimate HEEs in potentially sensitive populations that may not be suitable for experiment al validation."] EPA personnel have co-authored studies involving PBPK modeling and perchlora te (Merrill et al., 2005) and present for this preliminary determination, a model from Clewell et al. (2007) that was modified by making coding changes which served to improve the predictability of the model and therefore its overall usefulness. With this modified model, EPA is able to predi ct doses and changes in RAIU in pregnant women, fetuses, infants, and young children.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. See response to comment code 5220 for a discussion of alternative health reference levels. The modifications to the Clewell (2007) model were peer reviewed and found to be sound. The peer review report can be found on EPA’s website at http://water.epa.gov/drink/contaminan ts/unregulated/perchlorate.cfm.

EPA agrees that significant uncertainty in risk estimates remains whether or not the PBPK model is used. However, trading one uncertain estimation technique for another does not reflect progress unless the change sheds light on significant sources of uncertainty in the risk estimate. Given the incomplete nature of the PBPK model, i.e., the lack of representation of pharmacodynamics and differential life stage impact, and incomplete representation of pharmacokinetics, evaluating differential uncertainty between traditional approa ches and the PBPK model referenced in the October 2008 FRN appears to have limited if any value.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21053EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 192 of 1099 EPA Comment Code: 2400

Comment: 2. Perchlorate and Human Health in 2008: The EPA Preliminary Determination. These

comments include two sections. The first relates to scie ntific policy issues. Particular focus is placed on pharmacodynamic (PBPK) modeling. Several re ports in the general circulation press have suggested incorrectly that PBK modeling is unfamiliar in perchlorate risk assessment. These comments document that the PBPK modeling has been recognized by EPA and endorsed by the

NAS for its effectiveness in redu cing scientific uncertainty.

These comments conclude with a review of the statut ory criteria establishing EPA's authority in this proceeding. Citing the NAS report as well as subse quent studies, the comments demonstrate that the Agency is correct that none of the three criteria re quired for setting an NPDWR are met in this case.

Thank you for the opportunity to comment on these important issues. Please do not hesitate to contact me or Dr. Richard C. Pleus, if we can prov ide additional information or perspective in your

deliberations.

Sincerely, Michael Girard Chairman, Perchlorate Study Group

Response: The commenter is correct that application of PBPK modeling to EPA risk assessments is increasing, and that it has the potential to inform estimation of adverse effects and dosimetry across a broad range of questions. See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21100

EPA Comment Code: 2400

Comment: VII. The Published, Peer-Reviewed PBPK Mode l is Part of the Best Available Science

EPA Can Use for the Determination

One uncertainty in the derivation of the HRL as well as in the literature database is the lack of studies that measure radioactive iodine uptake (R AIU) in the sensitive population, pregnant women and the developing fetus. Obvio usly, it would be unethical to conduct such as study. However, Physiologically Based Pharmacokinetic (PBPK) modeling has been found to be useful in reducing uncertainty and in filling scientific gaps in huma n health data on a substance. EPA policy has been to use PBPK modeling for determining human equi valent exposures (HEEs) and adjusting default uncertainty factors.[FN5: U.S. EPA Risk Assessmen t Forum, A Review of the Reference Dose and Reference Concentration Process, December 2002.] The NAS perchlorate pane l agreed with EPA in finding PBPK modeling is "the best available a pproach" in determining HEEs (NAS, 2005).[FN6: The NAS panel also concluded the following: "By appl ying factors for life-stage differences (such as pregnant or lactating female rat vx adult male ra t) and for species differences (such as adult rat vs adult human or pregnant or lactating rat vs preg nant or lactating human), one can constrain PBPK simulations by using known physiologic measures and biochemical constants to estimate HEEs in potentially sensitive populations that may not be suitable for experimental validation."] EPA personnel have co-authored studies involving PBPK modeling and perchlorate (Merrill et al., 2005)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 193 of 1099 and present for this preliminary determination, a mo del from Clewell et al. (2007) that was modified by making coding changes which served to improv e the predictability of th e model and therefore its
overall usefulness. With this modified model, EPA is able to predict doses and changes in RAIU in pregnant women, fetuses, infants, and young children.

[Text Box: The utility of PBPK modeling has been previously recognized by EPA and has been endorsed by the NAS for use in re ducing scientific uncertainty.]

Using a 90th percentile water intake and based on data specifically for a pregnant woman, the model predicted that,

...the pregnant woman's dose of perchlorate woul d not exceed the reference dose if she consumed drinking water with a concentration of 15 ug/L or less, which is consistent with the derivation of the HRL from the reference dose, but based on average body weight, 90th percentile water consumption, and 90th percentile food expo sure for pregnant women. (73 FR 60280)

The model verified that exposures to 15 ppb of perchlorate in drinking water will not reduce RAIU significantly, even assuming concurrent exposure through food and water intake in the 90th percentile. This combination of high-end exposur e assumption is highly unlikely, probably at the extreme end of the population distribution. For th is hypothetical pregnant woman, the percent RAIU inhibition was 1.1%. The greatest inhibition was seen in 7 day old infants at 2.2%. These percent inhibitions are consistent with the 1.8% i nhibition of iodine uptake from the Greer et al. (2002) No Observed Effect Level (NOEL). In fact, although 2.2% is greater than 1.8% found in Greer et al., (2002), it is well within the standard error from Greer et al. (2002) of 8.3% and would still constitute a NOEL. The NAS report noted that "the very small 1.8% decrease in thyroid radioiodide uptake identified in Greer was well within the normal variation, and therefore 1.8% IUI does not define the limit beyond which adverse effects occurs has has been incorrectly argued. The PBPK modeling is in accord with results from other corroborative studies, such as Tellez et al. (2005), which show no adverse effect on sensitive populations.

In summary, EPA's PBPK modeling supports the point that the HRL derived by the agency is even more health protective than the already conserva tive NAS-based RfD that has been adopted by EPA. The modeling provides scientific support that incorporating an additional level of conservatism in deriving an HRL is unnecessary as the RfD is already very conservative; based on this support, a National Primary Drinking Wa ter Regulation would not provide a meaningful

reduction in risk.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

.

The commenter is correct that application of PBPK modeling to EPA risk assessments is increasing, and that it has the potential to inform estimation of adverse effects and dosimetry across a broad range of questions. EPA also agrees that the mo difications to the Clewell (2007) model were peer reviewed and found to be sound. The peer review report can be found on EPA’s website at http://water.epa.gov/drink/contamin ants/unregulated/perchlorate.cfm.

Commenter Name: Mark S. MayerEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 194 of 1099 Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28481

EPA Comment Code: 2400

Comment: Specific Comments Requested by EPA:

- Comments on Use of Physiologically-Based Phar macokinetic Model - South Dakota DENR does not have toxicologists and health effect/risk analysis experts on staff to make our own regulatory determinations for contaminant levels, but instead relies upon EPA to establish contaminant levels that are supported by a strong scientific basis and cost effective health benefits.

Response: The Safe Drinking Water Act requires EPA to use the best available, peer reviewed science in support of its decision. EPA will adhe re to this requirement developing a proposed national primary drinking water regulation incl uding a health risk reduction cost analysis.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28497

EPA Comment Code: 2400

Comment: ASDWA Responses to Specific Requests for

Comment:

Comments on Use of the Physiologically-Based Pharmacokinetic Model (PBPK) - ASDWA does not have any detailed comments to offer on the use of the PBPK model to evaluate or predict the health impact of perchlorate or about how this information could support a regulatory determination. State drinking water programs, with a few exceptions, do not have toxicologists or other health effect and risk analysis experts on thei r staffs to provide detailed evaluations of these issues. That is why very few states adopt their own regulatory standards but rely on EPA to set appropriate Maximum Contaminant Levels (MCLs). As stated earlier, ASDWA expects EPA to use sound scientific data from peer reviewed research to make regulatory determinations. States must explain to water systems and the public how the re sulting MCLs protect public health and a strong

scientific basis for the rule make s that justification credible. We do appreciate the rigor with which the Agency has explored this issue and the range of options being considered in connection with the

PBPK model as well as the evaluation of the rela tive sensitivity of the various life stages to perchlorate exposure in drinking water.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28521EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 195 of 1099 EPA Comment Code: 2400

Comment: Comment No. 4

Section III. 2. What Were the Key Scient ific Issues Raised by Commenters

Page & Paragraph Page 41885 Col 1, Para 4 Col 2, Para 2

Comment EPA has issued several PBPK guidance do cuments, including Use of Physiologically Based Pharmacokinetic Models to Quantify the Impact of Human Age and Interindividual Differences in Physiology and Biochemistry Pertinent to Risk (EPA/600/R-06/014A) and Approaches for the Application of Physiologica lly Based Pharmacokinetic Models and Supporting Data in Risk Assessment (EPA/600/R-05/043 F), and notes at its National Center for Environmental Assessment webpage (http://cfpub .epa.gov/ncea/cfm/recordisplay.cfm?deid=2044, accessed 15 September 2009), "P hysiologically-based pharmacokinetic (PBPK) models have increasingly been employed in chemical heal th risk assessments carried out by the U.S. Environmental Protection Agency (EPA), and it is anticipated that their use will continue to increase." Given such activities and statements, it is not clear from the current notice, why the agency is now proposing removing the PBPK mode ls from the evaluation of life-stage specific differences in susceptibility. In fact no reasons are given, other than a few commenter concerns about (1) the level of peer review and (2) the ex istence of uncertainty in the model parameters, neither of which provide a sound reason for discardi ng the models. This is particularly troublinggiven that EPA specifically released its final, peer-reviewed report on Inhibition of the SodiumIodide Symporter by Perchlorate: An Evaluation of Life Stage Sensitivity Using Physiologically Based Pharmacokinetic (PBPK) Modeling (EPA/600/R-08/106A) as supporting material for the19 August 2009 Federal Register notice (accessed on 15 September 2009 at the NCEA webpage http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=212508#Download). In the document, EPA definitively concludes that with minor modi fications proposed by th e Agency the Clewell et al. (2007) and Merrill et al. (2005) PBPK models are a cceptable to calculate the life stage differences in the degree of thyroidal NIS RAIU inhibition at a given level of perchlorate exposure.

Suggested Action, Revision and References (if necessary) It is recommended that the PBPK models

continue to be used in the evaluation of perchlorate life- stage susceptibility.

Category* S. M

Comment No. 5

Section III. 2. What Were the Key Scient ific Issues Raised by Commenters

Page & Paragraph Page 41885 Col 1, Para 4

Comment The current documentation of the background for the development of the HRL gives significant weight to public comments regarding pe er review of the models, which together with the lack of EPA response, gives the impression that th e models have, in fact, escaped rigorous peer review. The background documentation suggests that peer review has been limited to eight experts

and this is not the case.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 196 of 1099 Suggested Action, Revision and References (if necessa ry) It is recommended that the peer review of the models be appropriately documented. The PBPK models have undergone thorough, rigorous review by a variety of scientific panels comprised of experts from academia, regulatory agencies, the
National Academies of Science, an d independent consultants. Changes made to the original models by the EPA were independently reviewed by a panel of expe rts and deemed appropriate. Furthermore, while areas for improvement have been identified in each of the peer reviews, comments by the panels have always been pos itive and supportive of their intended use in identifying the susceptible life-stages for perchlorate inhibition.

Category* E, M

Comment No. 6

Section III. 2. What Were the Key Scient ific Issues Raised by Commenters

Page & Paragraph Page 41885 Col 2, Para 2

Comment As suggested in EPA (2009), there are indeed uncertainties in some of the model parameters, as there is always uncertainty in any calculation of risk. The benefit of using PBPK models is that the uncertainty in the calculations is more transparent than the typical default approach. For example, it is clear from evaluation of the model output that there is not enough data to adequately define exposure parameters (parti cularly in the young neonate) and urinary clearance parameters. By focusing on those model parameters with uncertainty, collection of the data needed to improve our knowledge and reduce uncertainty can be initiated. Furthermore, the effect of these model parameters on the predictions of inhibiti on can be explored. The fact that the overall predictions of inhibition across life-stages were not significantly changed despite the changes made to the model intake and clearance parameters by the EPA indicates that the mo dels are robust within the potential range of parameters ma de available in the data. The models help to define and decrease the areas of uncertainty, rather than increase them, which is what happens when the models are removed from consideration and life-stage comparis ons are made solely on estimates of average of upper bound estimate of food and water intake.

Suggested Action, Revision and References (if necessary) It is recommended that the PBPK models be utilized and the uncertainty analysis be performed appropriately.

Category* S. M

Comment No. 7

Section III. 2. What Were the Key Scient ific Issues Raised by Commenters

Page & Paragraph Page 41885 Col 2, Para 2

Comment Some of the uncertainty can be addresse d through the use mathematical and statistical tools to estimate the effect of the parameter vari ability on model predictions. Using statistical tools such as Monte Carlo analysis, we can determine ra nges of inhibition expected at proposed HRLs while taking into account variability in the para meters. Without the models, the uncertainty still exists. There is still a lack of data for exposure and clearance in the HRL approach but it is not asEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 197 of 1099 obvious. Discarding the models does not eliminate un certainty in lifestage dosimetry, but it is hidden within the additional uncertainty associated with the default calculations. Reverting to the default approach based on external exposure concentrations in media, does not improve the estimate of risk or increase the likelihood of protecting the public. Ra ther it allows the risk assessment to be driven by the data that is most readily available and easiest to explain than trying to deal with the more difficult task of incorporating the best available sc ience. We do view this approach as scientifically

defensible.

Suggested Action, Revision and References (if necessary) It is recommended that the PBPK models be utilized and the uncertainty analysis be performed appropriately.

Category* S. M

Comment No. 8

Section III. 2. What Were the Key Scient ific Issues Raised by Commenters

Page & Paragraph Page 41885 Col 2, Para 2

Comment The approach previously proposed for using the models to evaluate life-stage specific susceptibility to iodide uptake inhibition was a reasonable use of the models. They were not used to derive the HRL, but were used to verify that the recommended HRL was protective of all life-stages. Public comments and the subsequent revised proposal appear to imply that the previous calculations were performed using the PBPK models. This is not the case. According to the EPA (2008), the models were run to provide a second, independent test for the adequacy of the proposed HRL. This analysis was thoughtful, novel and informative to the level of risk associated with the proposed HRL. It is not clear why this approach was not fo llowed in the current assessment, particularly in light of the subsequent completion and positiv e result of the PBPK model peer review.

Suggested Action, Revision and References (if necessary) It is recommended that the PBPK models be used in a reasonable approach.

Category* S. M.

Comment No.

Section III.A. 4. Request for Comment on Alternative Approaches. a., b., c.

Page & Paragraph Page 41886

Comment Clarity needs to be improved relative to presentation of the PBPK model results.

It also would be helpful if the uncertainties associated with the various alternative options, such as use of PBPK model (e.g., iodide status, and other data deficiencies) were compared with other suggested methods for developing health risk leve ls (e.g., using human data available from "direct measurement") in a tabular format, to help impr ove the clarity of the be nefits/drawbacks of the alternative processes. For example, uncertainty wa s linked to the modeling code, the availability of data for the many variable parameters in the model, the combination and handling of the dataEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 198 of 1099 selected for use in simulations, and, in particular , the previous lack of human data for specific life stages including pregnant women and their fetuses, lactating women and their babies, and bottle-fed infants for which rat data were adapted. The inabili ty of the model to reflect iodide nutritional status also was cited by three peer reviewers as an important limitation. Recent and available "direct measurement" data, as cited here, for sensitive lif estages should be evaluated for potential use in reducing these identified areas of uncertainty. This would also help identify areas for potential future

research.

Suggested Action, Revision and References (if necessary) We recommend a tabular format of changes made to the EPA PBPK model in its last revision (May 2009) and the impact of those changes.

We recommend a tabular comparison of the impact on thyroid hormone levels from recent human data for perchlorate, thiocyanate, nitrate and iodide in healthy populations and additional modeling of these data to help determine the impact of low iodide for sensitive subpopulations, such as pregnant women and infants.

Category* E

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

The commenter is correct that application of PBPK modeling to EPA risk assessments is increasing, and that it has the potential to inform estimation of adverse effects and dosimetry across a broad range of questions. EPA also agrees that the mo difications to the Clewell (2007) model were peer reviewed and found to be sound. The peer review report can be found on EPA’s website at http://water.epa.gov/drink/contaminants/unreg ulated/perchlorate.cfm. However, the major reservation expressed was with the use of the mode l, not the validity of the internal calculations. EPA believes that the tabular comparison recommen ded above is an interesting approach that

should be considered at such time as sufficient data to conduct a cumulative assessment for chemicals affecting the NIS receptor become available.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28744

EPA Comment Code: 2400

Comment: The NDEP recommends that the EPA incorporat e the following key concepts into the decision-making process, as explained more fully in the attached comments:

1. Additional clinical data are needed to help refi ne the PBPK model. Data are needed for adults, including pregnant women, and for neonates concerni ng thyroidal iodine capacity and the effects of sodium-iodide symporter (NIS) upregulation on thyroidal iodine uptake and/or thyroxine levels.
Also, additional studies of other adults are need ed to evaluate the eff ects of temporary iodine deficiency and NIS upregulation on perchlorate comp etitive inhibition of thyroidal iodine uptake and/or free thyroid hormone levels. This additional research would provide useful data to considerEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 199 of 1099 in further refining the PBPK model to accurately re flect the effects of iodine deficiency in pregnant
women, fetuses and neonates.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. EPA plans to continue to evaluate the best available science on perchlorate in preparing a proposed maximum contaminant level and goal for perchlorate.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28798

EPA Comment Code: 2400

Comment: REQUEST FOR COMMENTS ON ALTERNATIVE APPROACHES

a. Using the PBPK model to evaluate the relative se nsitivity of life stages to perchlorate exposure in drinking water

NRDC Response: The PBPK model can be used to ev aluate life stage sensitivity, and it provides evidence that at the proposed HRL of 15 ppb, infa nts and young children will have a perchlorate

intake that exceeds the reference dose.

The EPA scientific staff evaluated the application of the PBPK model, particularly as it applies to sensitive life-stages.[FN26: EPA Office of Resear ch and Development. Inhibition of the sodiumiodide symporter by perchlorate: An evaluation of lifestage sensitivity using physiologically-based pharmacokinetic (PBPK) modeling. Preliminary Dr aft. October 2, 2008. EPA/600/R-08/106A. Docket ID No. EPA-HQ-OW-2008-06 92-0076] On October 2, 2008 , EPA issued the staff report on this evaluation, which identifies some very tr oubling findings, including evidence that consuming water contaminated at the HRL of 15 ug/L (or p pb) would lead to bottle-fed infants exceeding the RfD by 5- fold and young children exceeding the RfD by 2.8-fold, based on average food contamination rates, average body weights, and 90th percentile water consumption rates for each age group.[FN27: EPA Office of Research and De velopment. Inhibition of the sodium-iodide symporter by perchlorate: An evaluation of lif estage sensitivity using physiologically-based pharmacokinetic (PBPK) modeling. Preliminary Dr aft. Table 4. October 2, 2008. EPA/600/R08/106A. Docket ID No. EPA-HQ-OW-2008- 0692-0 076.] Specifically, the PBPK model predicts

that the RfD is exceeded for infants and children at the originally proposed HRL of 15 ppb, at 90th percentile water intake. (See Table 1 below). The table also identifies the magnitude by which the RfD is exceeded at EPA's origin ally proposed HRL of 15 ppb.

Table 1: Perchlorate intake from water at 15 ppb, wi th and without food intake, at 90th percentile water intake (L/day) [See PDF docket ID EPA-HQ- OW-2009-0297-0412]

These perchlorate intake values were also repor ted in the October 10, 2008 FR notice in Table 8.[FN29: 73 Fed. Reg. at 62078.] Note that the overwhelming majo rity of perchlorate for these age groups comes from water or breast milk, and not from solid food. These data, generated from the PBPK model predictions, provide substantial scientific support for the conclusion that infants (both breast- and bottle-fed) and young children would exceed the RfD if their dietary water were contaminated with perchlorate at the originally proposed HRL of 15 ppb.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 200 of 1099 Despite these conclusions, EPA announced its pre liminary determination not to regulate perchlorate in drinking water. Although that FR notice did repor t the staff conclusions, it contradicted them by concluding that "EPA believes drinking water with perchlorate concentrations at or below the HRL of 15 ug/L is protective of all subpopulations."[FN30: Id. at 60280] EPA failed to provide any data to support its conclusion, which is contradicted by the results of PBPK modeling as reported by staff experts and in the preliminary determ ination.[FN31: EPA Office of Research and Development. Inhibition of the sodium-iodide sympor ter by perchlorate: An evaluation of lifestage sensitivity using physiologically-based pharmac okinetic (PBPK) modeling. Preliminary Draft. October 2, 2008. EPA/600/R-08/106A. Dock et ID No. EPA-HQ-OW-2008-0692-0076.]

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. See response to comment code 5220 for a discussion of alternative health

reference levels.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28860

EPA Comment Code: 2400

Comment: Section III Alternative Approaches to Analyzin g Scientific Data Related to Perchlorate in Drinking Water

For a number of reasons we do not believe th at sodium iodide symporter (NIS) inhibition predictions based on Physiologically-Based Pharmacokinetic (PBPK) modeling should, at this time, be relied upon to establish or justify a perchlorate reference dose (RfD) nor to evaluate relative sensitivities between life-stages. Although the PBPK model previously relied upon, but now under reconsideration by EPA, provides a valuable expl oratory research tool and is a potentially useful predictor of perchlorate distribution and NIS effects in the adult, it is highly uncertain regarding the fetal and neonatal life-stages of most concern and may not reflect perchlorate effects on thyroid function. Our view on this issue is based on the following observations:

1) In response to peer review comments on the PB PK models, EPA noted that "the models have not been specifically parameterized to describe hypothyroid or iodine deficient individuals." In other words the model does not take into account responses in those with insufficient iodine intakes, the very group of most concern with respect to pe rchlorate exposures. In other documents EPA has also noted that the PBPK model did not account for within group variability in pharmacokinetics; uncertainty in several model parameters, including fetal and neonatal values derived from rodent models, and differences in adaptive responses. Although peer reviewer comments recommended that a much more robust uncertainty analysis be preformed on the model, EPA concluded that this was beyond the scope of the current effort and wo uld be difficult to conduct due to data gaps.
However, such an assessment is critical to d etermining the ultimate usefulness of the model predictions.

2) The perchlorate associated thyroid hormone alterations reported in Blount et al. 2006 and Steinmaus et al. 2007 in women with urinary iodine < 100 ug/L highlight some of these uncertainties, as they suggest that either the model estimates of iodide uptake inhibition (IUI) at lowEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 201 of 1099 perchlorate intake levels are inaccurate; that unex pectedly small increments in IUI may cause thyroid effects; and/or that perchlorate may act through additional mechanisms not captured in current models. Although NIS inhibition has been viewed as perchlorate's primary mode of action, other possible mechanisms that could contribute to its toxicity have been suggested. Based on a biologically-based dose response model of the hypothalamus-pituitary-thyroid axis and PBPK modeled perchlorate distribution and inhibition of thyroid iodide uptake, a recent assessment concluded that IUI was insufficient to explain observed changes in rat thyroid hormone levels attributable to perchlorate (McLanahan et al. 2009). These results suggest either that an additional mechanism of action exists, perhaps attributable to perchorate uptake into the thyroid and interference with other targets involved in hormone synthesis and release or that the PBPK modeling is inaccurate.

3) Although the impact of thyroid toxicants on the fetus can be buffered by the thyroid hormone synthesis and reserve capacities of the mother, io dide insufficiency and pregnancy-related stresses on maternal thyroid function increase the potential fo r perchlorate effects during fetal development (Glinoer 2001; Ginsberg et al. 2007 ). These are factors that the PBPK modeling does not adequately account for and could lead to a significant underestimate of NIS inhibition.

4) Available data indicate that neonatal exposures to perchlorate in breast milk are significant. The median perchlorate exposure to two week old nursin g infants in the U.S. was predicted to be 0.206 ug/kg/day (95th percentile = 0.744 ug/kg/day) (G insberg et al. 2007). Other data indicate that nursing infant perchlorate exposures in the U.S. ca n be even higher. Based on a breast milk intake rate of 0.172 L/kg/day and reported median breast milk perchlorate concentrations (Kirk et al. 2005 and 2007; Pearce et al. 2007a), we estimate that nurs ing infant perchlorate intakes in three U.S. cohorts ranged from 0.56 to 1.57 ug/kg/day. Dasgupta et al. (2008) estimated breast milk perchlorate intake rates ranging from 0.3-2.1 ug/k g/day, with intakes of 9 of 13 infants exceeding the National Research Council's (NRC) Rf D (NRC 2005) (Dasgupta et al. 2008).

Due to the significance of this exposure pathway, PBPK modeled estimates of perchlorate and

iodide concentrations in breast milk warrant clos e scrutiny and additional validation. In response to peer review comments, EPA added section 4.1.1 to the May 2009 report, "Inhibition Of The Sodium-Iodide Symporter By Perchlorate: An Evaluation Of Life Stage Sensitivity Using Physiologically Based Pharmacokinetic (PBPK) Mode ling." This section includes several informative comparisons of model predictions with published data but no comparison of predicted human breast milk perchlorate concentrations with publis hed data. A comparison of breast milk data from
Pearce et al 2007; Kirk et al 2005 and 2007 etc. combined with estimated US median perchlorate intakes (Blount et al 2006) should be completed, as this would provide important insight into model uncertainty regarding this critical exposure pathway.

Response: See response to comment ID 28923 under comment code 2400.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28868

EPA Comment Code: 2400EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 202 of 1099 Comment: COMMENTS IN RESPONSE TO TH E EPA NOTICE: ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2009-02 97; FRL-8943-9] RIN 2040-AF08 DRINKING WATER: PERCHLORATE SUPPLEMENTAL REQUEST FOR COMMENTS

Prepared for: PERCHLORATE STUDY GROUP

October 8, 2009

Intertox, Inc. 600 Stewart St. Suite 1101 Sea ttle, WA 98101 206.443.2115 phone 206.443.2117

facsimile

TABLE OF CONTENTS

EXECUTIVE SUMMARY..............................................................1 I.

INTRODUCTION.........................

................................... ....3 II. RESPONSES TO REQUEST FOR

COMMENTS ON ALTERNATIVE APPROACHES TO ANALYZING SCIENTIFIC DATA

RELATED TO PERCHLORATE IN DRINKI NG WATER.............7 III. OTHER

COMMENTS...................

................ ........................25 IV.

REFERENCES.................

................... ................. ...........36

APPENDICES

APPENDIX A SUPPLEMENTAL TABLES APPENDIX B INITIAL REVIEW OF
HOPONICK ET AL., 2009

LIST OF FIGURES

FIGURE 1. VISUAL REPRESENTATION OF UF, THE RFD, AND UNACCOUNTED FOR

CONTRIBUTION OF PERCHLORATE IN FOOD ARE COMPONENTS OF THE POD DOSE...20 FIGURE 2. TOTAL GOITROGEN LOAD IN PERCHLORATE EQUIVALENCE *

BASED ON URINARY MEASUREMENTS FROM WOMEN AGES 12 AND OLDER FROM

NHANES 2001-2002.**.... 22 FIGURE 3. URINARY REANALYSIS RESULTS OF THE

NHANES DATA 29 FIGURE 4. PLOTTING OF DATA REPORTED BY DASGUPTA ET
AL., 2008 TO ILLUSTRATE THE ASSO CIATION BETWEEN CONCENTRATIONS OF

IODINE AND PERCHLORATE IN URINE A ND MILK IN LACTATING WOMEN....32

EXECUTIVE SUMMARY

On August 19, 2009, the Environmental Protection Agency (EPA) issued a Federal Register (FR) notice requesting comments on alternative approaches to analyzing data related to EPA's perchlorate regulatory determination (the Notice; U.S. EPA, 2009b). The Notice says that "these additional comments are sought in an effort to en sure consideration of all the potential options for evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate through a national primary drinking water rule."

The following four points summarize the res ponse prepared by Intertox on behalf of the Perchlorate Study Group (PSG).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 203 of 1099 1. Interpretation of physiologically-based pha rmacokinetic (PBPK) modeling: The use of scientifically derived PBPK models is the best scientific approach among all alternatives for evaluating the relative sensitivity of different lif e stages, consistent with the conclusions of EPA's peer reviewers and the National Academy of Sc iences National Research Council (NRC). The current EPA PBPK model for perchlorate, however, uses values for some key parameters (e.g., urinary clearance) that are not supported by the scientific evidence. The model also does not account for up-regulation of the sodium iodide symporter (NIS). As a result, the model does not provide the best scientific estimates of iodide uptake inhibiti on (IUI) that would be associated with a particular perchlorate dose, and likely overestimates IUI from perchlorate exposure for various life stages. Further, input parameters are not selected from consistent points within their distributions, such that it is unclear whether the model output repres ents low, average, or upper-bound estimates of possible IUI. Nonetheless, the predicted levels of IUI in the Notice are low and would be indistinguishable from fluctuations resulting from differences in diet and feeding styles. No adverse health concern at any life stage would be expected based on exposure to perc hlorate at the point of departure dose (7 ug/kg-d). EPA should revise this model to represent science-based accurate information on PBPK parameters and use the results to determine whether regulation is necessary.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28880

EPA Comment Code: 2400

Comment: A Interpretation of the Physiologically Ba sed Pharmacokinetic (PBPK) Modeling

Properly conducted, PBPK models provide accurate, peer reviewed scientific information to reduce uncertainty about sensitive life stages. PBPK models for perchlorate have been under development for a number of years. In its 2005 assessment of perchlorate, the NRC identified several subpopulations that are potentially more sensitive than average adults to thyroid effects from perchlorate exposure, including pregnant women, f etuses, and infants, based in part on perchlorate PBPK models for pregnant and lactating rats and rat pups and adult humans. After the NRC evaluation, the perchlorate PBPK model was impr oved to include pregna nt women, the fetus, lactating women, and the neonate, and was publishe d in the peer reviewed literature (Merrill et al., 2005; Clewell et al., 2007).

Regarding the preliminary regulatory determination for perchlorate, EPA evaluated published PBPK models for perchlorate "based on their ability to provide additional information surrounding this critical effect for potentially sensitive subgroups and reduce some of the uncertainty regarding the relative sensitivities of these subgroups" (U.S . EPA, 2008a). EPA used public comments on the preliminary regulatory determination, as well as comments from an external peer review (Eastern Research Group, 2008), to further refine the mo del which is based on both pharmacokinetics and pharmacodynamics (U.S. EPA, 2009a) and used it to predict the relative RAIU inhibition for 17 distinct populations or life stages, including preg nant and lactating women, the fetus, and the neonate, assumed to be exposed to 0.007 mg/kg-d in drinking water. The results of this evaluation are presented in Table 1 of the Notice. From th ese results, EPA concluded that "by protecting theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 204 of 1099 fetus of the hypothyroid or iodide-deficient woma n from the effects of perchlorate on the thyroid, all other life stages and subgroups would be protected."

EPA requested comments on three general questions regarding its use of the PBPK model as an alternative approach to assessing the relative se nsitivity of different exposure populations. Responses to these questions follow. Note that the respons es to Questions 1 and 2 are combined, as the questions are not substantively different.

1. EPA requests comment on using the PBPK model to evaluate the relative sensitivity of the various life stages to perchlora te exposure in drinking water.

2. EPA requests comment on the utility of the PBPK model for predicting the impact of different perchlorate drinking water concentrations on se nsitive life stages to inform HRL selection.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.EPA does not agree th at the model used in the 2008 preliminary determination reflects both pharmacokinetics and pharmacodynamics. The model reflects a subset of pharmacokinetic parameters for various life stages . Pharmacodynamics is dose description of the dose-dependent effect of a chemical s on the target organ. Pharmacody namics may vary by life stage. The model depends upon the current RfD as an ex pression of the adverse effects of perchlorate, and any expression of pharmacodynamic variability is limited to some portion of the 10X uncertainty factor for intraspecies variability. The RfD was developed using data from adults, none of whom were pregnant. As such, it cannot reflect the potential variability among life stages due to pharamacodynamics. Data do not exist to desc ribe the pharmacodynamic variability among life stages for perchlorate.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28881

EPA Comment Code: 2400

Comment: PBPK modeling is valuable as it can integrate dozens of experimentally derived variables drawn from peer reviewed scientific studies to characterize chemical absorption, distribution, metabolism, excretion, and toxicity/effect. PBPK modeling is well established in the pharmacological and toxicological sciences, where it has been used for more than 80 years to understand the action of chemicals in the body. More recently, PBPK models have been used in filling scientific gaps in human health data, especial ly when conducting animal studies is infeasible, unethical, or impractical.

As stated by Mager et al. (2003) in a review of the use of PBPK models:

The resolution of PK/PD [pharmacokinetic/pharmac odynamic] models and parameters is best achieved by having relevant pharmacokinetics..., an understanding of the mechanism of action of the drug, appreciating the determinants of any time dependence in responses, and collecting a suitable array of experimental measurements as a fu nction of dose and time. When possible, such measurements should be sensitive, gradual, quantitative, reproducible, and meaningful.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 205 of 1099 This statement reflects scientific consensus about how scientific information should be used in a PBPK model. The EPA PBPK model is for the most part based on this philosophy and can be useful for informing risk management decisions. Not all parameters in this model, however, meet the criteria required for robust and predictive PBPK modeling. To be useful, the PBPK model inputs should be transparent and scientifically based. This would advance the overarching science policy articulated by the current EPA Administra tor, Hon. Lisa Jackson. [FN8: EPA Administrator Lisa Jackson, in her May 9, 2009 memorandum on scientific integrity stated, "While the laws that EPA implements leave room for policy judgments, th e scientific findings on which these judgments are based should be arrived at independently using well-established scientific methods, including peer review, to assure rigor, accuracy, and impart iality. This means that policymakers must respect the expertise and independence of the Agency's car eer scientists and independent advisors while insisting that the Agency's scientific processes meet the highest standards of rigor, quality, and integrity" ( http://www.epa.gov/Administrator/scientificmemo.html)]

While supportive of a science based PPBK model, an evaluation of the EPA PBPK model reveals that model does not produce the best and most sc ientific estimates of IUI. For example, some components of EPA's PBPK model for perchlorate ar e not supported by the scientific literature and result in IUI predictions that do not reflect best scientific estimates of IUI associated with a particular perchlorate dose. In particular, EPA's uses values for one of the key parameters in the PBPK model, the urinary clearance of perchlor ate, that are not suppor ted by the scientific literature.[FN9: Per EPA's evaluations, perchlorate PBPK model predictions are highly sensitive to urinary clearance rate, such that changes in it significantly impact predicted RAIU inhibition for a particular life stage and perchlorate dose. For ea ch of the 17 distinct populations or life stages
evaluated in the model, EPA used one of two diffe rent urinary clearance values: 0.05 L/h-kg for the pregnant woman at gestational weeks 13, 20, and 40 (which also impacts the RAIU prediction for the fetus at gestational week 40), and 0.13 L/h- kg for all other populations/life stages. If one calculates urinary clearance in L/h by multiplying these values by the corresponding scaled body weight, the resulting urinary clearance rates for the pregnant woman are much lower than for all other adults evaluated by the model: urinary cl earance rates range from 1.20 to 1.32 L/h for the pregnant woman, 3.21 to 3.28 L/h for the lact ating woman, 3.08 L/h for the woman of childbearing age, and 3.15 L/hr for the average ad ult. The assumption of reduced urinary excretion during pregnancy, however, is not supported by the bu lk of the scientific literature. The perchlorate urinary clearance rates used in the model are based on data collected in Greer et al. (2002). These values were originally described in the Merrill et al. (2005) model for adult humans, and were incorporated into the Clewell et al. (2003a, 2003b, 2007) models. Per Merrill et al. (2005), the 0.13 L/h-kg clearance rate is based on the mean "fit" urinary clearance rate for perchlorate for adult males and females (nonpregnant) in the Greer et al. ( 2002) study; the values for the 23 individuals in that study ranged from 0.06 to 0.24 L/h-kg. A ccording to Clewell et al. (2007), the 0.05 L/h-kg urinary clearance value applied to the pregnant woman (and fetus) was selected from the lower bound of this range, in part because this lower value was consistent with data from a study of perchlorate-exposed pregnant women in Chile (T ellez et al., 2005). Clewell et al. (2007) describes their rationale as follows: In the nonpregnant adul t model, Merrill and coauthors (2005a) fitted the perchlorate urinary clearance value to each indi vidual for which data were available and noted a marked variation between subjects. Values for urin ary clearance (ClUcp) ranged from 0.05 to 0.24 ng/L-h [sic], with an average of 0.13 ng/L-h [s ic]. Using the lower bound of these values (0.05 ng/L) [sic], the gestation model predicted serum le vels were within the range of the experimental values of Tellez et al. (2005)... Since the lower clea rance value lies within the range of the normal adult, improves the perchlorate pr ediction, and yields a more conservative estimate of risk, it wasEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 206 of 1099 used for all subsequent maternal simulations and dose metric calculations. Note that the actual lower bound of the perchlorate urinary clearance range from Greer et al. (2002) (reported in Merrill et al. (2005)) is 0.06 L/h-kg, not 0.05 L/h-kg. Further, th is value of 0.06 L/h-kg is for an adult male; no pregnant women were included in the study popu lation, and the lowest reported value for any woman is 0.09 L/h-kg. Clewell et al. (2007) indicated the lower-bound value from Greer et al. (2002) is consistent with data collected by Tellez et al. (2005). Tellez et al. (2005) evaluated perchlorate exposure in pregnant women in three cities in Ch ile exposed to perchlorate in water at average concentrations ranging from 0.5 to 114 ug/L. This paper says that urinary perchlorate was measured during two prenatal visits and one postnatal visit, and reported excretion in units of ug/L and ug/g creatinine. Unfortunately, no data are provided in the paper on time course of excretion, so it is unclear how Clewell et al. (2007) established that the lower bound of the urinary clearance rate for these populations was 0.05 L/h-kg. In selecting a urinary clearance value to use for the pregnant
woman, EPA considered two additional values: cl earance during pregnancy in the average adult based on Aboul-Khair et al. (1964); and clearance during pregnancy equal to nonpregnant average values. Aboul-Khair et al. (1964) evaluated urinary clearance of iodide in pregnant women in the United States and reported that "renal (urinary) clea rance for iodide is elevated to as much as two times control (nonpregnant) values during pregnan cy, and, while clearance then declines fairly rapidly towards control after birth, it is still elev ated in the first couple of months" (U.S. EPA, 2009a). EPA assumed that urinary clearance of perchlorate would have the same pregnant to nonpregnant ratio reported by Aboul- Khair et al. (1 964). EPA ran the model using all three values. Of these values, the clearance value used by Clewel l et al. (2007) resulted in the highest predicted RAIU inhibition. For example, at a dose of 7 ug /kg-d (a dose ten times the RfD of 0.7 mg/kg-d), EPA (2009a) reports a RAIU inhibition for the fet us of 11% using the Clewell et al. (2007) clearance value, 5.2% using the average non- pregnant adult clearance value, and 3.4% using the Aboul-Khair et al. (1964) clearance value. Regarding final selecti on of this value, EPA (2009a) says: Since there are no conclusive human pregnancy data to distinguish which of these alternatives is more likely, EPA selected option 1, the lower clearance value repor ted in the peer-reviewed paper by Clewell et al. (2007) for relative response estimation (life stage se nsitivity analysis), since this value leads to the most sensitive predictions... While this analysis uses the lowest urinary clearance value among the alternatives evaluated, it does not provide an ov erall upper-bound effect estimate because the impact of uncertainty and variability in parameters other than those examined here (e.g., uncertainty in thyroid NIS parameters and interindividual variabil ity in urinary excretion) was not evaluated. Thus, EPA selected a urinary clearance value for this population based on a nonscience consideration that lacked corroborating data in the face of other da ta supporting a higher value. EPA states that

selection of this value is not meant to reflect uncer tainty or a bounded estimate. This is inconsistent with the statement in the Notice regarding the use of conservatism in the model (U.S. EPA, 2009a), that: The PBPK model for each life stage is presum ed to represent a typical or average individual from that life stage. Thus, in evaluating specifi c PBPK parameter choices, especially for urinary clearance, EPA's objective was to ensure that th e values appropriately represented an average or central value for a given life stage and age. EPA fu rther elaborates (U.S. EPA, 2009a): In the case where more than one alternative clearance value ap peared to be equally likely (i.e., had a similar quality and amount of supporting data), then the more "sensitive" option was selected (i.e., the option that leads to predictions of the highest sens itivity to perchlorate- induced RAIU). The overall analysis did not seek to select parameters associated with highest predicted effect and is not intended to represent an upper-bound estimate of the av erage effect of perchlorate in these populations. Modeling choices are assumed to represent the best or most likely (central) estimate for an average individual within the population. There is uncerta inty about the average, an d EPA has selected from within the range of uncertainty, but there is st ill expected to be population variability around theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 207 of 1099 model predictions based on that choice, with the model prediction being near the center of the distribution. The Notice states that the urinary clea rance value was selected to "represent the best or most likely (central) estimate for an average individual within th e population." Selecting the lowest urinary excretion value-one that produces the hi ghest estimate of RAIU inhibition-is not the "average." The Notice declares that all three clearance values considered had a similar quality and amount of supporting data; in fact, this cannot be true based on the information presented. The 0.05 L/h-kg value was of low scientific quality (it is not supported by either source EPA cites as its primary basis, i.e., Greer et al. (2002) or Tellez et al. (2005)) and higher values are better supported by the scientific literature, as discussed below. The scientific literature shows that, although minimal, data are available on perchlorate urinary clearance or excretion rates during pregnancy, but do not suggest lower excretion of perchlorate during preg nancy. In the study of Chilean women, Tellez et al. (2005) reported higher urinary perchlorate excretion (measured as ug/g creatinine) during pregnancy relative to postpartum for women in tw o of the three cities evaluated (Chanaral and Taltal, which had mean concentrations of perchlora te in tap water of 5.8 and 114 ug/L). In the "low perchlorate" city (Antofagasta, with a mean tap water concentration of 0.5 ug/L), excretion was somewhat higher postpartum. Based on urine samples collected during the NHANES 2001-2002 study, Blount et al. (2007) reported higher urinary perchlorate in pregnant women (mean 3.27 ug/g creatinine, n = 115), relative to all women of repr oductive age (mean 2.97 ug/g creatinine, n = 662). Interpretation of data on urinary cl earance or excretion of iodide is complicated by the iodide status of populations; however, Smyth et al. (1997) reported that in an area of moderate iodine intake (median urinary iodide 82 ug/g creatinine), urin ary iodide excretion was increased during all three trimesters of pregnancy relative to nonpregnant controls. EPA's selection of the lowest identified urinary clearance value for the pregnant woman and fetus is inconsistent with the statement in the Notice about the Agency's use of conservatism in the model (U.S. EPA, 2009a): The PBPK model for each life stage is presumed to represent a typica l or average individual from that life stage. Thus, in evaluating specific PBPK parameter choices, esp ecially for urinary clearance, EPA's objective was to ensure that the values appropriately represented an average or central value for a given life stage and age. EPA further states, "there is still exp ected to be population variability around the model predictions based on that choice, with the mo del prediction being near the center of the distribution," and: While this analysis uses the lo west urinary clearance value among the alternatives evaluated, it does not provide an overall uppe r-bound effect estimate because the impact of uncertainty and variability in parameters other than those examined here (e.g., uncertainty in thyroid NIS parameters and interindividual variability in urinary excretion) was not evaluated. Nonetheless, in practice, selection of the lowest urinary cleara nce value for two of the subpopulations renders the RAIU inhibition predictions for these populations more conservative than for other populations, making application of model results to risk assessm ent difficult to interpret from a purely scientific basis.]

In addition to using the best science to support PBPK values, other parameters could be added, such as up-regulation of the NIS. Up-regulation of the NIS represents an adaptive response to iodine deficiency in the thyroid, but EPA (2009b) did not incorporate a mechanism of up-regulation in the EPA model. Incorporation of NIS regula tion into the model would more accurately reflect the probable response to perchlorate exposure in the environment.[FN10: Over the past decade, research regarding thyroid autoregulation and the regulation of expression of the NIS has proliferated. Evidence suggests that the NIS is up- regulated in response to iodine deficiency in the thyroid. Up-regulation of the NIS causes the numb er of NIS membrane proteins to increase; thus, when an individual is iodine deficient, the body increases the number of NIS "pumps" such that the thyroid is more effective at capturing iodide. This is a common adaptive mechanism that manyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 208 of 1099 tissues, including the thyroid gland, use to main tain hormone homeostasis. The Draft EPA Office of the Inspector General (OIG) report (U.S. EPA 2008b) appears to consider up-regulation of NIS expression as well. Earlier versions of the mode l using the rat did consider up- regulation, and showed no RAIU inhibition in the rat thyroid after 18 days of exposure at perchlorate doses up to 10 mg/kg-d (350,000 ppb assuming default body we ight and water intake) (Clewell et al., 2003a). Up-regulation was not included in the human model, "based on the fact that upregulation was not seen in the nonpregnant adult after 2 wk of doses as high as 1 mg ClO4- (Merrill et al., 2005)" and although "the current simulations cover lifetime exposures rather than a few weeks, theaccompanying data on thyroid hormones (TSH, T4) still do not show evidence of thyroidal upregulation (Crump et al., 2000; Tellez et al., 2005)" (Clewell et al., 2007). The NRC report, however, acknowledges the up- regulation of NIS expression, but did not incorporate it into their risk assessment. NRC (2005) states: ...rats compensated for the inhibition within 5 days of perchlorate administration, most likely by increasing the expre ssion of NIS in the thyroid. The data suggest that compensation occurs more quickly in rats because rats have a smaller reserve capacity of thyroid

hormones than humans.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28883

EPA Comment Code: 2400

Comment: Parameters used in the PBPK model were selected from inconsistent points within their distributions. For example, as described above, EPA (2009a) selected a lower bound value to describe the urinary clearance of perchlorate for the pregnant woman and fetus. In contrast, EPA reports that the urinary clearance values it sel ected for all other population subgroups fall in the middle of the range of possible values (U.S. EPA, 200 9a). As a result, it is difficult to interpret the model output because it is unclear whether the output represents lower-, middle-, or upper- bound predictions of possible IUI caused by perchlora te exposure."[FN11: When conducting calculations to reflect exposure within a population, each parameter can have a range of possible values. In order for PBPK model output to be meaningful, the basi s for selection of specific values within the range of possible values should be described and the relationship to the overall distribution for that parameter should be characterized (e.g., lower-bou nd, average, median, upper-bound). Further, in the absence of probabilistic assessment, if point estimates are selected for incorporation in the model, a consistent rationale should be applied in choosing values for the various parameters so that the location of the output within the overall dist ribution can be approximated. For example, when conducting baseline human health risk assessm ents for a reasonable maximum exposure (RME) scenario, EPA recommends estimating "a conservati ve exposure case (i.e., well above the average case) that is still within the range of possible exposures," and intake variable values for a given pathway should be selected so that the combination of all intake variables results in an estimate of the reasonable maximum exposure for that pathway (U.S. EPA, 1998a). The objective of evaluating conservative exposures is to generate an uppe r-bound estimate of exposure below which adverse health effects are unlikely. Note that although EPA presents the impact of alternative urinary clearance assumptions on model-predicted RAIU inhibition in its discussion document on the PBPK model (Table 4-2, U.S. EPA, 2009a), it do es not present this information in the Notice.]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 209 of 1099 Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28902

EPA Comment Code: 2400

Comment: IV. CONCLUSIONS

1. The use of scientifically derived PBPK models represents the best scientific approach for evaluating the relative sensitivity of different life stages and to compare to occurrence data. As constructed, however, the perchlorate PBPK mode l likely overestimates IUI from perchlorate exposures for various life stages. Only when the best available science is shared in a transparent process can the public be empowered to assist the Agency in achieving the best public health decisions. Nonetheless, the predicted levels of IUI in the Notice are very low and would be indistinguishable from fluctuations resulting from differences in diet and feeding styles. No adverse health concern at any life stage would be expect ed based on exposure to perchlorate at the POD dose (7 ug/kg-d).

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28909

EPA Comment Code: 2400

Comment: Specific issues on which USEPA requests comm ents in its August 18, 2009 notice are

discussed below:

Interpretation and Application of Physiologica lly-based Pharmacokinetic (PBPK) Modeling

In the October 10, 2008 notice, the PBPK model was used to evaluate the effects of the proposed HRL, 15 ug/L, on the perchlorate dose reaching th e thyroid and to estimate effects on the inhibition of thyroidal iodine uptake in sensitive subpopulations . It was assumed that the fetus of the pregnant woman was the most susceptible subpopulation, and our primary concern was that the exposure and health risks of bottle fed and breast fed infants and older children, as predicted by the PBPK model, were ignored.

Using 90th percentile water intakes, the PBPK model predicts that when water with 15 ug/L perchlorate is used to prepare formula, 7-day and 60-day old bottle-fed infants are exposed to more than 5 times the RfD, and that iodide uptake in 7- day old infants is decreased by 2.2% (Table 4-5). Exposures of 7-day and 60- day breast-fed infants and children 6-12 months and 1-2 years are also predicted to exceed the Reference Dose. Even if th e model was to use the median rather than theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 210 of 1099 90th percentile water intake, the RfD would be greatly exceeded for bottle-fed infants. We

recommend that USEPA consider the PBPK model's predictions of exposures and effects in these sensitive infants and children, as well as the exposure of the fetus through the pregnant mother, in evaluating the potential for perchlorate in drinki ng water to inhibit thyroidal iodine uptake.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination. See response to comment code 5220 for a discussion of

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28910

EPA Comment Code: 2400

Comment: However, there are several concerns that indicate the need for caution in using the PBPK model to determine a health-protective drinking water concentration for perchlorate. First, it is based on average weight babies and average wei ght healthy adults, including pregnant women. Furthermore, due to lack of availability of the needed data, only 40-week fetuses were considered and it was not possible to model effects on fetuses at earlier stages of development. Thus, the PBPK model may not adequately predict the effects of perchlorate on those who are particularly susceptible to its effects, such as low birth weight in fants, mothers or infants with iodine deficiency or hypothyroidism, and fetuses younger than 40 weeks.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28923

EPA Comment Code: 2400

Comment: Response to questions posed by USEPA:

1) PBPK Modeling (page 41886)

ACWA does not take issue with this type of pharmacokinetic modeling. However, in previous regulatory determinations and drinking water stan dards, pharmacokinetic models were only used in a secondary fashion, if at all, after the toxic end poi nt was identified by the relevant epidemiological data. We would like clarification on the justif ication for modifying existing procedures.

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28930EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 211 of 1099 EPA Comment Code: 2400

Comment: In this notice, the Agency specifically requests comments on certain approaches within their assessment, including the following:

1) Use of PBPK modeling analysis to inform the regulatory determination for perchlorate

2) Appropriateness of alternative health reference levels (HRLs) described in the notice to address and account for risk to all potentially sensitive life stages

3) Occurrence analysis including use of Bayesian model and U.S. Census data

Use of PBPK model: EWG supports the use of th e PBPK model to estimate the extent of iodine uptake inhibition in sensitive life stages only if significant limitations of the current model are

addressed.

In this notice, one of the approaches that the Ag ency considers is the following: "... use the PBPK modeling analysis to explore the relative sensitivi ty of the various life stages of concern to a fixed dose such as the point of departure (POD) or the reference dose (RfD)." In this case, the agency

notes that the "POD is the lowest dose adminis tered in the Greer et al clinical study...".

The Greer study included only 37 study participants who were divided into several study groups and administered different doses of perchlorate fo r 14 days (Greer et al 2002). The researchers determined that a daily perchlorate dose of 0.007 mg/kg/day was the no observed effect level (NOEL); the results from this study were used by the National Academy of Sciences (NAS) in setting the reference dose (RfD) fo r perchlorate of 0.7 ug/kg/day.

The Greer study results and assumptions drawn from them have been questioned in a peer-reviewed article that was published in Environmental Heal th Perspectives in 2005 (Ginsberg and Rice 2005). Two toxicologists, one from the Connecticut Department of Public Health and the other from the Maine Bureau of Health, conducted an analysis of the raw data from the Greer study and concluded the following: "Individual results of Greer et al. point to an effect in four of the seven individuals tested at the lowest dose (0.007 mg/kg/day), indicating that this dose is an effect level." In other
words, while Greer et al. and the NAS both conclu ded that 0.007 mg/kg/day is a no observed effect level (NOEL), closer analysis of the data reveals that four of the seven study subjects in this group experienced effects at this dose, thereby invalidating 0.007 mg/kg/day as a NOEL.

The Massachusetts Department of Environmental Protection (Mass DEP), which has set the most stringent drinking water standard for perchlora te nationally, had the following observations about the Greer study:

"MassDEP has concerns about the lowest dose in the Greer study being a no-effect level based on the facts that: due to the small number of subjects in the lowest dose group, there is low power to detect a statistically significant effect; averaging of group responses obscures positive individual inhibition; a non- statistically significant IUI (iod ine uptake inhibition) effect was observed at the lowest dose tested; and, good low dose corr oborating data is lacking" (MassDEP 2006).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 212 of 1099 In light of these valid criticisms of the Greer study, it is clear that any exposure modeling based on the results of this study, including the agency's current proposal to use PBPK modeling with a POD derived from this particular study, would not be accurate. The PBPK model also does not address iodine status, an important factor in determining vulnerability to perchlorate (Blount et al 2006b).

Response: See response to comment code 2100 for a discussion of the Reference Dose for perchlorate. See response to comment code 23 00 for a discussion of EPA’s use of the PBPK

models.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 29101

EPA Comment Code: 2400

Comment: EPA failed to provide any data to support its conclusion, and is contradicted by the results of PBPK modeling as reported by staff ex perts and in the Federal Register notice.[FN53: EPA Office of Research and Development. I nhibition of the sodium-iodide symporter by perchlorate: An evaluation of lifestage sensit ivity using physiologically-based pharmacokinetic (PBPK) modeling. Preliminary Draft. October 2, 2008. EPA/600/R-08/106A. Docket ID No. EPA-HQ-OW-2008-0692-0076.]

Response: See response to comment code 2300 for a discussion of PBPK modeling in this regulatory determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 213 of 1099 

### EPA Comment Code: 2410 Use of PBPK model to select life-stage-specific

HRLs

Individual Comments

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28558

EPA Comment Code: 2410

Comment: The Agency showed additional conservatism from the NRC recommendation in adjusting the preliminary guidance for perchlorate to 15 ppb in water in order to account for the relative source contributions of drinking water and dietary sources in order to protect pregnant
women and their fetuses. This level, as demons trated by the physiologically-based pharmokinetic (PBPK) modeling, is likewise protective of other potentially sensitive lifestages. The PBPK modeling for infants and young children do not exceed the 10x (i.e. ten fold) intraspecies factor set from the adult values thereby showing that the 10x intr aspecies factor is protective and provides no justification for increasing an uncertainty factor for perchlorate beyond the default (i.e. ten fold or 10x). For this reason, EPA has no basis for ad justing the reference dose (RfD) of 0.0007 mg/kg/day, or the methodology for setting the HAL based on a 70 kg adult consuming two (2)
liters of water. This traditional method, used previously by EPA with SDWA contaminants is sufficiently conservative as the level of water cons umed (two liters) is the 99th percentile estimate, and, this RfD is based on a no-effect level (NOEL) from the Greer et. al. 2002 study rather than a no adverse effect level (NOAEL).

Response: EPA does not agree that allowance for contri butions of perchlorate from sources other than drinking water introduces additional conservatism. Rather, allowance for other sources of perchlorate permits EPA to establis h a concentration of perchlorate in drinking water that maintains a tolerable risk level without adjusting the existing background.

The modeled estimates of exposure to various life stages, presented as alternative HRLs in the August 2009 supplemental request for comments, in dicate values as much as seven times that for pregnant females. However, the life stage variabili ty in the model estimates reflects pharmacokinetics only. Pharmacodynamic variability is not reflected nor can it be estimated using the modified Clewell (2007) model. Data permitting estimation of pha rmodynamic variability among life stages is not available. Therefore, it is not possible to deter mine whether the alternati ve HRLs are within the variability reflected in the RfD. EPA will continue to evaluate the significance of varying exposure estimates as the Agency develops a NPDWR for perchlorate.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28750

EPA Comment Code: 2410EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 214 of 1099 Comment: b. EPA requests comment on the utility of th e PBPK model for predicting the impact of different perchlorate drinking water concentrations on sensitive life stages to inform HRL

selection.

Comment A.4.b.1: Additional refine ment and supporting rationale for the current configuration of the PBPK model is needed based on actual human study observations to enable EPA to use this model for the stated purpose. This refinement should include an evaluation of the potential for sustained FT3 and/or FT4 reductions in humans incl uding pregnant women, fetuses, and neonates. Human data (likely including reproductive age females and adolescents) on the pharmacokinetic use of perchlorate for lowering thyroxine levels in hype rthyroid patients are available in both published reports and likely also in clinical trials and unpub lished data from various research groups. A critical step to support use of the PBPK model should include development of a quantitative term that defines the relationship between steady state blood perchlorate and the decrement in free and total thyroid hormones in reproductive age females. Much of the data needed for this refinement and supporting rationale are not currently available. Consequently, the EPA should send out queries searching for available unpublished human datasets relevant to the modeling evaluation, and encourage the development of appr opriate studies to acquire these data and permit support for and

use of the PBPK model.

One example of technical difficulties in the mode l is the consideration of iodine deficiency and associated NIS upregulation in the pregnant mother , fetus, and neonate. Additional clinical data are needed for adults (including pregnant women, an d in neonates) concerning thyroidal iodine capacity and the impact of NIS upregulation on thyroidal iodine uptake and/or thyroxine levels. Also,

additional studies of other adults are needed to evaluate the effects of temporary iodine deficiency and NIS upregulation on perchlorate competitive inhibition of thyroidal iodine uptake and/or free thyroid hormone levels. This additional research wo uld provide useful data to consider in further refining the PBPK model to accurately reflect the e ffects of iodine deficiency in pregnant women,

fetuses and neonates.

Response: See response to comment ID 28800 under comment code 2410. EPA agrees that the PBPK model used in prep aration of the 2008 Preliminary Regulatory Determination requires further refinement before it can be used to develop an HRL. EPA also agrees that the data required to permit the necessa ry modifications does not exist at this time. As
additional data become available, EPA will be able to determine whether further effort to develop a PBPK model for different life stages exposed to perchlorate is warranted. The attributes and components of that model cannot be determined at this time.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28800

EPA Comment Code: 2410

Comment: b. Utility of the PBPK model for predicting the impact of different perchlorate drinking water concentrations on sensitive life stages to inform the HRL

NRDC Response: The PBPK model can predict the impacts of perchlorate water contamination on different life stages; it predicts that sensitiv e populations are not protected by the proposed HRLEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 215 of 1099 As detailed in our response above, the EPA st aff report issued on October 2, 2008, describes findings from the PBPK model that consuming water that was contaminated at the HRL of 15 ug/L would lead to bottle-fed infants exceeding the reference dose by 5- fold and young children exceeding the reference dose by 2.8-fold, based on average food contamination rates, average body weights, and 90th percentile water consumption rates for each age grou p.[FN33: EPA Office of Research and Development. Inhibition of the sodium-iodide symporter by perchlorate: An evaluation of lifestage sensitivity using physiol ogically-based pharmacokinetic (PBPK) modeling. Preliminary Draft. October 2, 2008. Table 4. EPA/600/R-08/106A. Docket ID No. EPA-HQ-OW2008- 0692-0076.]

These findings from the PBPK model analysis are supported by other published studies. A related study estimated perchlorate doses that correspond to urinary perchlorate excretion (hereinafter referred to as "Blount (2007)").[FN34: Blount BC , Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. Perchlorate exposure of the US Popu lation, 2001-2002. J Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7. Epub 2006 Oct 18.] Calcul ating doses based on urinary excretion is feasible because perchlorate is not metabolized and has a short half- life of approximately 8 hours.[FN35: Ibid.] Blount (2007) showed that the adjusted geometric mean for perchlorate exposure in women was 0.059 ug/kg-day, and the 95th percentile ex posure was 0.215 ug/kg-day. This means that the adverse effects of decreased serum T4 and increased TSH in women with low dietary iodide (that is, urinary iodide below 100 ug/L) described by Blount (2006) are occurring at perchlorate exposures below the RfD of 0.7 ug/kg- day.[FN36: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid hor mone levels in adolescent and adult men and women living in the United States. Environ Heal th Perspect. 2006 Dec;114(12):1865-71.] As such, the proposed HRL of 15 ppb will not protect sensitive subpopulations.

An extensive literature review and health assessm ent by Ginsburg et al.[FN37: GL Ginsburg, DB
Hattis, RT Zoeller, and DC Rice. 2007. Ev aluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater : Focus on exposure to nursing infants. Environ Health Perspect. 115(3):361-369. http://www. ehponline.org/members/2006/9533/9533.html] published since the NRC review found that "drinking- water perchlorate must be < 6.9 ug/L to keep the median, and < 1.3 ug/L to keep the 90th-percentile nursing infant exposure below the RfD."[FN38: GL Ginsburg, DB Hattis, RT Zoelle r, and DC Rice. 2007. Evaluation of the U.S. EPA/OSWER preliminary remediation goal for pe rchlorate in groundwater: Focus on exposure to nursing infants. Environ Health Perspect. 115( 3):361-369.] Based on both exposure and toxicity information, and data on sensitive populations, th e proposed HRL of 15 ppb, which is more than twice as high as the limit proposed by Ginsberg et al, will leave significant portions of the population

at risk.

Response: EPA agrees that reassessing exposure assumptions and other life stages warrants further

consideration. EPA also considered applying the model directly to the exposures of other sensitive life stages to develop HRLs for these life stages. The NRC (2005) identified “the fetuses of pregnant women who might have hypothyroidism or iodide deficiency” as “the most sensitive population,” but also identified infants and developing children as additional “sensitive populations.” EPA derived potential alternative HRLs for 14 different life st ages as presented in the supplemental request for comments (EPA 2009). Alternative HRLs are es timates of the maximum concentration of perchlorate that can be consumed in drinking water without an individual’s total perchlorate doseEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 216 of 1099 from food and water exceeding the RfD. EPA ag rees that exposures reported in the literature suggest some life stages may be exposed to quantities of perchlorate above the RfD. National Research Council (NRC). 2005. Health Im plications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 217 of 1099 

### EPA Comment Code: 2420 Suggestions for alternative ways to use the PBPK model to inform the regulatory determination

Individual Comments

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28751

EPA Comment Code: 2420

Comment: c. EPA requests suggestions for ways to use the PBPK modeling analysis to inform the regulatory determination for perchlorate that are diff erent from those described in this notice or the
October 10, 2008 notice.

Comment A.4.c.1: Prior to use of the PBPK model as a part of the regulatory determination, the range and primary sources of uncertainty in the mo del output should be evaluated and described. Once properly validated and supported, the mode l may be used to evaluate a number of physiological and pharmacokinetic impacts of pe rchlorate competitive inhibition, including alternative approaches of basing the reference do se on clinically important changes in thyroidal iodine uptake and/or thyroxine levels.

Response: The modified Clewell (2007) model was subj ected to peer review by the Office of Research and Development, EPA. However, EP A agrees that additional modification and

refinement of the model is needed before it can be used to develop an HRL to determine the need

to establish an NPDWR. The extent and nature of modifications and refinements needed are not

clear at this time.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28801

EPA Comment Code: 2420

Comment: c. Using the PBPK modeling analysis to inform the regulatory determination for perchlorate that is different from those described in the October, 2008 FR notice

NRDC response: The PBPK model may be used to derive a science-based adjustment factor; the model support an adjustment factor of at least 15 -fold to inform the regulatory determination for perchlorate.

EPA normally uses a 10-fold default uncertainty factor to adjust for variations among individuals, called the intraspecies factor, when the Agency la cks adequate data to calculate variability between

individuals. EPA used this 10- fo ld intraspecies factor for its perchlorate hazard assessment on its IRIS database: "An intraspecies uncertainty factor of 10 is applied to protect the most sensitive population, the fetuses of pregnant women w ho might have hypothyroidism or iodideEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 218 of 1099 deficiency."[FN39: EPA. IRIS database. Perchlorate and perchlorate salts. http://www.epa.gov/ncea/iris/subst/1007.htm#re vhis] The Agency has adopted the practice of describing the default 10-fold intraspecies factor as being comprised of the product of two 3-fold factors, one for harmacokinetic variability, and the other for pharmacodynamic variability.[FN40: US EPA. Office of the Science Advisor: Staff Paper, Risk Assessment Principles & Practices. Page 69, Section 4.3.2. EPA/100-B-04/001. March, 2004. http://www.epa.gov/osa/pdfs/ratf-final.pdf] Pharmacokinetics describes the way that a compou nd such as perchlorate moves through the body, including its absorption, distribution, metabolis m and excretion. In contrast, pharmacodynamics describes what the compound does in the body, including depressing, stimulating, irritating, or killing cells or systems.

According to the IRIS glossary of terms, a physi ologically based pharmacokinetic (PBPK) model estimates the dose of a compound to a target organ or tissue by calculating the rate of absorption in the body, the distribution among target organs, th e metabolism of the compound, and the excretion of the compound.[FN41: IRIS Glossary. Physiolo gically Based Pharmacokinetic (PBPK) Model. http://www.epa.gov/ncea/iris/help_gloss.htm#p] In other words, the PBPK model, by definition and design, estimates the pharmacokinetics of a compound.

The data from EPA's staff report shows that EP A's reliance on a default uncertainty factor of 10 underestimates the variability between fetuses an d adults. The Executive Summary of the staff report states that "at a perchlorate dose of 7 ug /kg-day, the percent RAIU inhibition predicted by the model for the near-term fetus is 5-fold grea ter than the average adult....The same analysis predicts percent RAIU inhibition approximately 1- 2 fold higher for the breast- fed and bottle-fed infant (7-60 days) than for the average adult."[FN 42: See EPA Staff Paper, Executive Summary, p. 4 and Table 3; see also 73 Fed. Reg. 60278.] More specifically, for perchlorate, the variability between a near-term fetus (40 weeks gestation) and an adul t is 5.3-fold. Therefore, the PBPK model supports a pharmacokinetic adjustment factor of at least 5-fold.

The Agency has no information from the PBPK mo del, or from other data, to develop an intraspecies uncertainty factor for pharmacodynamic variability, particularly between adults and sensitive lifestages. Therefore, EPA should retain a factor of at least 3-fold or more to adjust for pharmacodynamic uncertainty, consistent with its current practice.

To be consistent with EPA policy and practice, EPA should use a total intraspecies uncertainty
factor of 15-fold, rather than 10 fold. Based on the data from the PBPK model to support a pharmacokinetic intraspecies variability factor of 5, and the lack of pharmacodynamic data to support a default factor of 3, the use of a 15-fol d uncertainty factor is supported by the available

data.

Response: EPA agrees that the modeled estimates of alternative HRLs reflect only pharmacokinetics and do not consider uncertainty due to pharmacodynamics. EPA’s RfDs typically factor in both, with a standard apportionment of 3. 16 for each. EPA does not believe that it is possible to determine whether a 10-fold uncertainty factor is sufficient to reflect both pharmacokinetics and pharmacodynamics. Howev er, EPA acknowledges that 10X may be insufficient. Data do not currently exist to prov ide an estimate of the pharmacodynamic component of the intraspecies uncertainty factor.

Commenter Name:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 219 of 1099 Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28884

EPA Comment Code: 2420

Comment: 3. EPA requests suggestions for ways to use the PBPK modeling analysis to inform the regulatory determination for perchlorate that are diff erent from those described in this notice or the
October 10, 2008 notice.

The PBPK model can provide useful information to ch aracterize the relative sensitivity of this life stage if model parameters are scientifically defens ible and selected from comparable points within their parameter distributions, and if nonscientific considerations do not introduce unexplained bias into the selection of parameter values. To be mo st useful, EPA should use probabilistic methods to characterize the uncertainty and variability around parameter di stributions and the range and likelihood associated with model-predicted RAIU i nhibition for each population or life stage. Use of probabilistic methods is consistent with the Agency's current recommendations for use of probabilistic methods in risk assessment to help inform risk management decisions.[FN12: http://www.epa.gov/fedrgstr/EPA-RESEA RCH/2009/August/Day-18/r19755.htm; http://vvww.epa.gov/raf/prawhitepaper/pdf/pra_mgr_summary_0609.pdf.]

Additional considerations would provide perspective on the significance of the IUI associated with low dose perchlorate exposure. For example, EPA should present the change in RAIU inhibition

when the RfD is modeled rather than the Greer et al. (2002) POD, which is ten fold higher.

Response: EPA believes that the modified Clewell (2007) model is useful in examining which life stages are most susceptible to the effects of perc hlorate. For example, the model indicates that a fetus may be seven times more sensitive to the e ffects of perchlorate than a pregnant woman. Themodel also allows for the estimation of the concentration of perchlorate in breast milk (thus breastfed infant exposure) at various maternal perchlorate ex posure levels. Data do not exist at this time to permit a more expansive development of the model for various life stages.

EPA believes that the RfD derived by the NRC usi ng the Greer et al. (2002) remains the appropriate estimate of health effects due to perc hlorate for use in assessment of risk.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28885

EPA Comment Code: 2420

Comment: Also, multiple chemical agents affect the upta ke of iodide into the thyroid in the same way as perchlorate. These goitrogens, which includ e thiocyanate and nitrate, can be found naturally in common foods, including produce, milk, and cured meats. Incorporation of thiocyanate and nitrate exposure into the PBPK model should prov ide useful information on the relative IUI caused by exposure to these agents and to perchlorate. Thus, daily diets for children and adults including these foods are predicted to have a greater effect on IUI than would result from drinking two liters of water containing perchlorate at environmenta lly relevant levels (e g., estimated perchlorate drinking water equivalent concentrations associated with the thiocyanate and nitrate present in theseEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 220 of 1099 diets are estimated to be at least 1,500 to 29,0 00 ppb). Based on these data, the contribution of perchlorate in drinking water at a concentration of 20 ppb (assuming consumption of 2 liters per day) to total daily IUI associated with a typic al diet would be a fraction of these values.

Response: EPA does not disagree that a total iodine inhibitor load, including naturally-occurring NIS inhibitors, should be considered. However, adequate data do not exist at this time to characterize adequately the relative affinity of various iodide uptake inhibitors for the NIS receptor.
In addition, no data exist to characterize their re lative potency in impacting thyroid hormone levels. Given this lack of data, EPA believes that it is prudent to consider the potential adverse health effects for perchlorate independently until data ar e developed to permit consideration of multiple goitrogens jointly.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 221 of 1099 

### EPA Comment Code: 2500 Other health effects studies, models, and data for EPA to consider (besides NAS/NRC report, NHANES biomonitoring data, and PBPK models already evaluated)

Individual Comments

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0648

EPA Comment ID: 19991

EPA Comment Code: 2500

Comment: According to the office of environmental health hazard assessment, see link: http://www.oehha.ca.gov/public_info/facts/faqpe rchlorate.html, perchlorate has not been scientfically proven to cause cancer in humans at the doses likely to be in drinking water. The University of California conducted 3 separate studies on the topic.

Response: EPA respectfully disagrees with this comme nt. In 2003, the National Research Council (NRC) of the National Academy of Sciences (NAS) was asked by EPA to assess the current state of the sciences regarding potential adverse effects of perchlorate exposure and to determine whether EPA’s prior perchlorate risk assessment findings were consistent with current scientific evidence. In a NRC 2005 review (“Health Implications of Pe rchlorate Ingestion”, (NRC, 2005)), the NRC recommended that data from the Greer et al. (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD) (NRC , 2005). From this Greer et al. (2002) human clinical study, the statistical no observed effect le vel (NOEL) for the perchlorate-induced inhibition of thyroid iodide uptake was determined to be 7. 0 ug/kg, which corresponded to an iodide uptake

inhibition of 1.8 %. The NRC concluded that the most health protective and scientifically valid approach to deriving a reference dose for perc hlorate was to base the perchlorate RfD on the inhibition of iodide uptake by the thyroid, and that iodide uptake inhibition, though not an adverse effect per se, is the most appropriate precursor ev ent, and would precede any more severe adverse health effects of perchlorate exposure in hu mans. The NRC recommended basing the RfD on a precursor to an adverse effect rather than an ad verse effect, per se. The precursor event precedes a downstream adverse effect in the dose response continuum. In this case, NRC used prevention of iodide uptake inhibition, a precursor to adverse thyroid effects, to establish a level at which no adverse effects would be anticipated in exposed populations. This approach is consistent with the Agency’s policy on the use of precursor events when appropriate in establishing the critical effect upon which an RfD is based (U.S. EPA, 2002 ). The NRC recommended that EPA apply an uncertainty factor of 10 to this NOEL of 7.0 ug/kg for the perchlorate-induced inhibition of thyroid iodide uptake, to account for differences in sensitivity between healthy adults and the most sensitive sub-population, consisting of fet uses of pregnant women who might have hypothyroidism or iodide deficiency. Iodide uptake inhibition has been identi fied in the literature as an area of concern in connection with increasing the risk of neurodev elopmental impairment in fetuses of high-risk

mothers. The NRC viewed the recommended uncertai nty factor of 10 as conservative and protective of health, given that the NOEL is based on a non -adverse effect (iodide uptake inhibition) which precedes the adverse effect in a continuum of possi ble adverse biological effects of perchlorate exposure. NRC recommended that using a non-adverse effect that is upstream of the adverse effectEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 222 of 1099 represents a more conservative, health-protective a pproach to the risk assessment for perchlorate, noting that the purpose of the 10-fold uncertainty factor is to protect sensitive subpopulations in the face of uncertainty regarding their relative sensitivity to perchlorate exposure. EPA has adopted the NRC’s recommendations in its “Integrated Risk Information System” (IRIS) (USEPA 2005), resulting in an RfD of 0.7 ug/k g/day, which was derived by appl ying a 10-fold (10x) uncertainty factor to the NOEL of 7.0 ug/kg/day. Greer MA, Goodman G, Pleus RC, Greer SE. Environ Health Perspect. 2002 Sep;110(9):927-37. Er ratum in: Environ Health Perspect. 2005 Nov;113(11):A732. National Research Council (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on En vironmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. USEPA. 2002. A review of the reference dose and reference concentration processes. Risk Assessment Forum, Washington, DC; EPA/630/P–02/0002F. USEPA. 2005. ‘‘Integrated Risk Information Syst em (IRIS), Perchlorate and Perchlorate Salts.’’ February 2005.

Commenter Name: Tatjana and Jeremy Thomas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0669

EPA Comment ID: 20242

EPA Comment Code: 2500

Comment: >From New York Times 3/2/04 ...".The stud y found crude effects on rats' brains from exposure to perchlorate. Parts of the brains were en larged. ....In the same study, benign tumors were spotted on two 19-week-old baby rats out of a gr oup of 30 whose mothers had been exposed to high levels of perchlorate. Scientists from the environmental agency say it is unusual to see tumors in baby rats that young, leading them to believe th at something must have occurred in the womb."

Concerned Citizen and a pregnant mother of two.

Attachments

EPA-HQ-OW-2008-0692-0669 .1 Comment attachment submitted by T. Thomas

EPA-HQ-OW-2008-0692-0669 .2 Comment attachment submitted by T. Thomas

Jeremy and Tatjana Thomas 40268 205th Av enue Pittsfield, IL 62363 (217) 285-5951

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 223 of 1099 health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Crystal D. Lay Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1557

EPA Comment ID: 20523

EPA Comment Code: 2500

Comment: 1. Perchlorate interferes with the functioni ng of the thyroid gland which can disrupt metabolism regulation in adults. However, the effects on children can be much worse causing irreversible developmental problems. This is partic ularly concerning when the U.S. Food and Drug Administration’s Total Diet Study:

Dietary Intake of Perchlorate and Iodine study re vealed that children two years of age have the highest total perchlorate intake per day and infant s have the second highest perchlorate intake per day. 2. The RFD of .07 Âμg/kg translates to a drinking water equivalent of 24.5 ppb, based on 2 liters consumed by an adult daily. However, this assumes that the only source of perchlorate is drinking water. The 2004-2005 Exploratory Surv ey Data on Perchlorate in Food Samples listed several foods that were found to have perchlorate. One milk sample revealed levels of over 10 ppb Âμg/L. Samples of green beans revealed levels as high as 25.9 ppb. Samples of oranges revealed levels as high as 23.3 ppb. This is alarming as these foods are all essential to growing children who may be more prone to higher levels of perchlora te already. The translated RFD of 0.7 Âμg/kg to

24.5 ppb is calculated for adults. This level may be even lower for children and does not include any

perchlorate intake from food they may consume. Another serious consideration is the seemingly high levels of perchlorate that could be consumed by infants if fed formula mixed with drinking water. For the reasons stated above, I urge EP A to reconsider setting a national maximum contaminant level for perchlorate in drinking water. The states that have already imposed a maximum contaminant level for perchlorate have set the standard much lower than 24.5 ppb, suggesting that those states have concluded that a safe level of perchlorate intake is less than 24.5 ppb.

Respectfully submitted,

Crystal D. Lay

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 224 of 1099 health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Jimmy Spearow Commenter Organization: Sacramento Chapter, Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-1672

EPA Comment ID: 20589

EPA Comment Code: 2500

Comment: Dear EPA This is a Public Comment Regard ing EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692).

Perchlorate is a chemical in rocket fuel that ha s been associated with decreased thyroid hormone levels in pregnant women, newborns and young ch ildren. Thyroid hormone is critical for growth and development, especially in the brains of fetuses and children. Perchlorate inhibits iodine uptake and the synthesis of thyroid hormone by the th yroid gland. The CDC showed that exposure to perchlorate levels as low as 5 ppb was associated with decreased thyroid hormone levels, especially in women with lower iodine levels. In other words, exposures at levels significantly lower than the level EPA assumes is "safe" i.e., the EPA RfD of 24.5 ppb, were linked to a lowering of thyroid hormone levels that can cause significant advers e health effects in exposed women and fetuses.

Since over 16 million Americans are at risk of ex posure to elevated levels of perchlorate, extrapolation of this study to the entire US popu lation indicates that approximately 2 million women of childbearing age are at risk from abnormally low thyroid hormone levels.

Adequate levels of thyroid hormone are also critical to normal growth and cognitive development in infants. Infants are likely to be particularly vulner able to perchlorate since they have rapid turnover of thyroid hormone, as well as, low reserves of thyroid hormone.

Response: EPA acknowledges and thanks you for pr oviding comments. EPA will continue to

evaluate the available science rela ted to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Register notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate fr equency of occurrence in drinking water, and the opportunity for health risk reduction through a nati onal primary drinking water standard, to help determine if it should be regulated. EPA consid ers both the extent of national occurrence and the severity of health effects for a contaminant, as wel l as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency considered national occurrence and the severity of health effects from perchlorate and concluded that regulation was warranted, so EPA ha s determined that perchlorate will be regulated.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20626

EPA Comment Code: 2500

Comment: NOVEMBER 10 2008EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 225 of 1099 US Environmental Protection Agency Office of Water Docket (Mailcode: 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: Comments on Regulatory Determination on Perchlorate Docket EPA-HQ- OW-2008-0692

Drs. Carol Bigelow, Larry Schwartz, and R. Thomas Zoeller are pleased to submit comments to the

US EPA on Docket ID No. EPA- HQ-OW-2008-0692, entitled "D rinking Water: Preliminary Regulatory Determination on Perchlorate". In brie f, the authors of docket ID No. EPA-HQ-OW2008-0692 propose that there be no national primary drinking water regulation, the rationale being that such would not present a "meaningful opportunity for health risk reduction for persons served by public water systems". EPA’s proposal not to regulate perchlorate in public water systems:

(1) Lacks the requisite scientific basis. Specifica lly, EPA regularly cites the nearly 4 year-old NAS report (NRC, 2005) without a critical evaluation of the science underlying the document and how new information should be integrated into it. This issue is most germane in the emphasis on the pregnant woman and fetus as the most sensitive population to perchlorate exposure. EPA fails to consider published, peer-reviewed data demonstrat ing that the current RfD for perchlorate exposure is not protective of neonates and infants (Ginsberg and Rice, 2005; Ginsberg et al., 2007).

(2) Lacks critical evaluation of the literature employ ed to justify its decision. Methodologically sound research indicates an association between perchl orate exposure and thyroid function in adult women with low iodine intake (Blount et al., 2006a; Steinm aus et al., 2007). If infants are no more sensitive to perchlorate than adult women, brain damage will occur at the median level of perchlorate exposure, according to published data (reviewed by (Ginsberg et al., 2007) ). Thus, the CDC study should reasonably replace the 6 year-old "Greer Study" (Greer et al., 2002) as the point of departure for RfD development.

(3) Fails to critically evaluate the reliability of nu ll findings. EPA justifies ignoring the Blount Study using a series of studies that identify no re lationship between perchlorate exposure and thyroid function in humans. However, EPA is apparently unaware of published data describing the variability of serum thyroid hormone measures in adults (Andersen et al., 2002; Andersen et al., 2003) and in neonates (Herbstman et al., 2008a; Herbstman et al., 2008b). It is our opinion that critical analysis of the null findings employed by EPA to justify ignoring the findings in the Blount Study will demonstrate that these null findings cannot be interpreted to indicate no relationship between perchlorate exposure and thyroid function.

(4) Relies on a PBPK model parameterized with weak data. It is discouraging that EPA went to the effort of obtaining the code for the Clewell et al. PBPK model and modified it without critically evaluating the data employed to parameterize the model.

Considering these 4 points, it is our opinion th at a scientifically valid RfD and HRL will be significantly lower than that the current proposal. Mo reover, the data are available to scientifically

defend a return to EPA’s draft RfD of 2002.

Response: EPA acknowledges and thanks you for pr oviding comments. EPA will continue to

evaluate the available science rela ted to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not toEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 226 of 1099 regulate perchlorate in drinking water (Federal Regi ster Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Register notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate fr equency of occurrence in drinking water, and the opportunity for health risk reduction through a nati onal primary drinking water standard, to help determine if it should be regulated. EPA consid ers both the extent of national occurrence and the severity of health effects for a contaminant, as wel l as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency considered national occurrence and the severity of health effects from perchlorate and concluded that regulation was warranted, so EPA ha s determined that perchlorate will be regulated.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20628

EPA Comment Code: 2500

Comment: Thyroid hormone insufficiency in the neonate an d infant leads to irreversible health consequences. Defects in thyroid hormone regula tion negatively impact brain development and may contribute to a cluster of irreversible neurological defects that includes autism. This literature - completely ignored by EPA’s analysis - is compelling public health rationale for regulating perchlorate exposure.

Perhaps the best examples of infants’ unique se nsitivity to thyroid hormone insufficiency are the studies of infants with congenital hypothyroidism (CH) (for review, see (Zoeller and Rovet, 2004)). These studies are particularly useful because sub jects are under continuous medical surveillance so there is good documentation of the relationshi p between endogenous thyroid hormone, levels of hormone supplementation, and developmental outcome (Heyerdahl and Oerbeck, 2003). The neuropsychological outcome of children diagnosed wi th CH at birth is associated with both the severity of CH and early treatment factors (how so on T4 was administered, starting dose and serum T4 levels during the first two years of life). Thes e T4 parameters were highly correlated with verbal IQ at age 20, and children with CH who ultimately completed high school had a significantly higher T4 starting dose than those who did not (Oerbeck et al., 2003). Strikingly, the difference in mean starting dose between these two groups was a mode st 2.1 ug/kg-day. Because iodine represents 65% (w/w) of T4, the amount of iodine associated wi th that T4 difference was only 1.37 ug/kg-day. Independent studies were consistent in their findings. In Selva et al. (2002) and Selva et al (2005), a difference in starting dose of only 12.5 μg/day (8. 13 ug/day iodine equivalent or 2.3 ug/kg/d) was associated with a significant difference in full scale IQ of 11 points (Selva et al., 2002; Selva et al., 2005). Thus, small differences in available thyroid hor mone (and the iodine associated with it) during the first few weeks of life can have significant lifeti me consequences including, especially, reduced IQ.

In addition, the experimental literature clearly de monstrates that specific neurodevelopmental events are irreversibly damaged by marginally-low th yroid hormone. These include neuronal migration (Lavado-Autric et al., 2003; Auso et al., 2004), syna ptic function (Gilbert and Sui, 2006, 2008), white matter development (Sharlin et al., 2008), and the development of nodular heterotopias (Goodman and Gilbert, 2007). Each of these developmental events will have cognitive and neurological sequelae in humans.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 227 of 1099 In its unsupported reliance on the NAS report of 2005 (NRC, 2005), EPA did not focus their analysis on the relevant vulnerable groups, the neonate and infant. In this regard, EPA failed to employ one of the largest, and critically relevant , data sets relating thyroid hormone to health consequences - that of neonates and infants (see (Chan and Rovet, 2003; Zoeller and Rovet, 2004)). The superficial reference EPA makes to the infant is wholly inadequate in the current version of this

document and should take into consideration th e issues developed above and expanded previously (Ginsberg et al., 2007). In addition, EPA should re view the issue of genetic factors that may impact individual sensitivity to perchlorate exposure (Scini cariello et al., 2005). Due consideration to this published literature will dramatically change the EPA’s analysis.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20631

EPA Comment Code: 2500

Comment: Also lacking in the science presented in docket ID No. EPA- HQ-OW-2008-0692 are the power considerations necessary to inference maki ng that is precise. Indeed, several of the studies relied upon by the US EPA lacked the statistical po wer needed to rule out a non-null association.

EPA has failed to address key questions regarding the studies it uses to defend ignoring the CDC study. Specifically, given the known variability in measures of thyroid function (Andersen et al., 2002; Andersen et al., 2003) and maternal, infant and delivery factors on neonatal and thyroid status (Herbstman et al., 2008a; Herbstman et al., 2008 b), to what extent do epidemiological studies exploring the relationship between perchlorate an d thyroid function provide reliable evidence of a null relationship? Andersen et al. (Andersen et al ., 2003) discuss the sources of variability in measures of thyroid hormone in adults. These are crit ical considerations to employ in estimating the ability of epidemiological studies to identify relati onships of interest betwee n perchlorate and thyroid function. Moreover, Andersen et al. (2002) found that to identify the homeostatic set-point within 5% precision required 85 individual measures of TSH and 25 of total T4. Given this degree of variation, studies comparing average measures of thyroid function and proxy measures perchlorate exposure have little - if any - ability to identify re lationships of interest. Therefore, EPA is required to determine which of the epidemiological studies it used in its analysis had the potential to identifyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 228 of 1099 a relationship between perchlorate exposure and thyroid function, and the degree to which null findings are meaningful.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Brie Brigham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1436

EPA Comment ID: 20894

EPA Comment Code: 2500

Comment: Perchlorate interferes with iodine uptake in the thyroid gland, leading to low thyroid production, termed hypothyroidism. Perchlorate also impedes the thyroid's ability to produce hormones that foster mental and physical developmen t. Robert Zoeller, a professer at the University of Massachusetts who specalizes in thyroid hormone and brain development stated a reduction in thyroid function in fetuses, newborns, and children co uld translate to a loss of IQ and an increase in behavior and perception problems. Zoeller also stated that the impacts are irreversible, meaning that even small changes in thyroid functions in early life have impacts on functioning through high school and even into people's early twenties.

Response: EPA acknowledges and thanks you for providing additional information related to perchlorate. EPA will continue to evaluate the avai lable science related to perchlorate. On August 19, 2009, EPA published a Federal Register noti ce requesting supplemental public comments on its preliminary determination not to regulate perchlora te in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Fe deral Register notice, EPA requested comments on additional interpretation of data on the level of hu man health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of heal th effects for a contaminant, as well as other factors (e.g., sources of exposure), when deci ding whether regulation presents a meaningful opportunity for health risk reducti on. Therefore, the Agency consid ered national occurrence and the severity of health effects from perchlorate and co ncluded that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense FundEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 229 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20944

EPA Comment Code: 2500

Comment: New data indicate that increases in TSH, resulting from decreased circulating thyroid hormones, may also increase perchlorate uptake in the thyroid (Tran et al. 2008).

There are critical windows in fetal, neonatal, and infant development where insufficient thyroid hormones are associated with disruptions in neur al development leading to cognitive deficits (Woodruff et al. 2008). The NIS is expressed in the placenta, and a recent study has shown that the NIS can transport perchlorate across the placental barrier and lead to increased exposure to the developing fetus (Tran et al. 2008). It is theref ore not unreasonable to suggest that perchlorate transport could be exacerbated by low maternal th yroid hormones that stimulate TSH release, which enhances perchlorate transport into the maternal th yroid, and across the placental barrier (Tran et al. 2008). Several studies have shown that even moderate maternal thyroid hormone insufficiency during these critical developmental windows can have a significant and lasting impact on the child, such as reduced IQ scores (Haddow et al. 1999 ; Morreale de Escobar et al. 2000; Pop et al. 2003). Comprehensive studies of the impact of perchlorate exposure on children of mothers that have low iodine intake are lacking, and increase d research in this area is needed.

This problem is complicated by extensive individu al variability such that the current ranges used to assess thyroid health may not effectively identify adverse downstream effects (Anderson et al. 2002). Therefore, the focus on modulation of thyroid hor mones rather than clinical endpoints may be warranted because important concerns have been ra ised regarding the current method used to assess thyroid health, specifically comparison of thyroi d hormone levels with pre-defined acceptable ranges. In their study Anderson et al conclude: "we found that individual reference ranges for serum

T3 and T4 are about half the wi dth of population based reference ra nges. Hence, a test result within the laboratory reference limits is not necessarily normal for the individual." This is consistent with, and may help explain the observation discussed above, that even small decrements in maternal T4 that do not constitute clinical hypothyroidism can impact neurological development in children. In fact, there is evidence that hypothyroidism is prevalent in the US, yet often undetected, and untreated (Aoki et al. 2007)

An additional complicating factor is that Centers for Disease Control and Prevention (CDC) data indicate that over thirty percent of US women ar e not obtaining sufficient iodine (Caldwell et al. 2005). Insufficient iodine intake can predispose the thyroid gland to adve rse effects of endocrine disrupters especially under phases of vulnerability during development and under adaptive challenges during diseases (Kohrle 2008). Thus, in sufficient iodine intake could increase vulnerability to perchlorate. Insufficient iodine intake, assesse d by comparing urinary iodine excretion to World Health Organization standards for iodine sufficiency, can increase sensitivity to uptake inhibition by perchlorate.

These major factors described above and summarize d below present a clear case that perchlorate exposure poses a significant health risk in the US:

* The principle mode of action of perchlorate is i nhibition of iodide uptake by the thyroid, * More than thirty percent of US women are not getting su fficient iodine, * Hypothyroidism is prevalent inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 230 of 1099 the US population, yet often undetected and untreated , * Neurological damage can occur in babies born to with subclinical hypothyroidism.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20990

EPA Comment Code: 2500

Comment: 2. EPA is ignoring data that demonstrates setting an MCL for perchlorate will provide a meaningful opportunity for health risk reduction

A. Data since the NRC report suggest that perchl orate is even more hazardous than previously thought.

Even based on older studies, EPA acknowledged in its preliminary determination that perchlorate may have adverse health effects. More recent studie s show that the effects on humans may be even more dangerous than EPA thought.

Data showing that perchlorate is actively transported into mammary epithelial cells by the sodium iodide symporter (NIS), resulting in an accumulati on of perchlorate in breast milk[FN23: Dohan, O, C Portulano, C. Basquin, A Reyna- Noyra, LM Amzel, and N Carrasco. 2007. The Na+/Isymporter (NIS) mediates electroneutral active trans port of the environmental pollutant perchlorate. PNAS 104(51):20250-20255.][FN24: Dasgupta, P. K., Kirk, A. B., Dyke, J. V., and Ohira, S.-I. (2008). Intake of Iodine and Perchlorate and Excr etion in Human Milk. Environ. Sci. Technol. 42, 8115-8121. Docket HQ-OW-2008-0692 NRDC comme nts on perchlorate HRL] suggests that perchlorate may not only inhibit iodide accumulation in maternal milk but also could be transferred through milk to the nursing infant where it would be predicted to inhibit iodide uptake in the infant's thyroid gland. The NIS also is found in the placenta and based on this new research, it seems likely that perchlorate is actively trans ported across the placenta. Because the fetus and developing infant require adequate iodide for thyr oid hormone function, any determination of a safe level of exposure to perchlorate should take in to account this mode of action for perchlorate toxicity.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 231 of 1099 Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21002

EPA Comment Code: 2500

Comment: C. Sensitive populations not protected by HRL

A related study estimates perchlorate doses that correspond to urinary perchlorate excretion (hereinafter referred to as "Blount (2007)").[FN 62: Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. Perchlora te exposure of the US Population, 2001-2002. J Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7. Epub 2006 Oct 18.] These calculations are feasible because perchlorate is not metabolized and has a short half-life of approximately 8 hours[FN63: Ibid.]. Blount (2007) showed that the adjusted geometric mean for perchlorate exposure in women was 0.059 ug/kg-day, and the 95th percentile exposure wa s 0.215 ug/kg-day. This means that the adverse effects described by Blount (2007) are occurring at perchlorate exposures below the RfD of 0.7 ug/kg- day, with the logical inference being that the proposed HRL will not protect sensitive subpopulations.

A study by Ginsburg et al.[FN64: GL Ginsburg, DB Hattis, RT Zoeller, and DC Rice. 2007. Evaluation of the U.S. EPA/OSWER preliminary re mediation goal for perchlorate in groundwater: Focus on exposure to nursing infants. En viron Health Perspect. 115(3):361-369. http://www.ehponline.org/members/2006/9533/9533.html] published since the NRC review found that, "drinking-water perchlorate must be < 6.9 ug/L to keep the median, and < 1.3 ug/L to keep the 90thpercentile nursing infant exposure below the RfD."[FN65: GL Ginsburg, DB Hattis,
RT Zoeller, and DC Rice. 2007. Evaluation of th e U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater: Focus on exposure to nursing infants. Environ Health Perspect. 115(3):361-369.] Based on both exposure and to xicity information, and data on sensitive populations, the proposed HRL, which is twice as high as the limit proposed by Ginsberg et al, will leave significant portions of the population at risk.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminaryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 232 of 1099 determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21057

EPA Comment Code: 2500

Comment: This year, the ATSDR released its Toxicologi cal Profile for Perchlorates (2008) as new data have become available since the last profile of perchlorates in 2005. As a part of their review, ATSDR derives minimum risk levels (MRLs) using available peer reviewed information. MRLs

"...are derived when reliable and sufficient data exis t to identify the target organ(s) of effect or the most sensitive health effect(s) for a specific duration for a given route of exposure. An MRL is an estimate of the daily human exposure to a hazardous substance that is likely to be without appreciable risk of adverse noncancer health effects over a specified duration of exposure. MRLs are based on noncancer health effects only and are not based on a consideration of cancer effects. These substance-specific estimates, which are intended to serve as screening le vels, are used by ATSDR health assessors to identify contaminants and poten tial health effects that may be of concern at hazardous waste sites. It is important to note that MRLs are not intended to define clean-up or action levels" (ATSDR, 2008). Considering the NRC report along with new studies published since the NRC report, "ATSDR has adopted the EPA's chronic RfD recommended by the NRC (2005) for the chronic MRL" (ATSDR, 2008).

ATSDR based their MRL on the same most sensitiv e population, pregnant women and their fetuses, although they also discussed other sensitive populations, preterm and nursing infants. They also

state that their decision "...was made after a carefu l evaluation of the NRC report and of studies that have been published after the NRC (2005) report. The results from newer studies do not change the bottom-line recommendation" (ATSDR, 2008).

The ATSDR Toxicological Profile for Perchlorates was peer reviewed and made available for public comments. "The expert peer reviewers on April 18 , 2007 concluded that the MRL should still be based on the RfD as recommended by the NRC Panel Report (2005) given the research data

available at the time of the 2007 peer review" (ATSDR, 2008).

Based on the traditional and foundational approach used in science, the weight of evidence-or the

number of well conducted studies in humans and animals with appropriate dose-response information-supports EPA's decision not to estab lish a NPDWR. As shown in the assessment by the NRC in 2005 and the subsequent literature published since then, including the ATSDR Toxicological Profile, the weight of evidence shows that,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 233 of 1099 * inhibition of iodide uptake in the thyroid glan d is a key biochemical event, * the inhibition of iodide uptake is not an adverse effect, * there ar e doses of perchlorate below which inhibit iodide uptake in healthy adults, * the dose of perchlorate that might be sufficient to cause an adverse effect is as sustained exposure greater than 0.4 mg/kg-d (NRC, 2005), and * there are natural occurring agents, such as thiocyanate and nitrate, that also effect iodide uptake in the thyroid gland.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21060

EPA Comment Code: 2500

Comment: The weight of evidence shows that the fetal brain is more sensitive to hypothyroidism than the neonate or infant brain (Boelaert and Fr anklyn, 2005). Breast milk concentrations of perchlorate have been measured at levels grea ter than the HRL (Kirk et al., 2005; Pearce et al., 2007b). However, the RfD assumes that if a pers on consumes 15 ppb of perchlorate not just once, but every day for a lifetime, they will be consumin g a concentration of perchlorate that is not anticipated to cause an adverse effect. Furthr ermore, a HRL, MRL, PH G[FN1: A Public Health Goal, or PHG, is the State of California's acceptable level of a chemical in drinking water that is not expected to cause an adverse effect if consumed ev ery day for a lifetime.], RfD, etc. are not bright lines above which health effects would be expected to occur. As noted with perchlorate, an RfD based on a no effect level for a non adverse effect in humans with an additional 10-fold uncertainty ("safety") factor provides a health protective appr oach. The development of a value lower than the RfD will only increase the level of caution. Therefore, if an infant consumes one dose of perchlorate that is greater than the RfD, it is not expected to be any more harmful than a lesser dose. Lastly, a solely breast fed infant will not ha ve exposures through other media.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 234 of 1099 drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21061

EPA Comment Code: 2500

Comment: II. KEY SCIENTIFIC STUDIES PUBLISHED SINCE 2005

Since the publication of the NRC report in 2005, several studies have been published that support

the conservative nature of the current EPA RfD. Ov erall, these studies demonstrate that perchlorate is a ubiquitous chemical in the environment, food , and the human body. In a recent study by Blount et al. (2007), all samples of urine measured had lo w, but detectable concentrations of perchlorate. The sources of perchlorate appear to be both natural and anthropogenic. There is an increasing body of literature demonstrating that much of the environmental perchlorate may be natural or due to non-point sources (DasGupta et al., 2005; SERDP, 2005; DasGupta et al., 2006; Rajagopalan et al., 2006).

[Text Box: The weight-of-evidence of human and animal studies that include sufficient doseresponse data, show that possible adverse health effects are several orders of magnitudes above environmentally-relevant levels of perchlorate and that the current RfD is a conservative toxicity guideline value such that contaminants present in drinking water at or below the HRL of 15 ppb would pose no significant health risk to the most sensitive individuals who consume the water on a daily basis over a lifetime.]

Despite the widespread low levels of perchlorate in the environment, studies have not demonstrated an adverse effect due to perchlorate exposure. The NRC report states,

"The committee emphasizes that inhibition of iodi de uptake by the thyroid has been the only consistently documented effect of perchlorate exposure in humans. The continuum of possible effects of iodide-uptake inhibition caused by pe rchlorate exposure is only proposed and has not been demonstrated in humans exposed to perchl orate (with the exception that in patients with hyperthyroidism doses of 200 mg daily or higher may reduce thyroid secretion). More important, the

outcomes at the end of the continuum are not inev itable consequences of perchlorate exposure." (NRC, 2005)[FN2: The noted dose of 200 mg/d is a conservative therapeutic value. When use of perchlorate to treat hyperthyroidism was comm on, doses of 400 mg/d were commonly prescribed, but were found to be slow to control thyrotoxicity and doses needed to be repeated 4 to 5 times/d, due to the rapid excretion of the dr ug. Although it still took an aver age of 9.4 weeks, doses of up to 2000 mg/d were given to reduce hyperthyroid ism to a remission state (Wolff, 1998).]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 235 of 1099 The new studies contribute to an already well developed database, adding more studies that are consistent with previous analyses. Furthermore, additional studies that are consistent with the literature also reduces uncertainty (reducing "what we do not know"), thereby reinforcing that the current RfD for perchlorate is both conservati ve and health protective. Thus, perchlorate concentrations equal to or above the EPA-reco mmended HRL of 15 ppb in water would also be conservative and health protective for sensitive populations.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21062

EPA Comment Code: 2500

Comment: A. Environmental Studies

EPA states: "If adequate human studies (confirmed fo r validity and applicability) exist, these studies are given first priority in the dose- response asse ssment, and animal toxicity studies are used as supportive evidence." and "If adequate human data are available, this information is used as the basis of the RfD (EPA, 1989). The scientific studies regarding perchlorate and health are predominately based upon human data, with a range of parameters and dose-response data. The types of human studies are clinical, occupational, or ecological. To date, there is only one epidemiological study which measures perchlora te exposures and outcomes in pregnant women and neonates (Tellez et al., 2005). In contrast to eco logical studies measuring collective exposures and outcomes, an epidemiological study measures individual exposure and outcome. There are also some well designed animal studies that have contribute d to the health effects database. Many of these studies investigate the relationship between pe rchlorate exposure and adverse outcomes among especially vulnerable groups. In addition to the clinical studies reviewed by NRC, epidemiological studies are valuable in exploring the health eff ects due to perchlorate in a chronically exposed genetically-diverse population that includes the population of concern (pregnant women and their fetuses).

In the EPA notice, several of these association st udies were taken together, leading EPA to conclude

that the results of "...studies of the effects of perchlorate exposure on hormone levels have been mixed" (p. 60266), citing Amitai et al. (2007) show ing no effects and Blount et al. (2006) identifyingEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 236 of 1099 hormonal changes (although none were outside norma l ranges). However, when the strength of the study design is taken into consideration, the wei ght-of-evidence demonstrates that the current RfD is a conservative toxicity guideline value such that contaminants present in drinking water at or below the HRL of 15 ppb would pose no significant health risk to the most sensitive individuals who consume the water on a daily basis over a lifetime.

Response: EPA acknowledges and thanks you for providing additional information related to perchlorate. EPA will continue to evaluate the avai lable science related to perchlorate. On August 19, 2009, EPA published a Federal Register noti ce requesting supplemental public comments on its preliminary determination not to regulate perchlora te in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Fe deral Register notice, EPA requested comments on additional interpretation of data on the level of hu man health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of heal th effects for a contaminant, as well as other factors (e.g., sources of exposure), when deci ding whether regulation presents a meaningful opportunity for health risk reducti on. Therefore, the Agency consid ered national occurrence and the severity of health effects from perchlorate and co ncluded that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21070

EPA Comment Code: 2500

Comment: In a peer-reviewed letter to the editor of Thyroid, Gibbs and Van Landingham (2008) reviewed data from their previously published study (T ellez et al., 2005), and showed that in a cohort of pregnant women in Chile, the data do not support the association between environmental perchlorate exposure and changes in thyroid horm ones and are consistent with the recent negative findings by both Pearce et al. (2007b) and Lamm et al. (2008), both presented at the Seattle SOT meeting.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael GirardEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 237 of 1099 Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21074

EPA Comment Code: 2500

Comment: B. Occupational or Clinical Studies

i. Braverman et al. (2005)

This study included 29 workers exposed for at least 1.7 years in an ammonium perchlorate plant and 12 unexposed volunteers; variables measured in the study included serum perchlorate, thiocyanate, nitrate, total T4, Free T4, total T3, Tg, and TSH; RAIU; and urinary iodine and perchlorate taken after 3 days off or 3 days working. The authors estimated that "half of the workers experienced average ClO4- doses in excess of 0.33 mg/kg-shif t over the year preceding this study." They found that there was a decrease in RAIU, but no change in thyroid hormones compared to unexposed controls. There was a slight increase in T3, T4, and free T4 after 3 days working compared to 3 days off. Again, the NRC committee has stated that "The committee does not think that transient changes in serum thyroid hormone or TSH concen trations are necessarily adverse effects" (NRC, 2005). The RAIU dose response curve the authors found was consistent with that of Greer et al. (2002).

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21075

EPA Comment Code: 2500

Comment: ii. Braverman et al. (2006)

In an effort to study the thyroidal effects of a prolonged (six months) exposure to low perchlorate levels in humans, Braverman et al. exposed 13 health y volunteers to 0, 0.5, or 3.0 mg/d of potassium perchlorate and measured urinary perchlorate leve ls, radioactive iodine uptake and serum T3, free T4, TSH and Tg concentrations. The 0.5 and 3.0 mg/d doses are equivalent to 250 and 1500 ppb, respectively, assuming a daily water ingestion of 2 li ters. The authors concluded that perchlorate atEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 238 of 1099 doses of up to 3 mg/day for six months "...had no effect on thyroid function, including inhibition of thyroid iodide uptake as well as serum levels of thyroid hormones, TSH and Tg" and, "...there was no significant change in the thyroid RAIU during perchlorate administration." (emphasis added)

This study was similar to Greer et al. (2002), but for longer exposures. The doses were 0.5 and 3.0 mg/d and the exposures were for six months. This st udy also did not restrict or control for dietary intake (Crawford-Brown et al., 2006).[FN6: "If one assumes that the individuals in the study by Greer et al. (2002) were exposed to the same background levels of perchlorate as the rest of the U.S. population (there is nothing in their diets or in th e study design to preclude this), then no further RSC adjustment is needed to reflect total exposures via all routes because the risk coefficient from the study already reflects the incremental risk fr om ingestion of perchlorate in water above and beyond the contributions to perchlorate exposur e via the other routes" (Crawford-Brown et al., 2006).] Therefore, the doses administered as part of this study were in addition to the background levels of perchlorate ingested-the impact of dietary iodine intake was not accounted for. The study would have benefited from a larger sample size ; however, data from the 14-day Lawrence et al. (2000, 2001) studies, and the Greer Study suppor t the results reported by Braverman et al. These studies all support the NOEL determined by Greer et al. (2002), and relied upon by the NRC as the

basis for its recommended RfD.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Ladd Larry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0037

EPA Comment ID: 28337

EPA Comment Code: 2500

Comment: Larry Ladd says regulate. Data gap 1: Chronic effects of ClO4- in the skin. Half-life is longer than in the thyroid or the blood (Yu et al 2002, pubmed id 12140178). No discussion of how ClO4- causes drug-induced lupus and erythema nodosum (Beickert & Heinicke 1968, pmed id 4181403), the role I- sometimes plays in re lieving erythema nodosum (Boyd 2007, pmed id 17618179; Sterling & Heymann 2000, pmed id 110046 29), or similar ailments caused by chaotropic
anions such as iododerma, bromoderma, and brom ism. Data gap 2: Variation in infant renal excretion of ClO4-. If pendrin is important in ClO4 - as well as I- excretion (for I- see Kim et al -- pmed id 19605545) , expect infant with acidosis (including low HCO3- from chronic diarrhea?) to retain more ClO4- (Frische et al 2003, pmed id 12556366). Data gap 3: Chaotropic effectsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 239 of 1099 preventing immuno- coagulation such as opsonizati on of B-19 parvovirus by IgG (Chehadeh et al 2009, pmed id 19450862, with the parvovirus outbre aks in Dharan after Patriot missile deployment, Mallouh & Qudah 1995 pmed 7715986 [corr ected per commenter's request, see docket ID 08090372] and western Pennsylvania during peak fireworks production, Beigi 2008, pmed id 18464909 in mind); opsonization of staph by pentraxin 3, which is dependent on a cysteine array (Holland et al, 2009 pmed id 19054079; Inforzato et al 2008, pmed id 18223257); defensin adhesion to coccidoidomycosis, H. pylori, mycobacteria, and influenza, which is also dependent on a cysteine array vulnerable to changes in salinity (Chandrababu et al 2009, pmed 19480463). Analysis is lacking of NIS and SCN- in the airway (Fragoso et al 20 04 pmed id 15345749; Pedemonte et al 2007 pmed id 17404297; Wang et al 2006 pmed id 17142773) an d nitrosation in the gastrointestinal tract (Suzuki et al 2003 pmed id 12940440). In regards to humo ral immunity, you need to evaluate the thickening of rat pup corpus callosum recorded in York et al 2005 (pmed id 16393938) with the migration paths of cd34+ stem cells within the rat brain (Jendelova et al 2005 pmed id 15929552).

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Steve Lamm Commenter Organization: Consultants in Epidemiology and Occupational Health, LLC (CEOH)

EPA Document ID: EPA-HQ-OW-2009-0297-0654

EPA Comment ID: 28487

EPA Comment Code: 2500

Comment: Is there an adverse neurodevelopmental effect with perchlorate exposure in an iodinesufficient population?

Are moderate perchlorate exposures associated with adverse neurodevelopmental or cognitive outcomes? The ecological study Chang et al. (2003) showed there was no increase in ADHD or autism or decrease in fourth-grade performance wi th perchlorate levels up to 24 ug/L in Nevada. This study was done in the US iodine-sufficien t population without distinguishing those with low iodine levels. The Lamm and Dohmland (1999) study found no increased incidence rate of congenital hypothyroidism in California and Nevada counties with perchlorate drinking water levels in the range of 4-16 ug/L.

Are moderate perchlorate exposures associated with lower levels of neonatal thyroxine (or elevated neonatal TSH)? Li et al. (2000a) and Li et al. (2000b) showed no effect on neonatal thyroxine levelsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 240 of 1099 or neonatal TSH levels, respectively, from environmen tal exposures to perchlorate that ranged up to 15 ug/L, also in Nevada.

At background levels of perchlorate exposure, are lower levels of neonatal thyroxine in the physiological range associated with adverse neur odevelopment outcome including cognition? Soldin et al. (2002) and Soldin et al. (2003) showed in case-control studies that neither childhood ADHD nor pediatric neurobehavioral diseases, respective ly, were impacted by variations in neonatal thyryroxine levels. These studies were conducted in Washington, DC, whose water supply has no known perchlorate contamination. Recently, Ok en et al. (2009) have demonstrated from a prospective cohort study of 500 children in Massach usetts that cognitive test scores at ages 6 month and 3 years were not associated with lower neonata l thyroxine levels. Further, newborn thyroxine

levels were not associated with maternal mea sures of thyroid function (thyroxine, TSH or thyroperoxidase antibody levels).

Are background perchlorate exposures associated with adverse maternal thyroid function measures? Pearce et al. (2007) presented results demonstrating that maternal thyroid function is not affected by environmental perchlorate exposure, based on urinary perchlorate levels of first trimester pregnant women in Cardiff, UK, where the population is mild ly iodine-deficient (i.e, median = 90 ug/L). Pearce et al. (2008) expanded the study in Turin, It aly, asking the same question for an iodinedeficient population.

Pearce et al. (2008) showed among 526 first trim ester pregnant women in Turin, Italy, an iodinedeficient population with a median urinar y iodine value of 50 ug/L, that there was no association between urinary perchlorate levels and free T4 levels (r2<0.0001, p = 0.9) or serum TSH (r2=0.002, p = 03). Their results were the same when they limited their analysis to the 433 women with urinary iodine values less than 100 ug/L. Th ey concluded that "These results, from the largest sample to date of women with low urinary iodine values, do not support the findings reported in the U.S. that similar levels of perchlorate exposure increase serum TSH and lower serum T4 in women with urine iodine concentrations < 100 ug/L."

The Pearce et al. (2008) study is a direct test of the hypothesis raised by the Blount et al. (2006) study, and, in particular for the population of great interest, pregnant women. This study is currently undergoing peer-review for the medical literature.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 241 of 1099 Commenter Name: Steve Lamm Commenter Organization: Consultants in Epidemiology and Occupational Health, LLC (CEOH)

EPA Document ID: EPA-HQ-OW-2009-0297-0654

EPA Comment ID: 28488

EPA Comment Code: 2500

Comment: In summary, the published studies demonstrate no adverse effect on infant thyroidal or neurodevelopmental health from perchlorate exposures up to 16-24 ug/L and no effect on neurodevelopmental or cognitive health with variations in normal neonatal thyroxine levels. Maternal thyroidal function has not been affected by background perchlorate levels either among UK women in a mildly iodine-deficient population or among Italian women in an iodine-deficient population, even those Italian women with urinary iodine levels less than 100 ug/L. These results challenge the interpretation of the Blount et al. (2006) analyses of the NHANES 2001-2002 crosssectional database.

These comments are respectively submitted. I would be happy to supply any reference material that is not already in the record, and I keep myself open to participate in any further scientific discussions

on these matters.

Cordially, Steven H. Lamm, MD, DTPH Consultants in Epidemiology and Occupational Health, LLC. 3401 38th street, NW #615 Washingt on, DC 20016 202/333-2364 Steve@CEOH.com

Associate in Department of Health Policy an d Management Johns Hopkins University-Bloomberg school of Public Health Assistant Professor, Depa rtment of Pediatrics (Epidemiology) Georgetown University

References:

Blount BC, Pirkle JL, Osterlich JD, Valentin-Blasi ni L, and Caldwell KL (2006). Urinary Perchlorte and Thyroid Hormone Levels in Adolescents and Women Living in the United States. Environ Health Persp., 2006 Dec;114(12):1865-1871.

Steinmaus C, Miller MD, and Howd R (2007). Impa ct of Smoking and Thiocyanate on Perchlorate and Thyroid Hormone Associations in the 2001-20 02 National Health and Nutrition Examination Survey. Environ Health Perspec, 2007 Sept;115(9):1333-1338.

Rasmussen LB, Ovensen L, and Christiansen E (199 9). Day-to-day and within-day variation in urinary iodine excretion. Eur J C lin Nutri, 1999; 53:401-407.

Andersen S, Pedersen KM, Pederson IB, and Laur berg P (2001). Variations in Urinary iodine Excretion and Thyroid Function. A 1-year study in healthy men. Eur J Endocr, 2001; 144:461-465.

Laurberg P. Andersen S, Bjarnadottir RI, Carl e A, Hreidarsson AB, Knudsen N, Ovesen L, Pedersen IB, and Rasmussen LB (2007). Evaluating Iodine Deficiency in Pregnant Women and young Infants - Complex Physiology with a Ri sk of Misinterpretation. WHO Public Health
Nutrition, 2007;10 (12A):1547-1552..EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 242 of 1099 Lamm SH, Hollowell JG, Engel A, and Chen R (200 7). Perchlorate, Thyroxine, and Low Urine

Iodine Association not seen with Low Creatini ne-adjusted Urine Iodine Among Women of Childbearing Age. Thyroid, 2007;17:S51.

Vanderver GB, Engel A, and Lamm S (2007). Ciga rette Smoking and Iodine as Hypothyroxinemic Stressors in U.S. Women of Childbearing Age: A NHANES III Analysis. Thyroid, 2007; 17(2):741-

746.

Chang S, Crothers C, Lai S, and Lamm S (2003). Pediatric Neurobehavioral diseases in Nevada Counties with respect to Perchlorate in Drinking Water; An Ecological Inquiry. Birth Defects Res part A, 2003; 67:886-892.

Lamm SH and Dohmland M (1999). Has Perchlora te in Drinking Water Increased the Rate of Congenital Hypothyroidism? J Occ En v Med, 1999; 41(5):409-411.

Li Z, Li FX, Byrd D, Dehy le GM, Sesser DE, Skeels MR, and Lamm SH (2000a). Neonatal Thyroxine Level and Perchlorate in Drinking Water. J Occ Env Med, 2000; 42(2):200-205.

Li FX, Byrd DM, Deyhle GM, Sesser DE, Skeel s MR, Katkowsky SR, and Lamm SH (2000b). Neonatal Thyroid-Stimulating Hormone Level and Pe rchlorate in Drinking Water. Teratology, 2000;

62:429-431.

Soldin OP, Nandedkar AKN, Japal KM, Stein M, Mo see S, Magreb P, Lai S, and Lamm SH (2002). Newborn Thyroxine Level and Childhood ADHD. Clinical Biochemistry , 2002; 35;131-136.

Soldin OP, Lai S, Lamm SH, and Mosee S (2003). Lack of a Relation Between Human Neonatal Thyroxine and Pediatric Neurobehavioral di sorders. Thyroid, 2003; 13(2):193-198.

Oken E, Braverman LE, Platek D, Mitchell ML, Lee SL, and Pearce EN (2009). Neonatal Thyroxine, Maternal Thyroid Function, and Child Cognition. J Cin Endo Metab, 2009;94(2):497-

503.

Pearce EN, Lazarus JH, Smythe PP, He X, Dall'Am ico D, Parkes AB, Smith DF, Burns RA, MAina A, Leung AM, and Braverman LE (2007). Thyroi d Function is Not Affected by Environmental Perchlorate Exposure in first Trimester Pregnant Women. Abstract # 275, 78th annual meeting of the American thyroid Association as cited (reference #18) in Bren t GA, Braverman LE, and Zoeller (2009) Invited Editorial: thyroid Health and the Environment. Thyroid, 2009; 17(9):807=809.

Pearce EN, Lazarus JH, Smyth PP, He X, Dall'Am ico D, Parkes AB, Rurns R, Smith DF, Leung AM, and Braverman LE (2008). Thyroid Function is Not Affected by Environmental Perchlorate Exposure among Iodine-Deficient Euthyroid Firs t Trimester Pregnant Women. Endocrine Society meeting (2008) abstract.

Attached are copies of the citations Rasmussen and Andersen cited in my submission: Comment Tracking Number: 80a3e697. [See PDF docket ID EPA-HQ- OW-2009-0297-0655; note this is copyrighted materials]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 243 of 1099 Attached are copies of the citation by Laurbe rg cited in my submission: Comment Tracking Number: 80a3e697. [See PDF docket ID EPA-HQ-O W-2009-0297-0656; note this is copyrighted material]

Attached are copies of the citation by Oken ci ted in my submission: Comment Tracking Number: 80a3e697. I hereby submit to your record by refe rence the three submissions we made to the record of the EPA Office of the Inspector General on March 10, 2009. That includes the Vanderver and Lamm papers and the two Lamm abstracts. [S ee PDF docket ID EPA-HQ-OW-2009-0297-0657; note this is copyrighted material]

Attached are copies of the citations Pearce 2007 and Pearce 2008 cited in my submission: Comment Tracking Number: 80a3e697. [See PDF do cket ID EPA-HQ- OW-2009-0297-0658]

These is the cover letter to our submission on Vanderver March 10, 2009 to the EPA OIG and the article. [See PDF docket ID EPA-HQ-OW-2009-0297-0659]

Here are submission 2 to the EPA-OIG March 10 , 2009. [See PDF docket ID EPA-HQ- OW-2009- 0297-0660]

This is submission 3 to the EPA_OIG concerning io dine supplementation. This is the cover letter. It will not accept the abstract, so I will send it separately. [See PDF docket ID EPA-HQ-OW-2009- 0297-0661]

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28503

EPA Comment Code: 2500

Comment: EPA discusses but does not ask for any specific comments related to studies published since they adopted the RfD for perchlorate. ASDWA does not have any additional research to offer and simply suggests that EPA review the ava ilable, peer reviewed, scientific data.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 244 of 1099 Response: EPA will continue to evaluate the available sc ience related to perchlorate as the Agency makes a regulatory determination for perchlorate.

Commenter Name: Jonathan Borak Commenter Organization: Yale School of Medicine

EPA Document ID: EPA-HQ-OW-2009-0297-0209

EPA Comment ID: 28510

EPA Comment Code: 2500

Comment: Blount et al. and Steinmaus et al. adopted the 100 ug/L level for their studies because it is the WHO/UNICEF/ICIDD criterion for iodine sufficiency (16). However, that level has been recommended as a benchmark for evaluating the median spot urinary iodine level of populations; it has not been advocated for determining iodine sufficiency in individuals. It is not a useful
benchmark for individuals because, as describe d below, individuals demonstrate significant variability of urinary iodine. Many individuals with sufficient iodine intake have spot urine levels <100 ug/L level from time to time.

Urinary iodine levels generally reflect dietary iodi ne intake over the prior 12-24 hour period, with peaks occurring about 8-12 hours after major meals, thus variations in day-to-day diet can lead to marked day-to-day variations in spot urine iodine (17). Significant day-to-day variations have also been documented in subjects with controlled dietary iodine intake.

For example, six adults studied for 30 days at the NIH Clinical Center were given a diet that provided a constant daily iodine intake (18). Follo wing a six- day stabilization period, daily 24-hour urine specimens were collected for iodine measurements. Day-to-day coefficients of variation (CV)

for 24-hour iodine excretion were calculated for each of two successive 12-day periods. Among individual subjects, CVs ranged from 7%-24.1%. Th us, even under controlled conditions, constant
diet and 24-hour urine collection, there was substantialday-to-day variability of iodine excretion.

Greater variability was seen in studies that did not restrict subjects' diets and iodine intake.

Rasmussen et al. measured iodine levels in 24-hou r urine samples collected on four consecutive days from each of ten subjects whose diets and iodine in take were not controlled. For individuals, day-today urinary iodine levels varied up to three-fold (19).

Burgi et al. collected morning urine samples from eleven subjects on 21 consecutive days. Diets and

iodine intake were not controlled. For individu als, day-to-day CVs ranged from 15%-75%; the average day-to-day CV for the group was 39%. Resul ts from individual subjects demonstrated hectic day-to-day variability (20).

Andersen et al. measured urinary iodine in 15 men sampled monthly for 12 months. Diets and

iodine intake were not controlled. Twelve-month aver aged urine levels for individuals ranged from 29-81 mg/L, but individual monthly urine levels ra nged from 10-260 mg/L. The CVs calculated for each subject's 12 monthly samples ranged from 20.1%-70.5 % (21).

In addition, urinary iodine excretion follows diurna l and seasonal cycles. Higher urine iodine levels are generally found in morning samp les and wintertime samples (17).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 245 of 1099 Because of such day-to-day variations in urine io dine excretion, studies that consider only isolated spot urine levels report significantly greater disper sion of individual urine levels than do studies which average urine levels over time. In other words, isolated spot urinary iodine levels are imprecise reflections of an individual's iodine sufficiency.

More generally, isolated urinary iodine levels pr ovide little useful information about the long-term iodine nutrition of an individual. For example, consider the views of the National Academy of Clinical Biochemists (17):

"In most circumstances the determi nation of urine iodine provides little useful information on the long-term iodine status of an individual, since the results obtained merely reflect recent dietary iodine uptake."

For such reasons, dividing a population into two groups solely on the basis of a single spot urinary
iodine level, as in the Blount and Steinmaus studie s, will almost certainly lead to significant exposure

misclassification. Blount et al. and Steinmaus et al. r ecognized that possibility, but argued that such misclassification would be "random error (not bias)" and thus "nondifferential and therefore likely
to bias estimates of association toward the null, not toward the positive effects" (14). That statistical argument is valid for nondifferential misclassificati on of binary exposure categories, but it is not necessarily valid for more complex sorts of misclassifications:

"Contrary to popular misconceptions, however, nondiffe rential exposure or disease misclassification can sometimes produce bias away from the null." (22)

The Blount et al. study classified individuals ba sed on single spot urine levels of iodine and perchlorate; Steinmaus et al. also included a spot urine level for thiocyanate. Misclassifications would not have been simple and binary. Still greater comp lexity and potential bias arise from the fact that day-to-day variations of iodine and perchlorate in take do not vary randomly from each other. For example, the FDA Total Diet Study (23) documents that some food groups (e.g., dairy) are major sources of both iodine and perchlorate, while others (e.g., grains, vegetables) are rich in only one or the other. Thus, day- to-day dietary variations ma y result in either strongly positive or strongly negative associations between these two anions. In any event, their relationship is unlikely to be random. Further complicating analytical assessment and interpretations is the fact that iodine and perchlorate have different serum half-lives and different urinary excretion rates (11,12).

It is not reasonable to minimize the importan ce of such misclassification by reliance on "popular misconceptions". Even more complex misclassifica tion bias and confounding can be expected when other 'NIS stressors' (e.g., thiocyanate and nitrate) are measured in isolated spot urines and included in the analysis. For such reasons, cross-sectional data based on isolated spot urine samples must be used with caution when inferring causation and esti mating the magnitude of potential interactions.

For the same reasons, isolated spot urine levels s hould not be used to characterize the proportion of a population deemed "iodine deficient"; doing so will overestimate the nu mber of "deficient" individuals. That concern was also expre ssed by the NAS Committee to Assess the Health Implications of Perchlorate Ingestion ("NAS Committee") (24):EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 246 of 1099 "... the distribution of iodide values measured in spot urine samples is broader than values measured repeatedly in individual subjects (21); this leads to overestimation of the number of subjects with both low and high values."

The NAS Committee also raised concerns about th e over-interpretation of NHANES spot urine iodine data to suggest that significant numbers of young adults (including pregnant women) had significant iodine deficiency because their spot urine levels were <100 ug/L (24)

"Furthermore, among people 15-44 years old, includ ing pregnant women, there were no differences

in serum TSH and T4 concentrations between thos e with urinary iodide values less than 50 ug/L and those with higher values (25); apparently, th e iodide intake in the former group was not low enough to cause a fall in T4 secretion."

In reviewing these concerns, the OIG concluded that there was "significant uncertainty" when NHANES data for isolated spot urinary iodine were used as the basis for determining iodine sufficiency in pregnant women:

"these results do represent a significant uncertainty in the science concerning this public health issue (i.e., what portion of the U.S. pregnant women population are moderately or mildly iodide deficient?)." (13)

In summary, use of simultaneous measurements of iodine, perchlorate and other NIS stressors in isolated spot urine samples to characterize cross- sectional populations can be expected to result in significant misclassification that may bias associatio ns toward or away from the null. Likewise, they are likely to overestimate the numbers of individu als at the extremes of the population distribution. Analytical findings and population characterizations based on such testing are likely to introduce significant uncertainty in regulatory d eterminations that rely upon them.

Thank you for this opportunity to comment upon and contribute to your regulatory determination for perchlorate.

Yours truly, Jonathan Borak, MD, DABT, FACP, FACOEM Clinical Professor of Epidemiology

and Medicine Yale School of Medicine

References

1. Blount BC, Pirkle JL, Osterloh JD, et al.: Urina ry perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect
114:1865-1871, 2006.

2. Wolff J: Perchlorate and the thyroid gl and. Pharmacol Rev 50:89-105, 1998.

3. Van Sande J, Massart C, Beauwens R, et al.: An ion selectivity by the sodium iodide symporter. Endocrinology 144:247-252, 2003.

4. Eskandari S, Loo DDF, Dai G, et al.: Thyroid Na+/I- Symporter. J Biol Chem 272:27230-27238,

1997.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 247 of 1099 5. De La Vieja A, Dohan O, Levy O, et al.: Mo lecular analysis of the sodium/iodide symporter: Impact on thyroid and extrathyroid pathophy siology. Physiol Re v 80:1083-1 105, 2000.

6. Wyngaarden JB, Wright BM, Ways P: The eff ect of certain anions upon the accumulation and retention of iodide by the thyroid gl and. Endocrinology 50:537¬549, 1952.

7. Wyngaarden JB, Stanbury JB, Rapp B: The effects of iodide, perchlorate, thiocyanate and nitrate administration upon the iodide concentrating mech anism of the rat thyroid. Endocrinology 52:568-
574, 1953.

8. Alexander WD, Wolff J: Thyroidal iodide tr ansport VIII. Relationship between transport goitrogenic and antigoitrogenic properties of cer tain anions. Endocrinology 78:581-590, 1966.

9. Greer MA, Stott AK, Milne KA: Effect of thiocya nate, perchlorate and other anions on thyroidal

iodine metabolism. Endocri nology 79:237-247, 1966.

10. Tonacchera M, Agretti P, Ceccarini G, et al.: Autoantibodies from patients with autoimmune thyroid disease do not interfere with the activity of the human iodide symporter gene stably transfected in CHO cells. Eur J En docrinol 144:611-618, 2001.

11. Tonacchera M, Pinchera A, Dimida A, et al.: Relative potencies and additivity of perchlorate, thiocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the human sodium iodide symporter. Thyroi d 14:1012-1019, 2004.

12. De Groef B, Decallonne BR, Van der Geyten S, et al.: Perchlorate versus other environmental sodium/iodide symporter inhibitors: potential thyr oid- related health effects. Eur J Endocrinol
155:17-25, 2006.

13. Office of Inspector General: Scientific Analysis of Perchlorate (Assignment No. 2008-0010) (at: http://www.epa.gov/oig/reports/perchlorate.htm). Washington, DC: U.S. Environmental Protection Agency, 2008.

14. Steinmaus C, Miller MD, Howd R: Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 Na tional Health and Nutrition Examination Survey. Environ Health Perspect 115:1333-1338, 2007.

15. US Food and Drug Administra tion: 2004-2005 Exploratory Surv ey Data on Perchlorate in Food (at: http://www.fda.gov/Food/FoodSafety/ FoodContaminantsAdulteration/ChemicalCo ntaminants/Perchlorate/ucm077685.htm). 2009.

16. WHO/UNICEF/ICCIDD: Assessment of Iodine Deficiency Disorders and Monitoring their Elimination (WHO/NHD/01.1). Geneva: World Health Organization, 2001.

17. Demers LM, Spencer CA: Laboratory Medicine Practice Guidelines: Laboratory Support for the Diagnosis of Thyroid Diseases (at: http://www.aacc.org/members/nacb/Archive /LMPG/ThyroidDisease/Pages/Thyroid DiseasePDF.aspx). Washington, DC: National Ac ademy of Clinical Biochemistry, 2002.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 248 of 1099 18. Vought RL, London WT, Lutwak L, et al.: Reliab ility of estimates of scrum inorganic iodine and daily fecal and urinary iodine excretion from si ngle casual specimens. J Clin Endocrinol 23:1218-
1228, 1963.

19. Rasmussen LB, Ovesen L, Christiansen E: Day-to -day and within-day variation in urinary iodine excretion. Eur J Clin Nutr 53:401-407, 1999.

20. Burgi H, Bangerter B, Siebenhuner L: High da y-to-day variability of urinary iodine excretion despite almost universal salt iodization in Swit zerland. In: Geertman RM (ed): 8th World Salt Symposium, Amsterdam: Elsevier Publishers, pp. 961-963, 2000.

21. Andersen S, Pedersen KM, Pedersen IB, et al.: Variations in urinary iodine excretion and thyroid function. A 1-year study in healthy men. Eur J Endocrinol 144:461-465, 2001.

22. Rothman KJ, Greenland S: Modem Epidemiolo gy. Philadelphia: Lippincott-Raven Publishers,
76-78, 1998.

23. Murray CW, Egan SK, Kim H, et al.: US F ood and Drug Administration's total diet study: Dietary intake of perchlorate and iodine. J Exp Sci Environ Epidemiol 18:1- 10, 2008.

24. National Academy of Sciences: Committee to A ssess the Health Implications of Perchlorate Ingestion. (available at http://vvww4.nas.edu Avebcr.nsf/ProjectScopeDisplay/BEST-K-03-05- A?OpenDocument). Washington DC: National Academies Press, 2003.

25. Soldin OP, Tractenberg RE, Pezzullo JC: Do th yroxine and thyroid-stimulating hormone levels reflect urinary iodine concentrations? Ther Drug Monit 27:178-185, 2005.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28529

EPA Comment Code: 2500

Comment: Comment No. 16EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 249 of 1099 Section IV. Consideration of Studies Published Si nce EPA Adopted the NAS RfD for Perchlorate

Page & Paragraph Page 41891

Comment We would like to call to EPA's attention the new data from the Cao, et al. 2009 perchlorate, thiocyanate, and nitrate manuscript de veloped in collaboration with the CDC, which the authors believe is the first study of its kind. Individual thyroid function and perchlorate, thiocyanate, and nitrate exposure were directly measured in abou t 50 infants born at the Children's Hospital of Philadelphia, the Hospital of the University of Pennsylvania, and affiliated clinics, in a study conducted in 2004-2005 where ninety-two fu ll term infants between birth and 1 year of age participated.

In general, the authors' draft manuscript states that associations between TSH and thiocyanate were larger than those between TSH and perchlorate and nitrate. Also, a mixed linear model (one goitrogen exposure at a time) showed that the three goitrogens all had significantly positive associations with TSH and T4. The average urinary thiocyanate level in these infants was almost 50 times higher than average perchlorate level, and th iocyanate was more strongly related to TSH than perchlorate. With all three [goitrogens] modeled si multaneously, all children with higher nitrate and thiocyanate had higher TSH, but high er perchlorate was significant only in children with low iodide.

Suggested Action, Revision and References (if necessary) As EPA continues to evaluate new perchlorate data as stated in the FR announcement this study should be a relevant consideration.

Category* O

Comment No. 17

Section IV. Consideration of Studies Published Si nce EPA Adopted the NAS RfD for Perchlorate

Page & Paragraph Page 41891

Comment The recent publication describing a model by M. Lorber entitled, "Use of a simple pharmacokinetic model to characterize exposure to perchlorate," Journal of Exposure Science and Environmental Epidemiology (2009) 19, 260-273 was not cited by EPA when evaluating perchlorate modeling alternatives. According to the author:

The primary benefit of these simple models is that they allow for an expanded study of the magnitude and patterns of external exposure. This is a different emphasis than the complex, PBPK models, which are used more to study the interna l fate (e.g., dose-to-target organs) and potential

health effects of contaminants to which an individu al is exposed. ...In short, these simple models are allowing for an expanded and more valid study of external patterns of exposure.

Suggested Action, Revision and References (if ne cessary) The EPA "in-house" model developed by M. Lorber should be given consideration as appropriate.

Category* SEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 250 of 1099 Comment No. 18

Section V. Next Steps

Page & Paragraph Page 41892

Comment Although EPA indicates that no additional research is needed to make a regulatory decision, Blount et al. (2009), the USEPA OIG pe rchlorate document (December, 2008), and others have stated that perchlorate, thiocyanate and nitr ate from dietary exposure, coupled with low iodine

intake merits further research.

Suggested Action, Revision and References (if nece ssary) We do not want to delay the regulatory process, but encourage further research in these areas to decrease uncertainty associated with perchlorate cumulative risk assessment.

Category* S

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: John P Gibbs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28551

EPA Comment Code: 2500

Comment: 2) MORE RECENT STUDIES

Subsequent to the NAS report, Braverman et al 2005 demonstrated the same dose response as Greer for iodine uptake inhibition, among workers wi th long term perchlorate exposure. There were no demonstrable adverse thyroid effects among the workers in this study or in a previous study at the same location (Lamm et al 1999). Benchmark ca lculations (Crump & Gibbs 2005) were performed

on the data from these two studies as well as wi th data from the Greer study. The lower 95% statistical confidence limits on benchmark doses estimated from a combined analysis of the two occupational studies ranged from 0.21 to 0.56 mg/kg-day for free T4 index and from 0.36 to 0.92 mg/kg-day for TSH. Corresponding estimates from th e short-term clinical study were within these

ranges.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 251 of 1099 Tellez et al 2005 conducted an epidemiological study among pregnant women in Chile and found no impact of perchlorate on maternal thyroid function du ring pregnancy or on infants at birth. Water perchlorate concentrations ranged from 4ppb to over 100 ppb. Amitai et al 2007 studied neonatal T4 in a region of Israel where perchlorate cont amination was found in the public water supply at

concentrations far in excess of those documented in the U.S. This study finds no change in neonatal T(4) levels despite maternal consumption of drinki ng water that contains perchlorate at levels in excess of the Environmental Protection Agency (E PA) drinking water equivalent level (24.5 microg/L). Therefore the perchlorate RfD is likely to be protective of thyroid function in neonates of mothers with adequate iodide intake.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28699

EPA Comment Code: 2500

Comment: Again, we certainly appreciate the need for mo deling when sufficient empirical data do not exist. However, in the case of perchlorate, si gnificant peer- reviewed literature is available that should be considered by EPA before rely ing on less certain modeling to generate HRLs. Response: EPA acknowledges and thanks you for providin g comments. EPA will continue to evaluate the available science related to perchlorate. On Au gust 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinking water (Federal Register Vo l. 74, No. 159, p. 41883). In this August 19, 2009 Federal Register notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate freque ncy of occurrence in drinking water, and the opportunity for health risk reduction through a nati onal primary drinking water standard, to help determine if it should be regulated. EPA consid ers both the extent of national occurrence and the severity of health effects for a contaminant, as wel l as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency considered national occurrence and the severity of health effects from perchlorate and concluded that regulation was warranted, so EPA ha s determined that perchlorate will be regulated.

Commenter Name: Tom PortaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 252 of 1099 Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28749

EPA Comment Code: 2500

Comment: Subject: Docket ID No. EPA-HQ-OW-0297

Reference: Drinking Water: Perchlorate Supplemen tal Request for Comments (Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices

The Nevada Division of Environmental Protection ( NDEP) provides herein, comments to assist the US Environmental Protection Agency (EPA) in thei r evaluation of the benefits of establishing a national primary drinking water rule for perchlorate. The EPA is evaluating whether establishing this rule would provide a significant reduction in human health risk by reducing exposure to perchlorate in drinking water. In that context, NDEP comments are provided in response to an August 19, 2009 notice within the Federal Register entitled "Dri nking Water: Perchlorate Supplemental Request for Comments", Docket ID No. EPA-HQ- OW-2009-0297.

Comments are arranged in the order presented within the above-referenced Federal Register Notice (Notice). The numerical designation follows that used in the Notice. The attached appendices provide supporting information, along with a refe rence to guide the reader to specific supporting information. These references provide examples, describe assumptions, and enhance the clarity of the comments. Applicable references are cited th roughout the text and appendices, and are listed at

the end of this document.

III. Alternative Approaches to Analyzing Scientific Data Related to Perchlorate in Drinking Water:

A. Interpretation of the Physiologically-Based Ph armacokinetic (PBPK) Modeling 4. Request for Comment on Alternative Approaches a. EPA requests comment on using the PBPK model to evaluate the relative sensitivity of various life st ages to perchlorate expo sure in drinking water.

Comment A.4.a.1: It is inappropriate to use the PB PK model to support a regulatory action because the underlying scientific evidence indicating se nsitivity of the fetus and/or neonate is lacking. Additional clinical data are needed to help refi ne the PBPK model. Data are needed for adults, including pregnant women, and for neonates concerni ng thyroidal iodine capacity and the effects of sodium-iodide symporter (NIS) upregulation on thyroidal iodine uptake and/or thyroxine levels.
Also, additional studies of other adults are need ed to evaluate the eff ects of temporary iodine deficiency and NIS upregulation on perchlorate comp etitive inhibition of thyroidal iodine uptake and/or free thyroid hormone levels. This additional research would provide useful data to consider in further refining the PBPK model to accurately re flect the effects of iodine deficiency in pregnant
women, fetuses and neonates. If the additional clinic al data support concerns for relative sensitivity
of the fetus and neonate, then a refined and validated PBPK model would be useful.

Comment A.4.a.2: Perchlorate is known to be well absorbed into the human body, and at sufficient doses can act as an inhibitor of iodine uptake into the thyroid due to competition with iodine for the sodium-iodide symporter (NIS) (NRC, 2005). Although this competitive inhibition of NIS is not an adverse health effect, it is apparently the first step in a cascade of events that ultimately reduces the production or release of thyroxine from the thyroid gland into the bloodstream by depleting storedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 253 of 1099 iodine in the thyroid. However, humans have multiple and redundant mechanisms for maintaining adequate amounts of free thyroid hormones (free thyroxine (FT4) an d the active hormone receptorbinding agent, free tri-iodothyronine (FT3)) when di et or environmental agents cause interruption of thyroidal iodine intake or in circulating acti ve hormone levels (Moore, 1984; Moulopoulis et al., 1988). Some of the most prominent homeostatic mechanisms for maintaining adequate levels of circulating FT3 in humans include:

1. NIS upregulation capacity to rapidly (within hours) increase thyroidal iodine uptake; 2. Organification of iodide within the thyroid into thyroglobulin, a protei n containing bound T4 subunits that act as a storage pool within the thyroid; 3. Thyroid stimulating hormone (TSH) secretion and thyrotropin releasing hormone (TRH) secretion triggered by various stressors (e.g., cold or fever) or by lowered FT3 in circulation, leading to increased production and secretion of T4 and T3 into the bloodstream; 4. Hypertrophy and/or increase number and volume of thyroid follicular cells (including induction of goiter) wi th long-sustained TSH stimulation typically from FT3 shortage in circulation; 5. Modulation of thyroid binding globulin (TBG) content in the circulation which alters the storage capacity and free vs. bound hormone balance in the circulation; 6. Modulation of iodide and thyroid hormone excretion via the kidneys, feces, and/or metabolic
breakdown of hormones; and 7. Modulation of th yroid function and thyroid hormone distribution by estrogens, human chorionic gonadotropin, leutinizing hormone, and other hormones during pregnancy and lactation.

The human body is recognized to maintain a sensitive and dynamic balance between TSH and FT3, and the thyroid injuries or diseases that signific antly alter this dynamic balance (in magnitude and/or duration) have the most clinical importance wi th respect to thyrotoxicity and adverse health consequences (Moore, 1984; Moulopoulis et al., 1988).

The homeostatic mechanism perhaps most relevant to perchlorate thyrotoxicity in humans and other mammals is the upregulation of NIS when dietary iodine is sufficiently low for an extended period such that thyroidal iodine stores become depleted. Such upregulation of thyroidal NIS leads to an increased number of NIS sites on thyroid follicle cells, which in turn has the impact of increasing iodine uptake and reducing the impact of competitive inhibition by perchlorate and other chemicals with NIS binding capacity such as nitrate, thiocyanate, and bromate. At relatively high doses of NIS competitive inhibitor agents in humans, the most immediate response is NIS upregulation, which restores thyroidal iodine upta ke and reduces the effects of most environmental doses of exogenous NIS inhibitors.

The available evidence in studies of rats subjected to subchronic doses of perchlorate indicates solely reversible thyroid effects in perchlorate-treated adults and an important role of homeostatic mechanisms (e.g., NIS upregulation) in effects not ed at doses (e.g., 1,000 ug/kg-day) more than 1000-fold higher than the perchlorate reference dose. Paulus et al. (2007) demonstrated that longterm iodine deficiency in rats leads to upregulation of NIS and increased resistance to as much as 5.6 mg/kg-day perchlorate inhibition of thyroidal iodine uptake. The highest dose of 28 mg/kg-day was reported to overwhelm the NIS upregulation in iodi ne deficient rats, leading to reduced thyroxine levels and corresponding TSH perturbations. Paulus et al. (2007) noted:

"The iodine-deficient animals in this study absorbed twice as much of an administered dose of 1311 into the thyroid as the iodine-sufficient animals (see Table 2). This increase in absorption by the animals on the iodine-deficient diet clearly outweighed other factors affecting absorption. ThisEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 254 of 1099 increase in absorption is presumably preceded by elevation in release of TSH via the hypothalamuspituitary-thyroid (HPT) axis, in response to lo w levels of thyroid hormone. It is known that upregulation of the thyroid by TSH is accompanie d by increased expression of NIS (Kogai et al., 1997). Thus, nutritional deficiency in iodine in duces the thyroid NIS system to be upregulated, increasing the population of NIS on the surface of th e follicular cells. The time required for changes in T3, T4, and TSH in response to nutritional defici ency in iodine vary within species and nutritional states but it is known that changes in concentration of the NIS occur rapidly (within hours) in response to changes in the level of TSH (Eng et al., 1999; Yu et al., 2002). It is now understood that this upregulation occurs as a response to iodine de ficiency, perhaps even in the absence of increases in TSH (Johnston et al., 2005). Moreover, during pr egnancy, upregulation occurs both by rises in thyroid-stimulating hormone (TSH) and in response to higher titers of the hormone human chorionic gonadotropin (Glinoer, 1997). It is proposed that changes in NIS populations occur rapidly (within hours) and that this is the salient mechanism for control of iodine concentrations in the thyroid (Eng et al., 1999).

Analyses of the results of this study indicate that a second effect of this upregulation is that the NIS system becomes much more refractory to inhibition of iodide uptake by perchlorate ion. [...I]n order to restrict normal transport of io dide, a greater fraction of a larger population of NIS would need to be blocked, and this would require a hi gher concentration of perchlorate."

Yu et al. (2002) identified similar NIS upregulation that compensated for 0.1 to 3 mg/kg-day perchlorate in euthyroid rats; the highest dose of 10 mg/kg-day was reported to overwhelm the NIS upregulation in euthyroid rats, leading to reduced thyroxin levels and corresponding TSH perturbations. Yu et al. (2002) noted:

"In the present study, the up-regulated thyroid, un der the influence of TSH, was able to overcome the blocking effects of perchlorate by increasing its capacity to sequester iodide and produce hormones. This is clearly a dose-dependent phe nomenon, which was overwh elmed by the blocking effects of high serum levels of perchlorate. []

A 90-day rat study of ammonium perchlorate identi fied reversible thyroid hormone perturbations at doses of up to 1,000 mg/kg-day without effects on thyroid weight or histopathology or any effects on sperm parameters, estrous cycle, bone marrow, or serum hormones; the highest dose of 10 mg/kg did increase thyroid weight and follicular cell hypertrophy (Siglin et al., 2000). Thus, it appears that NIS upregulation in the face of iodi ne deficiency increases the number of thyroidal receptors, thereby diluting impacts of low (< 100 ug/kg-day) to moderate (< 1,000 ug/kg-day) doses of perchlorate on reversible inhibition of thyroidal iodide uptake."

Consistent with the above observations in rats, long -term iodine deficiency in humans is known to rapidly induce NIS upregulation that enhances iodine uptake from the diet and leads to TSH release to maintain circulating thyroxine levels (Andersen et al., 2001). Short-term and relatively mild iodine deficiency also leads to NIS upregulation coincident with normal thyroxine levels and slightly decreased TSH release due to increased sensitivity of thyrocytes and a greater number of thyrocytes participating in thyroid function (Brabant et al ., 1992). Brabant et al. (1992) administered 900 mg/day (about 13 mg/kg-day in 3 divided doses) of perchlorate for 4 weeks in healthy male subjects in order to induce a short-term, mildly iodine-def icient state, which corresponded to an estimated 25% depletion in thyroidal iodine capacity. This high exposure regimen led to nominal changes in free thyroxine and near doubling of circulating thyr oglobulin, the latter which may also represent anEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 255 of 1099 adaptive response to iodine deficiency providing a greater thyroxine capacity in the form of thyroglobulin in the blood (B rabant et al., 1992).

Perchlorate has been used as a pharmaceutical ag ent in persons with abnormally high thyroxine production such as in Grave's Disease, with suffi ciently high regular dosages (e.g., 6,000 to 28,000 ug/kg-day) resulting in reduction of circulating FT3 and FT4 levels to limit the availability of thyroidal iodide via NIS inhibition. However, lower doses in humans administered orally for several days to 6 months do not appear to significantly im pact circulating levels FT3 or FT4 or TSH, or to change thyroid size, despite the demonstration of reduced efficiency (percentage of radioactive iodine uptake) of thyroidal iodide uptake (Law rence et al, 2000, 2001; Gr eer et al., 2002; Braverman et al., 2006; Braverman, 2009). Also, studies of occupational and environmental perchlorate exposures have failed to reveal any significant impa ct on thyroid function at doses that in some cases greatly exceed the currently proposed reference do se of 0.7 ug/kg-day by more than 100-fold (Amitai et al., 2007; Tellez et al., 2005; Gibbs et al., 1998; Li et al., 2000a,b, 2001; Lamm et al., 1999;
Braverman et al., 2005, 2006; Brav erman, 2009; Gibbs and Landingham, 2008; Kelsh et al., 2003; Huffier et al., 2006; Chang et al. 2003; Crump et al ., 2000; Gibbs et al., 2004; Leung et al., 2009; Pearce et al., 2007a,b).

With respect to sensitivity of the neonate life st age, Ginsberg et al. (2007) have argued that a combination of factors may put infants at greater risk, particularly during lactation. Because the breast is one of the extrathyroidal tissues known to express NIS, these researchers expressed the concern for potential adverse effects on neonatal growth and development due to the combination of possible iodine deficiency and possible accumula tion of perchlorate (and depletion of iodide) in breast milk. Kirk et al. (2005) reported on iodide an d perchlorate levels in dairy and breast milk in

the United States and observed a linear correlation between increasing perchlorate and decreasing iodide among 36 human breast milk samples (per chlorate concentrations ranged from 0.6 to 92.2 ug/L, mean 10.5 ug/L; iodide concentrations ranged from 4.5 to 184.5 ug/L, mean 63.3 ug/L. However, the reported high correlation (r2 > 0.9) was based on only six breast milk samples with perchlorate levels over 10 ug/L (K irk et al., 2005). Larger studies of iodine and perchlorate levels in breast milk (Pearce et al., 2007b) and colostrum (L eung et al., 2009) in Boston- area women reported no correlation of perchlorate to iodine in the mother 's milk (including colostrum) or in urine.

With respect to sensitivity of the fetus life stage, pregnant females and their offspring in the fetal and neonatal stages, if thyroid deficient, have been pos tulated as being vulnerable to perchlorate toxicity to the thyroid, although this has not been dem onstrated to date in human populations (Braverman, 2009). The available scientific studies do not poi nt to increased prevalen ce of cretinism, maternal goiter, or neonatal hypothyroidism in the genera l U.S. population or in small populations with perchlorate in public water supplies (Amitai et at 2007; Leung et at 2009; Li et al., 2000, 2001; Buffler et al., 2006; Crump et al 2000; Kelsh et al ., 2003; Gibbs et al., 2004; Chang et al., 2003).

McLanahan et al. (2009) reported a biologically-based dose-response model of the HPT axis coupled with a physiologically-based pharmacokinetic model of perchlorate in rats and concluded that perchlorate may have two modes of action: one in volving inhibition of NIS and a second involving reduced production/release of thyroxine from the thyroid. They pointed to findings of Yu et al. (2002) who noted:

"Recovery of serum thyroid hormones from the bl ocking effect of the 1.0 and 3.0 mg/kg-day doses of perchlorate lagged behind the TSH induced up-r egulation in thyroidal uptake of 125I. A TSH-EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 256 of 1099 induced "iodide sufficient" condition was evident in the thyroid; however, serum thyroid hormones were persistently low for days. The reason for this is unknown but suggests that, at high doses of perchlorate that may initially saturate the symporte r, perchlorate may cause secondary effects on the thyroid beyond competitive inhibition of thyroidal uptake of iodide."

However, rats are recognized to have considerably lower iodine storage capacity in the thyroid and hence may be expected to exhibit perturbations in circulating thyroxine and TSH more readily than would be expected in humans. McLanahan et al. (2009) also pointed to earlier studies indicating perchlorate may displace iodide on certain binding proteins at very high concentrations in vitro (Okabe and Hokaze, 1993; Yamada, 1967), and to recent reports that perchlorate is probably concentrated in thyroid cells at high doses (Tra n et al., 2008; Dohan et al., 2007). McLanahan et al. (2009) concluded that,

"A significant correlation of eff ects of ClO4- with serum thyroid hormones in humans has yet to he confirmed, so the importance of this potential mode of [mode of action] in humans is not known."

Moreover, the observed high dose effects on protein binding and on accumulation of perchlorate in the thyroid are reversible and not likely to be relevant to environmental perchlorate exposure levels in humans and are not associated with thyroi d pathology at moderate dosages (e.g., 100-1,000 ug/kg-day) in normal and iodine-deficient rats ba sed on detailed assessments (Paulus et at, 2007; Yu et al., 2002; Siglin et al., 2000).

In regards to sensitivity of different life stages to perchlorate thyrotoxicity, research is needed to examine the nature and extent of NIS upregulation in iodine deficient newborns and neonates, as well as assessment of the natural capacity of thyroi dal iodine stores at birth to buffer any impacts on circulating thyroxine when iodine intake is relative ly low or intermittent. It is generally known that thyroid deficiency leads to NIS upregulation (and increased thyroid volume) in pregnant and nonpregnant adults as well as in neonates, although the capacity of this protective mechanism is not well characterized in pregnant women or neonates . Consistent with the expected presence of NIS upregulation in mothers and infants, the availabl e scientific studies do not point to increased prevalence of cretinism, maternal goiter, or neona tal hypothyroidism in the general U.S. population or in populations with higher perchlorate levels in public water supplies (Amitai et al., 2007; Leung
et al., 2009; Li et al., 2000, 2001; Buffler et al., 200 6; Crump et al., 2000; Kelsh et al., 2003; Gibbs et al., 2004; Chang et al., 2003).

In summary, although high doses of perchlora te 1,000 ug/kg-day) for extended time periods can cause reversible perturbations in thyroid function, such impacts have not yet been demonstrated at moderate doses (< 100 ug/kg-day) or the relatively low environmental doses (< 10 ug/kg-day) likely to be relevant to drinking water exposures. These fi ndings, largely in human studies, suggest that the EPA-adopted reference dose of 0.7 ug/kg-day is a conservative and health- protective reference dose that incorporates a 10-fold uncertainty factor a pplied to the point of departure (7 ug/kg-day) to account for differences between healthy adults and the most sensitive population: fetuses of pregnant women who might have hypoth yroidism or iodide deficiency.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 257 of 1099 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28806

EPA Comment Code: 2500

Comment: Data shows that perchlorate is actively tran sported into mammary epithelial cells by the sodium iodide symporter (NIS), resulting in an a ccumulation of perchlorate in breast milk.[FN47: Dohan, O, C Portulano, C. Basquin, A Reyna- Noyra, LM Amzel, and N Carrasco. 2007. The Na+/I- symporter (NIS) mediates electroneutral a ctive transport of the environmental pollutant perchlorate. PNAS 104(51):20250-20255.][FN48: Da sgupta, P. K., Kirk, A. B., Dyke, J. V., and Ohira, S.-I. (2008). Intake of Iodine and Perchl orate and Excretion in Human Milk. Environ. Sci. Technol. 42, 8115-8121.] These data suggest th at perchlorate may not only inhibit iodide

accumulation in maternal milk but also would be tr ansferred in breast milk to the nursing infant where it would be predicted to inhibit iodide uptake in the infant's thyroid gland. The NIS also is found in the placenta and based on this new resear ch it seems likely that perchlorate is actively transported across the placenta. Because the fetus an d developing infant require adequate iodide for thyroid hormone function, any determination of a safe level of exposure to perchlorate should take into account this mode of action for perchlorate toxicity.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28807EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 258 of 1099 EPA Comment Code: 2500

Comment: c. On the most appropriate data to estimate alternative HRLs

NRDC response: The CDC (2006/2007) data represent the best available data.

The derivation of a health-based standard for pe rchlorate should reflect the best available data, including published data collected and analyzed by the CDC and described by Blount et al (2006) and Blount et al (2007).[FN49: Blount BC, Valent in-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. Perchlorate exposure of the US Population, 20 01-2002. J Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7. Epub 2006 Oct 18. Blount BC, Pi rkle JL, Osterloh JD, Valentin- Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect. 20 06 Dec;114(12):1865-71.] The CDC data have the following significant advantages over the Greer et al data used by EPA:

1. Although the CDC data are from a cross-sectional analysis, because the survey includes a large number of individuals, the variability represents rand om error, not bias, and the data are likely to be representative of chronic perchlorate exposure; 2. The number of individuals included in the CDC study are sufficient for the specific analysis of a sensitive subpopulation defined as women with low iodine intake; 3. A benchmark dose (BMD) analys is of perchlorate-related modulation of serum thyroid hormone concentrations is feasible; and 4. Perchlorate exposures, as measured by urinary perchlorate concentration, corresponding to the be nchmark dose low (BMDL) can be converted to an estimated dose in mg/kg-day, that can be use d as the point of departure for the derivation of

both the MCL and HRL.

From Blount et al (2006) we know that the mean for total serum T4 concentrations in women is 8.27 ug/dL and the 25th percentile of perchlora te exposure (equivalent to 1.6 ppb perchlorate in urine) is associated with a 10% drop in total se rum T4 in women with low iodine intake.[FN50: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid

hormone levels in adolescent and adult men and wo men living in the United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.] Importantly , the unique physiology of pregnancy and

interactions between the mother and fetus make both especially susceptible to the harmful effects of perchlorate; maternal T4 is the onl y source of thyroid hormone for the fetus in the first trimester.

Blount et al (2007) established that for women with low iodine intake (defined by the World Health Organization as urinary iodine < 100 ug/L),[F N51: World Health Organization (WHO). 1994. Indicators for assessing iodine deficiency disord ers and their control through salt iodization. WHO/NUT/94.7. Geneva: WHO/International Cou ncil for the Control of Iodine Deficiency Disorders.] very low levels of perchlorate expo sure were associated with decreased serum T4 and
increased serum TSH; the CDC estimates that 36% of U.S. women have iodine intakes in this range. For iodine-sufficient women (defined as urinar y iodine >= 100 ug/L), perchlorate exposure was

associated with increased TSH. Increased TSH is an indicator that the body is attempting to compensate for a decrease in thyroid hormone produ ction, and is clinically considered to be a more sensitive marker of subtle thyroid alteration than depressed levels of serum T4. When predicting changes in serum TSH with increasing perchlora te exposures, women with low iodine intake and TSH levels on the high end of the normal range (> 3.11 IU/L) appeared to be the most sensitive group. In this group, any increase in urinary perchlorate predicted an increase in TSH that was consistently more than twice the predicted increase in TSH for women with low iodine levels andEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 259 of 1099 median TSH levels. For unknown reasons, perchlorate was not associated with T4 or TSH levels in men. The observed changes in serum T4 and TSH in women are consistent with our understanding of how thyroid hormones are regulated in the body, and with the mechanism of toxicity of perchlorate.

Importantly, the extremely low levels of perc hlorate were associated with thyroid hormone disruptions - and the magnitude of these disruptions. The CDC researchers found that if a low iodine woman started with perchlorate exposure corresponding to 0.19 ppb in urine (the minimum level found), and then ingested enough perchlorate through food and/or drinking water to raise her urinary perchlorate level to 2.9 ppb (the median level found), her T4 levels would drop by 13%.[FN52: The drop in T4 predicted to be 1.06 ug/dL; the percentage decrease is calculated as compared to the average T4 level found in the CDC study (8.27 ug/dL).] Similarly, if her urinary perchlorate level increased to 5.2 ppb (the 75th percentile exposure), her T4 levels would drop by 16%. The maximum level of perchlorate exposure found was 100 ppb, which translated into a 29%

decline in T4.

d. On the merits of the approach EPA used to derive HRLs

NRDC response: The Greer data no longer represent the best available data.

Because the dose-response relationship used to dete rmine the RfD is derived exclusively from the Greer et al study, the HRL also is dependent on the Greer et al study to determine the maximum allowable level of drinking water contamination.

The Greer et al study [FN53: Greer MA, G Good man, RC Pleus, and SE Greer. 2002. Health effects assessment for environmental perchlorate contamination: the dose- response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.] reported on study results from intentional dosing of a small population (N=37) of healthy men and women, for only two weeks. That is, the study cannot repres ent realistic chronic exposure scenarios, and it cannot be considered representative of the U.S. population including infants and children. Moreover, the study lacked measurements of iodine status that is now known to be a critical variable. Other significant weaknesses with the Gr eer study included the fact that the low dose group contained only seven participants including only six women. Use of these limited data to calculate a regulatory trigger level has been wide ly criticized as inade quate by state scientific experts[FN54: Ginsberg G and D Rice. The NAS pe rchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] and by EP A's own Children's Health Protection Advisory Committee,[FN55: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] and no longer reflects the best available data.[FN56: EN Pearce, AM. Leung, BC
Blount, HR Bazrafshan, X He, S Pino, L Valentin -Blasini, and LE Braverman, 2007. Breast milk iodine and perchlorate concentrations in lactating Boston-area women. J Clin Endocrinol Metab. 92(5):1673-7.] [FN57: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] Despite these limitations, careful analysis of the Greer data reveal clear evidence of perchlorate toxicity in the low-dose group; th ree subjects showed no perchlorate effect, but fourEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 260 of 1099 subjects in the low-dose group had a measurable decrease in iodide uptake commensurate with perchlorate exposure.[FN58: For a complete analys is of the NAS review of perchlorate, see: Ginsberg G and D Rice. The NAS perchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117- 9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] Because the study authors relie d on averaged data rather than individual data, the more sensitive individuals in the study group were obscured

The short duration of the Greer study, only 14 days, mean that the cumulative effects of longer-term exposure are not accounted for. A study in rats found greater perchlorate toxicity to the thyroid from 90-day exposure than from 14- day exposur e (Springborn Laboratories 1998), suggesting that cumulative exposure may cause significant systemic injury that is not detectable in a short-term study. Although one sub-chronic (six month) huma n study with 13 volunteers has been promoted by industry as indicating that humans adapt to long-term exposure (Braverman et al. 2006[FN59: Braverman LE, EN Pearce, X He, S Pino, M Seeley, B Beck, B Magnani, BC Blount, and A Firek. 2006. Effects of six months of daily low-dose perchlorate exposure on thyroid function in healthy volunteers. J Clin Endocrinol Metab. Jul; 91(7):27 21-4. Epub 2006 Apr 24.]) this study was unlikely to have adequate statistical power to detect an e ffect because it failed to consider the widelyrecognized vulnerable populations, including infant s, children, and women with low dietary iodide. The Blount (2006) study showed that these populations are much more vulnerable to perchlorate toxicity than the average population; women are more sensitive than men, iodine-deficient (urinary iodide below 100 ug/L) women are more sensitiv e than iodine-sufficient women, and iodinedeficient women with TSH levels on the high end of the normal range are even more sensitive than other iodine-deficient women.[FN60: Blount BC , Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid hor mone levels in adolescent and adult men and women living in the United States. Environ He alth Perspect. 2006 Dec;114(12):1865-71.] Other

human studies suffer from the same limitations as the Greer study. For example, a study of chronically perchlorate-exposed pregnant wome n in Chile[FN61: Tellez RT, PM ChacÃ3n, CR
Abarca, BC Blount, CB Van Landingham, KS Crum p and JP Gibbs. 2005. Long-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal period. Thyroid 15(9):963-975.] that also failed to find an effect of perchlorate exposure had only three iodine-deficient female subjects out of 183 in total.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 261 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28831

EPA Comment Code: 2500

Comment: Iodine Deficiency and the IG Report

In addition to NAS, at least one peer reviewer, se veral researchers (Amitai et al., 2007, Crump et al. 2004, Braverman 2007, Tellez et al. 2006) and EPA's IG (December 2008 external review draft document, Scientific Analysis of Perchlorate) have suggested that iodine deficiency is the public health problem with respect to thyroid malfunction mo re so than perchlorate. Furthermore, the IG report suggests that improving the iodide nutriti on level for pregnant and nursing women is the most effective way to prevent low maternal total iodide uptake.

The draft report also states that because perchlorat e is only one of many chemicals that affect iodide uptake in the thyroid, EPA should have followed a cumulative risk assessment approach in its perchlorate risk assessment. EPA's only mention of the IG report in the NODA is to acknowledge that the IG Report commented that the agency's risk assessment " account for the activity of other compounds with similar actions on the thyroid." Th e FR then directs the reader to section III.C.2 for more information, but III C. 2 details issues raised by commenters regarding the occurrence analysis and not the risk assessment or the IG report.

AMWA recommends that the final IG report be released to the public and its recommendations considered in EPA's final regulatory determination, particularly with respect to the cumulative risk assessment and iodine deficiency.

The Science of Perchlorate

Several peer reviewers of EPA's PBPK model as well as the peer reviewers of EPA's 2008 health advisory referenced new studies that EPA failed to mention in this NODA. It is important for EPA as a scientific agency to objectively and correctl y characterize the science of perchlorate in the regulatory determination, and consider the body of epidemiological data as well as other health and occurrence information, particularly because the topic of possible effects to pregnant women,

infants and children is such an emotional one. Much has been written in the media about perchlorate and its effects and the public and decision makers look to the agency as well as to organizations like NAS to help interpr et what the science is telling us.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate. EPA does not disagree that a total iodine inhibitor load, including naturally-occurring NIS
inhibitors, should be considered. The Administra tor of EPA has suggested a new approach that considers cumulative risks of chemical mixtures. At this time we have not given this option full

consideration. EPA will continue to evaluate the ava ilable science related to perchlorate. On August 19, 2009, EPA published a Federal Register noti ce requesting supplemental public comments on its preliminary determination not to regulate perchlora te in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Fe deral Register notice, EPA requested comments on additional interpretation of data on the level of hu man health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of heal th effects for a contaminant, as well as otherEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 262 of 1099 factors (e.g., sources of exposure), when deci ding whether regulation presents a meaningful opportunity for health risk reducti on. Therefore, the Agency consid ered national occurrence and the severity of health effects from perchlorate and co ncluded that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28844

EPA Comment Code: 2500

Comment: In previous exposure assessments conducted by the EPA, such as arsenic, all available epidemiological data was factored into th e modeling assumptions, including sensitive subpopulations. EPA has clearly omitted significant p eer- reviewed studies that provide a significant weight of evidence finding that there is no adverse impact from exposure to perchlorate in drinking water in the subpopulations that are a focus of th is reassessment as summarized in Table 1. This omission represents a significant deficiency that countermands the Agency's stated commitment [FN3: Memo to Employees from EPA Administrator Li sa Jackson, entitled "Scientific Integrity: Our Compass for Environmental Protection". May 9, 2009. http://www.epa.gov/Administrator/scientificmemo.html ] and obligation under the SDWA to use the "best available peer reviewed science" for supporting sound and technical regulatory

determinations.

Table 1. Epidemiological Studies Assessing Effect of Perchlorate Exposure on Children [see PDF docket ID EPA-HQ-OW-2009-0297-0415]

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28882

EPA Comment Code: 2500

Comment: Dohan et al. (2003) provide perhaps the most comprehensive review of the NIS regulation at the time of the NRC report. Dohan et al. reported that "up-regulation of thyroid NISEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 263 of 1099 expression and iodide uptake activity by TSH has been demonstrated not only in rats in vivo but also in the rat thyroid-derived FRTL-5 [Fisher rat thyroid cell line] cell line and in human thyroid primary cultures. TSH up-regulates iodide uptake a ctivity by an increase in NIS transcription. They say: Both NIS mRNA and NIS protein levels decrea sed significantly after either 1 or 6 days of

iodide administration. NIS mRNA levels were alread y significantly reduced at 6 hours following the injected single dose of iodide. In contrast, a sign ificant decrease of NIS protein levels was detected only at 24 hours. After TSH withdrawal, a reduction of iodide uptake activity is observed in FRTL-5 cells. This is a reversible process, as iodide uptake activity can be restored by TSH. The NIS half-life is approximately 5 days in the presence and approximately 3 days in the absence of TSH (Dohan et al., 2003). Other studies support up- regulation of NIS during changing levels of iodine (e.g., Eng et al., 1999; Wagner et al., 2002; Merrill et al., 20 03; Pedraza et al., 2006; Norden et al., 2007; and Bizhanova and Kopp, 2009).]

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28898

EPA Comment Code: 2500

Comment: At a recent symposium on perchlorate held in conjunction with the annual Society of Toxicology (SOT) meeting in Seattle, Lamm et al. (2 008) presented their initial reanalysis of the NHANES dataset used by Blount et al. (2006) with an adjustment for urinary creatinine. Lamm et al.

considered a subset of women from the Blount et al. (2006) study who were of childbearing age (15- 44 years old; the Blount et al. (2006) study group included all women over the age of 12) as well as the interaction of thiocyanate and nitrate, both in urine. They found there was no significant association between perchlorate and total T4, includ ing women with urinary iodide less than 92 ug/g (Figure 3).

Figure 3. Urinary reanalysis results of th e NHANES data [see PDF docket ID EPA- HQ-OW2009-0297-0662]

In a peer-reviewed letter to the editor of Thyroid, Gibbs and Van Landingham (2008) reviewed data from their previously published study (Tellez et al., 2005), and showed that in a cohort of pregnant women in Chile, the data do not support the association between environmental perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 264 of 1099 exposure and changes in thyroid hormones and are c onsistent with the recent negative findings by both Pearce et al. (2007a) and Lamm et al. (2008), both presented at the Seattle SOT meeting.

More recently, Mendez et al. (2009) used proba bilistic modeling to estimate the total dose of perchlorate from food and drinking water using three drinking water scenarios based on UCMR1 data. The highest estimated dose through water an d food was 0.15 ug/kg-d at the 95th percentile, well below the RfD of 0.7 ug/kg- d. When compared to the NHANES 2001-2002 estimates based on urinary output (used by Blount et al.), they fo und that intraday variability contributed to the

overestimation of dose based on the NHANES data. Interestingly, they also found that the urinary excretion of perchlorate in NHANES 2003-2004 wa s significantly lower than in 2001-2002. Two data points do not represent a trend, but this lower urinary excretion may represent lower doses through food and water in subsequent NHANES studies.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28900

EPA Comment Code: 2500

Comment: Steinmaus et al. (2007)

Steinmaus et al. (2007) used the same dataset as Blount et al. (2006) to assess the correlation between smoking, thiocyanate and urinary perchlorate, and thyroid hormone levels. The same methodological issues reported for Blount et al. (2006) apply to this study. As in Blount et al. (2006), the authors did not find any inter action between perchlorate and sm oking and TSH or total T4 in women with urinary iodine levels greater than or equal to 100 ug/L or in men. They did conclude that in women with urinary iodine less than 100 ug /L, perchlorate increased the risk of lower total T4 and higher TSH, just as was reported in the Bl ount et al. study. This association was stronger

when the woman was also a smoker or had high urinary thiocyanate levels.

Amitai et al. (2007)

This ecological study aimed to "...assess the e ffect of gestational perc hlorate exposure through drinking water on neonatal thyroxine (T4)" by comparing T4 levels among newborns whoseEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 265 of 1099 mothers lived in areas with drinking water perchlor ate levels associated with "very high exposure" (10 to 100-fold greater compared to levels in the U.S.; >=340 ug/L), "high exposure" (42-94 ug/L), or "low exposure" (<3 ug/L). T4 levels were measur ed within 36 to 48 hours after birth but there was no comment on whether the infants were breast fed or formula fed during the postnatal period.

The authors found that there were no differences between neonatal T4 levels among the groups. This study provides evidence that the current RfD and values greater are conservative and health protective to the most sensitive individuals in the population.

Pearce et al. (2007)

The objective of the Pearce et al. study was "to determ ine whether breast milk iodine concentrations in Boston-area women are adequate for infant nutrition, and whether breast milk iodine concentrations may be associated with environm ental perchlorate or cigarette smoke exposure."

Pearce et al. measured breast milk iodine and perchlorate concentrations as well as iodine, perchlorate, and cotinine in urine. They then co mpared the levels found in breast milk to 17

commercial infant formulae. Neithe r breast milk nor urinary perchlorate levels were significantly

correlated with breast milk iodine concentrations . Although perchlorate was detectable in infant formulae, the levels were lower than in breast milk. A significant number of women in this study had iodine levels that were insufficient to meet the infant's needs, but the authors did not suggest this was due to perchlorate exposure or that it represents a chronic iodine deficiency.

Kirk et al. (2005)

With the aim to determine what amount of perchl orate children are exposed to, Kirk et al. measured perchlorate and iodide levels in cow and human breast milk and compared these values to corresponding levels of perchlorate in drinking wa ter in the area. Perchlorate was measurable in 81 of the 82 samples. The average perchlorate leve ls in cow milk and human milk were 2 and 10.5 ug/L, respectively. The maximum levels in cow an d human milk were 11 and 92 ug/L, respectively. There was no correlation between levels of perchlor ate in breast milk and perchlorate in drinking water. The authors speculated that there was a corre lation between higher levels of perchlorate and
lower levels of iodine in breast milk; however, th ey note that this relationship only existed for the breast milk samples with the highest perchlorate le vels (6 subjects out of 82). The authors recognize that this relationship may be coincidental due to the small number of samples with perchlorate levels greater than 10 ug/L, stating that "If we take all the available data, there is no meaningful correlation between the perchlorate and iodide levels in brea st milk." As with previous studies, due to the design, this study was not able to evaluate a causal relationship.

Kirk et al. (2007)

To determine the variability in the excretion of perc hlorate, thiocyanate, and iodide in human milk, Kirk et al. had lactating women collect six samples of milk on each of three days or as many samples as possible over three days. They found that a significant variation over time for all the anions tested. The average iodide, perchlorate and thiocy anate levels were 87.9 ug/L, 5.8 ug/L, and 35.6 ug/L, respectively. The study was not designed to determine whether perchlorate or thiocyanate contributed to IUI in mammary tissue. This study was a biomonitoring study and did not measure any adverse effects or exposures.

Dasgupta et al. (2008)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 266 of 1099 "The objective of this present study was to stud y the excretion of perchlorate, thiocyanate, and

iodine in milk and urine and relate the obser ved pattern within the broad framework of parallel/competitive transport by the NIS." Using br east milk and urine samples from 13 lactating women and using EPA default values for infant body weights and milk intakes, the authors mathematically modeled infant intakes and dose s of iodide, perchlorate, and thiocyanate. They calculated the fraction of iodide, perchlorate, and thiocyanate in breast milk compared to the total

that is excreted in both breast milk and urine. They used a ratio of these fractions in milk to determine the selectivity of either perchlorate or thiocyanate over iodide. They report "that 12 of 13 infants did not have an adequate intake of iodine ...and 9 out of 13 infants were likely ingesting perchlorate at a level exceeding the reference dose ..." They also concluded that the selectivity of perchlorate over iodide was 3.14+/-1.2.

There are a number of unresolved issues related to the experimental design of this paper. The population is small and there is no information on the selection process of the participants (i.e., they are not a random sample). Only three biological va riables were measured in the women. The rest of the variables, including the variables used to derive the conclusions, are calculated from these three

or are default values for infant intake and in fant weights. The three measurements were the concentrations of perchlorate, iodine, and th iocyanate in urine and breast milk. Where other

research has measured more biol ogically relevant information, such as serum concentrations of analytes that would be most reflective of relative concentrations at the NIS (Tonacchera et al., 2004; Pearce et al., 2007), this work is based on very f ew measured observations. The estimated doses, the key variable for understanding possible effects, are based on average body weight and intakes for an infant. For such a simple and critical variable an d in such a small study population, it is surprising that actual body weights were not measured.

In addition to study design, the data presented in this paper appear to contradict the interpretation by the authors of the paper. Based on estimated weig hts, the authors say that nine out of 13 infants are consuming daily doses in excess of the RfD, yet Table 1 of Dasgupta et al. suggests there are 8 infants who exceed the RfD of 0.7 ug/kg-d (subjects 1, 2, 8, 11, 13, 15, 16, 20). Furthermore, if one reviews these estimates to measured variables, th e infants with estimated perchlorate doses greater than the RfD are also estimated to have the greatest iodine intake. By plotting the values for total iodide excretion (column 4), tota l perchlorate excretion (column 7), estimated maternal breast milk iodide excretion (equivalent to estimated infant iodide intake; column 5), and estimated maternal breast milk perchlorate excretion (product of tota l perchlorate excreted and percent of perchlorate in milk; column 7 x column 9) found in Table 1 of the paper, the results demonstrate that perchlorate and iodide are positively correlated (S ee Figure 4). If perchlor ate was inhibiting the transport of iodide into milk, the association would be negative.

Figure 4. Plotting of data repor ted by Dasgupta et al., 2008 to illustrate the association between concentrations of iodine and perchlorate in urin e and milk in lactating women. [see PDF docket ID EPA-HQ-OW-2009-0297-0662]

In addition to the questions regarding interpretation of the data presented in this paper, there are concerns about the interpretation of their previo us work (Kirk et al., 2005) and how that study impacts this recent study. For example, Dasgupta et al. (2008) remark that "in real mothers perchlorate does inhibit the trans port of iodine into milk and beca use of competitive inhibition both analytes cannot be high at the same time." This statement, however, is based on a previous study inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 267 of 1099 which the researchers defined their cut off values[F N16: The cut off values from Kirk et al. (2005) were defined as follows: High iodide in breast milk was greater than 60 ug/L and high perchlorate in breast milk was greater than 20 ug/L.] above wh ich milk iodide or perchlorate was considered "high." They report that no milk samples had both high perchlorate and high iodide (Kirk et al., 2005). In the present study, they report the same tr end although they do not define a cut off value. Yet if the previous cut off values are applied to th e current study, there are many samples that had simultaneously high perchlorate and iodide (F igure 4). Based on the previous conclusions about competitive inhibition of analytes (Kirk et al., 2005), this study does not demonstrate that perchlorate competitively inhibits iodide transport into milk at the concentrations experienced by

these women.

Schier et al. (2009)

The authors measure the concentration of perchlor ate in reconstituted powdered infant formula and used this information to estimate a mean and upper- bound dose of perchlorate in infants solely fed formula. They also estimated the perchlorate concentration in water that would cause an infant in the 10th, 50th or 90th percentile of body weight to receive a dose equal to the RfD every day. The authors concluded that some infants could be at risk for exceeding the RfD even with minimal amounts of perchlorate in water used for reconstitu tion, but "the clinical relevance of exceeding the perchlorate RfD in both an iodide-sufficient and iodide-deficient state are unclear."

This study provides information to the literature on potential exposures given that all the assumptions made about exposure hold true. This study is focused on the exclusively formula fed infant. The most sensitive subpopulation for perchlora te health effects and the group that the RfD is based, is fetuses of hypothyroid mothers. This paper compares the RfD to estimated doses in a population that is not the considered the most sensitive. The RfD is an

...estimate with uncertainty spanning perhaps an or der of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

This report does not demonstrate that this populati on is receiving doses of perchlorate at or above the RfD. This study suggests that some individuals have the potential to exceed the RfD, if all the assumptions implied hold true. Exceeding the RfD is not or meant to be a bright line threshold of effects. As noted above, the perchlorate RfD is ba sed on a NOEL in addition to an UF adjustment.

McLanahan et al. (2009)

In an attempt to evaluate the mode of acti on of perchlorate, McLanahan et al. coupled a biologically-based dose response model of the hy pothalamic-pituitary- thyroid axis with a PBPK model for perchlorate. The model was based on rats and evaluated changes in serum thyroid hormones with exposure to doses of perchlorate up to 10 mg/kg-d (a DWEL of 350,000 ppb). With this high dose, the authors found that the model outputs were inconsistent with observed data from experimental studies (Yu et al., 2002). The authors must add a numerical adjustment factor to their model so that output from the model agrees with experimental data. They conclude that:

ClO4- administered in drinking water (or by other routes of administration) interacts with the rat thyroid gland itself, potentially altering thyroid horm one synthesis or secretion. This interaction is inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 268 of 1099 addition to blocking thyroidal uptake of iodide. Current presumptions of a single MOA for ClO4- on the HPT axis do not appear tenable based on these results.

Modeling can be very valuable in research. This model, however, is based exclusively on rats. As many have noted, rat and human thyroid endocrinology must be evaluated carefully as the differences between the two species are important. Rats have smaller stores of thyroid hormones and are more sensitive to IUI than humans (NRC, 20 05). This model is not able to predict output that is consistent with observed experimental data. Thus, without the addition of a numerical adjustment factor (called the "proportional inhibition term") this model does not produce comparable results to experimental data. The need for this numerical adjustment factor suggests unaccounted data needs or terms in the model, a species difference, or the effects of pendrin given the higher dose levels. The authors say no more than what is quoted above and provide no additional information as an explanation.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28918

EPA Comment Code: 2500

Comment: Please accept the attached comments from th e Association of California Water Agencies on the perchlorate supplemental request for comments. Thank you for your consideration.

Danielle

Attachment

September 16, 2009

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave., NW. Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2009-0297, Perchl orate Supplemental Request for CommentsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 269 of 1099 To Whom It May Concern:

The Association of California Water Agencies appreciates the opportunity to comment on the United States Environmental Protection Agen cy’s Supplemental Request for Comments on the perchlorate regulatory determination. ACWA represen ts over 450 public water agencies in California that collectively supply over 90% of the water deliv ered in California for domestic, agricultural and industrial uses. ACWA agencies are integrally involved in all aspects of surface water and groundwater management statewide to ensure that water supply needs are adequately addressed and are committed to ensuring that drinking water is safe for customers throughout California.

ACWA and its members have a long record of su pporting a timely and consistent standard setting process, both at the state and federal levels, devel oped through regulatory channels and governed by good science. This support extends to the USEP A regulatory determination for perchlorate. In California we have worked diligently with the O ffice of Environmental Health Hazard Assessment (OEHHA) and the Department of Public Health (DPH) on many drinking water regulations, including the recent adoption of a maximum contaminan t level of 6 parts per b illion for perchlorate.

As the Environmental Protection Agency reviews its initial regulatory determination for perchlorate including the potential options for evaluating whether there is a meaningful opportunity for human health risk reduction from perchlorate through a national primary drinking water regulation, ACWA would like to offer the following comments for consideration in addition to responses for questions posed by USEPA: Â Issues for consideration: Â 1) USEPA should carefully consider important epidemiological data when reviewing their regulatory determination.

In four recent rule-making efforts by the USEPA involving arsenic, disinfection byproducts (DBPs), radon, and uranium, the risk assessments are based entirely on epidemiological data. In the case of arsenic and DBPs, they devote significant ti me and resources to reviewing numerous epidemiological studies with one study selected in each case to actually quantify the risk.

For example, the Federal Register Notice of the Arsenic Rule had almost three pages of discussion of the epidemiological data (7025 - 7027) includin g reference to epidemiological papers Lewis et al.,
1999, Buchet et al., 1999; Kurttio et al., 1999, Che n et al., 1985; 1988; 1992; Wu et al., 1989, Hopenhayn- Rich et al., 1996; 1998, Smith et al., 1998, Morton et al., 1976; Valentine et al., 1992; Wong et al., 1992. In spite of several recent and well-designed studies available for review, the perchlorate regulatory determination appears to be the only instance where the epidemiological literature was not sufficiently considered.[FN1: Crump et.al., 2000, Tellez et.al., 2005, and Amitai et.al., 2007] Because USEPA routinely incorpora tes epidemiological data into these sorts of regulatory determinations, they should do so in this case as well.

Response: EPA acknowledges and thanks you for providing additional information related to perchlorate. EPA will continue to evaluate the avai lable science related to perchlorate. On August 19, 2009, EPA published a Federal Register noti ce requesting supplemental public comments on its preliminary determination not to regulate perchlora te in drinking water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Fe deral Register notice, EPA requested comments on additional interpretation of data on the level of hu man health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health risk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of heal th effects for a contaminant, as well as otherEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 270 of 1099 factors (e.g., sources of exposure), when deci ding whether regulation presents a meaningful opportunity for health risk reducti on. Therefore, the Agency consid ered national occurrence and the severity of health effects from perchlorate and co ncluded that regulation was warranted, so EPA has determined that perchlorate will be regulated.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28935

EPA Comment Code: 2500

Comment: The most recent studies show widespread exposures:

The notice in the Federal Register concludes with a section that discusses studies published since EPA adopted the NAS RfD for perchlorate. Since EPA adopted the NAS RfD of 0.7 ug/kg/day, several comprehensive studies have been published that shed new light on the degree of perchlorate contamination in the United States and the possible health implications of this contamination. In a fact sheet that accompanied the August 19th notice in the federal register, the agency notes, "The key focus of the re-evaluation has been consideration of exposure of infants and young children." EWG fully supports this renewed focus on the health threats that perchlorate presents for infants and young children. Research from the last few years has established that not only do infants and children have higher exposures to perchlorate wh en compared with adults, they are also more vulnerable to its toxic effects. A comprehensive epidemiological study from the CDC also calls into question the safety of the current RfD (Blount et al 2006b). Below, we list the evidence from recent

research that confirms that infants and childre n are particularly at risk from perchlorate contamination of drinking water and why EWG be lieves that a maximum contaminant level (MCL) of no higher than one ppb is a necessary public health measure:

- A major CDC bio-monitoring study found that children ages six to 11 have higher exposure to perchlorate compared with adults (Blount et al 2006a) - An FDA study that found perchlorate contamination of 74% of nearly 300 types of commonly consumed foods and beverages also confirmed that young children are exposed to more perchlorate, per unit of body weight, from contaminated food when compared with adults (Murray et al 2008) - A recent study from CDC scientists found that powdered infant formula is wi dely contaminated with perchlorate (Schier et al 2009) - Infants and children require more iodine on a body weight basis than adults and could therefore be more vulnerable to a thyroid toxin lik e perchlorate that inhibits iodine uptake by the thyroid gland (WHO 1998) - Breast milk testing in the U.S. has revealed wide-spread contamination with perchlorate (Kirk et al 2005, Kirk et al 2007 , Pearce et al 2007) - Adequate levels of thyroid hormones are critical to normal brain development in infants and children and even subtle decreases in these hormones during these critical periods can have irreversible effects on cognition (Haddow et al 1999, Pop et al 1999) - A major epidemiological study from the CDC finds that perchlorate exposures far below the current RfD are associated with significant changes in thyroid hormone levels in women (Blount et al 200b)

Each of these points is further discussed in detail below:

CDC bio-monitoring study finds that children ha ve higher perchlorate exposure: In 2006, CDC scientists published the results of a major bio- monitoring study in which nearly 3,000 AmericansEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 271 of 1099 ages six and older who are representative of th e U.S. population were tested for perchlorate. Every single participant was found to have been exposed to perchlorate. Furthermore, children ages six to 11 had the highest exposure of any group tested, with urinary perchlorate levels that were 1.6 times higher on average than in adults (Blount et al 2006a).

As far as EWG is aware, there has been no testing of urinary levels of perchlorate in children under the age of six or infants in the United States. While this is a significant data gap, there is reason to believe that infants and young children may be among the most highly exposed groups in this country. Infants are at risk for high exposures to perchlorate due to widespread contamination of breast milk and infant formula, while young children are especially at risk due to widespread food contamination, especially of dairy products such as cow's milk. Widespread contamination of foods that infants and young children consume heavily co upled with the fact that children consume more food and water per unit of body weight than adults and their relatively small size in comparison with adults virtually guarantees that infants and young children have even higher perchlorate exposures than children in the six to 11 age group and adults.

FDA finds widespread perchlorate contamination of commonly consumed foods and beverages: In 2008, scientists from the FDA published the results of a study in which 285 commonly consumed foods and beverages were tested for perchlorate. Their results revealed widespread food contamination in the U.S.; perchlorate contaminat ed 74% of foods and beverages that were tested. The FDA scientists went on to estimate daily perchlorate exposures from contaminated foods and beverages (excluding tap water) and found that exposures were highest among two year olds. For this age group, perchlorate exposures from cont aminated food and beverages ranged from 50 and

56% of the current EPA RfD of 0. 7 ug/kg/day (Murray et al 2008).

The FDA findings are especially concerning because they show that children have high baseline exposures to perchlorate from commonly consumed foods and beverages. Overall, the FDA analysis found that children ages 10 and under are most highly exposed to perchlorate from contaminated foods and beverages. This is because children con sume items from food groups that are heavily and consistently contaminated with perchlorate, especially dairy foods. In addition, their smaller size in comparison with adults means that, pound for po und, they are exposed to higher amounts of perchlorate than adults.

The FDA study, while concerning in itself, has even more profound implications for the children who live in any one of the 26 states in which perchlorate has been found in drinking water. EWG analysis finds that every proposed or final drinking water standard for perchlorate in the U.S. fails to protect two year olds from routine, daily, unsa fe exposure when combined food and water exposures are considered. A two-year-old of av erage size could exceed EPA's current RfD by drinking water with just four ppb of perchlor ate contamination (EWG 2008). A two-year-old of smaller size or with above average daily water c onsumption could easily exceed the RfD at even lower drinking water concentrations. The widespread food contamination by perchlorate leading to high baseline perchlorate exposures among children underscores the need to set an MCL of <1 ppb

to minimize combined food and ta p water exposure among children.

CDC scientists find perchlorate in infant formula: Earlier this year, CDC scientists published results of a study in which they tested 15 brands of in fant formula; they found perchlorate contamination

of all brands tested. The two most contaminated brands, made from cow's milk, accounted for 87% of the U.S. powdered formula market in 2000. The CDC team warned that mixing perchlorate-EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 272 of 1099 tainted formula powder with tap water containing "even minimal amounts" of the chemical could result in exposures that exceed the current RfD. Fo r example, they note that "reconstitution of PIFs (powdered infant formulas) with water containing pe rchlorate levels of at least 4 ug/l resulted in 26/48 (54%) dosing scenarios exceeding the RfD". In several other dosing scenarios, the formula was so heavily contaminated with perchlorate th at formula consumption alone resulted in exposure levels above the RfD (Schier et al 2009). This study again underscores how easily vulnerable populations such as formula fed infants can exce ed EPA's perchlorate RfD when cumulative exposures from contaminated food and tap water are considered.

Increased iodine requirements in infants, children su ggest particular vulnerability to perchlorate: The World Health Organization (WHO) recommends that the average adult should consume 2 micrograms of iodine per kilogram of body weight per day to meet daily nutritional requirements. In contrast, WHO recommends that young children an d infants ingest 3 and 7.5 times more iodine respectively per kilogram of body weight per day than non-pregnant adults (WHO 1998). This is because thyroid hormone production and turnover are greater in infants and children, compared with adults (Ginsberg et al 2007, Meikle 2007 ). High iodine requirements among infants and children may result in particular vulnerability to perchlorate related changes in thyroid hormone levels among these populations when compared with adults. This is because perchlorate interferes with iodine uptake by the thyroid gland, and si nce infants and children require more iodine that adults, any contaminant that disrupts this process may impact them more severely. This particular vulnerability is recognized by the National Academ y of Sciences, which noted in a 2005 report that in "pregnant women, infants, and children, and people who have low iodide intake or pre-existing thyroid dysfunction, the dose [of perchlorate] re quired to cause a decrease in thyroid hormone production may be lower [than for non- pregnant adults]" (NAS 2005).

Studies reveal widespread perchlorate contaminatio n of breast milk: In three recent studies from CDC and academic scientists, samples of human br east milk from different parts of the country were tested for perchlorate. Every single sample of breast milk in all three studies was positive for perchlorate (Kirk et al 2005, Kirk et al 2007, Pearce et al 2007). In addition, the average levels of perchlorate in breast milk in these studies woul d result in exposure above the agency's RfD for a significant numbers of breast-fed infants.

Further, in all three breast milk studies, a signif icant number of samples contained insufficient levels of iodine to meet the requirement of breast fed infants, meaning that not only would babies drinking this breast milk be exposed to hazardous levels of perchlorate by EPA's standards, but they would also be deficient in the iodine necessary to co unteract the thyroid hormone lowering effects of the contaminant, thereby magnifying potential health effects of perchlorate in these infants.

While there is no question that perchlorate in both food and tap water contributes to breast milk contamination, minimizing perchlorate in tap water is an important overall way in which to decrease this contamination. There is presumably a relati onship between the amount of perchlorate a woman consumes and the perchlorate concentration in her breast milk; decreasing her exposure by minimizing tap water contamination would most likel y result in decreased perchlorate levels in her
breast milk. In addition, those infants who are fed both breast milk and powdered formula have multiple sources of exposure from contaminated breast milk, formula, and tap water used to

reconstitute the formula. For all of these reasons , setting an MCL for perchlorate of <1 ppb would present a meaningful opportunity to reduce breast milk contamination and decrease perchlorate exposure among infants.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 273 of 1099 Infants and children particularly vulnerable to to xic effects of perchlorate: Adequate circulating levels of thyroid hormones are critical to maintaining normal metabolism in adults, but are especially important for infants and children. Infancy and early childhood are times of rapid growth and brain development, and any abnormal decreases in thyroi d hormone levels during these critical periods may lead to inhibition of these processes. Infants and children may suffer from stunted growth and delays in intellectual development if they have in adequate levels of thyroid hormones. These impacts on growth and brain development can be long- term and irreversible. These concerns recently prompted Dr. Melanie Marty, Chair of EPA's Children's Health Protection Advisory Committee (CHPAC) to state in a November 3rd, 2008 letter to the agency:

"The life-long consequences of impaired brai n development are sufficient to merit setting a protective MCL for perchlorate (CHPAC 2008)."

Perchlorate exposures below RfD affect thyroid hormone levels: Lastly, EWG would like to address the agency's current RfD for perchlorate. On the last page of the notice, the agency states, "EPA agrees that additional important data have beco me available since the RfD was derived in 2005.
However, EPA has evaluated the new data and has decided to make the regulatory determination based on the current RfD." EWG strongly disagrees with this finding and we urge EPA to revise the

RfD to reflect the most current science. The curre nt RfD was derived from the Greer study, which has been critiqued in the peer-reviewed literature and by a state regulatory agency, the Massachusetts Department of Environmental Protection.

A recent large-scale epidemiological study from CDC calls into question the actual safety of the agency's RfD (Blount et al 2006b). In September of 2006, CDC scientists published the first major epidemiological study using National Health and Nutrition Examination Survey (NHANES) data on the potential health impacts of chronic perchlor ate exposure. Researchers found a statistically significant, dose-dependent association between perchlorate exposure and changes in thyroid hormone levels in all of the women in the study. In women with lower iodine levels (one third of American women), perchlorate exposure far below the EPA RfD was associated with significant changes in thyroid hormone levels. This is the first study to establish iodine insufficiency among women as a risk factor for perchlorate induced th yroid toxicity. This new discovery highlights a major deficiency in the Greer study; the iodine status of the 37 participants in that study is unknown.

In the Blount study, women were classified ba sed on urinary iodine levels; those women with urinary iodine levels <100 ug/L had significant changes in both TSH and T4 associated with perchlorate exposures far below the current RfD. For a subset of women in the study with lower iodine levels [those with higher baseline thyroid stimulating hormone (TSH) values], exposure to perchlorate as low as five ppb in drinking water wa s associated with increases in TSH that fall into the range of a medical condition called subclinical hypothyroidism. While there is disagreement

about whether this condition should be treated in non- pregnant women, there is consensus in the medical community that pregnant women who develop this condition should be treated with thyroid hormone in order to ensure normal brain development of their fetus.

The results of the Blount study call into question the safety of the RfD and raise the possibility that perchlorate exposures in infants and children may be exerting a far more significant clinical effect that previously believed. As mentioned above, infants and young children are routinely exposed to perchlorate concentrations close to the current Rf D from formula, breast milk, and food exposure.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 274 of 1099 Even minimal drinking water contamination can lead to cumulative exposures that exceed the RfD among these vulnerable populations. The results from CDC's study, which did not include children under the age of 12, suggest that perchlorate expo sures far below the current RfD may significantly affect thyroid hormone levels in adult women. If th e results from the CDC study are extrapolated to vulnerable populations, millions of infants and children may be experiencing perchlorate-induced disruption in thyroid hormone levels during critic al stages of brain development and growth at current levels of exposure, far below the current RfD.

Response: EPA acknowledges and thanks you for providin g additional data related to perchlorate.

EPA will continue to evaluate the available science related to perchlorate. On August 19, 2009, EPA published a Federal Register notice requesting supplemental public comments on its preliminary determination not to regulate perchlorate in drinki ng water (Federal Register Vol. 74, No. 159, p. 41883). In this August 19, 2009 Federal Regis ter notice, EPA requested comments on additional interpretation of data on the level of human health concern, perchlorate frequency of occurrence in drinking water, and the opportunity for health ri sk reduction through a national primary drinking water standard, to help determine if it should be regulated. EPA considers both the extent of national occurrence and the severity of health effects for a contaminant, as well as other factors (e.g., sources of exposure), when deciding whether regulation presents a meaningful opportunity for health risk reduction. Therefore, the Agency c onsidered national occurrence and the severity of health effects from perchlorate and conclude d that regulation was warranted, so EPA has determined that perchlorate will be regulated.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 275 of 1099 

### EPA Comment Code: 2600 Comments on ex panding scope of risk assessment to include other goitrogens a nd/or dietary iodide deficiency

Individual Comments

Commenter Name: Jonathan Borak Commenter Organization: Yale School of Medicine

EPA Document ID: EPA-HQ-OW-2009-0297-0209

EPA Comment ID: 28508

EPA Comment Code: 2600

Comment: 3). OIG presented a compelling argument that perchlorate regulation should not be based on risk assessment of perchlorate alone, bu t on an assessment of the complex mixture of naturally-occurring NIS stressors that includes perchlorate. Moreover, "lack of iodine in the diet (a.k.a. iodide deficiency)" is the most important of those NIS stressors (13).

Response: See response to comment ID 28529 under comment code 2500.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528

EPA Comment ID: 28514

EPA Comment Code: 2600

Comment: EPA must also consider other exposure path ways and additional contaminants in the environment that impact thyroid function when esta blishing the MCL. Studies of perchlorate levels in food, including breast milk, show that the population is exposed through multiple pathways in

addition to contaminated drinki ng water. EPA should determine potential aggregate exposures based on a broad range of contamination levels, and not just the mean, which was the basis for

current estimates.

While data have also demonstrated a particular th reat to the significant number of individuals, especially women of child-bearing age who are io dide deficient, the current modeling does not include this threat. Given this widespread problem (CDC estimates up to 30% of women do not get sufficient dietary iodide), it is critical to take into consideration the potential for exposure to other thyroid- active agents. Consequently, EPA must c onsider the cumulative impact of perchlorate,

other substances in the environment that inhibit the uptake of iodide by the thyroid, and inadequate supplies of iodide in American diets, all of wh ich makes a stringent drinking water standard necessary to be truly health protective.

Response: See response to comment ID 28529 under comment code 2500.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28522

EPA Comment Code: 2600EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 276 of 1099 Comment: Comment No. 10

Section III.A. 4. Request for Comment on Alternative Approaches.

Page & Paragraph Page 41886

Comment We believe that at this time, PBPK mo deling is necessary to be able to more fully consider sensitive subpopulations' exposure to chem icals that bind to the NIS receptor such as perchlorate, thiocyanate, and nitrate from dietary sources and the significance of low levels of perchlorate in drinking water. EPA should consid er whether thiocyanate and nitrate may have a much greater impact than perchlorate for the most sensitive subpopulations with insufficient iodide

and how best this can be resolved.

Consideration should also be given to the differe nces in the rate of excretion of thiocyanate and nitrate in human urine compared to perchlorate and th e half- life of each (relative amount of time in the body from ingestion prior to excretion and the differences in the strength of iodide uptake inhibition).

Suggested Action, Revision and References (if necessary) We also recommend validation and/or comparison of the results of the current EPA revise d PBPK model (2009) with biological fluid data derived that are available from perchlorate exposur e studies. Studies include those recently published by the CDC and NIEHS (Blount et al., 2009) and th e longitudinal epidemiologic study of pregnant women in Northern Chile (references provided be low) as well as other scientifically sound human data. The CDC and NIEHS study reported not only new sensitive subpopulation-related perchlorate and iodide biological fluid data but they also compared thiocyanate and nitrate found in maternal and fetal compartments to levels found in other pu blished studies. We believe that consideration of

such data is consistent with EPA's statement made in the FR announcement that they will "...continue to evaluate any new perchlorate data to determine its relevance to the regulatory

determination in accordance with the SDWA."

References: Blount et al. 2009, "Perinatal Exposure to Perchlorate, Thiocyanate, and Nitrate in New Jersey Mothers and Newborns." Environ. Sci. Technol. http://pubs.acs.org/doi/pdfplus/10.1021/es9008486

Tellez et al. "Long-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonata l period." Thyroid 2005, 15, 963-975.

Category* S. M.

Response: See response to comment ID 28529 under comment code 2500. EPA concluded that the PBPK modeling analysis, in the context of the pe rchlorate regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman. The model also allows for the es timation of the concentration of perchlorate in breast milk (thus breast-fed infant exposure) at various maternal perchlorate exposure levels. However, because of the stated limitations, EPA has decided the model does not directly bear on the current decision regarding the need for a NPDWR for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 277 of 1099 Commenter Name: John P Gibbs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28552

EPA Comment Code: 2600

Comment: 3) OTHER NIS INHIBITORS

Although the NAS committee members were aware of the significance of other NIS inhibitors and had access to the Tonaccera et al 2004 study, they we re restricted by their charge to considering only perchlorate. All NIS inhibitors share the same mech anism of toxicity as perchlorate by blocking the uptake of iodide by the thyroid. The risk to pu blic health is from the combined amount of NIS inhibition acting on the body from all three NIS i nhibitors (thiocyanate, nitrate, and perchlorate). The combined total NIS inhibition load acting on the thyroid (not just perchlorate exposure) determines the total iodine uptake level and the subsequent potential for an adverse outcome. Adverse thyroidal effects of high concentrations of thiocyanate have been reported in numerous studies (Gibbs, 2006)

As noted in the OIG draft report, perchlorate, th iocyanate, nitrate and low iodine intake fit the criteria of a cumulative risk assessment. OIG repor ts that thiocyanate, nitrate, and iodine are found naturally in food and water sources, assuming that people are not exposed to any one of these chemicals alone, but in combination. Thus, the focus on one chemical does not in fact provide a scientifically accurate assessment of possible huma n health risk. The cumulative risk assessment approach provides the best opportunity to impact public health.

Response: See response to comment ID 28529 under comment code 2500.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28560

EPA Comment Code: 2600

Comment: The 15 ppb drinking water level proposed under the October 2008 preliminary guidance is sufficiently protective as few drinking water sy stems were shown to exceed this level in the 2000- 2001 sampling of water systems. Fewer systems are likely to even reach this level as states such as

California and Massachusetts have since set more stri ngent drinking water levels of 6 ppb or below, and sources of potential contamination are being remediated. For these reasons, EPA has difficulty justifying that meaningful public health protection will result from regulation as the percentage of the public residing outside of states where regula tions are already in place, and where perchlorate occurrence in drinking water supplies is at a meanin gful level, is remarkably small. It appears that EPA has attempted to push the limit lower in an attempt to justify larger numbers of population

affected in order to meet the SDWA criteria c oncerning exposure/occurrence. The Agency has not addressed in its analysis that the population of an ar ea that may be impacted fails to differentiate that

most adults and older children are not as sensitive to the effects of perchlorate as the fetus of a pregnant woman, the subpopulation identified by th e NRC as being the most sensitive. Instead,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 278 of 1099 EPA has attempted to use the total number of population exposed by a water provider with perchlorate occurring in drinking water as being e qually exposed and equally at risk. This assessment ignores that more targeted means of addressing poten tial sensitivities, or personal concerns, may be effected through the consumption of bottled water (a common practice that is not factored into EPA's analysis), or the provision of a diet with sufficient iodine to make a drinking water consumer less likely to be iodine deficient. Even with regu lation, EPA's efforts do nothing to focus public health efforts on attaining iodine sufficiency and, therefore, miss the real public health threat.

Response: EPA disagrees. EPA is using a data driven a pproach considering the totality of the best available, peer reviewed data to develop an NP DWR that is protective of human health. EPA will consider the economic impacts of the proposed MCL in developing theNPDWR.

Commenter Name: Richard M. Peekema Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0419

EPA Comment ID: 28687

EPA Comment Code: 2600

Comment: I believe the percentage of iodide deficien t women several decades ago was possibly half what it is at the present. It seems likely that the media coverage of excess salt intake has caused many individuals to self medicate, avoid salt, and indirectly limit their iodide intake. This changes the size of the population at risk. Similar changes are possible in the amounts of thiocyanate and nitrate which people ingest. The EPA provides the followi ng info on p.41892 in its FR solicitation for

comments:

An additional key scientific issue was raised by EPA's OIG in the report released for public comment "OIG Scientific Analys is of Perchlorate (External Review Draft)" (EPA, 2008g). The

report states,

The OIG [Office of Inspector General] Analysis conclu des that a single chemical risk assessment of perchlorate is not sufficient to assess and characteriz e the combined human health risk from all four NIS stressors, (i.e., thiocyanate, nitrate, perchlor ate and lack of iodide) and that * * * Only a cumulative risk assessment can fully characterize the nature and sources of risk affecting this public
health issue. Furthermore, a cumulative risk asse ssment allows an informed environmental decision to be made on how to mitigate the risk effectively.

The report goes on to say, Potentially lowering the perchlorate drinking water limit from 24.5 ppb to 6 ppb does not provide a meaningful opportunity to lower the public's risk. By contrast, addressing moderate and mild iodide deficiency occurring in about 29% of the U.S. pregnant and nursing population appears to be the most effective approach of increasing TIU [total iodide uptake] to healthy levels during pregnancy and nursing, thereby reducing the frequency and severity of permanent mental deficits in children.

I concur completely, and endorse this position. Additionally, the fact that iodide deficiency, thiocyanate, and nitrate content in the population at risk are all changing quantities over time make it inappropriate to set a hard and fast MCL that is scientifically sound. There is nothing wrong with changing an MCL when new information comes to light regarding the action of that contaminant onEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 279 of 1099 the population at risk. It is another matter, however , when the population at risk changes over time and should in prudence be mitigating that risk by other health means.

Response: EPA has determined that a NPDWR for perchlorate is warranted. See response to

comment ID 28529 under comment code 2500

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28696

EPA Comment Code: 2600

Comment: The Safe Drinking Water Act (SDWA) specifi cally mandates that the EPA use the "best available peer reviewed science" for supporting sound and technical regulatory determinations. However, to date the EPA seemingly has not consider ed the valuable epidemiological data available in peer-reviewed literature. The epidemiological studies and other human studies, most notably Greer 2002 (Greer, Goodman et al. 2002), take into account the relative source contribution (RSC). By utilizing the wealth of data provided in these st udies, the EPA would no longer need to consider Relative Source Contribution (RSC) when health effects, or no observed adverse effects levels (NOAELs), are calculated using these and other hu man-exposure studies. While a potential criticism lies in the theoretical absence of specific subjects with iodine deficiencies , we agree with the EPA's Inspector General in stating that regulatory a ction under the SDWA is not the appropriate or effective way to address the overarching public health issue - iodide deficiency. For these reasons alone, we believe that epidemiological data available for exposure to perchlorate through drinking

water should be evaluated before turnin g to the more nebulous PBPK modeling.

Response: See response to comment ID 28718 under comment code 2600 EPA concluded that the PBPK modeling analysis, in the context of the perchlorate regulatory determination, is useful in examining which life stages are most suscepti ble to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman. The model also allows for the estimation of the concentration of perchlorate in breast milk (th us breast-fed infant exposure) at various maternal perchlorate exposure levels. However, because of th e stated limitations, EPA has decided the model does not directly bear on the current decision regarding the need for a NPDWR for perchlorate

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28715

EPA Comment Code: 2600

Comment: Water Docket ID No, EPA - HQ - OW - 2009 - 0297

Supplemental comments regarding the fundamentally different outcomes between Greer, et al, 2002 and the Blount, et al, 2006 studies on low dose effects of perchlorate

By: Herwig Opdebeeck, SM, Opdebeeck Consulting[F N1: Mr. Opdebeeck can be reached at +41 79 658 7979, or h.opdebeeck@opdebeeck .ch.], October 8th, 2009EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 280 of 1099 Executive summary

In the Blount study, an association between perchlorate levels and TSH was found at levels four orders of magnitude lower than has been found in previous studies. However, this result does not appear to represent a causal relationship between perchlorate and TSH, due to the inconsistent results exhibited by perchlorate and the other goitrogens, thiocyanate and nitrate, within the same study. To our knowledge, no in depth study has be en published which explains these inconsistencies exhibited by the Blount study in a manner that would continue to support its conclusions and allow the study to be used as the basis for regulation of perchlorate. Instead, our analysis of the other substances not controlled for in this cross sectional study supports the conclusion that the inconsistent and unexpected results of the Blount study are the result of causal associations between these other substances and thyroid hormone levels.

Even though only a few of the many substances with the capability of affecting thyroid function were surveyed in the same NHANES database on which the Blount study was based, we found

several that showed the same association with TSH. Added to the fact that the association of those substances with thyroid hormone was at levels th at are known to cause those effects and not at levels four orders of magnitude lower as was the ca se for the perchlorate association, it is apparent that the association with thyroid hormone found in the Blount study is not due to perchlorate but due to a pool of goitrogenic substances of which the perchlorate background is only a marker.

In conclusion, not only didn't the Blount study show an upstream iodine inhibition (i.e., it didn't show a relationship between iodine and THs), but additionally perchlorate, which only represents 1% of the NIS goitrogen load, and all three NIS goit rogens seem to have been fully compensated by iodine - explaining the non-relationship of iodine with TH. For the NIS goitrogen perchlorate, it should also be noted that at background levels, it is a strong predictor of environmental iodine background levels. Additionally, goitrogenic compou nds shown to have a direct effect on TH levels
and at levels know to cause such effects, were found to be associated with TSH as well, without exhibiting the inconsistencies found in the Blount study. Finally, a plausible link can be found between those compounds and perchlorate, a marker for the goitrogenic pool through the chlorine

link.

Acronyms BW: Body weight of an adult (70Kg) DW: Drinking water DWL: Daily drinking water consumption in litres (2 L) DBP: Disinfection by-products EGP: Environmental goitrogenic pool (see GC) MCL: Maximum contaminant level NAS: National Academy of Sciences =NRC NIS: Sodium iodine symporter NOEL: Non observed effect level NRC=National Research Council = NAS DWS: Drinking water standard GC: goitrogeni c contaminants (substances that inhibit iodine uptake and therefore could affect TH levels or substances such as PCBs that directly affect TH levels) OIG: EPA's Office of Inspection General PH G: Public health goal RfD: Reference dose

sum23PCB= the sum of the concentrations of 23 PCBs in the NHANES 2001-2002 dataset. TGL: Total (NIS) goitrogen load TH: thyroid hormone UF: Uncertainty factor UPEC (or UTGL): Urinary perchlorate equivalent concentration expre ssed in PEC: [Perchlorate] + [nitrate/150] + [thiocyanate/8.8] with concentrations in weight.

Response: EPA will consider the totality of the best available, peer reviewed science in developing the NPDWR for perchlorate. Data will be ev aluated using a weight of evidence approach, considering each study in the c ontext of the entire database.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 281 of 1099 Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28718

EPA Comment Code: 2600

Comment: Summary

Preliminary note: When expressing a relationship between variables in a cross- sectional study we sometimes use the term "predictor of "(term used in Blount et al. study) which has the same meaning as "associated with" or "related with".

We statistically analyzed some of the other sub stances contained in the same NHANES 2001-2002 data on which the Blount et al. study was based, and found similar statistically significant

associations between some of those substances and TSH. We did not look for associations with T4 since, after adjusting for creatinine, the associat ion between perchlorate and T4 disappeared for the pertinent subpopulation, women of childbearing age with insufficient levels of iodine[FN4: Lamm SH, Hollowell JG, Engel A, Chen R (2 007). Perchlorate, thyroxine, and low urine iodine association not seen with low creatinine- adjusted urine iodi ne among women of childbearing age. Thyroid 17 (s1):S-51].

Indeed there exist many other goitrogenic substan ces that have a different mode of action not related to iodine uptake inhibition. The Blount study is about possible effects on THs of substances present in the population sample. Therefore, all known substances that affect TH levels, all goitrogenic contaminants (GC), should have been statistically tested and controlled for as well and not only those that act through the same mechanism as perchlorate. Since iodine levels are probably not relevant to explain the Blount TH level changes as they are not associated with TH levels in the same population sample, we should, in order to find a cause, not look with priority for goitrogens that affect NIS function (i.e. uptake of iodine) but GCs that directly affect TH levels.

EPA's current RfD for perchlorate is based on perc hlorate's ability to competitively inhibit the thyroid gland's uptake of iodide. It is, therefore, surprising that EPA does not raise this issue when commenting on the Blount study, but instead limits it self to discussing nitrate and thiocyanate. If the Blount et al. study was focused on the iodine uptake inhibition effect, then this would have been justified. But it was not. Instead, it was about the downstream effect, the effect on TH. There are
indeed hundreds of environmental contaminants, na tural and synthetic, that directly affect thyroid

hormone levels and which we can call the environm ental goitrogenic pool (EGP). Many have not

been studied and none were tested and controlled for in the Blount study, even though the levels of

some were available in the NHANES 2001-2002 database of the same population for which the perchlorate - TH relationship was found. We found that the relationship between some of those substances i.e., (certain organo- halogens) with TH was similar with the one of perchlorate.

We found that the sum of the concentrations of 23 PCBs from the NHANES 2001-2002 database was a predictor of TSH for the same Blount to tal population (p= 0.0037). For women, we found that sum23PCB was a significant predictor of TSH (p=0.0027) and that there was no iodine interaction, or in other words the relationship of su m23PCB was the same for all levels of iodine, orEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 282 of 1099 the PCB-TSH relationship was not influenced by the iodine level. For men sum23PCB was not a significant predictor of TSH.

For the total population sample, we also found th at pp-DDE was a significant predictor of TSH (p=0.0185). For women, but not for men, pp-DDE was a significant predictor of TSH (p=0.0040) and again without iodine interaction which is coherent.

We suggest that the main link between perchlorate and those goitrogenic contaminants that directly

affect TH levels is the element chlorine via chlo rophenols, some of which originate in disinfection by-products (DBP) and many other processes where chlorine derivates are involved. The threshold effect level on THs of organohalogens such as PCBs and other dioxin- like mostly chlorine based organic substances has been found to be in the range of 0.1 to 10 ug /l serum depending on the substance. The levels of those substances found in NHANES 2001-2002 is in this range and, as mentioned, a relationship between some of these sub stances and THs was found as well. This is in stark contrast with the four orders of magnitud e difference between the effect level of perchlorate on THs known from the body of the literature and the perchlorate levels that were related with THs found in the Blount study.

Opting for the broad picture and looking for the most likely cause of these effects produced leads which, when compared to the data, points toward a vast pool of goitrogenic compounds, natural and synthetic as the source of impacts to TH. Of thes e, the low level perchlorate background is only a marker, most probably through the chlo rine link, rather than the cause.

In order to answer the question presented in the heading, we propose the following steps:

2.1. Opting for the broad picture

We hear a lot about the value of holistic approaches and cumulative risk assessment in documents such as: US Environmental Protection Agency (US EPA), Framework for Cumulative Risk Assessment, EPA/630/P-02/001F, National Cent er for Environmental Assessment, Office of Research and Development, Washin gton, DC, 2003a, available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=54944.

This is an excellent opportunity to put it in pr actice. EPA's OIG in its December, 2008 study on perchlorate[FN5: Office of Inspector General Scient ific Analysis of Perchlorate ,Assignment No. 2008-0010, December 30, 2008.] certainly took an im portant step in that direction, and we agree that a cumulative approach is critical to the accurate ev aluation of perchlorate’s risks, and should be the underpinning for any regulatory decision making regarding perchlorate.

2.2. Looking for the "culprit(s)" where they are most likely to be

There exist many other goitrogenic substances which lead to TH level change, that have a different mode of action (not related to iodine uptake inhibition) than the traditional NIS affecting goitrogens. The Blount study is about possible effects on THs of background contaminants.
Therefore, all known contaminants that affect TH levels should have been statistically tested and controlled for as well and not only those that act through the same mechanism as perchlorate. Since background iodine levels are probably not relevant to explain the Blount TH level changes, as they are not related to TH levels in the same popu lation sample[FN6: 1. Charnley G, Perchlorate:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 283 of 1099 Overview of Risks and Regulation. Food and Chemica l Toxicology, 2008. 2. Soldin OP, Tractenberg RE, Pezzullo JC. Do thyroxine and thyroid-stimulating hormone levels reflect urinary iodine concentrations? Therapeutic Drug Monitoring. 2005, 27: 178-185.], we should not look primarily at goitrogens that affect the uptake of iodine (and therefore have only a potentially indirect effect on TH levels) but goitrogenic contaminants (GCs) that directly affect TH levels.

EPA's current RfD for perchlorate is based on perc hlorate's ability to competitively inhibit the thyroid gland's uptake of iodide. Therefore, it is surprising that EPA does not raise this issue when commenting on the Blount study, but limits itself to mentioning nitrate and thiocyanate. If the Blount study had been about iodine uptake inhibition effect then this would have been justified. But
it was not. Instead, it was about the downstream effect - i.e., the effect on TH levels. However, in the Blount study it was assumed that iodine uptake inhibition was the upstream effect, so much so that the study population had been split into 2 groups -- iodine deficient and iodine sufficient. This only created additional inconsistencies, as it ex posed additional "unexpected" relationships which should have been seen as a warning that something was amiss.

Limiting the whole issue to iodine uptake inhibi tors, of course, made the study much simpler to manage, but was not the right way to dr aw plausible conclusions about cause.

2.3. Looking for a lead

We quote from the January 2008 Thyroid journal:

"Toxicological models and limited epidemiologica l studies have indicated that many organohalogen aromatic compounds, including dioxins, polych lorinated biphenyls (PCBs), and polybrominated diphenyl ethers (PBDEs), may be classified as "endoc rine disruptors, as they have the potential to alter normal thyroid function."

"Because environmental exposures rarely occur singly , it is often difficult to disentangle a single exposure from other co-occurring environmental ex posures and conditions that may confer risks upon children. Therefore, there is often the poten tial for confounding, in which both the exposure and the outcome under investigation are related to a third factor that may distort the observed exposure-disease relationship."

"In epidemiologic studies, it is critically impor tant to identify, measure, and control for such

confounders."

Therefore, other substances could have caused the TH changes.

While NHANES 2001-2002 TH levels, as ment ioned before, do not reflect urinary iodine concentrations, serum PCBs, p,p'-DDE and HCB ba ckground levels predict TH levels[FN7: John
D. Meeker, Larisa Altshul, Russ Hauser. Se rum PCBs, p,p'-DDE and HCB predict Thyroid Hormone Levels in Men. Environ Res. 2007 June; 104(2): 296-304.] and some do so in NHANES 1999-2002 survey population as well[FN8: Mary E. Turyk, Henry A. Anderson, Victoria W. Persky. Relationships of Thyroid Hormones with Polychlo rinated Biphenyls, Dioxins, Furans, and DDE in Adults. Environmental Health Perspectives. Aug ust 2007,Volume 115, Number 8.]. However the background levels of only few such substances have been measured and tested against TH levels.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 284 of 1099 Yet in the NHANES 2001-2002 surve y, a few of those substances have indeed been measured and therefore can be tested for associations with other contaminants in the same survey.

2.4. Focusing initially on those type of substan ces that are already in the NHANES 2001-2002 survey of the same population surveyed by Blount

Since organochlorides such as PCBs, DDE and othe r organochlorides that have been shown to directly affect TH levels are included in that survey, it should have been obvious that those substances should have been considered in the Blount study in the first place -- or at least controlled for before any other relationship was suggested.

2.5. Comparing the data on the different " suspects" comprised in the NHANES dataset

Preliminary note: We did not look for associations with T4 since, after adjusting for creatinine, the association between perchlorate and T4 disappe ared for the pertinent subpopulation, iodineinsufficient (UI<100 ug/L) women of childbearing age (see ref. 4).

(a) Perchlorate versus TSH for the to tal (male plus female) population

The Blount study did not show that perchlorate was a significant predictor[FN9: In this paper we use the same term "predictor of" as used by Blount et al. which means the same as "associated with" and "related with", terms we also use in this paper.] of serum TSH. (p>0.05) for the total population.

(b) Sum of some PCBs versus TSH PCBs are one grou p out of a multitude of other substances that act on thyroid function (see details in Appendix 2).

We found that the sum of the concentrations of 23 PCBs from the NHANES 2001-2002 database was a predictor of TSH for the same total population (p= 0.0037)

(c) Perchlorate and PCBs versus TSH controlled for gender

For women (all), Blount's data indicates that perchlorate was a significant predictor of TSH (note that Blount did not publish a p value, but we found p= 0.0153 and R2=0.006) and no iodine interaction which is consistent if the predictor is not the cause.

For women < 100 ug/l UI, perchlorate was a significant predictor of TSH (p= 0.001).

For women > 100 ug/l UI, perchlorate was a sign ificant predictor of TSH (p= 0.0249) which is inconsistent if the predictor (perchlorate) is the caus e and consistent if the predictor is not the cause.

For men, Blount found that perchlorate was not a significant predictor of TSH. Further, as mentioned in our previous comment (EPA-HQ-OW-2 009-0297-0227), we found that in the Blount study there was a strong relationship between iodi ne and perchlorate (p<0.0001 and R2= 0.36). This is an additional indication that perchlorate could not have affected TSH, in addition to the other main arguments: i) an upstream iodine inhibi tion was not shown; ii) there was no relationship between iodine and THs; iii) perchlorate only represen ts 1% of total NIS related goitrogen load and; iv) perchlorate levels seem to have been compensated by iodine. In fact, iodine levels not only seemEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 285 of 1099 to fully compensate for perchlorate levels but also for the levels of the other two NIS goitrogens, nitrate and thiocyanate or conversely, low levels of iodine were compensated for by low levels of goitrogen load (see Appendix 3).

For women, we found that sum23PCB was a significant predictor of TSH (p=0.0027) and that there
was no iodine interaction, or in other words th e relationship of sum23PCB was the same for all levels of iodine or the PCB-TSH relationship wa s not influenced by the iodine level. For men sum23PCB was not a significant predictor of TSH.

(d) pp- DDE (dichlorodiphenyldichloroethylene) as a predictor for TSH In Appendix 2, we demonstrate in detail the relationship between pp-DDE, another dioxin-like organochlorinated compound found in the NHANES 2001-2002 datas et, and TSH. The associations compared with those of perchlorate are summarized as follows:

* For the total population sample, our study found that pp-DDE was a significant predictor of TSH (p=0.0185) * For women, but not for men, pp- DDE was a significant predictor of TSH (p= 0.0040). * Further we did some additional analyses and found the following additional relationships or outcomes when investigating the associat ion between pp-DDE and TSH: 1. There was no interaction between pp-DDE and iodine and gender, whic h is consistent (as it is expected in the case of a non-NIS goitrogen) 2. There was no interacti on between gender and iodine. 3. There was no interaction between iodine and pp-DDE, which is consis tent (as it is expected in the case of a nonNIS goitrogen) 4. There was no effect of iodine on TSH (see ref. 6), which is consistent (expected : see ref. 6) 5. After correcting fo r pp-DDE, an increase of perchl orate was associated with an increase of TSH, only for females (p=0.0003). 6. After correcting for perchlorate, an increase of ppDDE was associated with an increase of TSH, only for women (p=0.004).

Conclusion: Only one single goitrogenic organochlor inated substance directly affecting the level of THs is already associated with TSH at environmental background concentrations, and all other outcomes are consistent with expected results.

2.6. Looking for links between perchlorate and the members of the goitrogenous pool

To further support the absence of a causal relationship between perchlorate with TH, ideally a second relationship -- a relationship between perchl orate and those organo- halogens that directly affect TH levels -- should be found. Although it is difficult to statistically demonstrate this relationship, due to the presence of other confou nding environmental GCs, the most obvious and most widely spread common link is chlorine vi a chlorophenols. For additional explanation, see Appendix 1.

Following a summary of Appendix 1: -DBP road 1: From bleach/Cl2/Cl-/chloramine->-> ClO3 -> ClO4- -DBP road 2 (in presence of organic (C) material): From bleach/ Cl2/Cl-/ chloramine->-> phenols ->-> organochlorides / dioxins with DBP= Disinfection by- products

Since organo-chlorinated compounds are ubiquitous, and since we find at least 1/3 of the total dietary perchlorate where we find organo-chlorina ted compounds (see Appendix 1), and since many of those have been shown to affect TH levels, it is to be expected that low levels of perchlorate are associated with TH levels as found in the Blount study. This association, however, does not
demonstrate causation, as Blount suggests. Given the complicated and overlapping effect of manyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 286 of 1099 substances on TH levels, assigning cause to this association between perchlorate and TH levels defies logic and does not explain the inconsis tencies revealed within the study itself.

Instead, perchlorate appears to be a marker, a "w itness" of the presence of ubiquitous goitrogenic contamination caused by the net effect of hundreds of substances (See also section 2.8). Instead of representing the cause of the impact, perchlorate is correlated to the presence of other ubiquitous goitrogenic substances which contribute to the ov erall impact on TH. This alternative explanation makes logical sense, and explains the contradictions and inconsistencies regarding the other NIS goitrogens found in the Blount study.

2.7. Finally, the "alibi": background levels found compared with known effect levels

The known threshold effect level on THs of orga nohalogens such as PCBs and other dioxin-like substances has been found to be in the range of 0.1 to 10 ug /l serum depending on the substance[FN10: Lesa L. Aylward, Julie E. G oodman, Gail Charnley, Lorenz R. Rhomberg. A Margin-of-Exposure Approach to Assessment of Noncancer Risks of Dioxins Based on Human Exposure and Response Data. Environmental Heal th Perspectives. October 2008. Volume 116, Number 10.][FN11: Lawrence M. Schell, Mia V. Gallo, Melinda Denham, Julia Ravenscroft, Anthony P. DeCaprio, David O. Carpenter. Relations hip of Thyroid Hormone Levels to Levels of Polychlorinated Biphenyls, Lead, p,p'- DDE, and Other Toxicants in Akwesasne Mohawk Youth. Environmental Health Perspectives. June 2008, Volume 116, Number 6.] [FN12: Johan Maervoet,
Griet Vermeir, Adrian Covaci, Nicolas Van La rebeke, Gudrun Koppen, Greet Schoeters, Vera Nelen, Willy Baeyens, Paul Schepens, Maria K. Viaene. Association of Thyroid Hormone Concentrations with Levels of Organochlorine Compounds in Cord Blood of Neonates. Environmental Health Perspectives. December 20 07, Volume 115, Number 12.][FN13: Jonathan
Chevrier, Brenda Eskenazi, Asa Bradman, Laur a Fenster, Dana B. Barr. Associations between Prenatal Exposure to Polychlorinated Biphenyls and Neonatal Thyroid-Stimulating Hormone Levels in a Mexican-American Population, Salinas Valley, California. Environmental Health Perspectives. October 2007. Volume 115, Number 10.][FN14: Mary E. Turyk, Henry A. Anderson, Victoria W. Persky. Relationships of Thyroid Hormones with Polychlorinated Biphenyls, Dioxins, Furans, and DDE in Adults. Environmental Health Perspectives. August 2007, Volume 115, Number 8][FN15: June-Soo Park, Linda Linderholm, M. Judith Charles , Maria Athanasiadou, Jan Petrik, Anton Kocan, Beata Drobna, Tomas Trnovec, Åke Bergman, Irva Hertz- Picciotto. Polychlorinated Biphenyls and Their Hydroxylated Metabolites (OH- PCBs) in Pregnant Women from Eastern Slovakia. Environmental Health Perspectives Volume . January 2007, 115, Number 1.].

The background levels of those substances found in NHANES 2001-2002 are in this range and, as mentioned, a relationship between some with THs was also found in other NHANES data based studies (see ref. 6; ref.7-11 based on other datasets, s how similar levels). This is in stark contrast to the four orders of magnitude difference between the effect level of perchlorate on THs known from the body of the literature and the perchlorate levels that were related to THs found in the Blount study.

These contaminants appear to be part of a wider ubiquitous contaminant pool, natural and manmade, in which there are all kind of GCs acting with all kind of mechanisms that influence TH levels and thyroid function. Most seem to be linked, but additional study would be required to fully understand their complex relationships with one another and with TH. For more information about relationships between GCs, see Appendix 2.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 287 of 1099 Conclusion

Suggesting that a downstream effect (TH level changes) is caused by a substance (perchlorate) without controlling for other relevant substances an d at the same time neglecting to check whether that same substance has a link with a known upstream effect (iodine uptake inhibition) is not the
basis of sound science. On the other hand, lookin g for the most likely causes of an effect (rather than a results-oriented approach seeking only to demonstrate a connection between perchlorate and TH) should produce more plausible leads. Whe n comparing the data and the circumstantial evidence, those leads point towards a vast pool of goitrogenic compounds, both natural and synthetic, of which the perchlorate background onl y appears to be a marker most probably through

the chlorine link.

Response: See response to comment ID 28715 under comment 2600. See also response to

comment IDs 28529 and 28551 under comment code 2500. EPA is aware of the occurrence of perchlorate in some sources of hypochlorite/hypochlorous acid.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28720

EPA Comment Code: 2600

Comment: Appendix 2

The further development of the possible link perchlorate--organohalogens--TH

* Starting from an example: pp-DDE (dichlorodiphe nyldichloroethylene) is a chlorinated pesticide

while on the other side bromides are soil disi nfectants that form organobromides which are goitrogenic substances[FN19: Johan Maervoet, Griet Vermeir, Adrian Covaci, Nicolas Van Larebeke, Gudrun Koppen, Greet Schoeters, Vera Nelen, Willy Baeyens, Paul Schepens, Maria K. Viaene. Association of Thyroid Hormone Concen trations with Levels of Organochlorine Compounds in Cord Blood of Neonates. Environmental Health Perspectives. December 2007, Volume 115, Number 12.]. So, both of those persis tent organohalogens are often found together.

* Further, when bromine (a water disinfectant just as chlorine) and chlorine are involved, halogenated furanones can be produced by the re action of naturally occurring organic matter and

bromide with the disinfectant chlorine and chlorami ne. Research on their concentrations in drinking water is at an early stage and they are not regulated by EPA: http://pubs.acs.org/cen/news/86/i13/8613news7.html

[Clarification: A furanone is a furan where the H is substituted with Cl, becoming polychlorinated furanones or polychlorinated dibenzofuranones. A fu ran is short for dibenzofuran; a chlorinated dibenzofuran is a PCB with a furan ring in the middle].

* This shows their common link with PCBs. Therefore, the halogen bromine can join the second pathway for chlorine: From bleach/Cl2/ Cl2/Cl-/ chloramine, bromides ->-> furanones or phenolsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 288 of 1099 ->-> organohalogens /Dioxins. Thus all those persistent GCs are mostly related qualitatively and quantitatively with each other and appa rently related with perchlorate.

* Associations between NHANES 2001-2002 data for pp-DDE versus TSH and perchlorate versus TSH illustrate the following: - Association between pp-DDE and TSH, total population: significant (p=0.0185) - Association between pe rchlorate and TSH, total population: not significant (p> 0.05). - Association between pp-DDE and TSH, women: si gnificant (p= 0.0040) - Association between perchlorate and TSH: women < 100 ug UI, signific ant (p= 0.001) - Association between perchlorate and TSH: women > 100 ug UI, significant (p= 0.0249).

Conclusion: pp-DDE and other organo-halogens all s eem to be related to each other and with perchlorate within the goitrogenic pool.

Further, we performed some additional analys es on pp-DDE and found the following additional relationships or outcomes when investigating the association between pp-DDE and TSH: 1. There was no interaction between pp-DDE and iodine and gend er, which is consistent as it is expected in the case of a non-NIS goitrogen 2. There was no interaction between gender and iodine 3. There was no interaction between iodine and pp-DDE, which is consistent as it is expected in the case of a non-NIS goitrogen 4. There was no effect of iodine on TSH, which is consistent as it is expected (see ref. 6). 5. After correcting for pp-DDE, an in crease of perchlorate was associated with an increase of TSH, only for females (p=0.0003). 6. After correcting for perchlorate, an increase of ppDDE was associated with an increase of TSH, only for women (p=0.004).

Conclusion: The relation of those organohalogens wi th TSH seem to be consistent with an effect not depending on iodine levels, contrary to the pe rchlorate and other NIS goitrogen relations with TSH in the Blount study which are inconsistent no t only with an iodine de pendent effect but also

show an inconsistent effect between each other.

* Some components of this goitrogenic contaminan t pool have a stimulatory or agonistic effect, others an inhibitory or antagonistic effect[FN 20: Cornelia Schmutzler, Inka Gotthardt, Peter J.
Hofmann, Branislav Radovic, Gabor Kovacs, Luise Stemmler, Inga Nobis, Anja Bacinski, Birgit Mentrup, Petra Ambrugger, Ann ette Gruters, Ludwik K. Malendow icz, Julie Christoffel, Hubertus Jarry, Dana Seidlova-Wuttke, Wolfgang Wuttke, Josef Kohrle. Endocrine Disruptors and the Thyroid Gland-A Combined in Vitro and in Vi vo Analysis of Potential New Biomarkers. Environmental Health Perspectives. December 2007, Volume 115, Number S-1.][FN21: http://www.ourstolenfuture.org/Basics/chemlist.ht m]. Some do not have any effect at all at environmental doses. This may explain why in cross sectional studies as those based on the

NHANES data base the effect of th e sum of some PCBs apparently is not always greater than each individual effect as would be expected[FN22: Kevi n M Crofton, Elena S Craf t, Joan M Hedge, Chris Gennings, Jane E Simmons, Richard A Carchman, W Hans Carter, Jr., Michael J Devito. Thyroidhormone-disrupting chemicals: evidence for dose-dependent additivity or synergism. Neurotoxicology Division, National Health and Envi ronmental Effects Research Laboratory, Office of Research and Development, U.S. Environmen tal Protection Agency, Research Triangle Park, North Carolina, USA. Environ Health Perspect. 2005 Nov ;113 (11):1549-54 16263510 (P,S,G,E,B).] as each individual PCB on itself can be linked to other non identified and quantified goitrogens i.e. (once again) not controlled for covariates with opposite effects.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 289 of 1099 * As mentioned, there already exist 209 known congeners of PCBs alone. They vary based on the number and positions of chlorine atoms but also on their effect (strength and direction). Many have not even been studied on their goitrogenic effect. The fact that the few that were studied, here and in other studies, were found to be predictors of TSH levels is so much the more remarkable.

* Even different groups of chemicals with different mechanisms could have synergetic or antagonistic effects[FN23: Andreas Kortenkamp . Ten Years of Mixing Cocktails: A Review of Combination Effects of Endocrine-Disrupting Chemicals. Environmental Health Perspectives, December 2007, Volume 115, Number S-1.].

* Others may be linked to each other in certain environments and not in others. For example Polychlorinated Biphenyls (PCBs) and Polybromin ated Diphenyl Ethers (PBDEs) --both also called polyhalogenated phenolic compounds-- may have a cumulative effect where bromine and chlorine based disinfectants are used (for example for swi mming pools) and end up as DBPs (disinfection byproducts) in drinking water after having gone thru the purification plant. This link could not exist in places where one of both is not used.

* Other goitrogenic phenols, such as Bisphenol A, linked itself to polyvinylchloride (PVC) such as used in waterpipes, may be linked to this chloride and halogen pool.

* On the other side completely different types of GCs, even natural ones, could be linked indirectly to the pool as well: for example organohalogen based pesticides may be present in very low amounts in soybeans but the goitrogenic effect could instea d be primarily due to the isoflavones naturally present in soymilk[FN24: Daniel R. Doerge, Daniel M. Sheehan. Goitrogenic and Estrogenic Activity of Soy Isoflavones. Environmental Health Perspectives Supplements. June 2002, Volume 110, Number S3.] or the thiocyanates present in ra pe or broccoli or other natural goitrogens such as genistein, resveratrol, silymarin, linuron[F N25: Environmental Protection Agency, EPA/600/P03/002F).An Inventory of Sources and Environmen tal Releases of Dioxin-Like Compounds in the
United States for the Years 1987, 1995 and 2000 . Federal Register: December 1, 2006 (Volume 71, Number 231)] Page 69564-69565] Health Pers pectives Supplements. June 2002, Volume 110, Number S3.]

* Also fluorine is considered a goitrogen[FN26: Fl uoride in Drinking Water: A Scientific Review of EPA's Standards (NAS, 2006) http://www.iicph.org/docs/water- reg-20060830.htmhttp:// www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4769 57]. So, adding fluorine in salt for dental purposes could partially neutralise the effect of a dded iodine. Adding fluorine, another halogen, in drinking water, which is also common, would th en on itself be linked to perchlorate and the organohalogen DBPs.

* Further fluorine is a major constituent of phosphate fertilizers[FN27: http://fluoridealert.org/phosphate/overview.htm#2] and is taken up by the crop so it could, just as the goitrogenic pesticides and isoflavones, be part of the goitrogenic pool as well. Also iodine itself, the fourth halogen, is used as a disinfectant.

* Other factors, even the most unexpected (bir th delivery mode) may confound the effects[FN28: Julie B. Herbstman, Andreas Sjodin, Benjamin J. Apelberg, Frank R. Witter, Rolf U. Halden, Donald G. Patterson Jr., Susan R. Panny, Larry L. Needha m, and Lynn R. Goldman. Birth Delivery Mode Modifies the Associations between Prenatal Polychlorinated Biphenyl (PCB) and PolybrominatedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 290 of 1099 Diphenyl Ether (PBDE) and Neonatal Thyroi d Hormone Levels. Environmental Health Perspectives. October 2008, Volume 116, Number 10.].

* And finally the fact that "The R2 value of 0.061 reported by Blount et al. (2006a) for the association between TSH, perchlorate, and other significant covariates for lower-iodine women indicates that perchlorate accounts for only about 1% of the variation seen for TSH in that population"(quote extracted from ref.6.1) and that therefore about 99% is related directly to goitrogenic compounds once again strongly supports the role of perchlorate as a marker only and

not a cause.

Response: EPA cannot evaluate materials that have not been peer reviewed. See response to comment ID 28715 under comment 2600.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28721

EPA Comment Code: 2600

Comment: Appendix 3

Based on the principle of competitive uptake inhibiti on, it is impossible that perchlorate would have caused the TH changes found in the Blount et al, 2006 study

According to Tonacchera et al., Thyroid, 2004[FN29: Office of Inspector General Scientific Analysis of Perchlorate ,Assignment No. 2008-0010, December 30, 2008]

RAIU= 1.22 / (1.22 +PEC)

Where PEC =serum perchlorate equivalent concentr ation = [ClO4_] + [SCN_] / 15 + [I_] / 30 + [NO3_] / 240 = serum perchlorate + thiocyanate/15 + iodine /30 + nitrate concentration/240 and RAIU = Radioactive Iodine Uptake.

All concentrations are in umol.

The model is only valid for this specific lab trial set-up as described in Tonacchera et al., 2004 but has been generally accepted.

Assume that PEC A is a serum perchlorate equiva lent concentration equal to A and PEC B is a serum perchlorate concentration equal to B.

From the above equation it follows that if PEC A is < PEC B the RAIU, which is the incremental iodine uptake, is larger for PEC A than for PEC B.

This then also means that, if there is no iodine inhibition for a certain level B of PEC in human serum, there will not be any iodine uptake inhibition for a level A of PEC in human serum either, if

PEC AEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 291 of 1099 (Note that PEC includes here the iodine level as iodi ne itself is an iodine uptake inhibitor. Indeed the more iodine present the more the uptake of th e added (incremental) dose of iodine (marked here with radioactive iodine) will be inhibited and theref ore the less (radioactive) iodine of the dose will be taken up).

Further, since we assume steady state (see note below), perchlorate, SCN, iodine and nitrate urinary levels are proportional to perchlorate, SCN, iodine and nitrate effective serum levels or in other words if PEC is, for example, double in serum of person B compared to PEC in serum of person A (ceteris paribus) we can assume that urinary PEC of person B will be double the urinary PEC of person A and vice-versa.

Note: We quote: "In all risk assessments on perc hlorate iodine uptake inhibition "The central assumption is that the amount of perchlorate excr eted per day equals the amount ingested in the

bio-monitored individuals. This is true if these individuals are near or at steady state."(See: Evaluation of the U.S. EPA/OSWER Prelimin ary Remediation Goal for Perchlorate in Groundwater: Focus on Exposure to Nursing Infa nts ,Gary L. Ginsberg,1 Dale B. Hattis,2 R.
Thomas Zoeller,3 and Deborah C. Rice.(ehp, Dec. 2006).

If perchlorate risk assessments are based on th is assumption there is no reason why the same assumption could not be adopted here.

Also we can say that the segment of the general US population with an average of around 200 ug/l urinary iodine, which is well above the minimum WHO (World Health Organization) recommended level of 100 ug/l UI is on average not exposed to any iodine uptake inhibition and to such a level of inhibition as to cause TH (Thyroid Hormone) changes.

Hence, if using the Tonacchera RAIU equation but wi th urinary PEC instead, the segment of the US population with an average of 200 ug/l U iodine an d with an average U PEC B has no overall iodine uptake inhibition, then we can deduct that the segment of the US population with for example an average of 30ug/l U iodine (thus iodine level B>A) but with a PEC A < PEC B and therefore a larger incremental uptake of (radioactive) iodine, do es not have any iodine uptake inhibition as well.

We found that U PEC (as defined above) of the 1/8 segment of NHANES 2001-2002 female population with the average of 228 ug/l UI was higher than the U PEC of the 1/8 segment of NHANES 2001-2002 female population with the lowest av erage of 31ug/l UI (and also higher than that of the subsequent higher segments), See following table1: U PEC is called TGL (total (NIS) goitrogen load) here.

Table1: NHANES 2001-2002: Relationship between urinary iodine and TGL (sorted for iodine) [see PDF docket ID EPA-HQ-OW-2009-0297-0647]

Indeed, when applying the Tonacchera equation after converting molar concentrations into concentrations expressed in weight we have for wo men B with urinary iodine average of 228 ug/l (n=1109/8= 139) (See table 1 above, col.1 ):

RAIU-B i= 1.22 / (1.22 +PEC) where PEC = [ClO4- ] + [SCN-] / 8.8 + [I-] / 38 + [NO3-] / 150)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 292 of 1099 = 1.22 / (1.22 + 5.9+2205/8.8+228/38+74567/150) =1.22/(1.22 +5.9+251+6+497)=1.22/(1.22+760) =1.22/761.22 =0.0016

And for women with iodine average of 31 ug/l (n=1109/8= 139) (see table 1 above, col.1).

RAIU-A = 1.22 / (1.22 +1.5+967/8.8+31/38+1929 3/150) = 1.22 / (1.22 +1.5+110+0.8+129) =
1.22 / 242 =0.005.

Thus RAIU-A is about 3 times larger than RAIU-B which means that the incremental iodine uptake inhibition for A women with urinary I =31 ug/l has to be less than for B women with I = 228 ug/l. This is due to the substantially higher total goitrogen load of women with the higher iodine level; see following tables 2, 3 and 4

Table 2, iodine insufficient women ( <100ug/l UI): col. 9 : total goitrogen load(TGL) is about half and each of the 3 NIS goitrogens nitrate(col. 5), th iocyanate (SCN, col.7) and perchlorate (col.8) are about half of TGL for iodine sufficient women ( >1 00ug/l UI, table 3) and for the total population (table 4)or in other words women with sufficien t iodine have about double the NIS goitrogen load.[see PDF docket ID EPA-HQ-OW-2009-0297-0647]

Since, as mentioned, B women (228 ug/l UI) are no t exposed to iodine uptake inhibition, A women (31 ug/l UI) should not be exposed to iodine upta ke inhibition either and therefore TH levels could not be affected by the goitrogen load (of which perchlorate only represents 1%). In other words, since we can confidently assume that NIS goitroge n load does not affect iodine uptake in the

NHANES 2001-2002 women with mean iodine levels of 228 ug/l urinary iodine it follows from above calculations that NIS goitrogen load, and a fo rtiori perchlorate load which only represents 1% of this load, does not affect iodine uptake and a fortiori TH levels in NHANES 2001-2002 women with the lowest iodine levels of only 31 ug/l. as a mean.

Conclusion

Based on the above analysis of goitrogen levels, io dine uptake and using the Tonacchera equation, it is not possible that the ability of urinary perchlor ate to significantly predict TH changes in women with urinary iodine less than 100 ug/L reported by Bl ount et al., 2006, is directly associated with the joint goitrogen effect of nitrate, perchlorate an d thiocyanate. Thus, it is not possible that the association is directly connected to perchlorate alon e. More likely, the higher goitrogen load of

iodine sufficient women is related to a healthie r diet, one rich in vegetables and fruit.

Response: EPA cannot evaluate calculations th at have not been peer reviewed.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28739

EPA Comment Code: 2600

Comment: EPA must also consider other exposure pathways and additional contaminants in the environment that impact thyroid function when establishing the MCL. Studies of perchlorate levels in food, including breast milk, show that the population is exposed through multiple pathwaysEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 293 of 1099 in addition to contaminated drinking water. EPA should determine potential aggregate exposures based on a broad range of contamination levels, and not just the mean, which was the basis for

current estimates. While data have also demonstrated a particular threat to the significant number of individuals, especially women of child bearing ag e, who are iodide deficient, the current modeling

does not include this threat.

Given this widespread problem (CDC estimates up to 30% of women do not get sufficientdietary iodide), it is critical to take into consideration the potential for exposure to other thyroidactive agents. Consequently, EPA must consider the cumulative impact of perchlorate, other substances in the environment that inhibit the up take of iodide by the thyroid, and inadequate supplies of iodide in American diets, all of wh ich makes a stringent drinking water standard necessary to be truly health protective.

Response: EPA will consider a variety of sources of perchlorate in developing the

NPDWR. As demonstrated in the in the August 2009 Supplemental Request For Comments, breast fed infants is a group identified by EPA as of interest. See response to comment ID 28529 under comment code 2500.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28804

EPA Comment Code: 2600

Comment: Other contaminants are known to also interfe re with iodide uptake via a similar or identical mechanism. For example, the widespre ad water contaminant, nitrate has a shared

mechanism of action as does the chemical thio cyanate, found in cigarette smoke and in some foods.[FN44: Ginsberg G and D Rice. The NAS pe rchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sept; 113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov; 113(11):A732.] There is some in dication in the CDC data analyzed by Blount et al. that nitrate may be a factor in the modulation of thyroid hormone status. An independent analysis by OEHHA staff found an interaction between perchlorate and thiocyanate exposure and tobacco smoke exposure on thyroid hormone. It is also known that perchlorate and thiocyanate are found in breast milk.[FN45: Kirk, AB, Dy ke JV, Martin, CF, Dasgupta PK. 2007. Temporal patterns in perchlorate, thiocyanate, and iodide excretion in human milk. Envrion Health Perspect.115(2):182- 6.]

Response: See response to comment ID 28529 under comment code 2500.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28817

EPA Comment Code: 2600

Comment: Water Docket ID No, EPA - HQ - OW - 2009 - 0297 : commentsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 294 of 1099 Perchlorate: The Greer Non Observed Effect Level (NOEL) and the NAS Reference Dose (RfD) are significantly inaccurate and do not pr ovide a defensible basis for regulation

By: Herwig Opdebeeck, SM, Opdebeeck Consulting

In its Perchlorate Supplemental Request for Comment s, published in the Federal Register on August 19, 2009, EPA states that its preliminary regula tory determination will be based upon the RfD and

risk assessment derived from the 2002 Greer stud y. However, as discussed below, the Greer NOEL did not take into account background effects, incl uding the effects of other goitrogens, and is thus not a true NOEL. The true NOEL is the perchlor ate dose administered in the Greer study (7 ug/kg-day), plus the dose corresponding to the back ground effect. The fact that this background

level has not been added and is not taken into account, leads to a fundamental flaw in the perchlorate risk assessment and should not be relie d upon to either regulate perchlorate or establish

an RfD .

Response: EPA disagrees.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28819

EPA Comment Code: 2600

Comment: Indeed, analyzing the NHANES database, we found that the perchlorate NOEL -- identified in the Greer study as the point at which th e slightest decrease in iodine uptake occurs -- is not 7 ug /kg-day, but 157 ug /kg-day absent any perchlorate or perchlorate equivalent background level in the Greer cohort (which is assumed to be representative for the US population).

Second, and perhaps more significantly, even thou gh the level of background perchlorate is low, other goitrogens in the environment represent a ve ry significant perchlorate equivalent background, 22 times more potent than the Greer NOEL and more than 2,200 times more potent than the perchlorate background level itself for the gene ral population (for women with insufficient iodine (<100 ug UI) the total goitrogen load and perchlorate background are about half, see study addendum 1. This should reflect on the goitrogen level in general and the perchlorate level in particular of foetuses and breast-fed neonates). This perchlorate equivalent background mostly consists of thiocyanate and nitrate in food and water.

Therefore, the true NOEL is the Greer apparent NOEL + the background perchlorate equivalent level (PEC) and is, at 157ug/kg-dayPEC, 22 times larger than the apparent Greer NOEL of 7 ug /kg-day. This leads to a PEC RfD of 15.7 ug/k g-day instead of the NAS RfD of 0.7 ug/kg-day.

This background level should be taken into accoun t in evaluating whether regulation of perchlorate through the Safe Drinking Water Act would re sult in a meaningful opportunity for health risk reduction for persons served by public water systems, and in determining what constitutes a level of public health concern. For the reasons discussed be low, regulation of perchlorate would not achieve either of these goals, because the effect on iodine uptake (the basis for the NOEL) resulting from perchlorate in public drinking water systems is in consequential in comparison to the effect of other substances on iodine uptake. Due to the significant impact of these substances on iodine uptake,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 295 of 1099 even the elimination of perchlorate from the drin king water supply would result in (at best) only a negligible improvement in iodine uptake, and woul d have no effect on overall public health. If the purpose of the PHG is to be truly health protecti ve, the perchlorate equivalent drinking-water PHG would need to be shared with those other goitroge ns. For drinking-water, that would mean that the perchlorate PHG would need to be shar ed with the existing nitrate MCL.

Applying a default relative source contribution (RSC ) of 20%, and assuming that the goal is to avoid the slightest iodine uptake inhibition caused by perchlorate and/or nitrate, we come to the conclusion that, even using the much higher NOEL level discussed above, to achieve the intended
effect of the PHG, the MCL for nitrate would need to be drastically lowered (by more than 80 % if the perchlorate PHG were between 0 (zero) and 1 ppb and by more than 75% if the PHG were to be 15 ppb) and the vegetable and fruit intake of a large segment of the US population (all of the population with a balanced diet) would need to be limited to the daily consumption of fruit and vegetables equivalent to the nitr ate content of 2.3 ounces of lettu ce or equivalent to the thiocyanate

+ nitrate content of an even smaller amount of broccoli.

The logical conclusion of this analysis indicates th at either the nitrate MCL is too high to avoid iodine uptake inhibition, or a NOEL based on iodi ne uptake inhibition is not an appropriate effect on which to base a PHG for perchlorate. Because foods containing nitrate and thiocyanate are an integral part of a healthy diet, an d the effects on iodine uptake can be countered by adequate levels of iodine in the diet, logic dictates the latter conclusion.

This logical conclusion is further supported (if support would still be needed) by the fact that, as mentioned before; i) for women with insufficient io dine (<100 ug UI) the total goitrogen load and perchlorate background are about half, see study addendum 1; ii) according to the same NHANES database, urinary iodine is strongly and positivel y associated with urinary perchlorate which means that the more there is perchlorate background exposure the more there is background iodine exposure (see study addendum 2).

Response: See response to comment IDs 28529, 2855 1, and 20523 under comment code 2500

EPA cannot evaluate calculations that have not been peer reviewed. EPA believes the nitrate NPDWR appropriately derived.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28821

EPA Comment Code: 2600

Comment: 1.2. Determination of the background adjustment factor, BAF

1.2.1. Epidemiological studies: Quantitative Observational Study versus Experimental Study

In order to arrive at an RfD, an effect level is normally determined. The effect level is determined by means of epidemiological studies. By far the mo st common type of human epidemiological study is the quantitative observational study, which is one of the two that leads to dose-response information [FN3: R.L. Calderon ,The Epidemiology of Chemi cal Contaminants of drinking Water , US EPA, Food and Chemical Toxicology, 38, 2000.] (and wh ich cannot be controlled for substances that haveEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 296 of 1099 not been measured). The other type is the controlle d experimental study and is typically used to evaluate drugs or vaccines, but is seldom used to evaluate environmental contaminants.[FN3: R.L. Calderon ,The Epidemiology of Chemical Contaminan ts of drinking Water , US EPA, Food and Chemical Toxicology, 38, 2000.]

The quantitative observational study is in fact a dose-response study of the background level of the contaminant (which in the case of perchlorate is assum ed to be food and drinking water). This is not the case of an experimental study, where the dose -response of the administered dose is studied and not that of the background level. This type of study instead presumes that the background level of the substance is zero, and that the only cause of the effect of the substance in the bodies of the subjects is the administered dose of the substance.

Therefore, in an experimental study such as the Greer study, the effect level that would be found through such longitudinal experiment would not be th e true effect level. Instead, the true effect level would be the sum of the administered dose and the background effect level. The Greer 2002 study from which the RfD was derived was such an experi mental study, and the background perchlorate exposure level may have been confused with the administered dose or may simply have been overlooked. Indeed, experimental clinical studies on humans are, for obvious reasons, seldom done in order to estimate the dose- response of envi ronmental contaminants. The Greer 2002 trial, however, had as its endpoint a Non Observable Effect Level, which was considered a non adverse
effect level. This trial was, therefore, an ina ppropriate method to effecti vely determine the NOEL.

1.2.2. NIS Iodine uptake inhibitors have a cumulative effect

Normally the (adverse) effect level of each contaminant is established independently from other contaminants, as most toxins have a specific effect, th eir effect is not cumulative at all levels, or their cumulative effect is simply not well known. However , this is not the case for the NIS competitive iodine uptake inhibitors, or goitrogens, whose mode of action is well known and is known to be cumulative. Particularly for the three major goitro gens-- nitrate, perchlorate and thiocyanate -- their simple cumulative effect and their relative potency are well known. Thus, in the case of the Greer study, the background level is the perchlorate back ground level, plus the level of other goitrogens
with the same mode of action, i.e. the (competitive) inhibition of iodine uptake.

1.2.3. The Background Adjustment Factor BAF

Indeed, the Greer participants did have additiona l perchlorate doses through background food and drinking water perchlorate as well as background pe rchlorate equivalent caused by other goitrogens. This means that the NOEL from the Greer expe rimental study and which we call Greer_NOEL is lower than the real NOEL which we call PEC_NOEL (Perchlorate Equivalent Concentration NOEL) with PEC_NOEL = Greer_NOEL x BAF (Background Adjustment Factor) and with

BAF>1.

1.2.3.1. The perchlorate background adjustment

The median perchlorate background exposure in the US adult population is 4.6ug/day,[FN4: Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pi rkle JL, 2006a. Perchlorate Exposure of the U.S. Population, 2001-2002. Journal of Exposure Scien ce and Environmental Epidemiology, 1-8.] which is 0.066 ug/kg-day representing only 0.9 % of Greer- NOEL. Thus the mean total perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 297 of 1099 exposure of the Greer cohort = 7 ug/kg-day + 0.066 ug/kg-day = 7.07 ug/kg-day which for all practical purposes we round off and keep at 7 ug/kg-day.

It is worth noting here that the cross-sectional Blount et al, 2006 background study [FN5: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Ca ldwell L, 2006b. Urinary Perchlorate and Thyroid

Hormone Levels in Adolescent and Adult Men and Women Living in the United States. Environmental Health Perspectives 114(12): 1865-1 871.] showed a weak but statistically significant relationship of this very low background exposur e with an effect, and even more surprisingly a downstream adverse effect only. This same signific ant adverse effect relationship, however, is also shown to exist with the background level of some organo halogens in the same NHANES database but which are known, contrary to perchlorate, to cause that kind of weak adverse effect at such low

levels.

1.2.3.2. Other goitrogen background adjustment

In addition, the Greer trial participants were exposed to a perchlorate equivalent background in food and drinking-water from the goitrogens thiocyana te (SCN), nitrate (NO3-) and other goitrogens affecting iodine uptake into the NIS such as fl uoride, chlorate and several others. For practical purposes we will only take nitrate and thiocyanate in to account as those two are the most important and best documented goitrogens (Michael Zimmermann, European Thyroid Association (ETA) Symposium, Lisbon, September 9, 2009).

In the US adult population, serum background expo sure to nitrate expressed in serum perchlorate equivalent concentration (SPEC) is estimated at 0.167umol/l and that of thiocyanate at 1.333umol/l for a total of 1.567umol/l compared to a se rum Greer_NOEL for perchlorate estimated at 0.070umol/l.[FN6: See Office of Inspector General Sc ientific Analysis of Perchlorate ,Assignment No. 2008-0010, December 30, 2008, page 84 and 85 (goitrogen serum and urinary levels based on the NHANES 2001-2002 dataset).] Thus, perchlora te serum exposure of 0.070 umol/L at the Greer NOEL dose represents only 4.5 % of the total serum goitrogen load of 1.567umol/L or in other words the perchlorate equivalent concentration NOEL, PEC_NOEL, which is the real NOEL, is 22.4 times larger than the Greer_NOEL(which itse lf is more than 100 times larger than the perchlorate background). PEC_NOEL = Greer _NOEL x BAF= Gr_NOEL x 22.4 = 157 ug /kgday where BAF is a perchlorate equivalent BAF.

The Greer NOEL of 7ug/kg-day is not a true NO EL but a NOEL on top of the much larger (i.e. 21 times larger) perchlorate equivalent background level. Therefore, the true NOEL is the Greer apparent NOEL, plus the background equivalent perchl orate level, and is more than 22 times larger than the apparent Greer NOEL of 7 ug /kg-day. The background exposure level of perchlorate itself, however, is negligible as it is more than 100 times smaller than the Greer NOEL or more than 2,200 times smaller than the true NOEL, taking in to account only the most well-known goitrogens.

1.2.4. The true reference dose RfD

The true RfD is obtained by dividing the true NO EL by UF (uncertainty factor) which NAS set at 10. Thus the true RfD or PEC_RfD = PEC_NOEL/UF = 157ug/kg-day /10 = 15.7ug/kg-day, equivalent with the ingestion of 2 litres of 550 ppb perchlorate drinking-water if there were no other goitrogen exposure from drinking-w ater, food and any other source.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 298 of 1099 1.2.5. From the true RfD to Perchlorate Equivalent Concentration PHG

To derive a PHG (Public Health Goal) or MCL (Maximum allowed Contaminant Level) for drinking-water from an RfD, usually a RSC (Relative Source Contribution) is applied.

Assume that 80% of perchlorate + nitrate + thio cyanate background originate from food and 20% from drinking-water. A 20 % RSC is the lowest and most conservative RSC used in the derivation of a maximum contaminant level goal [FN7: Regula tory Determination Support Document for selected Contaminants from the second Drinking Water Contaminant Candidate List (CCL-2), US-EPA report 815-D-06-007, December 2006.]. It is the minimum default value.

If no other goitrogens were present in drinking -water, the PHG would then be: 15.7 ug/kg-day x 70kg/2Lx 0.20= 110 ppb or again 22 times the 5 ppb proposed by for example NJ Department of the Environment which used the same 20 %RSC [FN8: http://www.nj.gov/dep/watersupply/perchlorate_mcl_10_7_05.pdf].

1.2.6. The perchlorate-only PHG in relation to the total perchlorate-equivalent PHG

If other goitrogens are present, a PEC_PHG (i.e. the total perchlorate equivalent PHG) should be shared with those other goitrogens. This approach is the only sensible approach, as no distinction between the goitrogens can be made if the goal of the MCL is to be health protective.

For drinking water, nitrate would be the most signif icant other goitrogen. If the current nitrate MCL
were taken into consideration, then PEC_PHG shou ld be equal to PHG of perchlorate + MCL of nitrate expressed in PEC (Perchlorate Equivalent Concentration)[FN9: Nitrate PEC = [nitrate]/240 when expressed in molar weight and /150 when expressed in weight: De Groef B, Decallonne BR, Van der Geyten S, Darras VM, Bouillon R, 20 06. Perchlorate Versus Other Environmental Sodium/iodide Symporter Inhibitors: Potential Th yroid-related Health Effects. Eur J Endocrinol 155(1):17-25.].

As mentioned, the combined perchlorate + equi valent nitrate maximum level should be< 110 ppb or ([Nitrate] PEC+ [perchlorate] should be <1 10 ppb. Since the nitrate MCL = 44 ppm nitrate or 44,000/150ppb=293 ppb PEC, PE_PHG should be equal to PHG perchlorate + 293ppb. Hence, PHG perchlorate should be equal to 110 ppb-293 ppb= negative 183 ppb, which is of course not possible.[FN10: Note: if an RSC =1, as was the case for the nitrate MCL, would have been applied on the background perchlorate equivalent level as well, PEC_PHG would have been = (15.4 ug/kgday) x 70kg/2 l x 1= 539 ppb. Indeed in determini ng the drinking water nitrate MCL no RSC (i.e. RSC=1) taking into account food has been applie d even though nitrate levels in food such as vegetables are very significant (and as much significant in terms of BBS as iodine uptake inhibition).If this would have been done, it would on itself already have lowered substantially the nitrate MCL. A 0.2 default value, as we apply here for PEC, would have lowered it already to 8.8 ppm. According to the WHO (see ref. 12) the contri bution of drinking-water to nitrate intake is usually less than 14 so even lower than the cons ervative 20 % default value assumed here.]

Thus, we must conclude that either the nitrate MCL is too high to avoid iodine uptake inhibition, or a NOEL based on iodine uptake inhibition is not an appropriate effect on which to base a PHG for perchlorate -- or both. If, nevertheless, the iodine uptake inhibition NOEL is to be kept as theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 299 of 1099 relevant effect, the nitrate MCL should be lowered in the first instance from 44 to 14.2 ppm to allow a perchlorate PHG of for example 15 ppb, the one EPA currently proposes as an interim level.

There is an additional background adjustment, anot her RSC, to be made for nitrate. Contrary to perchlorate and thiocyanate for which the serum expo sure is proportional to the oral exposure, there is, besides an oral exposure, also an endogenous ex posure to nitrate estimated at 45% of total nitrate exposure.[FN11: Nitrate and Nitrite in Drinki ng Water, Subcommittee on Ni trate and Nitrite in Drinking Water, Commission on Life Sciences, NR C (National Research Council), page 38. Washington, DC, National Academy Press, (ISB N-10: 0-309-08370-2).] Th erefore there is an estimated relative source contribution of exogeno us (oral) nitrate of 55% only. Thus to allow a perchlorate PHG of 15 ppb the nitrate MCL should be further lowered to 14.2 x 0.55= 7.8 ppm nitrate (or 2.1 ppm N as nitrate instead of 10 ppm N as nitrate) or about 1/5 of the current MCL). (This cannot be significantly compensated for by further lowering the perchlorate PHG from 15 to 1ppb (a 93% decrease), since this would only allow an increase of the nitrate MCL from 7.8 ppm to a still very low 9.9 ppm( a 27% increase only), still ending up with less than 1/4 of the MCL).

So, even with a PEC of 110 ppb (based on a true RfD of 15.5ug/kg-day PEC and a RSC of 20%), it is obvious that either the nitrate MCL (=293 ppb PEC) is too high to avoid iodine uptake inhibition or a NOEL based on iodine uptake inhibition is not an effect on which to base a PHG for perchlorate, or both.

Further, since we used a 20% default RSC which re sulted in a perchlorate + nitrate MCL of 110 ppb for drinking-water, this means that the perchlor ate equivalent exposure through drinking-water would be 2 Lx 110 ug/lL = 220 ug per adult /day. This would also mean that the intake through food, which would represent 80%, would be 2 20x80/20= 880 ug per adult/day perchlorate equivalent. This seems high on first sight but in reality is not as it represents an ingestion of only 66 g (2.3 ounce) of lettuce containing an ordinary 20 00 ppm nitrate [FN12: Nitrate and nitrite in Drinking-water, Background document for devel opment of WHO Guidelines for Drinking- water Quality, Originally published in Guidelines for dr inking-water quality, 2nd ed. Addendum to Vol. 2 Health criteria and other supporting informat ion. Word Health Organization, Geneva, 1998.]; (Hydroponic lettuce can contain up to 6000 ppm (40,000 ppb PEC) nitrate) or an even lower amount of broccoli (broccoli contains a me an of 11,500 PEC nitrate and 2000 PEC thiocyanate).[FN13: Perchlorate, Thiocyanate, and Nitrate in Edible Cole Crops (Brassica sp.) Produced in the Lower Colorado River Region, C. A. Sanchez, B. C. Blount, L. Valentin-Blasini,R. I. Krieger, Published online: 26 October 2007, Sp ringer Science + Business Media, LLC 2007.]

Further, this also means that if the [perchlo rate + nitrate] MCL were only 110 ppb PEC, consuming 66 g /day of lettuce and 2 litres of 110 ppb PEC DW would already represent the maximum allowed daily dose though water and food and no other nitr ate carriers such as spinach, melon, cured meats and thiocyanate carriers such as broccoli and caulif lower, (which in themselves cause an average 8 times higher exposure load than nitrate)[FN14: Offi ce of Inspector General, Scientific Analysis of Perchlorate, Assignment No. 2008 -0010, December 30, 2008.] could be consumed that day by a healthy adult. Besides that, the nitrate level of the water consumed the same day could not exceed 1/5 of the current MCL if a perchlorate PHG of only 15 ppb would be chosen and 1/4 if a perchlorate PHG of 1 ppb would be chosen, as shown above.

Since in the US about half of the groundwater ex ceeds 10 ppm perchlorate and 6 % of groundwater exceeds 20 ppm[FN15: See ref. 12.] and almost all DW exceeds 1/5 of the MCL, the conclusionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 300 of 1099 should be that if a 15ppb or lower MCL for perchlorate is determined, the US population should basically stop consuming drinking water derive d from groundwater and vegetables and fruit containing thiocyanates and nitrates. Even bottled water would not help much as almost all contain more than 5 ppm nitrate (based on a quick supermarket inquiry by the author) or 33 ppb PEC. Even "pristine", expensive imported bottled water contains between 3 and 10 ppm nitrate or up to 66 ppb perchlorate equivalent.

Conclusion

The NAS RfD, derived from the Greer NOEL is not a true RfD, since the Greer NOEL does not include the perchlorate equivalent background. The true RfD, at 15.5ug/kg-day, is more than 22 times larger than the NAS RfD of 0.7ug/kg-day.

Even at this higher RfD, however, the impact of ot her goitrogens, such as nitrate, in drinking water and food and thiocyanate in food would make it im possible for any level of perchlorate regulation to have any meaningful impact on public health. One reason for this may be that the appropriate

"effect" to be considered in the evaluation of a NOEL should not be the point of iodine uptake
inhibition, since the contribution of nitrate and even more of other goitrogens such as thiocyanate already largely exceeds the level of iodine uptake inhibition in healthy diets. Based on the foregoing,

EPA is unable to demonstrate two of the three crit eria required to regulate perchlorate in drinking water - namely: (1) EPA cannot demonstrate that pe rchlorate will occur in public water systems at levels of public health concern, because it cannot accurately be determined what constitutes a level of public health concern based on the current studies, and (2) EPA is unable to demonstrate that regulation of perchlorate represents a meaningfu l opportunity for health risk reduction for persons served by the public water system, since even its elimination would not result in any meaningful improvement in public health.

Response: Please see the response to comment ID 28819 under comment code 2600.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0227

EPA Comment ID: 28823

EPA Comment Code: 2600

Comment: ADDENDUM 1

By: Herwig Opdebeeck, SM, Opdebeeck Consulting

The unexpectedly weak goitrogen load of the iodine-deficient female US population

The U.S. iodine insufficient female population, be sides an inadequate iodine containing diet, seems to have a generally unbalanced diet character ised by a low consumption of vegetables.

We refer again to the NHANES 2001-2002 data on urinary perchlorate (CLO4), nitrate (NO3), thiocyanate (SCN) and iodine where we show the re lationship between iodine and total goitrogen load (TGL).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 301 of 1099 Table 1, 2, 3: NHANES 2001-2002: Relationship between iodine and total goitrogen load (TGL) (sorted for T4) [see PDF docket ID EPA-HQ-OW-2009-0297-0227]

The first table is for women with <100 ug/l urinary iodine (women<100), n=384), the second for women with >100 ug/l urinary iodine (women>10 0, n= 725), the third for the total population (n=2080) (Individuals with >2000 ug/l urinary iodine have been removed).

From these tables the following observations can be made:

Preliminary note: The serum goitrogen load is a measure for the effective thyroid goitrogen load. Here we refer to the urinary (U) load which does not accurately reflect the effective serum load. For example the residence time of thiocyanate is much longer than the one of nitrate or perchlorate. However this does not matter here since the purp ose is only to compare th e urinary loads between the different population groups i.e. the relative lo ads and because we can assume that urinary loads are proportional to serum loads (for example a double urinary load also means a double serum load).

-Women with iodine levels < 100 have a total goitrogen load(TGL) expressed in PEC that is about 50% lower than women > 100 and than the overall population (columns 9 ).

-Split into the constituents, their perchlorate, ni trate and thiocyanate levels, over the entire T4 spectrum (Col. 2 ), are about 50%, 50% and 35% lower respectively (columns 8, 5 and 7).

- This means that women with insufficient iodine le vels happen to be those that are least susceptible to iodine uptake inhibition, if they would have been iodine sufficient.

-Urinary(U) perchlorate for all population groups re presents less than 1% of the total urinary goitrogen load expressed in PEC (columns 10) and, as shown in section 1 above, also of the total serum(S) load.

Conclusion

Women with insufficient iodine levels happen to be those that are least susceptible to iodine uptake inhibition, if they would have been iodine suffici ent. Improving their diet and iodine uptake would be the remedy.

Lowering instead the perchlorate intake by any rate (1, 10 or 100%) would not diminish NIS iodine uptake inhibition, also not for iodine-insufficient (<100) women since the NIS iodine uptake inhibition potential caused by TGL which is more than 100 times larger, is already 50 % lower than for iodine sufficient women (>100). So besides the fact that eliminating all perchlorate even the background level would still leave 99% of TGL untouc hed, this remaining 99% is only half that of

iodine sufficient women.

ADDENDUM 2

By: Herwig Opdebeeck, SM, Opdebeeck Consulting

The strong relationship of low levels of U-perchlorate with U-iodine levelsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 302 of 1099 In continuation of Addendum 1 : Nevertheless wome n with urinary iodine < 100 ug/l have a ratio of iodine to total goitrogen load (TGL) equal to about 0.2/1 for every T4 octille (1/8) while women > 100 ug/l have about a ratio equal to 0.8/1 also for every T4 octille (columns 13 of above 2 first tables of addendum 1) which means that, even th ough the goitrogen load for iodine-insufficient women is only about half that for iodine sufficient women, their iodine inhibition potential is 4 times higher so it is obvious that if iodine uptake inhibition in this subpopulation would occur it would be due to lack of iodine and not due to goitrogen load.

For perchlorate this is even more explicit since pe rchlorate, at low levels, is strongly related to iodine: see next figure[FN16: 1. Charnley G, Perc hlorate: Overview of Risks and Regulation. Food and Chemical Toxicology, 2008. 2. Soldin OP, Tr actenberg RE, Pezzullo JC. Do thyroxine and thyroid-stimulating hormone levels reflect urin ary iodine concentrations? Therapeutic Drug Monitoring. 2005, 27: 178-185. ] (fig.2) which is derived from the same NHANES 2001-2002

survey.

Fig 2 Relationship between urinary iodine and urinary perchlorate for the general population controlled for gender, T4 and TSH, p<0.0001 (ug/l, log scale) [see PDF docket ID EPA-HQ-OW2009-0297-0227]

This relationship also suggests that low levels of perchlorate are naturally linked to iodine (both are formed in the atmosphere and both are found in naturally nitrate -rich soils in the US S-W deserts and arid regions).

So women with low natural background levels of pe rchlorate have low natural background levels of iodine. For higher background levels of perchlorate the link with iodine ceases to exist or not enough data points exist for those higher levels.

Thus it seems that women with higher levels of iodine not only tend to have higher levels of natural perchlorate but additionally some from other contaminated (point) sources.

For the other 2 goitrogens this suggests that those iodine-insufficient women also consume significantly less vegetables than the iodine-suffi cient population. This could then also explain the higher non-natural levels of perchlorate from ve getables irrigated with synthetic perchlorate containing water such as the Colorado River (or, as mentioned before, this non- relationship can be due to a lack of data points at those higher levels ). Nevertheless those synthetic perchlorate levels are themselves still insignificant compared to the total goitrogen load.

All this strengthens once more the argument that in the US population the potential iodine uptake inhibition does not lay with goitrogens and even le ss with perchlorate but clearly with a lack of

iodine.

Conclusion - Even though the goitrogen load of iodi ne insufficient women is only about half that of goitrogen sufficient women, their ratio iodine to goitrogen load is much lower which suggests once again that the remedy is iodine. - For low backgrou nd levels of perchlorate there seems to exist a remarkable relationship with iodine which suggest that those lower levels are natural levels since synthetic perchlorate such as rocket fuel does not contain iodine. - It is once again suggested here that Iodine insufficient women seem to have also a diet low in vegetables besides a diet low in iodine containing food such as fish.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 303 of 1099 Response: EPA cannot evaluate calculations that have not been peer reviewed.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28878

EPA Comment Code: 2600

Comment: Fifth, the level of IUI that would be associ ated with exposure to perchlorate at the RfD is minimal compared to the IUI associated with other environmental goitrogens naturally present in many foods. Nitrate and thiocyanate are less po tent (Tonacchera et al., 2004) but more plentiful inhibitors of NIS activity than perchlorate (Bel zer et al., 2004). The potency of nitrate and thiocyanate relative to perchlorate has been demo nstrated in vivo (Wyngaarden et al., 1952, 1953; Greer et al., 1966; Belzer et al., 2004) and in vitro (Tonacchera et al., 2004). When based on perchlorate equivalence, the effects of perchlorate ar e much smaller than the ef fects of either nitrate or thiocyanate (Belzer et al., 2004; U.S. EPA, 2008b ). The potential for perchlorate to inhibit iodide uptake cannot be distinguished from the effects of other NIS inhibitors (De Groef et al., 2006). Because exposure to nitrate and thiocyanate would continue, the premise underlying EPA's attempt to isolate the effect of perchlorate is limited in its ability to provide an actual public health benefit.

Response: See response to comment IDs 28529 an d 28551 under comment code 2500.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28889

EPA Comment Code: 2600

Comment: One major scientific issue is that the effects of agents that affect IUI in the same way as perchlorate were not consid ered by the Notice.

Because perchlorate, nitrate, and thiocyanate co mpete with iodine for uptake by the NIS, the

combination of these chemicals in food or water wi ll affect iodine uptake to the thyroid as well as absorption into the body from the gut. The NIS is located in the small intestine and uptake of iodine can be reduced by sufficient doses of perchlorate (Brown-Grant, 1961). In defining a HRL, it is assumed that 100% of an ingested dose is able to reach the thyroid. Of the four chemicals (perchlorate, nitrate, thiocyanate, iodine), perchlorate has the highest affinity for the NIS, however,

the other three are more abundant in the diet. In the FDA Total Diet Study, the dose range of perchlorate was 2.4 to 9.1 ug/person-d and the do se range of iodine was 144 to 353 ug/person-d (Murray et al., 2008). Similar to biomonitoring stud ies (Blount et al., 2006) and dose models (Belzer et al., 2004), the OIG Draft Repor t (U.S. EPA, 2008b the results for exposures to nitrate, thiocyanate, and perchlorate found that perchlorate accounted for less than 1% of the predicted IUI in the total goitrogen load. Based on NHANES 2 001-2002, the average ur inary concentration of perchlorate was 4.8 ug/L, which was much lower than the urinary concentrations of nitrate, thiocyanate, and iodine at 55,017 ug/L, 2,04 2 ug/L, and 200 ug/L, respectively. Figure 2 demonstrates the relative contribution of perchlor ate to total goitrogen load using another set of
data, the NHANES 2001-2002 database.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 304 of 1099 Figure 2. Total goitrogen load in perchlorate e quivalence* based on urinary measurements from women ages 12 and older from NHANES 2001- 2002.** [see PDF docket ID EPA-HQ-OW-2009- 0297-0662]

One characteristic of this relationship is that as perchlorate dose increases in food, so does intake of nitrate, thiocyanate, and iodine. Figure 2 presents the cumulative intake of the four agents based on NHANES data using perchlorate equivalence of the urinary concentration of nitrate and thiocyanate. Two things become clear. First, as iodine level increases, so does total cumulative dose. Second, perchlorate contributes, by far, the smallest amount to total cumulative dose. The chart shows that as the goitrogen load increases, people tend to have increased intake of iodine, probably due to greater ingestion of total food.

Response: See response to comment ID 28529 under comment code 2500.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28928

EPA Comment Code: 2600

Comment: Background: Perchlorate is unique among chem ical contaminants for its ubiquity- it has been found as a contaminant in drinking water in at least 26 states, in 74% of nearly 300 types of commonly consumed foods and beverages tested by the Food and Drug Administration (FDA), and in the urine of 100% of Americans tested by th e Centers for Disease Control and Prevention (CDC) (GAO 2005, Blount et al 2006a, Murray et al 2008). Its primary clinical effects are on the thyroid gland, where it can disrupt the production of th yroid hormones that are critical for normal brain development and growth in the fetus, infants, and children. Perchlorate inhibits thyroid hormone synthesis by preventing iodine, the building block for thyroid hormones, from being taken up into the thyroid gland from the circulation. Iodine status is especially important in determining vulnerability to perchlorate, as confirmed by a r ecent large-scale epidemiological study from the CDC that found that women with lower iodine levels had more significant changes in thyroid

hormone levels associated with environmental perchlorate exposure when compared with women with higher iodine levels (Blount et al 2006a).

Response: EPA agrees that individuals with inadequate iodide nutritional status are more likely to be adversely impacted by perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 305 of 1099 

### EPA Comment Code: 3000 Perchlorat e Occurrence in Drinking Water

Individual Comments

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0469

EPA Comment ID: 19899

EPA Comment Code: 3000

Comment: Does the EPA's decision not to regulate perc hlorate in drinking water mean that it accepts an exposure of 420 ppb in Utuado, Puerto Rico, or has that town's water supply been thoroughly inspected and all water sources with more than 15 ppb have been shut down?

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Diane VanDe Hei Commenter Organization: AMWA

EPA Document ID: EPA-HQ-OW-2008-0692-1525

EPA Comment ID: 20446

EPA Comment Code: 3000

Comment: Other Considerations

AMWA believes that factors other than those discussed in the notice need to be considered. The contamination of water supplies by perchlorate is on-going and spreading unlike many other CCL contaminants where a determination not to regulate has been made, such as in the case of pesticides that are no longer used and have low and decreasi ng occurrence levels. Perchlorate, on the other hand, is expected to have increasing occurrence levels and impact increasing numbers of water systems - clearly a call for at least the actions outlined herein.

AMWA appreciates the opportunity to comment on EP A’s preliminary regulatory determination. If EPA has any question about our comments please do not hesitate to contact me or Erica Brown, Director of Regulatory Affairs, at 202-331-2820.

Sincerely,

Diane VanDe Hei Executive Director Cc: Cynthi a Dougherty, OGWDW Eric Burneson, OGWDW

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. Regarding perchlorate contamination of water supplies, EPA acknowledges that some systems may have had an increase in perchlora te occurrence. The Agency analyzed the additional information and decided that regulation of perchlorate due to occurrence and health implications

was warranted.

Commenter Name: Mark S. MayerEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 306 of 1099 Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28483

EPA Comment Code: 3000

Comment: - Comments on interpreting occurrence data - Because South Dakota does not have any
occurrence data, a new rule for Perchlorate would be another regulatory burden for our drinking water systems, but it would result in no posit ive health benefits for their customers.

Response: Using the criteria mandated by the 1996 SDWA Amendments EPA has determined that regulation of perchlorate in drinking water sy stems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528

EPA Comment ID: 28512

EPA Comment Code: 3000

Comment: Perchlorate has been found in over 400 drinki ng water sources in 26 states, potentially affecting tens of millions of peopl e. EPA's own data say that near ly 17 million people receive their water from public water systems where perchlorate has been found at levels exceeding 4 ppb. Were sampling routinely conducted with a detection limit of 1 ppb, that number would be much higherparticularly considering the estimated 20 million pe ople in the Southwest who receive drinking water

from the Colorado River.

Response: EPA estimates that at least 5.1 to 16.6 million people are served by PWSs, for which we have data, that have perchlorate contamination. EPA has determined that a NPDWR for perchlorate could reduce perchlorate exposures for these popula tions to levels below the potential alternative HRLs that EPA has identified as levels of public he alth concerns for purposes of this determination, and that such exposure reductions present a meanin gful opportunity for the reduction of health risks for persons served by PWSs.

Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28543

EPA Comment Code: 3000

Comment: Perchlorate has been found in more than 400 drinking water sources in 26 states, potentially affecting tens of millions of people. EPA's own data say that nearly 17 million people receive their water from public water systems wher e perchlorate has been found at levels exceeding 4 ppb.

Response: See response to comment ID 28512 under comment code 3000.

Commenter Name: Tom PortaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 307 of 1099 Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28747

EPA Comment Code: 3000

Comment: 4. The collection of new data for perchlora te in public water systems would provide reliable occurrence data to inform the establishment of a national primary drinking water standard. The need for new occurrence data is underscored by the significant improvements in water quality (considerably lower perchlorate concentrations) wi thin the Lower Colorado River System since the

UCMR 1 data were collected between 2001 and 2005. Additionally, newer and more sensitive analytical methods are now available that would pe rmit perchlorate analysis with reporting limits (detection limits) at or below 1 ug/L. Consequent ly, the new occurrence data would represent a more robust data set that would permit statistical analysis without the inherent limitations present in the current Bayesian modeling of the existing, outdated occurrence data.

Response: EPA acknowledges that there are newer and more sensitive analytical methods that are now available that would permit perchlorate analys is with reporting limits at or below 1 ug/L. The Agency does not believe that additional monitoring data is needed to determine that perchlorate meets SDWA’s criteria for regulating a contaminan t. EPA's UCMR data is nationally representative and sufficient for estimating the frequency and leve l of perchlorate contamination. In addition, the Agency plans to further evaluate perchlorate occu rrence as part of the proposed national primary drinking water regulation.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28754

EPA Comment Code: 3000

Comment: Comment C.4.a.2: The NDEP recommends EPA require collection of new occurrence data to support the latter two of the three criter ia that EPA most demonstrate in order to regulate this contaminant in drinking water; namely: (1) th e contaminant is known to occur (or there is a substantial likelihood that the contaminant will occur) in public water systems, with a frequency and at levels of public health concern; and (2) re gulation of such a contaminant presents a meaningful opportunity for health risk reduction for persons se rved by public water systems. The existing

occurrence data are both outdated and nonr epresentative of current conditions.

The Unregulated Contaminant Monitoring Program is designed to collect such data for use in evaluating and prioritizing contaminants on the Dr inking Water Contaminant Candidate List. It is an established program to "help ensure that future decisions on drinking water standards are based on sound science" (www.epa.gov/safewater/ucmr/ucmr 1/factsheet.html#list). Perchlorate was on the analysis list published for the first Unregulated Con taminant Monitoring Rule (UCMR 1) in 1999 to collect data from 2,800 large public water system s and 800 small public water systems throughout the United States, but as further discussed elsewhere herein, the data is now largely obsolete due to analytical method changes and perchlorate remediation work in the Southwest. The NDEP

recommends that EPA consider use of the esta blished and successful UCMR process to collect updated national public water system occurrence data.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 308 of 1099 The NDEP believes use of outdated (historical) occurrence data collected from 2001 through 2005 would be inappropriate because the quality of source water from the Lower Colorado River System has improved as a result of several successful remediation projects in the Las Vegas Valley. This source water provides the water supply for a larg e portion of the US population (approximately 26 million US residents) and for a large amount of irrigated vegetable crops. The current perchlorate concentrations in the Lower Colorado River System are significantly lower th an the concentrations present when the occurrence data were collected (2001 - 2005). The NDEP believes that collection of new occurrence data would permit a more accu rate assessment of the exposure scenario and lead to a conclusion that regulation of perchlorate unde r the Safe Drinking Water Act (SDWA) does not present a meaningful opportunity for health risk reduction for persons served by public water systems or through ingestion of the referenced irrigated crops. The following summary of perchlorate remediation efforts within the Las Vegas Valley and corresponding water quality improvements within the Lower Colorado River sy stem are provided to support this comment.

Response: EPA disagrees with the statement that UCMR 1 data is obsolete. The UCMR 1 includes sample results reported by 3,865 public water sy stems between 2001 and 2005. This is the best available data collected in accordance with accepted methods on perchlorate. EPA recognizes that changes in perchlorate levels may have occurred in water systems since the UCMR samples were collected. However, EPA does not believe that the regulatory determination should be further delayed when we have a robust data set that ca n be used to evaluate occurrence. EPA plans to further analyze available perchlorate data in de veloping a proposed drinking water regulation.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 309 of 1099 

### EPA Comment Code: 3100 UCMR 1 occurrence analysis

Individual Comments

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0163

EPA Comment ID: 20271

EPA Comment Code: 3100

Comment: First, Phillips and Chambless,(see referen ce 1 electronic attachment - "Phillips compliance data variability.pdf") [see PDF of do cket ID EPA-HQ- OW-2007-0068-0163] evaluated compliance data for several contaminants obtained fr om a cross section of state regulatory agencies and found consistently large variability in the me ans of quarterly samples taken for compliance purposes. This variability, expressed as the standa rd error of the mean divided by the mean, is significant enough (100% or more in many cases) to call into question the validity of decisions made

based on these data. There is no reason to assume th at the quality of the occurrence data from the UCMR effort would be any better than the quali ty of these compliance data, and NRWA strongly recommends that EPA resolve this quality issue befo re trying to make CCL2 regulatory decisions that are based on rather precise calculations of occurrence levels times the number of persons exposed.

Response: EPA respectfully disagrees with NRWA on the assertion that the validity of occurrence data from UCMR be compromised based upon an an alysis of variability in compliance monitoring data collected by public water systems. UCMR has gone under rigorous QA/QC measures to ensure that data variability is at a minimum. A detailed description of UCMR monitoring can be found in the Federal Register under docket number EPA– HQ–OW–2007–0068. The title of the reference that describes UCMR is “The Analysis Of Occurrence Data From The First Unregulated Contaminant Monitoring Regulation (UCMR 1) In Support Of Regulatory Determinations For The Second Drinking Water Contaminant Candidate List".

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20656

EPA Comment Code: 3100

Comment: Fifth, EPA has extensive monitoring data from public water systems on perchlorateoccurrence in drinking water. While your November 5th letter [See PDF Docket ID EPA-HQ-OW2008-0692-1749] states perchlorate has "wide occurrence," EPA’s UCMR 1 data suggests that drinking water perchlorate occurrence is much less frequent that other compounds (sodium, manganese, sulfate, and boron) for which EPA has determined Federal drinking water standards are not necessary. The monitoring data also show that, for an overwhelming majority of the US population served by public water systems, exposur e to perchlorate in drinking water is at a

concentration much less than EPA’s calculated HRL of 15 ppb. In fact, based on UCMR1, only 1.8% of public water systems had levels of perchl orate that were above the minimum reporting limit of 4 ppb.[FN8: US EPA, Unregulated Contaminant Monitoring Regulation 1 List 1 AssessmentEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 310 of 1099 Monitoring, 1999.] Although unpublished, the EPA’s merger of the NH ANES-UCMR1 datasets study has been peer-reviewed.

Response: Administrator Stephen Johnson replied to the SAB on January 9, 2009. The letter is available in EPA’s docket ID No. EPA-HQ-OW-2009- 0297 for this notice. EPA disagrees that only 1.8% of public water systems had levels of perchl orate that were above the minimum reporting limit. In the October 2008 FR notice, EPA presented in formation on the drinking water occurrence of perchlorate. The data source was EPA's UCMR 1 and the samples were collected between 2001 and 2005. A total of 34,331 samples were collected from 3,865 public water systems. EPA found that 4.1% of the systems (160 out of 3,865 systems) reported perchlorate at, or above, the MRL of 4ug/L.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21027

EPA Comment Code: 3100

Comment: 10. Also regarding UCMR sampling, your letter questions the UCMR sampling because it focused only on large PWSs and does not account for exposure from "local hot spots" due to blasting, fireworks, and industrial and military releases.

The UCMR is the most complete source of information on contaminant occurrence in the nation’s drinking water sources. The process for collecting da ta on unregulated contaminants in large as well as small water systems has been well established and relied upon by EPA for regulatory determinations from both the Contaminant Candidate List (CCL) 1 (issued July 2003) and CCL 2 (issued July 2008). Additionally the National Rural Water Association, a non-profit federation of state rural water associations (and has the largest utility membership) expressed support for EPA’s preliminary determination, stating "the Agency has relied on sound science" in making its decision."[FN9: National Rural Water Association, Drinking Water Preliminary Regulatory Determination on Perchlorate (Docket Number : EPA-HQ-OW-2008-0692), Nov. 10, 2008.]

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Ellen Blaschinski, M.B.A., R.S. Commenter Organization: Regulatory Services Branch, Connecticut Department of Public Health

EPA Document ID: EPA-HQ-OW-2008-0692-2091

EPA Comment ID: 21116

EPA Comment Code: 3100

Comment: Public supplies in Connecticut were tested for perchlorate as part of the 2001 Unregulated Contaminant Monitoring Rule (UCMR) round of testing. There were no detections in those systems at that time. However, that is a snapshot and not nearly the complete and ongoing surveillance that a federal MCL would provide. We note that the parallel UCMR testing in Massachusetts found very few detections of perchlor ate and yet additional testing by the State of Massachusetts found substantial public water cont amination on a site-related basis. Additional testing in Connecticut is warranted given the chan ging use pattern of perchlorate in blasting materials, fireworks and other applications.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 311 of 1099 Response: See response to comment ID 29097 under comment code 3100 and response to

comment code 6120.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28700

EPA Comment Code: 3100

Comment: It is important for EPA to properly character ize its estimates of the potential population exposed to perchlorate. Perchlorate cleanup along the Colorado River has been very successful in recent years, and this represents the water supply for 26 million people in the Southwest. Perchlorate was detected in the Las Vegas Wash in 1997. The contamination was due to past disposal practices at the perchlorate manufacturing sites in the Las Vegas valley. Due to efforts of the manufacturers, Tronox LLC (Kerr-McGee Chemical LLC) and Amer ican Pacific Corporation, working with the Nevada Division of Environmental Protection, perc hlorate concentrations entering Lake Mead and the lower Colorado River System have decreased dr amatically. The perchlorate load entering Lake Mead in 1998 was 1013 lbs/day; it has been currently reduced to 61 lbs/day.

Perchlorate concentrations have also decreased dramatically in the drinking water since 1998 throughout the lower Colorado River system. The aver age perchlorate concentration reported by the Authority and the City of Henderson for the Un regulated Contaminate Monitoring Rule (UCMR) averaged 9.6ug/L and 2.9 ug/L, respectively. Cu rrently, the perchlorate concentration in the Authority and the City of Henderson's drinking wa ter is an average of 2. 1ug/L. Drinking water providers along the lower Colorado River have reported similar decreases in perchlorate concentrations. The data collected for the UCMR may not reflect current perchlorate exposure for the Southwest. The average perchlorate concentrati on at Whitsett Reservoir for the last two years is 1.6 ug/L. This is the Colorado River source water for the Metropolitan Water District of Southern California and the Central Arizona Project. Californi a and Arizona blend with instate waters which

result in a lower concentration. Three states have adopted perchlorate standards of 6 ug/L or less, which requires the water wells to be shut down if above the state limit. The exposure to perchlorate has been reduced significantly in the Southwest.

If you have any questions about these comments, pl ease do not hesitate to contact me at 702-862- 3708 or Shane Snyder at 702-856-3668.

Sincerely, Kay Brothers Deputy General Manager Engineering and Operations

KB/df Enclosure

Reference:

Amitai, Y., G. Winston, et al. (2007). "Gestationa l Exposure to High Perchlorate Concentrations in Drinking Water and Neonatal Thyroxine Levels." Thyroid 17(9): 843-850.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 312 of 1099 Baier-Anderson, C., B. Blount, et al. (2006). "E stimates of Exposures to Perchlorate from Consumption of Human Milk, Dairy Milk, and Water, and Comparison to Current Reference Dose." Journal of Toxicology and Environmental Health - Part A 69: 319-330.

Blount, B. C., J. L. Pirkle, et al. (2006). "Uri nary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States." Environmental Health Perspectives Online.

Blount, B. C., L. Valentin-Blasini, et al. (2006) . "Perclorate exposure of the US population, 2001- 2002." Journal of Exposure Science an d Environmental Epidemiology 1-9.

Crump, K. S. and J. P. Gibbs (2005). "Benchmark calculations for perchlorate from three human cohorts " Environmental Health Perspectives 113: 1001-1008.

Dasgupta, P. K., P. K. Martinelango, et al. (2005). "The origin of naturally occurring perchlorate: The role of atmospheric processes." environm ental Science & Technology 39(6): 1569-1575.

Dyke, J. V., K. Ito, et al. (2007). "Perchlorate in Dairy Milk. Comparison of Japan versus the United

States." Environmental Scien ce & Technology 41: 88-92.

Greer, M. A., G. G. Goodman, et al. (2002). "Health Effects Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodine Uptake in Humans." Environmental Health Perspectives 110(9): 927-937.

Rajagopalan, S., T. A. Anderson, et al. (2006) . "Widespread Presence of Naturally Occurring Perchlorate in High Plains of Texas and New Mexico." Environmental Science & Technology 40:

3156-3162.

Richardson, S. D. (2004). Environmental mass sp ectrometry: emerging contaminants and current

issues. 76: 3337-3364.

Rickman, J. E. (2003). "LC/MS/MS Measures Perchlorate in 0.1-0.3 ppb Range." Trends in Analytical Chemistry 22(10): viii-ix.

Sanchez, C. A., R. I. Krieger, et al. (2005). "Potential perchlorate exposure from citrus irrigated with contaminated water." Analytica Chimica Acta peer- review.

Snyder, S. A., R. C. Pleus, et al. (2006). "Perchlo rate and chlorate in dietary supplements and flavor enhancing ingrediants." Analytica Chimica Acta 567: 23-32.

Snyder, S. A., B. D. Stanford, et al. (2009). Hypoc hlorite - An Assessment of Factors That Influence

the Formation of Perchlorate and Other Contamin ants., American Water Works Association. 140

pages.

Snyder, S. A., B. J. Vanderford, et al. (2005). "T race analysis of bromate, chlorate, iodate, and perchlorate in natural and bottled waters." Envi ronmental Science & Techno logy 39(12): 4586-4593.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 313 of 1099 Tellez, R. T., P. M. Chacon, et al. (2005). "L ong-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal period." Thyroid 15:

963-975.

Valentin-Blasini, L., J. P. Mauldi n, et al. (2005). "Analysis of perchlorate in human urine using ion chromatography and electrospray tandem mass spectrometry." Analytical Chemistry 77(8): 2475-

2481.

Response: EPA is aware of perchlorate cleanup along the Colorado River and believes that it has properly characterized the estimate of population exposed to perchlorate in drinking water. See response to comment ID 28856 under comment code 3100.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28756

EPA Comment Code: 3100

Comment: Consequently, the NDEP believes use of outdated (historical) occurrence data collected from 2001 through 2005 would be inappropriate because the source water (Lower Colorado River System) for a large portion of the US population and for a large amount of irrigated vegetable crops has substantially improved as a result of several successful remediation projects in the Las Vegas Valley. The current perchlorate concentrations are significantly lower than the historical

concentrations when the occurrence data wer e collected (2001 - 2005). Moreover, current concentrations of perchlorate in the Lower Color ado River System are less than health-protective levels for the approximately 26 million US reside nts who use this water for drinking water and numerous agricultural operations for irrigating crops. The NDEP believes that collection of new occurrence data would provide for a more accurate assessment of the exposure scenario applicable to this large segment of the US population, and le ad to a conclusion that regulation of perchlorate under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by public water systems or consuming the above-referenced irrigated crops.

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Andersen, S, Pedersen, KM, Pedersen, IB, et al. 2001. Variations in urinary iodine excretion and thyroid function. A 1-year study in healthy men. Eur. J. Endocrinol. 144: 461-465.

Brabant, G, Bergmann, P, Kirsch, CM, et al. 1992. Early adaptation of thyrotropin and thyroglobulin secretion to experimentally decreased iodine supply in man. Metabolism 41(10): 1093-1096.

Braverman, LE, Pearce, EN, He, X, et al. 2006. Eff ects of six months of daily low-dose perchlorate exposure on thyroid function in healthy volunteers. J. Clin. Endocrinol. Metab. 91(7): 2721-2724.

Braverman, LE. 2009. Environmental perchlorate: perhaps much ado about nothing. Endocr. Pract. 15(1): 50-52.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 314 of 1099 Braverman, LE, He, X, Pino, S, et al. 2005. The ef fect of perchlorate, thiocyanate, and nitrate on thyroid function in workers exposed to perchlorate long-term. J. Clin. Endo crinol. Metab. 90(2):

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Burner, PA, Kelsh, MA, Lau, EC, et al. 2006. Thyroi d function and perchlorate in drinking water: an evaluation among California newborns, 1998. Envi ron. Health Perspect. 114(5): 798- 804.

Chang, S, Crothers, C, Lai, S, et al. 2003. Pediatric neurobehavioral diseases in Nevada counties with respect to perchlorate in drinking water: an ecolo gical inquiry. Birth Defects Res. A. Clin. Mol.

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Crump, C, Michaud, P, Tellez, R, et al. 2000. Does perchlorate in drinking water affect thyroid function in newborns or school-age children? J. Occup. Environ. Med. 42(6): 603-612.

Dohan, O, Portulano, C, Basquin, C, et al. 2007. The Na+/I- symporter (NIS) mediates electroneutral active transport of the environmenta l pollutant perchlorate. Proc. Natl. Acad. Sci. 104(51): 20250-20255.

Eng, PH, Cardona, GR, Fang, SL et al. 1999. Es cape from the same Woff-Chiaikoff effect is associated with the decrease in thyroid sodium /iodide symporter messenger ribonucleic acid and protein. Endocrinol 40:3404-3410.

Gibbs, JP, Narayanan, L, and Mattie, DR. 2004. Crump et al. study among school children in Chile: subsequent urine and serum perchlorate levels are c onsistent with perchlorate in water in Taltal. J. Occup. Environ. Med. 46: 516-517.

Gibbs, JP, Ahmad, R, Crump, KS, et al. 1998. Evaluation of a population with occupational exposure to airborne ammonium perchlorate fo r possible acute or chronic effects on thyroid function. J. Occup. Environ. Med. 40(12): 1072-1082.

Gibbs, JP, and Van Landingham, C. 2008. Urinary perchlorate excretion does not predict thyroid function among pregnant women. Thyroid. 18(7): 807-808.

Glinoer, D. 1997. The regulation of thyroid fu nctioning pregnancy: Pathways of endocrine adaptation from physiology to pat hology. Endocr. Rev 18:404-433.

Greer, MA, Goodman, G, Pleus, RC, et al. 2002 . Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ. Health Perspect. 110(9): 927-937.

Johnston, S, Branch, RB, Brent, G, et al. 2005. Health implications of perchlorate ingestion. National Academy Press. Washington DC.

Kelsh, MA, Buffler, PA, Daaboul, JJ, et al. 2003. Primary congen ital hypothyroidism, newborn thyroid function, and environmental perchlorate ex posure among residents of a southern California community. J. Occup. Environ. Med. 45(10): 1116-1127.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

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15:963-975

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Yamada, T. 1967. Effects of perchlorate and ot her anions on thyroxine regulation of thyroid function. J Biol Chem 174:555-564.

Yu, KO, Narayanan, L, Mattie, DR, et al. 2002. Th e pharmacokinetics of perchlorate and its effect on the hypothalamus-pituitary-thyroid axis in the male rat. Toxicol. Appl. Pharmacol. 182: 148-159.

Response: See response to comment ID 28856 under comment code 3100 and ID 28754 under

comment code 3000.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28839

EPA Comment Code: 3100

Comment: With respect to using UCMR data to es timate concentrations above 4 ug/L, again AMWA urges EPA to recognize that occurrence in finished water at many water systems has

decreased.

Response: See response to comment ID 28856 under comment code 3100.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28856

EPA Comment Code: 3100

Comment: Current National Exposure to Drinking Water Perchlorate

AWWA believes that the population exposed to pe rchlorate that was indicated by EPA's UCMR1 data is no longer valid. In an informal survey conducted by AWWA, we found that many sources that had detected perchlorate from UCMR1 monitori ng are either no longer being used or are being treated per the requirements of maximum contaminan t levels (MCL's) established in California and Massachusetts. Additionally, successful treatment of the perchlorate source to Colorado River

contamination has lowered concentrations to be low 4 ug/L. AWWA believes that EPA would be well served to work with state primacy agencies to evaluate the 160 water systems with perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 318 of 1099 detections from UCMR1 to determine the actu al national population currently exposed to perchlorate above 4 ug/L. AWWA be lieves this information will further help inform EPA as to whether there is a meaningful opportunity for health risk reduction by regulating perchlorate.

Response: EPA acknowledges that there may be changes (i ncreasing or decreasing) in the levels of perchlorate in public water systems since the UCMR data were collected from 2001 to 2005. EPA

believes the UCMR data are best available data collected in accordance with accepted methods on the frequency and level of occurrence in drinking water. Therefore EPA is basing its occurrence evaluation on these collected data for the regu latory determination and will further evaluate perchlorate occurrence as part of the proposed rulemaking.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28870

EPA Comment Code: 3100

Comment: 3. Use of data on perchlorate occurrence in drinking water: The occurrence analysis presented in the Notice relies on data that are nearly a decade old and it assumes exposure to maximum concentrations detected anywhere within a public water system (PWS), even in untreated source water. Therefore, the analys is most likely overestimates con centrations of perchlorate in drinking water. Additionally, the Notice's estima tes of populations exposed to perchlorate are overstated because it assumes the entire populati on served by a PWS is exposed to the maximum
concentration, even if the detection was in untrea ted source water, and it overlooks the steps that have been taken- particularly in California, Ma ssachusetts and New Jersey-that substantially reduce the national population that may be exposed to envir onmental levels of perchlorate. The process the Notice followed to develop the estimated populations is not transparent, and as a result, it is not possible to independently calculate the estimate d values in the Notice based on the information given. Independent calculations resulted in esti mated population sizes that are about half of the Notice's estimates, even when conservative assum ptions were used. EPA should use more current data to estimate occurrence as levels in drinking water have decreased since UCMR1 monitoring.

Response: See response to comment ID 28856 under comment code 3100 in regards to changes in the levels of perchlorate occurrence. With resp ect to EPA’s evaluation of populations exposed to perchlorate, the Agency has presen ted analyses as part of its October 2008 Federal Register Notice, August 2009 Federal Register Notice, and the Fi nal Federal Register Notice that explains EPA’s estimation of populations potentially exposed to perchlorate. Using the UCMR 1 data, EPA took into account the potential for overestimating populations exposed to perchlorate using UCMR 1 monitoring data in which one can assume that th e entire population served by a PWS is exposed to the maximum concentration from a single detection. Therefore, to respond to this concern, EPA also developed a central value estimate by assum ing the population was equally distributed among all entry points and added only the proportion of the total population served by those entry points in a PWS that had at least one sample with perchlor ate concentrations greater than the HRL being

evaluated.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 319 of 1099 EPA Comment ID: 28890

EPA Comment Code: 3100

Comment: C. Use of Data on Perchlorate Occurrence in Drinking Water

To estimate how many people potentially could be exposed to perchlorate in drinking water, EPA used data from its first cycle of the UCMR1 (http://www.epa.gov/safewater/ucmr/ucmr1/index.html). The Notice presents the resulting population estimates in Table 3. The Agency estima ted the size of the population exposed to perchlorate at different threshold levels (4 ug/L or higher, 5 ug/L or high er, etc.) by assuming that the entire population served by a public water system (PWS) is exposed to perchlorate at concentrations above a threshold level if at least one sample collected in the PWS contained perchlorate at or above the threshold level (even if all other samples are lower, or nondetect). Based on this assumption, the Notice reports an esti mate of 16.6 million (M) people exposed to perchlorate at concentrations above the method re porting limit (MRL) of 4 ug/L. In addition, the Agency developed an alternative assessment by assuming that populations served by PWSs are equally distributed among entry points to the PWS and that only those portions of the population served by entry points with reported concentratio ns above the threshold are exposed. Based on this assumption, the Notice reports an estimate of 5.1M people exposed to perchlorate at concentrations above the MRL of 4 ug/L.

The Notice asks for comment on three general questions regarding the use of occurrence data to estimate exposure to perchlorate. Re sponses to these questions, based on the best available scientific
information, follow.

Response: No response necessary to this summary of EPA information.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28892

EPA Comment Code: 3100

Comment: Scientific and statistical concerns with the Notice's use of the UCMR1 data set include the following:

* UCMR1 covers the years 2001 to 2005; some of th ese data are nearly a decade old. Data collected during this time overestimate current concentrati ons of perchlorate in drinking water. Guidelines EPA has established since 1992, including inter im guidance for remediation and water exposure levels, and remediation of contaminated sites by re sponsible parties, have resulted in reductions in perchlorate levels in ground and surface water. Fo r example, public information shows that annual average concentrations of perchlor ate at the Las Vegas drinking water intake in Lake Mead declined almost 60% between 2000 and 2004 (from 13 .1 ppb to 5.6 ppb), and the annual average concentrations in the Metropolitan Water District Colorado River Aqueduct intake at Lake Havasu on the Lower Colorado River declined about 50% between 2000 and 2004 (from 6.4 ppb to less than 4 ppb), and in 2004 nine of the twelve mont hly samples were at levels too low to detect (i.e., below 4 ppb) (http://www.epa.gov/region/toxic/perchlorate/per_nv.html). The Colorado RiverEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 320 of 1099 supplies water for agriculture in Arizona and Calif ornia as well as drinking water for Southern

California.

* Environmental exposure levels of perchlorate are declining. Although not an occurrence study, a recent study reports that urinary concentration of perchlorate is lower in NHANES 2003-2004 participants compared to NHANES 2001-2002[ FN15: NHANES 2001-2002 is the basis for the study by Blount et al. (2006). See following section for the full discussion on Blount et al. (2006).] suggesting population exposure was lower du ring 2003-2004 (Mendez et al., 2009).

* Examination of the UCMR1 data set demonstrates that several major U.S. cities did not detect perchlorate in their drinking water. These cities are large metropolitan areas with corresponding large populations and include Washington DC, New York City, Newark, Baltimore, Philadelphia, Pittsburgh, Minneapolis/ St. Paul, Chicago, Milwauk ee, Detroit, Cleveland, Indianapolis, Memphis,
Nashville, Atlanta, St. Louis, San Francisco, Seattl e, and Portland. Perchlorate is not ubiquitous in drinking water, but areas of detection appear to be regionalized. This does not diminish the importance of perchlorate where it has been detect ed at levels above the MRL (4 ug/L). States where significant perchlorate is present, e.g., Ca lifornia, have either promulgated drinking water standards or adopted EPA interim guidance. As a result, the trend of occurrence is toward lower

water concentrations.

* The population estimates presented in Table 3 of the Notice could not be validated. The Notice does not present all of the assumptions used to calculate population sizes. When extremely conservative assumptions are made, calculated population sizes are still much lower than EPA's estimates. For example, if it is assumed that th e entire population served by a PWS is exposed to perchlorate at levels above the MRL when at least one sample collected in the PWS contained perchlorate at or above the MRL (even if all othe r samples did not detect perchlorate) and that the size of the population is the maximum associated with the category assigned to a given PWS (i.e., very small, small, medium, large, very large), the computed maximum exposed population size is approximately 10.5M-this is approximately 60% of EPA's maximum estimate of 16.6M. This lower estimate is still extremely conservative and unlikely to accurately represent the size of the exposed population. The entire population served by the PWS is not likely to be served water from the entry point that had the highest reported concentration, and actual population sizes for each PWS are likely to be distributed across the range of popu lation sizes associated with a given population category. Alternatively, if it is assumed that th e population served by a PWS is equally distributed among entry points to the PWS and the total expos ed population is computed based only on those entry points where perchlorate was detected above the MRL (i.e., in a manner consistent with the last column of EPA's Table 3), the estimated populat ion size is about half of EPA's 5.1M estimate.

* It appears that EPA included monitoring data for untreated source water in its exposure estimates. Based on the data retrieved from EPA's UCMR1 website, the UCMR1 data includes a total of 34,728 analyses for perchlorate (EPA reports 34,221 analyses), with 647 d etections of perchlorate at or above the MRL (EPA reports 637 detects). These detections include 288 detections in source water (out of 10,684 samples, or a frequency of detection of 2.7%) and 348 detections in entry point water (out of 23,319 samples, or 1.5%) (perch lorate was not detected in any samples from the midpoint of distribution systems (n = 16), the poi nt of maximum retention (n = 19), or the location in distribution systems where disinfectant residual is lowest (n = 6); perchlorate was detected in 11 of 684 samples from "unknown" locations). Thus, it is questionable as to whether the number ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 321 of 1099 people presented in the Notice is likely to drink untreated source water from PWSs, and data from drinking water entry points indicates that concentr ations at the entry points are generally lower.

These observations indicate that using the UC MR1 database to extrapolate exposures to concentrations below the MRL would be inappropriate, as it would produce highly inaccurate

estimates.

Response: Regarding the comment that UCMR data overestimates current concentrations of perchlorate in drinking water, see response to comment ID 28856 under comment code 3100.

Regarding the comment that perchlorate is not ubiquitous in drinking water but areas of detection appear to be regionalized, UCMR data is the mo st extensive nationally representative occurrence data for perchlorate in public water systems; th erefore, EPA analyzed this data and additional occurrence data in making a regulatory determination for perchlorate as required by Congress. See SDWA Section 1445(g).

Regarding validation of population estimates, see responses to comment IDs 28856 and 28870 under comment code 3100. Also, see "The Analysis Of Occurrence Data from The First Unregulated Contaminant Monitoring Regula tion (UCMR 1) In Support Of Regulatory Determinations For The Second Drinking Water Contaminant Candidate List" for a description of how the UCMR 1 population analysis was conducted.

EPA disagrees with the commenter that approxima tely half of perchlorate water samples in the

UCMR 1 database are from untreated source water s. The data EPA used to evaluate perchlorate occurrence from UCMR 1 was only taken from fini shed water. EPA did allow monitoring at source water sampling points; however, if perchlorate wa s detected in a source water sample, the UCMR 1 required that follow-up samples be collected at the entry point to the distribution system and follow the monitoring frequency specified in the rule for the contaminant and water source type. A detailed description of UCMR monitoring can be found in the Federal Register under docket number EPA– HQ–OW–2007–0068. The title of the reference that describes UCMR is "The Analysis Of Occurrence Data From The First Unregulated Cont aminant Monitoring Regulation (UCMR 1) In Support Of Regulatory Determinations For The Second Drinking Water Contaminant Candidate

List."

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28904

EPA Comment Code: 3100

Comment: 3. EPA's proposed analysis of occurrence da ta is concerning in that the estimated population sizes in the Notice could not be reproduced, the data from UCMR1 are not current and likely overestimate current exposures, and the hi ghest concentration detected anywhere in a PWS was used to estimate exposures for all people served by the PWS, even if the sample was collected from untreated source water or all other sample s were nondetects. Altogether, these assumptionsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 322 of 1099 produce an inaccurate and overly conservative es timate of potential human perchlorate exposures from drinking water.

Response: See response to comment IDs 28856 and 28870 under comment code 3100.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 29097

EPA Comment Code: 3100

Comment: EPA assumes that if the drinking water testi ng at the entry point reports at least one sample above the detection limit during the 20 00-2005 UCMR sampling period, the entire population that draws drinking water from that inta ke is exposed. EPA then multiplies this estimate of the exposed population by an estimate of the proportion of the national population that is pregnant during any given year.

The major overestimate in EPA's calculation c oncerns the population ex posed above the HRL. Under the UCMR regulation, public water syst ems were required to take multiple samples throughout the year at each sampling point. Large public water systems were required to monitor throughout a three-year period. Many of the samp ling points only reported a single detection during the sampling period. Few systems reported perchl orate detections in every sample. Therefore, assuming the total population is exposed at any give n time is a gross overestimate. A more likely estimate is the ratio of positive defects to total samples multiplied by the service population.

There are many reasons why a system may have in termittent or a single d etection. At the beginning of the UCMR sampling period, laboratory experience with detecting perchlor ate was evolving. There have been many anecdotal reports of false detec tions. Even where perchlorate was found in the drinking water, its occurrence may have been intermittent. Since perchlorate can be naturally formed and then fall to the earth in precipitation, it is likely that watershed concentrations ebb and flow with the natural water cycle.

EPA's estimate in the proposed determination also overestimates the likely number of individuals with drinking water concentrations above the HR L for several other reasons. First, EPA failed to remove individuals who primarily consume bottled water or have in-house treatment systems. EPA did exclude these individuals in its analysis of the UCMR/NHANES data sets.

Second, EPA did not account for system changes in response to the UCMR monitoring. Some states have enacted state-specific drinking water stan dards. Others have issued advisory levels. Public water systems have responded and have made chan ges to reduce perchlorate concentrations. These changes are exactly the responses the Safe Drinking Water Act encourages. By prompting local actions, drinking water issues are separated into the local and national concerns. EPA should properly account for these local actions in its population estimate so as to reinforce its finding that exposure does not occur with sufficient fr equency to warrant national regulation.

More importantly, EPA should provide the public context for this exposure estimate. Even though there may be potentially exposed individuals abov e the HRL, the overwhelming scientific evidenceEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 323 of 1099 from clinical studies, environmental studies, and from PBPK modeling demonstrates that no one faces an appreciable risk of adverse effect from exposures at EPA's reference dose.

Response: EPA has used the best available data on the frequency and level of perchlorate occurrence in drinking water, the population exposed to perchlorate, and the levels of public health concern to determine that there is a meaningfu l opportunity for health risk reduction through a national primary drinking water regulation. EPA belie ves that this analysis is appropriate for making the determination to regulate perchlorate which w ill initiate a more rigorous health risk reduction, cost analysis, and other analyses required by th e Safe Drinking Water Ac t for proposed drinking water standards. EPA believes that it is appropriate to consider the single highest value reported in a public water system and the highest level within a entry point into the system. While EPA does acknowledge that perchlorate concentrations may fluctuate over time, the duration of life stages

where individuals are most sensitive to the eff ects of perchlorate exposur e (i.e., pregnancy and infancy) are relatively short. Therefore EPA believes it is appropriate to use the single highest result from a quarterly or semi-annual sample to determin e if these populations are exposed at levels of

health concern.

EPA does not believe that multiplying the ratio of positive detects to total samples by the service population is appropriate because this approach woul d not account for the fact that during certain periods of time the whole populati on was potentially exposed to perc hlorate in drinking water at

levels of health concern. EPA does not believe that is appropriate to remove persons who use in

house treatment or consume bottled water for th ese estimates of population potentially exposed. The bottled water consumption and in house treatment data were available for NHANES participants but are not collected or reported un der the UCMR. EPA believes that a more rigorous evaluation of the variation in drinking water consum ption can be made as part of the health risk reduction and cost analyses required under SDWA for proposed national primary drinking water regulations.

EPA does not believe that it is appropriate to adju st estimates of perchlorate occurrence from those

measured under UCMR. EPA believes that the UCMR is the best available data on the frequency and level of perchlorate occurrence in public wate r systems nationally. EPA acknowledges that levels of perchlorate may have decreased in some public water systems as a result of state regulation or of water system decisions. However, those may also be instances in which levels of perchlorate may have increased due to new contamination. EPA further notes that public water systems would conduct monitoring under the national primary dr inking water regulation we expect to promulgate. Systems which do not detect perchlorate at levels exceeding the MCL will not be required to take action to lower perchlorae levels. Therefore if systems have already taken actions to address perchlorate in their drinking water, these systems ma y not have to take any further steps to remove perchlorate .

Regarding the statement that no one faces an appreci able risk of adverse effects from exposures at EPA’s reference dose, a recent study (Steinmaus et al., 2010) examining the perchlorate concentration in drinking water and its associati on with neonatal thyroid hormone levels in over
400,000 newborns, concluded that there is a statis tically significant association with perchlorate exposure and increased neonatal thyroid hormone levels. This study has shown that, at environmental concentrations of perchlorate greate r than 5 ug/L, the odds of elevation in thyroid stimulating hormone (TSH) levels at birth was si gnificantly greater, when compared to hormone levels in newborns from communities unexposed to perchlorate. Steinmaus et al. (2010) groupedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 324 of 1099 geographic communities in California according to whether their respective estimated average perchlorate concentrations were either more or le ss than 5 ug/L, therefore, unexposed communities in this particular study were defined as havi ng less than 5 ug/L drin king water perchlorate concentrations (representing an average estimate of perchlorate concentrations of the different water systems supplying a given community, and weighted by the number of water sources used by each system). Therefore, for the Steinmaus et al. (2010) study, this particular unexposed group includes communities with estimated average perchlorate concentrations of 5 μ g/L or less, as well as all

communities with no measurable environmenta l perchlorate concentrations. The U.S. EPA reference dose for perchlorate is 0.7 ug/kg/da y. EPA has adopted the NRC’s recommendations regarding the reference dose for perchlorate in its “Integrated Risk Information System” (IRIS) (USEPA 2005), resulting in an RfD of 0.7 ug/kg/da y, which was derived by applying a 10-fold (10x) uncertainty factor to the NOEL of 7.0 ug/kg/day.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 325 of 1099 

### EPA Comment Code: 3120 UCMR 1 statis tical methodology and nationally representative sample of small systems

Individual Comments

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20420

EPA Comment Code: 3120

Comment: The other concern is that, as noted earlier, without a federal MCL, detections of high level contamination (e.g., 1300 ug/L of perchlorate in a public water supply in Boxborough MA) will go undetected leading to high localized exposures. This high level of contamination would not have been detected without a state initiated testing program (MADEP, 2005). Given the unpredictable
nature of these extreme concentrations, national monitoring is clearly needed.

The 2001 Unregulated Contaminant Monitoring Regu lation (UCMR) for perchlorate focused upon larger public water supplies and is not indicative of the numbers of peopl e exposed or extent of exceedances possible from localized hot spots du e to contamination of water from blasting, fireworks or industrial/military releases.

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. EPA intends to consider compliance m onitoring requirements and request comment as part of the expected proposed national primary drinking water regulation for perchlorate. EPA disagrees with the statement that the UCMR is no t indicative of the numbers of people exposed to perchlorate. Under UCMR 1, EPA collected samples from all the large PWS (3,865) and 800 small PWS which were a stratified random sample of public water systesms selected to represent drinking water occurrence nationally. EPA has determined that UCMR 1 is the best available scientific perchlorate occurrence data collected in accord ance with acceptable analytical methods. EPA’s determination is based upon the fact that UCMR1 is the most nationally representative study of the frequency and levels of perchlora te in drinking water systems.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20932

EPA Comment Code: 3120

Comment: Because perchlorate is not currently regulated under the SDWA, data on perchlorate contamination in New Mexico public water systems is limited. Under the Unregulated Contaminant Monitoring Rule,[FN1: 40 C.F.R. [section] 141.40 .] public water systems serving communities of greater than 10,000 persons were required to moni tor for perchlorate for one year between 2001 and 2003. A "statistically representative" number of additional smaller systems were also required to monitor for perchlorate for one year during this time period. However, with few exceptions, that monitoring data does not appear to have been re ported to the State of N ew Mexico. Therefore, theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 326 of 1099 Environment Department has only a very incomplete picture of perchlorate contamination in public water systems in the State.

Response: EPA has made the UCMR monitoring data pub licly available. EPA has determined that this data is the best available data (collected in accordance with accepted methods) on the occurrence of perchlorate nationally.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 327 of 1099 

### EPA Comment Code: 3140 UCMR 1 entry-point-level estimation of perchlorate

exposure

Individual Comments

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20952

EPA Comment Code: 3140

Comment: Perchlorate is Present at Sufficient Levels and Frequency to Constitute a Public Health

Concern

EPA's determination of whether perchlorate is pr esent at sufficient levels and frequency to constitute a public health concer n begins with an analysis of occurrence and population estimates for perchlorate at various thresholds. Since the da ta on occurrence may not represent water samples delivered to the entire service population, EPA cons iders two values fore each threshold or cutpoint considered (e.g., 4, 5, 7, 10, 12, 15, 17, 20 and 25 ug/L); the first value is the service population, and the second is an estimate below th e service population, that is derived from the service population divided by the number of entry or sample points. The second value is in all cases substantially lower than that of the service popula tion. To ensure the protection of public health, we

recommend that the more conservative number - th at of the entire service population - should be considered as the potentially impacted population.

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120. In the Federal Register notice “Final Regulatory Determination on Perchlorate” EPA considers a range of estimates of the population serv ed by PWSs that had at least one sample with perchlorate concentrations greater than the poten tial HRLs. The population range represents both a high end estimate, as well as a central value estima te. The high end estimate is derived by adding the entire system population of all PWSs in which at least one sample was found to contain perchlorate above thethreshold. EPA considers this a high end estimate because it is based on the assumption that the entire system population is served water from the entry point that had the highest reported perchlorate concentration. In fact, many PWSs have multiple entry points into which treated water is pumped for distribution to their consumers. For the PWSs with multiple entry points, it is unlikely that the entire service population receives water fr om the one entry point with the highest single concentration. Therefore, EPA also provides a cen tral value estimate of the population served water with perchlorate above a threshold. EPA devel oped this central value estimate by assuming the population was equally distributed among all entry points and added only the proportion of the total population served by those entry points in a PWS that had at least one sample with perchlorate concentrations greater than the threshold. EPA considered both the high end estimate and central value estimate in making this final regulatory determination. The Agency considered the central value estimate as well because this is likely a bett er estimate of the population exposed to perchlorate at levels of public health concern.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 328 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28525

EPA Comment Code: 3140

Comment: Comment No. 14

Section III. B. 3. Alternative Approaches for Calculating HRLs

Page & Paragraph Page 41889 Table 3

Comment Example of comment # 2: In the use of the UCMR 1 data, the EPA indicates that an adjustment was made for water systems with mu ltiple entry points to decrease the estimated population exposed to the "threshold of interest. " However, in reviewing the outcome of this analysis (Table 3, EPA 2009), the reviewer is unable to readily duplicate the adjusted population estimates provided.

Suggested Action, Revision and References (if nece ssary) The Table 3 values need to be reviewed and insured to be readily duplicable by external reviewers.

Category* E

Response: A more detailed description of the methodology for conducting a proportional population analysis of UCMR 1 data, such as the an alysis used to derive the population estimates for entry or sample points having at least one detection greater than the threshold of interest in column five of Table 3 of the August 2009 FR Notice, can be found in the document titled “The Analysis Of Occurrence Data From The First Unregulated Contaminant Monitoring Regulation (UCMR 1) In Support Of Regulatory Determinations For The Second Drinking Water Contaminant Candidate List” in docket number EPA–HQ–OW–2007–0068. Please refer to the Proportional Populations

Section of this document under Section 4.3 “Sample-Point-Level Analyses”.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28866

EPA Comment Code: 3140

Comment: We also wish to note that the population esti mates in column 5 of Table three would be likely to underestimate those exposed in MA, and qui te likely other states, due to mixing of supplies from multiple entry points.

Response: Please see the response to comment ID 20952 in comment code 3140. In addition to the central value population estimates provided in the “Final Regulatory Determination on Perchlorate” notice, EPA also considered estima tes of the total population served by drinking water systems in which at least one sample was found to contain perchlorate above the threshold (i.e., the high end estimate) to account for the mixing of supplies from multiple entry points to the distribution system.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 329 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28933

EPA Comment Code: 3140

Comment: Occurrence analysis: EPA's occurrence analysis grossly underestimates the number of people at risk from perchlorate because of an in appropriately high detection and reporting threshold of four ppb.

In table 3 of the notice in the federal regis ter, the Agency lists the occurrence and population estimates for perchlorate above a number of threshol ds, starting at 4ppb. This data is derived from the Agency's Unregulated Contaminant Monitoring Rule (UCMR) 1; the Agency estimates that a total of 16.6 million people in the United States are served by public water systems with at least 1 detection of perchlorate at > 4 ppb.

In table 2 of the federal register, the agency finds that HRLs as low as 1 are necessary to prevent children ages two and younger who have higher water ingestion rates and cumulative perchlorate exposures that can easily exceed the RfD. In additi on, as mentioned above, the degree of perchlorate contamination of some powdered infant formulas is so high than an HRL as low as 0 is justified for infants six months and younger. Therefore, the find ing of perchlorate in drinking water at any level presents risks to vulnerable populations and unt il the minimum reporting level (MRL) is decreased to reflect this, the agency's numbers are an underestimate.

Response: EPA acknowledges that there are newer and more sensitive analytical methods that are now available that would permit perchlorate analysis with reporting limits below 4 ug/L (the MRL for perchlorate under the UCMR 1 was 4 ug/L); however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at the time an assessment is made. EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure info rmation in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). As part of th e rulemaking process, EPA plans further analyze perchlorate occurrence data to estimate the addi tional number of PWSs and entry points and the population served at levels of public health concern.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 330 of 1099 

### EPA Comment Code: 3150 Potential use of a Bayesian model to estimate number of PWSs and population serv ed at a range of thresholds

Response to Code 3150 : EPA continues to evaluate the utility of the Bayesian model(s) in the development of a NPDWR for perchlorate. EPA plans to be transparent in explaining the analysis and any assumptions made when presenting the an alysis in connection with the proposed NPDWR. EPA does not intend to distinguish the source of pe rchlorate in drinking water but does intend to assess the number of water systems impacted by a potential regulation.

Individual Comments

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28500

EPA Comment Code: 3150

Comment: a. EPA requests comment on the potential use of a Bayesian model to estimate the number of public water systems, and populations serv ed by such systems, with at least one estimated sample detection greater than 1, 2, 3, 4, 5, 7, 10, 12, 15, 17, 20, and 25 [mu]g/L.

ASDWA feels that it is necessary to do further modeling to estimate perchlorate levels below the analytical method MRL used in the UCMR monitoring and the Baysean modeling approach

discussed in the notice strikes us as a reasonabl e one. Data from Massachusetts with a lower detection limit can be used to refine and validate the modeling so that more precise estimates can be made of occurrence at these very low levels. EPA should also include any new data received as a result of this notice in its analysis.

Response: See response to comment code 3150. EPA has reviewed other occurrence data.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28694

EPA Comment Code: 3150

Comment: September 17, 2009

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460

SUBJECT: Comments on the Drinking Water: Pe rchlorate Supplemental request for Comments Docket ID No. EPA-HQ-OW-2009-0297

The Southern Nevada Water Authority (Authorit y) appreciates the opportunity to comment on the preliminary regulatory determination for perchl orate as listed in the August 19, 2009 Federal Register (74 FR 41883). The Authority is a coopera tive agency formed in 1991 to address SouthernEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 331 of 1099 Nevada's unique water needs on a regional basis. Officials of the Authority are charged with managing the region's water resources and provid ing for approximately 2 million area residents' present and future water needs. Th e Authority is governed by a se ven- member board comprised of representatives from each of its member agenci es, which include the cities of Boulder City, Henderson, Las Vegas and North Las Vegas, as well as agencies serving customers in unincorporated Clark County and the town of Laughlin.

The Authority's responsibilities include managing wa ter supplies available to Southern Nevada and regional conservation programs as well as buildin g and operating regional facilities to provide a reliable drinking water delivery sy stem to all member agencies.

Interpretation of the Physiologically-Bas ed Pharmacokinetic (PBPK) Modeling

The Authority strongly encourages the use of sound science in the consideration of federal regulation of perchlorate. While modeling such as the PBPK and Bayesian hierarchical models suggested in the noted Federal Register (FR) are of value when empirical data are unavailable, the

use of these models for the elucidation of heal th reference levels and national occurrence, respectively, are not necessary as sufficient data already exist.

Response: EPA continues to evaluate the utility of the Bayesian model(s) in the development of a NPDWR for perchlorate. EPA plans to be tran sparent in explaining the analysis and any assumptions made when presenting the analysis in connection with the proposed NPDWR. See response to comment code 3150.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28698

EPA Comment Code: 3150

Comment: Occurrence Analysis

The Authority also does not support the use of Ba yesian hierarchical models to extrapolate the Massachusetts' occurrence data to develop a por trait of sub-4 ug/L perchlorate occurrence nationwide. While we understand the great value of Bayesian models, we see no reason for applying these models considering that the preponderance of data suggest that perchlorate is not relevant to human health even at 4 ug/L and considering th e inappropriateness of applying a relative source contribution (RSC) factor to perchlorate when usi ng the Greer study or others where dietary contributions have already been accounted. Moreover, other studies have already shown that perchlorate is ubiquitous in the environment at concentrations above approximately 0.050 ng/L (Rickman 2003; Richardson 2004; Snyder, Vanderford et al. 2005), owing largely to the atmospheric formation and subsequent deposition of perchlora te in rain (Dasgupta, Martinelango et al. 2005; Rajagopalan, Anderson et al. 2006).

Response: See response to comment code 3150. EPA di sagrees with the commenter’s view that perchlorate is not relevant to human health even at 4 ug/L and that applying an RSC factor to perchlorate is inappropriate. See response to comment code 5220 for an explanation of EPA’sEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 332 of 1099 rationale in concluding that perchlorate is rele vant to human health at or below 4 ug/L. See response to comment code 5210 for an ex planation of EPA’s use of an RSC.

Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28712

EPA Comment Code: 3150

Comment: Additional Comments on Occurrence Analysis and Potential Use of a Bayesian Model

EPA has requested comments on the appropriateness of its exposure model to estimate the number of public water systems and populations served by such systems. The American Water Works Association and other water industry associations have suggested that the use of Bayesian modeling is not necessary to support the Agency's regulato ry decision-making for perchlorate. Metropolitan suggests that any methodology employed by EPA to interpret occurrence data be consistent with other established methods used with other regulatory development.

Response: EPA continues to evaluate the utility of the Bayesian model(s) in the development of a NPDWR for perchlorate. EPA plans to be tran sparent in explaining the analysis and any assumptions made when presenting the analysis in connection with the proposed NPDWR. See response to comment code 3150.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28746

EPA Comment Code: 3150

Comment: 3. Use of a Bayesian model for the purposes stated in the August 19, 2009 Federal Register requires additional justification as it will lead to an overestimation of the low-level occurrence of perchlorate if calibrated to select geographical areas and/or small data sets.

Response: See response to comment code 3150.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28753

EPA Comment Code: 3150

Comment: C. Occurrence Analysis 4. Request for Comment on Alternative Approaches a. EPA requests continent on the potential use of a Bayesia n model to estimate the number of public water systems, and populations served by such systems, with at least one estimated sample detection greater than 1, 2, 3, 4, 5, 7, 10, 12, 15, 17, 20, and 25 ug/L.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 333 of 1099 Comment C.4.a.1: Use of a Bayesian model for the stated purpose is not recommended nor supported by the NDEP. The NDEP understands that the national occurrence data for perchlorate were generated between 2001 and 2005. Further, we understand that EPA Method 314 was used for analysis of the occurrence data. The typical reporti ng limit associated with EPA Method 314 is 4 ug/L. EPA required the collection and submittal of the national occurrence data knowing this

limitation.

It is not clear how use of a Bayesian model now for revaluating the existing occurrence data could be considered as a reasonably defensible approach fo r analysis. This is because it likely will lead to an overestimation of the low- level occurrence of perc hlorate if calibrated to select geographical areas and/or small data sets.

Response: See response to comment code 3150.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28808

EPA Comment Code: 3150

Comment: REQUEST FOR COMMENT ON ALTERNATIVE APPROACHES

a. On the use of a Baysian model to estimate number of public water systems.

NRDC response: NRDC has no opinion on this.

Response: No response necessary

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28837

EPA Comment Code: 3150

Comment: 74 FR 41891: "EPA requests comment on the potential use of a Bayesian model to estimate the number of public water systems and p opulations served by such systems, with at least one estimated sample detection greater than 1, 2, 3, 4 ug/l, etc."

The Bayesian extrapolation of UCMR1 occurrence da ta is a complex analysis and therefore EPA needs to be transparent in explaining the analys is in its final regulatory determination. AMWA requests that EPA also clearly state the assumptions of the mo deling effort. AMWA recommends that the effort recognize that the data availabl e shows that perchlorate occurrence is not evenly distributed across the country.

Response: EPA continues to evaluate the utility of the Bayesian model(s) in the development of a NPDWR for perchlorate. EPA plans to be tran sparent in explaining the analysis and any assumptions made when presenting the analysis in connection with the proposed NPDWR. See response to comment code 3150.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 334 of 1099 Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28853

EPA Comment Code: 3150

Comment: Occurrence Analysis

The Agency requested comments on the appropriaten ess of using a Bayesian model to estimate perchlorate occurrence in public water systems and populations served by such systems. This

estimate would use UCMR1 data that had a laborat ory detection level of 4 ug/L and project national occurrence at levels below 4 ug/L. While AWWA recognizes the validity of Bayesian modeling, we believe that the study as proposed is not necessa ry to support the Agency's regulatory decision making for perchlorate. The weight of evidence as discussed in our comments does not support the need for further analysis of occurrence since regulation of perchlorate would not present a meaningful opportunity for health risk reduction for persons served by public water systems.

Response: The Agency has concluded that there is a meaningful opportunity for health risk reduction for persons served by public water sy stems through a National Primary Drinking Water Rule for perchlorate. EPA acknowledges that th e use of Bayesian modeling is not necessary for making a regulatory determination on perchlorate. EPA continues to evaluate the utility of the Bayesian model(s) in the developmen t of a NPDWR for perchlorate.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28854

EPA Comment Code: 3150

Comment: Multiple studies have presented data demonstrating that perchlorate is widely found at low levels and may originate from anthropogenic and/or natural sources; it even occurs in some dietary supplements [FN14: Snyder, S., Pleus, R., Vanderford, B., J. Holady. 2006. Perchlorate and chlorate in dietary supplements and flavor enhanc ing ingredients. Analytica Chimica Acta, 567:1:26.] and groundwater more than 28,000 years old [FN15: Plummer, L. N.; Bohlke, J. K.; Doughten, M. W. 2006. Perchlorate in pleistocene and holocen e groundwater in North-Central New Mexico. Environ. Sci. Technol. 40:1757.]. Since the majo r route of exposure is food and not water, estimating low level concentrations of perchl orate in the minor source will not provide any additional useful information. The only reason to deter mine perchlorate concentrations in water is to estimate human exposure. Given th e previous discussion and the Agency 's assessments, there clearly

is sufficient data from human studies that have be en completed to sufficiently characterize exposure. These studies (e.g. NHANES, FDA Total Diet Study) ex amined urine, saliva, and breast milk and in all cases the study subjects had perchlorate. Th ere were no studied individuals who did not have perchlorate. So we know that in th e U.S., exposure to perchlorate is very close to universal. Further, examination [FN16: Brandbuber , P, Clark, S. and K. Morley. (publication pending) The Occurrence of Perchlorate in Public Drinking Water System s, Journal AWWA.] of the existing UMCR dataset provides no general indicator of a causal relationship between occurrence and known locations of perchlorate releases with exception of locations at extremely high levels that were typically adjacentEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 335 of 1099 to industrial and military users of perchlorate. In the vast majority of UCMR occurrences, an obvious source could not be easily identified. Stud ies [FN17: Jackson, W., Rainwater, K., Anderson, T., Lehman, T., Tock, R., Rajagopalan, S., and M. Ridley. 2004. Distribution And Potential Sources Of Perchlorate In The High Plains Region Of Texas Final Report. Submitted to the Texas Commission on Environmental Quality. ],[FN18: Duncan, P.B, Morris, R.D., and E. Vavricka. 2005. Forensic identification of anthropogenic and naturally occurring source of perchlorate. Environmental Forensics, 6:205-215.],[FN19: Da sgupta, P., Martinelango, P., Jackson, W., Anderson, T., Tian, K., and R. Tock. 2005. The Origin of Naturally Occurring Perchlorate: The Role of Atmospheric Processes Environ. Sci. Technol., 39:6:1569 -1575.],[FN2 0: Balaji Rao, Todd A. Anderson, Greta J. Orris, Ken A. Rainwater,* Srin ath Rajagopalan, Renee M. Sandvig, Bridget R.
Scanlon, David A. Stonestrom, Michelle A. Wa lvoord, and W. Andrew Jackson (2007) Widespread

Natural Perchlorate in Unsaturated Zones of the Southwest United States Environ. Sci. Technol, 41:4522-4528.] of natural occurrence also do not provide a sound basis for predicting occurrence of perchlorate, unlike other inorganic substances that may associate with specific geological formations

such as radionuclides and arsenic.

The Agency has proposed a statistical Bayesian pro cedure to estimate the distribution of censored perchlorate data. There are several different such procedures (Maximum Likelihood Estimate, Kaplan-Meier Non-Parametric techniques, Regressi on on Order Statistics) however that all make assumptions about the nature of the distribution, whether normal, log-normal, or non-normal. The Agency has not explained why this particular model would be used versus one of the other approaches noted here. Nor does the Agency explain what population distribution is being assumed. Without this information, it is impossible to comment on the validity of the proposed procedures for this or potentially future applications of this approach. Regardless, all such procedures must assume that a single population of results is being estimated. However there appear to be multiple populations of results, those resulting from natura l sources, munitions, Chilean fertilizers, etc. There may, of course, be more than one natural source as cited in the studies previously noted. Given the fact that the occurrence data is mostly poly-modal du e to multiple sources in areas such as California and Massachusetts, the use of any statistical procedure that is based on a mono-modal distribution will have little likelihood of producing useful results.

Response: See response to comment code 3150.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28865

EPA Comment Code: 3150

Comment: Section III C: Occurrence Analysis

4(a)) EPA's proposal to use a Bayesian model to es timate the number of public water systems, and populations served by such systems, with sample detections at various levels appears to be a reasonable approach. Further details regarding the specific model inputs are, however, needed in order to assess the usefulness of the model. MassDEP will provide U.S. EPA with Massachusetts perchlorate monitoring data to assist in this effort. However, we wish to note that the sampling results and data distribution for MA may not reflect the situation in other states.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 336 of 1099 Response: EPA appreciates MassDEP’s offer to provide EPA with Massachusetts perchlorate monitoring data and acknowledges that MA’s sa mpling results and data distribution may not be representative of other states. S ee response to comment code 3150.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28891

EPA Comment Code: 3150

Comment: 1. EPA requests comment on the potential use of a Bayesian model to estimate the number of public water systems, and the population served by such systems, with at least one estimated sample detection greater than 1, 2, 3, 4, 5, 7, 10, 12, 15, 17, 20, and 25 ug/L.

With regard to perchlorate's regulatory determina tion, extrapolating the frequency of occurrence of perchlorate in U.S. drinking water at concentrat ions less than the MRL of 4 ug/L is unnecessary because scientific data provide no evidence that adve rse health effects can occur at these levels. Data for average adults (e.g., Greer et al., 2002) suggest that IUI at water concentrations less than 245 ppb (the drinking water equivalent of the POD) woul d be statistically insignificant, and the Notice suggests, based on EPA's PBPK model for several life stages, that IUI at water concentrations corresponding to the RfD (i.e., 24 .5 ppb) would be less than 2%.

Further, UCMR1 data are insufficient for estima ting population sizes exposed to concentrations greater than the MRL of 4 ug/L, and therefore may not be used to reliably estimate exposures below
the MRL. As elaborated below, examination of EP A's occurrence analysis is made difficult by the fact that the Notice lacks the requi red transparency concerning the assumptions it used to calculate sizes of populations potentially exposed to different threshold concentrations (Table 3, U.S. EPA, 2009b). The Notice's summary of the UCMR1 data likely overestimates current exposure concentrations and the number of people exposed to perchlorate above various threshold levels.

Response: See response to comment code 3150. See response to comment code 5220 for an explanation of EPA’s rationale in concluding that adverse health effects occur at levels below 24.5 ppb. EPA believes that UCMR1 data are sufficient for estimating population sizes exposed to concentrations greater than the MRL of 4 ug/L. See response to comment ID 28525 under

comment code 3140 for an ex planation of the EPA’s population analysis of UCMR 1 data.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28913

EPA Comment Code: 3150

Comment: We support the use of Bayesian statistical models and approaches to estimate the occurrence of perchlorate in public water systems and the number of people exposed at concentrations below the minimum reporting leve l (MRL) in the occurrence studies on which the analysis is based. Response: See response to comment code 3150.

Commenter Name: Danielle BlacetEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 337 of 1099 Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28925

EPA Comment Code: 3150

Comment: 3) Potential use of Bayesian model (page 41891)

ACWA feels that the Bayesian model would not be useful for the purposes of this determination as we already know that at low enough concentrations perchlorate is widely found, if not ubiquitous. Dr. Shane Snyder and others have completed research that indicates perchlorate exists in basically every water source studied and that US exposure to perchlorate is very close to universal. Several human exposure studies (e.g. NHANES) have also look ed at urine, saliva, and breast milk and every single study subject in each study had perchlora te--there were no studied individuals who did not have perchlorate. Estimating this data is not necessary when real data is already available.

In addition, since the major route of exposure is food and not water, estimating low level concentrations of perchlorate in the minor sour ce will not provide any additional useful information to determine if this chemical needs to be regulated.

Further, while the USEPA is proposing to use a statistical Bayesian procedure to estimate the distribution of censored perchlorate data, it has no t been explained why this particular model would be used and not some other model nor do they explain what population distribution is being assumed. However, all such procedures must assume a single population of results being estimated. In the case of perchlorate, there appear to be multiple populations of results, those resulting from potentially several distinct natural sources, munitions , and Chilean fertilizers. Given the fact that the data should be poly-modal due to these multiple sources found in areas such as California and Massachusetts, the use of any statistical procedur e that is based on a mono-modal distribution will have little likelihood of producing useful results.

Again, ACWA appreciates the opportunity to submi t comments on this critical determination, and USEPAâ€TMs efforts to protect public health throug h the provisions of the federal Safe Drinking

Water Act. We trust USEPA will consider all of th e good science that is available when making a final regulatory determination.

If you have any questions, please feel free to call our offices at 916- 441-4545 or 202-434- 4760.

Sincerely,

Danielle Blacet Regulatory Advocate

Abby Schneider, Ph.D. Federal Legislative Representative

Response: EPA did not use the Bayesian model to make the regulatory determination on perchlorate. EPA continues to evaluate the utility of the Bayesian model(s) in the development of a NPDWR for perchlorate. EPA may no t necessarily distinguish the sour ce of perchlorate in drinking

water but does intend to assess the number of wa ter systems impacted by a potential regulation.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 338 of 1099 

### EPA Comment Code: 3160 Use of Census da ta to estimate populations that are in the sensitive life stage

Individual Comments

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28501

EPA Comment Code: 3160

Comment: b. EPA requests comment on using U.S. Cen sus data to estimate the portions of the population that are in the sensitive life stage at any one time.

US Census data are appropriate to estimate the population numbers for subpopulations that may be more vulnerable to perchlorate. As mentioned ab ove, if sensitive subpopulations are going to be considered when making the regulatory determina tion, accurate estimates of how many people will be protected are critical to the decision.

Response: Please see the response to comment ID 28809 in comment code 3160.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28809

EPA Comment Code: 3160

Comment: b. On the use of US Census data to estimate portions of the population that are in the sensitive life stage at any one time

NRDC response: Yes, the U.S. Census data is appropriate for this use.

Yes, EPA should use the U.S. census data. The U. S. census is mandated by the U.S. Constitution, and is conducted every 10 years, with the next one planned for 2010. These data are used by Congress, as well as governments at the local, sta te, and tribal level to make important decisions about setting priorities, providing services, disb ursing funds, and even distributing Congressional seats.[FN62: See e.g. http://2010.census.gov/2 010census/] The census data are widely recognized
to be reliable, credible, and useful.

There is a valid concern that these data under- represent certain populations, such as certain ethnic minorities, who may be "unregistered" for census purpos es. This may be relevant to the use of these data for this perchlorate assessment, because the children of ethnic minorities may not be fully represented. If anything, these data would undere stimate the number of children under 1 year old.

Response: Please see response to comment ID 28867 under comment code 3160. EPA will further take into consideration the effect contaminants have on sensitive life stages that comprise a meaningful portion of the general population (such as infants, children, pregnant women, theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 339 of 1099 elderly, and individuals with a history of seri ous illness) as we develop the proposed NPDWR, as required by Section 1412(b)(1) of the Safe Drinking Water Act.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28867

EPA Comment Code: 3160

Comment: 4(b)) EPA requested comments on using US Ce nsus data to estimate the portions of the population that are sensitive at any one time to perchl orate in drinking water. This analysis is used as one factor in EPA's decision-making on the need for a drinking water standard for perchlorate, based on the number of people in the U.S. who wo uld be at risk. MassDEP believes that it is inappropriate to consider sensitive groups one-b y-one using census or any other data. EPA should certainly consider perchlorate exposures to fetuses, infants and young children up to 2 years of age. However, EPA should also, for several reasons, consider the entire population's exposure. First, Blount et al. (2006) and Steinmaus et al. (2007) reported an association between perchlorate exposure and decreased T4 and increased TSH in iodine deficient adult women and increased TSH
in all women. As such, we believe that all women sh ould be included in EPA's analysis as a sensitive subgroup. Secondly, as previously noted, there are other sensitive members of the population beyond fetuses, infants and women, and they should also be factored into EPA's framework for considering the extent of the population at risk to perchlorate exposures from drinking water. Lastly, because significant exposures to other thyroid toxi cants are known to occur, other members of the population may also be at increased risk. Thus, any estimate derived based on exposures to the fetus, neonate and women as a group will still be an underestimate of those actually at risk.

We appreciate the opportunity to comment. For fu rther information please contact Carol Rowan West at 617-292-5510 (Carol.RowanWest@sta te.ma.us), C. Mark Smith at 617-292-5509 (C.Mark.Smith@state.ma.us) or Tsedash Zewdie at (617) 292-5842 (Tsedash.Zewdie@state.ma.us).

References

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasi ni L, Caldwell KL. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-1871.

Ginsberg GL, Hattis DB, Zoeller RT, Rice, DC . 2007. Evaluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater: focus on exposure to nursing infants. Environ Health Perspect 115:361-369.

Glinoer D. 2001. Pregnancy and iodine. Thyroid 11:471-481.

Greer MA, Goodman G, Pleus RC, Greer SE. 2002 . Health effects assessment for environmental perchlorate contamination: the dose response fo r inhibition of thyroidal radioiodine uptake inhumans. Environ Health Perspect 110:927-937.

Iglesias P and Diez JJ (2009). Thyroid dysfunction and kidney disease. Eur J of Endocrinol 160: 503-

515EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 340 of 1099 McLanahan ED, Andersen ME, Campbell Jr. JL, Fisher JW. 2009. Competitive inhibition of thyroidal uptake of dietary iodide by perchlorate does not describe perturbations in rat serum total T4 and TSH. Environ Health Perspect 117(5):731-738.

Miller M, Crofton KM, Rice DC, Zoeller T (2009) . Thyroid disrupting chemicals: Interpreting upstream biomarkers of adverse outcomes. Environ. Health. Perspect. 117:1033-1041.

Steinmaus C, Miller MD, Howd R. 2007. Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 na tional health and nutrition examination survey. Environ Health Perspect 115:1333-1338.

Response: EPA considered the population estimates serv ed by PWSs that were monitored under UCMR 1 for which the highest reported perchlorate concentration was greater than various threshold concentrations when determining that a regulation for perchlorate was warranted. These population estimates are for people at all life st ages. EPA has determined that a NPDWR for perchlorate could reduce perchlorate exposures for these populations to levels below the potential

alternative HRLs that EPA has identified as levels of public health concerns for purposes of this determination, and that such exposure reducti ons present a meaningful opportunity for the reduction of health risks for persons served by PWSs . Please see the final regulatory determination notice for further discussion of this analysis.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28893

EPA Comment Code: 3160

Comment: 2. EPA requests comment on using U.S. Cen sus data to estimate the portions of the population that are in the sensitive life stage at any one time.

U.S. Census data might be useful if PWS data ar e paired with U.S. Census data for the same
locations. As discussed above, the relevance of the UCMR1 data to current exposure is unclear since
the UCMR1 data, which were collected from 20 01 to 2005, likely overestimate current concentrations, and approximately half of the perc hlorate water samples in the UCMR1 database are from untreated source waters. Evaluating perchlora te in drinking water at low concentrations (e.g., less than the concentration corresponding to the Rf D of 24.5 ppb) is unnecessary as no adverse health effects are expected at these levels.

Response: Please see response to comment ID 28809 under comment code 3160.

EPA acknowledges that there may be sources that had detected perchlorate from UCMR1 monitoring that are either no longer being use d or are being treated per the requirements of

maximum contaminant levels established in California and Massachusetts; however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at the ti me an assessment is made. UCMR data is the mostEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 341 of 1099 extensive nationally representative occurrence da ta for perchlorate in public water systems; therefore, EPA analyzed this data and additional occurrence data in making a regulatory determination for perchlorate as required by SDWA Section 1445.

EPA disagrees with the commenter that approxima tely half of perchlorate water samples in the

UCMR 1 database are from untreated source water s. The data EPA used to evaluate perchlorate occurrence from UCMR1 was only taken from finish ed water. EPA did allow monitoring at source water sampling points; however, if perchlorate wa s detected in a source water sample, the UCMR 1 required that follow-up samples be collected at the entry point to the distribution system and follow the monitoring frequency specified in the rule for the contaminant and water source type.

EPA disagrees that evaluating perchlorate in drinki ng water at low concentrations (e.g., less than the concentration of 24.5 ppb) is unnecessary. Since the NRC also identified infants and developing children as additional life stages, EPA derived poten tial alternative HRLs for 14 life stages (age groups) using the RfD and life stag e-specific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life st age. EPA is evaluating these potential alternative HRLs and considers them to be levels of public he alth concern for purposes of this determination. For further discussion of this issue please see today’s notice.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28914

EPA Comment Code: 3160

Comment: We also support the use of U.S. Census da ta to estimate the numbers of pregnant
women, infants, and children.

Response: Please see the response to comment ID 28809 in comment code 3160.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 342 of 1099 

### EPA Comment Code: 3170 Accounting for variation of perchlorate levels in public water systems over time

Response to Code 3170 : EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120. EPA notes that systems or entry/sample points with at least one detect above the threshold may not expose the population to th is level at all times. At any particular time, perchlorate levels may be lower or higher than the highest estimated sample detection. However, EPA believes that estimating the number of system s, entry points and populations with at least one

detection above the various threshold concentrations identified in the final perchlorate regulatory determination notice is appropriate for the perchl orate regulatory determination because a single quarterly or semi-annual sample more closely refl ects the short term exposure during the life stages identified by the NRC (i.e., fetuses, pre-term newborns, infants and young children) than does the estimated mean concentration of perchlorate at a system.

Individual Comments

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28502

EPA Comment Code: 3170

Comment: c. EPA requests comment on how the Agency should account for the variation of perchlorate levels over time in public water syst ems. EPA believes that estimating the number of systems, entry points and populations with at leas t one detection above the HRL is appropriate for the perchlorate regulatory determination because a single quarterly or semi- annual sample more closely reflects the short term exposure during li fe stages of concern (i.e., fetuses, pre-term newborns, infants and young children). However, EPA requests comment on whether the Agency should consider other approaches such as estima ting the number of systems, entry points and populations with two or more detections above HRL or some other approach.

ASDWA agrees with EPA's premise that a single occurrence above the HRL could indicate a cause for concern about health impacts due to short ter m exposure, if the value is not an anomaly. However, on the other hand, a single value above th e HRL, especially if the HRL is 15 ug/l or almost 4 times the MRL, that is not supported by additional detections in other samples, could be questionable and indicative of a sampling or laborator y error. EPA should consider an analysis that considers a single sample above the HRL, but with additional detects, as the occurrence criteria. This considers the impact of short term possible health impacts but would tend to eliminate outliers.

Response: See response to comment code 3170. EPA intends to present the perchlorate occurrence analysis that is used to develop the NPWDR.

Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28611

EPA Comment Code: 3170EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 343 of 1099 Comment: You also request comment on how the Agency should account for variation of perchlorate levels over time in public water syst ems. This is simple: the Agency should act with extreme precaution.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28617

EPA Comment Code: 3170

Comment: You also request comment on how the Agency should account for variation of perchlorate levels over time in public water syst ems. This is simple: the Agency should act with extreme precaution.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28810

EPA Comment Code: 3170

Comment: c. On how the Agency should account for the variation of perchlorate levels over time, based on estimating the number of systems, entry points and sampling.

NRDC Response: If EPA plans to consider the low- end estimate of the population exposed, it must develop a justifiable estimate.

As part of the occurrence analysis, EPA attemp ted a high-end and a low-end estimate of the population exposed to perchlorate from contaminated drinking water. The high-end estimate, which is the population served by a system with a contam inated entry-point is an appropriate point to use. However, EPA did not employ the best method to estimate population exposure for the low-end estimate. For systems with multiple entry poi nts, EPA estimated an equal proportion of the population was served by each entry point. However , EPA acknowledged that "[t] his approach may provide either an overestimate or an underestimat e of the population served by the affected entry point" but failed to provide any reasonable uncertainty analysis. An uncertainty analysis is a mathematical measure of the "goodness" of the resul t, and therefore our confidence in it. With such an analysis it is impossible to determine the fitn ess of the value as a basis for making regulatory decisions related to health protection or scientific quality. Therefore, EPA cannot justify using this

estimate to model the occurrence of and ex posure to perchlorate in drinking water.

There are two problems with assuming that every entry point equally se rves a population. First, it is possible that one entry point could serve a larg e majority of the population and other entry points serve many fewer. Basing the estimate on the proporti on of the flow rate of water sent to the system by a given entry point would provide a more accurate representation of the population exposed. Second, having a detection at one entry point do es not preclude the possibility that other entry points in the system are also contaminated. For example, one groundwater source may distributeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 344 of 1099 water to multiple wells which separately contribute water to a system. Therefore, assuming that one contaminated entry point contributes equally to the flow of the entire distribution system is a weak way to estimate the population exposed. Because EPA can neither determine whether this
estimation is an overestimate or an underestimate, or provide an analysis of the uncertainty, it should not be used as part of the regulato ry determination for perchlorate.

NRDC Response: Estimating the water systems with at least one entry point with a sample above the detection limit is appropriate for the perchlorate regulatory determination.

The perchlorate monitoring program was not de signed to specifically detect high levels of perchlorate. While we are not aware of evidence that there are large fluctuations of perchlorate levels in groundwater, detecting perchlorate in drinking water is a signal of a bigger, not smaller, contamination problem. When sporadic sampling is conducted in a system - such as taking a single quarterly or semi-annual sample - detections of contamination are a reflection of a widespread problem. It much more likely that a monitoring program would miss detections and particularly elevated spikes, rather than catch them. Much like searching for a needle in a haystack,if you find one, it is likely because there are many more; howev er if you don't find one, that does not mean there are none. Therefore, each finding of contam ination in monitoring data should be treated seriously, as if it is representative of a widespread problem.

Response: For a discussion on variation of perchlorate levels over time see response to comment code 3170. For a discussion of the analysis EPA use d to derive the population estimates that EPA considered in the final regulatory determination see response to comment ID 28525 under comment code 3140. EPA believes that an uncertainty analysis is unnecessary due to the fact that the Agency not only considered central value estimates, as th e commenter requested, but the Agency evaluated high end estimates as well. Please see res ponse to comment ID 20952 under comment code 3140.which explains in detail what EPA did to account for high and low end population estimates. EPA agrees that each finding of contamination shou ld be taken seriously and that is part of the

reason that we have determined th at perchlorate occurs or there is a substantial likelihood that perchlorate will occur with a frequency and at leve ls of public health concern in public water

systems.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28894

EPA Comment Code: 3170

Comment: 3. EPA requests comment on how the Agency should account for the variation of perchlorate levels over time in public water syst ems. EPA believes that estimating the number of systems, entry points and populations with at leas t one detection above the HRL is appropriate for the perchlorate regulatory determination because a single quarterly or semiannual sample more closely reflects the short term exposure during life stages of concern (i.e., fetuses, preterm newborns, infants and young children). However, EPA requests comment on whether the Agency should consider other approaches such as estimating the number of systems, entry points and populations with two or more detections above HRL or some other approach.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 345 of 1099 As discussed above, there are fundamental scientific and statistical issues with the UCMR1 database for estimating current exposures to perchlorate in drinking water, so any application of the data
therein would be unreliable. First, UCMR1 da ta are likely to overestimate current exposure

concentrations because data were collected fr om 2001-2005 and subsequent remediation and treatment has reduced these concentrations, and appr oximately half of the perchlorate water samples

in the UCMR1 database are from untreated source waters. Second, data in the UCMR1 database are insufficient for estimating population sizes because, for PWSs with multiple entry points to the distribution system, the database does not specify the size of subpopulations distributed water from specific entry points where perchlorate was detected.

Response: EPA acknowledges that there may be sour ces that had detected perchlorate from UCMR1 monitoring that are either no longer being used or are being treated per the requirements of
maximum contaminant levels established in California and Massachusetts; however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at the ti me an assessment is made. UCMR data is the most extensive nationally representative occurrence da ta for perchlorate in public water systems; therefore, EPA analyzed this data and additional occurrence data in making a regulatory determination for perchlorate as required by SDWA Section 1445.

EPA disagrees that data in the UCMR1 database are insufficient for estimating population sizes. EPA presents in today’s Federal Register notice a range of estimates of the population served by PWSs that had at least one sample with perchlorate concentrations greater than the threshold concentrations. The population range represents both a high end estimate, as well as a central value estimate, both derived using the UCMR 1 monitori ng data. The high end estimate of the population served drinking water above a threshold is derive d by adding the entire system population of all PWSs in which at least one sample was found to contain perchlorate above the threshold. Many PWSs have multiple entry points into which treated water is pumped for distribution to their consumers. For the PWSs with multiple entry points, it is unlikely that the entire service population receives water from the one entry point with the hi ghest single concentrati on. Therefore, EPA also provides a central value estimate of the population served water with perchlorate above a threshold in today’s notice. EPA developed this central va lue estimate by assuming the population was equally distributed among all entry points and added only the proportion of the total population served by those entry points in a PWS that had at least on e sample with perchlorate concentrations greater

than the threshold. In regards to the commenter’s concern that approximately half of the perchlorate water samples in

the UCMR1 database are from untreated source wa ters, please see response to comment ID 28893

under comment code 3160.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28915

EPA Comment Code: 3170

Comment: As discussed in the notice, short-term exposur es during sensitive life stages are of concern for perchlorate. We agree that the short time frame of concern should be considered in evaluating perchlorate's occurrence. The NJ DEP (2009) MCL proposal considers the shortEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 346 of 1099 timeframe of concern for perchlorate in its notific ation and monitoring requirements. If a public water system receives results of a sample which exceed the MCL, a confirmation sample must be taken within 72 hours, as opposed to within two w eeks for contaminants with chronic health effects.

Enforcement of the MCL will be based on the aver age of the initial sample and the confirmation sample. Also, public notification of an MCL violat ion must take place with 14 days, as opposed to 30 days for contaminants ith chronic health effects.

Because of the short time period of exposure that is of concern for perchlorate, we agree with USEPA that data for systems, entry points, an d populations with at least one detection above the HRL should be used in the regulatory determination . We agree that it is appropriate to base the occurrence analysis for the regulatory determinati on on the maximum concentration detected rather than on the average concentration.

Response: See response to comment code 3170. EPA ag rees with the commenter in regards to basing the occurrence analysis on th e maximum concentration detected.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 347 of 1099 

### EPA Comment Code: 3200 Supplemental dr inking water occurrence data from

California and Massachusetts

Individual Comments

Commenter Name: Pete McHugh Commenter Organization: Santa Clara County Board of Supervisors

EPA Document ID: EPA-HQ-OW-2008-0692-0681

EPA Comment ID: 20021

EPA Comment Code: 3200

Comment: Perchlorate is a contaminant found in drinking water in California and at least 34 other states. It interrupts the uptake of iodine in th e thyroid and may adversely affect thyroid function, which can then interrupt many hormones in the bo dy. Infants, children, and pregnant women are particularly vulnerable populations.

As of 2005, there were 456 drinking water sources wi th perchlorate detections in 12 counties in California. In our county, an 18 square mile plume of perchlorate contamination requires the monitoring and remediation of hundreds of wa ter wells. Although the source of Santa Clara County's perchlorate contamination and discharger ha s been identified, drinking water quality is not expected to return to baseline levels for at least 12 years at best.

Response: Using the criteria mandated by the 1996 SDWA Amendments, EPA has determined that regulation of perchlorate in drinking water sy stems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28829

EPA Comment Code: 3200

Comment: Population Estimates

AMWA agrees with EPA that its population estimate is high for systems with at least one perchlorate detection and multiple entry points into the distribution system. This is because EPA based the estimate upon the assumption that an en tire system's population would be served water from the entry point with the perchlorate detection . However, in systems with multiple entry points, AMWA agrees it is unlikely that the system's entire service population would receive water that contains perchlorate at the highest concen tration detected at a single entry point.

In addition, AMWA agrees with comments referen ced by EPA on page 41890 of the FR notice that some states have higher concentrations of perchlor ate in drinking water than others. In addition, the exposure to perchlorate of the population in states th at already have regulatory limits for perchlorate will be capped at those levels. For example, staff from the Massachusetts Department of Environmental Protection indicated to AMWA that it will possibly require the PWS with the highest concentration of perchlorate during the commonw ealth's last compliance sampling round to shutEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 348 of 1099 down its well and find a new source of water for its service population. Compliance data for the Los Angeles Department of Water and Power (A ppendix A [see PDF docket ID EPA-HQ-OW-2009- 0494]) shows very few detections, with a ll samples below California's MCL of 6 ppb.

With regard to UCMR data, many of the utilities in the southwest and western states with perchlorate detections have since seen their c oncentrations drop. Whether because of state standards, local cleanups at the Tronox (forme rly Kerr McGee) facility or for other reasons, EPA must take this into consideration in its final population estimates. For example, SNWA had perchlorate detections in 2003 ranging from 10 - 17 ppb. Today the concentrations range from 1 to 3 ppb. There are many utilities in CA and AZ that are served by Metropolitan Water District (MWD) of Southern California and the Central Ariz ona Project that had detecti ons in the range of 3 to 6 ppb in 2002 to 2004 that have not had detections of perchlorate in the last 2 years. For example, please see the data from Consumer Confidence Reports from Phoenix (http://phoenix.gov/ftpalias/payf/ qualre05.pdf) and Scottsdale (http://www.scottsdaleaz.gov/AssetFactory.aspx?did= 28404). In addition, AMWA is also providing annual average perchlorate concentrations from the Alfred Merritt Smith Water Treatment Facility(AMSWTF) at the Southern Nevada Water Authority (Appendix B [see PDF docket ID EPA-HQOW-2009-0297-0494]), and MWD data from the Whittsett intake (Appendix C [see PDF docket ID EPA-HQ-OW-2009-0297-0494]). This is raw water data from the Colorado River intakes at these utilities, which is blended with local water supplies.

EPA also should take care to recognize in it s population exposure estimates the differences between perchlorate in ground water and surface water. Many groundwater systems do not run all of the system's wells continuously. Wells with higher c oncentrations of perchlorate may be blended with lower concentrations, causing a diluting effect. Concentration of surface water sources may change due to precipitation. These factors could cause EPA's estimates to be more conservative than stated

in the NODA.

It is important for EPA to properly characterize it s estimates of the potential population exposed to perchlorate. AMWA recognizes that these estimates include ranges, but the best data available must be used so that these estimates are as thoughtf ul and accurate as possible. Overestimating the populations affected would effectively lead to an overestimation of the benefits. Overestimating populations affected by perchlorate exposure in drin king water could also effectively build a basis for a body of literature that mischaracterizes the situation, which could then be perpetuated and

misused as the information is referenced in the future.

Response: EPA acknowledges that there may be sour ces that had detected perchlorate from UCMR1 monitoring that are either no longer being used or are being treated per the requirements of

maximum contaminant levels established in California and Massachusetts; however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at the ti me an assessment is made. UCMR data is the most extensive nationally representative occurrence da ta for perchlorate in public water systems; therefore, EPA analyzed this data and additional occurrence data in making a regulatory determination for perchlorate. EPA agrees that it is important to properly characterize the estimates of potential population exposed to perchlorate. Please see response to comment ID 28810 in comment code 3170.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 349 of 1099 Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28838

EPA Comment Code: 3200

Comment: With regard to using data from the Commonwealth of Massachusetts to help characterize the distribution of very low perchlor ate concentration occurrence, AMWA is concerned about extrapolating these data to determine a nati onwide distribution for two reasons. First, 89% of public water systems in Massachusetts are solely gr oundwater systems. In addition, a large number of these systems are non-communi ty water systems. Secondly, th e mechanics of perchlorate persistence and occurrence in ground water across the country differ due to factors such as soil retention, subsurface geology, etc.

Therefore, AMWA recommends that EPA extrapolate this data nationwide only for systems that use groundwater, taking care to recognize the propor tion of Massachusetts data that are community water systems vs. non-community water systems as we ll as the differences in other factors that would likely affect these numbers.

Response: EPA did not extrapolate data from Massachuse tts nationwide to aid in the determination of a regulation for perchlorate. EPA did analyze the best available and most extensive nationally representative occurrence data from UCMR along with additional occurrence data, and concluded that regulation of perchlorate was warranted. The Agency evaluated supplemental drinking water monitoring data for perchlorate from California and Massachusetts, and believes that these States’ monitoring results are generally consistent with the results EPA collected under the UCMR 1.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 350 of 1099 

### EPA Comment Code: 3300 Other drinking water occurrence studies, models, and data for EPA to consider (bes ides UCMR 1 and California and Massachusetts data already evaluated)

Response to Code 3300 : Thank you for providing additional da ta on the occurrence of perchlorate. In August 2009, the Agency sought comments on additional approaches to analyzing data related to EPA's perchlorate regulatory determination. These a dditional comments were sought in an effort to ensure consideration of all the potential options for evaluating whether there is a meaningful opportunity for health risk reduction of perchlorate through a national primary drinking water rule.

EPA evaluated the additional occurrence data receiv ed and has considered it along with the UCMR 1 data, which is currently the best available and mo st extensive nationally representative monitoring program for perchlorate in public water systems.

Using the criteria mandated by the 1996 SDWA Amendments, EPA has determined that regulation of perchlorate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Individual Comments

Commenter Name: Douglas, J. Feldman, PE Commenter Organization: Office of Water Resources, Suffolk County Department of Health Services (SCDHS)

EPA Document ID: EPA-HQ-OW-2008-0692-0297

EPA Comment ID: 19753

EPA Comment Code: 3300

Comment: The Suffolk County Department of Health Services (SCDHS), located within the County of Suffolk, in New York State, has conducted a search of our records for the past 10 years as it relates to sampling for the chemical perchlora te. The Department has found that of the 5882 samples obtained for perchlorate analyses, between 1998 and 2008, approximately 420 samples were found to contain perchlorate with concentrations that ranged between 1ppb and 49 ppb - with the mean value of 7.17 ppb. This data indicates that approximately 7% of these samples that were checked for perchlorate contained the chemical. It should be noted that of the 420 samples that were positive, 18 were found in community water supply distribution systems; 49 were found in non-community public water supply wells, and 351 were obtained from private wells.

The Long Island aquifer has been designated as "sole source" by the USEPA and is particularly sensitive to perchlorate discharges, due in part to the sand and gravel material that exist above and within our aquifer systems. The Department has been involved with determining and remediating the sources of perchlorate plum es impacting public and private wells within our County. An
extensive amount of time, effort and cost was ex pended by the Department in performing these

tasks.

Response: Please see the response to comment code 3300.

Commenter Name: Marcia Willhite Commenter Organization: Illinois Environmental Protection AgencyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 351 of 1099 EPA Document ID: EPA-HQ-OW-2007-0068-0155

EPA Comment ID: 20258

EPA Comment Code: 3300

Comment: The Illinois EPA has detected an d confirmed the presence of these contaminants in soil and potable resource groundwater. Perchlorate has been found at: Crab Orchard National Wildlife Refuge (1,200 micrograms per liter ("μg/l")), Sava nna Army Depot (1.2 to 12 μg/l), and Chanute Air Force Base (2.9 μg/l). In additi on, there are several other potential sites where it is suspected that perchlorate will be found, but the groundwa ter has not been tested for perchlorate.

Response: Please see the response to comment code 3300.

Commenter Name: Kathy M. Kinsey Commenter Organization: Maryland Department of the Environment

EPA Document ID: EPA-HQ-OW-2008-0692-1421

EPA Comment ID: 20427

EPA Comment Code: 3300

Comment: A Uniform Federal Drinking Water Standard is Necessary to Protect Public Health

On the merits of EPA's preliminary determinati on, based on an initial review, the Department submits that perchlorate is present in ground and surface drinking water at levels of public concern and that establishment of a drinking water stan dard presents a meaningful opportunity to reduce the health risk perchlorate presents, particularly to the vulnerable and sensitive subpopulations - pregnant and lactating women, fetuses, and youn g children. There are no technological impediments to removing perchlorate from ground or surface wa ter. Technology capable of removing perchlorate from ground and surface water is already in use. For larger surface water systems eliminating or reducing the source of the contamination woul d likely be the most practical solution.

Section 1412(b)(1)(A) of the Safe Drinking Wa ter Act requires EPA to establish a maximum contaminant level for a contaminant if: (1) the contaminant may have an adverse effect on the health of persons; (2) the contaminant occurs or presents a substantial likelihood that it will occur in public water systems at a frequency and at levels of publ ic concern; and (3) EPA determines that regulation of the contaminant presents a meaningful opportunity for health risk reduction for persons served by public drinking water supplies. In the case of perchlorate, each of the criteria is satisfied.

There is no genuine dispute that perchlorate may have an adverse effect on human health. Perchlorate is known to interfere with thyroid function. Lower thyroid hormone levels can cause changes that adversely impact brain developm ent. In its preliminary determination, EPA acknowledges that at sufficiently high doses, pe rchlorate can interfere with thyroid function in pregnant women, fetuses, newborns and young children.

In Maryland, perchlorate is present at signific ant levels in ground and surface water at three Department of Defense facilitie s. At Aberdeen Proving Ground in Harford County, Maryland, perchlorate has been detected in groundwater at seven different locations and at levels as high as 350 parts per billion ("ppb"). Perchlorate from other area s of the installation has contaminated the water supply for the City of Aberdeen. In the absence of a federal drinking water standard, the State has set an advisory level of 1 ppb for the Ci ty treatment system's finished water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 352 of 1099 Although no public drinking water supply wells have been impacted, perchlorate levels in ground water at the Naval Support Facility at Indian Head have been detected at levels as high as 2,900 ppb. At a number of other sites in Cecil County, Maryland, perchlorate contamination was detected in ground water monitoring wells at levels as high as 230,000 ppb in the late 1990's. In the one case where perchlorate contamination has impacted th e drinking water supply, the Department has provided bottled water to affected residents and required installation of a treatment system to

address the contamination. Perchlorate contaminati on has also been detected in the Potomac River, the source of drinking water for millions of Mary land, Virginia, West Virginia and District of Columbia residents. EPA sampling detected perchlora te levels up to 8 ppb in one of Maryland's Potomac River water supply intakes.

Establishing a federal drinking water standard th at would protect the millions of people, including pregnant women, infants and young children, who ar e served by drinking water that is currently contaminated or at risk of contamination by pe rchlorate is necessary to protect public health.

Response: EPA agrees with the commenter that the three criteria for determining whether a contaminant should be regulated from SDWA section 1412(b)(1) are satisfied for perchlorate. Please see the responses to comment codes 6120 and 3300.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20438

EPA Comment Code: 3300

Comment: Occurrence

As noted above, one of the criteria for evaluati ng the need for potential regulatory actionis occurrence. In 2005, AWWA prepared an assessment of data collected under the first Unregulated Contaminant Monitoring Rule (UCMR1). AWWA r ecently completed a follow-up of this initial assessment using the final UCMR1 data set considered by EPA in this proposed decision. There were very subtle differences, in total numbers, but th at did not result in a significant difference in the overall findings. This analysis is summarized below and has been submitted to a peer-reviewed journal and is pending publication.

The evaluation by Brandhuber et.al. (pending pub lication) consolidated existing potable water perchlorate occurrence information taken from UCMR1 and other recently completed occurrence studies. The detection of perchlorate in drinking water was determined to be geographically widespread but at very low concentrations. Sig nificantly, there was little correlation between perchlorate detection in drinking wa ter and known points of perchlorate release to the environment identified by the USEPA. Perchlorate has been det ected in drinking water in at least 26 States and Puerto Rico and in approximately 5% of the nation's large community water systems (>10,000 population served). When detected, perchlorate was typically present at concentrations of less than 12 ug/L and was generally found in less than one half of the sources for systems which sampled multiple sources. No statistically significant differe nce in the rate of perchlorate occurrence between surface and ground waters was identified.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 353 of 1099 Extrapolating the results of the occurrence studies re viewed by this report, it appears that nationally less than 1% of all drinking water systems would be impacted if an MCL of 20ug/L were established. An MCL of 2 ug/L could impact appr oximately 4% of public water systems nationally. At this level, regional impacts in California and Texas would be greater due to the higher geographical concentration of detections in those states . Yet it should be noted that water systems in Massachusetts, New Jersey and California have alre ady established regulatory limits of 2 ug/L, 5 ug/L and 6 ug/L respectively, thereby capping the population exposure potential from community drinking water sources in those states.

The estimated population exposure calculated from UCMR1 findings has also been greatly reduced by the effectiveness of mitigating contamination sources on the Colorado River to levels below 2 ug/L. This reduction in levels in the Colorado Ri ver alone represents a reduction in the exposure potential of approximately 20 million persons in several western states, primarily California and Arizona. In addition, a recent telephone survey of water systems detecting perchlorate indicated that at least 50 MGD of water production has been taken off line nationally due to the presence of perchlorate since UCMR1 monitoring was completed.

Response: Thank you for providing the additional analysis of data on the occurrence of perchlorate. EPA notes that New Jersey proposed an MCL of 5 μg/L in April 2009, but this standard has not been finalized. In July 2006 , Massachusetts set an Maximum Contaminant Level (MCL) of 2 μg/L. Additionally, In October 2007, California set an MCL of 6 μg/L. Please see response to comment ID 28755 in comment code 330 0. Using the criteria mandated by the 1996 SDWA Amendments, EPA has determined that regula tion of perchlorate in drinking water systems presents a meaningful opportunity to reduce health ri sk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Paul J., P.E. Ponturo Commenter Organization: Long Island Water Conference

EPA Document ID: EPA-HQ-OW-2008-0692-1260

EPA Comment ID: 20622

EPA Comment Code: 3300

Comment: November 7, 2008

Water Docket Environmental Protection Agency Ma ilcode 2822 T 1200 Pennsylvania Ave., NW Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2008-0692 Dr inking Water: Preliminary Regulatory Determination on Perchlorate, FR 10/10/08

Gentlemen:

On behalf of the Long Island Wa ter Conference, an association of public water supply professionals in Nassau and Suffolk Counties in NY, I am pleased to present our comments on the referenced preliminary regulatory determination.

Our member suppliers have a long history of re sponsiveness in meeting the increasing needs for comprehensive water supply monitoring, research and groundwater protection programs. We haveEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 354 of 1099 worked cooperatively with our regional regulatory agencies to provide monitoring and oversight that dramatically exceeds federal EPA re quirements. Aggressive monitoring is necessary and desirable in protecting public health. We have also worked with regional regulatory agencies in water supply and water resource management studies and supported the integration of local regulations which combine discharge controls, land use, and the storage of hazardous substances into an advanced source water protection system.

Long Island was one of the first designated Sole Source Aquifer systems in the United States, and with a total population of nearly three million, is co nsidered to be one of the most intensively used and critical Aquifer systems in the country.

This preliminary regulatory determination therefore is significant to every public water supplier on Long Island. Approximately 250 community water supply wells in Nassau and Suffolk County have indicated detection of perchlorate in concentrat ions greater than 1 ppb. Consistent with EPA's
occurrence evaluation, a much smaller number of sources exhibit concentrations greater than 5 ppb (approximately 25) or 10 ppb (appr oximately 10). The Health Reference Level (HRL) of 15 ppb used by EPA to reach this determination is close to the NYS Department of Health's Action Level (discussed below); no Long Island public water sup plier customer is being currently exposed to

concentrations in excess of this Level.

Response: Please see the response to comment code 3300.

Commenter Name: Paul J., P.E. Ponturo Commenter Organization: Long Island Water Conference

EPA Document ID: EPA-HQ-OW-2008-0692-1260

EPA Comment ID: 20623

EPA Comment Code: 3300

Comment: We do not have a technical basis upon which to criticize EPA's determination. Based upon its interpretation of Safe Drinking Water Ac t criteria, EPA has determined there is not a "meaningful opportunity for health risk reduction" through a national drinking water regulation. EPA's conclusion is based upon its own analysis of available data indicating that perchlorate was found at levels of public health concern (the HRL) in less than 1 percent of public drinking water systems sampled.

However we do wish to point out that without a greater understanding of perchlorate formation processes and the possibility that unmeasured perc hlorate may exist in other salts in common use, one may still lack statistical confidence in ut ilization of the UCMR data to estimate population exposures in drinking water. Unlike other parts of the country, a clear source for many of Long Island's perchlorate contamination occurrences ha s not emerged over the past 10 years. The highest recorded perchlorate concentration in a well on Long Island was traced to a completely unregulated activity, as described below.

Perchlorate monitoring of public water supplies on L ong Island began in the sp ring of 1998. Initially in response to perchlorate detection reports el sewhere in the US, the Suffolk County Water Authority (SCWA) voluntarily collected samples from wells at five wellfields. The samples were sent to the Montgomery Watson Laboratory for analysis. Of the initial sample results one well - #3 at the Old Country Road wellfield in Westhampton - indi cated a concentration of perchlorate of 30 ppb.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 355 of 1099 The SCWA removed this well from service. At th e end of 1998, NY State Department of Health provided an Action Level of 18 ppb. This well late r showed concentrations as high as 127 ppb in samples collected during subsequent test pumping. Initial thoughts were directed to the former military uses of property immediately upgradient of the well at a former BOMARC missile site. This was discounted, upon submission of evidence that solid fuel rockets were not deployed at this site.

By late 1998, attention turned to a review of more r ecent activities subsequent to the takeover of the BOMARC site by Suffolk County - specifically the Suffolk County Police Department (SCPD) practice of disposal of confiscated fireworks and munitions by burning. Between November 1998 and February 2000, a total of 18 profile wells wer e installed by the Suffolk County Department of Health Services' (SCDHS) Bureau of Groundwa ter Resources in locations upgradient and downgradient of the fireworks disposal pit, whic h was located in the northwest corner of the site. Groundwater flow direction and water quality data appe ared to eliminate other activities in the area as potential sources. Perchlorate was detected in 9 test wells downgradient of the pit, in concentrations as high as 3,370 ppb. Although the pit and burning practices have been modified, fireworks disposal at the site continues, and to da te such disposal is not covered under any NY State environmental regulation. In subsequent years, SCDHS also investigated the contamination of a number of private wells and one non- communitysupply well in Yaphank, NY, which later traced to fireworks testing and a practice of stabilizing "dud" fireworks by a process called "soaking." This process utilizes water indrums to leach out the perc hlorate from the dud, stabilizing the firework for subsequent disposal by burning.

Local laboratory capacity has been developed at SC WA, SCDHS and at private labs to assist in the monitoring effort, which began in earnest before the UCMR implementation date, and monitoring

continues.

Response: Please see response to comment code 3300.

Commenter Name: Mic Stewart Commenter Organization: Metropolitan Water District of Southern California

EPA Document ID: EPA-HQ-OW-2008-0692-1784

EPA Comment ID: 20661

EPA Comment Code: 3300

Comment: November 6, 2008

Attention: Docket ID Number EPA-HQ-OW-20 08-0692 OSWER Docket EPA Docket Center Mailcode: 2822T Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC

20460

Dear Environmental Protection Agency:

The Metropolitan Water District of Southern Ca lifornia (Metropolitan) is submitting comments on

U.S. Environmental Protection Agency's (EPA's) Preliminary Regulatory Determination on Perchlorate (73 Federal Register 60262). The proposed action by the EP A not to regulate the drinking water contaminant perchlorate will aff ect how state and local officials can respond to localized perchlorate contamination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 356 of 1099 Metropolitan is a regional water supply agency that provides supplemental water to nearly 19 million people throughout the southern California area. Ou r major source of supply, the Colorado River, was contaminated from industrial production of perchlorate for solid rocket fuel and subsequent improper disposal methods. Perchlorate contamina ted groundwater seeping into Lake Mead through the Las Vegas Wash area found its way into the Colorado River, which supplies Metropolitan and other downstream users. Levels as high as 20 parts per billion (ppb) were detected in Lake Mead and levels as high as 9 ppb have been detected at the intake to Metropolitan's conveyance system. Following the detection of perchlorate in the Color ado River, Metropolitan along with the EPA and regulatory agencies in Nevada, organized the forces necessary to successfully treat and decrease the sources of perchlorate loading. Since 2006, moni toring has indicated levels at or below 2 ppb entering Metropolitan's conveyance system.

Response: Please see the response to comment code 3300.

Commenter Name: Stephen A. Owens Commenter Organization: Arizona Department of Environmental Quality

EPA Document ID: EPA-HQ-OW-2008-0692-1785

EPA Comment ID: 20665

EPA Comment Code: 3300

Comment: November 7, 2008

Comment Clerk Water Docket Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW. Washington, DC 20460

Re: Arizona Department of Environmental Qua lity Comments on Federal Pr eliminary Regulatory

Determination on Perchlorate Do cket EPA-HQ-OW-2008-0692

Dear Sir:

In response to the notice in the Federal Register of October 10, 2008 (Volume 73, Number 198) the Arizona Department of Environmental Quality (A DEQ) is offering comments on the Preliminary Regulatory Determination on Perchlorate. ADEQ offers these comments in role of the delegated authority responsible for protecting public health in Arizona through rules promulgated under the Federal Safe Drinking Water Act.

Perchlorate contamination is known to be presen t in Arizona water supplies. Arizona, along with other arid western states, relies heavily upon the Colorado River as a critical source of our population's drinking water supply. The overall "hea lth" and water quality of the Colorado River and

other surface water sources are of the utmost c oncern for Arizona. Perchlorate contamination has impacted the Colorado River due to industrial sources in the Las Vegas area. The source of this contamination has been controlled more effectively by the responsible parties; however the risk of perchlorate contamination in the Color ado River water supply still exists.

A Consumer Confidence Report issued by the City of Phoenix (City) in 2007 is one example of a direct perchlorate related impact on Arizona citizens . According to City records, roughly ninetyeight percent of all potable water produce annually is derived from surface sources, including water from the Colorado River. In 2004, the City collected 39 2 finished water distribution samples (as aEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 357 of 1099 precautionary measure) to gather more informati on on the occurrence of perchlorate in the public water system supply. Thirty-nine of those sample s tested at, or above, the minimum detection level of four (4) part per billion for the presence of perchlorate.

Perchlorate contamination is not strictly limited to surface waters of the Southwest. A perchlorate occurrence study conducted by ADEQ (Perchlorate in Arizona: Occurrence Study of 2004) revealed numerous groundwater sources with detectable leve ls of perchlorate. One well located in Yuma County tested positive in 2004 for levels of perc hlorate in the 15 parts per billion (ppb) range. Groundwater is a critical source of drinking water in Arizona and under Arizona law all aquifers in the state are designated by st atute for drinking water use.

Response: Please see the response to comment code 3300.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20933

EPA Comment Code: 3300

Comment: Nevertheless, the limited available drin king water data that the Environment Department has reviewed show significant perchlor ate contamination in several public drinking water systems around the State. In the Department 's view, perchlorate contamination in drinking water occurs at levels and at a frequency that is a public health concern in New Mexico.[FN2: See SDWA [section] 1412(b) (1)(A)(ii), 42 U.S.C. [section] 300g-1(b)(1)(A)(ii) (Westlaw 2008).]

At Cannon Air Force Base, near Clovis, New Mexico, the Environment Department received data in 1999 showing perchlorate concentrations of 46 micr ograms per liter (ug/L) in production well PW-2 and 21 ug/L in production well PW-7. These wells are both active drinking water production wells that serve users on the Base.[FN3: N.M. Environmen t. Dep't, Perchlorate Survey 2001 Final Report, vol. 1, tab "Cannon" (unpublished compilation).] Da ta that the Environment Department gathered in 2001 from Cannon showed perchlorate contaminat ion of 23.5 ug/L in PW-12, another drinking water production well.[FN4: Id.] Data collected from the system in 2003 and submitted to the Environment Department under the Unregulated Contaminant Monitoring Ruleshows a perchlorate level at 30 ug/L.[FN5: Safe Drinking Water In formation System, State version (SDWIS/State). The State has not verified the accuracy of this data.] In addition, the Government Accountability Office (GAO) has compiled data on perchlorate contamination throughout the United States, including New Mexico. In its 2005 report, GAO similarly repor ted perchlorate at 46 ug/L in drinking water at Cannon Air Force Base.[FN6: GOVERNMENT ACCOUNTABILITY OFFICE, A SYSTEM TO TRACK SAMPLING AND CLEANUP RESULTS IS NEEDED, AT 37 (GAO-05-462) (May 2005).]

At the Melrose Bombing Range, also near Clovis , the Environment Department received data in 1999 showing perchlorate contamination in prod uction well PW-11, an active drinking water production well for the facility, at 25 ug/L.[FN7: N.M. Environment. Dep't, Perchlorate Survey 2001 Final Report, vol. 2, tab "Melrose" (u npublished compilation).] Data the Environment Department obtained in 2001 from Melrose showed perchlorate concentrations of 30.3 ug/L and 40.7 ug/L in PW-11(shown as MAFR Well-11), and a perchlorate concentration of 5.52 ug/L in PW-13 (shown as MAFR Well-13), an other on-site facility drinking water supply wel1.[FN8: Id.]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 358 of 1099 At Kirtland Air Force Base, data collected in 20 04 show perchlorate contamination in Well #17, a drinking water supply well, at 1 2.6 ug/L.[FN9: Letter from Carl J. Lanz, Chief, Restoration Section,
Kirtland Air Force Base, to Sandra Martin, Chi ef, Hazardous Waste Bureau, N.M. Environment Dep't (Mar. 31, 2004).] Kirtland is located adjacent to the City of Albuquerque, which is the State's largest metropolitan area having a population over 50 0,000. Yet there is very little available data on perchlorate in drinking water on and around Kirtland.

The GAO also reported perchlorate contamination in the municipal drinking water supply for the City of Deming, New Mexico at 20 ug/L, and for the City of Des Moines, New Mexico at 5 ug/L. GAO reported perchlorate in the drinking water supply for the City of Clovis, New Mexico, operated by the American Water Company, at 7 ug /L. GAO also reported perchlorate in the water supply for the community of Mountain View Albuquerque, in the South Valley of Albuquerque, New Mexico, at 5 ug/L.

The Environment Department has gathered additional data demonstrating widespread perchlorate contamination in groundwater at several militar y installations and nuclear weapons facilities throughout the State. In many cases, this contamin ation threatens present and future drinking water supplies.

At Los Alamos National Laboratory, perchlorate c ontamination has been monitored in groundwater beneath much of the 40-square mile facility. Of particular significance, sampling conducted beginning in 2005 shows perchlor ate concentrations ranging between 30 ug/L and 256 ug/L in intermediate wells located in Mortandad Canyon. More recent data shows that this contamination has remained relatively constant. A deeper m onitoring well, Well R-15, shows a perchlorate concentration of 7 ug/L. The highest contaminati on, 256 ug/L in intermedi ate well MCOBT-4.4, is within 2000 feet from PM-5, a municipal drinking water production well for Los Alamos County. Low concentrations of perchlorate, below 1 ug/L , have been detected in PM-5. Neither the sources of the perchlorate contamination, nor the nature and extent of the perchlorate plume, are fully characterized. The perchlorate contamination thre atens the Los Alamos County water supply, which serves approximately 20,000 people.

At Sandia National Laboratories, adjacent to the Ci ty of Albuquerque, perchlorate has been found in the EOD Hill monitoring well at concentrations ra nging from 680 ug/L to 4300 ug/L. Data from 2006 and 2007 show that perchlorate has b een detected in CYN-MW6 monitoring well at concentrations between 6.56 ug/L and 8.93 ug/L. Perchlorate data at Sandia is limited, however.

At the United States Army White Sands Missile Ra nge, near Socorro, New Mexico, high levels of perchlorate contamination in soil and groundwater is widespread. In 2000, perchlorate was detected in 22 of 23 groundwater monitoring wells at concentrations ranging from 5 ug/L to 21,000 ug/L.[FN10: N.M. Environment. Dep't, Perchlor ate Survey 2001 Final Report, vol. 2, tab "White Sands" (unpublished compilation).] Currently, th e highest concentrations are 19,000 ug/L. The Army has vigorously resisted conducting any co rrective action to remedy the contamination.

At Holloman Air Force Base, groundwater data collected in September 1999 showed perchlorate levels of 15.5 ug/L in monitori ng well NM-39-02-01, 15.2 ug/L in monitoring well NM-39-02-02, and 38.9 ug/L in monitoring well NM-39-03.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 359 of 1099 At Kirtland Air Force Base, data collected in 2006 showed perchlorate levels in monitoring well KAFB-2622 at 8.4 ug/L, and in monitoring well KAFB-2624 at 11 .0 ug/L. Data collected in 2008 showed perchlorate in the "School House Mesa We ll" at 5.19 ug/L. Yet very little groundwater monitoring data has been obtaine d for perchlorate at Kirtland.

Response: Please see response to comment code 3300.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21026

EPA Comment Code: 3300

Comment: 9. Your letter asserts that in the absence of a federal MCL, high perchlorate levels in drinking water will go undetected and ther efore national monitoring is needed.

The use of Unregulated Contaminant Monitoring Rule (UCMR) sampling data for regulatory determinations is well established. The nationally- representative UCMR 1 results show that perchlorate does not occur frequently or at levels of public health concern in public water systems. Additionally, as evidenced by more recent samplin g results from Lake Mead, the Las Vegas Wash, and the Metropolitan Water District of Southern Ca lifornia (MWD), perchlorate levels continue to decline since the time of the UCMR 1 sampling. The preliminary determination assumes that the concentrations measured in the UCMR 1 survey are still occurring. In fact, levels in many of the highest reported drinking water systems have significantly declined due to source control.

Response: Please see the response to comment ID 28755 in comment code 3300.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21095

EPA Comment Code: 3300

Comment: Additionally, as evidenced by sampling resul ts from Lake Mead, the Las Vegas Wash, and the Metropolitan Water District of Southern Calif ornia, perchlorate levels continue to decline since the time of the UCMR 1 sampling. Th e preliminary determination assumes that the concentrations measured in the UCMR 1 survey are still occurring. In fact, levels in many of the highest reported drinking water systems have significantly declined due to source control.

Response: Please see the response to comment ID 28755 in comment code 3300.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28499

EPA Comment Code: 3300EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 360 of 1099 Comment: Comments on interpreting occurrence data - Because many states do not have significant occurrence of perchlorate and some ha d no occurrence, states are concerned that the burden of a possible rule would fall heavily on these states and their water systems with little actual

reduction in health risk for their water consumer s. ASDWA is also familiar with new data from Nevada (submitted separately) that indicate a reducti on in perchlorate levels since the UCMR data were collected. These data need to be included in the analyses along with the modeling approach and use of census data that are addressed in the specific questions.

Response: EPA acknowledges the commenters concern for a federal perchlorate regulation and that some states had no occurrence during UCMR1 monitoring; EPA analyzed additional occurrence data received along with UCMR data (w hich is the best available and most extensive nationally representative occurrence database for pe rchlorate in public water systems known to date) and using the criteria mandated by the 1996 SD WA Amendments, determined that regulation of perchlorate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120. When EPA proposes

a NPDWR that includes a maximum contaminant level, EPA will analyze and consider both the costs and benefits that would result from regulation and present these analyses for public comment. See SDWA section 1412(b)(3)(C).

Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28709

EPA Comment Code: 3300

Comment: September 18, 2009 Attention: Docket ID Number EPA HQ-OW-2009-0297 EPA

Docket Center Mailcode: 2822T Environmenta l Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460

Dear Environmental Protection Agency:

The Metropolitan Water District of Southern Ca lifornia (Metropolitan) is submitting comments on U.S. Environmental Protection Agency's (EPA) Dr inking Water: Perchlorate Supplemental Request for Comments (74 Federal Register 41883). This EPA notice follows the previously proposed action by the EPA not to regulate the drinking water co ntaminant perchlorate which will affect how state and local officials can respond to localized perchlorate contamination.

Background on the Southern California Situation

Metropolitan is a regional water supply agency that provides supplemental water to nearly 19 million people throughout the southern California area. Ou r major source of supply, the Colorado River, suffered significant contamination from industrial production of perchlorate for solid rocket fuel and subsequent improper disposal methods. Perchl orate-contaminated groundwater seeping into Lake Mead through the Las Vegas Wash found its way into the Colorado River, which supplies

southern California and other downstream users. Le vels as high as 20 parts per billion (ppb) were detected in Lake Mead and levels as high as 9 ppb have been detected at the intake to Metropolitan's conveyance system, located approximately 160 miles south of the Las Vegas Wash.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 361 of 1099 In 1997, the source of perchlorate contamination in the Colorado River was traced to a chemical manufacturing facility formerly owned by Ke rr-McGee Corp., and now owned by Tronox, Inc. Tronox, previously a chemical subsidiary of Kerr- McGee, has assumed the responsibility of the ongoing perchlorate remediation activities in Henderson, Nevada. Another large perchlorate groundwater plume is also present in the Henderson area from a second industrial site, and although not known to have reached Las Vegas Wash yet, re mediation activities are ongoing for cleanup of that plume by American Pacific Corporation.

Following the detection of perchlorate in the Color ado River, Metropolitan, along with the EPA and agencies in Nevada including the Nevada Divisi on of Environmental Protection (NDEP), organized the forces necessary to successfully treat and decr ease the sources of perchlorate loading. Under NDEP oversight, remediation efforts began in 19 98 and the treatment operations became fully operational in 2004. These efforts have reduced perc hlorate loading into Las Vegas Wash from over 1,000 lbs/day (prior to treatment) to 60-90 lbs/da y since early 2007. These have resulted in over 90 percent reduction of the perchlorate loading entering the Colorado River system.

Perchlorate levels in Colorado River water at La ke Havasu have decreased significantly in recent years from a peak of 9 ppb in May 1998 as a result of aggressive clean-up efforts at Henderson, Nevada (see Figure 1). Levels have remained less than 6 ppb since October 2002, and have been generally less than 2 ppb since June 2006.

Figure 1. Declining Perchlorate Levels at La ke Havasu [see PDF docket ID EPA- HQ-OW-2009- 0297-0496]

Response: Please see response to comment code 3300.

Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28711

EPA Comment Code: 3300

Comment: On January 12, 2009, Tronox filed for Chapter 11 bankruptcy protection (U.S. Bankruptcy Court, Southern District of New York). The company cited the significant

environmental liabilities taken on from Kerr-McGee as a primary cause of its financial liabilities. Tronox has indicated plans to restructure the comp any while continuing its operations. Metropolitan is concerned that the outcome of the bankruptcy proceedings could potentially impede or even reverse the ongoing cleanup efforts aimed at reme diating perchlorate contamination entering the Colorado River. If perchlorate treatment in the Las Vegas Wash area were discontinued, modeling results suggest that perchlorate levels in the Colorado River could spike to concentrations as high as 9 ppb in as little as 18 months. This level of perc hlorate would result in non-compliance by drinking

water utilities with California's exis ting MCL for perchlorate of 6 ppb.

While the State of California does have a 6 ppb MCL fo r perchlorate, this drinking water standard is not enforceable outside the State. EPA's role in establishing and enforcing a national drinking water standard for perchlorate will be critical in the l ong-term remediation of perchlorate contamination inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 362 of 1099 the Colorado River and hundreds of U.S. Departme nt of Defense sites around the country. Since the detection of perchlorate contamination thro ughout the southwest region and in hundreds of local groundwater wells, Metropolitan, its member agencies, and the drinking water community have called on the EPA to make a regulatory determinati on on perchlorate consistent with the tenets of the Safe Drinking Water Act. Metropolitan belie ves that the unique factors surrounding regional perchlorate contamination in the Colorado River system need to be considered.

Response: The commenters concerns regarding the outcome of the bankruptcy proceedings are outside of the scope of this action. Regardin g your comment that EPA "make a regulatory determination on perchlorate consistent with tenen ts of the Safe Drinking Water Act," using the criteria mandated by the 1996 SDWA Amendments, EPA has determined that regulation of perchlorate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28713

EPA Comment Code: 3300

Comment: Additionally, Metropolitan would like to sugge st that EPA take the additional time necessary to review and quantify occurrence data co llected by the Agency and by individual states including California to better represent possible exposure and occurrence. Perchlorate occurrence is expected to increase unlike other contaminants on the Contaminant Candidate List such as pesticides that are no longer in use.

Response: Please see the response to comment code 3300.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28755

EPA Comment Code: 3300

Comment: The Lower Colorado River System provides dr inking water to approximately 26 million
residents of Nevada. Arizona, and Califor nia through three primary diversions:

1) Southern Nevada Water Authority (SNWA) an d Black Mountain Inc. Intakes in Lake Mead, which serve approximately 2 million residents within the Las Vegas Valley (distributed through portions of the City of Las Vegas, the City of Henderson, and Clark County);

2) The Central Arizona Project (CAP) canal, whic h conveys water from Lake Havasu (near Parker Dam) to several locations throughout Arizona including the Phoenix and Tucson Valleys and serves approximately 5 million residents of Arizona; and

3) The Colorado River Aqueduct operated by the Metropolitan Water District (MWD) of Southern California to convey water from Lake Havasu (near Pa rker Dam) to several communities in southernEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 363 of 1099 California including several within the greater Los Angeles area and the greater San Diego area. We understand that MWD serves approximately 19 million end users through various wholesale and retail agreements. We also understand that wa ter quality measurements collected and posted by MWD for the Colorado River Aqueduct are tracked under "Whitsett Intake".

Additionally, the Colorado River System also is use d for irrigating much of the nation's vegetable crops grown in the Imperial Valley of California an d the Yuma, Arizona area. This water is conveyed through the All American Canal from a diversi on near Yuma, Arizona to numerous locations in southern California near the US / Mexico International border.

Remediation of perchlorate source areas within the Las Vegas Valley has substantially reduced (by approximately 90 %) the amount of perchlora te entering the Colorado River System (NDEP, 2009c). Corresponding water quality improvements ha ve been realized along the entire southern reach of the Colorado River extending from Lake Mead, though Lake Mohave and Lake Havasu, to the US/Mexico International border. Data colle cted by numerous entities (i.e., NDEP, SNWA, MWD, CAP, EPA, and others) since approximatel y 1997/1999 though current have documented the improvements in water quality throughout the lower Colorado River System. The reductions in perchlorate entering the Colorado River System can be observed in the graphs of perchlorate data provided in Appendix A [See PDF docket ID EP A-HQ-OW-2009-0297-0639] and Appendix B [See PDF docket ID EPA- HQ-OW-2009-0297-0640] an d are attributable to several successive remediation events including ( NDEP, 2009d; NDEP, 2009c):

* initial Seep capture by Kerr McGee (now Tronox) in 1999; * construction of a slurry wall and extraction well field in 2001; * operation a full-sc ale groundwater treatment system in 2002; * expansion of the Seep area extra ction well field in 2003; * transition from an ion exchange system to Fluidized Bed Reactor (FBR) treatment system in 2004; * continued operation and optimization of the FBR and well fields from 2005 through current; * initial installation of an In-situ Bioremediation (ISB) system by AMPAC in 2005; * initial start-up and operation of the ISB system in 2006; and * continued operation and optimization of the ISB system from 2007 through current.

The referenced reduction in perchlorate mass loading to the Colorado River system (via the Las Vegas Wash, a tributary to Lake Mead) were immediately recognized following the initial Seep capture and treatment using disposable ion exchange (IX) resin implemented by Kerr McKee (Tronox) in late 1999. The mass loading values dropped approximately 40% from approximately 900 - 1,000 pounds per day to approximately 500 - 60 0 pounds per day by December 2001 as can be seen on the "Perchlorate Loading 12-Month Rolling Average" graph in the NDEP maintained Northshore Road data set in Appendix c [S ee PDF docket ID EPA-HQ- OW-2009-0297-0641] (NDEP, 2009b). Continuous reductions in perchlorate mass are seen in the Northshore Road data beginning with operation of the full-scale remedi ation system in October 2002. The decrease in perchlorate mass loading continued through conver sion to an FBR system in October 2003 and its one-year shake-down period. Decreases in perchlor ate mass loading have continued from late 2004 through the present, as Tronox optimized th eir remediation system and AMPAC initiated remediation of a second perchlorate plume in mid 20 06 as can be seen on each of the three data graphs for the Northshore Road dataset in Appendix A [See PDF docket ID EPA-HQ-OW-2009- 0297-0639] (NDEP, 2009d). Greater than 90% decr ease in mass loading has been sustained since February 2007 (i.e., for more than two and one half years) as can be seen in the Northshore Road tabular data presented in Appendix C [See PDF docket ID EPA-HQ- OW-2009-0297-0641] and the related Breakthrough Curve in Appendix D [See PDF docket ID EPA-HQ-OW-2009-0297-0642]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 364 of 1099 (NDEP, 2009b; NDEP, 2009a; McGinley & Associ ates, 2003). These trends are expected to

continue.

Water quality improvements within the Colorado Rive r system are documented within the Southern Nevada Water Authority (SNWA) intake data for Lake Mead as can be seen in the Perchlorate Monthly Stream Report provided in Appendix E [See PDF docket ID EPA-HQ-OW-2009-0297- 0643] (SNWA, 2009a). Yearly average SNWA Intake da ta for one of the two existing intakes in Lake Mead show a precipitous drop in perchlorate concen trations from approximately 13.4 ug/L in year 2000, through approximately 10 - 11 ug/L during years 2001, 2002, and 2003, to approximately 2 - 2.5 ug/L in years 2007, 2008, and 2009 as can be seen in the Perchlorate - Yearly Average - AMSWTF Raw Water graph and tabular data provided in Appendix F [See PDF docket ID EPAHQ-OW-2009-0297-0644] (SNWA, 2009b). These water quality improvements correspond to the significant reduction in perchlorate mass loading to the Colorado River System via the Las Vegas

Wash.

Seasonal water quality fluctuations that are present in the Lake Mead data are a result of seasonal lake stratification and mixing events as can be se en in the graph of Saddle Island Intake Data in Appendix E [See PDF docket ID EPA-HQ- OW-2 009-0297-0643] (SNWA, 2009a). Lake Mead typically destratifies annually due to changes in temperature and wind driven mixing. The surface waters routinely mix to a depth of 30 - 45 feet below the lake surface level throughout the summer (that allows for stratified water quality conditions ) and the surface layer deepens to 100 feet in the autumn. The lake destratifies in the late winter, resulting in more uniform water quality as constituents are dispersed throughout the wate r column. Therefore, water intake structures (including those at Hoover Dam) will be subject to the water quality present within the water column adjacent to the intake structure an d this water quality will change seasonally.

Water quality improvements are also noticeable with in the NDEP maintained Willow Beach data set provided in Appendix G [See PDF docket ID EPA-HQ- OW-2009-0297-0645] (NDEP, 2009c).

These data were collected from the Arizona side of the Colorado River within Lake Mohave approximately 11 miles downstream of Hoover Dam (Lake Mead). It is thought that these data represent mixed water quality conditions applicable to downstream users. Review of these data shows that perchlorate concentrations have been sustained at less than 4 ug/L, from June 2004 through current as can be seen on the graph of pe rchlorate concentration and tabular data provided in Appendix G [See PDF docket ID EPA-HQ- OW-2009-0297-0645] (NDEP, 2009c).

Water quality trends at the Metropolitan Water District (MWD) of Southern California Whitsett Intake also show improved water quality over time , with sustained perchlorate concentrations at less than 4 ug/L from June 2004 to November 20 05 and less than 2.3 ug/L from November 2005 through present as can be seen in the MWD Whi tsett graphical and tabular data provided in Appendix H [See PDF docket ID EPA-HQ-OW-20 09-0297-0646] (MWD, 2009). These sustained declines in perchlorate concentrations le d to several actions by MWD including:

* Lowering of the reporting (detection) limit from 4 ug/L to 2 ug/ L in September 2003; * Change in analytical methods to EPA Method 331 in Ja nuary 2007 and EPA Method 332 in July 2008 to permit a 0.1 ug/L reporting limit; and * Change in sample frequency from monthly to quarterly in January 2007. [bullets corrected based on docket ID EPA-HQ-OW- 2009-0297-0649]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 365 of 1099 Similar water quality trends are reported by the Central Arizona Project (CAP) for perchlorate

concentrations measured in CAP Intake water ne ar Lake Havasu, Arizona. The similar water quality results reported from MWD and CAP are a result of both entities drawing source water from the same reservoir (Lake Havasu) near Parker Darn, Arizona.

Response: Thank you for providing additional data on the occurrence of perchlorate. EPA acknowledges that there may be sources that had detected perchlorate from UCMR1 monitoring that are either no longer being used or are being treated; however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at the time an assessment is ma de. UCMR data is the most extensive nationally representative occurrence data for perchlorate in pu blic water systems; therefore, EPA analyzed this data and additional occurrence data in making a regulatory determination for perchlorate. However, there will be another opportunity to consider n ew data during development of a proposed NPDWR for perchlorate.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28811

EPA Comment Code: 3300

Comment: NRDC Response: Only Massachusetts has fi nalized a drinking water standard for perchlorate; California and New Jersey have not.

As noted in the Federal Register notice, one commenter incorrectly suggests that the population exposed would be capped because of regulatory limits in Massachusetts, California, and New Jersey. As a matter of fact, only Massachusetts has pr omulgated an MCL of 2 ppb for perchlorate in drinking water. California has set an unenforceable public health goal of 6 ppb.[FN63: California
Office of Environmental Health Hazard Assessment, Public Health Goal for Perchlorate. See e.g. http://oehha.ca.gov/public_info/facts/Perchlora tefacts.html.] New Jersey has proposed, but has not finalized, an enforceable standard of 5 ppb. [FN64: New Jersey Department of Environmental Protection, New Jersey Register, March 16, 2009 http://www.state.nj.us/dep//rules/notices/031609a.html]

Response: In July 2006, Massachusetts set an Maximu m Contaminant Level (MCL) of 2 μg/L and
in October 2007, California set an enforceable MCL of 6 μg/L. New Jersey proposed an MCL of 5 μg/L in April 2009 but has not finalized it.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28912

EPA Comment Code: 3300

Comment: Occurrence AnalysisEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 366 of 1099 USEPA seeks information on the occurrence of perc hlorate at concentrations below the MRL of 4 ug/L in the Unregulated Contaminant Monitoring Ru le (UCMR) studies. In studies conducted by NJDEP between 2003 and 2005, subsequent to UCMR sampling, the laboratory was able to achieve a MRL of 1 ug/L or lower using EPA Method 314. 0. In this study, community and non-community public water systems were chosen based on their potential vulnerability to perchlorate contamination. Reasons for sampling included proximity to military installations and unexploded ordnance, and proximity to previous UCMR-tested si tes that showed perchlorate detections; a few of the individual public wells that had tested high in the original UCMR sampling were sampled. Most, but not all, of these samples were taken befo re treatment. A small nu mber of these were point of entry (POE) samples. Perchlora te was detected in 11 of the 67 public water systems tested at 1 ug/L or above (NJDWQI, 2005).

Response: Please see the response to comment code 3300.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28934

EPA Comment Code: 3300

Comment: In 2005, EWG published findings from a na tional analysis of tap water contamination based on data provided by public water suppliers from seven states, including Texas and California (EWG 2005). In our analysis, perchlorate levels above the level of quantification were considered significant; we found that over 26 million people in these seven states were served by water systems that had at least one perchlorate detection. Since this data was gathered from only seven states, we expect that the actual number of people in all 50 st ates who are served by public water systems with at least one perchlorate detection would be much higher.

EWG recommends that the agency consider an y perchlorate detections above the level of quantification as significant; this would give a more accurate picture of the number of U.S. residents who are actually drinking pe rchlorate contaminated water.

Response: Please see response to comment code 5220. Also, see response to comment code 3300.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 367 of 1099 

### EPA Comment Code: 4000 Evaluation of Perchlorate Exposure from Sources Other than Drinking Water

Individual Comments

Commenter Name: Peter King Commenter Organization: American Public Works Association (APWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0156

EPA Comment ID: 20261

EPA Comment Code: 4000

Comment: Moreover, APWA supports EPA's assessment th at additional investigation is necessary to ascertain total human exposure and health risk s of perchlorate and MTBE before a preliminary determination may be made regarding these chemical s. Finally, we agree that it is important for the Agency to try and identify data that can be used to estimate the contributi on of perchlorate exposure from food versus drinking water and we feel as though the urinary bio-monitoring approach is appropriate.

Response: EPA agrees with the commenter and has refi ned its urinary biomonitoring approach to apportioning perchlorate exposur e between food and water.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20280

EPA Comment Code: 4000

Comment: USE OF ALTERNATIVE APPROACHES WOULD ENABLE EPA TO MAKE A

DETERMINATION ON PERCHLORATE WITH GREATER SPEED AND SCIENTIFIC

CERTAINTY

In its Support Document, EPA presents a number of alternatives for evaluating the third statutory criterion, of "meaningful opportunity for health risk reduction" for perchlorate.[FN4: US EPA Regulatory Determinations Support Document fo r CCL2, May 2007 [hereinafter, CCL 2 Support Document].] Many of these approaches take adva ntage of the extensive scientific information available on perchlorate.

EPA outlines several options in its Support Document for using the superior biomonitoring data for its regulatory determination. Clearly, real-time human data can be uniquely valuable and would

enable EPA to make a determina tion on perchlorate with greater speed and scientific certainty. Using such powerful new data, EPA can make a determination more quickly and with more scientific certainty than was possible in the past . The National Health and Nutrition Examination Survey (NHANES) biomonitoring data provides a more reliable estimate of total perchlorate exposure in the US population than the fallback of extrapolating from food data.[FN5: Benjamin C. Blount et al., Perchlorate Exposure of the US Population, 2001-2002, J. Expos. Sci. Envtl. Epidemiol., Oct. 2006 [hereinafter Blount 2006c].]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 368 of 1099 The biomonitoring data demonstrates that total pe rchlorate exposure from all sources is below the EPA’s health benchmark for virtually all US resi dents. Since drinking water exposure is a small subset of total exposure, it follows that reducing this small subset by a small amount through regulation will not meet the meaningful risk reducti on criterion of the Safe Drinking Water Act.

There are two additional approaches that merit Agency consideration, further suggesting that drinking water perchlorate levels pose no meanin gful risk to human health. One approach posits that it is unnecessary for EPA to adjust for tota l exposure because Greer et al.[FN6: Monte A. Greer et al., Health Effect Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodide Uptake in Humans, Envtl. Health Perspectives, Sep. 2002, at 927.] and other studies relied on by the NAS panel are studies of total exposure. The last approach posits that EPA could consider the comp arative effect on iodine uptake inhibition (IUI) of perchlorate exposure in drinking water to other di etary goitrogens in determining whether there is meaningful opportunity for risk reduction.

In Attachment 2 [See PDF of docket ID EPA-HQ-OW-2007-0068-0168], we discuss the supplemental or alternative approaches that EP A can adopt to directly answer the question of whether regulation of perchlorate in drinking water will result in meaningful reduction in human

health risk.

Response: EPA agrees that biomonitoring offers some unique advantages with this type of

contaminant which is not metabolized and excreted via urine (and milk in lactating women). The limitation in the use of NHANES is it addresses ages 6 and above.

However, EPA disagrees that biomonitoring data de monstrates that total perchlorate exposure from

all sources is below the EPA’s health benchmar k for US residents. The effect of additional perchlorate added via water in the Greer et al. study over the amounts in food and other iodine

inhibitors in food was reflected in the RfD. It is unknown whether the background levels of inhibitors altered the shape of the dose response curve to either lessen or increase the dose of perchlorate required to detect iodine uptake inhibi tion in the subjects. We presume a straight line i.e., that regardless of the background in the subj ects, the incremental additional perchlorate required was 0.07 ug/kg/day to arrive at the NOEL for th e additional perchlorate. Given that this notice regards whether or not to regulate perchlorate in drinking water, allowing a normal background of goitrogens in the subjects' diets reveals the addition al amount in water needed to produce inhibition. It could be argued that apportionment between food and water has already taken place since this is not total perchlorate, but added water over and above the food. Because these variables are unknown outside of a sequestration study where preci se amounts of perchlorate from all food and water is measured, EPA assumes additional perchlor ate from any source, food or water, produces the iodine uptake inhibition reflected by the RfD.

Regarding the comment that EPA could consider th e comparative effect on iodine uptake inhibition of perchlorate exposure in drinking water to other dietary goitrogens in determining whether there is meaningful opportunity for risk reduction, EPA belie ves that the approach has merit; however, a cumulative risk assessment would require significant new data collection and would unnecessarily delay regulatory decision making for perchlor ate. The Administrator will make regulatory determinations on a case-by-case, contaminant specific basis. In making a regulatory determination,

the Administrator considers the adverse health effect of the particular contaminant at issue as well as

the occurrence or likelihood of occurrence of th e contaminant in public water systems with aEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 369 of 1099 frequency and at levels of public health concer n. Finally, it is the sole judgment of EPA’s Administrator to determine whether there is a meaningful opportunity to reduce health risk for persons served by public water systems.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1724

EPA Comment ID: 20616

EPA Comment Code: 4000

Comment: After reading the EPA report, it is clear the EPA did not consider the fact that perchlorate is concentrated many times (19X was ci ted) in lettuce, which is watered in California by perchlorate contaminated water. Studies of perchlorate concentrations in lettuce found in supermarkets across the US finds high concentrati ons of perchlorate in lettuce, which is usually grown in California. The EPA study did not utilize this information in its findings. Until the EPA allows this information into its deliberations, their study, and findings, are not complete. DOD has effectively blocked the lettuce findings, and Presid ent Bush has refused to allow the EPA to conduct further studies, saying we are at war, which protec ts DOD from the costs of clean-up. If the reader would consider his or her own family, women would probably be found taking Synthroid due to thyroid issues. Might the fact that women tend to ea t more salads than men correlate? None of these issues are addressed by the EPA.

Response: Leafy vegetables do concentrate salts such as perchlorate as water evaporates from leaves (evapotranspiration). EPA has evaluated earl y studies of perchlorate content of food and reported these findings in the May 1, 2007 Federa l Register notice. The data from FDA's total diet study as well as biomonitoring studies by EPA/CDC have further refined the contribution of food to perchlorate exposure in various age/sex groups as discussed in the October 10, 2008 and August
19, 2009 notices. EPA does not believe that th e widespread presence of perchlorate in food overrides the need for public health risk reduction for persons served by PWSs with perchlorate contamination. EPA recognizes that a drinki ng water regulation would not eliminate total perchlorate exposure, but believes that the reducti on in perchlorate exposure in drinking water presents a meaningful opportunity for health risk reduction for persons served by PWSs contaminated by perchlorate.

Commenter Name: Apparent Mass Mailing #6 - Earth Justice

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20886

EPA Comment Code: 4000

Comment: EPA's analysis fails to consider that th e combination of food and drinking water exposure to perchlorate in the U.S. population exceed s the reference dose set by EPA. Nor does it incorporate the more protective methodology behind the recent state regulatory actions. These flaws must be remedied for the sake of the millions of U.S. families exposed to dangerous levels of perchlorate contamination.

Response: EPA considers the combination of food and drinking water through the relative source contribution (RSC). The RSC is the percentage of the reference dose remaining for drinking waterEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 370 of 1099 after other sources of exposure to perchlorate have been considered (e.g., food). See the August 2009 Federal Register notice (41887) fo r a detailed discussion of RSC derivation.

Regarding the comment about incorporating methodologies behind recent state regulatory actions, States use different methodologies or assumptions to derive their own standard based on their unique exposure scenarios. EPA has used the best available peer reviewed science in making this regulatory determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 371 of 1099 

### EPA Comment Code: 4110 Dietary studies – FDA’s 2005-2006 total dietary study (TDS)

Individual Comments

Commenter Name: Commenter Organization: Ag Council et al

EPA Document ID: EPA-HQ-OW-2008-0692-1987

EPA Comment ID: 20976

EPA Comment Code: 4110

Comment: FDA's Food Sampling Results Reveal that Perchlorate Concentrations are Below the Level of Concern and that Iodine intake Actually Exceeded NAS-Recommended Levels for all Groups Across the US Population.

When perchlorate was first discovered in food, the FDA began sampling produce and bottled water in an effort to characterize perchlorate occurrence in food. FDA later expanded its perchlorate sampling effort to include other vegetables, fruits and milk to gain a greater understanding of the range of foods that contain perchlorate. FDA's e fforts included a total dietary survey (TDS), the results of which were provided to US EPA for use in determining total perchlorate exposure in the US population.

TDS is a market basket survey of various foods anal yzed for perchlorate and iodine, conducted by FDA from 2003-2006. In early 2008, FDA published it s testing results for 285 food samples in each of three cities in each of the four regions of the country. FDA evaluated the food data based upon estimated food consumption patterns of 14 age/sex groups from 6-11 month-old infants up to 70+ year-old men and women.

FDA found that the average daily intake of perchlorate was well below both the NAS RfD and health reference level (HRL). FDA identified child ren 2 years of age as having the highest average intake of perchlorate at 0.35 to 0.39 ug/kg bw/day, wh ich at the upper end is slightly more than half
of the RfD, but still below the HRL.

For iodine, FDA found that each of the 14 age/se x groups, including infants, children, and women of childbearing age exceeded the average intake le vels estimated by the NAS to meet requirements for healthy individuals.

In light of these findings, FDA continues to st and by its prior recommendation that consumers

should not alter their infants' and children's diets and eating habits. Indeed, many of the foods at issue are major dietary sources of iodine an d other nutritionally essential substances.

Response: No response necessary to this summary of FDA TDS information.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21065

EPA Comment Code: 4110EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 372 of 1099 Comment: iii. Murray et al. (2008)

The Food and Drug Administration (FDA) total diet study (TDS) was "designed to monitor the U.S. food supply for chemical contaminants, nutritional elements, and toxic elements." Based on measurements of perchlorate and iodine in mark et baskets, the Murray et al. report estimated intake doses. The sampling approach is based on "market baskets" that are collected four times per year.
Each market basket contains 285 foods, collected si multaneously in three cities within a region. The modeled group estimated to have the greatest di etary exposure to perchlorate was children age 2 (0.35 to 0.39 ug/kg-day). This is due to the high intake of dairy products coupled with low body weight. The modeled dose for the most sensitive population, the fetuses of pregnant women, was not specifically modeled, but the estimated dose fo r women of child bearing age was 0.09 to 0.11 ug/kg-d.[FN3: The estimated doses for women ages 14-16, 25-30, and 40-45 were all 0.09 to 0.11 ug/kg-d.] Adult men age 25 to 30 years old were estimated to be expos ed to 0.08 to 0.11 ug/kg-day. Of the foods measured in this study, spinach, tomatoes, and cantaloupe had the highest levels of perchlorate at 40, 78, and 24.4 ug perchl orate/kg wet weight of food, respectively.

This study can be used to estimate exposures to perchlorate based on actual food concentrations. Even at the highest estimate, this dose was less th an the U.S. EPA RfD of 0.7 ug/kg-day. The study does not aim to evaluate overall body steady-state serum concentrations of perchlorate, only dose. Children age 2 have a higher renal excretion rate than adults or infants do, which would reduce their steady-state serum concentration despite the higher intake.[FN4: Perchlorate is a non-metabolized pharmaceutical agent with nearly complete urinary excretion. Data on adult and child clearances is available for other pharmaceuticals making it possible to extrapolate the rate of a child's clearance of perchlorate compared to an adult's. Based on the clearance of gabapentin, gentamicin, isepamicin, ticarcillin, and vancomycin, the clearance in a child is 1.6 times that of an adult (unpublished data).]

Response: EPA does not believe that the widespread presence of perchlorate in food overrides the need for public health risk reduction for persons served by PWSs with perchlorate contamination. The Agency presented an extensive evaluation of dietary exposure to perchlorate in the October 2008 and August 2009 notices (73 FR 60262; US EPA 2008a and 74 FR 41883; USEPA 2009b). EPA has used this dietary exposure data to account for the relative source contribution (RSC) of perchlorate from food. EPA recognizes that a dr inking water regulation would not eliminate total perchlorate exposure, but believes that the reducti on in perchlorate exposure in drinking water presents a meaningful opportunity for health risk reduction for persons served by PWSs contaminated by perchlorate. Please see respons e to comment code 5220 for a discussion of EPA’s revised approach to deriving potential HRLs.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28679

EPA Comment Code: 4110

Comment: US FDA's Food Sampling Results Reveal that Perchlorate Concentrations are Below any Meaningful Level of Concern and that Iodine Intake Actually Exceeds NAS- Recommended Levels for all Groups Across the US Population.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 373 of 1099 When perchlorate was first discovered in food, the U.S. FDA began sampling produce and bottled water in an effort to characterize perchlorate occu rrence in food. FDA later expanded its perchlorate sampling program to include other vegetables, fruits and milk to gain a greater understanding of the range of foods containing perchlorate. FDA's work included a total dietary survey (TDS), the results of which were provided to US EPA for use in d etermining total perchlorate exposure in the US population.

The Total Dietary Survey is a market basket survey of various foods analyzed for perchlorate and iodine, conducted by FDA from 2003-2006. In ea rly 2008, FDA published its testing results for 285 food samples in each of three cities in each of the four regions of the country. FDA evaluated the food data based upon estimated food consumption patterns of 14 age/sex groups from 6-11 monthold infants up to 70+ year-old men and women.

FDA found that the average daily intake of perchlorate was well below both the NAS' recommended RfD and USEPA's current 15 ppb health reference level (HRL). FDA identified children 2 years of age as having the highest averag e intake of perchlorate at 0.35 to 0.39 ug/kg body weight/day, which at the upper end is slightly more than half of the RfD, but still below the HRL.

Response: In the October 2008 preliminary regulatory determination, EPA had derived a single HRL of 15 μg/L based upon the RfD, an estimate of perchlorate exposure from food for pregnant women, and traditional adult body weight (70 kg) an d drinking water consumption (2 L/day) values. This single HRL was derived to reflect exposure to a pregnant woman and her fetus, which the NRC identified as “the most sensitive population.” Since the NRC also identified infants and developing children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure info rmation in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water th at may result in total perchlorate exposures (from food and water) greater than the RfD for individual s at each life stage. These HRLs are calculated based on individuals who consume an average am ount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 pe rcent of their cohorts. EP A is evaluating these potential alternative HRLs and considers them to be levels of public health concern for purposes of

this determination.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28680

EPA Comment Code: 4110

Comment: These results, taken together with the results of EPA's 2006 tests of nearly 40,000 water samples from across the U.S.,[FN1: Office of Wa ter: The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR1) in support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List (EPA 815-D-06-008);] which show that perchorate levels were less than seven parts per billion in 99% of the samples, provide no evidence that individuals ingest perchlor ate at daily doses exceeding the Reference Dose.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 374 of 1099 They also suggest that there is little likelihood th at such exposures would occur. This conclusion is further supported by data from the U.S. Cen ters for Diseases Control's National Health and Nutrition Examination Survey (NHANES) biomonitoring dataset (see below).

Response: Since the NRC also identified infants and developing children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) usi ng the RfD and life stagespecific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th
percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluati ng these potential alternative HRLs and considers them to be levels of public health concern fo r purposes of this determination. The CDC NHANES biomonitoring data set does not include data for all life stages.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 375 of 1099 

### EPA Comment Code: 4130 Dietary studie s -- other studies, models, and data (besides FDA’s 2005-2006 TDS, a nd 2003-2005 exploratory data)

Individual Comments

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0170

EPA Comment ID: 20289

EPA Comment Code: 4130

Comment: July 24, 2007 US Environmental Protecti on Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Avenue , NW Washington, DC 20460

RE: Supplemental Comments on Regulatory Dete rminations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List Rule, Docket ID: EPA-HQ- OW-2007-0068

In May 2007, the US Food and Drug Administrati on posted a Preliminary Estimation of Perchlorate Dietary Exposure Based on FDA 2004/2005 Exploratory Data on the web at www.cfsan.fda.gov/~news/whatsnew.html. Perchlor ate exposure from consumption of 27 foods and beverages was estimated via a Monte Carlo simulation. The Monte Carlo simulation sums perchlorate exposure values based on food intake and perchlorate concentration levels randomly drawn from a range of possible values for each f ood from a particular iteration to yield a total exposure for an individual. The summary of their analysis is presented in their Table as follows:

[Table. Summary of Population-Based Perchlorate Exposures]

FDA did not consider other dietary goitrogens such as nitrate and thiocyanate in their analysis in order to place these results in perspective. Although thiocyanate is the most significant dietary goitrogen that shares the same mechanism of action as perchlorate, the food content of thiocyanate precursors is not widely reported. On the other hand , the nitrate contents of various dietary sources has been widely reported in the peer reviewed li terature and nitrate is known to share the same mechanism of action as perchlorate (competitive inhi bition of iodine uptake by the thyroid). Nitrate is known to be approximately 1/240th as potent as perchlorate on a weight ingested basis in the inhibition of iodide uptake (IUI ). (Tonacchera et al., 2004)

Due to the data gap, the Perchorate Study Grou p (PSG) contracted with Kenny Crump and Cynthia Van Landingham of Environ in Ruston, LA to pe rform a similar Monte Carlo analysis of nitrate consumption to assess the relative importance of these two dietary goitrogens on IUI [See PDF of docket ID EPA-HQ- OW-2007-0168-0170]. Using the re lative potencies of nitrate and perchlorate derived from Tonacchera, the nitrate data summaries from Crump & Van Landingham, Table 4 can be compared directly with the perchlorate summaries from FDA in their Table 2. These comparisons are presented below.

[Table 2 See PDF of docket ID EPA-HQ-OW-2007-0168-0170]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 376 of 1099 Thus, this analysis indicates that dietary nitrate is two to three orders of magnitude more significant than dietary perchlorate in IUI by the thyroid. Controlling dietary perchlorate is thus relatively insignificant to overall thyroid health th an is controlling dietary nitrate intake.

Thank you for allowing us the opportunity to submit this supplemental information for consideration by the Agency in making a regulatory determination on perchlorate.

Sincerely, Michael Girard The Perchlorate Study Group

Attach:

[Attachment - see PDF]

Response: EPA considers the combination of food and drinking water through the relative source contribution (RSC). The RSC is the percentage of the reference dose remaining for drinking water after other sources of exposure to perchlorate have been considered (e.g., food). See the August 2009 Federal Register notice (74 FR 41883; USEPA 2009b) for a detailed discussion of RSC derivation. EPA acknowledges that nitrate and thiocyanate have the same mode of action as perchlorate, and that the effects of combined expo sure to perchlorate, nitrate, and thiocyanate are
additive, EPA does not believe there are sufficient scientific data currently available to assess and

characterize the combined risk of these contam inants. EPA has committed to a drinking water strategy that outlines four principles to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchl orate should be further delayed. Therefore, EPA intends to develop a proposed rule for perchlora te. At such time as a NP DWR is promulgated, EPA is required to review and revise, as appropriate, its drinking water standards at least every six years. Any revision must at least maintain or improve public health protection. When there are sufficient

scientific data to assess the cumulative risks of perchlorate and other contaminants, EPA will review this information to evaluate whether any new or revised NPDWRs are appropriate.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20440

EPA Comment Code: 4130

Comment: Since the NRC published its findings in 2005, several studies have been completed that provide data necessary to evaluate; the, populati on exposure potential. In the study developed by Mendez et.al. (2008), probabilistic (Monte Carlo) simulation was used to estimate the potential contribution of drinking water to the aggregate perchlorate intake by the presumed most sensitive population, reproductive age women. The full repo rt is attached as Appendix A [see PDF Docket ID EPA-HQ-OW-2008-0692-1424] to these co mments. Food perchlorate concentration

distributions were derived from the FDA 2004 -5 Exploratory Sampling dataset. Food and waterconsumption data were obtained from the USDA Continuing Survey of Food Intake by Individuals (CSFII) from 1994-96 and 1998. The M onte Carlo simulation derives three distributions of perchlorate concentrations in drinking water , corresponding to "raw" data from EPA's UCMR1 national perchlorate sampling, data from the UC MR1 with low-level "background" perchlorate concentrations added to a portion of the entry points below detection limits, and UCMR1 data forEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 377 of 1099 large California systems, again wi th "background" perchlorate con centrations added to a proportion

of non-detect observations.

Inclusion of the estimated nationa l drinking water distributions in the simulation resulted in increases in estimated median perchlorate intakes 3-20 percent greater than those seen when only dietary sources were evaluated. The perchlorate in take distributions estimated based on diet and water intake were found to be very similar to the distributions estimated based on perchlorate

excretion data from 2001-2002 and 2003-2004 Nati onal Health and Nutrition Examination Survey (NHANES) data sets. The intake estimates base d on diet and water and estimates derived from urinary excretion analyses suggestthat approximately two to five percent of reproductive age women in the U.S. receive perchlorate intake greater th an 2x10-4 mg/kg-day, which is approximately onethird of the RfD for perchlorate. This proportion does not appear to be strongly affected by reasonable assumptions related to background dr inking water contamination. The proportion of women with intakes above the RfD (7x10-4 mg/kg- day) cannot be estimated accurately from either the dietary intake analysis or NHANES data becaus e of the sparcity of data in the upper percentiles of the distribution, but is likely to be considerably lower than two percent nationally. In addition, the proportion of women adversely effected by perchlora te exposure is likely to be even lower, since perchlorate appears to adversely effect thyroid function only in women with insufficient iodine intake. (Blountet al. 1996).

This finding, that the total dietary exposure (food and drinking water) of reproductive age women in the U.S. is approximately one-third of the Rf D for perchlorate at the 95th percentile, is complimentary to the finding referenced in the proposed decision based on a joint assessment prepared by EPA-CDC. Given this evidence rela ted to limited exposure potentials and estimated

intakes well below the RfD it is clear there is limited potential for perchlorate to present a significant adverse affect on the nation's health, including sensitive subpopulations.

Response: EPA disagrees and has decided to regulate perchlorate in drinking water. See response to

comment code 6120. EPA estimates that at least 5. 1 to 16.6 million people are served by PWSs, for which we have data, that have perchlorate cont amination. EPA has determined that a NPDWR for perchlorate could reduce perchlorate exposures for these populations to levels below the potential

alternative HRLs that EPA has identified as levels of public health concerns for purposes of this determination, and that such exposure reducti ons present a meaningful opportunity for the reduction of health risks for persons served by PWSs.

Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28545

EPA Comment Code: 4130

Comment: EPA must also consider other exposure path ways and additional contaminants in the environment that impact thyroid function when esta blishing the MCL. Studies of perchlorate levels in food, including breast milk, show that the population is exposed through multiple pathways in addition to contaminated drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 378 of 1099 Response: See response to comment ID 20289 under comment code 4130. Additionally, EPA does apportion the exposure to perchlorat e to food and derived the drinki ng water allowance considering the portion of the RfD already used by food.

Commenter Name: Robert E. Brackett Commenter Organization: Grocery Manufacturers Association (GMA)

EPA Document ID: EPA-HQ-OW-2009-0297-0413

EPA Comment ID: 28706

EPA Comment Code: 4130

Comment: GMA is concerned that Environmental Protection Agency's (EPA) approach to assessing potential risks of perchlorate in dr inking water will be widely misunderstood and misinterpreted, leading to confusion and unnece ssary concern among US consumers, and food importers, global policy makers, and regulatory bodie s about perchlorate in US food products. GMA believes that sound public health policy requires th at the relevant government agencies, including EPA, send a clear and consistent message to cons umers that any hypothetical risks of perchlorate exposure to pregnant women and mothers of infants estimated by EPA are eas ily avoided by eating iodine-rich foods or taking an iodine supplement. This approach confers the double benefit of decreasing risk of disease associated with inadequate iodine intake as well as mitigating any potential risks of environmental exposure to perchlorate. We will elaborate below.

First, it is important for EPA to be clear with th e public that exposure to perchlorate, or to other substances in the diet that may interfere with iodi ne uptake by the thyroi d, is only a potential problem in individuals with iodine deficiency. There is no evidence that iodine deficiency is currently a serious situation in the United States.[FN1: FD A has estimated iodine intake by the US population using data from the Agency's Total Diet Study (http://www/fda.gov/Food/FoodSafety/FoodCo ntaminantsAdulteration/ChemicalContamin ants/Perchlorate/ucm077572.htm)]

Based upon common food consumption patterns in the United States, and the availability of iodine within the US diet, only those individuals consumin g highly restrictive diets or those deliberately avoiding iodine are at high risk of deficiency. In addition to naturally rich sources of iodine, such as fish and shellfish, iodine can be found in meat, poultry, and dairy products as well as in many manufactured food items including cereals and bake d goods. Further, table salt is frequently consumed in an iodized form. Many dietary supplements, including prenatal multivitamin and mineral supplements contain iodine.[FN2: C Fi elds, M Dourson, J Borak. Iodine-deficient vegetarians: a hypothetical perchlorate-suscep tible population? Regulatory Toxicology and Pharmacology 42 (2005):37-46] Despite the fa ct that data from NHANES I and NHANES III surveys suggested a decline in iodine consumption, data from more recent NHANES analyses show that iodine consumption has stabilized to a medi an level considered adequate based upon the World Health Organization guidelines for population ade quacy.[FN3: KL Caldwell, R Jones, JG Hollowell. Urinary Iodine Concentration: United National Health and Nutrition Examination Survey 2001- 2002. Thyroid 15(7) 2005: 692-699] The Institute of Medicine's Food and Nutrition Board Dietary Reference Intake report for iodine concluded th at infants under six months of age fed a diet exclusively of breastmilk have adequate and appr opriate intake levels to support normal growth and development.[FN4: http://www.nap.edu/catalog.php?r ecord_id=10026] In addition, infant formula manufacturers are required to fortify infant formul a sold in the United States with iodine basedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 379 of 1099 upon the Food and Drug Administration's (FDA) in fant formula composition regulations found at

21 CFR 107.

There is no evidence of pervasive iodine deficiency in the United States in infants, children or adults. Some populations are hypothetically more at risk for effects of perchlorate consumption, most notably women of child-bearing age and pregnant women. Because of inadequate iodine consumption during pregnancy can lead to negative birth outcomes, any further reduction uptake by the thyroid from exposure to perchlorate could pose a risk. However, there is no evidence of widespread iodine deficiency among women of child bearing age or pregnant women in the United States. Therefore, any potentially susceptible su bpopulation could be targeted with interventions

such as education about diet duri ng pregnancy and food sources of iodine, or supplementation. Adequate prenatal care should include an eval uation of a women's diet to assess for potential micronutrient deficiencies and appropriate counseli ng to help women plan their diets to address their changing nutrient needs during pregnancy should be provided.

Response: EPA agrees that promoting iodide nutrition is good public health policy and may have a positive influence in reducing the iodide uptake inhibition effects associated with exposure to perchlorate. However, the Agency does not think it is appropriate to rely on the promotion of iodide nutrition in this case, especially since thes e activities are outside of EPA’s SDWA authority. The three SDWA criteria for a positive regulatory determination have been satisfied. While the health concerns associated with perchlorate may be addressed through other means, it is the Administrator’s judgment that a standard limiting perchlorate in drinking water can reduce health risk, particularly to fetuses, infants and children.

Commenter Name: Robert E. Brackett Commenter Organization: Grocery Manufacturers Association (GMA)

EPA Document ID: EPA-HQ-OW-2009-0297-0413

EPA Comment ID: 28708

EPA Comment Code: 4130

Comment: GMA notes with interest the draft review of the EPA perchlorate assessment by the EPA Office of Inspector General (OIG draft)[FN5: http://www.epa.gov/oig/reports/2009/20081230-200 8-0010.pdf]. The OIG draft points out that there are other compounds occurring naturally in food s that act in similar ways as perchlorate, and that regulating the perchlorate level in drinking water is therefore unlikely to make any material difference. The best way to protect public health would be to assure that the iodine status of sensitive subpopulations is adequate. As discussed a bove, there is no evidence that the iodine status of sensitive subpopulations is inadequate, we agree with OIG that promoting adequate iodine intake by the population appears to be a superior approach to regulating perchlorate as a contaminant in public drinking water systems.

Third, GMA is concerned that EPA's approach to a ssessing potential risks of perchlorate in drinking water will lead to confusion and unnecessary conc ern among importers of US food products about the potential for perchlorate in commodities and f ood products exported by the United States. FDA has reported finding perchlorate in targeted moni toring of some foods, and continues to test additional food types for perchlorate to further enhance the assessment of dietary exposure to consumers. EPA's concern is manmade sources of pe rchlorate, but perchlorate is known to form in the atmosphere and to occur naturally in the environment, notably in certain geographic depositsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 380 of 1099 mined for fertilizer, the safety of perchlorate in food is scheduled for thorough evaluation on an international basis by the Joint FAO-WHO Expert Committee on Food Additives and Contaminants (JECFA) in 2010.[FN6: Tolerable Da ily Intakes (TDIs) established by JECFA form the basis for food standards and maximum residue limits (MRLs) in foods established by the Codex Alimentarius Commission (Codex). Codex was crea ted in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in th e food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations ( http://www.codexalimentarius.net/web/index_en.jsp).]

In summary, we reiterate that sound public health policy requires the relevant government agencies, including EPA, to send a clear and consistent me ssage to consumers. Any hypothetical risks of perchlorate exposure to pregnant women and mother s of infants as estimated by EPA are easily avoided by eating iodine-rich foods or taking an iodine supplement. This approach will not only mitigate any risk that may be associated with en vironmental exposure to perchlorate, but will also

decrease the risk of disease associ ated with inadequate iodine intake.

GMA appreciates this opportunity to provide co mments on EPA's approaches to the interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking water. We urge EPA to work in concert with FDA to assure that consumers are given balanced and consistent advice and perspective concerning the theoretical risks of chemical exposures, including risks to sensitive subpopulations. Providing this balance and pers pective is particularly critical in the case of chemicals that may occur in foods that are sources of essential nutrients conferring substantial

overall net benefits to health.

Sincerely yours, Robert E. Brackett, Ph.D. Senior Vice President and Chief Science and Regulatory

Affairs Officer

Response: See response comment ID 287 06 under comment code 4130.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28932

EPA Comment Code: 4130

Comment: EWG supports the agency's decision to develop HRLs based on life stage and drinking water ingestion rates but we would like to bring attention to some findings from a recent CDC study

of infant formula contamination that we believe wo uld change the HRLs for infants six months of age and under. In this study, researchers tested 15 brands of powdered infant formula for perchlorate and found contamination in every brand; the two most contaminated brands, made from cow's milk, accounted for 87 percent of the U.S. powdered formula market in 2000 (Schier et al 2009).

In Table 4 of the CDC study, the researchers es timate the minimum water pe rchlorate concentration

needed to reach the current RfD for infants at one month and six months of age at different body weight percentiles. At the highest perchlorate concentration found in the formula samples (5.05EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 381 of 1099 ug/l), the researchers found the estimated mini mum water perchlorate concentration needed to reach the RfD was zero for the following four exposure scenarios:

- One month old infant, 10th percentile body weight - One month old infant, 50th percentile body weight - One month old infant, 90th percentile bod y weight - Six month old infant, 90th percentile body weight

In fact, in all four of these exposure scenarios, infants would exceed the current RfD from formula consumption even with perchlorate levels at zero in the water used to reconstitute it. A recent GAO report found that by six months of age, less than 30% of infants are exclusively breast-fed (GAO 2006); in addition, powdered infant formulas acco unt for 50 to 60% of the total infant formula market. This means that millions of infants per ye ar may be exposed to powdered infant formula that is so heavily contaminated with perchlorate that formula exposures alone in these infants may

exceed the current RfD.

These results suggest that for infants six months of age and younger who are fed powdered formula, there is no safe HRL since any can of powdered fo rmula may be contaminated with perchlorate at high enough concentrations that formula consum ption alone results in exposures above the RfD. EWG recommends that the agency incorporate thes e exposure dosing scenarios from the formula study and modify the HRLs for infants six months and younger to reflect these findings.

Response: EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information in th e August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlora te exposures (from food and water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th
percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluati ng these potential alternative HRLs and considers them to be levels of public health co ncern for purposes of this determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 382 of 1099 

### EPA Comment Code: 4210 Biomonitoring -- urinary data from the 2001-2002 NHANES study, and EPA/CDC’s NHANES-UCMR analysis

Individual Comments

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20456

EPA Comment Code: 4210

Comment: Blount, et al. [FN12: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, and Caldwell KL. 2006. Urinary Perchlorate and Thyroi d Hormone Levels in Adolescent and Adult Men and Women Living in the United States. Envir onmental Health Perspectives (114)12: 1865-71.] evaluated 2001-2002 biomonitoring results from the National Health and Nutrition Examination Survey (NHANES) looking at urinary perchlorate, urinary iodine, and thyroid hormone levels and determined that total thyroxine (T4) and thyroid stimulating hormone (TSH) levels were related to urinary perchlorate in women. TSH and T4 levels were used as indicators of how well the thyroid was functioning. TSH causes the thyroid gland to produce triiodothyronine (T3) and T4. Both hormones are needed for normal brain development. Perchlorate was a significant positive predictor of TSH in women with urinary iodine >100 ug/l and significant positive predictor of TSH and negative predictor of T4 in women with low urin ary iodine (< 100 ug/l). This implies that women and fetuses of women with low dietary intake of iodine can be impacted by perchlorate at current exposure levels in the United States population. This is especially of concern because recent NHANES data show that nearly 17% of reproductive aged women in the United States have urinary iodine levels less than 50 ug/l. The World Health Organization classifies someone as being iodine deficient at a urinary iodine level below 100 ug/l.

Response: EPA agrees that low iodide nutritional stat us increases the likelihood of negative impacts due to perchlorate.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20906

EPA Comment Code: 4210

Comment: * EPA presents results from an unpublished study and relies on this study to justify a HRL of 15 ug/L (ppb) for perchlorate in drinking water, although this study does not look at risks to young children or breast-fed infants;

Response: In the October 2008 preliminary regulatory determination, EPA had derived a single HRL of 15 μg/L based upon the RfD, an estimate of perchlorate exposure from food for pregnant women, and traditional adult body weight (70 kg) an d drinking water consumption (2 L/day) values. This single HRL was derived to reflect exposure to a pregnant woman and her fetus, which the NRC identified as “the most sensitive population.” The study supporting this HRL was made available to the public through the regulations .gov web site and was peer reviewed outside theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 383 of 1099 Agency. The study focused on the most sensitive life stage available in the data (biomonitoring data are not available for children under the age of 6).

In the August 9, 2009, notice (74 FR 41883; US EPA 2009b), EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information. These potential alternative HRLs are the concentrat ions of perchlorate in drinking water that may result in total perchlorate exposures (from food an d water) greater than the RfD for individuals at each life stage. These potential alternative HRLs are calculated based on individuals who consume an average amount of perchlorate from food (ex cept for pregnant women where EPA used a 90th percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts.

EPA is evaluating these potential alternative HRLs an d considers them to be levels of public health concern for purposes of this determination.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20914

EPA Comment Code: 4210

Comment: EPA presents new information from unpublished study that does not include young children: In its assessment, EPA presents an u npublished study in which EPA and CDC researchers merged urine perchlorate levels from the NHANES study and water contamination data from the Unregulated Contaminants Monitoring Regulation with the goal being to "derive the dose of perchlorate coming from food alone by eliminat ing possible sources of water contribution" (EPA 2008). Individuals from the NHANES study wer e categorized into three groups depending on whether the counties in which they resided were fo und to have drinking water contaminated with perchlorate or not. Using this approach, EPA was ab le to estimate daily perchlorate intakes for those with likely perchlorate exposure through drinking water and those without; EPA concluded that "The mean total exposure for people that are more likely to be exposed to perchlorate in food and water was calculated to be 0.101 ug/kg/day. Th e average exposure for people more likely to be exposed to perchlorate from food alone was 0.090 ug/kg/day" (EPA 2008).

This approach allows EPA to estimate that the popu lation they consider to be most at risk, pregnant women and the developing fetus, can be exposed to perchlorate levels in drinking water as high as 15 ug/L and still not exceed the RfD. The most glar ing flaw with EPA’s study is that it does not include young children. The FDA research establishes that young children have the highest perchlorate exposures from food and therefor e, are most likely to exceed EPA’s RfD from additional exposures to contaminated drinking water. The NHANES data does not include information on children under the age of 6 so EPA’s study using NHANES data has an enormous data gap which basically invalidates the findings from this study.

Response: EPA believes that the UCMR-NHANES data merge is valid for the age groups that were represented. The study was peer reviewed outside the Agency and made available to the public through the Regulations.gov web site. EPA has incor porated analyses of these life stages less thanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 384 of 1099 six years of age in the 2009 August Federal Regi ster Notice using data from FDA Total Diet Study to estimate dietary exposure.

Commenter Name: Matt Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2116

EPA Comment ID: 21966

EPA Comment Code: 4210

Comment: Perchlorate can cause massive problems to growth, health, and development of children. A study by the Centers for Disease Con trol detected perchlorate in one out of 2,820 people. The sources for these contaminations range from Food to Groundwater to Breast Milk. The Food and Drug Administration found perchlorate in 74% of all foods tested. Future Generations will face mental retardation, loss of hearing, and deficits in motor skills if further contamination

continues.

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120. Also see response to comment ID 20886 under comment code 4000 for a discussion of how EPA considered exposure to perchlorate from food.

Commenter Name: Tina Carroll Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2189

EPA Comment ID: 22381

EPA Comment Code: 4210

Comment: According to your own website, ?Tests of drinking water at APG have detected perchlorate in four production wells and in the finished water supply for the city of Aberdeen.? Additionally, in 2004/2005 exploratory surveys, th e FDA found ranging perchlorate levels in raw milk in Maryland.

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120. Also see response to comment ID 20886 under comment code 4000 for a discussion of how EPA considered exposure to perchlorate from food.

Commenter Name: Brenda Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2191

EPA Comment ID: 22391

EPA Comment Code: 4210

Comment: Perchlorate can cause massive problems to growth, health, and development of children. A study by the Centers for Disease Con trol detected perchlorate in one out of 2,820 people. The sources for these contaminations range from Food to Groundwater to Breast Milk. The Food and Drug Administration found perchlorate in 74% of all foods tested. Future Generations will face mental retardation, loss of hearing, and deficits in motor skills if further contamination

continues.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 385 of 1099 Response: EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120. Also see response to comment ID 20886 under comment code 4000 for a discussion of how EPA considered exposure to perchlorate from food.

Commenter Name: Richard M. Peekema Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0419

EPA Comment ID: 28684

EPA Comment Code: 4210

Comment: Comment on EPA-HQ-OW-2009-0297

This document gives a detailed review made earlie r of the 2006 CDC urinary analysis data. That review raised questions that are still relevant to the discussion of MCL levels for drinking water. In the pages that follow, a number of conclusions can be reached.

SUMMARY AND CONCLUSIONS

1. Perchlorate was detected and quantified in the urine of all 2820 samples tested with a new analytical technique. 50% of those samples exceede d the 4 ppb median value, and 10% of those samples exceeded 10 ppb. That urinary perchlora te could not be explained as coming from water but instead being continually re- su pplied by the food being eaten.

2. The correlation of the thyroid T4 hormone with urinary perchlorate as reported by Blount et al. could not be repeated exactly because the sample elimination criteria were insufficiently detailed. A least squares fit to all the data showed less correla tion than Blount reported. The scatter plot of the data being correlated deserves as much consideration as correlation coefficients and relevance numbers reported by the statistical analysis. A sear ch for a similar correlation between T4 and nitrate proved negative.

3. Iodide deficiency in women of child bearing age appears to define the population at greatest risk to perchlorate in the drinking water. The percenta ge of such women appears to be increasing over time, presumably from reduced iodized salt intake being invoked by personal dietary responses to public clamor over excessive salt. A water cont aminant specification based on a population that has

other means to control its risk but fails to do so is also not appropriate.

4. The effects of thiocyanate and nitrate cannot be ignored. But the levels of those ions in the population at risk also change with time. Reduced smoking in the population, and better control of nitrate runoff into drinking water aquifers will chan ge the effect of those ions over time. Like the changing iodide deficiency over time, it is ina ppropriate to regulate a contaminant level that will change as the population at risk changes. Th e conclusions of the OIG report are endorsed.

Respectfully submitted, Richard M. Peek ema, retired chemist San Jose, CA

Response : EPA will consider the best available data in evaluating the potential effects of perchlorate and exposure to the public. This includes the study by Blount and others that described their analysis of NHANES data. The findings and limitations of this study have been described in previous federal register notices concer ning perchlorate in drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 386 of 1099 EPA agrees that perchlorate exposure may resul t from both food and drinking water. Previous analyses have estimated the portion of the perc hlorate exposure from food. EPA considered the portion of perchlorate exposure from food in de veloping the potential alternative HRLs. See responses to comment IDs 20616 an d 20886 under comment code 4000. Analyses performed by Blount et al. depend u pon weighting of subjects with respect to their representation for the population. Without applicat ion of appropriate weighting, the analysis cannot be properly reproduced. EPA agrees that data indicate an increase in th e number of women exhibiting low iodide status. However, this is only one of a variety of factors th at will be considered in determining whether a NPDWR for perchlorate is warranted. Additional consideration of exposure and developmental stage will also be important factors to ev aluate as EPA develops the proposed NPDWR.

EPA received a number of comment s that the Agency should cons ider the comparative effect on iodine uptake of perchlorate exposure in drinki ng water to nitrate and thiocyanate exposure in drinking water in determining whether there is a meaningful opportunity for risk reduction. EPA’s Office of Inspector General (USEPA, 2008c) believe s that a NPDWR for a group of chemicals may be appropriate based on a yet-to-be-conducted cumulative risk assessment that assesses and

characterizes the combined human health risk from perchlorate, nitrate, and thiocyanate. While EPA acknowledges that nitrate and thiocyanate have the same mode of action as perchlorate, and that the effects of combined exposure to perchl orate, nitrate, and thio cyanate are additive, EPA

does not believe there are sufficient scientific data currently available to assess and characterize the

combined risk of these contaminants. EPA has commi tted to a drinking water strategy that outlines four principles to expand public health protecti on for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchlorate should be furthe r delayed. Therefore, EPA intends to develop a proposed rule for perchlorate.

Commenter Name: Richard M. Peekema Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0419

EPA Comment ID: 28685

EPA Comment Code: 4210

Comment: CDC URINE PERCHLORATE ANALYSES

In 2006 the US Center for Disease Control (CDC) released supplemental analyses of urine samples collected for the earlier National Health and Nutrition Examination Survey (NHANES 2001- 2002).[FN1: http://www.cdc.gov/nchs/about/majo r/nhanes/] That new data was based on an improved analysis for perchlorate that was sensit ive to 0.05 ppb,[FN2: Valentin- Blasini L, et al.; Anal. Chem. 77: 2475-2481 (2005)] an d showed that every one of the participants had measurable levels of perchlorate in their urine.

A statistical analysis of that data by Blount et al.[FN3: Blount BC, et al.; Environ Health Perspect. 114: 1865-71 (2006)] claimed a correlation between very small amounts of perchlorate and reduced thyroid T4 hormones in iodide deficient women. They suggested that extremely low levels of perchlorate could affect the health of such women. The Blount article has been cited as evidence that the MCL of 6 ppb issued by the California Department of Public Health is too high.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 387 of 1099 The urinary analyses reported by the CDC includ ed more than just perchlorate. Some 2800 individual urine samples were analyzed by the CDC fo r perchlorate, thiocyanate, nitrate, and iodine. The results of those urine analyses were downloaded from the CDC, copied into a spreadsheet, and are analyzed here to a relatively simple exten t. The frequency distribution of the perchlorate concentration is shown in Figure 1, and the cumulative distribution is shown in Figure 3. This population has a median urine perchlorate value of 4.0 ppb and a 10%-90% range of 1.2 - 10 ppb, surprisingly high values.

Figure 1. Distribution of Perchlorate Analysis [see PDF docket ID EPA-HQ- OW-2009-0297-0419]

Figure 3. Cumulative Distribution [see PDF docket ID EPA-HQ-OW-2009-0297-0419]

What is the source of this perchlorate? The biolog ical half life of perchlorate in the body is only eight hours.[FN4: Greer MA, et al.; Environ Health Perspect 110: 927-937 (2002)] That means that every 8 hours, an individual excretes half the pe rchlorate from his body. Since perchlorate is not detected in about 96% of community water supplies, water cannot be the source of that urinary perchlorate. The detected perchlora te must be coming from dietary intake (vegetables, grains, milk, meat, medication, etc.). The perchlorate intake mu st be continual or it would soon drop to zero.

T4 HORMONE CORRELATION WITH URINARY PERCHLORATE

Blount's statistical analysis (fn.3) showing a pe rchlorate-T4 correlation was based on a regression of serum T4 concentrations vs. the logarithm of the ur inary perchlorate concentr ation. (Log[ClO4-] is a normally distributed parameter in the population, wh ile [ClO4-] is not.) The CDC data on urinary analyses yielded 416 female persons of age >=12 years and <100 ppb urinary iodide [the criterion for iodide deficiency] and where T4 data were also available. Blount's correlation cites a sample size of 348, an elimination of 16% of the samples. The referenced article discusses complicated procedures that were used for eliminating sample s, but gives few details of those methods.

The results of this analysis here for 416 persons are summarized in the Table 4 below, with a comparison to Blount's numbers. The simple linear regression of the data without sample elimination and weighting shows some but much less correlation than Bount's. Figure 5 is a scatter plot for the perchlorate-T4 analysis using all the perchlorate data with no sample elimination. The line in this figure is calculated from the slope an d intercept determined by the least squares fit to the 416 data points.

Figure 5. Correlation of Thyroid t4 with Pe rchlorate [see PDF docket ID EPA-HQ- OW-2009- 0297-0419]

The correlation coefficients in Table 4 show a 10 fold better correlation by Blount than was

achieved here. Blount declares his correlation to be statistically significant, but it apparently required extensive sample pruning to achieve those re sults. Our correlation here is weaker and would probably not be considered statistically signific ant. The CDC cautions against using their data without taking into account their study design and associated sample weights. When sample weights were incorporated into the frequency distribution, there was a small but not significant difference. With CDC sample weights, the median urinary perc hlorate value was projected to be 3.8 ppb for the US population instead of 4.0 ppb for the sample popu lation. However, the simple regression used in Table 4 and Figure 5 could not accommodate sample weights.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 388 of 1099 Did this analysis confirm Blount's correlation? Th ese results are a limited confirmation of Blount's correlation, but not necessarily of his conclusi ons. The implied connection between perchlorate and

T4 is tenuous at best.

Table 4. Statistical Analyses of CDC Data [s ee PDF docket ID EPA-HQ- OW-2009-0297-0419]

Attempts here using the released CDC data to demonstrate a similar effect by nitrate were unsuccessful. The results of simple linear regression of T4 levels against nitrate concentration and against log nitrate concentration are also summarized in Table 4 above.

In this analysis, there seems to be no connection between nitrate and T4. All the anion data are for urinary concentrations, whereas the iodide uptake occurs in the serum near the NIS. One might expect perchlorate, which is metabolically inert, to have similar concentrations in serum and urine. On the contrary, nitrate is not equally inert, an d there could be sizable differences between serum nitrate and urinary nitrate. That migh t explain why no nitrate effect was seen.

The truly surprising result of the CDC data is the appearance of urinar y perchlorate in every individual tested. Even more surprising is the 4 ppb median value. This can only be explained by food and not contaminated water. Considering the s hort half life of perchlorate in the body and for discussion assuming no source for it other than water, urinary concentrations are virtually equivalent to drinking water of the same concentration, namely more than 4 ppb for 50% of the population and more than 10 ppb for 10% of the population.

Response: EPA believes that perchlorate exposure may result from both food and drinking water. Previous analyses have estimated the portion of the perchlorate exposure from food. EPA considered the portion of perchlorate exposure from food in developing the potential alternative HRLs. See responses to comment IDs 20616 and 20886 under comment code 4000. EPA believes that Blount’s interpretation of the relationship between T4 and perchlorate concentrations as reported in the peer reviewed literature are authoritative. Blount lists the shortcomings of his analysis in his paper. EPA does not believe that the widespread presence of perchlorate in food overrides the need for public health risk reduction for persons served by PWSs with perchlorate contamination. The Agency presented an extensive ev aluation of dietary exposure to perchlorate in the October 2008 and August 2009 notices (73 FR 60262; USEPA 2008a and 74 FR 41883; USEPA 2009b). EPA recognizes that a drinking water regulation woul d not eliminate total perchlorate exposure, but believes that the reduction in perchlorate expo sure in drinking water presents a meaningful opportunity for health risk reduction for persons se rved by PWSs contaminated by perchlorate.

Commenter Name: Richard M. Peekema Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0419

EPA Comment ID: 28686

EPA Comment Code: 4210

Comment: IMPORTANCE OF OTHER ANIONSEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 389 of 1099 Other anions cannot be ignored in assessing the le vel of perchlorate that sensitive individual can tolerate. The following table summarizes the CDC data released on urinary concentration and the relative potency established for them. Tonacchera et al.[FN5: Tonacchera M, et al.; Thyroid 14:1012- 1019 (2004)] have shown perchlorate to be 15, 30, and 240 times more potent than thiocyanate, iodide, and nitrate respectively, for inhibiting radi oactive iodide uptake in the Human Sodium Iodide Symporter (NIS). The relative blocking potency valu es reported by Tonacchera are shown in Table

2.

Table 2. Anion Concentrations & NIS Potency [see PDF docket ID EPA-HQ- OW-2009-0297- 0419]

In view of the urinary nitrate concentrations and the NIS potency shown in Table 2 above, one might expect to see a similar correlation between nitrate and the T4 hormone in iodide deficient women. Even though 240 times less potent than perchlorate, nitrate at 53,000 ppb would be equivalent to 221 ppb perchlorate which would have influenced T4. Attempts here using the released CDC data to demonstrate a similar effect by nitrate were unsuccessful. The results of simple linear regression of T4 levels against nitrate con centration and against log nitrate concentration were

summarized earlier in Table 4.

Response: Nitrate shares a common mode of action with perchlorate. However, data do not exist at this time to permit a scientific ally defensible estimation of the relative potency of perchlorate and nitrate. The Tonacchera paper, an in vitro study evaluating the function of human receptors hybridized into animal cells, does not prov ide sufficient evidence to support a meaningful comparison.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 390 of 1099 

### EPA Comment Code: 4220 Biomonitoring -- breast milk studies discussed in

the notice

Individual Comments

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20992

EPA Comment Code: 4220

Comment: Finally, other recent studies have demonstrated that perchlorate is actively transported into mammary epithelial cells by the sodium-iodide symporter (NIS), resulting in an accumulation of perchlorate in breast milk.[FN27: Dohan, O, C Po rtulano, C. Basquin, A Reyna-Noyra, LM Amzel, and N Carrasco. 2007. The Na+/I- symporter (NIS) mediates electroneutral active transport of the environmental pollutant perchlorate. PNAS 104(51) :20250-20255.],[FN28: Dasgupta, P. K., Kirk, A. B., Dyke, J. V., and Ohira, S.-I . (2008). Intake of Iodine and Perchlorate and Excretion in Human
Milk. Environ. Sci. Technol. 42, 8115-8121.] In fact, in the Dasgupta study, perchlorate was concentrated in breast milk three times more than iodine. Also of note, only one infant out of 13 in this study was found to have adequate iodine intake.

EPA has not adequately accounted for the concentrati ons of perchlorate in breast milk, the unique susceptibility of breast feeding neonates, or the fa ct that a significant portion of the U.S. population
is iodine deficient, and therefore more susceptible to perchlorate toxicity.

Response: In the October 2008 notice EPA discusses a number of studies that investigated perchlorate in human breast milk including perc hlorate concentrations. See response to comment

code 2100 for a discussion of EPA’s RfD and how th at value both accounts for the most sensitive populations who are expose to perchlorate includ ing iodine deficient populations. See response to

comment code 5220 for a discussion of alternative HRLs. EPA has examined the relative sensitivity of the breast fed infant as part of its analysis for this regulatory determination as shown in Table 1 of the August 19 2009 Federal Register Notice.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21063

EPA Comment Code: 4220

Comment: i. Tellez et al. (2005)

This was a longitudinal epidemiologic study of th e effects of environmental perchlorate exposure on the thyroidal status of pregnant women and neonates. Perchlorate is found naturally at high levels in Chilean soils and water supplies. Some have quest ioned the relevance of this study to the U.S. population as historically, Chile has had high leve ls of dietary iodide supplementations. However, this supplementation has been decreased to levels that are similar to U.S. levels. In this study, the maternal excretion (and therefore ingestion) of iodine was at levels that were between those reported

in NHANES I and NHANES III. The authors mea sured maternal and neonatal TSH, Tg, and freeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 391 of 1099 T4. They also measured neonatal birth weight, le ngth, and head circumference. They found that "...perchlorate in drinking water at 114 ug/L di d not cause changes in neonatal thyroid function or fetal growth retardation." The levels of iodine in breast milk were not associated with perchlorate exposure. The levels of maternal iodine in urine were intermediate to that found in NHANES I and

NHANES III and consistent with the World Heal th Organization (WHO) recommendations. This study strengthens the evidence that the RfD and HRL are conservative health based values.

Response: The data underlying EPA notes that the data underlying the definition of iodide uptake inhibition as a precursor effect and the relationship of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in adults; it may not reflect the relationship of the precursor event to adverse outcomes in neonates and infants, who may not have iodide stores

sufficient to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a precurs or event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 levels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (Greer et al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[T]he minimal prolonged decrease in thyroid hormone production that would be associated wi th adverse health effects is not known; any decrease is potentially more likely to have adve rse effects in sensitive populations (people with thyroid disorders, pregnant women, fetuses, and in fants) but data are not available to determine the magnitude of the decrease needed to cause adverse effects in those populations.”

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21064

EPA Comment Code: 4220

Comment: ii. Amitai et al. (2007)

This ecological study aimed to "...assess the e ffect of gestational perc hlorate exposure through drinking water on neonatal thyroxine (T4)" by comparing T4 levels among newborns whose mothers lived in areas where drinking water perc hlorate levels were very high (>=340 ug/L), high (42-94 ug/L), or low (<3 ug/L). T4 levels were measured within 36 to 48 hours after birth, but there was no comment on whether the infants were breast fed or formula fed during the postnatal period. They found that there were no differences between ne onatal T4 levels among the groups. This study provides evidence that the current RfD and values greater are conservative and health protective to the most sensitive individuals in the population.

Response: Please see the response to comment ID 21063 under comment code 4220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21076

EPA Comment Code: 4220

Comment: C. Breast Milk StudiesEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 392 of 1099 For many infants, breast milk is the sole sour ce of food and therefore represents the greatest potential exposure to perchlorate. Although th e population theoretically considered the most susceptible to the effects of high levels of perchlor ate is developing fetuses, the effects of doses of perchlorate that are sufficiently high to block iodi de uptake by the thyroid may alter normal growth and development in infants and children. Taken together, the following studies show that there is no association between environmentally relevant levels of perchlorate in drinking water and perchlorate
or iodide in breast milk. Furthermore, no effect, adverse or otherwise, has been found due to environmentally relevant doses of perchlorate.

i. Pearce et al. (2007b)

The objective of the Pearce et al. study was "to determine whether breast milk iodine concentrations in Boston-area women are adequate for infant nutrition, and whether breast milk iodine concentrations may be associated with environm ental perchlorate or cigarette smoke exposure."

Pearce et al. measured breast milk iodine and perchlorate concentrations as well as iodine, perchlorate, and cotinine in urine. They then co mpared the levels found in breast milk to 17

commercial infant formulae. Neithe r breast milk perchlorate nor urinary perchlorate levels were significantly correlated with breast milk iodine concentrations. Although perchlorate was detectable
in infant formulae, the levels were lower than that in breast milk. A significant number of women in this study had iodine levels that were insufficient to meet the infant's needs, but the authors did not suggest this was due to perchlorate exposure or that it represents a chronic iodine deficiency.

ii. Kirk et al. (2005)

With the aim to determine what amount of perchl orate children are exposed to, Kirk et al. measured perchlorate and iodide levels in cow and human breast milk and compared these numbers to corresponding levels of perchlorate in drinking water in the area. Perchlorate was measurable in 81 of the 82 samples. The average perchlorate levels in cow milk and human milk were 2 and 10.5 ug/L, respectively. The maximum values of cow an d human milk were 11 and 92 ug/L, respectively. There was no correlation between levels of perchlor ate in breast milk and perchlorate in drinking water. They speculated that there was a correlation b etween higher levels of perchlorate and lower levels of iodine in breast milk.[FN7: The Kirk et al study uses an arbitrary and non-scientific method of speculating on this relationship. Kirk et al., wr ite: "...we divide iodide levels [in human breast milk] in two groups, those above 60 ug/L and those below, this being the iodide content for many infant feed formulas"; "we...divide perchlorate c ontent in two groups, high and low, in this case arbitrarily dividing the span of the observed perc hlorate range in two equal halves." and "at this point with limited resources, we have been able to analyze only a few samples. Thus, they divide data set using no scientific rationale and then exclude data. The authors state, "If we take all the available data, there is no meaningful correlation between the pe rchlorate and iodide levels in breast milk."] However, this relationship only existed for the brea st milk samples with the highest perchlorate levels (6 subjects out of 82). The authors recognize that this relationship may be coincidental due to the small number of samples with perchlorate levels greater than 10 ug/L, stating that "If we take all the available data, there is no meaningful correlati on between the perchlorate and iodide levels in breast milk." As with previous studies, due to the design, this study is not able to evaluate a causal relationship.

iii. Dasgupta et al. (2008)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 393 of 1099 In a very recently released study, Dasgupta et al. report the results of their study. "The objective of this present study was to study the excretion of pe rchlorate, thiocyanate, and iodine in milk and urine and relate the observed pattern within the broa d framework of parallel / competitive transport by the NIS." Using breast milk and urine samples from 13 lactating women and using EPA default values for infant body weights and milk intakes, the authors mathematically modeled infant intakes and doses of iodide, perchlorate, and thiocyanate. Th ey calculated the fraction of iodide, perchlorate, and thiocyanate in breast milk compared to the tota l that is excreted in both breast milk and urine. They used a ratio of these fractions in milk to d etermine the selectivity of either perchlorate or thiocyanate over iodide. They report "that 12 of 13 infants did not have an adequate intake of iodine...and 9 out of 13 infants were likely inge sting perchlorate at a level exceeding the reference dose..." They also concluded that the selectivity of perchlorate over iodide was 3.14 +/- 1.2.

[Text Box: Taken together, studies on perchlorate in breast milk show that there is no association between environmentally relevant levels of perchlora te in drinking water and perchlorate or iodide in
breast milk. Furthermore, no effect, adverse or ot herwise, has been found due to environmentally relevant doses of perchlorate.]

There are a number of concerns related to the expe rimental design of this paper. The population is small and there is no information on the selection process of the participants (e.g., they are not a random sample). There are only three biological variables that were measured from these women. The rest of the variables, including the variables used to derive the conclusions, are calculated from these these three in addition to using default values for infant intake and infant weights. The three measurements were the concentrations of of perc hlorate, iodine, and thiocyanate in both urine and

breast milk. Where other research has measured mo re biologically relevant information, such as serum concentrations of analytes which would be mo st reflective of relative concentrations at the NIS (Tonacchara et al., 2004; Pearce et al., 2007) thus, this work is limited. The estimated doses, the key variable for understanding possible NIS effects, are based on average body weight and intakes for an infant of that age with the concentration in breast milk. For such a simple and critical variable, it is suprising that actual body weights were not measured.

In addition to study design, the data presented in this paper appears to contradict the interpretation by the authors of the paper. Based on estimated we ights, the authors state that 9 out of 13 infants are consuming daily doses in excess of the RfD. However, from examining Table 1 from Dasgupta
et al., there are 8 infants who exceed the RfD of 0.7 ug/kg-d (subjects 1, 2, 8, 11, 13, 15, 16, 20).
Furthermore, if one reviews these estimates to measured variables, the infants with estimated perchlorate doses greater than the RfD are also es timated to have the greatest iodine intake. By plotting the values for total iodide excretion (co lumn 4), total perchlorate excretion (column 7),

estimated maternal breast milk iodi de excretion (equivalent to estimated infant iodide intake; column 5), and estimated maternal breast milk perchlora te excretion (product of total perchlorate excreted and percent of perchlorate in milk; column 7 x column 9) found in Table 1 of the paper, the results demonstrate that perchlorate and iodide are positiv ely correlated (See Figure 3). If perchlorate was inhibiting the transport of iodide into milk, the association would be negative.

[Figure 2: Plotting of data reported by Dasgupta et al., 2008 to illustrate the association between concentrations of iodine and perchlorate in urine and milk in lactating women - See PDF Docket ID EPA-HQ-OW-2008-0692-1855]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 394 of 1099 In addition to the concerns regarding interpretation of the data presented in this paper, there are concerns about the interpretation of their previo us work (Kirk et al., 2005) and how that study impacts this recent study. For example, Dasgupta et al. state in this current paper that "in real mothers perchlorate does inhibit the transport of iodine into milk and because of competitive inhibition both analytes cannot be high at the sa me time." However, this statement is based on a previous study in which the researchers defined th eir cut off values[FN8: The cutpoints from Kirk et al. (2005) were defined as follows: High iodide in breast milk was greater than 60 ug/L and high perchlorate in breast milk was greater than 20 ug /L.] above which milk iodide or perchlorate were considered "high." They report that no milk samples had both high perchlorate and high iodide (Kirk et al., 2005). In the present study, they report the same trend although they do not define a cut off value. However, if the previous cut off values are applied to the current study, there are many samples that had simultaneously high perchlora te and iodide (Figure 3). Based on the previous conclusions about competitive inhibition of anal ytes (Kirk et al., 2005), this study does not demonstrate that perchlorate competitively inhibits iodide transport into milk at the concentrations experienced by these women. Response: In the October 2008 notice EPA discusses a number of studies that investigated perchlorate concentrations in human breast milk. P oor iodide uptake and subsequent impairment of the thyroid function in pregnant and lactating wo men have been linked to delayed development and decreased learning capability in their infants and children (NRC, 2005). Additionally, deficiency during childhood reduces child growth and cognitive motor function (Zimmerman, 2009). EPA has considered the portions of the population who are mo st sensitive to the effects of perchlorate and has determined that perchlorate may have an adverse effect on the health of persons. Please also see the response to comment ID 20992 under comment code 4220.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 395 of 1099 

### EPA Comment Code: 4230 Biomonitoring -- other biomonitoring studies,
models, and data for EPA to consider (other than NHANES and breast milk studies discussed in the notice)

Individual Comments

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21077

EPA Comment Code: 4230

Comment: iv. Dohan et al. (2007)

Animal, particularly rodent, studies are an implic it and valuable aspect of toxicology. There are, however, significant differences between human an d rodent thyroid physiology. U.S. EPA states,"The fundamental mechanisms involved in the function and regulation of the pituitaryhypothalamus-thyroid system in rats are qualitatively similar to those in humans. However, differences in binding proteins, binding affinities of the proteins for the hormones, turnover rates of hormones, and thyroid stimulation by placental hor mones lead to important quantitative differences between the two species. The bioc hemical and physiologic differen ces between rats and humans related to the thyroid affect their responses to goit rogens, such as perchlorate. Therefore, although studies in rats provide useful qualitative informat ion on potential adverse effects of perchlorate exposure, they are limited in their utility for quantitatively assessing human health risk associated with perchlorate exposure" (U.S. EPA, 2005).

The main purpose of the Dohan et al. publication is to demonstrate that perchlorate crosses cell membranes via the NIS; to demonstrate perchlorate' s ability to be excreted in breast milk; and to develop a mathematical model to characterize thei r experimental results. The in vitro experiment and system they use is unique, creative, and provides the first evidence of perchlorate crossing a cell membrane using Mardin-Darby canine kidney (MDCK) cells transfected with the human NIS. It provides further evidence regarding questions a bout breast milk perchlorate levels and whether perchlorate blocks iodide at the symporter or comp etes against iodide in crossing the NIS. Thus, it decreases uncertainty in the risk assessment process. It is important to remember that this is the first study of its kind, it was conducted in vitro (cell culture), and it was conducted in a non-human cell line with artificially introduced human symporters. From a perspective on cell membrane transport, this work provides qualitative information.

The author's discussion of the in vivo part of th e study's relevance to environmental exposures of perchlorate and human health is, however, far reac hing and not supported by the results of this experiment. High acute doses of perchlorate wer e given to the rats. The rats were given an intraperitoneal injection of nearly 8 mg/kg/d in addition to a drinking water exposure of 13.6 mg/kg/d.[FN9: Assumes a 250 g rat with a daily water intake of 5.5 ml/100 g body weight.] The perchlorate doses administered in this study are high enough such that they should effectively block, with complete inhibition, iodide transport by the NIS in these rats, which provides no information about the effects at environmentally relevant doses. The results cannot be used to draw conclusions about what happens from a human health standpoi nt or mechanistic function at environmentally

relevant concentrations.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 396 of 1099 Response: In the October 2008 notice EPA discusses a number of studies that investigated perchlorate concentrations in human breast milk . In the final regulatory determination notice EPA discusses the uncertainty about the point in the cont inuum of effects at which adversity occurs, and that these were major considerations in determining whether perchlorate is likely to have an adverse effect on health at a range of life stages. The conc lusions of the study by Dohan et al. (2007) that NIS translocates perchlorate in epithelial mammary cells in vivo, based on rat models, represents a

valuable contribution to the current scientific liter ature on the biological mechanisms of perchlorate uptake in mammary cells and its potential inhibito ry effect on iodine, and its potential relevance to nursing neonates and infants. The data underlying the definition of iodide uptake inhibition as a precursor effect and the relations hip of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in a dults; it may not reflect the relationship of the precursor event to adverse outcomes in neonates and infants, who may no t have iodide stores

sufficient to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a precur sor event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 le vels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (G reer et al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[T]he minimal prolonged decrease in thyroid hormone production that w ould be associated with advers e health effects is not known; any decrease is potentially more likely to have adverse effects in sens itive populations (people with thyroid disorders, pregnant women, fetuses, and infants) but data are not available to determine the magnitude of the decrease needed to cause adverse effects in those populations.”EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 397 of 1099 

### EPA Comment Code: 4300 Other perchlor ate exposure studies, models, and data for EPA to consider (other than dr inking water, diet, and biomonitoring)

Individual Comments

Commenter Name: Erik Lokensgard Commenter Organization: Division of the Biological Sc iences, University of Chicago

EPA Document ID: EPA-HQ-OW-2008-0692-0320

EPA Comment ID: 19808

EPA Comment Code: 4300

Comment: I also recommend that pool chlorination systems be investigated for their potential role in perchlorate pollution. I'm sure that every family would prefer safe tap water to every family having a pool.

Thank you for your time, Erik Lokensgard Division of the Biological Sciences University of Chicago

Response: There may be perchlorate generated from stored hypochlorite solutions used in pools; however, under this action EPA is evaluating wh ether perchlorate should be regulated under the Safe Drinking Water Act. EPA is not seeking to d etermine the source of perchlorate as part of this

action.

Commenter Name: Jeremy Ginoza Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0635

EPA Comment ID: 19983

EPA Comment Code: 4300

Comment: Perchlorate has been shown in animal studies to disrupt thyroid function (see references below). Please err on the side of less public health exposure, not more. Place the burden not on the delicate balance of human organs and tissues, but on profitable corporations to act responsibly.

--Jeremy Ginoza, 4th year medical student

Effects of maternal exposure to ammonium perchl orate on thyroid function and the expression of thyroid-responsive genes in Japanese quail em bryos. Chen Y, Sible JC, McNabb FM. Gen Comp Endocrinol. 2008 Sep 6.

"Our study shows that maternal perchlorate exposure led to embryonic hypothyroidism and may have interfered with embryonic development."

"Embryos from eggs of perchlorate-exposed hens had hypertrophied thyroid glands and significantly lower thyroidal hormone storage, in dicating hypothyroidism in these embryos. The embryonic hypothyroidism was associated with decreased embryonic growth, delayed hatching and greater mortality during hatching."

Effects of prolonged exposure to perchlorate on th yroid and reproductive function in zebrafish. Mukhi S, PatiÃ±o R. Toxicol Sci. 2007 Apr;96(2):246-54. Epub 2007 Jan 6.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 398 of 1099 "At 10 weeks of exposure, perchlorate at both co ncentrations caused thyroidal hypertrophy and colloid depletion."

"In conclusion, prolonged exposure of adult zebrafis h to perchlorate not only disrupts their thyroid endocrine system but also impairs reproducti on and influences early F1 development."

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment

code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 399 of 1099 

### EPA Comment Code: 5000 SDWA Criteria

Individual Comments

Commenter Name: Thomas L. Schoaf Commenter Organization: Cities of Litchfield Park and Goodyear, AZ

EPA Document ID: EPA-HQ-OW-2008-0692-1552

EPA Comment ID: 20519

EPA Comment Code: 5000

Comment: Under the Safe Drinking Water Act (SDWA) , the EPA considers three criteria to determine if a drinking water standard should be established for a contaminant. Those criteria are that: i) there is a potential adverse human health e ffect ; ii) it is known or likely to occur at a level and frequency of concern in Public Water Systems (P WSs); and, iii) regulation presents a meaningful opportunity for health risk reduction.

The EPA has determined that perchlorate presents an adverse human health effect. It is important

to note that the EPA has also determined that perchlorate has a greater impact on sensitive populations, specifically pregnant women and developing fetuses.

In evaluating potential exposure, the EPA concluded th at perchlorate occurs at levels in excess of its

selected health risk level threshold of 15 ug/L in less than 1% of PW Ss. Even at this percentage, the EPA reports that its upper end estimate of populati on exposed to perchlorate at levels in excess of its selected health risk level is 2 million people. If the EPA had applied a more conservative relative source contribution factor, the upper end exposure estimate could be as high as 14 million people. We think that these exposure estimates alone warra nt a determination that "regulation presents a meaningful opportunity for risk reduction." However , we are concerned that the EPA's evaluation of impacted public water supply systems (PWSs) ma y underestimate potential future exposure. By focusing only on known contamination at existing PWSs, the EPA does not consider likely impactsone of the SDWA criteria. For example, without th e strength of a promulgated standard to require cleanup of the impacted aquifers at the PGA No rth Superfund Site, exposure to perchlorate will likely occur as future PWSs or future entry poi nts to existing PWSs are brought on-line. By considering likely occurrences of perchlorate expo sure, we believe that there is a known or likely exposure at a level and frequency of concern.

Response: EPA has determined that regulation of perchl orate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20935

EPA Comment Code: 5000

Comment: Section 1412(b)(1)(A) of the SDWA provides that the EPA Administrator shall "promulgate a national primary drinking water regulation for a contaminant if the Administrator

determines that:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 400 of 1099 (i) the contaminant may have an adverse effect on the health of persons; (ii)the contaminant is

known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public he alth concern; and (iii)in the sole judgment of the Administrator, regulation of such contaminant pr esents a meaningful opportunity for health risk reduction for persons served by public water systems.

42 U.S.C. [section] 300g-1(b )(1)(A) (Westlaw 2008).

Section 1412(b)(1)(C) of the SDWA further provid es that in determining whether to regulate drinking water contaminants, the Administrator must take into consideration:

the effect of such contaminants upon subgroups th at comprise a meaningful portion of the general population (such as infants, children, pregnant wome n, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifi able as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.

42 U.S.C. [section] 300g-1(b)(1)(C) (Westlaw 2008).

The Environment Department respectfully submits that each of the three criteria in section 1412(b)(1)(A) is met for perchlorate. Moreover, the risk of adverse health effects from perchlorate ingestion is greater for certain sensitive subgroups of the general population as described in section 1412(b)(1)(C).

Response: See response to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20939

EPA Comment Code: 5000

Comment: For EPA to base a final decision not to establish primary drinking water regulations for perchlorate under the SDWA on this analysis would be arbitrary, capricious, and not in accordance with the plain requirements of the SDWA.

Response: See response to comment code 6120.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20942

EPA Comment Code: 5000

Comment: Perchlorate Meets the Three Criteria Need ed to Justify Promulgation of a National

Standard There are three criteria that must be met to justify the promulgation of a national public drinking water regulation:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 401 of 1099 a) The contaminant may have an adverse effect on human health b) The contaminant occurs with a frequency and at levels of public health concer n, and c) The promulgation of standards presents a meaningful opportunity to reduce health risk.

In our view, perchlorate meets all three of these cri teria: perchlorate poses a significant health risk, is present at sufficient levels and in a sufficient number of public water systems to constitute a public health concern, and by promulgating a standard, EPA has a meaningful opportunity to reduce health

risk.

Response: See response to comment code 6120.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21093

EPA Comment Code: 5000

Comment: III. The Current Scientific Literature Pr ovides Overwhelming Support for EPA's Findings under the Safe Drinking Water Act's Criteria for this Determination

In the SDWA, EPA is directed by Congress to make a determination whether to set a National Primary Drinking Water Regulation (NPDWR) based on the following criteria:

a) the contaminant may have an adverse effect on the health of persons;

b) the contaminant is known to occur in public water systems with a frequency and at levels of public health concern; and,

c) in the sole judgment of the Administrator, re gulation of such contaminant presents a meaningful opportunity for health risk reduction for persons se rved by public water systems (73 FR 60264).

Response: See response to comment code 6120.

Commenter Name: Anthony Russo Commenter Organization: Chemistry Council of New Jersey (CCNJ)

EPA Document ID: EPA-HQ-OW-2009-0297-0673

EPA Comment ID: 28689

EPA Comment Code: 5000

Comment: The Agency must be able to support it s determination with credible, properly interpreted science. Pursuant to the SDWA, EP A's final regulatory determination whether to establish a primary drinking water standard for perchlorate is based upon the following statutory

criteria:

* The contaminant may have an adverse effect on the health of persons; * The contaminant is

known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public he alth concern; and * In the sole judgment of theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 402 of 1099 Administrator, regulation of such contaminant pr esents a meaningful opportunity for health risk reduction for persons served by public water systems.

Response: No response necessary for this comment.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28825

EPA Comment Code: 5000

Comment: September 17, 2009

Water Docket Environmental Protection Agency Ma ilcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460

Re: Comments on the Drinking Water: Perchlor ate Supplemental Request for Comments Docket ID No. EPA-HQ-OW-2009-0297

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the preliminary regulatory determination for perc hlorate as listed in the August 19, 2009 Federal Register (74 FR 41883). AMWA strongly supports the process required by the 1996 Amendments to the Safe Drinking Water Act that places a str ong emphasis on science and focuses on contaminants which: may have an adverse effect on humans; occur or are likely to occur at levels of public health concern; and provide a meaningful opportunity for health risk reduction.

Response: No response necessary for this comment.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28871

EPA Comment Code: 5000

Comment: 4. Science-based considerations: The Safe Drinking Water Act (SDWA) has three requirements-all three of which must be met to sa tisfy the law. The scientific literature addresses these requirements for perchlorate. The science clea rly shows EPA's statutory criteria for setting a

standard are unmet in this case:

Response: EPA disagrees with the statement that "the sc ience clearly shows EPA's statutory criteria for setting a standard are unmet." In making fina l regulatory determinations, EPA uses the criteria mandated by the 1996 SDWA Amendments. Specifically, EPA has found that perchlorate may have an adverse effect on the health of persons, that perchlorate occurs or there is a substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of public health concern, and that regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons se rved by public water systems. The Federal Register notice for this action describes how EPA eval uated these three criteria in light of the best available peer reviewed data to make a prelimin ary regulatory determination for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 403 of 1099 

### EPA Comment Code: 5100 SDWA Criterion #1 – EPA’s determination that perchlorate may have adverse eff ects on the health of persons

Individual Comments

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20421

EPA Comment Code: 5100

Comment: The Safe Drinking Water Act (SDWA) requires the Administrator to establish an MCL

when three conditions are met. The CHPAC feels st rongly that all three conditions are met in the case of perchlorate. The first condition, that th e contaminant has an adverse effect on the health of persons, is met for perchlorate. Perchlorate interferes with thyroid function and can lower circulating thyroid hormone levels in humans; lowered thyroid hormone levels and consequent impacts on the developing brain have been demonstrated in perchlorate-dosed animals. The developing fetus and infants are vulnerable to pe rchlorate due to the exqui site sensitivity of brain development to thyroid hormone levels, and the fact that newborns have no stores of this hormone.

Response: See response to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20936

EPA Comment Code: 5100

Comment: As to the first criterion, it is without di spute that perchlorate in drinking water has anadverse effect on the health of persons. According to the National Research Council, perchlorate can adversely affect the function of the thyroid "beca use it is an ion that competitively inhibits the transport of iodide into the thyroid" by a pr otein known as the sodium/iodide symporter.[FN13:
NATIONAL RESEARCH COUNCIL, HEALTH IMPLICATIONS OF PERCHLORATE INGESTION 6 (2005).] Iodide deficiency resulting fr om perchlorate ingestion is more likely to have a negative effect in sensitive populations, such as people with thyroid disorders, pregnant women, fetuses, and infants.[FN14: Id.] In pregnant wome n, severe iodide deficiency can result in major neurodevelopmental deficits and goiter in their offspring.[FN15: Id.] Lesser degrees of iodide deficiency may also cause important neurodevelopmenta l deficits in infants and children.[FN16: Id.] EPA expressly recognizes the adve rse health effects of perchlora te ingestion.[FN17: See 73 Fed. Reg. 60262, 60275 (Oct. 10, 2008).]

Response: EPA agrees with the commenter.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28846

EPA Comment Code: 5100EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 404 of 1099 Comment: The study by Mendez et.al. [FN13: Me ndez, W., Dederick' E., and J. Cohen. 2009. Drinking water contribution to aggregate perc hlorate intake of reproductive-age women in the United States estimated by dietary intake simulati on and analysis of urinary excretion data. Journal of Exposure Science and Environmental Epidemiology advance online publication 16 September 2009.] further supports findings that the NOEL ba sed RfD is sufficiently conservative and health protective of sensitive subpopulations. This study finds that the total dietary exposure (food and drinking water) of reproductive age women in the U.S. is approximately one-third of the RfD for perchlorate at the 95th percentile, which is comple mentary to the findings of the joint assessment prepared by EPA-CDC. Given this evidence rela ted to limited exposure potentials and estimated
intakes well below the RfD, it is clear that there is limited potential for perchlorate to present a significant adverse affect on the nation's health, including sensitive subpopulations.

Response: EPA disagrees that there is a limited potential for perchlorate to present a significant adverse effect on the nation’s health, including sensit ive subpopulations. EPA has determined that perchlorate occurs or there is a substantial like lihood that perchlorate will occur with a frequency and at levels of health concern in public water systems. EPA has made this determination by comparing the best available data on the occurren ce of perchlorate in PWSs to potential health reference levels (HRLs) for perchlorate.

Since the NRC also identified infants and developi ng children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information in the August 9, 2009, not ice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perc hlorate in drinking water that may result in total perchlorate exposures (from food an d water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their

cohorts.

EPA is evaluating these potential alternative HRLs an d considers them to be levels of public health concern for purposes of this determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28872

EPA Comment Code: 5100

Comment: a) The SDWA requires that the contaminant must have an adverse effect on the health of persons. The weight-of-evidence, after examining the published scientific literature, demonstrates no documented adverse effects in humans exposed to perchlorate at environmental levels.

Response: EPA disagrees. EPA disagrees that the “weight of evidence” demonstrates no documented adverse effects in humans exposed to perchlorate at environmental levels. See the final regulatoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 405 of 1099 determination for further discussion of the basis of EPA’s conclusion that perchlorate may have an adverse health effect on persons.

EPA has determined that perchlorate meets SDWA’s criteria for regulating a contaminant —that is, perchlorate may have an adverse effect on the health of persons; perchlorate is known to occur or there is a substantial likelihood that perchlorate w ill occur in public water systems with a frequency and at levels of public health concern; and in th e sole judgment of the Administrator, regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons served by public water systems.

After careful review and consideration of public comments on the May 2007, October 2008, and August 2009 notices, and information available at this time, EPA has made this determination by comparing the best available data on the occurren ce of perchlorate in PWSs to potential health reference levels (HRLs) for perchlorate as disc ussed in the regulatory determination final notice.

Since the NRC also identified infants and developi ng children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information in the August 9, 2009, noti ce (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perc hlorate in drinking water that may result in total perchlorate exposures (from food an d water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their

cohorts.

EPA is evaluating these potential alternative HRLs an d considers them to be levels of public health concern for purposes of this determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 406 of 1099 

### EPA Comment Code: 5200 SDWA Criterion #2 – EPA’s determination that perchlorate occurs infrequently at leve ls of health concern in public water

systems

Response to Code 5200 : EPA has determined that perchlorate occurs or ther e is a substantial likelihood that perchlorate will occur with a frequency and at levels of health c oncern in public water systems. EPA has made this determination by comparing the best available da ta on the occurrence of perchlorate in PWSs to potential health reference levels (HRLs) for perc hlorate. EPA collected and analyzed drinking water occurrence data for perchlorate from 3,865 PWSs between 2001 and 2005 under the UCMR 1. The minimum reporting level (MRL) for perchlorate under the UCMR 1 was 4 μ g/L. EPA found that 160 (approximately 4.1 percent) of the 3,865 PWSs that sample d and reported had at least 1 analytical detection of perchlorate (in at least 1 samp ling point) at levels greater than or equal to the

MRL of 4 μ g/L. These 160 PWSs are located in 26 States and 2 territories. Of these 160 PWSs, 8 are systems serving 10,000 or fewer people and 152 ar e systems serving more than 10,000 people. These 160 systems reported 637 detections of perchlora te at levels greater than or equal to 4 μ g/L, which is approximately 11.3 percent of the 5,629 samp les collected by these 160 PWSs and approximately 1.9 percent of the 34,331 samples collected by all 3,865 PWSs. The average concentration of perchlorate for those samples with positive detections for perchlorate was 9.85 μ g/L and the median

concentration was 6.40 μ g/L.

EPA derived potential alternative HRLs for 14 life stages (age groups) usi ng the RfD and life stagespecific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life stage.

Based on percent of public water system estimates for perchlorate above thresholds of interest in Table 1 in the Federal Register Notice, and th e range of potential alternative HRLs, EPA has determined that perchlorate is known to occur or th ere is a substantial likelihood that it will occur with a frequency and at levels of public health concern.

In light of the discussion in this notice and the information available at this time, the Administrator finds that regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons served by public water systems. Therefor e, EPA will initiate the process of proposing a NPDWR for perchlorate.

Individual Comments

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Administrators (ASDWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0169

EPA Comment ID: 20286

EPA Comment Code: 5200

Comment: Perchlorate:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 407 of 1099 Based on state input, it does not appear that perchlorate is being detected in very many public water systems. Thus, while it may be a critical issue at a small number of water systems, it does not appear, at this stage, to be a nationwide probl em that impacts most or all states.

Response: See response to comment code 5200.

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20422

EPA Comment Code: 5200

Comment: The second condition, that the contaminan t occurs in public water supplies with a frequency and level of public health concern, is al so met for perchlorate. The UCMR data show that millions of Americans are exposed to perchlorate in public supplies at concentrations greater than 6 ug/L, the highest of three recently set state drinking water targets for perchlorate. The only way the second condition is not met is if an inappropria tely high health benchmark is set. The CHPAC strongly feels that this is the case with USEPA's HRL of 15 ug/L as this would cause large numbers of infants to receive daily doses of perchlor ate that are well above the Agency's RfD.

Response: See response to comment code 5200.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20435

EPA Comment Code: 5200

Comment: 10. EPA Underestimates Numbers of At Risk Citizens. Due to the fact that MassDEP believes the HRL should be 2 ppb we conclude more than 16.6 million people are exposed to unsafe levels of perchlorate in their drinking water, and that this is a significant national public health issue.

Response: Regarding your comment that EPA underestim ated the number of people at risk, see response to comment code 5200. Regarding your comme nt that this is a significant national public health issue, EPA has determined that regulation of perchlorate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. This action initiates the process to establish a national pr imary drinking water regulation for perchlorate including the maximum concentration of perchlora te that is allowed in public drinking water

systems.

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20638

EPA Comment Code: 5200

Comment: Dear Sirs,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 408 of 1099 Based on EPA’s analysis of exposure data and relati ve source contribution, we agree that perchlorate is not occurring in the public water supply at levels that cause concern for health risks.

Response: EPA disagrees with the commenter that the pe rchlorate is not occurring in the public water supply at levels that cause concern for heal th risks. See response to comment code 5200.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20907

EPA Comment Code: 5200

Comment: * Even EPA’s own flawed assessment finds th at up to 2 million people may be exposed to perchlorate at levels that are of concern and yet, EPA chooses not to take any meaningful action.

Response: EPA has determined that regulation of perchl orate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20937

EPA Comment Code: 5200

Comment: As to the second criterion, EPA estimates that 16,000 to 28,000 pregnant women would be exposed to perchlorate at levels exceeding the health reference level (HRL) of 15 "at any given time."[FN18: Id. at 60277.] EPA thus concludes that "perchlorate occurs infrequently at levels of health concern in public water systems."[FN19: Id.] EPA's analysis is seriously flawed for several

reasons.

First, the analysis fails to consider future health effects on women who have not yet become pregnant, and on their future fetuses. This failure is at odds with the plain language ofthe SDWA. Section 1412(b)(1)(A)(ii) requires EPA to consid er not only whether a contaminant is known presently to occur in public water systems so as to cause public health concern, but also whether

"there is a substantial likelihood that the contam inant will occur in public water systems with a frequency and at levels of public health con cern."[FN20: 42 U.S.C. [section] 300g-1(b)(1)(A)(ii) (Westlaw 2008) (emphasis added).] Thus, Congress wise ly directed EPA to consider potential future health effects in its analysis. But EPA has subtl y avoided this consideration in its perchlorate analysis. EPA asks, "Is perchlorate known to o ccur or is there a substantial likelihood that perchlorate occurs at a frequency and at a leve l of public health concern in public water systems?"[FN21: 73 Fed. Reg. at 60275 (emphasis a dded).] EPA then answers this question in the negative because the agency finds that no more than 16,000 to 28,000 pregnant women "could be exposed at levels exceeding the HRL at any give n time." EPA effectively takes a snapshot of perchlorate exposure at one instant in time. EPA do es not take into account the millions of women who will become pregnant and who could be expos ed to perchlorate above the HRL in future months, years, and decades. EPA's failure to accoun t for future health effects is contrary to the

SDWA.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 409 of 1099 Second, the analysis fails to consider health eff ects on infants. According to the National Research Council, infants comprise a subpopulation that is part icularly sensitive to perchlorate exposure. For example, studies have shown that children with a mild iodide deficiency - which perchlorate can cause - have learning disabilities and perfor m less well on tests of mental and psychomotor ability.[FN22: NATIONAL RESEARCH COUNCIL, supra note 13, at 59.] Moreover, the HRL for infants is likely below the 15 ug/L that EPA d etermined for pregnant women.[FN23: See letter from Melanie A. Marty, Ph.D., Chair, Children's Health Protection Advisory Committee, to EPA Administrator Stephen L. Johnson, at 2 (Nov. 3, 2008 ).] EPA's failure to consider the adverse health effects of perchlorate ingestion on infants, a sens itive subgroup, in (preliminarily) determining that perchlorate occurs infrequently in public water system s at levels of health concern is also contrary to

the SDWA.

Third, the analysis fails to take into considerati on health effects on persons with thyroid disorders. According to the National Research Council, peopl e with thyroid disorders would be expected to be more sensitive to the effects of perchlor ate ingestion.[FN24: NATIONAL RESEARCH COUNCIL, supra note 13, at 51.] Again, EPA's failu re to consider the adverse health effects of perchlorate ingestion on persons with thyroid disorders in (preliminarily) determining that perchlorate occurs only infrequently in public wate r systems at levels of public health concern is contrary to the SDWA.

Response: See response to comment code 5200. NRC specifies the fetus of a mother with hypothyroidism or iodine deficiency and low birthweight and premature infants as the most sensitive populations. Since the NRC also identified infants and developing children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) usi ng the RfD and life stagespecific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th
percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluati ng these potential alternative HRLs and considers them to be levels of public health co ncern for purposes of this determination.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21028

EPA Comment Code: 5200

Comment: 11. Your letter asserts that millions are exposed to perchlorate at levels exceeding the 6 μg/L, the highest of the state MCLs to be established.

In our comments, the PSG has compared the risk opportunity from detects in public water systems (PWSs) between perchlorate and other compound s that EPA has decided not to regulate. The percentage of PWSs with perchlorate detections wa s very low (3.6 percent) compared to the next lowest unregulated compound, manganese at 68 per cent. Sodium, for example, was detected in all PWSs. Perchlorate also has one of the lowest popu lations served by PWSs with detections aboveEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 410 of 1099 half the HRL with 2.2 million people. Perchlorate is well within the range of values for the

evaluation criterion EPA uses.

Additionally, it bears repeating that EPA has incorp orated an additional level of conservatism into an already conservative and health protective NA S-based RfD. Specifically, any exposures above the RfD, if they indeed occur, must first be cons idered in the context of a non-adverse effect.

Response: Regarding the suggestion to compare the risk opportunity from detects in public water systems between perchlorate and other compounds th at EPA has decided not to regulate, EPA does not believe it's appropriate to factor these comparisons into the decision whether to regulate a

contaminant. The Administrator will make thes e determinations on a case-by-case, contaminant specific basis. In making a regulatory determinati on, the Administrator considers the adverse health effect of the particular contaminant at issue as we ll as the occurrence or likelihood of occurrence of the contaminant in public water systems with a freque ncy and at levels of public health concern. In addition, even if such a comparison were appropriate, pe rchlorate has, at least at the lower levels of public health concern identified, an occurrence that is substantially larger than most of the contaminants for which EPA has made a negative d etermination. Finally, it is the sole judgment of

EPA’s Administrator to determine whether there is a meaningful opportunity to reduce health risk for persons served by public water systems. Regarding the comment that any exposures above the RfD must first be considered in the context of a non-adverse effect, the data underlying the defi nition of iodide uptake inhibition as a precursor effect and its relationship to the continuum of adverse thyroid outcomes reflects an understanding

of effects in adults.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21096

EPA Comment Code: 5200

Comment: EPA's UCMR monitoring found a mean concentration of less than 10 ppb in systems with perchlorate - over 100 times lower than the NAS adverse effect level. Only a few systems have found any samples with concentrations greater than 100 ppb. Even the maximum level detected in the US is approximately 50 times lower than the dose at which the NAS panel determined adverse effects could begin. Specifically, the NAS panel noted that "...a sustained exposure of more than 0.4 mg/kg per day would most likely be required to cause a sufficient decline in iodide uptake and thyroid hormone production to result in adverse he alth effects in normal adults." (NAS 2005) For these reasons, perchlorate is not known or likely to occur in public water systems with a frequency and at levels of public health concern.

Response: See response to comment code 5200.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28873

EPA Comment Code: 5200EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 411 of 1099 Comment: b) The SDWA requires that the contaminant must be known to occur in PWSs with a frequency and at levels of public health concern. Whe re perchlorate is found, it is at levels often an order of magnitude below levels that cause IUI, it self a nonadverse effect. EPA data indicate average perchlorate concentrations in public drinking wa ter systems are <10 parts per billion (ppb), and 99% of samples were <7 ppb. These levels are all belo w the equivalent concentration corresponding to the RfD, assuming a standard EPA default body weight and drinking water consumption rate, as well as the HRL of 15 ppb proposed by EPA in 2008 (U.S. EPA, 2008a).

Response: See response to comment code 5200.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 412 of 1099 

### EPA Comment Code: 5210 Derivation of the RSC

Response to Code 5210 : EPA routinely applies a relative source contribution (RSC) to allow for the possibility that not all exposure will come from water, recognizing the importance of keeping the total exposure dose (e.g., water plus diet) below the RfD.

EPA believes that use of an RSC for perchlorate is appropriate because the Gr eer et al. (2002) study, upon which the RfD is based, did not measure the levels of perchlorate in their food, and the sample size is small (37 healthy adults).

The RSC is based on the best available peer revi ewed science from the FDA (Total Diet Study) and estimates of exposure based on the NHANES/UCMR da ta which are robust evaluations of dietary exposure to perchlorate. A more detailed discussion of the derivation of the RSC can be found in the 2009 Federal Register Notice.

Individual Comments

Commenter Name: Thomas Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0162

EPA Comment ID: 20268

EPA Comment Code: 5210

Comment: In developing a drinking water regulation for perchlorate, EPA needs to address the Relative Source Contribution (RSC) for perchlorate in food and water. The proposal in the May 1st Federal Register notice is a starting point for making an appropriate RSC decision. AWWA recommends that EPA not adjust for RSC, since the subjects in the Greer study were exposed to background levels of perchlorate in addition to an experimental dose, as discussed on pg. 24046 of the May 1st Federal Register notice.

Alternatively, if EPA doesn't accep t the above recommendation, then EPA should derive the value of average daily rate of intake from backgrou nd sources (ADRIB) from the mean (preferred approach) or upper tail (less preferred approach) of the NHANES data specific either to the entire sampled population or to individuals using bottled water. This background value should then be subtracted from the Reference Dose (RfD) and th at result used to calculate the Drinking Water Equivalent Level (DWEL). This Modified ADRI a pproach better approxima tes the target average daily rate of intake (ADRI) that must be reache d to ensure the RfD is not exceeded when water is added to the perchlorate contribution from all other sources combined (ADRIT).

From a technical perspective, some of the options presentation in the May 1st Federal Register simply do not make sense. For example, the EP A option of a regression of the NHANES urinary data versus UCMR is not feasible and should not be considered. It would result in only a couple of dozen data points, an insufficient number to allow a meaningful regression.

Appendix A [See Appendix A in PDF of dock et ID EPA-HQ-OW-2007-0068-0162] to these comments is a report by Dr. Douglas Crawford- Br own of the University of North Carolina-Chapel Hill that was prepared on behalf of AWWA. Dr . Crawford- Brown’s report explains the aboveEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 413 of 1099 recommendations in greater detail, comparing and c ontrasting alternative approaches to selecting a valid RSC value. We ask that his report be c onsidered to be part of these comments.

Response: See response to comment code 5210.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20281

EPA Comment Code: 5210

Comment: BIOMONITORING DATA SUGGESTS THERE IS NO NEED TO ACCOUNT

FOR PERCHLORATE EXPOSURES FROM OTHER SOURCES

In the absence of extensive biomonitoring data, EP A has historically created an HRL by multiplying the Drinking Water Equivalent Level (DWEL) of the RfD by a Relative Source Contribution (RSC) for the constituent (a factor of the proportion of exposure expected to co me from water). EPA’s Support Document outlines several options that EPA suggests for its RSC determination using the biomonitoring data and food surveys. If performed in a scientifically valid manner, the data shows that EPA would calculate an RSC of one (whic h yields an HRL of 24.5 ppb drinking water equivalent).

EPA also references other approaches to calculate the RSC that appear to be at variance with the best available scientific information, representing overly conservative departures from customary EPA policy or apparently requiring m onths of additional computations.

Ultimately, it appears that these approaches would yield essentially the same result: an RSC of one, which would render them duplicative.

Attachment 3 [See PDF of docket ID EPA-HQ-OW- 2007-0068-0168] provides detailed exploration of the issues raised in this section. Our analysis finds that proper application of the best available science through any of the Agencys uggested approaches will yield the same conclusion - perchlorate in drinking water is a small fraction of total ex posure. Using the most reliable of the approaches EPA outlines, the RSC factor is essentially equal to one.

Response: See response to comment code 5210.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20959

EPA Comment Code: 5210

Comment: Checking some outcomes from the current EPA HRL determination exercise

-Apart from the above considerations, the EPA RSC derived from the FDA TDI study seems to correspond fairly well with the average perchlorate drinking water levels found in the U.S.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 414 of 1099 Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20961

EPA Comment Code: 5210

Comment: Additionally and apart from this, the EPA RSC has been checked against estimated average perchlorate dietary uptake via drinking water (section 3.1.)

Also the EPA HRL has been checked against the HRL obtained the conventional way but with additional available data integrated (section 3.2.)

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20964

EPA Comment Code: 5210

Comment: 1.2. The dose-response trial set-up

For clinical dose-response trials similar to the Gr eer trial, there are 3 possible trial set-ups.

1.2.1. Trial set-up type 1 leading to RSC < 1

The NOEL and therefore the RfD are based on a dose-response trial without food and without drinking water background level contribution.

Or in other words the subjects that are administer ed the doses have a perchlorate free food diet and drink purified water.

Therefore to arrive at the HRL the food backgrou nd (FBG) level in the population will have to be estimated and subtracted from the RfD(which is based on the NOEL) . Therefore the RSC < 1 i.e.

not all the RfD is attributed to DW.

Example:

Note: The examples are for illustrative purposes only. An UF of 4 is applied to allow smaller figures.

NOEL1= 10ug/kg-day. RfD1 =2.5ug/kg-day

The FBG contains 1.25 ug/kg-day (0.5 or 50% of RfD). Thus the part of the RfD attributed to DW

is 0.5 RfD or 50 % of the RfD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 415 of 1099 HRL1= maximum level of contaminant that DW should contain = [(RfD1 Ã— BW) /DWI] Ã— RSC=2.5 x70/2x0.5= 43.75 ppb.

Fig.1: NOEL based on dose-response trial without perchlorate food /drinking water background: RSC [see PDF Docket ID EPA-HQ-OW-2008-0692-1798]

1.2.2. Trial set-up type 2 leading to RSC=1

The NOEL and therefore the RfD are based on a dose-response trial with food background (FGB) and without drinking water backgrou nd (DWBG) level contribution.

Or in other words the subjects that are administer ed the doses have a food diet with perchlorate background but drink purified water.

Therefore to arrive at the HRL, the FBG level in the population is already included in the NOEL

and thus does not have to be estimated and not subtracted from the RfD. Therefore RSC = 1 or

100% i.e. all of the RfD is attributed to DW.

The effective NOEL2 is larger than the dose NOEL1.

Example: NOEL1 = 10ug/kg-day. FBG= 1.25 ug/kg-day. NOEL2 = NOEL1 + FBG=10 + 1.25 = 11.25 ug/kg-day.

RfD2 =1.125 ug/kg-day.

The food diet background as mentioned has already been accounted for.

The part of RfD2 attributed to water is 1 or 100 % of RfD2.

HRL2 = [(RfD2Ã— BW) /DWI] Ã— RSC=1.125 x70/2x1 = 39.4 ppb.

Or in other words, since NOEL1 is a dose added on top of the food background (see fig. 2) the

whole RfD is attributed to DW.

Fig. 2: NOEL based on dose-response trial with perc hlorate food background and without drinking water background: RSC = 1 [see PDF Dock et ID EPA-HQ- OW-2008-0692-1798]

1.2.3. Trial set-up type 3: RS C is arithmetically >1

The NOEL and therefore the RfD are based on a dose-response trial with food background and with drinking water background level contribution.

Or in other words the subjects that are administer ed the doses have a food diet with perchlorate background and drink already contaminated water.

Since the NOEL1 is added on top of the food background (see drawing), the whole RfD is

attributed to DW.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 416 of 1099 Now, the DW background (DWBG) itself is on top of the NOEL1 .Therefore, arithmetically, the

RSC must be <1.

Example 1: NOEL1 = 10ug/kg-day. FBG= 1.25 ug /kg-day. DWBG = 0.625 ug/kg-day. NOEL3=

NOEL1 + FBG +DWBG=10 + 1.25 +0.625 = 11.9 ug/kg-day. RfD3 =1.19 ug/kg-day.

HRL3 = [(RfD2 +DWBG) Ã— BW)/DWI] Ã— RSC= [(RfD3 Ã— BW)/DWI] Ã— RSC= (1.19 x70/2) x1 = 41.65 ppb.

Example 2: Assume perchlorate 1.5 ppb DW ba ckground and NOEL2 =0.7 ug/kg-day.

1.5 ppb background DW= 1.5 /70 x2= 0.04 ug/kg-day and HRL3 = (0.7+0.04) x 70 /2 x1 =26 ppb which arithmetically comes down to an RSC of 1.04 as 0.74x70/2 x 1.04= 26 ppb as well.

Fig. 3: NOEL based on dose-response trial with pe rchlorate food background and with drinking water background: RSC > 1 [see PDF Dock et ID EPA-HQ- OW-2008-0692-1798]

More considerations about the RSC and practical examples can be found in: http://oehha.ca.gov/water/reports/howdsot.html.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20972

EPA Comment Code: 5210

Comment: 3.1. RSC check

If the contribution from food would be 10% (see EPAâ€TMs table 8) and which is derived from the TDS study model then of the 0.04 ug /kg-day tota l average perchlorate background exposure, 0.036 ug /kg-day would come from water.

Even, as already noted above, this is low compared to the other goitrogens, it would still translate into a US average drinking water content of 1. 3 ppb (0.036 x70/2) which appears somewhat high

but still close to EPAâ€TMs data on U.S. wide DW perchlorate levels. Therefore the TDS model may be an accurate enough tool to estimate RSCs.

Response: See response to comment code 5120 for a disc ussion of the relative source contribution.

Commenter Name: Commenter Organization: Ag Council et al

EPA Document ID: EPA-HQ-OW-2008-0692-1987

EPA Comment ID: 20977

EPA Comment Code: 5210EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 417 of 1099 Comment: EPA's Calculation of the Relative Source Contribution for its Preliminary

Determination also Reveals that the Food Cont ribution is Below the Level of Concern.

The US Centers for Disease Control’s National Health and Nutrition Examination Survey (NHANES) biomonitoring data provides a sup erior measure of actual human exposure to perchlorate from all sources, including food an d water. FDA's TDS and food sampling data, which provides an approximation of human exposure to perchlorate from food, in fact validates EPA's

calculation of the relative source contribution from food.

Response: See response to comment ID 28919 under comment code 5210.

Commenter Name: Kate Sande Commenter Organization: Minnesota Department of Health , Health Risk Assessment Section

EPA Document ID: EPA-HQ-OW-2009-0297-0663

EPA Comment ID: 28703

EPA Comment Code: 5210

Comment: Relative Source Contribution (RSC) MDH acknow ledges the extensive national database of perchlorate exposure information that includes perchlorate concentrations found in food and beverages as well as biomonitoring data. We unde rstand EPA's use of the NHANES biomonitoring data to estimate the 90th percentile food dose fo r pregnant women leading to the derivation of the drinking water RSC. For infants and young children, EPA states that the RSC is based on the central tendency dietary perchlorate exposure derived fr om FDA's Total Diet Study. MDH does wonder whether an RSC based on average dietary perchl orate exposure will protect individuals who have higher dietary doses. However, EPA's RSC for ch ildren 12- months and younger (0.59) based on the central tendency exposure is not much higher than the default RSC used by MDH for infants (0.5).

MDH uses 0.2 as the relative source contribution (R SC) default value for volatile chemicals for all exposure durations. However, for non-volatile chemical s, an RSC of 0.5 is used for acute and shortterm exposure durations and 0.2 is used for subchronic and chronic exposure durations.

Response: See response to comment code 5210. EPA believe s that the central or mean estimates of dietary intake of perchlorate from the total diet st udy are the best available peer reviewed data for determining the relative source contribution.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28919

EPA Comment Code: 5210

Comment: 2) Exposure from other sources

The best evidence to date suggests that perchlorate is ubiquitous in the United States but UCMR data and other research suggest that little of this exposure is via drinking water. In addition, USEPA used the Greer et al study that used individuals who did not control or measure their exposure to perchlorate from food, a major source of perchlora te. This means that the ubiquitous background of perchlorate exposure found in the United States wa s built into the study, which was measuring theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 418 of 1099 effect of additional exposure above the background . This, along with the use of the no observed effect level (NOEL) versus no observed adverse eff ect level (NOAEL), actually makes the study more robust and has additional protection built into it. When the USEPA later uses uncertainty factors in their review, they are double-counting those factors.

The use of a relative source contribution (RSC) does not appear to be warranted in this situation. Given the very small contribution to perchlorate ex posure from drinking water , the precedent set by USEPA when they evaluated sodium was that the RSC should be ignored. It is also important to note that other more dominant goitrogens have much greater occurrence than perchlorate in drinking water.

Response: See response to comment code 5210 for a discussion of the RSC.

EPA does not believe the conditions for the sodi um regulatory determination are comparable to those for perchlorate. Dietary exposure alone do es not exceed the reference dose; however, for some people in water systems with perchlorate c ontamination the dietary exposure combined with drinking water exposure may result in a total dose th at exceeds the RfD for pe rchlorate. This is of particular concern among sensitive life stages.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 29076

EPA Comment Code: 5210

Comment: Furthermore, based upon available epidemiological and other human studies, the use of RSC is inappropriate. For these reasons, it is unlikely that modeling a compound known to form naturally and occur ubiquitously represents an a ppropriate representation of actual conditions.

Response: See response to comment code 5210.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 419 of 1099 

### EPA Comment Code: 5220 De rivation of the HRL

Response to Code 5220 : EPA has reversed its October 2008 preliminary determination not to develop an NPDWR for perchlorate and now conclude s, based on the analysis presented in today’s notice, that perchlorate meets the criteria for re gulating a contaminant in Section 1412(b)(1)(A) of SDWA. EPA has found that 1.) perchlorate may have an adverse effect on the health of persons; 2) perchlorate is known to occur or there is a substanti al likelihood that perchlorate will occur in public water systems with a frequency and at levels of public health concern; and 3) in the sole judgment of the Administrator, regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons se rved by public water systems. In proposing a national primary drinking water standard, EPA w ill seek public comments on the proposed standard, and analyses on which it is based, pursuant to SDWA requirements.

EPA has made this determination by comparing the best available data on the occurrence of perchlorate in PWSs to potential health reference levels (HRLs) for perchlorate. HRLs are not final

determinations about the level of a contaminant in drinking water that is necessary to protect any particular population. Rather they are benchmarks against which EPA comp ares the concentration of a contaminant found in public water systems to determine if it is at levels of public health

concern.

In the October 2008 preliminary regulatory deter mination, EPA had derived a single HRL of 15 μg/L based upon the RfD, an estimate of perchlor ate exposure from food for pregnant women, and traditional adult body weight (70 kg) and drinking water consumption (2 L/day) values. This single HRL was derived to reflect exposure to a pregnant woman and her fetus, which the NRC identified as “the most sensitive population.”

Since the NRC also identified infants and developi ng children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information in the August 9, 2009, noti ce (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perc hlorate in drinking water that may result in total perchlorate exposures (from food an d water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their

cohorts.

EPA is evaluating these potential alternative HRLs an d considers them to be levels of public health concern for purposes of this determination. EPA has compared these values to the data provided by PWSs subject to the first Unregulated Contaminan t Monitoring Rule (UCMR 1). EPA collected and analyzed drinking water occurrence data for pe rchlorate from 3,865 PWSs between 2001 and 2005 under the UCMR 1. The minimum reporting level (MRL) for perchlorate under the UCMR 1 was 4

μ g/L.

EPA found that 160 (approximately 4.1 percent) of the 3,865 PWSs that sampled and reported had at least 1 analytical detection of perchlorate (in at least 1 sampling point) at levels greater than or equal to the MRL of 4 μg/L. Table 1 of today's no tice presents the number and percentage of PWSsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 420 of 1099 that reported perchlorate at levels exceeding va rious threshold concentrations. Note that the MRL for perchlorate under the UCMR 1 was 4 μg/L.

Given the range of potential alternative HRLs, EPA has reversed its October 2008 preliminary determination not to regulate perchlorate in drinking water. Based on the data in Table 1 and the range of potential alternative HRLs, EPA has deter mined that perchlorate is known to occur or

there is a substantial likelihood that it will occur with a frequency and at levels of public health

concern.

Table 2 of today’s notice presen ts EPA’s estimates of the population served by PWSs that were monitored under UCMR 1 for which the highest reported perchlorate concentration was greater

than the thresholds identified in Table 1. These population estimates are for people at all life stages. EPA has determined that a NPDWR for perchlora te could reduce perchlorate exposures for these populations to levels below the potential alternative HR Ls that EPA has identified as levels of public health concerns for purposes of this determina tion, and that such exposure reductions present a meaningful opportunity for the reduction of heal th risks for persons served by PWSs.

Individual Comments

Commenter Name: Apparent Mass Mailing #2 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19690

EPA Comment Code: 5220

Comment: The maximum safe level for perchlorate in drinking water is now 15 times higher than

what the EPA declared safe in 2002. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water

in 35 states in the U.S.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Apparent Mass Mailing #2 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19690

EPA Comment Code: 5220

Comment: The maximum safe level for perchlorate in drinking water is now 15 times higher than

what the EPA declared safe in 2002. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water

in 35 states in the U.S.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: A. Lane Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0276

EPA Comment ID: 19781EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 421 of 1099 EPA Comment Code: 5220

Comment: According to the EPA’s own data, 16 million Am ericans are at risk of being exposed to Perchlorate. The maximum safe level for perchlora te in drinking water is now 15 times higher than

what the EPA declared safe in 2002.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0422

EPA Comment ID: 19873

EPA Comment Code: 5220

Comment: Please follow our own Environmental Protection Agency's recommendations for levels of perchlorate allowed in drinking water, set in 2002. Thank you.

Response: EPA's 2002 draft risk assessment was revi sed based upon the 2005 National Research Council's (NRC) recommendations. EPA has developed potential health reference levels (HRLs) for perchlorate for purposes of this regulatory deter mination. HRLs are not final determinations about the level of a contaminant in drinking water that is necessary to protect any particular population. Rather they are benchmarks against which EPA co mpares the concentration of a contaminant found in public water systems to determine if it is at levels of public health concern. See response to comment codes 5220 and 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0475

EPA Comment ID: 19903

EPA Comment Code: 5220

Comment: The maximum safe level for perchlorate in drinking water is now 15 times higher than

what the EPA declared safe in 2002. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water

in 35 states in the U.S.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: S. G. Gompf Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0490

EPA Comment ID: 19911

EPA Comment Code: 5220

Comment: Since 2002, the EPA's maximum safe level for perchlorate in drinking water raised 15- fold! Why was the bar lowered? As an American mother and a physician, I have to question why theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 422 of 1099 EPA appears to be acting against the interests of its constituents in thismatter, and whether the EPA is acting in the interest of hidden benefactors in industry.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0493

EPA Comment ID: 19915

EPA Comment Code: 5220

Comment: Millions of Americans in over 35 states are exposed to this chemical as maximum safe level for perchlorate in drinking water is now 15 times higher than what the EPA declared safe in

2002. PSR 2008.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: A. L. Segall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0506

EPA Comment ID: 19926

EPA Comment Code: 5220

Comment: I understand that the amount of perchlorate in our drinking water is now 15 times the amount that the government determined was safe in 2002. It seems clear that we should not allow such a large amount of this chemical to be in our drinking water.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0525

EPA Comment ID: 19938

EPA Comment Code: 5220

Comment: Please renew the 2002 EPA Standards concerning Perchlorate. It is in the Nations best

interest.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: K. Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0646

EPA Comment ID: 19989

EPA Comment Code: 5220

Comment: It is unacceptable that the maximum safe leve l for perchlorate in drinking water is now 15 times higher than what the EPA declared safe in 2002. How does that happen? This is a hugeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 423 of 1099 defeat for the environment and for public health; it would be laughable if it wasn't such a serious

issue.

As the Environmental Protection Agency, you are supposed to be protecting the environment and public health. If you are going to raise your "maximum safe level" for perchlorate, why don't you just go ahead and change your name to the Che mical Companies' Protection Agency? That would be a much more suitable monkier for the actions you are taking.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20279

EPA Comment Code: 5220

Comment: REVIEW OF THE NAS REPORT AND SUBSEQUENT PEER-REVIEWED

STUDIES AFFIRMS USE OF THE RfD AS THE HEALTH REFERENCE LEVEL

EPA must often make important decisions on the basis of less information than it would wish; and perchlorate is a welcome exception.

There is extensive scientific literature, most notab ly a comprehensive, authoritative review of the range of peer-reviewed studies by the Nationa l Research Council of the National Academy of Sciences (NAS). The success of EPA, along with ot her agencies, in obtaining this review has put the Agency in an unusually well-informed position, back ed by the deliberations and judgment of the nation’s highest scientific body. The NAS Report, followed by the Agency’s own RfD process, is supplemented by subsequent, peer-reviewed studies. Taken together, these comprise a solid basis for an EPA regulatory determination.

EPA’s RfD is the best health benchmark to use as the health reference level (HRL). EPA concurred with the conclusion of the NAS panel in the ad option of the panel’s recommendation as EPA’s RfD. This RfD is based on the NAS panel’s emphati cally conservative approach of establishing the point of departure at the No Observed Effect Level (NOEL), rather than EPA’s customary No Observed Adverse Effect Level (NOAEL). Consisten t with EPA’s design for RfDs, the NAS panel selected its recommended RfD to be protective of all sensitive populations. Subsequent peerreviewed studies affirm and reinforce the conclusion that the RfD is a conservative, health protective value that protects all members of society, even the most sensitive population.

Further discussion of these studies and our comment s is contained in Attachment 1 [See PDF of docket ID EPA-HQ-OW-2007-0068-0168].

Response: EPA is utilizing the RfD to derive potential alternative health reference levels and evaluate the opportunity for health risk reduction through a drinking water regulation for perchlorate. See response to comment code 5220.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental ProtectionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 424 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20431

EPA Comment Code: 5220

Comment: 2. EPA’s HRL Is Not Sufficiently Health Pr otective. MassDEP continues to believe that EPA’s Reference Dose (RfD) and the associated Heal th Reference evel (HRL) for drinking water for perchlorate are insufficiently health protective of neonatal exposures. There is compelling evidence to support a national drinking water standard for perchlorate at a value well below EPA’s HRL of 15 ppb.

* Literature publications (Zoeller and Rice, 2004; Zoeller, 2006; Ginsberg et al., 2007) and state agency risk assessments (MassDEP, 2006; CA, 20 04) support a more health protective RfD and drinking water value. EPA’s HRL of 15 ppb is 7. 5 times higher than MassDEP’s drinking water standard of 2 ppb and 2.5 times higher than Ca lifornia’s standard of 6 ppb. EPA’s evaluation

includes no discussion of these alternative assessm ents. * The results of Blount et al (2006) and Steinmaus et al (2007) demonstrate thyroid effects associated with a dose of 0.06 ug/kg/day in
iodide insufficient women, which is well below, and calls into question the protectiveness of, EPA’s RfD of 0.7 ug/kg/day. * Although acknowledged in EPA’s evaluation, potential interactive effects between thiocyanate, a metabolite of cyanide found in tobacco smoke and some common foods, and perchlorate, were not accounted for. Such in teractions heighten concern regarding perchlorate induced thyroid hormone effects in women with se rum iodine levels < 100 ug/L. * Use of a more appropriate and health protective RfD would lower the acceptable drinking water limit for perchlorate, resulting in a substantial increase in the total number of citizens exposed to unacceptably high levels of this toxicant from drinking water. This would clearly create a "meaningful opportunity for health risk reduction" through a national perchlorate drinking water regulation under the Safe Water Drinking Act.

Response: See response to comment code 5220.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20432

EPA Comment Code: 5220

Comment: 3. Infant Exposures at the HRL Exceed EP A’s Insufficiently Protective RfD. EPA’s calculations (Table 8, Federal Register publication) demonstrate that perchlorate intake by nursing and bottle-fed infants and children to 2 years of ag e, attributable to the consumption of drinking water at 15 ug/L (and not even considering othe r dietary sources of exposure) would substantially exceed EPA’s insufficiently health protective RfD value. Based on EPA’s own calculations, a bottlefed infant would receive a dose of perchlorate 5 times higher than EPA’s RfD and 50 times higher

than MassDEP’s RfD. Consistent with EPA’s assessm ent, in a study conducted in Texas Dasgupta et al. (2008) also showed that the majority the infants (9 out 13 infants) in their study ingested perchlorate at a level that exceeds the EPA referen ce dose. Furthermore, this study indicates that breast milk iodide concentrations decrease as perc hlorate levels increase in breast milk (Dasgupta et al., 2008), potentially raising risks to nursing infa nts. Due to potential impacts on children’s health, this data alone justifies the establishment of a lower, more appropriately health protective HRL for perchlorate. By discounting this information in the evaluation, EPA is de facto adopting an evenEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 425 of 1099 higher, less protective RfD for these sensitive subgroups. EPA’s explanation for discounting these findings- that the model’s predicted iodide uptake inhibition (IUI) level at 15 ppb would be insignificant- is unjustified for at least three reasons.

a. The predicted IUI in these groups is very uncertain due to model limitations.

b. Although EPA indicates that iodide uptake i nhibition of 2.2% is non- adverse, no objective data exists to support this determination and no objective sa fe level of IUI, especially in the neonate, has been established. In fact, the Blount et al. (2006) and Steinamus et al. (2007) studies indicate that 2.6 ug/L of urinary perchlorate (which equates to an approximate dose level of 0.06 ug/kg/d in iodine

deficient women was associated with decreased T4 and increased TSH levels, consistent with the mode of action of perchlorate. Iodide uptake inhibi tion at this dose level would be predicted by the model to be very small suggesting either that the mo del is inaccurate; the effect is not solely due to

IUI or low levels of IUI are adverse.

c. Allowing up to 2.2% iodine uptake inhi bition also exceeds NRC’s hypothesized non-adverse effect level of 1.8% IUI (NRC, 2005) although 1.8% IUI is considered an adverse effect level by many scientists (US EPA 2002; Ginsberg and Rice, 2005; and MassDEP, 2006).

Response: See response to comment code 5220 for a di scussion of the alternative Health Reference Levels. Regarding the predictions of iodide uptake inhibition Physiologically-Based Pharmacokinetic (PBPK) Modeling , EPA reviewed, modified, and applied the perchlorate PBPK models, which were originally developed by Merrill et al. (2005) for adults and Clewell et al. (2007) for other life stages, to estimate the iodide uptake inhibition in the thyroid for each life-stage (73 FR 60262; USEPA 2008a). Estimated ingestion rates were then used to estimate the internal dose and resulting iodide uptake inhibition for several life stages, including susceptible populations (e.g., pregnant women and their fetuses, as well as breast-fed and bottle-fed infants).

In the August 2009 notice, EPA stated that it was re-evaluating how best to incorporate the PBPK modeling analysis into its evaluation of perchlora te- if at all. The Agency sought comments on ways to use the PBPK modeling analysis to inform the regulatory determination.

Several commenters support the use of the PBPK model to inform the regulatory determination only if the significant limitations of the current model are addressed. For example, the inability of the model to reflect iodide nutritional status was cited by commenters and three of the four peer reviewers as an important limitation. Also, several commenters stated that the risks to breast-fed infants and young children are not adequately addre ssed. They challenged that the modeling analysis is based on average weight infants and healthy adults , while the sensitive life stages for perchlorate include premature infants and hypothyroid women.

After further consideration of the peer review and public comments, EPA concludes that the PBPK modeling analysis, in the context of the perchlorat e regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman.

The model also allows for the estimation of the co ncentration of perchlorate in breast milk (thus breast-fed infant exposure) at various maternal pe rchlorate exposure levels. However, because of the stated limitations, EPA has decided the model does not directly bear on the current decisionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 426 of 1099 regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20449

EPA Comment Code: 5220

Comment: Further, it is our opinion that the informati on provided in the proposal indicates that 15 ug/L is not a health protective drinking water c oncentration, and that the HRL should be set at a lower level that is protective of public health for all exposed subpopulations. A primary concern is that the exposure and health risks of bottle-fed infants, as predicted by the PBPK model, are ignored in the proposal. The PBPK model predicts th at when the perchlorate concentration in water used to prepare formula is 15 ug/L, 7-day and 60- day old bottle-fed infants are exposed to more than 5 times the RfD, and that iodide uptake in 7-day old infants is decreased by 2.2% (Table 8). Even if the model were to use the median rather than the 90th percentile water intake, the RfD would be greatly exceeded. The model also predicts that a breast-fed infant would be exposed to more than twice the RfD from perchlorate in the mother’s milk due to maternal ingestion of water contaminated with 15 ug/L perchlorate. The weane d 6-12 month old is predicted to be exposed to

almost 3 times the RfD when water with 15 ug/L perchlorate is used to prepare fluids and foods.

Response: See response to comment code 5220 and response to comment ID 20432 under

comment code 5220.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20451

EPA Comment Code: 5220

Comment: Decision not to regulate perchlorate ba sed on population exposed above the HRL

The estimation of the number of people exposed to pe rchlorate at a level of public health concern in public drinking water is determined by the perchlor ate concentration chosen as the HRL. Setting an HRL at an inappropriately high concentration, 15 ug/L, greatly reduces the size of the population predicted to be exposed at a level of public he alth concern. Table 2 of the proposal shows that approximately 2 million people (in 0.8% of systems) or, alternatively, an estimated 0.9 million people served by 0.29% of points-of-entry (POEs) are exposed at or above an HRL of 15 ug/L. USEPA states that this number of people is not sufficien t to warrant regulation. However, if the level were to be set at 5 ug/L, for example (a concentrati on that still would result in bottle-fed infants being exposed slightly above the Reference Dose, based on the exposure assumptions in Table 8), 5 to 7 times more individuals would be exposed abov e the HRL than at 15 ug/L: 14.6 million people (3.2% of systems) or 4 million people served by 1.9% of POEs would be exposed above 5 ug/L. Therefore, by setting the drinking water concentration higher than it should be from a health viewpoint, USEPA has also significantly minimized the need for regulation of perchlorate from an occurrence viewpoint.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 427 of 1099 Response: See response to comment code 5220.

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20459

EPA Comment Code: 5220

Comment: * Roughly, 17% of reproductive-aged women in the United States are especially susceptible to perchlorate toxicity due to inadequate dietary intake of iodine and are susceptible to hypothyroxinemia and hypothyroisism during pregnancy. There is a possibility that some women in the child-bearing age in the United States are getti ng less than the recommended daily iodide intake

level.

* Iodine deficiency during early pregnancy may ca use irreversible neurodevelopmental deficits in offspring.

* Exposure to perchlorate is likely to furthe r reduce iodide uptake by the thyroid.

* As many as 350,000 pregnant women within the United States may be exposed at any given time to perchlorate levels considered unsafe.

Because there is uncertainty regarding our unders tanding of perchlorate toxicity, exposure, and presence in the environment, a cautious approach for protecting sensitive populations should be taken. The department concludes that EPA’s health reference level is not adequately protective of the health of sensitive subpopulations and the de termination that a meaningful opportunity for risk reduction through the regulation of perchlorate in drinking water is not supported from a public health perspective.

Response: See response to comment code 5220.

Commenter Name: Denise F. Sipple Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1621

EPA Comment ID: 20548

EPA Comment Code: 5220

Comment: Many experts disagree with your assessment that drinking water with 15 parts per billion of perchlorate is safe and acceptable. Scientis ts from the California Environmental Protection Agency and the Massachusetts Department of Envi ronmental Protection have set stricter standards to will ensure that the most vulnerable populations -- pregnant women, infants, and small children -- are protected from the advers e impacts of perchlorate.

EPA's analysis fails to consider that the comb ination of food and drinking water exposure to perchlorate in the U.S. population exceeds the refere nce dose set by EPA. Nor does it incorporate the more protective methodology behind the recent state regulatory actions. These flaws must beEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 428 of 1099 remedied for the sake of the millions of U.S. fa milies exposed to dangerous levels of perchlorate

contamination.

Thank you and God Bless.

Response: See response to comment code 5220.

Commenter Name: Dick Wilson Commenter Organization: Anaheim Public Utilities Department

EPA Document ID: EPA-HQ-OW-2008-0692-1530

EPA Comment ID: 20556

EPA Comment Code: 5220

Comment: Dear US EPA,

As a community water system in the State of California, Anaheim Public Utilities believes that continuing the process for establishing a drinki ng water standard for perchlorate would fall well within SDWA guidelines. Although the Preliminary Regulatory Determination on Perchlorate finds that a health reference level of 15 ug/l appears to be a reasonable estimate for a potential drinking
water standard, the States of California and Massach usetts have established drinking water standards for perchlorate at much lower levels. Therefore, we conclude that there is ample evidence that the actual level of public health concern for perchlorate is truly much lower than the health reference level mentioned in the Preliminary Regulatory Determination.

Thank you for your consideration of this comment. Sincerely,

Dick Wilson Environmental Services Manager An aheim Public Utilities De partment 714-765-4277 dwilson@anaheim.net

Response: See response to comment code 5220.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20648

EPA Comment Code: 5220

Comment: IV (B), p 60275. The formula used to calcula te the health risk level for perchlorate uses the default body weight for an adult male, and de fault drinking water consumption of 2 L/day. Recent EPA exposure assessment guidance (U.S. EPA, 2004) recommends using exposure data more relevant to the actual persons at risk . OEHHA has accepted that guidance in its risk assessments and is disappointed that EPA itself has not. Specifically, since the greatest risk of exposure to perchlorate appears to be in pregnant women and in infants, we believe that body weights and drinking water consumption values whic h are fully protective of these groups should be utilized in this risk assessment. The upper 95th pe rcentile drinking water consumption rates appear to us to be adequately protective. Applying this health-protective value to the EPA reference dose of 0.7 ug/kg-day and relative source contri bution of 0.62 yields the following:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 429 of 1099 Pregnant women: (0.0007 mg/kg-day x 0.62) / 0.055 L/kg-day = 0.008 mg/L

For infants, the comparable calculation is more complicated, because the reference dose of 0.7 ug/kg-day was calculated for an adult, as was th e relative source contribution. However, if those values were retained, the following result is obtained:

Infants: (0.0007 mg/kg-day x 0.62) / 0.221 L/kg-day = 0.002 mg/L

If the starting point for calculation of the Rf D were the BMDL of 0.0037 mg/kg- day, these numbers would be correspondingly lower, although again, a health- protective dose and relative source contribution for infants should be calculated separately. It seems to us that numbers in this range should be being used in making the decision wh ether or not to regulate perchlorate in drinking

water.

IV (B)(3), p 60277. Table 7, Health Reference Le vels for Pregnant Women. We are concerned that

EPA continues to use the obsolete default values of 70 kg for body weight and 2 L/day of water consumption when these values certainly do not apply to pregnant women. These defaults are specifically intended for the population in general, and should be superseded by more specific and appropriate values when a risk assessment is being conducted for a defined subpopulation (U.S. EPA, 2004, 2005).

Response: See response to comment code 5220.

Commenter Name: Tim Cranford Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1896

EPA Comment ID: 20781

EPA Comment Code: 5220

Comment: Perchlorate has been linked to thyroid problems in vulnerable segments of our population, such as newborns, pregnant women and youn g children. The current "safe" levels of this chemical for drinking water is now set at so me 15 times higher than was set in 2002.

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1983

EPA Comment ID: 20821

EPA Comment Code: 5220

Comment: The facts are that the maximum safe level for perchlorate in drinking water is now 15 times higher than what was declared safe in 20 02. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Amer icans at risk. Perchlorate has been found in the drinking water in 35 states in the U.S.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 430 of 1099 Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Lee Walsh Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1997

EPA Comment ID: 20832

EPA Comment Code: 5220

Comment: It is absolutely outrageous that the allowable level of known toxin Perchlorate be increased by 1500% in the drinki ng water of the American people. At what benefit? What purpose can this possibly serve, to deliberately poison our own people?

Lee Walsh Albuquerque, NM

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Mary Moore Commenter Organization: Lindon Park Neighborhood Association (LPNA)

EPA Document ID: EPA-HQ-OW-2008-0692-2002

EPA Comment ID: 20834

EPA Comment Code: 5220

Comment: A more thorough investigation of the po tential impact of perchorlate on fetuses, children and women seems appropriate. Even the model currently employed by EPA appears to propose a health reference level that exposes young children to perchlorate levels above the

reference dose.

Response: See response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20915

EPA Comment Code: 5220

Comment: EPA’s flawed assessment still finds that millions of people are exposed to potentially harmful levels of perchlorate: EPA’s assessment is fundamentally flawed for the reasons described above. In this assessment, EPA determines that 15 ug/L (15 ppb) is an appropriate health reference level (HRL); this number was arrived at, in part, by using data from the unpublished study that was just described in the preceding section of this document. It should be noted that in the Blount study, women with lower iodine levels who had exposure to perchlorate in drinking water as low as 2 ppb had an associated 11% decrease in thyroid hormone levels (Blount et al. 2006b). It is clear that the EPA HRL is not protective of public health since levels of perchlorate exposure far below 15 ug/L result in significant changes in thyroid hormone levels.

Response: See response to comment code 5220.

Commenter Name: Caroline Baier-Anderson, PhDEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 431 of 1099 Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20951

EPA Comment Code: 5220

Comment: EPA concludes that a health risk level (HRL ) of 15 ug/L would be adequate to protect public health. We strongly disagree. As documented in the previous sections, the HRL is based on a flawed reference dose, and does not adequately take into account either the role of individual variability or iodine status factors that recent stud ies have demonstrated play a critical role in determining an individual's response to perchlorat e. When combined with what is known about the biology of thyroid homeostasis and the increased sens itivity of the fetus and neonate, it is clear that the HRL will not adequately protect sensitive subpopulations in the US.

Response: See response to comment code 5220.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20953

EPA Comment Code: 5220

Comment: Determining the number of facilities where pe rchlorate concentrati ons exceed a healthprotective level depends on the selection of a health-pro tective level; as a result of this circular logic,

if the health risk level is under- protective, then a smaller number of facilities will be identified. A lower, more protective health risk level will identi fy a larger number of facilities, and therefore exposed individual. As we have documented in the previous sections, the health risk level selected by EPA is not adequate to protect sensitive subpopulations. Hence, EPA underestimates the number of facilities that are supplying pe rchlorate-contaminated drinking water.

Response: See response to comment code 5220.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20956

EPA Comment Code: 5220

Comment: Summary

1. When to apply a RSC and when not

Applying a RSC when determining the HRL for perchl orate is not justified as the NOEL found thru the clinical dose-response trial on which the HRL is based already incorporates a RSC thru the background level that was present.

Response: See response to comment code 5210.

Commenter Name: Herwig OpdebeeckEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 432 of 1099 Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20958

EPA Comment Code: 5220

Comment: -Consequently, to be health protective, a join t DW HRL of nitrate and perchlorate of 45 ppb total perchlorate equivalent should be proposed.

-If for nitrate the same UF=10 would be applied as for perchlorate, the HRL for perchlorate alone, after subtraction of this adjusted nitrate MCL wo uld be 26.7 ppb which is close to the 27 ppb derived from the total perchlorate equivalent Rf D when attributing a 40% share of nitrate plus thiocyanate in this goitrogenic background conform with the NHANES data. It is also close to the current EPA DWEL of 24.5 ppb.

Consequently those 2 alternative data based appr oaches seem to confirm once more the NRS RfD

and the current EPA DWEL based on a RSC of 1.

Response: While EPA acknowledges that nitrate and th iocyanate have the same mode of action as perchlorate, and that the effects of combined expo sure to perchlorate, nitrate, and thiocyanate are
additive, EPA does not believe there are sufficient scientific data currently available to assess and

characterize the combined risk of these contam inants. EPA has committed to a drinking water strategy that outlines four principles to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchlor ate should be further delayed. Therefore, EPA is developing a proposed rule for perchlorate. Once the perchlorate standard is promulgated, EPA is required to review and revise, as appropriate, its dr inking water standards at least every six years. Any revision must at least maintain or improve public health protection. When there are sufficient

scientific data to assess the cumulative risks of perchlorate and other contaminants, EPA will review this information to evaluate whether any revisions of NPDWRs are appropriate.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20960

EPA Comment Code: 5220

Comment: -Also the PBPK model used by EPA arrives at a HRL that closely matches the one obtained by using the total perchlorate equi valent level and applying an RSC =1.

Because food exposure data and other relevant variables were recently available including for the most sensitive subpopulations, EPA chose to use a refined approach rather than EPAâ€TMs former "default" approach to estimate the RSC leading to the HRL. However it may be useful to compare this HRL and the HRL that would have been obtained by using the former "default" RSC approach particularly when adding additional considerations and evidence not taken into account neither by the former not by the latter approach.

Response: See response to comment code 5220 for a desc ription of the potential alternative HRLs

and comment code 5210 for a discussion of the RSC.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 433 of 1099 Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20962

EPA Comment Code: 5220

Comment: 1. Determination of HRL applying an RSC or not

1.1. Introduction

(Note: from hereon we specify the NOEL, RfD and HRL as NOEL1,NOEL2 ,NOEL3 and NOEL4 ;RfD1,RfD2 ,RfD3 and RfD4 ;HRL1 , HRL2, HRL3 and HRL4 according to their subsequent specific meanings in this comment while with NOEL, RfD and HRL is meant their general meaning).

EPA bases its HRL for DW (drinking water) on the NRC (National Research Council) RfD (Reference Dose, 0.7ug/kg-day) according to the following equation:

HRL = [(RfD Ã— BW)/DWI] Ã— RSC with BW= Body weight = 70 kg and DWl = drinking
water daily intake in litres.

Response: No response necessary to this summary of EPA information.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20966

EPA Comment Code: 5220

Comment: 2. The very particular case of perchlorate

Two particular considerations should be taken into account in determining a "state of the art" HRL for perchlorate besides the fact that the RSC should be equal to 1 and the fact that the full effective

NOEL and RfD should be taken into account.

A. The background is known for perchlorate

To our knowledge this is the first time that ba ckground data are available that would allow to calculate an effective NO(A)EL for a contaminant for which a RSC is not needed to set a HRL.

Using the data and regression curves presented in Blount et al., (2006,b) (2) the average urinary perchlorate level of 2.84 ug/l (with a 95% confiden ce interval of 2.54-3.18 ug/l) translates into an average exposure or total background( food +DW) of around 0.04 ug /kg-day (which is 17times lower than the 0.7 ug /kg-day RfD).

The estimation of the effective Greer NOEL (NOE L3) is therefore still ? NOEL1 ? Âμg /kg-day.

At first sight this is reassuring as it does not ma tter much if the backgrou nd perchlorate would beEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 434 of 1099 taken into account or not or whether the backgr ound food perchlorate level would have been subtracted already or not since NOEL3 is almost equal to NOEL1 meaning that also HRL3 would be almost identical to the HRL1 of 24.5 ppb.

It also shows that perchlorate background levels (food +DW) in the U.S. population are very low to start with as they represent only around 0.5 %( = 0.04/7) of the effective perchlorate NOEL3 and apparent perchlorate NOEL1 and 5% of the RfD.

Yet there is more to be considered.

Response: See response to comment code 5210 for a discussion of the RSC and comment code 5220 for a discussion of the potential alternative HRLs.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20969

EPA Comment Code: 5220

Comment: Yet, surprisingly, even though EPA refers to those goitrogens when discussing the Blount et al., (2006b) (2) biomonitoring study it do es not take into account the available data that would allow it to significantly refine the RfD and the corresponding HRL.

If EPA would have done so, EPA would have fo und that the background level of the other goitrogens are, as noted, much more important than the one of perchlorate itself and should therefore been taken into consideration a priory. As mentioned the total perchlorate equivalent RfD should have been 1.28 ug/kg-day and the old DWEL of 24.5 ppb should be replaced by one of around 45 ppb for [perchlorate +nitrate /240].

The current MCL for nitrate is 44 ppm (10 ppm as nitrate) which translates into a 183 ppb perchlorate equivalent (44,000/240).

For Methemoglobinemia on which the nitrate MCL was based, a RSC of 1 and a UF of 1 was applied. A RSC of 1 was justified as explained abov e however an UF of 1 may, as suggested by CDC (9), or may not have been justified .However for nitr ate to be as health protective for iodine uptake inhibition as the perchlorate RfD the same UF as perchlorate should have been applied when assuming that 44 ppm is a NOEL. On the contrary most probably 44 ppm is already above the NOEL (10).

In that case the new nitrate MCL would have an equivalent of 18.3 ppb perchlorate. This would then leave a HRL of 45 -18.3 = 26.7 ppb for perchl orate alone which, by the way, is close to the current EPA DWEL of 24.5 ppb.

Response: See response to comment ID 20958 under comment code 5220.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 435 of 1099 EPA Comment ID: 20971

EPA Comment Code: 5220

Comment: 3. A few checks of the current EPA approach in setting a HRL

As noted before, when, because of the trial set-up, the dose that allowed to determine a NOEL (or NOAEL) was not complementary to a background dietary level, the application of an RSC< 1 is necessary to come to a HRL for water only.

In that case most of the time a default RSC is use d because of lack of more precise data. This makes the RSC an imprecise tool .Therefore a data based estimate such as the FDA TDS model used by FDA would, while still a model, have been an improvement.

However, as explained, trying to derive a HRL from the perchlorate RfD, applying an RSC<1 is not justified since the food contribution was already taken care of.

Yet the data on the perchlorate background and the total equivalent perchlorate background can be

used to check the RSC based on the FDA TDS model and to check the EPA HRL based on the

PBPK model

Response: See response to comment code 5210.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20973

EPA Comment Code: 5220

Comment: 3.2. HRL check

For the most sensitive population, as designa ted by EPA, and assuming a same nitrate and thiocyanate background intake as the Greer cohort , the perchlorate food dose for the highest 10% of this population segment is 0.26 ug/kg-day(see EPA table 6).

The (new) RfD that remains for DW would then be : 0.77-0.26 = 0.51 ug/kg-day which leads to a DW HRL of 17.8 ppb (0.51x70/2) which is close to the 15 ppb found by EPA for this sensitive

group.

(1) Greer, M.A., G. Goodman, R.C. Pleuss, and S.E. Greer. Health effect assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodide uptake in humans. Environ Health Pers pect. 2002. Vol. 110. pp. 927-937

(2) Blount, B.C., J.L. Pirkle, J.D. Osterloh, L. Valentin-Blasini, and K.L. Caldwell. Urinary perchlorate and thyroid hormone levels in adolesce nt and adult men and women living in the United States. Environmental Health Perspectives. 2 006b. Vol. 114, No. 12. pp. 1865-1871.

(3) EPA, Office of Water , Office of Science an d Technology, Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (EPA-822-B-00-004), 2000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 436 of 1099 (4) Tonacchera M., Pinchera A., Dimida A., Ferrarini E., Agretti P., Vitti P., Santini F., Crump K., Gibbs J. Relative Potencies and additivity of perc hlorate, thiocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the hu man sodium iodide symporter. Thyroid 14: 1012-

1019. 2004.

De Groef B., Decallonne BR., Van der Geyten S., Darras VM., Bouillon R. Perchlorate versus other environmental sodium/iodide symporter inhibitors : potential thyroid-related health effects. European Journal of Endocri nology. 2006, 155: 17-25.

(5) Cardoso A. P., Ernesto M., Nicala D., Miri one E., Chavane L., Nâ€TMzwalo H., Chikumba S., Cliff J., Mabota A. P. , Haque M. R., Bradbury J. H. Combination of cassava flour cyanide and urinary thiocyanate measurements of school childre n in Mozambique. International Journal of Food Sciences and Nutrition. May 2004. Volume 55, Number 3, 183-190

(6)Smith R. G., Malcom R. M. Urinary sulphur and thiocyanate excretion in cyanide poisoning. American Society for Pharmacology and Experimental Therapeutics. Journal of Pharmacology And Experimental Therapeutics. 1930. Vol. 40, Issue 4, 457-471, http://jpet.aspetjournals.org/cgi/content/abstract/40/4/457

(7) Florin T. H. J., Neale G., Cummings J. H. Th e effect of dietary nitra te on nitrate and nitrite excretion in man. MRC Dunn Clinical Nutrition Centre, 100 Tennis Court Road, Cambridge CB2 IQL. Addenbrooke's Hospital, Hills Road, Camb ridge CB2 2QQ. (Received 5 September 1989 - Accepted 11 May 1990.

(8) Vermeer I. T. M., Pachen D. M. F. A., Dallinga J. W. , Kleinjans J. C. S, van Maanen J. M. S.

Volatile N-Nitrosamine Formation after Intake of Nitrate at the ADI Level in Combination with an Amine-rich Diet. Department of Health Risk Anal ysis and Toxicology, Maastricht University, The Netherlands. Environmental Health Perspectives. August 1998. Volume 106, Number 8.

(9) Manassaram D.M., Backer L. C., Moll D. M. A Review of Nitrates in Drinking Water: Maternal Exposure and Adverse Reproductive and Develo pmental Outcomes. Centers for Disease Control
and Prevention, National Center for Environmental He lath, Health Sudies Branch, Atlanta, Georgia, USA. Environmental Health Perspectives. March 2006. Volume 114, number 3.

(10) TAJTAKOVA M.; SEMANOVA Z., TO MKOVA Z., SZÃ–KEOVA E., MAJOROS J., RADIKOVA Z., SEBÃ–KOVA E., KLIMES I., LANGER P. Increased thyroid volume and frequency of thyroid disorders signs in schoolch ildren from nitrate polluted area. Chemosphere, ISSN 0045-6535 CODEN CMSHAF. 2006, vol. 62, no4, pp. 559-564 [6 page(s) (article)] (18 ref.).

RADIKOVA Z., TAJTAKOVA M., KOCAN A., TRNOVEC T., SEBÃ–KOVA E., KLIMES I.,

LANGER P. Possible Effects of Environmental Nitrates and Toxic Organochlorines on Human Thyroid in Highly Polluted Areas in Slovakia. Th yroid ISSN 1050-7256. 2008, vol. 18, no3, pp. 353- 362 [10 page(s) (article)].

Response: See response to comment ID 20958 under comment code 5220.

Commenter Name: Jennifer Sass, PhD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 437 of 1099 Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20985

EPA Comment Code: 5220

Comment: In simple terms, the HRL is the maximum contamination level of perchlorate that could be in drinking water, and still keep daily human consumption levels from exceeding the RfD of 0.7 ug/kg/day. EPA reports that for pregnant women, exposure to pe rchlorate from food is 0.263 ug/kg/day at the 90th percentile (based on data fr om a national food survey), representing nearly 38% of the RfD, thus leaving an RSC (Relativ e Source Contribution) for water of 62% (FR at 60276). This is equivalent to 0.437 ug/kg/day fr om water, assuming an average body weight of 70 kg, and a daily water consumption of 2 L (90th pe rcentile adult water consumption). That is, 0.437 ug x 70 kg body wt. = 30.6 ug perchlorate in 2 L (the daily consumption amount). This is 15 ug/L, or 15 ppb, the HRL.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21007

EPA Comment Code: 5220

Comment: However, even if EPA proceeds with its d etermination not to regulate perchlorate and instead finalizes an HRL, that level must be adjust ed to account for the actual data from the PBPK model showing that hundreds of thousands of infant s would exceed the safe daily perchlorate intake levels at the proposed HRL.

These comments are respectfully submitted for your consideration,

Jennifer Sass, Ph.D. Mae Wu, JD

COMMENTS SUPPORTED BY THE FOLLOWING:

Center for Public Environmental Oversight a proj ect of the Pacific Studie s Center Lenny Siegel,
Executive Director Mountain View, CA

Citizens for Safe Water Around Badger La ura Olah, Executive Director Merrimac, WI

Clean New York Bobbi Chase Wilding, Or ganizing Director Schenectady, NY

Concerned Citizens of the Plainview-Old Bethpa ge Community Inc. Carol Meschkow, President
Plainview, New York

Environmental Health Fund Judith Robinson, Di rector of Programs Jamaica Plain, Boston

Greenpeace Rick Hind Washington, DCEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 438 of 1099 Institute for Agriculture and Trade Policy David Wallinga, MD Minneapolis, MN

Natural Resources Council of Maine Matt Prindiv ille, Project Director Toxics and Sustainable
Production Maine, USA

Physicians for Social Responsibility Evan Krasner, MD, Executive Director SF Bay Area Chapter

ScienceCorps Kathy Burns, Ph.D. Boston, MA

Response: See response to comment code 5220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21058

EPA Comment Code: 5220

Comment: The EPA has determined that setting a NPDWR will not present a meaningful opportunity for health risk reduction based on assessmen ts done by multiple authoritative scientific bodies, numerous well conducted human and animal experiments using a range of doses of perchlorate, and the occurrence and concentration of perchlorate in drinking water systems in the

U.S. One of the rationales for this decision was the calculation of the HRL which was based on the RfD. The RfD combined this previous knowledge to determine a dose which is well above the threshold in healthy adults that does not cause inhi bition of iodide uptake and dividing that dose by 10 to account for sensitive populations.

Response: See response to comment ID 20279 under comment code 5220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21078

EPA Comment Code: 5220

Comment: III. IODINE SUFFICIENCY IN THE UNITED STATES

A significant degree of attention and concern rela ted to perchlorate exposure has been focused upon the hypothetical iodine-deficient person. However, unless the doses of perchlorate are sufficient to significantly impair long term (not transient) iodi de uptake, which would be considerably greater than 0.007 mg/kg-d (~240 ppb based on healthy ad ults; Greer et al. 2002), perchlorate exposure would not exacerbate iodine deficiency. As stated a bove, this dose was adjusted by an uncertainty ("safety") factor of 10. Thus, the approach used by EPA in deriving their HRL based on the RfD of 0.7 ug/kg-d, remains a conservative and health pr otective approach that accounts for substantial uncertainty. The NRC definitively states

"...a dose that does not inhibit thyroid iodide upta ke will not affect thyroid function, even in subjects with an abnormal thyroid gland or a very low iodide intake."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 439 of 1099 There is concern that there are low iodine levels in the U.S. population. The concern is that low iodine levels in a pregnant woman for prolonged periods of time can cause a change in thyroid hormones that may affect the ne urodevelopment of the fetus.

First and foremost, it is important to note th at no study has demonstrated that exposure to environmentally-relevant levels of perchlorate causes or is associated with iodine deficiency. Taken at face value, Blount et al. (2006) show an associ ation between thyroid disruptions and perchlorate; however, even if this association represented an ac tual biological effect at doses below the inhibition of iodine uptake, this hypothetical effect does not raise or lower the measured thyroid hormones outside of the normal ranges and do not show any adverse effect due to the exposure. An epidemiological study of chronically exposed populations in Chile, including children who were exposed throughout gestation via maternal exposur e and in infancy through breastmilk and later dairy, show no adverse effects with exposure much higher than the RfD even with iodine intakes similar to that in the U.S. (Tellez et al., 2005).

Second, the TDS and NHANES both show that population intake of iodide exceed the recommended adequate intake for iodine (Murray et al., 2008; Blount et al., 2006). Although there have been questions regarding iodine sufficiency in the U.S., Borak (2005) points out that there has not been consistency regarding the application of WHO definitions of iodine insufficiency and interpreting the great variability in daily iodine leve ls (Borak, 2005). For instance, for a population to be considered iodine deficient by the WHO defi nition, the median urinary iodine concentration must be below 100 ug/L and at least 20% of th e population must be below 50 ug/L. Borak notes that much of the confusion in the interpretation of NHANES data comes from this seemingly high number of people that may be be low 50 ug/L urinary iodine. He explains "...the reason for such seemingly inconsistent criteria is the need to antici pate potentially large variability when iodine levels are measured in spot urine samples" (Borak, 2005).

Third, despite the presence of perchlorate in brea st milk, studies have s hown that this level of perchlorate does not cause adverse effects in ch ildren (Tellez et al., 2005; Amitai et al., 2007).
Moreover, these studies have all shown doses of perchlorate that are below the NOEL from Greer et al. (2002), and are therefore insufficient to inhibi t iodide uptake by the NIS. If a person, or a population, is iodine insufficient, reducing perchl orate, at environmental relevant concentrations, will not improve iodine insufficiency. Supplemental iodine will (e.g., iodized salt) reduce or negate iodine insufficiency.

Fourth, the NRC perchlorate panel concluded that iodide deficiency if it even exists in the U.S., is mild and "...perchlorate exposure most likely woul d not exacerbate it" (NRC, 2005). Finally, the RfD is a conservative health protective value that is based on a NOEL with the addition of a safety factor
to account for the most sensitive individuals. The HRL, which is even more conservative than the RfD, was calculated based on pregnant women and was verified using PBPK modeling to consider whether the HRL would be protective of other sensitive subpopulations, including infants, by factoring in body weight, water intake, and food intake.

Response: The data underlying the definition of iodide uptake inhibition as a precursor effect and the relationship of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in adults; it may not re flect the relationship of the precursor event to adverse outcomes in neonates and infants, who may not have iodide stores sufficient to offset the effects of reduced iodide uptake. The less resilie nt neonatal and infant system makes the exposureEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 440 of 1099 gap between a precursor event (iodide uptake i nhibition due to perchlorate) and reduced T3/T4 levels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (Greer et al., 2002; Sa vin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[T]he minimal prolonged decrease in thyroid hormone production that would be
associated with adverse health effects is not known; any decrease is potentially more likely to have adverse effects in sensitive populations (people with thyroid disorders, pregnant women, fetuses, and infants) but data are not ava ilable to determine the magnitude of the decrease needed to cause adverse effects in those populations.” With regards to conclusions of the NRC panel on the effects of perchlorate exposure EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. See response to comment code 5220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21098

EPA Comment Code: 5220

Comment: V. EPA's Methodology to Support the HR L Could be Explained More Completely

In the preliminary determination, EPA puts fort h a methodology to measure the contribution of food to total exposure by combining two nationally- representative data sets. The best available scientific understanding supports EPA's use of ac tual data as opposed to default parameters to

derive the RSC. As EPA set out in its 2007 noti ce, EPA has multiple options to estimate the contribution of food to total exposure. At that ti me, the PSG presented analysis of the scientific merits of these options. The conclusions in those comments remain valid: no matter which scientifically-valid approach EPA takes, EPA can an d should conclude that a national drinking water standard would not yield a meaningful reduction in human health risk.

The approach outlined in the proposed determination and background document appears to have several limitations. These limitations may be omissions in the description and not in the methodology. While adequate to meet EPA's statutor y obligation, we suggest that EPA's description could benefit from additional explanation. These suggestions are listed below.

* Sample Description. Both UCMR and NHANES are nationally representative samples. The sample frame and the sample weights are published and have undergone peer review. EPA takes a subsample from these data sets and compares them for its analysis. EPA's analysis could benefit from a more complete description of the characte ristics of these subsamples. Further description would assist the public especially since EPA is co mparing absolute levels of perchlorate measured in drinking water and in total exposure. Many facto rs could influence absolute amounts of food and drinking water consumption in a person at a given ti me such as climate, weight, age, and income. It is unclear from the analysis how the sample popu lations in Bins I, II, and III compare on these characteristics. For example, if the Bin III (and more importantly, its subgroups) population has a larger Body Mass Index (BMI) than the average US population, the sample population may consume more food than average. In this scenario, Bin II I's absolute amount of perchlorate may be larger than the typical person in the US.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 441 of 1099 * Sample Population Size. The importance of describi ng the sample in more detail is magnified by the small number of individuals in the sample re sults EPA uses. EPA uses the 90th percentile result from the 98 pregnant women in Bin III. EPA has not described the statistical relation of this sample to the US population. In addition, based on the shap e of the distribution described in Blount (2006), the upper percentile results must be driven by relatively few observations. In other words, the analysis relies on the results from just a few women of unknown relationship to the whole US population or the subpopulation of pregnant women.

Viewed in this way, EPA's analysis is a convenienc e, non-statistically representative sample that is comparable to other study populations in Greer et al . (2002), Pearce et al. (2007), Tellez et al. (2005), and Amati et al. (2007). These studies all show that for total doses in excess of the RfD, there are no measurable adverse health effects on the study populations, including sensitive populations.
Therefore, while EPA constructs this study population to estimate an RSC, it primarily reinforces the PSG's position that no effects occur below the RfD even for sensitive subpopulations. Until EPA provides more description of its study popula tion, its advantages over the other published, peerreviewed studies is unclear.

* Temporal Comparison. In its background docu ment, EPA describes how it linked the two study populations in the dimension of space - EPA assign ed individuals to the bins based on whether a drinking water system in the county reported an y single detection of perchlorate. EPA notes, but does not fully describe, how EPA handled temporal associations. The UCMR data was gathered from 2000 to 2005 according to EPA. The NH ANES survey was conducted during 2001 and 2002. It is not clear whether EPA only used the UCMR counties that reported detections in 2001 and 2002 or all years in the UCMR dataset. This considerat ion is important since many systems that detected perchlorate did not do so routinely. If EPA used the UCMR data from all years, EPA should describe how many individuals in the Bin III subgrou ps lived in counties wi th an actual detection during the 2001-2002 time period.

Additionally, on the NHANES sample, it is unclear how EPA adjusted the food consumption data to reflect seasonality. People eat different foods at different times of the year. While NHANES adjusts for this fact in its study design, it is un clear how and if EPA did so in its subsample. For example, if 50 percent of th e pregnant women in Bin III wer e surveyed by NHANES in the summer, the food consumption patterns (and the distribution of absolute levels of perchlorate) would be different than if only 25 pe rcent were sampled during that time.

* Concentrations below Detection Limits Assumed to be Zero. EPA notes that one limitation is that the analysis assumes that all detections belo w 4 ppb are assumed to zero. EPA states:

It is uncertain how the 4 ug/l detection limit in the UCMR might affect the assignment of NHANES to Bin III. However, EPA believes that th e classification is reasonable and that it is unlikely that any false negatives would significantly change the findings because there is a low frequency of occurrence above the method reporting limit (less than two percent of all samples had detects), it is reasonable to assume that there would be a corresponding low frequency of occurrence below it if at all. (EPA envisions a scenario with a high frequency of occurrence at very low concentrations unlikely). (pg 13)

First, while the misclassification problem among bins is interesting, it is clear how the detection limit will bias the results within Bin III. Bin III is sup posed to represent individuals that only receiveEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 442 of 1099 perchlorate through food. EPA uses the Bin III result s to calculate the dose received from food. If some of this dose actually derives from drinking water, EPA is overestimati ng the dose from food, underestimating allowance available from drin king water, and underestimating the HRL.

Consider this scenario. In the pregnant women subg roup of Bin III, the 98 pregnant women have an average estimated perchlorate intake of 0.123 ug /kg/day. In the analysis, EPA assumes the water contribution is zero. Suppose the true water conc entration for the 98 women is 1/2 the detection limit (or 2 ug/l), a common EPA assumption in risk assessments and other 13 drinking water exposure scenarios. The women then receive a dose of 0.057 ug/kg/day from drinking water. This amount is 46 percent of their total dose. Their estimated food dose is correspondingly lower, the
relative source contribution would be lower, and th e HCL should be greater than 15 ppb. While the 1/2 the detection limit is merely an assumption, it illustrates the main point - the censoring of the

data due to the detection limit can have a large effect on the Bin III results.

This effect will only be large if a significant pr oportion of the Bin III population has concentrations of perchlorate in drinking water below the le vels of detection. EPA finds "high frequency of occurrence at very low concentrations unlikely." If "high" means 90 percen t of the population, this scenario is unlikely.

Table 2 in the proposed determination shows the estimated population served with at least one sample above the detection limit has an exponential shape to it (each time the concentration is cut in half, the estimated population exposed at that level doubles.) It is reasonable to assume that this relationship continues below the detection limit . By assuming all people in Bin III receive no perchlorate from drinking water, EPA overestimates the concentration from food and creates an overly conservative HRL.

In summary, EPA's approach is scientifically appr opriate in using actual observed data to estimate the RSC and the HCL. All approaches have limitati ons; however, any limitations in EPA's analysis

have to be viewed in context of the extensive bod y of literature on perchlorate's mode of action and measured effects in humans. When EPA's analysis is viewed in the context of the NAS findings and other published studies, EPA's analysis is one more way to demonstrate that total exposure to perchlorate in the US is common and without advers e effect. EPA's analysis is more than adequate to demonstrate that perchlorate does not occur at a frequency and level of health concern to warrant

an NPDWR.

Response: See response to comment code 5220 for a di scussion of the alternative Health Reference levels. Your observations regarding some limitations of the Huber et al. study are correct, and as you note changes in dietary habits or food sources over a year or the possibility of small water contribution to what is considered food-only sour ce would change results in a minor way. Because NHANES collects samples at different times of the year the result we obtained will be applicable for the entire year, and small changes would not be significant from a health standpoint. The gap in the

data of course is the lack of information on child ren less than 6 years old which has become a focus

of concern.

Commenter Name: Ellen Blaschinski, M.B.A., R.S. Commenter Organization: Regulatory Services Branch, Connecticut Department of Public Health

EPA Document ID: EPA-HQ-OW-2008-0692-2091

EPA Comment ID: 21115EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 443 of 1099 EPA Comment Code: 5220

Comment: However, in the October 10th Preliminary Regulatory Determination, EPA decided not to set a federal MCL for perchlorate. This was based upon the establishment of a drinking water Health Risk Limit (HRL) of 15 ug/L as the bright line for eval uating how many people would be exposed to concentrations of concern. The nume rical target of 15 ug/L can be questioned on a number of fronts given that other recent derivations by states governments have yielded drinking water targets of 2 to 6 ug/L (New,Jersey, Massachusetts, California). The EPA assessment supporting the 15 ug/L HRL was reasonable in some regards (e.g., the mannner in which the relative source contribution was derived) but is not well justified when it comes to the level of exposure allowed for breast and bottle- fed infa nts. EPA's own assessment puts this early life exposure at 2 to 5 times greater than the Agency's RfD, with this justified by the use of an exploratory pharmacokinetic model which has no possi bility of being validated for children. Given that this a key population to protect, it is essent ial that the HRL be set such that the RfD is not exceeded in this group. This is especially the case given that the health protectiveness of the RfD has been questioned by the CDC study, which shows quite clearly that effects on thyroid hormone status are possible at levels of perchloratc belo w the RfD in adult women (Blount et al. 2006).

The establishment of a lower HRL, more in line with recent derivations within several states, would yield a considerably larger public health impact than what was put forth by EPA in its draft
determination. Therefore, this needs to be carefully reassessed. Our recommendation for a reassessment is in line with EPA's own Science Advisory Board which called EPA's decision premature stating that; "Given perchlorate's wi de occurrence and well-documented toxicity to humans, the Science Advisory Board strongly belie ves that there must be a compelling scientific basis to support a scientific determination not to regulate perchlorate as a national drinking water contaminant" (SAB letter, November 5, 2008).

Response: See response to comment code 5220.

Commenter Name: Mark S. Mayer Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28482

EPA Comment Code: 5220

Comment: - Comment on the Health Reference Level Issues - South Dakota DENR agrees the process presented appears to be reasonable.

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Richard Nieuwenhuis Commenter Organization: New Jersey Farm Bureau (NJFB)

EPA Document ID: EPA-HQ-OW-2009-0297-0665

EPA Comment ID: 28534

EPA Comment Code: 5220EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 444 of 1099 Comment: Moreover, the Environmental Protection Agency has not presented any sound scientific evidence that sufficiently explains why the previo us health reference level (HRL) that supports a drinking water equivalent of 15 ug/L is inad equate. The 15 ug/L HRL was established from scientifically supported literature and based on the most sensitive sub-population, plus an added tenfold safety factor.

We understand that the scientific evaluation of perchlorate has become complicated over the past few years but believe that there remains a signif icant need for more comprehensive scientific

evaluation and debate.

We appreciate your attention to our concerns.

Sincerely, Richard Nieuwenhuis President

Response: See response to comment ID 28799 under comment code 5220.

Commenter Name: Anthony Russo Commenter Organization: Chemistry Council of New Jersey (CCNJ)

EPA Document ID: EPA-HQ-OW-2009-0297-0673

EPA Comment ID: 28688

EPA Comment Code: 5220

Comment: October 6, 2009

Water Docket Environmental Protection Agen cy Mailcode 2822T 1200 Pennsylvania Avenue Washington, DC 20460

RE: "Drinking Water: Perchlorate Supplemental Request for Comments" 74FR159:41883, August
19, 2009

Dear Sir/Madam:

The Chemistry Council of New Jersey (CCNJ) represen ts the interests of over 100 manufacturers in the business of chemistry in the Garden State. Our mission is to advance members' interests, operational and environmental excellence, sc ience education and community outreach.

The CCNJ appreciates this opportunity to provide co mments on the above referenced public notice regarding alternative approaches to the interpretati on of scientific data relevant to a regulatory determination for perchlorate in drinking water.

CCNJ has several concerns about this issue. We belie ve that good public policy must be developed and proposed using sound, proven scientific data and presented in a manner which the public can understand and make informed judgments to dete rmine application and appropriate risk prevention practices.

Repeated scientific investigation, including a la ndmark National Academy of Sciences (NAS) review, result in a clear and consistent conclusion: low levels of perchlorate are not dangerous to public health. We should not ignore this data. Without th e presentation of supporting scientific literatureEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 445 of 1099 justifying alternative analysis, it becomes difficult for EPA to demonstrate wh y this alternative would support a science based regulatory determination under the Safe Drinking Water Act (SDWA). Not only has EPA not presented any justification for an analysis based on an alternative health reference level that uses water intake and body weight measur ements at specific life stages, but EPA has also not presented any scientific evidence that indica tes why the previous HRL that supports a drinking water equivalent of 15 ppb, based on the most sensitive subpopulation, with an added ten fold safety

factor and derived from the scientifica lly supported literature is inadequate.

Response: See response to comment ID 28799 under comment code 5220.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28799

EPA Comment Code: 5220

Comment: EPA tried to support its conclusions that a 15 ppb HRL is safe by avoiding reference to the RfD, and instead referring to the level of inhibition of radioactive iodide uptake (RAIU) on which the NRC report (NRC, 2005) based its reco mmended RfD.[FN32: 73 Fed. Reg. at 60277.]

EPA cannot shift its evaluation of acceptable exposure estimates to a discrete biological endpoint

that leads to exceedances of the RfD.

Response: In the October 2008 preliminary regulatory determination, EPA had derived a single HRL of 15 μg/L based upon the RfD, an estimate of perchlorate exposure from food for pregnant women, and traditional adult body weight (70 kg) an d drinking water consumption (2 L/day) values. This single HRL was derived to reflect exposure to a pregnant woman and her fetus, which the NRC identified as “the most sensitive population.” Since the NRC also identified infants and developi ng children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perc hlorate in drinking water that may result in total perchlorate exposures (from food an d water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their cohorts. EPA has developed potential health referen ce levels (HRLs) for perchlorate for purposes of this regulatory determination. HRLs are not final determinations about the level of a contaminant in drinking water that is necessary to protect any particular population. Rather they are benchmarks against which EPA compares the co ncentration of a contaminant found in public water systems to determine if it is at levels of public health concern.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28802

EPA Comment Code: 5220

Comment: RESPONSE TO REQUEST FOR COMMENTS ON THE HRLEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 446 of 1099 In simple terms, the HRL is the maximum tolerable am ount of perchlorate that could be in drinking water, considering that perchlorate is also in f ood, and still keep daily consumption levels from exceeding the RfD. The 2008 proposed HRL of 15 ppb was calculated as follows: For all populations, including pregnant women, EPA determine d that the RfD is 0.7 ug/kg/day. This value is posted on the IRIS database based on recomme ndations from a committee of the NRC. EPA reports that for pregnant women, exposure to perc hlorate from food is 0.263 ug/kg/day at the 90th percentile (based on data from a national food sur vey), representing nearly 38% of the RfD, thus leaving an relative source contribution (RSC) for wa ter of 62%.[FN43: 73 Fed. Reg. at 60276)] This is equivalent to 0.437 ug/kg/day from water, assumi ng an average body weight of 70 kg, and a daily water consumption of 2 L (90th percentile adult wa ter consumption). That is, 0.437 ug x 70 kg body wt. = 30.6 ug perchlorate in 2 L (the daily consum ption amount). This is 15 ug/L, or 15 ppb, the HRL proposed in the October 2008 FR notice.

Response: No response necessary to this summary of EPA information.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28916

EPA Comment Code: 5220

Comment: Based on the above comments, we urge USEPA to reconsider its proposed HRL of 15 ug/L.

Response: See response to comment ID 28799 under comment code 5220.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 29096

EPA Comment Code: 5220

Comment: Because the RfD was based exclusively on th e dose-response calculations derived from the Greer et al study, then the HRL also relies on th at data to derive a maximum allowable level of drinking water contamination. The derivation of a health-based standard for perchlorate should reflect the best available data, including published data collected and analyzed by the CDC and described by Blount (2006) and Blount (2007).[FN43: Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. Perchlorate exposure of the US Population, 2001-2002. J Expo Sci EnvironEpidemiol. 2007 Jul;17(4):400-7. Epub 2006 Oct 18. Blount BC, Pirkle JL, Osterloh JD, ValentinBlasini L, Caldwell KL. Urinary perchlorate and th yroid hormone levels in adolescent and adult men and women living in the United States. Envir on Health Perspect. 2006 Dec;114(12):1865-71.] As noted above, these data have the following advantages over the Greer et al data:

1. Although the CDC data are from a cross-sectional analysis, because the survey includes a large number of individuals, the variability represents rand om error, not bias, and the data are likely to be representative of chroni c perchlorate exposure;EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 447 of 1099 2. The number of individuals included in the CDC study are sufficient for the specific analysis of a sensitive subpopulation defined as women with low iodine intake;

3. A benchmark dose (BMD) analysis of perchlor ate-related modulation of serum thyroid hormone
concentrations is feasible; and

4. Perchlorate exposures, as measured by urinary perchlorate concentration, corresponding to the benchmark dose low (BMDL) can be converted to an estimated dose in mg/kg-day, that can be used as the point of departure for the derivation of both the MCL and HRL.

The mean for total serum T4 concentrations in wo men is 8.27 ug/dL and the 25th percentile of perchlorate exposure (equivalent to 1.6 ppb perchlorate in urine) is associated with a 10% drop in total serum T4 in women with low iodine intake.[FN44: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlor ate and thyroid hormone levels in adolescent and adult men and women living in the United States . Environ Health Perspect. 2006 Dec;114(12):1865- 71.]

Response: See response to comment ID 28863 under comment code 2110.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 448 of 1099 

### EPA Comment Code: 5225 Use of alternative HRLs specific to sensitive life stages, as described in Table 2 of the August 2009 FR notice.

Individual Comments

Commenter Name: W. Cucinotta Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0038

EPA Comment ID: 28338

EPA Comment Code: 5225

Comment: Enclosed are my comments on your approach es for deriving HRLs on Perchlorates and other chemicals in our drinking water.

4.

a. No, I do not feel EPA appropriately took into account specific and appropriate exposure values for all potentially sensitive life stages, including in fants, children and the fetuses of pregnant women. Any exposure to these type of chemicals should be eliminated and controlled to protect Americas' drinking waters. The 70 kg body weight and 2 liter per day consumption used for past regulatory determinations are grossly inappropriate levels to consider safe.

b. I feel none of these these values are low enou gh to be appropriate levels to determine health concerns against which to compare the levels of pe rchlorates found in public water systems. I urge you to adopt the smallest exposer levels considered or preferably lower them to no (0) exposure at

all.

c. I feel the EPA did not use the best available and most appropriate data to estimate alternative HRLs in Table 2 because you cannot control how much water any one person consumes or the amount of perchlorate exposure from other source s. No, your drinking water ingestion rates in Table 2 do not take into account the life stages (birth to 6 months, and women ages 15-44) and does not provide an accurate representation of the ex posure to the most vulnerable life stages because you cannot control how much water any one pers on consumes or the amount of perchlorate exposure from other sources.?

Response: See response to comment code 5220 for a discussion of HRL derivation. Regarding health implications of exposures above the poten tial alternative HRLs, EPA notes that the data underlying the definition of iodide uptake inhibi tion as a precursor effect and the relationship of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in adults; it may not reflect the relationship of th e precursor event to adverse outcomes in neonates and infants, who may not have iodide stores sufficien t to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a precursor event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 levels likely to be narrower than
for adults, and in fact, the distinction between the two may be blurred for the very young (Greer et
al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[T]he minimal prolonged decrease in thyroid hormone production that would be associated with adverse health effects is not known; any decrease is potentially more likely to have adverse effects in sensitive populations (people with thyroid disorders, pregnant women, fetuses, and infants) but data are notEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 449 of 1099 available to determine the magnitude of the decr ease needed to cause adverse effects in those populations.”

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28498

EPA Comment Code: 5225

Comment: Comments on the Health Reference Leve l (HRL) Issues - While we are generally comfortable with the development of the alternative HRLs in Tabl e 2 (page 41888), the key question is: what HRL should be used as the basis of the regulatory determination? This is where we have some concern. Ideally, the regulation of a contaminant would be targeted at the most sensitive subpopulations, no matter how small the subpopulation. However, we must also be cognizant of resource limitations and practical constraints. It may not be feasible to protect very small subpopulations with a general regulation but rather, it may be more appropriate to use other risk reduction approaches to target small groups that may have special sensitivity. We cannot recommend a specific HRL without a full understanding of the implications on the burden for water systems and states, which these data do not pr ovide. The HRL of 15 ug/l, derived using the traditional approach, is a good starting point an d would cover a large percentage of the population. In addition, EPA should evaluate a range of HRLs between 15 and 4 ug/l in connection with more sensitive subpopulations. The Agency could then c onsider these values, in combination with occurrence data, in order to determine the populations that could be protected by regulation and whether regulation at these lower levels would present a "meaningful opportunity for health risk reduction", as required by the Safe Drinking Water Act.

Response: See response to comment code 5220.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28518

EPA Comment Code: 5225

Comment: Department of Defense Comments on the August 19, 2009 USEPA Federal Register Notice [EPA-HQ-OW-2009-0297; FR L-8943-9] Drinking Water: Perchlorate Supplemental Request for Comments Pages 41883-41893

Comments submitted by: Chemical Material Ri sk Management Directorate Organization: Department of Defense Date Su bmitted: 18 September 2009

*Comment categories: Science or methods (S); Edit orial, grammar/spelling, clarifications needed (E); or Other (O). Also please indicate if Ma jor (M), i.e. affects the outcome, conclusions or implementation of the assessment.

Comment No. 1

SectionEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 450 of 1099 Page & Paragraph Global

Comment As noted in his 9 March 2009 memora ndum on Scientific Integrity, President Obama recognizes that science and the scientific process must inform and guide Administration decisions on a wide range of issues, including improvement of public health, protection of the environment. The memo underscores the importance of scientific integrity by further noting that if the public is to trust the science and scientific process inform ing public policy decisions there should be transparency in the preparation, identification, an d use of scientific and technological information in policymaking. In embracing the President's commitment to scientific integrity, Administrator Jackson notes in her 9 May 2009 memorandum to EPA employees that th e Agency's regulatory decisions should include a full explanation of the science issues addressed by the Agency, the data relevant to those issues, and the interpretations an d judgments underlying the Agency's scientific findings and conclusions.

Suggested Action, Revision and References (if ne cessary) To ensure consistency with Administration and Agency commitments to scientific integrity, the following issues need to be considered in a transparent and scientifically defensible manner pr ior to the determination of any Health Reference Level (HRL), because they can impact the conclusions drawn by the EPA in the potential for health risk reduction for perchlorate in drinking water. Wh ile these issues do not address all requests for comments on alternative approaches, they focus on i ssues that will have the most significant impact on the determination and acceptance of an alternative HRL. The main issues associated with the alternative approaches presented by EPA (2009) in clude the following: 1. The lack of transparency and assurance of quality in the determination of al ternative HRLs. 2. Inadequate characterization of exposure to sensitive subgroups, specifically infants an d the fetuses of pregnant women. 3. A lack of justification for elimination of the PBPK models from consideration in the determination of an HRL. 4. Recommended applications for the PBPK models in the development of an HRL.

Category* S, M

Response: EPA believes that it has been consistent with Administration and Agency commitments to scientific integrity. The August 2009 notice clearly discusses the basis for alternative health reference approaches and that EPA was re-evalu ating how best to incorporate PBPK modeling analysis into its evaluation of perchlorate, if at all.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28519

EPA Comment Code: 5225

Comment: Comment No. 2

Section

Page & Paragraph GlobalEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 451 of 1099 Comment The current documentation of the suggested alternative HRLs based on body weight and water consumption of other life stages is inadequa te. The development of this alternative approach relies heavily on the FDA total dietary survey (M urray et al. 2008) and the first Unregulated Contaminant Monitoring Regulation (UCMR 1). While these studies are well conducted and provide a significant resource for information, the document ation provided is not sufficient to demonstrate their application, nor to insure their reproducibility by other parties.

Suggested Action, Revision and References (if necessary) To insure clarity it is recommended that sufficient documentation be provided. Under the Da ta Quality Act (Section 515 of the Treasury and General Government Appropriations Act of 2001 (PL 106-544, H.R. 5658), Federal agencies are charged with ensuring the quality, integrity, an d objectivity of information provided. See also

comment #s 11 and 14.

Category* E, M

Response: EPA disagrees that the documentation of the suggested alternative HRLs is inadequate. In the October 2008 and August 2009 notices, EP A presents in detail the Unregulated Contaminant Monitoring Rule data as well as the Food and Drug Administration’s Total Diet Study in 73 FR

60269–72. EPA has described how those studies have been used in deriving health references. EPA believes these are the best available peer reviewed data and that they have been applied in a reproducible manner.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28520

EPA Comment Code: 5225

Comment: Comment No. 3

Section

Page & Paragraph Global

Comment By removing the PBPK models from consideration, the agency has effectively removed consideration of the age-dependent variations in biology, and is apparently assuming that alldifferences may be accounted for by addressing the differences in exposure. There are many agedependent differences, including exposure, clearance, protein binding, and NIS capacity, as well as extrathyroidal sites of iodide inhibition (placenta, milk) that influence perchlorate toxicology. The models were developed using specific data to qua ntify these differences, and while uncertainty may exist in specific parameter values, it is certainly be tter to estimate parameter values from data rather than ignoring their existence. Factors such as cleara nce, maternal-fetal transfer, and extrathyroidal inhibition cannot be addressed in a standard analys is based on adjusting Points of Departure (PoDs) by exposure differences. Indeed, in the current proposal, the uncertainty associated with these parameters is added to other uncharacterized uncerta inty, which does not improve estimates of risk.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 452 of 1099 The alternative HRL approach represents, in fact, a decision to become less informed about the processes governing potential increased risk to th e sensitive populations, giving the impression that it is better to ignore the uncertainty related to re al biology than to attempt to account for it.

Suggested Action, Revision and References (if nece ssary) Instead of using the 90th percentile for exposure and an RSC, a more mathematical approach should be used to assess uncertainty in model predictions (i.e., Monte Carlo). This would help defi ne expected ranges of inhi bition after taking into account both variability in exposure and intraspeci es variability in biological parameters. Not only would this be a more quantitative way of accounting for uncertainty in exposure, but it would also

address commenter's concerns about the mode l parameter uncertainty and transparency.

Category* S. M

Response: EPA disagrees that by not using the PBPK mode l the Agency is deciding to become less informed. See response to comment ID 20432 un der comment code 5220 for a discussion of EPAs

decision not to utilize the PBPK model.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28523

EPA Comment Code: 5225

Comment: Comment No. 11

Section III. B. 3. Alternative Approaches for Calculating HRLs

Page & Paragraph Page 41888 Column 1 Para 1

Comment Example of comment # 2: The document relies on information to characterize ingestion to early life stages, which represent a sensitive subgroup, based on sample sizes that do not meet minimum data requirements. While EPA (2009) states that these are the best available data, there is no indication that a comprehensive literature search was conducted to determine if additional data could be used to supplement or validate the data provided.

Suggested Action, Revision and References (if necessary) It is recommended that a comprehensive literature search be performed and documented.

Category* E

Comment No. 12

Section III. B. 3. Alternative Approaches for Calculating HRLs

Page & Paragraph pg 41888 Column 1-3

Comment Based on the EPA's analysis of percent radioactive iodide uptake (RAIU) inhibition estimated with the PBPK model (Table 8, EPA 20 08), the NRC (2005) identified the 7-day oldEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 453 of 1099 breast-fed infant and the fetus of the pregnant wo man at 40 weeks as the most sensitive subgroups. Yet, in their attempt to develop alternative HR Ls based upon body weight and water consumption, which appears to be the only alternative presen ted, EPA (2009) has not adequately characterized exposure to perchlorate by these subgroups. The Relative Source Contribution for perchlorate from food for the birth to 12 month life stages (Table 2, EPA 2009) is based on information provided in the FDA Total Dietary Survey (Murray et al. 2008 ). The EPA (2009) states that because no

information was available from the TDS for the life st ages from birth to 6 months of age, estimates for the nearest age range (6-12 months) was used. Th e intake from food provided by Murray et al. (2008) largely results from the determination of perchlorate in baby food and commercial formula ingested by children aged 6-11 months. From birt h to six months, however, baby food would not be a significant portion of the diet. If intake is a ssumed to be mainly from commercial formula, the RSC may be similar, but this is a major uncertainty. Furthermore, intake from breast milk is not addressed at all using the HRL approach. It is not reasonable to assume the same dietary ingestion in the newborn ingesting breast milk alone, and the ch ild that is eating solid food. It is, in fact, impossible to define perchlorate exposure in the brea st-fed infant or the fetus, using this revised approach for defining an HRL.

Suggested Action, Revision and References (if necessary) It is recommended that the alternative HRLs not be used to estimate risk for this sensitive subgroup.

Environmental Protection Agency (EPA). 2008. Drinking Water: Preliminary Regulatory

Determination on Perchlorate. Federa l Register 73(198):60262-60282.

National Research Council (NRC). 2005. Health Im plications of Perchlorate Ingestion. National
Academies Press, Board on Environmental Studies and Toxicology. January, 2005.

Category* S. M

Response: Regarding the recommendation to conduct and document a comprehensive literature search on information to characterize ingestion to ea rly life stages, EPA believes that it did just that in developing EPA’s “Child-Specific Exposure Factors Handbook.” The information in the Handbook represents the best available peer revi ewed data on drinking water ingestion rates for various life stages.

Regarding the recommendation that alternative HRLs not be used to estimate risks for sensitive groups, EPA strongly disagrees. The NRC (2005) iden tified fetuses of iodide deficient pregnant women are the most sensitive life stage and also identified infants and developing children as sensitive life stages. . EPA estimates that at least 5.1 to 16.6 million people are served by PWSs, for
which we have data, that have perchlorate contamination.

EPA has determined that a NPDWR for perchlor ate may reduce perchlorate exposures for these infants, children, and pregnant women to levels below the RfD, and therefore believes that this perchlorate exposure reduction presents a meaningful opportunity for the reduction of health risks for persons served by PWSs.

EPA has made this determination based on a consid eration of the best available peer reviewed

science and data collected in accordance with acce pted methods related to perchlorate occurrence inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 454 of 1099 drinking water, the presence of perchlorate in foods, and the health effects of exposure to perchlorate. National Research Council (NRC). 2005. Health Im plications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28524

EPA Comment Code: 5225

Comment: Comment No. 13

Section III. B. 3. Alternative Approaches for Calculating HRLs

Page & Paragraph Page 41888 Column 1-3

Comment The major problem with the current approa ch is the lack of characterization of exposure by those sensitive subgroups identified by NRC (200 5): the 7-day old breast fed infant and the fetus of the pregnant woman at 40 weeks of gestation. The available dietary surveys and drinking water ingestion rates are incapable of providing a means to determine potential intake for these sensitive subgroups.

Suggested Action, Revision and References (if necessary) Incorporation of a PBPK model at this step would provide a reasonable method for estimati ng maternal transfer of perchlorate. One of the major strengths of the PBPK models is that they provide a platform for estimating fetal and infant dose using biological data on transfer rates and pharmacokinetic data in both the animal and human. These models have been tested against human iodide data, and when available, perchlorate data. It is

true that the data sets available for validation wer e extremely limited. However, even limited data are better than the complete lack of data available to support the new approach. Derivation of an HRL

for the breast fed infant and fetus needs to consid er such complex biological processes as placental transfer, active uptake in the mammary gland, and extrathyroidal inhibition. In 2008, the PBPK

models were used to address these issues. The curre nt approach does not utilize the PBPK models, and in the process does not consider what is known about the important biological determinants of perchlorate transfer to the fetus and infant, the identified sensitive subgroups.

Category* S. M

Response: See response to comment ID 20432 under comment code 5220.

Commenter Name: Shannon Cunniff Commenter Organization: Department of Defense (DOD)

EPA Document ID: EPA-HQ-OW-2009-0297-0411

EPA Comment ID: 28526

EPA Comment Code: 5225

Comment: Comment No. 15EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 455 of 1099 Section IV. Consideration of Studies Published Si nce EPA Adopted the NAS RfD for Perchlorate

Page & Paragraph Pages 41889 41891

Comment EPA requests comment on whether EPA used the best available and most appropriate

data to estimate alternative HRLs in Table 2.

The HRL it is too simplistic and does not take in to account the full range of scientific knowledge regarding coexposure to chemicals known to also bind to the NIS receptor. For example, it does not allow taking into account other relevant issues c oncerning thiocyanate and nitrate co-exposures. It also does not consider factors such as potential di fferences in the perchlorate "half-life" compared to thiocyanate and nitrate, and comparison of thyroid hormone effects.

Suggested Action, Revision and References (if necessary) Evaluate the above referenced (see Comment #10) human sensitive subpopulation data using direct measurement of biological fluids to derive the HRL for perchlorate considering the cumu lative risk of other goitrogens (thyocianate and nitrate from dietary sources). These data should be considered for use in and/or validation of the

EPA models.

Since not just perchlorate but also thiocyanate and nitrate are present in commonly ingested foods, as well as mother's and bovine milk, they all impact iodide uptake inhibition, and thus should be

evaluated

Category* S

Response: While EPA acknowledges that nitrate and th iocyanate have the same mode of action as perchlorate, and that the effects of combined expo sure to perchlorate, nitrate, and thiocyanate are
additive, EPA does not believe there are sufficient scientific data currently available to assess and

characterize the combined risk of these contam inants. EPA has committed to a drinking water strategy that outlines four principles to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchl orate should be further delayed. Therefore, EPA intends to develop a proposed rule for perchlora te. At such time as a NP DWR is promulgated, EPA is required to review and revise, as appropriate, its drinking water standards at least every six years. Any revision must at least maintain or improve public health protection. When there are sufficient

scientific data to assess the cumulative risks of perchlorate and other contaminants, EPA will review this information to evaluate whether any revisions of NPDWRs are appropriate.

Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28610

EPA Comment Code: 5225

Comment: As suggested by previous commenter's, I believe that the Agency's proposed HRL, of 15 micrograms/Liter, is too high. The alternative HRLs presented in Table 2 of your request forEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 456 of 1099 comment notice, dated August 5, 2009, do not use the most appropriate data. The data in Table 2 uses mean ingestion rates from the CSFII. The CSFII is already several years out of date.

Response: See response to comment code 5220. Regardin g use of CSFII data, EPA believes that it is the best peer reviewed science that is av ailable on the consumption of drinking water.

Commenter Name: Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28616

EPA Comment Code: 5225

Comment: As suggested by previous commenter's, I believe that the Agency's proposed HRL, of 15 micrograms/Liter, is too high. The alternative HR Ls presented in Table 2 of your request for comment notice, dated August 5, 2009, do not use the most appropriate data. The data in Table 2 uses mean ingestion rates from the CSFII. The CSFII is already several years out of date.

Response: Regarding the Agency's proposed HRL of 15 ug/L being too high, see response to comment code 5220. Regarding use of CSFII data, EPA believes that it is the best peer reviewed

science that is available.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28676

EPA Comment Code: 5225

Comment: The California agriculture groups submitting this letter appreciate the opportunity to comment on USEPA's August 19, 2009, Federal Register notice seeking comment on "additional approaches available for analyzing data related to EPA's perchlorate regulatory determination. The attached letter contains specific comments and in formation. Thank you for your consideration.

October 8, 2009

Mr. Eric Burneson Office of Ground Water and Dr inking Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC

20460

Subject: California Agriculture Industry Comme nts on Docket Identification (ID) EPA-HQ-OW2008-0692-Perchlorate Supplem ental Request for Comments

Dear Mr. Burneson:

The undersigned California agriculture groups appreciate the opportunity to comment on USEPA's August 19, 2009, Federal Register notice seekin g comment on "additional approaches available for analyzing data related to EPA's perchlorate re gulatory determination." Since a national primary drinking water standard for perchlorate would di rectly impact public perception of the safety of agricultural commodities known to contain trace amounts of perchlor ate, it is critical that EPAEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 457 of 1099 establish the appropriate science-based methodolog y before proceeding with a final regulatory

determination.

The California agriculture industry is a $37 billion industry that produces more than 350 different crop and livestock commodities and generates an es timated $100 billion in related economic activity. California agriculture accounts for approximately 7. 5% of all employment and supports more than a million on-farm jobs. California agriculture is al so the leading global exporter of agricultural commodities, sending almost 20% of our agri cultural production to foreign markets.

EPA's Proposed Alternative Health Reference Leve ls are Not Scientifically Justified and will

Undermine Public Confidence in the Sa fety of Agricultural Commodities.

EPA's August 19, 2009, Federal Register notice states that the "additional alternatives under

consideration could result in health reference levels which are much lower than the level identified in the October 2008 notice." This statement causes grea t concern for the California agriculture industry because it implies that exposure to trace amounts of perchlorate may be harmful to human health, when in fact, the rich body of scientific literature on perchlorate does not support this conclusion. It is well established that many agricultural commodi ties contain trace amounts of perchlorate, but these levels are widely recognized as being orders of magnitude below any level that may pose a risk of adverse human health effects. EPA's promotion of the alternative health reference level concept will needlessly rekindle public concern about the safety of agricultural commodities and will drive some consumers away from these products to avoid perchlorate exposure. The negative impacts on public health associated with such a shift in dieta ry habits will vastly outweigh the risk of harm associated with exposure to trace amounts of perchlorate.

Response: We appreciate your concern that food not be negatively impacted by evaluations of perchlorate in drinking water. The drinking water re gulatory determinations health reference levels (HRLs) are calculated for public tap water and consider how much of the RfD is already taken by food exposure using a relative source contributi on (see response to comment code 5220). Drinking water with perchlorate at levels less than the HRL may prevent the water- plus-food components of exposure from exceeding the RfD.

Commenter Name: Anthony Russo Commenter Organization: Chemistry Council of New Jersey (CCNJ)

EPA Document ID: EPA-HQ-OW-2009-0297-0673

EPA Comment ID: 28690

EPA Comment Code: 5225

Comment: The Agency has sufficient data to show that perchlorate will not have an adverse effect on the health of persons at the levels expected in public drinking water systems, having based its RfD on a no observed effect level (NOEL) of a precursor to an adverse effect. Based on the
available data, neither the first nor the second criteria of the SDWA are met.

EPA along with other experts including th e NRC committee, ATSDR and OEHHA have all identified the most sensitive life stage as the fet uses of hypothyroid or iodine deficient pregnant women. The NRC committee determined that all sensitive subpopulations, including infants, would be protected by the drinking water equivalent of EPA's reference dose, 15 parts per billion (ppb). By proposing to base its calculation of alternative heal th reference levels (HRL) on specific life stages asEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 458 of 1099 opposed to the calculation based on the most sens itive sub- population (fetus), EPA would establish a scientifically unsupportable precedent that could then be applied to every other water contaminant

for which and MCL has been established. EPA's calc ulation of alternative health reference levels (HRL) is not the best available science and thus ru ns contrary to EPA's duty under the Safe Water Drinking Act.

Response: See response to comment ID 28338 under comment code 5225.

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0667

EPA Comment ID: 28697

EPA Comment Code: 5225

Comment: Alternative Health Reference Levels (H RLs) Based Upon Body Weight and Water Consumption of Other Life Stages

Studies have clearly proven that perchlorate is a naturally occurring chemical which is absolutely ubiquitous in the environment (Sanchez, Kriege r et al. 2005; Snyder, Vanderford et al. 2005;
Valentin-Blasini, Mauldin et al. 2005; Baier- Ande rson, Blount et al. 2006; Blount, Pirkle et al. 2006; Blount, Valentin- Blasini et al. 2006; Snyder, Pleus et al. 2006; Dyke, Ito et al. 2007). The evidence of perchlorate's ubiquity is indisputable based on the recent NHANES and FDA Diet Study, which clearly demonstrated that perchlorate is present in the human diet; thus, increasing the challenge of demonstrating "a meaningful opportunity for health risk reduction for persons served by public water systems" through federal regulation of perchl orate in drinking water. Moreover, a recent study led by the Authority (Snyder, Stanford et al. 2009) has demonstrated that the use of hypochlorite for the disinfection of water may contribu te perchlorate at levels within the range of HRLs shown in the FR. Therefore, we urge the EPA to consider the consequences of suggesting HRLs that do not consider epidemiological data that include in utero perchlorate exposure.

Response: EPA has carefully considered epidemiological data for perchlorate and determined that perchlorate meets SDWA’s criteria for regulating a contaminant.

EPA agrees that perchlorate is naturally occurri ng. A 2006 study by a Texas Tech researcher (Dasgupta et al., 2006) identifies three principal so urces of the perchlorate in the environment: its use as an oxidizer (rocket propellants, fireworks, flares and explosives), its presence in Chilean nitrate fertilizer, and formation via atmospheric processes.

Perchlorate is soluble and is taken up by plants along with water and nutrients. Its presence in food specifically is related to: (1) past propellant leakag e into irrigation source water (e.g., Colorado River) which is applied to fields of crops that are dist ributed nationally; (2) smaller application of Chilean fertilizer to certain crops, i.e., principally in orga nic farming; and finally (3) rainfall and localized irrigation with ground water containing natural perchlorates.

Regarding the comment that the use of hypochlorite for the disinfection of water may contribute perchlorate at levels within the range of HRLs shown in the FR, EPA agrees that perchlorate has been found as an impurity in sodium hypochlori te which is commonly used by public water systems as a disinfectant to inactivate pathogenic micro-or ganisms. Reported concentrations of perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 459 of 1099 introduced as a result of disinfection using sodium hypochlorite range from 1 ppb to 8 ppb (Greiner et al., 2008).

The extent to which perchlorate could be introdu ced into water from sodium hypochlorite depends on the operational practices of water utilities. In part icular, the longer sodium hypochlorite is stored, the greater the concentration of perchlorate. These risk/risk tradeoffs can be addressed by implementing best management practices including storage in the dark at cool temperatures and use within 45 days of its manufacturing date. Pe rchlorate contamination resulting from sodium hypochlorite usage is more likely to occur in small drinking water systems than large.

Commenter Name: Kate Sande Commenter Organization: Minnesota Department of Health , Health Risk Assessment Section

EPA Document ID: EPA-HQ-OW-2009-0297-0663

EPA Comment ID: 28701

EPA Comment Code: 5225

Comment: The Health Risk Assessment Unit with the Minnesota Department of Health appreciates the opportunity to submi t comments in regards to EPA's Drinking Water: Perchlorate Supplemental Request for Comments (Docket ID No: EPA-HQ- OW-2009-0297). Please see our

detailed comments found in the attached document.

October 8, 2009

Response to U.S. EPA, Drinking Water: Perchl orate Supplemental Request for Comments Docket ID No: EPA-HQ-OW-2009-0297

The approach taken by the Minnesota Department of Health (MDH) to develop health-protective guidelines for groundwater is consistent with alterna tive approaches considered by the U.S. EPA in the development of a drinking water guideline for perchlorate. The approach used by MDH to develop health risk limits (HRLs) for drinking water are much more aligned with the process outlined by the EPA in the August 19, 2009 Federal Register announcement than the process

described in the December 2008 Perchlorate Inter im Drinking Water Health Advisory report.

MDH supports EPA's August 2009 re-evaluation of the process used to develop drinking water guidelines for perchlorate. The previous approach used by the EPA in Interim Health Advisory Report was inconsistent with EPA risk assessment guidance. The use of the PBPK model appeared to be used to justify perchlorate exposure in infants and young children at levels above the RfD, an approach we would not endorse as health protective. Additionally, MDH was concerned by the lack of consideration of life stage sensitivities in the interim report, especially the absence of appropriate intake rates that were protective of sensitive subpopulations.

Response: See response to comment code 5220 for a discussion of the HRLs. See response to

comment ID 20432 under comment code 5 220 for a discussion of the PBPK model.

Commenter Name: Kate Sande Commenter Organization: Minnesota Department of Health , Health Risk Assessment Section

EPA Document ID: EPA-HQ-OW-2009-0297-0663

EPA Comment ID: 28702EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 460 of 1099 EPA Comment Code: 5225

Comment: Our comments include a discussion about how MDH accounts for life-stages sensitivities when developing HRLs and how our approach compares with the alternative approaches EPA is considering for developing a perc hlorate drinking water guideline. We have also included an example of how MDH would calcul ate a HRL for perchlorate using EPA's RfD of 0.0007 mg/kg-day and comments comparing the MDH dr inking water guidelines and the alternative HRLs that EPA is considering (listed in Table 2, section III.B-3 of the Federal Register announcement).

Note: If this were a chemical review conducted by MDH, we would independently review the toxicological literature to derive our own RfD, which may not result in the same RfD adopted by EPA for perchlorate.

Section III, B-4.a - Request for comments about appr opriate exposure values that consider sensitive life stages

Intake Rates MDH strongly supports EPA's reconsider ation to use life-stage specific, high end (95th percentile) drinking water intake rates in the development of alternative HRLs. This is consistent with the approach used by MDH and EPA's recomme ndation to evaluate exposures that are shorter than chronic durations to account for higher intake rates than can occur during shorter periods (EPA, 2002). Additionally, MDH agrees with EPA's approach to use appropriate and relevant body weights for sensitive individuals when calculating intake rates.

To account for lower body weights and higher water intake rates by infants and young children during acute and short-term exposure durations, MD H uses an intake rate of 0.289 L/kg-day, based on the 95th percentile intake for an infant up to 3-months (EPA 2004 & EPA 2008a). The subchronic intake rate we use is 0.077 L/kg-day based on the time-weighted average of the 95th percentile intake from birth up to 8 years of age. The chronic intake rate used by MDH is 0.043 L/kg-day and is based on the time-weighted-average of the 95th percentile intake over approximately 70 years.

Response: See response to comment code 5220.

Commenter Name: Kate Sande Commenter Organization: Minnesota Department of Health , Health Risk Assessment Section

EPA Document ID: EPA-HQ-OW-2009-0297-0663

EPA Comment ID: 28704

EPA Comment Code: 5225

Comment: Section III, B-4.b - Request for comments on the alternative HRLs in Table 2 and which would be an appropriate guideline

The formula used by MDH to calculate a non-cancer health protective drinking water guideline is:

Non-cancer Guidelineduration = (RfDduration x RSC x 1000) / Intake RatedurationEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 461 of 1099 In the table below (Table 1) you will find the rang e of perchlorate concentrat ions in drinking water

that MDH would derive based on our standard in take rates and relative source contributions described above for multiple exposure durations (a cute, short-term, subchronic, and chronic). The drinking water concentrations derived below are for comparison purposes only and do no reflect current MDH guidance.

Table 1. MDH drinking water guidelines compared to EPA HRLs for perchlorate. [see PDF docket ID EPA-HQ-OW-2009-0297-0663]

*We adjusted the life stages used by MDH to conform to EPA's life stages listed in Table 2, section III.B-3 of the Federal Register announcement, however normally, MDH categorizes health guidelines by exposure durations as outlined in EPA's Reference Dose Process guidance (EPA, 2002).

**MDH does not calculate guidlines for each life stage listed in Table 2, section III.B-3 so we only included EPA HRLs that correspond to the life st ages we consider at MDH. The EPA HRLs that were most appropriate for comparison were the ones ca lculated using the 95th percentile intake

rates.

*** We felt a chronic MDH guideline provided the most appropriate comparison to EPA's HRL for pregnant women. The EPA HRL is higher than the MDH guideline because MDH used our default

RSC of 0.2 and EPA used an RSC of 0.62.

Using the MDH HRL approach to calculate theoretical perchlorate drinking water guidelines resulted in a range of perchlorate concentrations of 1-3 ug/L which account for all life stages and sensitive subpopulations. Based on these concentrations, it is likely we would select 1 ug/L as the guideline to ensure the most sensitive individual s are protected. The EPA HRL of 2 ug/L for infants less than 3-months old is much more comparable to the MDH guideline than the interim HRL of 15 ug/L.

Section III, B-4.d Request for comments on the merits of the approach to derive HRLs for sensitive life stages based on the RfD combined the life stage specific exposure data

MDH agrees with the approach of developing HRLs based on the RfD combined with life stage specific exposure data. When developing an HRL, MDH conducts an independent review of the toxicological literature to develop an RfD and calcul ates a drinking water guideline using intake rates

and relative source contributions that are protective of life-stage sensitivities.

MDH commends the alternative approaches described in the EPA Drinking Water: Perchlorate Supplemental Request for Comments announcement. They show that EPA is seriously weighing all life stages and highly exposed sensitive subpopulati ons in the development of a perchlorate HRL.

Thank you for the opportunity to comment. Pl ease contact Kate Sande (651-201-4902) kate.sande@state.mn.us) with the Health Risk Assessment Section in the Environmental Health Division if you have any questions concerning these comments.

Attachment: ReferencesEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 462 of 1099 References

Greer MA; Goodman G; Pleus RC, Greer SE. 2002 . Health Effects Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodine Uptake in
Humans, Environmental Health Pers pectives110(9): 927 - 937. URL: http://www.ehponline.org/members/2002/1 10p927-937greer/greer-full.html

Minnesota Department of Health (MDH). 2008. State of Need and Reasonableness, Technical Support Document for the Health Risk Limit Rules for Groundwater. State of Minnesota, Minnesota Department of Health. URL: http://www.health.state.mn.us/divs/eh/risk/rules/hrlsonar08.pdf

National Research Council (NRC). 2005. Health imp lications of perchlorate ingestion. The National Academy Press. URL: http://www.nap. edu/catalog.php?record_id=11202#toc

U.S. EPA. 2002. A Review of the Reference Do se and Reference Concentration Process. Risk
Assessment Forum, December 2002. URL: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=55365

U.S. EPA. 2004. Estimated Per Capita Water Ingest ion and Body Weight in the United States - An Update Based on Data Collected by the United Sta tes Department of Agriculture's 1994-1996 and 1998 Continuing Survey of Food Intakes by Individu als. Office of Water, and Office of Science and Technology, October 2004. URL: http://www.epa.gov/waterscience/criteria/drinking/percapita/2004.pdf

U.S. EPA. 2005. Reference Dose for Chronic Oral Exposure (RfD) for Perchlorate and Perchlorate Salts. Integrated Risk Information System, February 2005. URL: http://www.epa.gov/iris/subst/1007.htm

U.S. EPA. 2008a. Child-Specific Exposure Facto rs Handbook. National Center for Environmental Assessment, September 2008. URL: http://cfpub.epa.gov/ncea/CFM/recordisplay.cfm?deid=199243

U.S. EPA. 2008b. Interim Drinking Water Health Advisory for Perc hlorate. Health and Ecological
Criteria Division, Office of Science and Technol ogy, and Office of Water, December 2008. URL: http://www.epa.gov/ogwdw000/contaminants/unregulated/pdfs/healthadvisory_perchlo rate_interim.pdf

Response: See response to comment code 5220.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28752

EPA Comment Code: 5225

Comment: B. Alternative HRLs Based Upon Body Weight and Water Consumption of Other Life Stages 4. Request for Comments a. EPA requests comment on whether the alternative HRLsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 463 of 1099 described in this notice appropriately take into account specific and appropriate exposure values for all potential sensitive life stages, including infa nts, children and the fetuses of pregnant women (rather than the 70 kg body weight and 2 liter per day consumption used for past regulatory determinations).

Comment B.4.a.1: The available data do not indi cate a differential effect on potentially sensitive subpopulations (fetuses and neonates). Consequently, alternative HRLs should not be developed for a postulated sensitive sub- population (fetuses and ne onates). Development of alternative HRLs for a postulated sensitive sub-population should be predicated on reasonably rigorous scientific evidence demonstrating the need for such specifici ty. The current reference dose approach is generally believed to be sufficiently conservative to prevent health impacts with a margin of safety.

We understand that the EPA does not find a ne ed to reevaluate the curre nt EPA-adopted RfD of 0.7 ug/kg-day, which is a conservative and heal th-protective reference dose that has a 10-fold uncertainty factor applied to the point of depart ure to account for differences between healthy adults and the most sensitive population: f etuses of pregnant women who might have hypothyroidism or iodine deficiency. Therefor e, the development of alternate HRLs appears unnecessary because the health of the most se nsitive sub-population (fetuses and neonates) has already been considered in setting and adopting the RfD. The need for application of a second tier uncertainty factor has not been demonstrated by the available studies. Application of an appropriately calculated relative source contri bution (RSC) term, as was conducted during development of the January 2009 Health Advisory (HA), appears adequate and appropriate.

It is recommended that EPA support the design and collection of additional clinical data to

determine if additional refinement of the RfD is n eeded to further address health protection of these sub-populations.

b. EPA requests comment on the alternative HRLs in Table 2 and which of these values would be appropriate levels of health concern against which to compare the levels of perchlorate found in public water systems.

Comment B.4.b.1: The available evidence in human populations indicates that all of the values identified in Table 2 are likely to be protective against adverse health effects. The NDEP notes that

the reference dose calculation includes a 10-fol d uncertainty, which was applied to the point of departure during development of the RfD to acco unt for differences between healthy adults and the most sensitive population. NDEP believes that, based upon the currently available data, there is not adequate scientific basis at this time to depart fr om the health-protective Health Advisory level of 15 ug/L. This health- protective value already incorp orates a 10-fold uncertainty factor to account for differences between healthy adults and the most sensitive population: fetuses of pregnant women who might have hypothyroidism or iodide deficiency.

c. EPA requests comment on whether EPA used the best available and most appropriate data to estimate alternative HRLs in Table 2. EPA speci fically requests comment on the drinking water ingestion rates in Table 2 (denoted by footno te c) where the sample size does not meet the minimum data requirements as described in the "Third Report on Nutrition Monitoring in the United States" (LSRO, 1995). Does aggregate life stages (birth to 6 months, and women ages 15 - 44) address sample size limitation and still provide an accurate representation of the exposure to the most vulnerable life stages?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 464 of 1099 Comment B.4.c.1: The fact that some of the data sets relied upon do not meet the minimum data requirements is one of the inherent problems in trying to regulate to a specific subpopulation rather than for the general population. If there was reas onably rigorous scientific evidence supporting the need for such special treatment to be protective ag ainst perchlorate health effects, an exception to minimum data requirements might be reasonable. However, the absence of such evidence, including considerable human data not supporting specia lized sensitive receptor concerns, makes it inappropriate to incorporate these data for perchl orate regulation. The EPA-adopted reference dose of 0.7 ug/kg-day is a conservative and health-prote ctive reference dose that has a 10-fold uncertainty factor applied to the point of departure to accoun t for differences between healthy adults and the most sensitive population: fetuses of pregnant women who might have hypothyroidism or iodide deficiency. Consequently, additional adjustments to the RSC assumptions represent a second source of multiplicative conservatism that appear unn ecessary to protect the sensitive sub-population.

Comment B.4.c.2: Separating the data into aggrega te life stages (birth to 6 months, and women ages 15 - 44) is not necessary as it provides no discer nable value in the calculation of an HRL, HA, or MCL. Steps such as these (separating life stages and grouping some life stages as aggregate life stages) might be justified if there were data demons trating a valid concern for adverse health effects of perchlorate at or near the adopted Health Advisory.

d. EPA requests comment on the merits of the approach described here of deriving HRLs for sensitive life stages based on the RfD combined with the life stage specific exposure data and whether there are other approaches that may be useful for deriving HRLs.

Comment B.4.d.1: The merits of deriving HRLs as described in the August 19, 2009 Federal Register Notice include greater specificity of the risk-based calculations to the receptor population presumed to be of greatest concern, and perhaps reduced uncertainty in the degree of public health protection. However; the need for such an approach for deriving alternate HRLs for perchlorate

that is more refined and conservative is not clea rly supported by the availabl e scientific evidence.

Response: EPA does not believe that an HRL of 15 ug/L adequately accounts for the greater exposure to perchlorate on a per body weight basis that infants and develo ping children have in comparison to adults. This greater exposure is not accounted for within the RfD as the 10-fold uncertainty factor accounts for greater sensitivity to the same exposure, not the fact that a child is likely to be exposed to a greater dose on a per body weight basis. See response to comment code 5220. Regarding the use of exposure data that meet minimum data requirements, EPA has relied on aggregated infant life stage data (i.e., birth to six months) that meet minimum data requirements for calculating the 90th percentile. EPA believes that the 90th percentile values within sensitive life stages appropriately account for variation in consumption on a per body weight basis and are protective of highly exposed individuals in these life stages.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28803

EPA Comment Code: 5225

Comment: a. Whether alternative HRLs take into account specific and appropriate exposure values for all potentially sensitive life stagesEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 465 of 1099 NRDC response: It is appropriate for the HRL to a ccount for an infant's body weight, an infant's dietary intake and relative source contribution fr om water, and other contaminants that share a common mode of toxicity to perchlorate.

A bodyweight assumption appropriate for an adult female does not protect fetuses, infants or children. For example, infants consume almost six times more water (and therefore contaminants) than adults, on average, in proportion to their bod y weight. Therefore, it would not be appropriate to use an adult body weight when converting a refere nce dose into a drinking water standard that is protective of infants and children.

Many infants are breastfed for at least part of thei r first year of life, and perchlorate from both water
and food does enter breast milk. Therefore, the appropriate choice for the breastfeeding scenario is to use an RSC value that reflects perchlorate the mother is taking in through food and drinking

water since she is the source for the infant's breast milk.

Response: See responses to comment codes 5210 and 5220.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28805

EPA Comment Code: 5225

Comment: b. On which of the alternative HRLs in Ta ble 2 would be appropriate against which to compare levels of perchlorate in public water systems

NRDC response: A level of perchlorate below 1 ppb is required to adequately protect vulnerable

newborn babies and their recommended sole source of nutrition, breast milk.

In June 2006, the State of Massachusetts Depart ment of Environmental Protection (MA DEP) and its scientific advisors (MA DEP/DPH Advisory Committee) "unanimously concluded that [the RfD] did not fully account for the uncertainties su rrounding science's understanding of perchlorate toxicity and exposures."[FN46: MA DEP, "Upda te To 'Perchlorate Toxicological Profile And Health Assessment'" March 2006, page xii.] Fo llowing recommendations from their scientific experts, MA DEP finalized an enforceable perc hlorate Maximum Contaminant Level for drinking water and a perchlorate Cleanup Standard of 2 ppb based on a review and assessment of all data available at the time. Likely because the Blount (2006) data were not yet available, the MA DEP drinking water and cleanup standards failed to consider the special exposure patterns of infants born
to low-iodide women, whom we now know are among the most at-risk population based on both high exposure and vulnerability to permanent and se vere neurological impacts. Therefore, an MCL must be below 1 ppb to be truly health protective.

Response: See response to comment code 5220.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 466 of 1099 EPA Comment ID: 28827

EPA Comment Code: 5225

Comment: PART I

EPA's Alternative HRL analysis. It is not clear wh ether EPA's new analysis resulting in new health reference levels (HRLs) is a one-time approach uni que to perchlorate, due to a particular concern about certain subpopulations as noted in the 20 05 National Academies of Science, National Research Council (NAS) report, or a new approach for determining contaminant levels that are of a concern for public health at various life stag es based on EPA's 2005 Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants (2005 Guidance) that will be applied to future regulations.

If it is EPA's intent to apply the 2005 Guidance in this way for future regulations then EPA should clearly state this. AMWA also believes that the anal ysis should be sent to NAS for review since this

is the first time that the 2005 Guidance has been a pplied in an analysis with implications for rule development, which would have major im plications for future rulemakings.

The analysis could be specific to perchlorate as th e contaminant is unique with respect to its health endpoints. As suggested in the peer review document of the drinking water health advisory for perchlorate, "...the biological impacts of perchl orate are very different from those for chemical compounds which have direct target organ toxicity and/or do not directly affect the availability of

an essential element for which homeostasis occurs."

AMWA requests that EPA clearly explain the app licability of the alternative HRL analysis when issuing a final regulatory determination on perchlorate.

In addition, if the most sensitive subpopulation is th e fetus of iodide deficient pregnant women, is the analysis showing new HRLs for children focused on those children who are iodine deficient? AMWA requests that EPA make this clear in it s final determination. AMWA also recommends that EPA should make clear in its final regulatory d etermination whether it still considers the fetuses of pregnant women who are iodine deficient to be the most sensitive subpopulation.

Finally, AMWA asks that EPA discuss the significance of the lack of bioaccumulation of perchlorate in the body as noted in Greer et al., 2002 and NAS, 2005 after exposure and how this is accounted for in its exposure estimates in the HRL analysis.

Response: EPA believes that alternative HRLs descri bed in the August 2009 notice appropriately take into account specific and appropriate exposure values for infants, children and the fetuses of pregnant women (rather than the 70 kg body weight and 2 liter per day consumption used for past regulatory determinations). This analysis is applicab le to perchlorate because individuals at these life stages are particularly sensitive to the effects of perchlorate.

EPA will consider using life stage specific exposure factors where the best available science indicates life stages are particulary sensitive.

EPA's analysis of HRLs does not assu me bioaccumulation of perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 467 of 1099 Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28830

EPA Comment Code: 5225

Comment: NOEL vs. NOAEL

The 2005 National Research Council report recomm ended an RfD of 0.0007 mg/kg by employing two margins of safety. The first was to use the point of departure as a conservative NOEL vs. a NOAEL. In addition, the report recommended appl ying an additional factor of 10 to protect all sensitive groups, including the fetuses of pregna nt women with iodine deficiency and children and

infants.

AMWA asks that EPA clearly explain the signific ance of the NOEL vs. NOAEL in the alternative analysis of HRLs, as it appears that the agency is compounding safety factors that already account for the sensitivity and variability between population groups.

Response: EPA has clearly and consistently explained the basis of departure for the perchlorate RfD using the NRC report language.

EPA does not believe that accounting for specific and appropriate exposure values for all potentially sensitive life stages, including infants, children an d the fetuses of pregnant women "compounds," or "double-counts," the uncertainty factor that has already been applied.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28836

EPA Comment Code: 5225

Comment: 74 FR 41889: "EPA specifically requests comme nt on the drinking water ingestion rates in Table 2 where the sample size does not meet the minimum data requirements as described in the "Third Report on Nutrition Monitoring in the United States (LRSO, 1995)."

Response: AMWA believes that if th e sample sizes for estimates of in gestion rates in Table 2 do not meet minimum data requirements set forth in CDC's LRSO, then they should not be used for HRL development that could be used as a basis for national policy.

Response: As EPA states in the August 2009 notice, for six life stages in Table 2 (birth to < 1 month, 1 to < 3 months, 3 to < 6 months, 16 to 18 years and 18 to 21 years and for pregnant women), the sample size used to estimate some of the drinking water ingestion rates (denoted in Table 2 by foot note "c") do not meet the minimum data requirements as described in the "Third Report on Nutrition Monitoring in the United States ." However, these are the best available data to characterize drinking water ingestion for these spec ific life stages. EPA also notes that these data clearly show the trend that drinking water mean ingestion rate on a per body weight basis increases as the life stage age decreases. Although the approach may have shortcomings, EPAEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 468 of 1099 interpolations/extrapolations are reasonable an d in accordance sound and objective scientific practices.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28840

EPA Comment Code: 5225

Comment: In closing, AMWA again urges EPA to have the alternative HRL and PBPK analysis reviewed as it is a new analysis that was developed by applying for the first time the 2005 Guidance. The potential precedent that will be set if these anal yses are used in rulemaking will have significant ramifications for how future drinking water poli cy is developed. In addition, AMWA recommends

that EPA consider all available science as well as the most recent occurrence data as it prepares its final regulatory decision.

If you have any questions about these comments, please contact me or Erica Brown, Director of Regulatory Affairs and Scientific Program Development at 202-331-2820 or via email: brown@amwa.net.

Sincerely,

Diane VanDe Hei Executive Director Cc: Peter Silva, OW Cynthia Doughtery, OGWDW Eric Burneson, OGWDW Attachment [see PD F docket ID EPA-HQ-OW-2009-0297-0494] Response: EPA has evaluated the available science to inform the regulatory determination.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28843

EPA Comment Code: 5225

Comment: Interpretation of the Physiologically-Based Pharmacokinetic (PBPK) Modeling

AWWA recognizes the value of usi ng models for risk assessment purposes. The Agency, in response
to concerns raised in October 2008, elected to re assess exposure to life stages and broaden the scope of "the most sensitive population" which previo usly had been defined by the National Research Council (2005) as "the fetuses of pregnant wo men who might have hypothyroidism or iodine deficiency." The assessment appropriately follows EPA's Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants (USEPA, 2005) which recommends the following 10 age groups be considered in exposure assessments for children.

- Less than 12 Months old: birth to < 1 month, 1 to < 3 months, 3 to < 6 months and 6 to < 12 months. - Greater than 12 months old: 1 to < 2 years, 2 to < 3 years, 3 to < 6 years, 6 to < 11 years, 11 to < 16 years, and 16 to < 21 years.

AWWA recognizes these important subpopulations, yet is troubled by the lack of recognition in the modeling efforts to incorporate the findings from the most recent and well designed epidemiologicalEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 469 of 1099 studies. These studies provide direct dose-response assessments that should be included into the Agency's modeling effort rather than making presum ptive calculations for pu rposes of estimating a Health Reference Level (HRL) for each life stag e examined. The majority of these studies have

shown no adverse health effects to women of child bearing age, newborns, and school age children who were exposed to significant amounts of perchl orate via drinking water at levels below and above the EPA accepted Reference Dose (RfD) of 0.0007 mg/Kg-day), as well as to other goitrogens. These studies also address the reque st for comment regarding the use of the PBPK model to "explore the relative sensitivity of various life stages".

Response: See response to comment ID 28338 under comment code 5225.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28845

EPA Comment Code: 5225

Comment: Alternative HRLs Based Upon Body Weight and Water Consumption of Other Life Stages

AWWA believes that it is unnecessary for the Agency to adjust for Relative Source Contribution (RSC) when calculating a HRL, since the RfD is based on a No Observed Effects Level (NOEL) and the Greer [FN7: Greer, M., Goodman, G., Pl eus, R., and Greer, S. 2002. Health effects assessment for environmental perchlorate contamination: the dose-response for inhibition of thyroidal radioiodine uptake in humans. Environm ental Health Perspectives, 110:927.] study only measured the incremental exposure to drinking water. The body of data on which the National Research Council (NRC) based their conclusions produced a No Observed Effects Level (NOEL) (not considered a No Observed Adverse Effects Level [NOAEL]because the biochemical changes

measured were not considered adverse in and of themselves) of 0.007 mg/Kg-day. The NRC further recommended a total uncertainty factor of 10 for in traspecies extrapolation (the data were from humans), resulting in a recommended RfD of:

RfD = 0.007 / 10 = 0.0007 mg/Kg-day

The Agency [FN8: USEPA. 2005. EPA Sets Refere nce Dose for Perchlorate. New release dated 02/18/2005. http://yosemite.epa.gov/opa/admpress.nsf/ b1ab9f485b098972852562e7004dc686/c1a57d 2077c4bfda85256fac0 05b8b32!Op enDocument] accepted the NRC's RfD. Typically the RfD would be multiplied by the RSC for ingestion of drinki ng water to obtain a limit on exposure. However, this practice arose from the common use of clinical, epidemiological, or experimental animal studies in which individuals were exposed solely through the route of interest (e.g. ingestion of water). Given a sole route of exposure it is necessary to correct for the fact that individuals in the general population would likely be exposed to a compound through multiple routes. As a result, the application of an RSC in the regulatory proce ss is based on the (often unstated, but nonetheless implicit) assumption that the study population was NOT exposed through routes other than the one of interest, while the general population was exposed through ALL routes.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 470 of 1099 This assumption is not fully warranted in the case of perchlorate because the individuals in the Greer study maintained a normal diet during the period of the study.[FN9: Crawford-Brown, D., Raucher, B., and M. Herrod 2006. Inter-Subject va riability of risk from perchlorate in community water supplies. Environmental Health Perspectives, 114:7:975.] Therefore, they should have been exposed to perchlorate from non-drinking-water rou tes at an Average Daily Rate of Intake (ADRI) value roughly equivalent to that of the gene ral population that is the target of regulatory determinations. This is supported by the FDA's Total Diet Study [FN10: Murray, C.W III, S.K. Egan, H. Kim, N. Beru, P.M. Bolger. 2008. US Food and Drug Administration's Total Diet Study: Dietary Intake of Perchlorate and Iodine. Jo urnal of Exposure Science and Environmental Epidemiology 18:571.] and the NHANES assessments [FN11: Blount, B.C., J.L. Pirkle, J.D.
Osterloh, L. Valentín-Blasini, and K.L. Caldwell. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environmental Health Perspectives. 114:12:1865.],[FN12: Bl ount, B.C., L. Valentin-Blasini, J. D. Osterloh, J.P. Mauldin, and J.L. Pirkle. 2007. Perchlorate Exposure of the US Population, 2001-2002. Journal of Exposure Science and Environmental Epidemiology 17:4 00.], which suggests a ubiquitous exposure to perchlorate from various food sources. If this is the case, application of an RSC would in effect

"double count" the influence of the non- drinki ng-water exposures, because the NOEL from the Greer study already reflected thes e background exposures (absent these background exposures, the NOEL of 0.007 mg/Kg-day would be expected to be higher).

Since the RfD is based on a NOEL versus the traditional NOAEL, EPA is already building in extra levels of protection. The current request for comment s recognizes that this is a departure from the traditional approach and that the NOEL which is based on "using a nonadverse effect that is upstream of the adverse effect is a more conserva tive and health protective approach". The NRC's use of a precursor to an adverse effect is represen ted in Figure 1. The RfD represents a point of departure (POD) that precedes the inhibiti on of iodine uptake by the thyroid.

Figure 2 provides a generic representation of the difference between the NOEL and NOAEL. Given the very conservative and precautionary nature of the RfD, further adjustment of the RfD as suggested by the Agency for purposes of reco mmending HRLs is unwarranted. This is further supported by the epidemiological studies that cover multiple life stages at perchlorate levels above and below the suggested HRLs and observed no adverse effects.

Figure 1. Depiction of Point of Departure (POD ) used to derive NOEL [see PDF docket ID EPAHQ-OW-2009-0297-0415]

Figure 2. Perchlorate RfD represents a conser vative point of departure (POD) for hazard assessment [see PDF docket ID EPA-HQ-OW-2009-0297-0415]

Response: See response to comment code 5210.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28862

EPA Comment Code: 5225EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 471 of 1099 Comment: 4) MassDEP supports setting the HRL on the basis of the life stage(s) with highest exposure and risk with a 90% percentile ingestion rate, which is standard practice. Based on Table 2, this would support an HRL of 2 ppb (or perhaps somewhat lower depending on the exposure estimate for the 7-day old). It is worthwhile to not e that the alternative HRLs calculated using the 95th percentile exposure values for early life stages are not very different than the HRL values estimated using the 90th percentile ingestion rates, especially considering the rounding involved in the final calculation of the HRLs. Although EPA's concern about sample size and aggregation of life stages is legitimate, the aggregati on of life stages in the current document (birth to < 6 months) yield closely similar HRL values derived for life stages birth to < 1 month, 1 to < 3 months, and 3 < 6 months and birth < 6 months and therefore appear to be reasonably stable estimates (Table 2).

Response: See response to comment code 5220.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28864

EPA Comment Code: 5225

Comment: 6) We believe that EPA has used the best av ailable exposure data for deriving the HRLs. Use of the 90% percentile ingestion rate addresse s uncertainties regarding the issue of minimum data set deficiencies for ingestion rates.

Response: EPA has selected HRLs based on the 90th percentile ingestion rates as a basis for the final regulatory determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28869

EPA Comment Code: 5225

Comment: 2. Derivation of alternative Health Reference Levels (HRLs) based upon body weight and water consumption rates for sensitive life stages: The alternative HRL calculation which relies on life-stage specific body weight and water consumpt ion rates is not scientifically justified. Authoritative bodies (e.g., NRC, EPA, the Agency for Toxic Substances and Disease Registry, the California Environmental Protection Agency Office of Environmental Health Hazard Assessment (OEHHA)) have conducted rigorous scientific asse ssments and have determined that the fetus of the hypothyroid pregnant woman is the most sensit ive to perchlorate's potential health effects, not the infant as suggested by the alternative HRL calculation. The Notice provides no scientific evidence that shows otherwise and offers no just ification for basing a HRL on an alternative population that is not the most sensitive. Further, the values given in the Notice for specific exposure assumptions do not meet the Agen cy's own guidelines for data quality. Response: See response to comment ID 28752 under comment code 5225 for a discussion of considering life stage specific exposure data in calculating HRLs.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 472 of 1099 Regarding the comment that the values given in the notice for specific exposure assumptions do not meet the Agency's own guidelines for data qua lity, see response to comment ID 28836 under

comment code 5225.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28879

EPA Comment Code: 5225

Comment: II. RESPONSES TO REQUEST FOR COMMENTS ON ALTERNATIVE

APPROACHES TO ANALYZING SCIENTIFIC DATA RELATED TO PERCHLORATE IN

DRINKING WATER

Compared to the EPA PBPK model, the alternative HRLs listed in the Notice are not scientifically rigorous.

The Agency's process is not transparent in how it might use any of the three alternative approaches described in the Notice to revise its regulatory determination for perchlorate. For example, the Notice does not remark if it intends to use both the PBPK model and the HRL "model." Further, the Notice is not clear about how the Agency intends to integrate the results of these alternative approaches with existing knowledge about the threshold for IUI in average adults.

The comments in this document assume EPA does not intend to apply both the PBPK model and alternative HRLs based on body weight and water c onsumption. Further, this document assumes that EPA seeks input on whether one approach is sc ientifically more accurate than the other for extrapolating from a no effect dose measured in adults to sensitive subpopulations. Overall, the scientific community supports the use of PBPK modeling when all parameters are based on scientific experiments (Mager et al., 2003). When sc ientifically validated, PBPK models can be useful to reduce uncertainty about sensitive life stages. In contrast and as will be discussed below, the HRLs based on body weights and water consumption rates do not reflect a similar scientific basis.

It is important to note the difference between the results in Table 1 of the Notice (which presents the PBPK model-predicted RAIU inhibition for ea ch life stage) and Table 2 (which presents the alternative HRLs based on body weight and water consumption). The RAIU inhibition estimates in Table 1 were computed using a dose of 0.007 mg/kg-d, the Greer et al. (2002) POD. This dose is equivalent to 245 ppb of perchlora te in drinking water if one uses standard EPA default values for body weight and drinking water consumption.[FN7: 0. 007 mg/kg-d x (70 kg adult / drinking 2 L of water per day = 0.245 mg/L or 0.245 ppm or 245 ppb.] The HRLs in Table 2 are based on the perchlorate RfD which is ten times lower, i.e., 0. 0007 mg/kg-d or 24.5 ppb. Therefore, anyone comparing Tables 1 and 2 should recognize a 10-fold difference in the underlying dose assumptions. For example, the highest RAIU inhibition reported in Table 1 is 12.5% for the lactating woman and breast-fed infant exposed to a dose of 0.007 mg /kg-d. At the 10-fold lo wer RfD in Table 2, the RAIU inhibition for the lactating woman and breast -fed infant would be approximately 2%, a value that would not be significantly different from norma l fluctuations because of differences in diet and feeding styles. There is no credible scientific eviden ce that this effect has any biological significance.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 473 of 1099 Based on the EPA PBPK model, at the RfD, the RAIU inhibition for the exclusively breast-fed infant would be approximately 2%, a value that would not be significantly different from normal

fluctuations due to diet.

Response: EPA was transparent in our August 2009 discussion of how we might consider the alternative HRLs in lieu of the single HRL of 15 ug/L used for the October 2008 notice. The agency was also clear that we were reconsidering our app lication of the PBPK model in light of how the comments we had received from both our peer reviewers and the commentors on the notice. See response to comment ID 28923 under comment code 2400 for a discussion of our decision not to use the PBPK modeling to inform the final regulatory determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28886

EPA Comment Code: 5225

Comment: B. Derivation of Alternative HRLs Base d on Body Weight and Water Consumption

Rates for Sensitive Life Stases

The NRC panel and subsequent studies consistently identify the fetus as the most sensitive population for perchlorate health effects evaluation.

In October 2008, EPA calculated an HRL for perc hlorate in drinking water based on the RfD and a RSC of 62%, and EPA's default body weight and wa ter consumption rates for an adult (U.S. EPA, 2008a). Based on a comment regarding the adequacy of EPA's proposed HRL to be protective of sensitive life stages, EPA presented an alternative calculation of an HRL in the Notice based on weight-normalized water intakes for specific life stages.[FN13: For example, EPA says, "One
commenter cites a March 8, 2006, letter from the Children's Health Protection Advisory Committee

to the EPA Administrator. The commenter stat es, "[T]he committee emphasized the higher exposure of infants to perchlorate and greater suscep tibility to serious negative effects associated with perchlorate exposure. Neither of these issues, however, was given adequate consideration in the Preliminary Determination."] EPA has not presented any scientific evidence for why its proposed HRL in October 2008 was inadequate to protect ot her life stages or why it would be necessary to add additional safety factors to the RfD in the form of life stage-specific intake rates. In contrast to the PBPK model, the alternative HRL approach:

* is based primarily on one variable (the water intake rate);

* uses data that are not derived from scientific experiments bu t from a summary obtained in a survey that relies on subject recall rather than direct measurement;

* relies on methods that are incapable of measurin g, estimating, or predicting the effects of a chemical on the body; and

* produces results that are qualitative at best.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 474 of 1099 In summary, determining the most sensitive life stag es based on water consumption rates implicitly makes general assumptions about numerous body functi ons in lieu of actual scientific data about physiological differences between these populati on groups. This "model" does not account for absorption, distribution, or excretion, regardless of the individual's state of development. It implicitly assumes that the potential for exposur e is directly proportional to body weight, without scientific supporting data.

PBPK modeling provides a more sc ientifically defensible approach to characterize the relative sensitivity of different life stages to perchlorate exposure. The Notice's alternative HRL calculations are insensitive, duplicative, and not scientifically warranted.

The Notice should be transparent that the alternati ve HRL calculation it presents is an arithmetic calculation based on only three variables: the RfD, an RSC, and life stage specific water intake rates. Of these, the only scientifically defensible valu e is that upon which the RfD is based- the POD derived from Greer et al. (2002). The RSC is based on the mean intake of perchlorate from the Food and Drug Administration (FDA) Total Diet Study for the nearest age range, and the 90th percentile intake from a NHANES-UCMR analysis for pregnant women and women ages 15-44 that wasconducted for preliminary regulatory determination. Using the 90th percentile is a not a sciencedriven decision. The water intake by body weight is arbitrarily categorized by age (i.e., what is physiologically unique about 6 months of age vers us 5 months of age?). Further, the consumption values for the infant are based on a study in which the study participant had to recall their own (or their infant's) consumption over two non-consecu tive days; no direct measurements were taken. Recall studies are subject to error (called recall bi as) from lapses in memory on estimations of amounts consumed (i.e., what, when, and how much did I eat or drink?). In addition, the population size in this study does not meet EPA's data quality standards.

The EPA has asked for comment on four general que stions regarding the Notice's alternative HRL calculations. Responses to these questions, based on th e best available scientific information, follow.

1. EPA requests comment on whether the alternative HRLs described in this notice appropriately take into account specific and appropriate exposure values for all potentially sensitive life stages, including infants, children and the fetuses of pr egnant women (rather than the 70 kg body weight and 2 liter per day consumption used fo r past regulatory determinations).

The HRL methodology that the Notice describes do es not appropriately account for sensitive life stages for several reasons: (1) the most sensitive population has already been considered in the perchlorate RfD; (2) EPA provides no scientific justification for why this alternative HRL is necessary; and (3) there are no scientific data that meet EPA data quality requirements to substantiate the calculations used to develop these HRLs.

Response: The NRC (2005) identified "the fetuses of pregnant women who might have hypothyroidism or iodide deficiency" as "the most sensitive population," but also identified infants and developing children as additional "sensitive populations." Infants and young children have greater exposure to contaminants in food and water because of greater consumption of food and water on a per unit body weight basis. Therefore, these life stages may be the most vulnerable populations when their relative exposure is consider ed. Therefore, EPA used this approach to derive HRLs by evaluating exposures at different life stages. See response to comment ID 28752 under

comment code 5225 for more discussion.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 475 of 1099 EPA believes that data to evaluate drinking water consumption on a per body weight basis are critical for comparison to the RfD for perchlorate. EPA further believes that the exposure data used by the Agency are the best available peer reviewed data.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28888

EPA Comment Code: 5225

Comment: The historic standard procedure for converti ng the RfD into drinking water equivalent levels (DWELs) assumes 2 liters (67.6 oz) per day of water consumption and a body weight of 70 kg (154 lbs). One important purpose of converting the RfD (in units of mg/kg-day) to a DWEL (in units of ug/L or ppb) is to make it easy to compare water concentrati ons of contaminants to government guidelines. In doing so, EPA conserva tively opts for higher than average intake and lower than average body weight. Thus, these default values are not symmetrically representative of the population. The water consumption (2 liters) default is approximately equal to the 88th percentile water intake for adults aged 20 thro ugh 64 (U.S. EPA, 1997). The default body weight of 70 kg is approximately equal to the 27th percentile of the distribution for adult males aged 18-74 and the 70th percentile of the distribution for adul t females (U.S. EPA, 1997). Because the conversion uses the ratio of body weight to water intake, the us e of lower percentiles in the numerator than are

used in the denominator leads to a biased overestimate of the dose.

The DWEL is based on the RfD. The RfD is defined as (NRC, 2005):

...an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be wi thout risk of deleterious effects during a lifetime. It can be derived from a NOAEL, LOAEL, or BMD, with UFs generally applied to reflect limitations of the data used.

Therefore, by definition, the RfD already accoun ts for the most sensitive population and lifetime exposures. In the most recent review of th e RfD process, the EPA technical committee recommended (U.S. EPA, 2002):

The intraspecies UF is applied to account for variations in susceptibility within the human population (interhuman variability) and the possibility (given a lack of relevant data) that the database available is not representative of the do se/exposure-response relationship in the subgroups of the human population that are most sensitive to the health hazards of the chemical being assessed. As the reference concentration/dose is defined to be applicable to "susceptible subgroups," this UF was established to account for uncertainty in that regard.

EPA remarks that additional factors should not be applied to determine a MCLG. For example, in the Disinfectant and Disinfection Byproduct rule (en acted during the Clinton Administration), EPArejected additional safety factors for children or adjusting the default adult bodyweight/consumption parameters:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 476 of 1099 EPA disagrees that an additional safety factor shou ld be applied to provide additional protection for children or that drinking water consumption relati ve to body weight of children should be used in developing the MCLG (maximum contaminant limit goal). The MCLG presented for chlorite and chlorine dioxide are considered to be protective of susceptible groups, including children, given that

the RfD is based on a NOAEL derived from devel opmental testing. Additionally, current methods for developing RfDs are designed to be protective for sensitive populations. The 2 liter per day water consumption and the 70 kg body weight assu mptions are viewed as ad equately protective of all groups (U.S. EPA, 1998b).

Lifetime exposure includes exposure during infan cy. An RfD that failed to account for exposure during infancy would fail to satisfy the standard definition. Applying life stage specific drinking
water values would, in effect, "double count" the UF that has already been applied.

EPA requests comment on the alternative HRLs in Table 2 and which of these values would be appropriate levels of health concern against which to compare the levels of perchlorate found in public water systems.

The calculated values presented in Table 2 are not scie ntifically justified. Although this table presents levels that have been found in public water systems, there is no health effect associated with the values presented. In fact, every life stage calculat ion in Table 2 corresponds to a no effect level, based on IUI which is a fully reversible, nonadverse effect that occurs on a routine and daily basis.

The NRC noted that the dose at which perchlorat e might cause hypothyroidism is greater than 0.4 mg/kg-d (14,000 ppb using default drinking water and body weight conversions). It states (NRC, 2005):

On the basis of the studies of long-term treatmen t of hyperthyroidism in which patients continued to be given perchlorate after their hyperthyroidism resolved and the clinical studies of healthy adults, the perchlorate dose required to cause hypothyroidism in adults would probably be more than 0.40 mg/kg per day, assuming a 70-kg body weight.

Importantly, the NRC (2005) also emphasizes:

The committee emphasizes that inhibition of iodide uptake by the thyroid has been the only consistently documented effect of perchlorate exposure in humans. The continuum of possible effects of iodide-uptake inhibition caused by pe rchlorate exposure is only proposed and has not been demonstrated in humans exposed to perchl orate (with the exception that in patients with hyperthyroidism doses of 200 mg daily or higher may reduce thyroid secretion).

The PBPK results, as presented in Table 1 of the Notice, show the 1 week old breastfeeding infant to have the greatest RAIU inhibition when its moth er is given a dose 10 times greater than the RfD (e.g., exposure at water concentration of 245 ppb). Th is assumes that the infant would be exclusively breastfed. In calculating the HRL, the age groups that had the greatest intake per body weight, however, were the youngest infants who are exclusi vely formula fed. Based on the PBPK model, the bottle fed infant had a 1.5% change in RAIU inhibi tion, which is well within the normal variation of

RAIU inhibition.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 477 of 1099 2. EPA requests comment on whether EPA used the best available and most appropriate data to estimate alternative HRLs in Table 2 (denoted by footnote c) where the sample size does not meet the minimum data requirements as described in the "Third Report on Nutrition Monitoring in the United States" (LSRO, 1995). Does aggregating lif e stages (birth to 6 months, and women ages 15- 44) address sample size limitation and still provide an accurate representation of the exposure to the most vulnerable life stages?

The drinking water intake rates in the age grou ps are based on USDA Continuing Study of Food Intakes by Individuals from 1994-1996 and 1998. This was a large study of dietary recall and was reported by Kahn and Stralka (2008). Although this may be the best study that the Agency could
find, it is neither sufficient nor does it meet th e scientific standards the EPA's own guidelines demand for a regulatory process.

First, compared to the science-based data used in a PBPK model, water intake is an insensitive variable. It cannot be used for measuring, estimating , or predicting the effects of a chemical on the body. In fact, it does not and cannot estimate or pr edict any effects in the body. This study is not based on a specific experiment, but a summary of data obtained in a survey based on recall rather

than direct measurements. The best and most scient ific process would be to measure and record the

exact amount of fluid or food inta ke at the time of ingestion.

Second, as noted by EPA in the Notice, for some life stages, the data do not meet EPA guidelines on data quality.[FN14: The Notice states "The sample sizes for the estimates of ingestion rates for these life stages do not meet the minimum data requirements as described in the "Third Report on Nutrition Monitoring in the United States" (LSRO, 1995)."] Water intake as the sole variable makes general assumptions about numerous body functions in lieu of actual data. For example, in effect, this calculation does not account for absorpti on, distribution, or excretion, regardless of developmental state. This calculat ion implicitly assumes that the bod y's disposition of perchlorate is directly proportional to body weight. There are no scientific data to support these assumptions.

Third, the study population in Kahn and Stralka (2 008) may not be representative of the U.S. population. The body weights presented by Kahn and Stralka (2008) are lower than that found in 1996-2000 NHANES data, as presented by EPA in the Child Specific Exposure Factors Handbook (U.S. EPA, 2008d) and may not be representative of the general population. For one month olds, the Kahn and Stralka (2008) mean, 90th and 95th pe rcentile body weights are 20, 45, and 24% lower than the NHANES 1996-2000 data. A greater body weight will result in a lower total dose, if intake is the same. The comparison body weights for the th ree youngest age groups are presented in Table 1 in Appendix A.

Fourth, Kahn and Stralka (2008) is a recall study. As noted above, this is a study in which the study participant had to recall their own (or their infa nt's) consumption over two non-consecutive days.

No direct measurements were taken. Recall studies are subject to bias from errors in memory when recalling the amounts consumed (i.e., what, when, an d how much did I eat or drink?). For example, it is possible and not unusual that the person reporting the infant intake estimated a high value for intake. If this occurred for one or two individuals in the study, the data would be skewed (as observed by inspection), overestimating the statisti cal estimation of the 90th and 95th percentile water consumption values.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 478 of 1099 Applying life stage specific drinki ng water values is, in effect, "double counting" the uncertainty factor that has already been applied.

Furthermore, a dietary recall study should repr esent the entire population, not just tap water

consumers. The water intake from Kahn and Stra lka (2008) were calculated based on individual parameters. EPA chose to use the data for con sumers of water only, yet individuals commonly use water from other sources (e.g., bottled, in juice or soda). Since the EPA is interested in developing a MCL, sources of water that would be regulated ar e municipal water systems. One effect of choosing not to use the analysis of all individuals is that th e results are higher than what would be reflected if all data were used. That is to say, this would not be a science-based decision. The results of using ingestion rates from consumer versus all individuals on the alternative HRLs are presented in Table 2 in Appendix A. To illustrate the effect noted a bove of limiting the population, in infants less than one month of age, the proposed alternative HAL based on consumers only was 3 ug/L; if the value for all individuals is used, the water concentration would be 8 ug/L.

EPA reports intake rates and alternative HRLs ba sed on the mean, 90th, and 95th percentiles. Kahn and Stralka (2008) lack sufficient study size and methodology to reliably inform the science related to the general population, as the Notice acknowledges.

One way to gauge whether the 90th and 95th pe rcentile values suggested in the Notice are statistically unreliable is a simple comparison to blood volume. The average adult has a blood volume of approximately 5 L and drinks approxima tely 1.4 L/d, or 27% of their blood volume (U.S. EPA, 1997). It is well understood that infants and children consume more than adults when normalized for body weight, but using the intake ra tes suggested by EPA, the 95th percentile one month old infant would consume 2.6 L/d or 280% of their blood volume. This is the equivalent of the average adult consuming just under 4 gallons, ev ery day. Comparisons of water intake to blood volume are presented in Appendix A, Table 3.

The RfD is based on the study by Greer et al. (200 2) and the researchers in this study did not control dietary intake of perchlorate or other natu ral agents such as nitrate, thiocyanate, or iodine. Perchlorate has been detected in many foods, including but not limited to milk, lettuce, and cantaloupe (Murray et al., 2008). No perchlora te was reported detected in Portland's city water supply (the location of the study) according to UC MR1. Thus, assuming that Murray et al, (2008), is correct, subjects would have received perchlorate from food (See Figure 1). Therefore, the dose of perchlorate that resulted in a NOEL was in addition to the background level of perchlorate ingested through food. If the background dose of perchlor ate from all sources was 0.02 to 0.234 ug/kg-d (the 5th and 95th percentile estimated doses from Blou nt et al. (2007)), then all doses in Greer et al. (2002) underestimate the true dose by this am ount and the RSC has already been considered.

Figure 1. Visual representation of UF, the RfD, an d unaccounted for contribution of perchlorate in food are components of the POD dose. [see PDF docket ID EPA- HQ -OW-2009-0297-0662]

3. EPA requests comment on the merits of the approach described here of deriving HRLs for sensitive life stages based on the RfD combined with the life stage specific exposure data and whether there are other approaches that may be useful for deriving HRLs.

Given the strength of the underlying science in the EPA PBPK model, the proposed HRLs in the Notice do not address sensitive life stages in a scientifically justified manner.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 479 of 1099 Some have suggested that perchlorate should be regulated differently because its acute effects may be detrimental during sensitive life stages. This as sumes that the UF applied to the RfD is not large enough to account for the most sensitive life stage. Such a claim wo uld be not supported by scientific evidence. First, toxicologically speaking, an acute effect is an effect seen after one high dose or an exposure of less than 24 hours. No published study has demonstrated an effect after one exposure to perchlorate at environmental levels. Ev en if acute is meant to refer to effects over several weeks to months (more commonly ter med "subchronic") of exposure, no study

demonstrates adverse effects at environmental leve ls, nor would an effect be expected based on the current scientific literature. As the Greer et al. (2 002) study demonstrated, any IUI at the POD dose

is within normal variation and there is no evidence that any effects, much less any adverse effects, would be expected at doses near the RfD, on a short-term or chroni c (lifetime) basis.

Response: See response to comment ID 28752 under comment code 5225 for a discussion of the use of life stage specific exposure values for d etermining HRLs. See response to comment code

5210 for a discussion of the relative source cont ribution. See response to comment ID 28338 under

comment code 5225 for a discussion of the heal th implications of exposure above the RfD.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28903

EPA Comment Code: 5225

Comment: 2. The proposed use of alternative HRLs based upon body weight and water consumption of other life stages is not a scientifically-based process. If there were a lack of data for a particular chemical, then perhaps this approach would be defensible. For perchlorate, however,

where the effort of scientists to reduce uncertain ty has been long standing and focused, the use of body weight and water consumption would increa se uncertainty. The PBPK modeling provides greater and more biologically significant information.

Response: See response to comment ID 20432 under comment code 5220 for a discussion of EPA's decision regarding the use of the PBPK model in the regulatory determination.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28911

EPA Comment Code: 5225

Comment: Alternative HRLs Based Upon Body Weight and Water Consumption of Other Life Stages

In the October 10, 2008 notice, the proposed Heal th Reference Level (HRL) for perchlorate of 15 ug/L was derived using exposure assumptions for a pregnant woman/fetus exposed to the RfD of 0.7 ug/kg/day with a Relative Source Contribution (RSC) factor of 0.6. In developing this HRL,

USEPA assumed that the fetus is the most sensit ive subpopulation, more sensitive than the infant, so that the infant could be safely exposed to much higher doses than the fetus.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 480 of 1099 We strongly disagree with the assumption that exposure of infants to perchlorate above the Reference Dose is acceptable. We urge USEPA to use exposure assumptions for all potentially sensitive life stages, especially infants and children, to derive alternative HRLs that are protective of all sensitive subgroups. A similar approach that considers exposure assumptions for infants was used by the NJDWQI (2005) in developing its reco mmendation for a perchlorate MCL, and by NJDEP (2009) in developing its MCL proposal. We strongly support USEPA's approach based on combining the RfD, which is intended to pro tect sensitive subpopulations, with exposure data specific for sensitive life stages such as infants. We do not advocate other approaches for deriving

HRLs.

Response: See response to comment code 5220.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28924

EPA Comment Code: 5225

Comment: 2) Alternative Health Reference Levels (page 41889)

ACWA has reviewed the table referenced in th e request for comments and we believe that an

educated answer is not feasible as the various le vels are not based on science connecting exposure to any actual observed adverse health effect. We enco urage USEPA to seek out or initiate studies that may better inform such a significant dataset.

Response: See response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28929

EPA Comment Code: 5225

Comment: On August 19, the agency published a noti ce in the Federal Register seeking comments on its additional approaches to analyzing data rela ted to its perchlorate regulatory determination. These new approaches differ from EPA's prior assessment primarily because they focus on the risks of perchlorate exposure to infants and children, as opposed to the prior assessment that focused on risks to the fetus of the hypothyroid or iodide-deficient woman. EWG fully supports these approaches. Although fetal development is a highly vulnerable life stage for perchlorate exposure, research from the last several years has confirmed that infants and children are an equally high-risk population group due to their small size relative to adults and their high level of perchlorate exposure via water and food.

Response: See response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 481 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28931

EPA Comment Code: 5225

Comment: Appropriateness of alternative HRLs: EWG su pports the alternative HRLs if they are modified to reflect risks to infants from widespre ad perchlorate contamination of powdered infant formula and if infants under six months of age are not aggregated in the agency's exposure

assessment.

Further in its assessment, the agency also lists a nu mber of new Health Reference Levels (HRLs) as an alternative to its proposed HRL of 15 ppb fr om December, 2008. The agency derived these new HRLs by evaluating exposure to perchlorate at di fferent life stages. In Table 2 of the notice, the Agency lists HRLs for 14 different life stages at three different drinking water ingestion rates (average, 90th, and 95th percentile).

Ten of the life stages are for children 16 years ol d or younger, indicating the Agency's recognition that perchlorate exposures vary during each stage of childhood.

For drinking water ingestion rates at the 90th and 95th percentile rates for infants in the three youngest life stages, the Agency notes that the sample sizes for the estimates of ingestion rates do not meet established minimum data requirements. The actual sample sizes for these three groups are 37 (birth to <1 month), 108 (1 to < 3 months), and 269 (3 to <6 months). While they may not meet minimum data requirements, EWG strongly support s their use because these are the best data available (EPA 2008), and because aggregating these age groups masks significant exposure disparities in these critical life stages.

Infants in the youngest two life stages (birth to <1month and 1 to <3 months) have especially high drinking water ingestion rates. HRLs derived from the aggregated life stage of birth to <6 months would place some of the very young infants at high risk of exceeding the current RfD. For example, the HRL for the aggregated life stage at the mean ingestion rate is 4 ug/L. This would leave infants under three months of age at high risk of exceed ing the RfD because they require an HRL of 3 or less to limit cumulative exposure below the RfD.

The HRLs are lowest for children ages two and under, consistent with the published data showing that infants and children have high baseline perchl orate exposures from food and relatively high water ingestion rates; therefore, infants and young children can easily exceed the current RfD by drinking tap water contaminated with even very small concentrations of perchlorate (Murray et al 2008, EWG 2008). For infants six months of age and under, the agency estimates HRLs from 1 to 5 parts per billion, depending on the exact age and mean drinking water ingestion rate.

Response: See response to comment code 5220.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 29098

EPA Comment Code: 5225EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 482 of 1099 Comment: 3) Other sensitive populations should not be forgotten when EPA is addressing levels of health concern and potential numbers of people exposed to perchlorate in drinking water. Other sensitive subgroups not explicitly addressed includ e individuals with low iodine intake, untreated thyroid conditions, those suffering from cardiovascul ar and renal diseases (Miller et al. 2009; Iglesias and Diez 2009), individuals exposed to mixtures of other thyroid stressors, the elderly who are often prone to thyroid problems, and people with thyroi d cancer. The results of Blount et al 2006 also

indicate that women should be considered a sens itive group, certainly at the current RfD.

Response: EPA has calculated HRLs for women ages 15-44 as part of the final regulatory

determination.

EPA agrees that these are sensitiv e groups and will consider them during the rulemaking process.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 483 of 1099 

### EPA Comment Code: 5230 Calculation of frequency of exposure above the HRL among pregnant women

Individual Comments

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20457

EPA Comment Code: 5230

Comment: Table 2 presents a subset of EPA developed estimates of the population served by water systems for which the highest reported perchlorate concentration was greater than various threshold concentrations ranging from 4 ug/L to 25 ug/L. If lower threshold values derived from California, New Jersey, or Massachusetts were applied, the es timated number of potential exposed population would greatly increase. No value was estimated for a threshold corresponding to Massachusetts MCL of 2 ug/L, but is likely to be doubled that projected for a threshold value of 4 ug/L with greater than 30 million people within the United St ates potentially served by Public Water Systems with at least one detection greater than the thre shold. The population estimates for entry or sample points having at least one detection greater than th e threshold would likely be over 10 million, half of whom are female and greater than 210, 000 may be pregnant at anyone time.

[Table 2. Occurrence and Population Estimates for Perchlorate Above Various thresholds - see PDF Docket ID EPA-HQ-OW-2008-0692-1529]

Response: Please see response to comment code 5220.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20649

EPA Comment Code: 5230

Comment: IV (B)(4), p 60277. The calculation of fre quency of exposure makes the argument that a small proportion of women is pregnant at any one time, and therefore th e percentage of the population at risk is quite limited, and there is no meaningful opportunity for a health risk reduction. This calculation ignores the fact that every individu al is born of a pregnant female, and therefore the entire population of exposed individuals can be at risk at a critical formative period. The logical flaw in the EPA argument was to count pregnant female s as at risk, rather than their fetuses, which assumes the effect is transient (in the pregnant females) rather than potentially permanent (in their offspring).

Response: Please see response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working GroupEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 484 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20916

EPA Comment Code: 5230

Comment: However, even with the many errors, flaws, and omissions in EPA’s assessment, EPA still estimates that up to 2 million people throughou t the U.S. could potentially be consuming water with levels of perchlorate that exceed th is HRL. Here is EPA’s exact statement:

"EPA’s best estimate is that 0.9 million people (wi th an upper bound estimate of 2 million people) may be consuming water containing perchlorate at levels that could exceed the HRL for perchlorate and the Agency estimates that fewer than 30,000 of them are pregnant women at any given time" (EPA 2008).

It is astounding that EPA does not think it is neces sary to set a stringent drinking water standard for perchlorate in order to protect 30,000 pregnancies annually. In addition, the 2 million people at risk include infants and children, so the subpopulations within this number that would benefit from a stringent drinking water standa rd would far exceed 30,000.

Response: Please see response to comment code 5220.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21101

EPA Comment Code: 5230

Comment: VIII. EPA Should Publish a More Accurate Estimate of the Population Exposed above

the HRL in the Final Determination

In the proposed determination, EPA estimates that 16,000 pregnant wome n may consume drinking

water with concentrations above the HRL of 15 ppb. It was appropriate to estimate pregnant women, because although we all begin life as a fetus, the fetal exposure period is finite and an individual becomes less susceptible to the effects of possible reduced thyroid function as he ages. The actual number is likely to be much lower th an the estimate in the proposed determination.

Response: Please see response to comment code 5220.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 485 of 1099 

### EPA Comment Code: 5240 Consideration of other sensitive subpopulations (e.g., infants, children, and persons with iodine deficiency or thyroid disorders) when establishing the HRL

Individual Comments

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20419

EPA Comment Code: 5240

Comment: A number of states have recently establishe d perchlorate drinking water standards or goals that are more appropriate than USEPA's HRL published in the Oct 10th FR notice. The New Jersey MCL is 5 ug/L, the California Public Health Goal is 6 ug/L and the Massachusetts MCL is 2 ug/L. These drinking water values were intended to keep perchlorate exposures below the RfD for all groups including young children. Approximatel y 4% of public water supplies serving 17 million

Americans would be in exci.edance of an HRL between 2 and 6 ug/L. This is 15 million more at risk individuals than currently estimated by the Ag ency. Thus, the proposed HRL of 15 ug/L has the potential to leave large numbers of infants inadequately protected against perchlorate.

Response: EPA has determined that perchlorate meets th e criteria for regulating a contaminant in Section 1412(b)(1)(A) of SDWA . When EPA proposes the NPDWR for perchlorate, the Agency will also propose a Maximum Contaminant Level Goal (MCLG) for perchlorate. See response to

comment code 5220.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20627

EPA Comment Code: 5240

Comment: Perchlorate interferes with thyroid function in both animals and humans. A consideration of known differences in thyroi d physiology between adults and neonates/infants supports the conclusion that the neonate and in fant are the most "at risk" population.

Three important differences in thyroid physiology between adults and neonates/infants supports the conclusion that this population is the most vulnerable to perchlorate exposure (reviewed by (Ginsberg et al., 2007)):

1) Serum half-life of the thyroid hormone T4 is sub stantially longer in the adult relative to the neonate (7-10 days (Chopra and Sabatino, 2000)) ve rsus 3 days (Lewander et al., 1989; van den Hove et al., 1999). This means that for adults, serum thyroi d hormone levels are stable in the face of the daily fluctuations in perchlorate exposure and iodi ne uptake that might arise from drinking water contaminated with perchlorate. In contrast, the shorter serum half-life of T4 in the neonate means that there will be a much more rapid response to th e inhibition of iodine uptake by perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 486 of 1099 2) The adult thyroid gland stores a considerable amount of hormone, possibly enough for several months of normal secretion (Greer et al., 2002). Consequently, adults can presumably function normally without new hormone synthesis for extende d periods. In contrast, the neonatal thyroid gland contains essentially no extra hormone and the amount of thyroid hormone in the neonatal gland represents a single day’s worth of hormone (van den Hove et al., 1999). Therefore, the neonate must generate new hormone on a daily basis and perturbations in iodine uptake can have significant consequences.

3) The adult thyroid system can compensate for low thyroid hormone levels and the consequences of low thyroid hormone are likely to be reversible. This is in contrast to the neonatal thyroid gland which does not readily compensate for low thyroi d hormone (reviewed by (Ginsberg et al., 2007)), and the consequences of low thyroid hormone at th is time are not reversible (reviewed by (Rovet, 2002; Zoeller and Rovet, 2004).

Thus, neonates and infants represent unique "at risk" populations in the matter of perchlorate exposure and its effects on public health.

Response: See response to comment code 5220.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20632

EPA Comment Code: 5240

Comment: Considering that the Blount study (Blount et al ., 2006a) is the only study available to the EPA that had the ability to identify a relationshi p between life-time, low-dose perchlorate exposure and thyroid function, this study should supercede the Greer 2002 study for the derivation of the RfD. This study demonstrates that, in women with low urinary iodide, perchlorate exposure at the 50th percentile is associated with a 1.06 ug/dL reduction in serum total T4. While this may be of uncertain clinical significance to adult women, it is clinically significant to an infant during highly sensitive periods of postnatal brain development. In addition, the EPA would then be in a stronger position because it would be regulating on hormone reduction, rather than iodide uptake inhibition. Moreover, it is now conclusively shown that pe rchlorate is transported by the sodium/iodide symporter (NIS) (Dohan et al., 2007) and is found at high levels in human milk (Kirk et al., 2007; Pearce et al., 2007). Thus, the US EPA should recalculate the RfD and HRL based on the CDC study as the point of departure.

Response: See response to comment ID 29096 under comment code 5220.

Commenter Name: Lenny Siegel Commenter Organization: Center for Public Environmental Oversight

EPA Document ID: EPA-HQ-OW-2008-0692-2019

EPA Comment ID: 20853

EPA Comment Code: 5240

Comment: November 24, 2008EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 487 of 1099 US Environmental Protection Agency Office of Water Docket (Mail Code: 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

Ref: Docket EPA-HQ-OW-2008-068

Dear Sirs/Mmes:

In the October 10, 2008 Federal Register EPA ma de a preliminary determination that not enough people in the United States are exposed to significan t levels of perchlorate in public drinking water systems to merit the issuance a national primary drin king water regulation. This is one of the most disappointing and convoluted EPA documents that I have ever reviewed.

To reach that conclusion, it proposes to specify a health reference level of 15 parts per billion (ppb) based on its current reference dose of .7 microgra ms per kilogram per day and a calculation of dietary sources of perchlorate other than drinking water. As other commenter s have explained, EPA has failed to recognize that this health reference le vel exposes young children to levels of perchlorate

above the reference dose.

Response: See response to comment code 5220.

Commenter Name: Apparent Mass Mailing #6 - Earth Justice

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20885

EPA Comment Code: 5240

Comment: Many experts disagree with your assessment th at drinking water with 15 parts per billion of perchlorate is safe and acceptable. Scientis ts from the California Environmental Protection Agency and the Massachusetts Department of Envi ronmental Protection have set stricter standards to will ensure that the most vulnerable populations -- pregnant women, infants, and small children -- are protected from the advers e impacts of perchlorate.

Response: See response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20905

EPA Comment Code: 5240

Comment: * EPA continues to consider pregnant women to be the population most at risk and ignores recent evidence that breast-fed infants and young children are the most highly exposed populations;

Response: See response to comment code 5220.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 488 of 1099 EPA Comment ID: 20913

EPA Comment Code: 5240

Comment: EPA focuses on risks to pregnant women while ignoring evidence of risks to breastfed infants and young children: There have been at leas t four published studies that highlight widespread perchlorate contamination of human breast milk. The most recent of these also postulated that perchlorate is preferentially excreted into breast m ilk when compared with iodine. Just as troubling, the average levels of perchlorate in breast milk in these studies would expose a significant number of breast fed infants to perchlorate levels above EPA RfD of 0.7 ug/kg/day. Breast fed infants do not get thyroid hormones through breast milk and m ust produce these hormones themselves; they are completely dependent on maternal iodine for thyr oid hormone production and perchlorate exposure through breast milk could significantly inhibit th is process. Adequate levels of thyroid hormones during infancy are integral to norma l growth and brain development.

Yet, despite growing evidence that breast fed infa nts are one of the most highly exposed populations and are uniquely vulnerable to perchlorate, EPA chooses to ignore this data. EPA does not even acknowledge this population as being at risk. In fa ct, EPA notes that "The subpopulation that is the most sensitive to perchlorate exposure is the fet us of the iodine-deficient pregnant women" while ignoring the evidence of risks to infants (EPA 2008).

Similarly, young children are also highly exposed to perchlorate; FDA found that perchlorate contaminates 74% of 300 commonly consumed foods and beverages (Murray et al. 2008). It is well established that children eat and drink more, pound for pound, than adults. For this reason, perchlorate contamination of food is especially concerning for young children. FDA finds that among 2 year olds, perchlorate exposures from c ontaminated food and beverages alone fall between 50 and 56% of EPA RfD of 0.7 ug /kg/day (Murray et al. 2008). EWG analysis of FDA data finds that additional exposures to perchlorate from c ontaminated drinking water could easily result in combined exposures that exceed the EPA RfD. Th e average two year old will exceed EPA’s RfD for perchlorate by drinking water that is contaminat ed with as little as 4 ppb of perchlorate (EWG 2008).

EPA does not explore risks to young children in any detail in their assessment, despite clear evidence from FDA research that perchlorate expo sures from food are higher for young children than any other demographic group. As mentioned earlier, EPA focuses on the developing fetus of iodine-deficient pregnant women as the subpopulati on that is at highest risk from perchlorate exposure while explicitly ignoring evidence that breast -fed infants and young children are also at risk.

Response: EPA believes the NRC appropriately based the RfD on iodide uptake inhibition to the thyroid, for the reasons discussed in its report. See response to comment ID 28927 under comment

code 2110.

Commenter Name: Lucy Allen Commenter Organization: Pacific Institute

EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 20926

EPA Comment Code: 5240EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 489 of 1099 Comment: Concern raised by the Children’s Health Advisory Committee regarding the unique levels of exposure and developmental impacts of perchlorate on breast-fed infants were not addressed, and the reference dose[FN1: 0.7 ug/kg /day, or 49 ug/day for an adult weighing 70kg] upon which the EPA based the preliminary decision may not adequately protect the health of breastfed infants. While the health risk posed by pe rchlorate to fetuses of pregnant women with hypothyroidism was considered in the preliminary regulatory determination, we are concerned that the health risk to breast-fed infants was not adequately addressed. Recommendations provided by the Children's Health Protection Advisory Committee (CHPAC) in its March 8, 2006 letter have not been appropriately adopted,[FN2: Children’s Health Protection Advisory Committee. (2006, March 8). Letter to Stephen L. Johnson, EPA Admi nistrator. Accessed Oct. 28, 2008 from http://www.ewg.org/files/chpac-epa_ltr.pdf.] which is especially disconcerting in light of the U.S. Government Accountability Office’s (GAO) recent finding that the EPA has routinely failed to respond to this committee’s findings.[FN3: U.S. Government Accountability Office (GAO). (2008).

Environmental Health: EPA Efforts to Address Children's Health Issues Need Greater Focus, Direction, and Top-level Commitment. Accessed November 4, 2008 from http://www.gao.gov/new.items/d081155t.pdf.] Despi te the EPA’s recognition that children may be more vulnerable to environmental hazards, the GAO found that the EPA has failed to proactively seek advice from the CHPAC and "largely disregarded key recommendations" from the committee.[FN4: GAO. (2008). Environmental Heal th: EPA Efforts to Address Children’s Health Issues Need Greater Focus, Direction, and Top Level Commitment. Retrieved Oct 27, 2008 from http://www.gao.gov/new.items/d081155t.pdf.] In the case of perchlorate, the committee emphasized the higher exposure of infants to pe rchlorate and greater susceptibility to serious negative effects associated with perchlorate expos ure. Neither of these issues, however, was given adequate consideration in the Preliminary Determination.

* Perchlorate is actively transported into human breast milk where it concentrates, resulting in exposure levels above the reference dose for infants feeding on this milk. In the Preliminary Determination for perchlorate, the EPA used a reference dose designed to "estimate the daily oral dose that is likely to have no appreciable risk of deleterious effects during a lifetime"[FN5: National Research Council (NRC). (2005). Health Implicatio ns of Perchlorate Ingestion. Washington, D.C.: The National Academies Press, 208.] of 0.7 ug /kg/day. However, the CHPAC calculated that infants would be exposed to perchlorate levels approximately 5-10 times higher than this reference dose with a maternal exposure of 24.5 ug/L of perchlorate in wa ter, plus a dietary intake of 8.4 ug/day. Because maternal exposure in this calc ulation is above the EPA’s reference dose, we recalculated infant exposure with a total maternal perchlorate exposure equal to the reference dose (0.7 ug/kg/day). The results showed that a breast-f ed infant would be exposed to approximately 5-8 times the reference dose.[FN6: Calculation of infa nt exposure to perchlorate: Nursing Infant Dose (ug/kg/d) = (ug/L in human milk/ug perchlorate in gestion-day) *[(24.5 ug perchlorate/L water)* (L water ingested/day)+ (baseline US dietary ingestion rate, ug/d)]*(L human milk ingested/day/infant body weight) Modified formula used by us to estimate infant exposure, with total maternal exposure equal to EPA’s reference dose of 0.7 ug/kg/day (assuming adult body weight of 70 kilograms, as was used by EPA in the Preliminary Regula tory Determination): Maternal exposure: ( 0.7 ug/kg/day)*(70kg)= 49 ug/day Nursing Infant Dose (ug/kg/d) = (ug/L in human milk/ug perchlorate ingestion-day)*(49 ug/day)*(L human milk ingested/day/infant body weight) Aside from the maternal daily perchlorate exposure, we used the same parameter values as were used by

the CHPAC. Please see the letter from CHPAC of March 8, 2006 for an explanation of these parameter values. Our infant exposure calcul ations: (0.458 day/L)*(49 ug/day)* (0.634 L milk/day/3.69 L) = 3.85 ug/kg/day (0.737 day/L )*(49 ug/day)* (0.634 L milk/day/3.69 L) = 6.20EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 490 of 1099 ug/kg/day Calculation comparing infant exposure (calculated above) to the reference dose: 3.85 ug/kg/day / (0.7 ug/kg/day)= 5.5 6.20 ug/kg/day / (0.7 ug/kg/day)= 8.86]

* Infants are more susceptible to the serious neurol ogical development effects of perchlorate, which can result in irreversible impacts. Due to their life stage, infants can suffer serious neurodevelopmental impacts because their central nervous system is still developing and is susceptible to small deficits of thyroid hormone level; they lack hormone reserves that adults have accumulated to buffer hormone deficits; and they ma y experience a slower cl earance of perchlorate

from their bodies.

Response: Since the NRC also identified infants and developing children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) usi ng the RfD and life stagespecific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th
percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluati ng these potential alternative HRLs and considers them to be levels of public health con cern for purposes of this determination.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20947

EPA Comment Code: 5240

Comment: Perchlorate and Iodine in infants

The CDC study does not capture either perchlor ate exposure or thyroid hormone response in infants, which is an important sensitive subpopulation. A recent study measuring iodine intake in breastfeeding infants found that only 1 in 13 infa nts was receiving adequate levels iodine, based on Institute of Medicine Guidelines (Dasgupta et al. 2008 ). In fact, six infants in the lower half of the group were receiving only between 12 and 29% of the suggested intake values for iodine (Dasgupta et al 2008). In this same study, the ingestion of perchlorate in human milk exceeded the reference dose for perchlorate in 9 out of 13 infants. The co ncentrations of perchlorate and iodine reported in this study were generally similar to earlier studie s, including Kirk et al. 2005 and 2007 and Blount et

al. 2007.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20980

EPA Comment Code: 5240EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 491 of 1099 Comment: In addition to its preliminary determination not to regulate perchlorate in drinking water, EPA has proposed an HRL of 15 micrograms /L (ug/L, equal to parts per billion, ppb) of perchlorate in drinking water, assuming 62% of th e daily perchlorate dose comes from water, and the rest comes from food.[FN4: 73 Fed. Reg. at 60275.][FN5: Calculation of the HRL: For all populations, including pregnant women, the RfD is 0.7 ug/kg/day. EPA reports that for pregnant women, exposure to perchlorate from food is 0.263 ug/kg/day at the 90th percentile, representing nearly 38% of the RfD, and thus leaving an RSC (r elative source contribution) for water of 62% (FR at 60276). This is equavelent to 0.437 ug/kg /day from water, assuming an average body weight of 70 kg, and a daily water consumption of 2 L. Th at is, 0.437 ug x 70 kg body wt. = 30.6 ug perchlorate in 2 L (the daily consumption amount). This is 15 ug/L, or 15 ppb, the HRL.] The HRL "will be the basis for the health advisory value in the health advisory document the Agency expects to issue at that time. Thereafter, it may be appropr iate to use the health advisory value as a "to be considered" (TBC) value in developing potential cleanup levels for perchlorate at Superfund sites."[FN6: Id. at 60265.] The HRL is not protective of sensitive sub- populations and EPA's own scientists have produced strong evidence using PBPK modeling that this level of water

contamination would mean bottle-fed infants would ex ceed the EPA reference dose or ‘safe’ level of 0.7 ug/kg/day by five- fold, and young children wo uld exceed the reference dose by 2.8-fold (based on average food contamination ra tes, average body weights, and 90th percentile water consumption rates for each age group). Furthermore, EPA's HR L determination did not include consideration of a subpopulation that is likely to be highly exposed to perchlorate and uniquely sensitive: the breastfeeding neonate.

Response: See response to comment code 5210 for a discussion of the RSC and response to

comment code 5220 for a discussion of HRLs.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20991

EPA Comment Code: 5240

Comment: B. EPA's analysis fails to consider the heal th risks perchlorate poses to key sensitive sub-populations.

EPA has stated in its preliminary determination that the most sensitive subpopulations are women of reproductive age and the fetus. This determi nation improperly excludes consideration of other sensitive subpopulations including pre-term infant s, neonates and breast-feeding infants. Recent studies demonstrate that infants born to low-iodide women are the most at-risk population, because of both high dietary exposures and because infan cy is a highly sensitive developmental stage. Disruptions to normal hormone activity during this time is likely to result in permanent abnormalities. EPA has not adequately accounted for this sub-population in its analysis or its PBPK modelling.

Infants are routinely being exposed to unsafe levels of perchlorate and a major route of exposure is through contaminated breast milk. A collaborative study from the CDC and Boston University examined breast milk samples from 49 Boston area women and found the median breast milk perchlorate level was 9.1 ppb (range 1.3 to 411 pp b).[FN25: EN Pearce, AM. Leung, BC Blount, HREPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 492 of 1099 Bazrafshan, X He, S Pino, L Valentin-Blasini, an d LE Braverman, 2007. Breast milk iodine and perchlorate concentrations in lactating Boston-area women. J Clin Endocrinol Metab. 92(5):1673-7.]

To make matters worse, the Boston study found that 47 percent of the babies tested were not getting adequate levels of iodine from breast m ilk. Since the effects of perchlorate are compounded by insufficient iodide consumption, these babies are at even greater risk for thyroid hormone disruption. Notably, the Boston study also found that even moms who ingested extra iodine by using iodized salt or taking multivitamins containing iodine did not always have sufficient iodine in their breast milk. This finding un derscores the need for the governme nt to take effective actions to significantly reduce perchlorate contamination of food and drinking water.

The Boston study also measured perchlorate concentr ations in the mother's urine, finding a median level of 3.0 ppb. More important than the actual values, however, is the fact that these concentrations are remarkably similar to levels of perchlorate found in the much larger Centers for Disease Control and Prevention (CDC) study of perc hlorate exposure that tested the urine of more than 2,800 individuals.[FN26: Blount BC, L Valent in-Blasini, JD Osterloh, JP Mauldin, and JL Pirkle. 2007. Perchlorate exposure of the US popula tion, 2001-2002. J Expo Sci Environ Epidemiol. 17(4):400-7.] In that study, the median urinar y perchlorate concentration was 3.6 ppb. Since the perchlorate exposures in the two studies are so clos ely aligned, one can assume that the high levels found in the Boston women's breast milk are, unfortunately, likely to be typical of the general U.S. population.

Response: See response to comment code 5220.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20993

EPA Comment Code: 5240

Comment: C. EPA ignores data showing that pre-birth and newborn infants are a highly vulnerable sub-population based on health impacts.

EPA's preliminary regulatory determination foc uses on the number of pregnant women who are affected by perchlorate contamination; but this anal ysis ignores the fact that prebirth and newborns are also a highly vulnerable subpopulation.

An earlier analysis by scientists with the CDC of a nationally representative sample of 2,299 U.S. residents greater than 12 years of age has documen ted that exposure to perchlorate poses potential health risks to women of child-bearing age and especi ally to their babies (hereinafter referred to as "Blount (2006)").[FN29: Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.] These data were not
available at the time of the NRC review, but ha ve since been published. This study tested the association of chronic perchlorate exposure, as mea sured by urinary perchlorate excretion, with total serum thyroxine (T4) concentration, and thyroi d stimulating hormone (TSH) concentration.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 493 of 1099 For women with low iodine intake (defined by th e World Health Organization as urinary iodine < 100 ug/L),[FN30: World Health Organization (WHO). 1994. Indicators for assessing iodine deficiency disorders and their control through salt iodization. WHO/NUT/94.7. Geneva: WHO/International Council for the Control of Iodine Deficiency Disorders.] very low levels of perchlorate exposure were associated with decrea sed serum T4 and increased serum TSH; the CDC

estimates that 36% of U.S. women have iodine in takes in this range. For iodine-sufficient women (defined as urinary iodine >= 100 ug/L), perchlor ate exposure was associated with increased TSH. Increased TSH is an indicator that the body is a ttempting to compensate for a decrease in thyroid hormone production, and is clinically considered to be a more sensitive marker of subtle thyroid alteration than depressed levels of serum T4. When predicting changes in serum TSH with increasing perchlorate exposures, women with low io dine intake and TSH levels on the high end of the normal range (> 3.11 IU/L) appeared to be the most sensitive group. In this group, any increase in urinary perchlorate predicted an increase in TSH that was consistently more than twice the predicted increase in TSH for women with low iodine levels and median TSH levels. For unknown reasons, perchlorate was not associated with T4 or TSH levels in men. The observed changes in

serum T4 and TSH in women are consistent with our understanding of how thyroid hormones are regulated in the body, and with the mechanism of toxicity of perchlorate.

Importantly, the extremely low levels of perc hlorate were associated with thyroid hormone disruptions - and the magnitude of these disruptions. The CDC researchers found that if a low iodine woman started with perchlorate exposure corresponding to 0.19 ppb in urine (the minimum level found), and then ingested enough perchlorate through food and/or drinking water to raise her urinary perchlorate level to 2.9 ppb (the median level found), her T4 levels would drop by 13%.[FN31: The drop in T4 predicted to be 1.06 ug/dL; the percentage decrease is calculated as compared to the average T4 level found in the CDC study (8.27 ug/dL).] Similarly, if her urinary perchlorate level increased to 5.2 ppb (the 75th percentile exposure), her T4 levels would drop by 16%. The maximum level of perchlorate exposure found was 100 ppb, which translated into a 29%

decline in T4.

The unique physiology of pregnancy and intera ctions between the mother and fetus makes both especially susceptible to the harmful effects of perc hlorate. Maternal T4 is the only source of thyroid

hormone for the fetus in the first trimester. Recent studies have shown that the cognitive development of the fetus is impaired in mothers with even mild disruptions in thyroid hormone levels, prompting the medical community to recommend thyroid hormone replacement therapy for pregnant women who are found to have sub-clin ical hypothyroidism (mildly elevated TSH but normal T4).[FN32: Cooper, D. 2004. Sub-clinical th yroid disease: consensus or conundrum. Clinical Endocrinology 60 (410-412); Haddow JE, Palomake GE, Allan, WC, Williams JR, Knight GJ, and Gagnon J, et al. Maternal thyroid deficiency duri ng pregnancy and subsequent neuropsychological development of the child. New England Journal of Medicine 1999: 341: 54 9-555; Pop VJ, Kuijpens J., van Baar, AL, Verkert, G. et al. 1999. Low ma ternal free thyroxine concentrations during early pregnancy are associated with impaired psyc homotor development in infancy. Clinical Endocrinology 50 (149); Surks M., Ortiz E., Daniel s G., Sawin C., Col N., Cobin R., Franklyn J. Hershman J., Burman K., Denke M., Gorman C. , Cooper R., Weissman N. 2004. Subclinical Thyroid Disease. Subclinical Thyroid Disease. Jo urnal of the American Medical Association 2004: 228-238.]

An analysis by Environmental Working Group repor ted that if the CDC's results for low iodine women with high-normal TSH levels are extrapol ated to the general population, one would expectEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 494 of 1099 more than 2 million women in the U.S. to become subclincally hypothyroidic as a result of drinking water contaminated with just 5 ppb of perchlor ate.[FN33: Environmental Working Group. 2006. Thyroid Threat: Under Proposed Rocket Fuel Stan dards, Many Women Would Need Treatment To Protect Baby. Available at: http://www.ewg.org/n ode/20968] If these women became pregnant, they would require medical treatment to restore th eir thyroid hormones to normal levels and protect their babies from IQ deficits and abnormal development.

Response: See response to comment code 5220.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20995

EPA Comment Code: 5240

Comment: An MCL below 1 ppb is required to adequately protect vulnerable newborn babies and
their recommended sole source of nutrition, breast milk

In June 2006, the State of Massachusetts (MA DEP) and its scientific advisors (MA DEP/DPH Advisory Committee) "unanimously concluded that [the RfD] did not fully account for the uncertainties surrounding science’s understanding of perchlorate toxicity and exposures."[FN45: MA DEP, "Update To 'Perchlorate Toxicological Pr ofile And Health Assessment'" March 2006, page xii.] Following recommendations from their scient ific experts, MA DEP finalized a Perchlorate Maximum Contaminant Level for drinking water and a Perchlorate Cleanup Standard of 2 ppb

based on a review and assessment of all data availabl e at the time. Likely because the Blount (2006) data were not yet available, the MA DEP drinking wa ter and cleanup standards failed to consider the special exposure patterns of infants born to low- iodide women, whom we now know are the most at- risk population based on both high exposure and vulnerability to permanent and severe neurological impacts. Therefore, an MCL must be below 1 ppb to be truly health protective.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21006

EPA Comment Code: 5240

Comment: Furthermore, a maximum contaminant level below 1 ppb would afford reasonable protections to the health of the susceptible populations of pregnant women and breast-fed infants.

Response: See response to comment code 6120.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21018

EPA Comment Code: 5240EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 495 of 1099 Comment: Having reviewed your letter in detail, I’ll now address the specific issues raised.

1. You express concern with in utero and postnatal development, particularly neonates with greater exposure than adults and who lack stores of thyroid hormone.

Specifically, your letter states that EPA’s HRL of 15 μg/L is a flawed benchmark and would allow daily exposures to infants that are 2-5 times high er than the Reference Dose (RfD) and that this lifestage must be adequately protected.

Based upon the conservative and health-protective NAS-based RfD and even more conservative Health Reference Level (HRL) benchmark, this lifes tage will receive significant protection. The HRL

relies on the NAS-recommended RfD that has several le vels of caution built into calculation of the dose. The NAS report recommended an RfD of 0.7 μg/kg-d based on a level that causes no inhibition of iodine update or a No Observed Effect Level (NOEL)--the dose at which no effects occur, adverse or otherwise (NAS, 2005). The NAS panel stated that using a NOEL as the point of departure is a more conservative and health-prote ctive approach than EPA’ s customary approach of using the adverse effect (i.e., using a dose at whic h there is no observable adverse effect level or the Lowest Observable Adverse Effect Level; (NAS, 2005). The NAS panel also took care to distinguish

between a No Observable Adverse Effect Level (NOAEL) and a NOEL. The experts observed that

there was confusion between the two and clarified that the NOAEL is based upon an adverse effect, whereas the NOEL is based upon a dose at whic h no effect occurs, adverse or otherwise. (NAS, 2005). EPA adopted the RfD recommended by the NAS and confirmed that it was conservatively
based on the NOEL, not the NOAEL.

In using a NOEL, the NAS committee adopted a notably cautious, health-protective approach. In addition, the NOEL has an additional safety factor of 10 added this factor to ensure protection for the most sensitive individuals in a population, in th is case, hypothyroid or iodine-deficient pregnant women and their developing fetuses. Importantly , the NAS panel did consider other sensitive populations in addition to pregnant women and thei r fetuses. They also considered the potential effect on infants, developing children, people w ho have compromised thyroid function, and people who are iodidedeficient. While it has been argued that the infant or child is the more sensitive individual in the population; experts from the NAS perchlorate panel, US EPA, CA OEHHA, and others agree that pregnant women and their fetuses are the most sensitive, thus these other sensitive groups would be protected if the most sensitive group is protected.

Response: The comment is addressed to the Children’s Health Protection Advisory Committee, not
to EPA, therefore, a res ponse is not appropriate.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21023

EPA Comment Code: 5240

Comment: 6. Your letter states EPA’s HRL is too high for infants and would allow daily exposures to infants that are 2-5 times higher than the RfD.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 496 of 1099 Perchlorate is not known or likely to occur in pub lic water systems with high enough frequency nor does it occur at levels or public health concern. The NHANES studies and breast milk biomonitoring studies, notwithstanding their lim itations, reveal that the US population is not exposed to levels of perchlorate that could cause an adverse effect, even when all exposure sources -

in food and water - are considered. EPA’s UCMR monitoring found a mean concentration of less than 10 ppb in systems with perchlorate - more than 100 times lower than the NAS’ estimated effect level. Only a few systems have found any samples with concentrations greater than 100 ppb. Even the maximum level detected in the US is approxima tely 50 times lower than the dose at which the NAS panel estimated adverse effects could begin.

Response: The comment is addressed to the Children’s Health Protection Advisory Committee, not
to EPA, therefore, a res ponse is not appropriate.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21099

EPA Comment Code: 5240

Comment: VI. Sensitive Subpopulations Could Be Exposed to Drinking Water with Greater than 15 ppb Perchlorate without Adverse Health Effects

As stated in these comments, in the Intertox summary, and in our comments to EPA's May 1st, 2007 notice, EPA should use an HRL equal to the RfD to reflect the conservative approach of the RfD and the ample evidence that exposure at th e RfD have no effect on individuals, including sensitive subpopulations.

However, even if EPA uses its methodology in the final determination, EPA should use a larger Bin III subgroup to mitigate the potential limitations discussed previously. Using the sample group of females of childbearing age increases the sample size significantly. Switching the subpopulation of concern to women of childbearing age increases the sample size by five-fold, lowering the reliance on just a few observations. More importantly, it captures the subpopulation the NAS panel

identified as the most sensitive - fetuses of wome n with low iodine consumption. The most critical period for the fetus in a woman with sustained iodine deficiency may even occur before she knows she is pregnant. As EPA notes, assigning one value for consumption, body weight, and other parameters to represent all of pregnancy is di fficult. For these reasons , if EPA continues its approach, we recommend EPA use the HRL derived from the Bin III estimate of food consumption for all women of childbearing age.

Response: EPA agrees that would increase the populati on of interest from 97 to 503 but took a conservative approach in looking at women w ho knew they were pregnant during the NHANES survey. We also performed a curve fitting and an an alysis to eliminate outliers. The calculated water dose of 0.559 vs 0.502 for pregnant women would ha ve resulted in an HRL of 19 to 20 vs 15 using the pregnant population.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 497 of 1099 EPA Comment ID: 28513

EPA Comment Code: 5240

Comment: In responding to this threat, EPA must set a drinking water standard for perchlorate that protects the most vulnerable subpopulations, part icularly pregnant women, fetuses, infants, and small children. By interfering with the thyroid's ability to take up iodide, perchlorate can suppress the development of thyroid hormones critical to growth, development, and metabolism. This puts fetuses and children at particular risk for learning and behavioral disabilities; impaired gait, vision, and hearing; and even mental retardation. Expo sure calculations must therefore consider the ingestion rates for these populations, and the reference dose should consider the particular vulnerabilities of these age groups. EPA should also include in its calculations low birth weight babies and underweight infants, as these populations may be extremely vulnerable.

Response: See response to comment code 5220.

Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28544

EPA Comment Code: 5240

Comment: In responding to this threat, EPA must set a drinking water standard for perchlorate that protects the most vulnerable subpopulations, part icularly pregnant women, fetuses, infants, and small children. By interfering with the thyroid's ability to take up iodide, perchlorate can suppress the development of thyroid hormones critical to growth, development, and metabolism. This puts children at particular risk for lear ning and behavioral disabilities; im paired gait, vision, and hearing; and even mental retardation. Exposure calculations must therefore consider the ingestion rates for these populations, and the reference dose should cons ider the particular vulnerabilities of these age groups. EPA should also include in its calculations low birth weight babies, and underweight infants as these populations may be extremely vulnerable.

Response: See response to comment code 5220.

Commenter Name: Diane Henshel Commenter Organization: The School of Public and Environm ental Affairs, Indiana University

EPA Document ID: EPA-HQ-OW-2009-0297-0492

EPA Comment ID: 28600

EPA Comment Code: 5240

Comment: We disagree with the currently recommended HRL of 15 ug/L in drinking water. We have done a landscape scale analysis of newborn Low Birth weight in California counties in which perchlorate was detected in drinking water in at le ast 2 samples. Total number of counties included in the analysis was 13. Interestingly, at least one of the counties which we considered to have relatively high levels of perchlorate in the drin king water was included as a reference county in another study using the same health data, but using different methods to determine effect.

We used regression analysis correlating the incidenc e of very low birth weight (LBW), as determined by the California Department of health services, wi th the mean concentration of perchlorate in theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 498 of 1099 drinking water samples in which perchlorate wa s at or above the detection limit. We found a statistically significant positive correlation betwe en the presence of perchlorate- contaminated drinking water and LBW percentage at the populati on level, even when taking a measure of poverty (%uninsured) into account. Notably, there seems to be no threshold for LBW effects (although the lowest mean concentration evaluated was 3 parts per billion [ppb] perchlorate) and the relationship saturated by 10 ppb perchlorate in drinking water. Note that the effect of perchlorate on low birth weight appears to saturate below the EPA recommended HRL, and had no detectable threshold for the data used. (The detection limit was between 2 - 4 ug/L) Not only is the recommended HRL above a level at which there appears to be a posit ive correlation with increased incidence of LBW in newborns, but it is well above the saturating do se. Thus using 15 ug/L as an inflection point to analyze the differences in effects for populations ex posed to perchlorate in DW above and below 15 ug/L would be biasing the results of the study towa rds artificially finding no effect of perchlorate on LBW (a false negative).

Diane Henshel dhenshel@indiana.edu

Attachment [See PDF Docket ID EPA-HQ-OW-2009-029 7-0492; note this is copyrighted material]

Response: See response to comment code 5220.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28736

EPA Comment Code: 5240

Comment: September 18, 2009

Water Docket Environmental Protection Agency Mailcode 2822T 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Re: Docket ID No. EPA-HQ-OW-2009-0297

Submitted via www.regulations.gov

The Children's Environmental Health Network (the Network) appreciates the opportunity to comment on the importance of regulating perchlor ate in drinking water. We wish to associate ourselves with the comments submitted by Cl ean Water Action, the Center for Public Environmental Oversight et al on this topic.

The Network is a national organization whose missi on is to promote a healthy environment and to protect the fetus and the child from environmen tal health hazards. The Network's Board and committee members include internationally- recognized experts in children’s environmental health science and policy who serve on key Federal advisory panels and scientific boards. We recognize that children, in our society, have unique moral standing. The Children's Environmental Health Network was created to promote the incorporation of basic pediatric facts such as these in policy and practice:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 499 of 1099 * Children;s bodies and behaviors differ from adul ts. In general, they are more vulnerable than adults to toxic chemicals. * Children are growing. Pound for pound, children eat more food, drink
more water and breathe more air than adults. Thus, they are likely to be more exposed to substances

in their environment than are adults. Children ha ve higher metabolic rates than adults and are different from adults in how their bodies absorb, detoxify and excrete toxicants. * Children's systems, including their nervous, reproductive, digestive, respiratory and immune systems, are developing. This process of development creates periods of vulnerability when toxic exposures may result in irreversible damage when the same expos ure to a mature system may result in little or no damage. * Children behave differently than adults, leading to a different pattern of exposures to the world around them. For example, they exhibit hand-to-mouth behavior, ingesting whatever substances may be on their hands, toys, household items, and floors. Children play and live in a different space than do adults. For example, very young children spend hours close to the ground where there may be more exposure to toxicants in dust, soil, and carpets as well as low-lying vapors such as radon, mercury vapor or pesticides. * Children have a longer life expectancy than adults; thus they have more time to develop diseases with long latency periods that may be triggered by early environmental exposures, such as cancer or Parkinson's disease.

Clear, sound science underlies these principles . A solid consensus in the scientific community supports these concepts.

The world in which today's children live has changed tremendously from that of previous generations. There has been a phenomenal increase in the substances to which children are exposed. According to the EPA, more than 83,000 industri al chemicals are currently produced or imported into the United States. Thousands of chemicals are ubiquitous in our environment worldwide.

Traces of hundreds of chemicals are found in all humans and animals. Every day, children are exposed to a mix of chemicals, most of them unte sted for their effects on developing systems. Many of these chemicals are readily passed across the placenta to the fetus, to the infant via breast milk, or via toys and other children's products. Many of thes e chemicals are also ingested in food and water. Many also are absorbed by children through the lungs by respiration of contaminated air.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28738

EPA Comment Code: 5240

Comment: In responding to this threat, EPA must set a drinking water standard for perchlorate that protects the most vulnerable subpopulations, part icularly pregnant women, fetuses, infants, and small children. By interfering with the thyroid's ability to take up iodide, perchlorate can suppress the development of thyroid hormones critical to growth, development, and metabolism. This puts fetuses and children at particular risk for learning and behavioral disabilities; impaired gait, vision, and hearing; and even mental retardation. Expo sure calculations must therefore consider the ingestion rates for these populations, and the reference dose should consider the particular vulnerabilities of these age groups. EPA should also include in its calculations low birth weight babies, and underweight infants as these populations may be extremely vulnerable.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 500 of 1099 Response: See response to comment code 5220.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28815

EPA Comment Code: 5240

Comment: However, even if EPA proceeds with its d etermination not to regulate perchlorate and instead finalizes an HRL, that level must be adjust ed to account for the actual data from the PBPK model showing that hundreds of thousands of infant s would exceed the safe daily perchlorate intake levels at the proposed HRL.

These comments are respectfully submitted for your consideration,

Jennifer Sass, Ph.D. Mae Wu, JD

Response: See response to comment code 5220.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection (MassDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0495

EPA Comment ID: 28861

EPA Comment Code: 5240

Comment: Section III(B): Comments on Alternative Approa ches for Calculating Health Reference Levels (HRLs)

1) MassDEP recommends that EPA use the approach to setting HRLs as shown in Section III,

Subsection B-3.

2) We support EPA's reassessment of exposure assum ptions for life stages, including fetuses of gestation week 40, infants and developing child ren. Application of EPA's Guidance on Selecting Age Groups for Monitoring and Assessing Childho od Exposures to Environmental Contaminants is appropriate along with application of EPA's Gu idance for Risk Characterization to convey the variability in risk levels experienced by different individuals in the population. In doing so, EPA has appropriately taken into account specific and appropriate exposure values for many but not all potentially sensitive life stages. Because of the poten tial sensitivity of the early neonatal period from birth to several days thereafter, we believe that expo sures to the bottle-fed 7- day old should also be considered. In EPA's Interim Drinking Water Health Advisory for Perchlorate, the 7-day old bottlefed infant was estimated to have the highest perchlorate exposure per body weight.

Response: See response to comment code 5220. Since the NRC also identified infants and developing children as additional life stages, EP A derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life stage-specific exposure info rmation in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water th at may result in total perchlorate exposures (from food and water) greater than the RfD for individual s at each life stage. These HRLs are calculatedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 501 of 1099 based on individuals who consume an average am ount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 pe rcent of their cohorts. EP A is evaluating these potential alternative HRLs and considers them to be levels of public health concern for purposes of

this determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28876

EPA Comment Code: 5240

Comment: Vulnerable populations have been considered since the first risk assessment in 1998. All of EPA's interim guidance and the current RfD (whi ch is the basis for the 2008 HRL) are based on the most sensitive subpopulation, the developing fetus.

A small percent of those who commented on EPA's preliminary regulatory determination opined

that the infant or child is the most sensitiv e population to perchlorate health effects; however, experts, including authoritative bodies such as the National Academy of Sciences (NAS) National Research Council (NRC) perchlorate committee as we ll as federal and state agencies such as the EPA, the Agency for Toxic Substances and Disease Registry (ATSDR), the California Environmental Protection Agency Office of Envir onmental Health Hazard Assessment (OEHHA),
and others, conclude that the fetus is the most sensitive population to protect (all others being less sensitive than the fetus are therefore protected). Fu rthermore, questions about alternative life stages being more sensitive to perchlorate exposure have been addressed in the past; EPA began focusing on the most sensitive life stage as the foundation of he alth protection as early as 1998 in its first risk assessment (U.S. EPA, 1998a).

Response: Since the NRC also identified infants and developing children as additional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) usi ng the RfD and life stagespecific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water that may result in total perchlorate exposures (from food and water) greater than the RfD for individuals at each life stage. These HRLs are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th
percentile dietary intake estimate), but who consum e equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluati ng these potential alternative HRLs and considers them to be levels of public health con cern for purposes of this determination.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28887

EPA Comment Code: 5240

Comment: Some have opined that the infant is the most sensitive individual in the population, but no scientific basis for this has been presented. The weight of evidence shows that the fetal brain is more sensitive to hypothyroidism than the neonate or infant brain (Boelaert and Franklyn, 2005).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 502 of 1099 There is no scientific evidence presented in the No tice that demonstrates that other life stages are more sensitive with regard to the development of health protective toxicity guidelines values than

the fetus.

The NRC considered all possible sensitive populati ons in addition to pregnant women and their fetuses; this included infants, developing child ren, people who have compromised thyroid function, and people who are iodide-deficient, as sensitive to perchlorate exposure. Based on its assessment, the NRC committee states that "...fetuses and pret erm newborns constitute the most sensitive populations although infants and developing child ren are also considered sensitive populations" (NRC, 2005). The purpose of defining an RfD base d on "the most sensitive population" is that all other populations, including those that are more sens itive than average (but less sensitive than the most sensitive), would not be expected to have adverse effects, including at doses that exceed the RfD. To date-and with substantial scientific justif ication-the EPA, ATSDR, th e states of California, Massachusetts, and New Jersey all regard fetuses to be the most sensitive population for health

effects evaluations.

The RfD is an estimate or a representation of the a cceptable level of risk fo r a lifetime of exposure.

It is not a threshold above which adverse effects occur.

Reliable scientific studies published since NRC (200 5) continue to demonstrate that no observable effect occurs at doses below the RfD. On a weigh t-of-evidence basis, the scientific literature demonstrates no significant health risk to the most sensitive individuals who consume water on a daily basis over a lifetime at environmentally releva nt doses. Overall, these studies demonstrate that perchlorate is a ubiquitous chemical. It is naturally formed and is ubiquitous in the environment (Dasgupta et al., 2005), food (Murray et al., 20 08), and the human body (Blount et al., 2006; Pearce et al., 2007b).

The RfD is an estimate of the acceptable level of risk for a lifetime of exposure. It is not a threshold above which adverse effects occur. This is particularly true for the perchlorate risk assessment which
is based on a NOEL, a more conservative POD than a NOAEL or LOAEL. EPA is correct in setting acceptable exposure levels with margins of sa fety. This allows, for example, an individual to consume a dose above the RfD on one day and in gest a lower dose on a subsequent day. When considering perchlorate, the issue relative to other chemicals is less of a concern: perchlorate is not metabolized, does not bioaccumualate, and the half-life is approximately 8 hours. Thus, in the rare

instance of an exceedence of the RfD over the s hort term, perchlorate leaves the body quickly. Currently, EPA's use of a ten-fold intraspecies factor in the RfD effectively covers the potential for differences in sensitivity and exposure.

The RfD is based on a NOEL for IUI. IUI is not adve rse. It is not scientifically justified to use drinking water rates for specific life stages to lo wer the HRL when the current RfD already has an OF applied to account for the most sensitive indi viduals. EPA offers no justification for why other life stages might be currently at risk or why a dditional protection is needed. EPA remarks "The NRC (2005) identified 'the fetuses of pregnant women who might have hypothyroidism or iodide deficiency' as 'the most sensitive population,' but also identified infants and developing children as additional 'sensitive populations.'" The purpose of defining an RfD based on "the most sensitive population" is that all other populations, including those that are more sensitive than average, would not be expected to have adverse effects, includ ing at doses that exceed the RfD. In addition,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 503 of 1099 reporting that the HRL could be lower in a group th at is not the most sensitive without scientific support is not in compliance wi th the scientific method.

Bereft of scientific evidence, the Notice fails to present justification to alter the HRL based on specific life stages, particularly when the current RfD already has an uncertainty factor applied to

account for the most sensitive individuals.

The purpose of defining an Rf D based on "the most sensitive population" is that all other populations, even if they are more sensitive than average, would still be unlikely to suffer adverse
effects, even at doses that exceed the RfD.

Response: EPA disagrees, the life stages at which indivi duals are most sensitive and therefore at greatest risk of adverse effect (the fetus, infant, and developing child) are inherently less than a lifetime. See response to comment ID 28338 un der comment code 5225. Since the NRC also identified infants and developing children as addi tional life stages, EPA derived potential alternative HRLs for 14 life stages (age groups) using the Rf D and life stage-specific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47

μ g/L and are the concentrations of perchlorate in dr inking water that may result in total perchlorate exposures (from food and water) greater than the Rf D for individuals at each life stage. These HRLs

are calculated based on individuals who consume an average amount of perchlorate from food (except for pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their cohorts. EPA is evaluating these potential alternative HRLs and consid ers them to be levels of public health concern for purposes of this determination. See response to comment 5220.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 504 of 1099 

### EPA Comment Code: 5300 SDWA Criterion #3 – EPA’s determination that regulating perchlorate with a NPDW R would not represent a meaningful opportunity to reduce health risks for persons served by public water systems

Response to Code 5300 : Using the criteria mandated by the 1996 SDWA Amendments EPA has determined that regulation of perchlorate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems and has decided to begin development of a national primary drinking water regulation for perchlorate. See response to

comment code 6120.

Individual Comments

Commenter Name: Apparent Mass Mailing #1 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19688

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: Apparent Mass Mailing #1 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19688

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0117

EPA Comment ID: 19698

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: J Mason Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 505 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0145

EPA Comment ID: 19727

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: A. Lane Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0276

EPA Comment ID: 19782

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: S. G. Gompf Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0490

EPA Comment ID: 19912

EPA Comment Code: 5300

Comment: By EPA's own data collection, perchlorate is present in drinking water in 35 states; by independent studies, the EPA has permitted up to 40 million Americans to be exposed to this

harmful chemical.

Setting a standard for perchlorate is absolu tely â€ ̃a meaningful opportunity for health risk reduction.â€TM I urge the EPA to do so in accord ance with the Safe Drinki ng Water Act and protect

the health of America's mothers and children.

Response: See response to comment code 5300.

Commenter Name: Rebecca Fletcher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0530

EPA Comment ID: 19943

EPA Comment Code: 5300

Comment: We need to create standards for regulating the presence of this chemical in our water. Setting a standard for perchlorate will absolutely present â€ ̃a meaningful opportunity for health risk reduction.â€TM I urge you to do so in accordan ce with the Safe Drinki ng Water Act and protect

Americansâ€TM health.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 506 of 1099 Thank you!

Wishing you good health, Rebecca Fletcher

Florence, MA 413-863-9038

Response: See response to comment code 5300.

Commenter Name: Margaret Baco Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0624

EPA Comment ID: 19997

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will ab solutely present â€ ̃a meaningful opportunity for health risk reduction.â€TM I urge you to do so in accordance with the Safe Drinking Water Act and protect Americansâ€TM health. The absolute lowes t level should be established immediately, with the commitment to essentially eliminate fu rther contamination. Clean water is our greatest

national resource.

Response: See response to comment code 5300.

Commenter Name: Apparent Mass Mailing #4 - Natu ral Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20017

EPA Comment Code: 5300

Comment: All Americans deserve healthy and clean dr inking water. The EPA should not finalize this decision until the scientific review is compl ete and should make decisions that are consistent with the agency's own scientists. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity for health risk reduction."

Response: See response to comment code 5300.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0776

EPA Comment ID: 20186

EPA Comment Code: 5300

Comment: * a national primary drinking water regu lation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 5300.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 507 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0671

EPA Comment ID: 20245

EPA Comment Code: 5300

Comment: Perchlorate is found in drinking water in 35 states, and according to the EPAâ€TMs own data, 16 million Americans are at risk of being exposed to this dangerous chemical. Setting a standard for perchlorate will absolutely presen t â€ ̃a meaningful opportunity for health risk

reduction.â€TM

Response: See response to comment code 5300.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0163

EPA Comment ID: 20272

EPA Comment Code: 5300

Comment: Second, Rubin, etal (see reference 2 electronic attachment - "Rubin trade off health risk final.pdf") [see PDF of docket ID EPA-HQ- OW-2 007-0068-0163] have documented quantitative evidence that when regulatory costs increase in th e order of $25 per month, significant numbers of customers are forced into spending choices that have health outcomes that may outweigh the projected benefits of the regulation. NRWA strongly feels that when evaluating whether a regulation will result in a meaningful health benefit, EPA must take these effects into consideration. This is essentially an affordability issue and NRWA reco mmends that EPA include appropriate affordability

criteria in its CCL evaluation and its future d eterminations when regulating or not regulating perchlorate.

Response: EPA has determined that the following three SDWA criteria for regulatory determination have been met for perchlorate: (1) It has an adverse effect on the health of persons; (2) It is known to occur in public water systems with a frequency and at levels of public health concern; and (3) In the sole judgment of the Ad ministrator, regulation of perchlorate presents a meaningful opportunity for health risk reduction for persons served by public water systems. . This action notifies interested parties of EPA’s determina tion to regulate perchlorate, and thus imposes no requirements on public water systems. This action also initiates the process to develop a national primary drinking water regulation (NPDWR) for perchlorate. EPA will now begin developing a proposed NPDWR and Maximum Contaminant Level Goal (MCLG). EPA plans to publish the proposed NPDWR for public comment along with heal th risk reduction benefits, and cost analyses, feasibility analyses and other analyses required for regulatory development under the SDWA. In proposing an NPDWR the Administrator will also de scribe variance technology for perchlorate that

the Administrator finds are available and affordab le for public water systems of varying size, considering the quality of the source water to be treated.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20282

EPA Comment Code: 5300EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 508 of 1099 Comment: EVALUATION OF POTENTIAL HEALTH EFFECTS ALONG WITH

OCCURRENCE AND EXPOSURE RESULTS REVEALS THAT REGULATION OF

PERCHLORATE WOULD NOT PRESENT A MEANINGFUL OPPORTUNITY FOR RISK

REDUCTION

EPA establishes the HRL based on the RfD and the RSC and then compares the occurrence data to the health benchmark. Assuming an RSC of one (wh ich yields an HRL of 24.5 ppb drinking water equivalent), the population exposed to perchlorate in drinking water above EPA’s evaluative criteria

- 1⁄2 and 1 times the health benchmark - are small fr actions of the total population served by public drinking water systems. The populations exposed to perchlorate above these benchmarks is lower than the populations for other chemicals for whic h EPA has determined a drinking water standard would not reduce risk in a meaningful manner.

A comparison of occurrence data for perchlor ate and relevant compounds from EPA’s CCL 1 regulatory determinations and CCL2 proposed determi nations reveals that perchlorate ranks as a lower opportunity for risk reduction than sodium, mang anese, sulfate, and boron, all four of which EPA has made or proposed determinations not to regulate.

Further explanation of our evaluation of the thir d statutory criteria for meaningful opportunity for

risk reduction is contained in Attachment 4 [See PDF of docket ID EPA-HQ-OW-2007-0068- 0168].

Response: See response to comment ID 21028 under comment code 5200.

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20423

EPA Comment Code: 5300

Comment: The third condition of the SDWA, that the Agency has a meaningful opportunity for health risk reduction, is also met for perchlorate. The setting of an MCL will trigger requirements for testing to determine whether there are exceedance s, and fortunately, sensitive test methods and effective treatment systems are readily available. Therefore, the Administrator has the opportunity to intervene to protect the health of millions of pr egnant women and their fetuses, and lactating women and infants across the country who would otherwise be exposed to unsafe levels of perchlorate.

Response: See response to comment code 5300.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20434

EPA Comment Code: 5300

Comment: 9. MassDEP Believes That a National Perchlorate Drinking Water Standard Provides a Significant Risk Reduction Opportunity. Table 2 of the Federal Register publicationEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 509 of 1099 provides information on the occurrence and popula tion estimates for perchlorate above various thresholds. The table shows that up to 2.0 milli on people would be provided drinking water above 15 ppb, a value that, based on EPA’s own estimates, is not protective of the breast or bottle fed infant, yet which is EPA’s proposed HRL. EPA does not explain in the Federal Register how it reached its conclusion that protecting up to 2.0 million people is not a meaningful opportunity for risk reduction for persons, in particular in fants, served by public water systems.

Response: EPA has determined that perchlorate meets the criteria for regulating a contaminant in Section 1412(b)(1)(A) of SDWA. As previously discussed in the Federal Register Notice, perchlorate may have an ad verse effect on the health of persons and perchlorate is known to occur or there is a substantial likelihood that perc hlorate will occur in public water systems with a frequency and at levels of public health concern. Moreover, in light of the discussion in this notice and the information available at this time, the Administrator finds that regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons served by public water systems. Therefore, EP A will initiate the process of proposing a NPDWR for perchlorate. See response to comment code 6120 and 5220. See response to comment code 5220.

Commenter Name: J. Green Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0148

EPA Comment ID: 20462

EPA Comment Code: 5300

Comment: Setting a standard for perchlorate will absolutely present ‘a meaningful opportunity for health risk reduction.’ I urge you to do so in accordance with the Safe Drinking Water Act and protect Americans’ health.

Response: See response to comment code 5300.

Commenter Name: Raimonde Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1513

EPA Comment ID: 20502

EPA Comment Code: 5300

Comment: With respect to EPA- HQ-OW-2008-0068:

It is recognized that this issue has been a difficu lt one and much work on behalf of EPA with it's extensive resources and interest groups, the dominant ones also possessing significant resources. However, EPA's proposal to avoid regulation fails to meet the Agency's overarching mandate to protect human health and the environment. We k now of specific cases where in fact perchlorate exposure has affected public health and in those cases, there is little choice but for the public to consume a basic resource made available by their communities or their other limited means of water supply.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 510 of 1099 Although considering the argument regarding si gnificance of the percentage of water supplies affected accounting for a small percentage, EPA ha s inproperly weighted its importance. What it has thus done, is use a predjudiced method to arrive at a conclusion that by regulating perchlorate, it would have no material effect on improving human health. This is clearly incorrect as the data reviewed by the wider scientific community has c oncluded that there are negative health effects resulting from exposure, some of them quite seri ous. We further know through no small body of evidence that regulating contaminants has dem onstrated, without question, the improvement on public health. By arbitrarily setti ng the criteria at some percenta ge affected is contrary to sound public health protection and contrary to the public's expectation for EPA.

For EPA to conclude based on the guidance criteria interpreted narrowly to mean that some percentage of affected are not significant is plainl y contrary to the principles of the mandate to protect human health and the environment.

I encourage the Agency to reconsider this matter and set a national standard.

Response: See response to comment code 5300.

Commenter Name: Thomas L. Schoaf Commenter Organization: Cities of Litchfield Park and Goodyear, AZ

EPA Document ID: EPA-HQ-OW-2008-0692-1552

EPA Comment ID: 20520

EPA Comment Code: 5300

Comment: Given that the first two SDWA criteria have been met, and that there are available technologies to treat perchlorate, we believe that th e third and final criterion has also been met and that a national standard set by the EPA pres ents a meaningful and appropriate risk reduction opportunity.

Further, a national standard is necessary to avoid a patchwork of potentially conflicting regulations amongst the various states . This is even more crit ical given that many states share water resources (such as the Colorado River water shared by Arizona and six other western states).

Therefore, we, the undersigned, request that th e EPA reconsider its determination and establish a national maximum contaminant level for perchlorate

Respectfully,

Thomas L. Schoaf, Mayor City of Litchfield Park

James Cavanaugh, Mayor City of Goodyear

cc: Senator John McCain Senator Jon Kyl Congre ssman Trent Franks Senator Robert Blendu Representative John Nelson Representative Je rry Weiers Councilmembers, City of Goodyear Councilmembers, City of Litchfield Park

Water Docket, Docket ID No. EPA-HQ-OW- 2008-0068 Environmental Protection Agency Mailcode : 2822T, 1200 Pennsylvania Ave., NW, Washington, DC 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 511 of 1099 Mary Aycock U.S. Environmental Protection Agen cy Region IX 75 Hawthorne Street SFD-8-2 San
Francisco, CA 94105-3901

Cathy O'Connell Arizona Department of Environmental Quality 1110 W. Washington Street
Phoenix, AZ 85007

Response: See response to comment code 5300.

Commenter Name: Jimmy Spearow Commenter Organization: Sacramento Chapter, Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-1672

EPA Comment ID: 20590

EPA Comment Code: 5300

Comment: The data show that not regulating this ha rmful chemical in our drinking water is unacceptable. We disagree with the EPA statment th at a national standard for perchlorate "would not present 'a meaningful opportunity for health risk reduction.'" Setting a standard for perchlorate will absolutely present 'a meaningful oppor tunity for health risk reduction.'

Response: See response to comment code 5300.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association

EPA Document ID: EPA-HQ-OW-2008-0692-1669

EPA Comment ID: 20620

EPA Comment Code: 5300

Comment: Rubin, etal (see reference 1 electronic attach ment - "Rubin trade off health risk final.pdf") [See PDF Docket ID EPA-HQ-OW-2008 -0692-1669] have documented quantitative evidence that when regulatory costs increase in th e order of $25 per month, significant numbers of customers are forced into spending choices that have health outcomes that may outweigh the projected benefits of the regulation. NRWA strongly feels that when evaluating whether a regulation will result in a meaningful health benefit, EPA must take these effects into consideration. This is essentially an affordability issue and NRWA reco mmends that EPA include appropriate affordability criteria in its final determination to not regulate perchlorate.

Response: See response to comment code 5300, comment ID 20272.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20651

EPA Comment Code: 5300

Comment: IV (C), p 60280. A meaningful opportunity for health risk reduction. When drinking water consumption estimates that are protective of the exposed population are included in theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 512 of 1099 population exposure estimates, the number of peopl e exposed to estimated excessive levels of perchlorate is markedly increased. When it is cons idered that the population at risk is not pregnant
women, but their fetuses - and we all are fetuses once in our life - the population at risk balloons. Therefore it seems to us that the opportunity for a meaningful health risk reduction has been greatly

understated.

Response: See response to comment code 5300.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20655

EPA Comment Code: 5300

Comment: Fourth, since the scientific literature on perchlorate is extensive, EPA can rely on multiple approaches to determine that there would not be a meaningful opportunity for risk reduction through a national drinking water standard . As the PSG has stated in its public comments to EPA’s May 1, 2007 notice (see attached)[No atta chement provided], EPA reached its conclusions through several approaches, all with ample scientif ic justification. The literature on human health effects from perchlorate consists mainly of clinic al, occupational, or ecological studies. There are also some well designed animal studies that have contributed to the health effects database. As EPA has stated repeatedly, PBPK modeling allows the agency to give policy officials more scientific support for interspecies and intraspecies uncertainty factors. Following EPA’s first draft risk assessment for perchlorate in 1998, Dr. Curtis Klaassen, the Chair of the external peer review panel stated, "...a predictive risk assessment for perchlor ate is possible and should be pursued in the next iteration of this assessment."[FN7: Curtis Kl aassen, US EPA Perchlorate Peer Review Workshop, 1999.] EPA’s consideration of its findings in it s preliminary determination is exactly the use of compelling scientific information to support its policy decisions your November 5th letter [See PDF Docket ID EPA-HQ-OW-2008- 0692-1749] endorses.

Response: No response necessary to the information provided by the commenter.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20657

EPA Comment Code: 5300

Comment: While determining a "meaningful opportunity for risk reduction" is appropriately a policy decision it must be based on the best availa ble scientific data. The best available data on perchlorate exposure suggest that very few indivi duals will be exposed to a dose of perchlorate greater than the RfD by drinking water with a pe rchlorate concentration above the HRL. Further,

since the HRL is based on the NAS-recommended re ference dose which is set at the no observed effect level (NOEL), which the NAS panel noted is a more conservative and health protective approach than using EPA’s traditional approach of relying on the no observed adverse effect level (NOAEL)[FN9: NAS at 169, (pdf version).], along with an additional safety factor applied to it, the quantifiable incremental risk would appear to be very small.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 513 of 1099 Response: See response to comment code 5200. Regard ing the comment about exposures above the RfD, the data underlying the definition of iodi de uptake inhibition as a precursor effect and its relationship to the continuum of adverse thyroid outcomes reflect s an understand ing of effects in adults. The relationship of th e precursor event to the adverse outcome in children has not been

studied. EPA notes that the data underlying the definition of iodide uptake inhibition as a precursor effect and the relations hip of iodide uptake inhibition to the continuum of adverse outcomes reflects an understanding of effects in a dults; it may not reflect the relationship of the precursor event to adverse outcomes in neonates and infants, who may no t have iodide stores

sufficient to offset the effects of reduced iodide uptake. The less resilient neonatal and infant system makes the exposure gap between a precur sor event (iodide uptake inhibition due to perchlorate) and reduced T3/T4 le vels likely to be narrower than for adults, and in fact, the distinction between the two may be blurred for the very young (G reer et al., 2002; Savin et al., 2003; van den Hove et al., 1999). The NRC noted that, “[T]he minimal prolonged decrease in thyroid hormone production that w ould be associated with advers e health effects is not known; any decrease is potentially more likely to have adverse effects in sens itive populations (people with thyroid disorders, pregnant women, fetuses, and infants) but data are not available to determine the magnitude of the decrease needed to cause adverse effects in those populations.”

Commenter Name: Lyndsey Crum Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1732

EPA Comment ID: 20678

EPA Comment Code: 5300

Comment: November 10, 2008

Eric Burneson Office of Ground Water and Drin king Water Standards and Risk Management Division Environmental Protection Agency

RE: [EPA-HQ-OW-2008-0068; FRL-8727-6] Drinking Water: Preliminary Regulation

Determination on Perchlorate

The agency should adopt its determination not to enact a NPDWR for perchlorate on the basis of the authority to promulgate NPDWR unde r the Safe Drinking Water Act.

The agency’s notice indicates that SDWA re quires EPA to promulgate an NPDWR for a

contaminate if three conditioned are identified: (a) The contaminate may have an adverse effect on the health of persons; (b) the contaminate is known to occur or there is a substantial likelihood that the containment will occur in public water systems with frequency and at levels of public health concern; and (c) in the sole judgment of the Admi nistrator, regulation of such contaminate presents a meaningful opportunity for health risk reduction for persons served by public health water

systems.

The research presented and previous comments do not clearly establish condition two, and by
construction, condition three. Therefore EPA is not required to regulate perchlorate in public water

systems.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 514 of 1099 Response: See response to comment code 5300.

Commenter Name: Heather Hesse-Stromberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1763

EPA Comment ID: 20697

EPA Comment Code: 5300

Comment: Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought. A national prim ary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 5300.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1983

EPA Comment ID: 20820

EPA Comment Code: 5300

Comment: The EPA is not accurate in determining that NPDWR for perchlorate would "not present a meaningful opportunity for health risk reduction for persons served by public water systems."

Response: See response to comment code 5300.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20897

EPA Comment Code: 5300

Comment: November 11, 2008

U.S. Environmental Protection Agency Water Docket EPA Docket Center 1200 Pennsylvania Avenue, NW Washington, DC 20460

Letter to EPA re: Preliminary Regulatory Deter mination on Perchlorate (Docket ID No. EPA-HQOW-2008-0692)

Dear Administrator Johnson:

Environmental Working Group (EWG) strongly disagr ees with EPA’s recent finding that setting a national drinking water standard for perchlorate would not present "a meaningful opportunity for health risk reduction for persons served by public water systems" (EPA 2008). The science provides overwhelming evidence that the tens of millions of people drinking perchlorate in tap water face realEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 515 of 1099 health risks that only EPA can protect them from. But the agency has chosen not to act and by failing to act, EPA has sacrificed its scientific integrity.

Response: See response to comment code 5300.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20938

EPA Comment Code: 5300

Comment: As to the third criterion, EPA conclude s that a national primary drinking water regulation for perchlorate would not present a me aningful opportunity to reduce health risks for persons served by public water sy stems.[FN25: 73 Fed. Reg. at 60280.] EPA bases this conclusion on the flawed analysis, described above, in which the agency determined that perchlorate occurs only infrequently at levels of public health c oncern. EPA reiterated th at of the 900,000 to two million people who may be ingesting public drinking water at levels above the HRL of 15 ug/L, "fewer than 30,000 of them are pregnant women at any given time."[FN26: Id.] EPA's conclusion fails to account for the reduced health risks to preg nant women in the future, and to their fetuses; to infants; and to persons with thyroid disorders.

Response: EPA believes that regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction and has decided to regulate perchlorate in drinking water. See response to comment code 6120.

EPA has made this determination based on a consid eration of the best available peer reviewed

science and data collected in accordance with acce pted methods related to perchlorate occurrence in drinking water, the presence of perchlorate in foods, and the potential health effects of exposure to perchlorate.

EPA has determined that perchlorate meets the cr iteria for regulating a contaminant in Section 1412(b)(1)(A) of SDWA. As previously discussed in the Federal Register Notice, perchlorate may have an adverse effect on the health of persons and perchlorate is known to occur or there is a substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of public health concern. EPA believes th at the UCMR 1 is the best available data on the frequency and level of perchlorate occurrence in public water systems nationally. UCMR 1 indicated that 5.1 to 16.6 million people are served by PWSs, for which we have data, that have detected perchlorate above the minimum reporting level. In light of the discussion in this notice and the
information available at this time, the Administrato r finds that regulation of perchlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons served by public water systems. Therefore, EPA will initiate the process of proposing a NPDWR for perchlorate. See response to comment code 6120 and 5220.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20981EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 516 of 1099 EPA Comment Code: 5300

Comment: The U.S. population is about 300 million peopl e with about 6.8%, or 20 million, under 5 years old. On average, therefore, there are about 4 million kids in each year of life (from zero to five). With 4 million kids under 1 year old, includin g infants, there are 400,000 in the 90th percentile of water consumers, meaning that at the proposed HRL, these 400,000 would have a perchlorate intake, each day for their whole first year of lif e, that exceeds the reference dose. EPA's proposed
model shows that there are 400,000 children under the age of 1 who would exceed the daily reference dose and this is likely underestimate of the highly exposed. Thus, the evidentiary record does not support EPA's proposed determination. Ra ther, the evidentiary record makes clear that regulating these exposures does represent "a meaningful opportunity for health risk reduction for persons served by public water systems."

Response: See response to comment codes 5200 and 5300.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21000

EPA Comment Code: 5300

Comment: The U.S. population is about 300 million people.[FN55: U.S. Census Bureau quick facts. 2006. http://quickfacts.census.gov/qfd/states/00000.htm l] Of the total, about 6.8%, or 20 million, are under 5 years old, an average of about 4 million kids of each year of life. This is a reasonable estimate supported by the fact that there were about 4,329,000 live birt hs in the U.S. in 2007.[FN56: National Vital Statistics Reports, Vol 57, No 5. http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57 _05.htm] If there are 4 million children less than 1 year old, including infants, then 400,000 of them would be in the 90th percentile of water consumers. This means that at the proposed HRL, 400,000 children and infants will exceed the reference dose for perchlorate every day for their entire first year of life.

As part of its basis for the preliminary determination not to regulate perchlorate because it does not feel there is a meaningful opportunity to reduce heal th risks, EPA acknowledged that perchlorate

could have an adverse effect on human heal th.[FN57: 73 Fed. Ref. at 60275.]

Furthermore, EPA's own staff experts have provided data to show that at the HRL, 400,000 infants and children would consume perchlorate on a daily basis that exceeded the reference dose. Rather, EPA states that 30,000 pregnant women would be ex posed to these levels of perchlorate, and that number does not provide a meaningful opportunity to reduce health risks. While we take issue with EPA's determination that reducing the exposure of 30,000 pregnant women to perchlorate is not meaningful, EPA must explain why reducing the exposure of 400,000 children and infants to perchlorate is not a meaningful oppor tunity to reduce health risks.

Response: See response to comment codes 5200 and 5300.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 517 of 1099 EPA Comment ID: 21005

EPA Comment Code: 5300

Comment: Second, even without those peer review comments, existing data on perchlorate exposure and effects, especially on vulnerable su bpopulations, demonstrates that setting a national primary drinking water standard for perchlorate would provide a meaningful opportunity for health risk reduction. EPA is therefore required to set such a standard under the Safe Drinking Water Act.

Response: See response to comment code 5300.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21029

EPA Comment Code: 5300

Comment: 12. Finally, your letter argues that th e "meaningful opportunity for risk reduction"

criterion is met because an MCL w ill trigger testing for exceedances.

While determining a meaningful opportunity for risk reduction is appropriately a policy decision it

must be based on the best available scientific data . The best available data on perchlorate exposure suggest that very few individuals will be exposed to a dose of perchlorate continuously for years greater than the RfD by drinking water with a pe rchlorate concentration above the HRL. Further,
since the HRL is based on the NAS-recommended RfD which is set at the NOEL, which the NAS panel noted is a more conservative and health pr otective approach than using EPA’s traditional approach of relying on the no observed adverse effect level (NOAEL) [FN10: NAS at 169, (pdf version).], along with an additional safety factor app lied to it, the quantifiable incremental risk would appear to be small.

I hope you find these comments helpful; we would be happy to talk further with you about this important issue. Further, if the CHPAC opts to co nvene a public meeting on perchlorate, the PSG would welcome an opportunity to present the scient ific literature and our public comments. For your convenience, we have included those comments for your review. Our comments review the science of perchlorate beginning with the co mprehensive NAS review followed by subsequent studies and then apply them in the statutory and policy framework in which EPA has made its preliminary determination. Thank you for your time and attention.

Sincerely, Michael Girard Chairman, Perchlorate Study Group cc: Marcus Peacock, Deputy Administrator Benjamin Grumbles, Assistant Admi nistrator, Office of Water Cynthia Dougherty, Director, Office of Ground Water and Drinking Water Eric Burneson, Chief, Targeting and Analysis Branch

Response: See response to comment ID 20657 under comment code 5300.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21090EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 518 of 1099 EPA Comment Code: 5300

Comment: Public water systems do not offer a mean ingful risk reduction op portunity since EPA's data show that only a few percent of systems have had detectable levels of perchlorate and virtually all of them are routinely below EPA's unusually protective reference dose (RfD). EPA also has extensive data that show the US population's total exposure to perchlorate - from food and water - is below the RfD for 99.996 percent of the popula tion. EPA should spend its limited resources on significant potential threats to human health in or der to most effectively protect the public health.

The comments below present a detailed analysis of the issues relating to EPA's determination. The

attachment from Intertox describes in more detail the state of the scientific literature. The overwhelming weight of scientific evidence in dicates that EPA is acting correctly in its determination not to establish a Federal drinking water standard.

Response: See response to comment code 5200.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21097

EPA Comment Code: 5300

Comment: IV. The Scientific Literature Supports EPA's Findings that There is Not a Meaningful Opportunity for Risk Reduction from a National Drinking Water Standard

The evaluation of data on the health effects of perchlorate, national occurrence, and exposure using the SDWA "meaningful risk reduction" criteria support EPA's determination that an NPDWR for perchlorate is unnecessary.

Following the release of the NAS report, EPA set an RfD for perchlorate at 0.7 ug/kg-d. The RfD is defined as "...an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensit ive subgroups) that is likely to be without an appreciable risk of deleterious effects during a li fetime (EPA, 2005). The RfD does not distinguish between perchlorate in drinking water and in food. In establishing the amount of perchlorate that would be expected to pose no risk to health in dr inking water alone, the RSC is factored in resulting in the HRL or "the benchmark against which EP A compared the concentration of a contaminant found in public water systems to determine if it is at a level of public heal th concern (73 FR 60275)."

EPA has established that it would not be meanin gful to set an NPDWR, but is now considering issuing a Health Advisory (HA), in the form of an MCLG.

If EPA decides a Health Advisory is necessary, the RfD is sufficiently conservative to serve as the HA. As presented in the PSG's comments on the Ma y 1, 2007 notice, the best available scientific analysis demonstrates that all of EPA's approaches lead to an RSC of essentially one. Drinking water is not a meaningful contributor to total perchlorat e exposure - and not even a minor source of total inhibition of iodine uptake, the non-adverse effect that is the basis of the RfD.

Alternatively, the HRL identified in its preliminary determination could also serve as an even more conservative, but no more protective, HA. What is stri king is that either approach would be highlyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 519 of 1099 conservative. In fact, the high level of conservati sm, and health protection, is far greater than EPA indicated by the agency's longstanding policie s, themselves properly weighted toward greater protection.

The HRL relies on the NAS-recommended RfD that ha s several levels of conservatism (that is, exceptional health protection) built into calculat ion of dose. As EPA has noted, its RfD was based upon the recommendations of the NAS which, as noted, used a much more conservative and health-protective approach to derive its r ecommended safe dose than EPA has previously used.[FN3: NAS, at 170-71.] EPA embeds an additiona l level of conservatism in calculating the final HRL by verifying their calculations using PBPK modeling of pregnant women as opposed to relying on the standard of assuming an adult as the focus of its calculations.

To determine the RSC, the EPA uses the NHANES-UCMR data to estimate doses to people who were exposed through food only (73 FR 60273). Th e UCMR 1 shows the median concentration of perchlorate in drinking water to be 6.4 ug/L (73 FR 60269). The 90th percentile estimated dose to the women exposed only through food was 0.263 ug/kg/d which corresponds to 38% of the RfD. This leaves 62% of the RfD left for exposure thro ugh water. Using this data, a HRL was calculated

as such:

HRL = (RfD x BW / DWI) x RSC Where, RfD = 0. 7 mg/kg-d BW = 70 kg DWI = drinking water
intake = 2 L/d RSC = 62%

This results in a HRL of 15 ppb. The deriva tion of the HRL was based on the body weight and water intake of an adult[FN4: The standard EP A default procedure for converting dose into drinking water equivalent levels assumes 2 liter s (67.6 oz) of water consumed per day and a body weight of 70 kg (154 lbs). These default values are not symmetrically representative of the population. This water consumption (WC) default is approximately equal to the 88th percentile water intake for adults aged 20 through 64 (calc ulated from Table 3-11 of U.S. EPA's Exposure Factors Handbook; EPA, 1999). However, the defaul t body weight of 70 kg is approximately equal to the 27th percentile of the distribution for adul t males aged 18-74 and the 70th percentile of the distribution for adult females (from EPA, 1999; Ta bles 7-3 and 7-4).], not the pregnant woman and

her fetus. The EPA modeled the amount of IUI in a pregnant woman an d her fetus using PBPK modeling and found that the amount of IUI expected was equivalent to the NOEL from Greer et al. (2002). EPA then compares this HRL to perchlorat e occurrence data in drinking water to evaluate the percent of the population exposed to perchlorate above the HRL.

For the perchlorate determination, EPA may also use the evaluation criteria under the CCL 1 regulatory determinations to determine whether a meaningful opportunity to regulate health risk exists. EPA's regulatory evaluation process follows the recommendations on a protocol from EPA's stakeholder advisory panel, the National Drinki ng Water Advisory Council (NDWAC). To assist EPA in evaluating the third st atutory criteria, the NDWAC pr otocol recommended "that EPA consider estimating the national population exposed above half the health reference level (or benchmark) and the national populati on exposed above the health reference level (or benchmark)."

EPA used this approach for evaluating substances in its CCL 1 regulatory determinations. This approach allows EPA's decision-making process to be replicated and therefore provides greater transparency and objectivity into the agency's final decisions rendered on the third statutory criterion. It also has the support of major stake holders and has been subject to public comment. TheEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 520 of 1099 PSG points out that EPA could, in addition to its valid reasoning in the preliminary determination, relay a similar evaluation process for its perchlorate determination.

A comparison of occurrence data for perchlor ate and relevant compounds from EPA's CCL 1 regulatory determinations and the CCL 2 determinati ons reveals that perchlorate ranks as a lower opportunity for risk reduction than th e sodium, manganese, sulfate, and boron, all of four of which EPA has made determinations not to regulate.

If the HRL is 15 ppb, EPA estimates that between 0.29 percent and 0.8 percent of PWSs have at least one detection greater than 15 ug/L, affecti ng 0.9 million to 2 million people served. Between 1.14 percent and 2.12 percent of PWSs had at leas t one detect with concentrations at 1/2 of the HRL (7 ug/L), affecting between 0.8 percent and 2.5 percent of the population served or between 2.2 million and 7.2 million people served, respectively.

[Table 1: Comparison of Risk Opportunity betw een Perchlorate and Other Compounds - See PDF Docket ID EPA-HQ-OW-2008-0692-1855]

The percentage of PWSs with perchlorate detecti ons was very low (3.6 percent) compared to the next lowest unregulated compound, manganese at 68 percent. Sodium, for example, was detected in all PWSs. Perchlorate also has one of the lowest p opulations served by PWSs with detections above half the HRL with 2.2 million people. Perchlorate is well within the range of values for the

evaluation criterion EPA uses. Like these other cons tituents, perchlorate is widely found in the diet

and has minimal adverse health effects at the RfD. Although EPA's approach of using actual food data has more scientific justification, even if EPA adopts its customary approach for the proposed regulatory determination, it should find that pe rchlorate does not pose a meaningful opportunity to

reduce risk.

Response: See response to comment codes 5300 and 5200. EPA considered national occurrence and the severity of health effects from perchlora te and concluded that regulation was warranted, so EPA has determined that perchlorate should be subject to an NPDWR. The Agency plans to prepare and make available a regulatory health e ffects support document as part of its regulatory promulgation process. If an NPDWR is promulga ted a health advisory will be unnecessary. EPA agrees with the commenter that the RfD is conservative and protective of health. Regarding the PBPK model, after further consider ation of the peer review and public comments, EPA concludes that the PBPK modeling analysis, in the context of the perchlorate regulatory determination, is useful in examining which life stages are most suscepti ble to the effects of perchlorate. For example, the model indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman. The model also allows for the estimation of the concentration of perchlorate in breast milk (th us breast-fed infant exposure) at various maternal perchlorate exposure levels. However, because of th e stated limitations, EPA has decided the model does not directly bear on the current decision regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate. Regarding the suggestion to compare the risk opportunity from detects in public water systems between perchlorate and other compounds th at EPA has decided not to regulate, EPA does not believe it's appropriate to factor these comparisons into the decision whether to regulate a

contaminant. The Administrator will make thes e determinations on a case-by-case, contaminant specific basis. In making a regulatory determinati on, the Administrator considers the adverse health effect of the particular contaminant at issue as we ll as the occurrence or likelihood of occurrence ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 521 of 1099 the contaminant in public water systems with a freque ncy and at levels of public health concern. In addition, even if such comparisons were appropriate, the occurrence level of perchlorate at the levels of public concern identified by EPA are higher than most of the contaminants for which EPA has made a negative determination. Finally, it is the so le judgment of EPA’s Administrator to determine whether there is a meaningful opportunity to reduce he alth risk for persons served by public water

systems.

Commenter Name: Tigris Powers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2244

EPA Comment ID: 22427

EPA Comment Code: 5300

Comment: All Americans deserve healthy and clean dr inking water. The EPA should not finalize this decision until the scientific review is compl ete and should make decisions that are consistent with the agency's own scientists. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity for health risk reduction."

Sincerely, Tigris Powers 2421 Topanga Skyline Drive Topanga, CA 90290

Response: See response to comment code 5300.

Commenter Name: Kraig Erickson Commenter Organization: RMC Water and Environment (RMC)

EPA Document ID: EPA-HQ-OW-2008-0692-2299

EPA Comment ID: 24979

EPA Comment Code: 5300

Comment: All Americans deserve healthy and clean dr inking water. The EPA should not finalize this decision until the scientific review is compl ete and should make decisions that are consistent with the agency's own scientists. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity for health risk reduction."

Again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

Response: See response to comment code 5300.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0521

EPA Comment ID: 28476

EPA Comment Code: 5300

Comment: In this time of severe economic stress in our society, it is particularly important that the benefits of a regulation be carefully weighed agai nst the costs and only those with an overriding benefit/cost advantage be promulgated. For perchlora te it is clear that this advantage does not exist uniformly and in fact, for some communities the aforementioned reference provides evidence thatEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 522 of 1099 the adverse health effects caused by the cost of the regulation may equal or outweigh the projected

benefits.

Rubin, etal (see reference 1 electronic attachment - "Rubin trade off health risk final.pdf") have documented quantitative evidence that when regula tory costs increase in the order of $25 per month, significant numbers of customers are forced into spending choices that have health outcomes that may outweigh the projected benefits of the regulation. NRWA strongly feels that when evaluating whether a regulation will result in a meaningful health benefit, EPA must take these effects into consideration. This is essentially an affordability issue and NRWA recommends that EPA include appropriate affordability criteria in its final determination to not regulate perchlorate.

Response: See response to comment ID 20272 under comment code 5300.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28874

EPA Comment Code: 5300

Comment: c) The SDWA requires that the regulation of such contaminants must present a meaningful opportunity for health risk reduction for persons served by public water systems. For perchlorate, no possible health benefit can occu r when estimated exposure levels are below the NOEL for a nonadverse effect. Further, EPA adjus ted the NOEL ten-fold lower to derive the RfD to account for sensitive subpopulations.

Response: See reponse to comment code 5200, comment ID 21028.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28922

EPA Comment Code: 5300

Comment: 4) ACWA believes that the maximum cont aminant levels (MCLs) established in Massachusetts and California have significantly reduced the current public exposure to perchlorate in drinking water. ACWA feels this has had an impact on the meaningful oppor tunity for health risk reduction that is available through a national drinking water standard for perchlorate.

Response: EPA acknowledges that there may be sour ces that had detected perchlorate from UCMR1 monitoring are either no longer being use d or are being treated per the requirements of

maximum contaminant levels established in California and Massachusetts; however, the 1996 amendments to the Safe Drinking Water Act require the Agency to consider the best available, peer reviewed science when developing drinking water standards. In applying these principles, "best available" usually refers to the availability at th e time an assessment is made. See response to

comment code 5300.

Commenter Name: Lucy Allen Commenter Organization: Pacific InstituteEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 523 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 29099

EPA Comment Code: 5300

Comment: We understand the need to balance costs and benefits in drinking water regulations, however, costs associated with the regulation of pe rchlorate will ostensibly be low, except in those cases where high levels of perchlorate exist and dr inking water must be treated. For other systems, costs can be limited to periodic monitoring (e.g., once in every 4 years, as is done with radionuclides). The cost of regulating perchlora te in our country’s public drinking water, when compared with the myriad potential health-related costs, including added pressure on public health care systems, missed work and school days due to sickness, etc., may very likely prove the most costeffective option.

In light of these concerns we sincerely hope that the EPA reevaluates it s Preliminary Decision, taking into account the impact of this regulation on all vulnerable populations, the potential for remediation efforts, and the potential future cont amination of drinking water. In addition, we hope that the agency fulfills its duty to protect the public health of the thousands of individuals who are affected by unsafe perchlorate exposure through public drinking water.

Sincerely, Lucy Allen Research Analyst Pacific Institute

Courtney Smith Research Analyst Pacific Institute

Response: Regarding the costs associated with regulating perchlorate, see response to comment ID 20272 under comment code 5300. Regarding EPA reev aluating its preliminary decision, see response

to comment code 5300.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 524 of 1099 

### EPA Comment Code: 6000 EPA Actions

Individual Comments

Commenter Name: Stephen Haterius Commenter Organization: The National Association of State Departments of Agriculture (NASDA)

EPA Document ID: EPA-HQ-OW-2009-0297-0500

EPA Comment ID: 28485

EPA Comment Code: 6000

Comment: The significance of this issue goes far beyond setting unwise regulatory precedent. An overly conservative perchlorate standard that is not based on sound, peer-reviewed science and an appropriate risk-based assessment could unintentionally lead to unjustified food scares on a wide variety of fresh fruits, vegetables, and dairy prod ucts. Food scares of this nature could where particular commodities are "black listed" without regard to science would have devastating economic impacts on agriculture producers and processors. Finally, the economic impacts associated with unfounded concerns over traces of perchlorate in food could lead to the relocation of agricultural production to countries that have food safety standards that are significantly lower than in the

United States.

We appreciate your attention to our concerns an d once again encourage you to extend the comment period for an additional 30 days.

Sincerely, Stephen Haterius Executive Director

Response: EPA believes that perchlorate meets the specific criteria for regulating a contaminant in Section 1412(b)(1)(A) of the Safe Drinking Water Act and therefore has determined that EPA should regulate perchlorate in drinking water. EPA discusses this conclusion in more detail in today’s perchlorate Federal Register notice. EPA agr ees that perchlorate is more widespread in foods than in public water systems, but EPA does not be lieve that the widespread presence of perchlorate in food overrides the opportunity for public health risk reduction for persons served by public water systems with perchlorate contamination. EPA’s acti on considers the presence of perchlorate in food but would not impose regulatory requirements on perc hlorate in food. Regulation of perchlorate in foods is outside the scope of this determination whic h is made under the authority found in the Safe Drinking Water Act, as amended in 1996.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 525 of 1099 

### EPA Comment Code: 6100 EPA’s prelimin ary determination not to regulate perchlorate

Individual Comments

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28743

EPA Comment Code: 6100

Comment: September 16, 2009

U.S. Environmental Protection Agency Mailcode 2822T 1200 Pennsylvania Ave., NW. Washington,

DC 20460

Subject: Docket ID No. EPA-HQ-OW-0297

Reference: Drinking Water: Perchlorate Supplemen tal Request for Comments (Federal Register / Vol. 74, No. 1591 Wednesday, August 19, 2009 / Notices

Attached, please find comments provided by the Nevada Division of Environmental Protection (NDEP) in response to the referenced "Supplemen tal Request for Comments" noticed by the U.S. Environmental Protection Agency (EPA) in the August 19, 2009 Federal Register; Docket ID No. EPA-HQ-OW-2009-0297. These comme nts are provided to assist the EPA in their efforts in evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate through a national primary drinking water rule.

The NDEP understands that in order to regulate a contaminant in drinking water [i.e., develop a maximum contaminant level (MCL)], EPA must determine that the contaminant meets the following three criteria:

1) The contaminant may have an adverse effect on human health;

2) The contaminant is known to occur (or there is a substantial likelihood that the contaminant will occur) in public water systems, with a frequency and at levels of public health concern; and

3) Regulation of such a contaminant presents a me aningful opportunity for health risk reduction for persons served by public water systems

The NDEP believes that the EPA cannot reliably demons trate that all three criteria can be met (with respect to perchlorate) when all of the studies an d available literature are used and new occurrence data are collected to inform the decision. Many studies have been conducted and the results peer reviewed and published since the National Academy of Science (NAS), National Research Center (NRC) provided their review in 2005. A number of these studies were conducted explicitly to fill data gaps present at that time. A thoughtful revi ew of the entirety of the studies and literature, coupled with collection and analysis of up-to-date occurrence data, is recommended to allow EPA to meet its charge on this important decision.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 526 of 1099 Response: EPA has continued to review all the available data published concerning perchlorate in drinking water as it is made available. The regula tory determination made in today's Federal Register notice was based upon a consideration of the best available peer reviewed science and data, both recent as well as the information available and discussed in earlier Federal Register notices.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 527 of 1099 

### EPA Comment Code: 6110 Comments urging EPA not to regulate perchlorate

Response to Code 6110 : After review of the available science, data and public comments, EPA has determined that perchlorate may have an adve rse effect on the health of persons and that perchlorate is known to occur or there is a substan tial likelihood it occurs in public water supply systems with frequency and at levels of public health concern. EPA has also determined that regulation of perchlorate presents a meaningful oppor tunity to reduce health risk for persons served by public water systems. The basis for EPA’s d etermination is described in the Federal Register Notice for the final regulatory determination.

Individual Comments

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20278

EPA Comment Code: 6110

Comment: July 2, 2007

US Environmental Protection Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: Comments on Regulatory Determinations Re garding Contaminants on the Second Drinking

Water Contaminant Candidate List Rule Docket EPA-HQ-OW-2007-0068

The Perchlorate Study Group (PSG) is pleased to submit comments to EPA on Docket ID No. EPA-HQ-OW-2007-0068, entitled Drinking Water: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List- Preliminary Determinations; Proposed Rule.[FN1: 72 Fed. Re g. 24015 (2007) (proposed May 1, 2007).]

The PSG is committed to ensuring that the best avai lable science is made available in public debate and in the subsequent setting of regulatory st andards.[FN2: In section 1412(b)(3)(A) of the 1996 Amendments to the Safe Drinking Water Act, Congress required EPA to use the best available science and data: "The Administrator shall use: (i ) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best ava ilable methods (if the reliability of the method and the nature of the decision justifies use of the data).] The member companies of the PSG include Aerojet, AMPAC, ATK, and Tronox.

The PSG has worked cooperatively and effectively with the US Environmental Protection Agency (EPA) and other federal agencies, state gove rnments, water purveyors, and other business organizations to:

* increase scientific and medical understanding of perchlorate’s possible effects on human health;
and,

* assess the level of perchlorate in drinking water that will pose no cognitive risk.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 528 of 1099 In seeking public comment on its Second Contam inant Candidate List (CCL 2) Preliminary Determinations, EPA has expressed particular in terest in receiving information regarding the adequacy of available occurrence and exposure da ta with respect to making a regulatory determination for perchlorate. In addition, EPA ha s asked for public input on scientific analysis options that would assist the Agency in reachi ng a regulatory determination for perchlorate.

The PSG members are manufacturers and users of pe rchlorate who are actively remediating areas of past releases, and are citizens concerned with the protection of the public’s health. As such, the PSG member companies have a strong and unique commitment to ensuring that the best available science is applied in regulatory decision making.

Based on its thorough evaluation of the best avai lable science, as well as consideration of the Agency’s statutory authorities, the PSG respectfully submits:

* in light of the National Academy of Sciences comprehensive review, as well as numerous, peerreviewed studies, the Agency has more than sufficient data on perchlorate’s human health effects to make a regulatory determination for perchlorate on an expedited basis; and

* the extensive scientific record indicates that esta blishing a drinking water standard for perchlorate would not yield a meaningful opportunity to reduce ri sk to human health, as required under the Safe Drinking Water Act.

ANALYSIS AND OBSERVATIONS

EVALUATING THE 3 STATUTORY CRITERIA FOR THE REGULATORY

DETERMINATION PROCESS

To determine whether to regulate a contaminant with a Federal drinking water standard, EPA evaluates three Safe Drinking Water Act criteria .[FN3: In section 1412(b)(1)(A) of the Safe Drinking Water Reauthorization Act of 1996, Congress estab lished three criteria for use by EPA in making drinking water regulatory determinations: (i) th e contaminant may have an adverse effect on the health of persons; (ii) the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and, (iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems. (See, 110 Stat. 1613, 1619; 42 USC. §300 g-1(b)(1)(B)(ii)(II)).] EPA has determined that it

must make an affirmative determination on all three cr iteria to move forward with regulation. If the Agency determines that a regulation is appropriate, EPA can make its regulatory determination for perchlorate in two ways:

1. through its longstanding approach used in the CCL 1 rulemaking and proposed for the CCL 2
determinations; or,

2. applying supplemental or alterna tive approaches reflecting new sc ientific information, using the uniquely conservative derivation of the perchlorate reference dose (RfD) for perchlorate, as well as the exceptionally deep and authoritative scientific literature on toxicity and population exposure.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 529 of 1099 No matter which approach EPA takes, the best av ailable science runs inevitably to the conclusion that a perchlorate standard will not yield a meanin gful opportunity to reduce risk to human health as required by the Safe Drinking Water Act.

EPA has more than sufficient data on perchlorate’ s human health effects as well as on occurrence and exposure to make a determination on perchlora te without delay. EPA is to be commended for its efforts to obtain public comment relating to the prospective use of supplemental or alternative approaches. These approaches are scientifically rigorous and upto- date, based on the peer- reviewed literature. Our collective goal of applying the best available science would point toward their use.

Nonetheless, should the agency elect to apply an approach based strictly on toxicology and modeled exposures, we anticipate it will yield the same conclusi ons, albeit, after a period of unnecessary delay.

Response: Please see the response to comment code 6110.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group (PSG)

EPA Document ID: EPA-HQ-OW-2007-0068-0168

EPA Comment ID: 20283

EPA Comment Code: 6110

Comment: CONCLUSION

In summary, EPA has an extraordinary wealth of comp rehensive, authoritative scientific information relating to perchlorate’s health effects, supplem ented by extensive occurrence and exposure data. The Agency is therefore excepti onally well-positioned to issue a wellconsidered regulatory

determination.

In this case, the Agency can rely on the scientific review by the NAS and its own subsequent analysis in setting a reference dose pursuant to the NAS Report. Subsequent, peer-reviewed studies provide

additional information that corroborates the conclusions of the NAS and EPA.

The Agency can use its RfD as the HRL. EPA should take into account that the RfD is based on an unusually conservative point of departure, a NOEL (as opposed to the Agency’s customary No Observed Adverse Effect Level), with an added safety factor of 10.

Ultimately, regardless of which approach EPA takes, the best available scientific data supports a determination that there is not a meaningful opportunity for risk reduction as required by the Safe Drinking Water Act.

The Perchlorate Study Group appreciates the opport unity to submit comments on this issue. If you have any questions regarding these comments, please do not hesitate to contact Michael Girard at (916) 355-2945.

Sincerely, Michael Girard The Perchlorate Study Group Attach:

[Attachment 1 - see PDF] [Attachment 2 - see PDF] [Attachment 3 - see PDF] [Attachment 4 - see PDF] [Attachment 5 - see PDF]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 530 of 1099 Response: Please see the response to comment code 61 10. In light of the discussion presented in the final regulatory determination notice and the info rmation available at this time, EPA expects to select an MCLG from among the range of potential alternative HRLs in the August 9, 2009 notice (74 FR 41883). These levels range from 1 μg/L to 47 μg/L and are the concen trations of perchlorate in drinking water that may result in total perchl orate exposures (from food and water) greater than the RfD for individuals in each life stage.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20437

EPA Comment Code: 6110

Comment: November 10, 2008 U.S. Environmental Protection Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Drinking Water: Preliminary Regulatory Determination on Perchlorate Docket EPA-HQ-OW2008-0692

The American Water Works Association apprecia tes the opportunity to comment on the preliminary regulatory determination for perchlorate as detaile d in the October 10, 2008 Federal Register notice (73 FR 60262). AWWA is an international, nonprofit , scientific and educational society dedicated to the improvement of drinking water quality and su pply. Founded in 1881, the Association is the largest organization of water suppl y professionals in the world. Ou r 60,000 plus members represent the full spectrum of the drinking water community: treatment plant operators and managers, environmental advocates, engineers, scientists, academicians, and others who hold a genuine interest in water supply and public health. Our membership includes more than 4,700 utilities that supply roughly 80 percent of the nation's drinking wa ter. Based on this broad membership base, these comments should be considered as representative of the drinking water community in general.

AWWA has always been a strong' advocate of the process established under Section 1412(b) of the 1996 SDWA Amendments to ensure that appropr iate and scientifically based standards are developed and enforced by the Agency. The SDWA defined three (3) key criteria for identification of contaminants for potential regulation:

i.the contaminant may have an adverse effect on the health of persons;

ii.the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency an d at levels of public health concern; and

iii.in the sole judgment of the Administrator, re gulation of such contaminant presents a meaningful opportunity for health risk reduction for pers ons served by public water systems.

Based on these SDWA criteria and currently available, AWWA supports EPA's proposed regulatory determination for perchlorate: Additionally, A WWA supports the EPA decision to issue a Health Advisory for perchlorate at the time of the fi nal determination which provides important technical guidance to Federal agencies, State government s, and other public health officials.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 531 of 1099 The above conclusion is supported by independentl y developed assessments of both occurrence and exposure commissioned by AWWA. This research suppor ts the finding that a national standard for perchlorate would not present a meaningful opportuni ty for health risk reduction for persons served by public water systems. The following provides a summary of our findings which are in the process of being submitted for peer-review.

Response: Please see the response to comment code 6110.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20442

EPA Comment Code: 6110

Comment: Conclusion

Based on our own analysis and related data pres ented in the proposed decision, AWWA believes that EPA's decision is supported by the criteria established in the SDWA. AWWA appreciates the opportunity to comment on these important drinking water issues. If you have any questions about these comments, please feel to call Kevin Morley or me in our Washington Office at 202-628-8303.

Yours Sincerely, Thomas W. Curtis Deputy Executive Director

cc: Benjamin Grumbles - USEPA OW Cynthi a Dougherty - USEPA OGWDW Eric Burneson - USEPA OGWDW Brian Mannix - USEPA OPEI Alan Roberson Kevin Morley

References

Blount BC, Valentin-Blasini L, Osterloh JD, Mauldi n JP, Pirkle JL. (2006) Perchlorate exposure of the U.S. population, 2001-2002. Journal of Expo sure Science and Environmental Epidemiology 17(4):400-7.

Brandbuber, Phillip, Clark, Sarah and Morley, Kevin M. (pending publication in Journal AWWA ).

The Occurrence of Perchlorate in Pu blic Drinking Water Systems.

Crawford-Brown, Doug, Raucher, Bob and Harrod, Megan. 2006. Inter- Subject Variability of Risk From Perchlorate in Community Water Supplies. Environmental Health Perspectives 114:7:975.

Mendez, William and Dederick, Elizabeth (2008). Es timating the Contribution of Drinking Water to Aggregate Perchlorate Intake of Reproductive Age Women in the U.S. Report prepared for the
American Water Works Association, see enclosed Appendix A.

Appendix A: Estimating the Contribution of Drinki ng Water to Aggregate Perchlorate Intake of Reproductive Age Women in the U.S.

Response: Please see the response to comment code 6110.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 532 of 1099 Commenter Name: Colby Goodliffe Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1515

EPA Comment ID: 20504

EPA Comment Code: 6110

Comment: I recommend that EPA should not change its determination regarding the regulation of perchlorate. There is no need for every public wate r system in the US to test for a contaminant that only a few water sources contain. Let the states handle this on a case-by-case basis. I manage a public water system and we already spend thousands of dollars each year to test for contaminants that are not in our water and never have been in our water. I agree that we need to do as much as possible to ensure that our drinking water is safe, but the blanket regulations that govern drinking

water are ineffective and facilitate wa steful spending of tax dollars.

Colby Goodliffe

Response: Please see the response to comment code 6110. The Agency analyzed occurrence data from the Unregulated Contaminant Monitoring Rule (UCMR), which is nationally representative, and found that perchlorate occurred in 26 states and 2 territories. Today’s determination merely initiates the process of establishing a national prim ary drinking water regulation. It does not impose any requirements on public water systems. EP A will provide an opportunity to comment on the proposed regulation, along with health risk reducti on and cost analysis, feasibility analysis, and other relevant analyses.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association

EPA Document ID: EPA-HQ-OW-2008-0692-1669

EPA Comment ID: 20617

EPA Comment Code: 6110

Comment: November 10, 2008

U.S. Environmental Protection Agency O ffice of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Drinking Water: Preliminary Regulatory D etermination on Perchlorate (Docket Number: EPAHQ-OW-2008-0068)

To Whom It May Concern:

NRWA commends EPA for their proposed regulatory determination for perchlorate. We believe the Agency has relied on sound science and that a national standard for perchlorate would not result in a meaningful opportunity for health risk reduction.

Response: EPA believes that regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction. This deter mination is based on the best available peer

reviewed science and data collected in accordance wi th accepted methods related to perchlorate’s occurrence in drinking water, the presence of perchlor ate in foods and the potential health effects ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 533 of 1099 exposure to perchlorate, and EPA’s population expo sure evaluation as described in more detail in the final regulatory determination.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association

EPA Document ID: EPA-HQ-OW-2008-0692-1669

EPA Comment ID: 20619

EPA Comment Code: 6110

Comment: In this time of severe economic stress in our society, it is particularly important that the benefits of a regulation be carefully weighed agai nst the costs and only those with an overriding benefit/cost advantage be promulgated. For perchlora te it is clear that this advantage does not exist uniformly and in fact, for some communities the aforementioned reference provides evidence that the adverse health effects caused by the cost of the regulation may equal or outweigh the projected

benefits.

Response: EPA believes that regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction. EPA believes th at regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction. This determination is based on the best available peer reviewed science and data collected in accordance with accepted methods related to perchlorate’s occurrence in drinking water , the pr esence of perchlorate in foods and the potential health effects of exposure to perchlorate, and EPA’s population exposure evaluation as described in more detail in the final regulatory determination. EPA has not performed a cost/benefit analysis for this final determination. EPA will perform such an analysis, as required by SDWA § 1412(3)(C), for the proposed regulation. The Agency has analyz ed occurrence data from the Unregulated Contaminant Monitoring Rule (UCMR), which is nationally representative, and found that perchlorate occurred in 26 states and 2 te rritories affecting millions of people

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20640

EPA Comment Code: 6110

Comment: Acknowledgements

The authors have collectively studied the toxicity of perchlorate since 1991 on behalf of US EPA and the nonprofit corporation Toxicology Excellen ce for Risk Assessment (TER A) at the request of the Perchlorate Study Group. Opinions expressed in this commentary, however, reflect solely those of the authors and not of any organization or ot her individual. Resources to support this technical commentary were provided by the Perchlorate Stud y Group, based in part on work supported by the developmental reserve fund of TERA.

Summary

We agree with EPA’s decision to not regulate perchl orate on a national level at this time. Although the data do provide support for the conclusion that at sufficiently high doses, perchlorate may have adverse effects on sensitive groups within the US population, we agree with EPA’s analysis thatEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 534 of 1099 perchlorate is not occurring in the public water suppl y at levels that cause concern for health risks. In particular, EPA’s analysis of relative source contribution based on the FDA Total Diet Study and estimates of exposure based on the NHANES/UCR da ta give an excellent understanding of the potential for exposure for pregnant women, the sensitive population for perchlorate exposure.

Response: Please see the response to comment code 6110. As the federal register notice explains in greater detail, EPA has determined that, pursuant to the NRC’s findings, infants and developing children are additional sensitive populations.

Commenter Name: Michael Dourson Commenter Organization: Toxicology Excellence for Risk Assessment

EPA Document ID: EPA-HQ-OW-2008-0692-1562

EPA Comment ID: 20643

EPA Comment Code: 6110

Comment: Conclusion

In this Federal Register notice, EPA is making a preliminary regulatory determination that a national primary drinking water rule is not necessary fo r perchlorate because a national primary drinking water regulation would not provide a meaningful opportunity to reduce health risk. In addition, EPA is announcing its plans to publish a Health Advisory, which will provide Federal, Regional, State, and Local public health officials with information regarding health risks posed from perchlorate-contaminated drinking water. Based on EPA’s analysis of exposure data and relative source contribution, we agree that perchlorate is not occurring in the public water supply at levels
that cause concern for health risks. However, we also recommend that EPA update its RfD prior to publishing a Health Advisory for the following reasons:

* Additional important data on pregnant women and their offspring have become available since the time of the development of the EPA’s RfD in 2005, which necessitate a reconsideration of the existing value. This reconsideration is consisten t with recommendations of the NAS (2005) in its

report.

* The excellent relative source contribution eval uation of EPA, based on well supported and clearly
described work of the FDA, necessitates a rethinki ng of the any RfD, since the underlying studies may not have measured perchlorate in the food of the human subjects.

* The 2005 "RfD" of the NAS does not follow the existing EPA method.

References

Barnes DG, Dourson ML. 1988. Reference dose (RfD): Description and use in health risk assessments. Regul Toxicol Pharmacol 8: 471-486.

Environmental Protection Agency. 2002. A review of the Reference Dose (RfD) and Reference Concentration (RfC) processes. Risk Assessmen t Forum. EPA/630/P- 02/002F, December.

Environmental Protection Agency. 2008. Integrated Risk Information System (IRIS). Online at www.epa.government/iris.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 535 of 1099 Faustman EM, Omenn GS. 2001. Risk Assessment. In: Casarett and Doull’s Toxicology: The Basic Science of Poisons (Klaassen CD, ed .). 6th Edition. McGraw-Hill, 92.

Lehman, A.J. and O.G. Fitzhugh. 1954. 100-fold ma rgin of safety. Assoc. Food Drug Off. U.S.Q.

Bull. 18:51-58.

National Research Council/National Academy of Sc iences (NRC/NAS). 2005. Health Implications of Perchlorate Ingestion. NAS Press, Washington D.C.

Strawson J, Zhao Q, Dourson M. 2004. Reference Dose for Perchlorate Based on Thyroid Hormone Change in Pregnant Women as the Critical Effect. Regulatory Toxicology and Pharmacology 39: 44-65.

Tellez RT, Chacon PM, Gibbs J, Crump C, Abarca CR. 2005. Chronic Environmental Exposure To Perchlorate And Thyroid Function During Pregnancy And The Neonatal Period. THYROID: 15(9):

963-975.

Response: Please see the response to comment code 61 10. In a NRC 2005 review of the state of the sciences regarding potential perchlorate adve rse health effects and mode-of-action (“Health Implications of Perchlorate Ingestion”, NRC (200 5)), the NRC recommended that data from the Greer et al. (2002) human clinical study be used as the basis for deriving a perchlorate reference dose (RfD) (NRC 2005). From this Greer et al. (2002) human clinical study, the statistical no observed effect level (NOEL) for the perchlorate-induced inhi bition of thyroid iodide uptake was determined to be 7.0 ug/kg, which corresponded to an iodide uptake inhibition of 1.8%. NRC concluded that the most health protective and scientifically va lid approach to deriving a reference dose for perchlorate, was to base the perc hlorate RfD on the inhibition of iodi de uptake by the thyroid, and that iodide uptake inhibition, though not an adve rse effect per se, is the most appropriate precursor event, and would precede any more severe adverse he alth effects of perchlorate exposure in humans. The NRC recommended basing the RfD on a precursor to an adverse effect rather than an adverse effect, per se. In this case, NRC used prevention of iodide uptake inhibition, a precursor to adverse thyroid effects, to establish a level at which no adverse effects would be anticipated in exposed populations. This approach is consistent with th e Agency’s policy on the us e of precursor events when appropriate in establishing the critical e ffect upon which an RfD is based (U.S. EPA, 2002). The NRC recommended that EPA apply an uncertainty factor of 10 to this NOEL of 7.0 ug/kg for the perchlorate-induced inhibition of thyroid iodide uptake, to account for differences in sensitivity between healthy adults and the most sensitive sub -population, consisting of fetuses of pregnant women who might have hypothyroidism or iodide de ficiency. EPA has also considered data derived from the Tellez et al. (2005) study. Blood seru m perchlorate concentrations predicted through PBPK modeling from data from a study of school children in Chile (Tellez et al. 2005) were within the range of the measured concentrations, and the concentrations of perchlorate in breast milk predicted from the model were within two standard deviations of the measured concentrations. Therefore, PBPK modeling predictions of blood serum perchlorate concentrations were consistent with empirical results, and the predicted extent of iodide inhibition in the most sensitive population (the fetus), based in part on data from Tellez et al. (2005), was not found to be significant at EPA’s RfD of 0.7 ug/kg/day.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 536 of 1099 EPA agrees that additional important data have become available since the RfD was derived in 2005.
However, EPA has evaluated the new data and has decided to make the regulatory determination based upon the current RfD. EPA will continue to evaluate any new perchlorate data to determine its relevance to the regulatory determination in accordance with the SDWA.

Greer MA, Goodman G, Pleus RC, Greer SE. He alth effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 2002 Sep;110(9):927-37. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732. National Research Cou ncil (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academies Press, Board on Environmental Studies and Toxicology, January, 2005, Washington, D.C. 276pp. Télle z RT, Chacón PM, Abarca CR, Blount BC, Van Landingham CB, Crump KS, Gibbs JP. Long-Term Environmental Exposure to Perchlorate Through Drinking Water and Thyroid Function During Pregnancy and the Neonatal Period. Thyroid. 2005 Sep;15(9): 963-75.U SEPA. 2002. A review of the reference dose and reference concentration processes. Risk Assessment Forum, Washington, DC; EPA/630/P–02/0002F.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20653

EPA Comment Code: 6110

Comment: P.O. Box 13222 Sacramento, CA 95813 November 18, 2008

Dr. Deborah L. Swackhamer, Chair Science Ad visory Board Environmental Protection Agency

Dr. Joan Rose Chair SAB Drinking Water Committee Environmenta l Protection Agency

Dear Dr. Swackhamer and Dr. Rose:

We read with great interest your November 5, 2008 letter to Administrator Johnson concerning EPA’s preliminary determination on a national drinking water standard for perchlorate. This letter states that "the SAB strongly be lieves that there must be a compelling scientific basis to support a determination not to regulate perchlorate..." We completely agree. Through the efforts of EPA’s
Office of Water, Office of Solid Waste and Emer gency Response, and Office of Research and Development over the last decade, the Agency has developed this compelling scientific basis.

First, the overall scientific literature concerning perchlorate’s potential e ffects on human health is extensive. There are very few compounds subject to EPA regulation that can rest on multiple pillars of scientific evidence, including animal stud ies in multiple species, occupational studies, environmental epidemiology studies, and human clin ical trials. There are also very few compounds

in which the mechanism of action is clear and occurs with welldefined, non-adverse precursors. And, there are very few compounds that have been subject to a rigorous and comprehensive National Academy of Sciences (NAS) review of the health effects.

As the NAS panel stated, unless these precursor ef fects occur, the subsequent adverse effects will not occur. To cite the NAS report,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 537 of 1099 The committee emphasizes that inhibition of iodide uptake by the thyroid has been the only consistently documented effect of perchlorate exposure in humans. The continuum of possible effects of iodide-uptake inhibition caused by pe rchlorate exposure is only proposed and has not been demonstrated in humans exposed to perchl orate (with the exception that in patients with hyperthyroidism doses of 200 mg daily or higher may reduce thyroid secretion). More important, the

outcomes at the end of the continuum are not inevitable consequences of perchlorate exposure.[FN1: National Academy of Sciences, Health Implications of Perchlorate Ingestion, 2005, at 165 (pdf version). The noted dose of 200 mg/d is a conservative therapeutic value. When use of perchlorate to treat hyperthyroidism was comm on, doses of 400 mg/d were commonly prescribed, but were found to be slow to control thyrotoxicity and doses needed to be repeated 4 to 5 times/d, due to the rapid excretion of the dr ug. Although it still took an aver age of 9.4 weeks, doses of up to 2000 mg/d were given to reduce hyperthyroid ism to a remission state (Wolff, 1998).]

Although no longer the drug of choice in the clin ic for treating thyrotoxicosis, perchorate is still used medically. For example, perchlorate is used to treat amiodarone (an antiarrhythmetic agent) induced thyrotoxicosis.[FN2: 2 J. Wolff, Perchlor ate and the Thyroid Gland, Pharmacol Rev. 1998; 50(1):89-105.] In other words, except for its delib erate medical use, exposure to perchlorate has not been shown to have caused reduced thyroid function in humans. In addition to the NAS conclusions, newer studies indicate that exposures to perchlorate at environmentally relevant levels have not been demonstrated to cause any effect on the health of persons.[FN3: See, Benjamin C. Blount, et al., Perchlorate Exposure of the US P opulation, 2001-2002, J Expos. Sci Envtl Epidem. 2006c; Benjamin C. Blount et al., Urinary Perchlorate and Thyroid Hormone Levels in Adolescent and Adult Men and Women Living in the United St ates, Envtl Health Perspect., 2006b, 1865-71;
Rafael Tellez Tellez et al., Chronic Environmenta l Exposure to Perchlorate Through Drinking Water and Thyroid Function During Pregnancy an d the Neonatal Period, Thyroid, 2005, 963-975; Yona Amitai et al., Gestational Exposure to High Perchlorate Concentrations in Drinking Water and Neonatal Thyroxine Levels, Thyroid, 2007, 843-850; Craig Steinmaus et al., Impact of Smoking and Thiocyanate on Perchlorate and Thyroid Hormone Associationsin the 2001-2002 National Health and Nutrition Examination Survey, Envtl Health Perspect, 2007, 1333-38.] The weight-of-evidence suggests that adverse effects do not occur following chronic exposures to perchlorate at doses much greater than the RfD.[FN4: See, Te llez et al., 2005; Amitai et al., 2007; Lewis E. Braverman et al., The Effect of Perchlorate, Thiocyanate, and Nitr ate on Thyroid Function in Workers Exposed to Perchlorate Long-Term, J. Clin. En docrinol. Metab., 2005, at 700.]

Second, this extensive scientific literature has un dergone several major peer reviews. EPA convened peer review panels of its draft risk assessments in 1999 and 2002. The University of Nebraska

Medical Center convened a State-of-the- Scie nce Symposium and peer review in 2003. From October 2004 to January 2005, the NRC panel of 15 national experts held several meetings and solicited extensive public comment. While the SAB can contribute to the findings of these panels, EPA already has extensive, independent scientific analysis of perchlorate to underpin its final

determination.

Response: Administrator Stephen Johnson replied to the SAB on January 9, 2009. The letter is

available in EPA’s docket ID No. EP A-HQ-OW-2009-0297 for this notice.

Commenter Name: John C. Vest Commenter Organization: Public Service Department, Town of Mooresville, NC

EPA Document ID: EPA-HQ-OW-2008-0692-1567EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 538 of 1099 EPA Comment ID: 20667

EPA Comment Code: 6110

Comment: John C. Vest, P.E. Public Services Directo r PO Box 878 Mooresville, NC 28115 (704)

790-4290

November 7, 2008

Water Docket Environmental Protection Agency 12 00 Pennsylvania Avenue, NW Washington, DC

RE: Docket ID No. EPA-HQ-OW-2008-0068 Dr inking Water: Preliminary Regulatory

Determination on Perchlorate

The Public Services Department of the Town of Mooresville, North Carolina agrees with the Environmental Protection Agency's determination that a national primary drinking water regulation (NPDWR) for perchlorate would not present a mean ingful opportunity for health risk reduction for persons served by public water systems.

Our determination is based on several factors including research studies submitted by the EPA, NAS/NRC and FDA as well as articles released by accredited organizations. Authorities concur exposure to perchlorate is not limited to public wa ter sources but is also found in food products.

Public water sources found with maximum levels of perchlorate affect a small population of the country and would be better managed at a local level. The results of testing by a third party laboratory in 2002 showed no significant level of pe rchlorate in the Town of Mooresville's drinking water supply. All test results were below the detection limit of 4u/l.

Should you have any questions, please do not hesitate to contact us.

Sincerely,

John C. Vest, P.E. Pub lic Services Director

Response: EPA believes that regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction. EPA believes th at regulating perchlorate in drinking water presents a meaningful opportunity for health risk reduction. This determination is based on the best available peer reviewed science and data collected in accordance with accepted methods related to perchlorate’s occurrence in drinking water , the pr esence of perchlorate in foods and the potential health effects of exposure to perchlorate, and EPA’s population exposure evaluation as described in more detail in the final regulatory determination. Specifically, The Agency analyzed occurrence data from the Unregulated Contaminant Monitoring Rule (UCMR), which is nationally representative, and found that perchlorate occurred in 26 states and 2 territories affecting millions of people. EPA agrees that perchl orate contamination is widespread in foods; however, EPA does not believ e that the widespread presence of perchlorate in food overrides the opportunity for public health risk reduction for persons served by PWSs with perchlorate contamination.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 539 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1851

EPA Comment ID: 20740

EPA Comment Code: 6110

Comment: We are over-regulating ourselves to death! Th e drinking water is safe enough - there's no need to keep upping the bar. This hits people in the pocket book for no good reason.

Response: Please see the response to comment code 6110.

Commenter Name: Commenter Organization: Ag Council et al

EPA Document ID: EPA-HQ-OW-2008-0692-1987

EPA Comment ID: 20974

EPA Comment Code: 6110

Comment: November 26, 2008

US Environmental Protection Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: Docket ID No. EPA-HQ-OW-2008-0692. Co mments on US EPA Preliminary Regulatory

Determination on Perchlorate.

The undersigned representatives of the California agricultural industry are pleased to submit the following comments regarding US EPA's prelimin ary regulatory determination on perchlorate. California agriculture is a diverse and important se ctor of our economy. It is a $37 billion industry that produces over 350 different crop and livesto ck commodities and generates an estimated $100 billion in related economic activity. California agri culture accounts for approximately 7.5% of all employment and supports over a million on farm j obs. California agriculture is also the leading exporter of agricultural commodities, sending almost 20% of our agricultural production to foreign

markets.

Based upon the available scientific studies as well as the available exposure and occurrence data, the undersigned support EPA's decision not to establish a national primary drinking water regulation for perchlorate. Both the US Food and Drug Admi nistration's (FDA) food sampling data and total dietary survey, along with EPA's calculated relative source contribution reveal that total perchlorate exposure in the US population is well below established levels of human health concern, even for sensitive subpopulations.

Response: Please see response to comment code 61 10. The Agency presented an extensive evaluation of dietary exposure to perchlorate in th e October 2008 and August 2009 Federal Register notices. EPA has used this dietary exposure data to account for the relative source contribution (RSC) of perchlorate from food and derived potenti al alternative HRLs for 14 life stages using the RfD and life stage-specific exposure information in the August 9, 2009 Federal Register notice. These levels range from 1 ug/L to 47 ug/L. EPA also evaluated the populations exposed to perchlorate from both food and drinking water in the August 2009 Federal Register notice and the final regulatory determination. EPA recognizes that a drinking water regulation would not eliminate perchlorate exposure in drinking water but belie ves that the reduction in perchlorate exposureEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 540 of 1099 presents a meaningful opportunity for health risk reduction for persons served by PWSs contaminated by perchlorate.

.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21052

EPA Comment Code: 6110

Comment: November 26, 2008

Docket ID No. EPA-HQ-OW-2008- 0692 Water Docket U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Av e., NW Washington, DC 20460

RE: Comments in Response to the EPA Notice, Drinking Water: Preliminary Regulatory Determination on Perchlorate [EPA-HQ-OW-2 008-0068; FRL-8727-6] RIN 2040-ZA02

Dear Sir or Madam:

The Perchlorate Study Group (PSG) is pleased to submit comments in response to the abovecaptioned EPA regulatory proceeding.

Please note that there are two sets of comments.

1. Perchlorate and Human Health in 2008: The Implications of New Science for the EPA Preliminary Determination. The most important issue s for consideration by the Agency relate to the state of the science. The unswerving focus of th e PSG has been to analyze and make available the

best available scientific information. The scientific comments were prepared by Intertox, a highlyrespected firm with extensive experience in the scient ific considerations relating to perchlorate.

The Intertox report concludes that the scientific evidence supports the Agency's decision not to establish a national primary drinking water standard for perchlorate, because "there is no meaningful opportunity for health risk reduction."

The most important source of scientific inform ation on the human health issues relating to perchlorate is an extensive report undertaken by the National Academies of Science, released in 2005. The NAS report has been relied upon by the EPA in subsequent regulatory actions.

The Intertox scientific comments bring the scientif ic information up to date, examining studies published after the NAS report. The Intertox study, like the NAS study, does not recommend a level for EPA's possible adoption. The Intertox report finds that even with highly conservative assumptions, there would be "no significant health risk to the most sensitive individuals" at a level of at or below 15 parts per billion.

Response: Please see the response to comment code 6110.

Commenter Name: Michael GirardEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 541 of 1099 Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21054

EPA Comment Code: 6110

Comment: PERCHLORATE AND HUMAN HEALTH IN 2008: THE IMPLICATIONS OF

NEW SCIENCE FOR THE EPA PRELIMINARY DETERMINATION COMMENTS IN

RESPONSE TO THE EPA NOTICE DRINKING WATER: PRELIMINARY REGULATORY DETERMINATION ON PERCHLORATE [EPA-H Q-OW-2008-0068; FRL-8727-6] RIN 2040-

ZA02

FINAL

Prepared for: PERCHLORATE STUDY GROUP

November 25, 2008

Intertox, Inc. 600 Stewart St. Suite 1101 Seattle, WA 98101

206.443.2115 phone 206.443.2117 facsimile

TABLE OF CONTENTS I. INTRODUCTION....................

............................ ...............1 II. KEY

SCIENTIFIC STUDIES PUBLISHED SINCE 2005...... .........................6 A. ENVIRONMENTAL

STUDIES.................

.................................... .6 B. OCCUPATIONAL OR CLINICAL

STUDIES................. .........................12 C. BREAST MILK

STUDIES.................. .....................................13 III . IODINE SUFFICIENCY IN THE UNITED

STATES.......................... .......18 IV. CONCLUSIONS......................

......................... ...............20 IV.

REFERENCES.................

................... ................. ..........21

LIST OF APPENDICES

APPENDIX A. REVIEW OF BL OUNT ET AL., 2006

LIST OF FIGURES FIGURE 1. URINARY REANALYSIS RESULTS OF THE NHANES

DATA......................10 FIGURE 2. PLO TTING OF DATA REPORTED BY DASGUPTA ET
AL., 2008 TO ILLUSTRATE THE ASSO CIATION BETWEEN CONCENTRATIONS OF

IODINE AND PERCHLORATE IN URINE AND MILK IN LACTATING

WOMEN................... ........................................15

I. INTRODUCTION

The Environmental Protection Agency (EPA) has re leased its preliminary regulatory determination on perchlorate for public comment. The EPA is re quired by the Safe Drinking Water Act (SDWA) to publish Maximum Contaminant Level Goals (M CLG) and national primary drinking water regulations (NPDWR) IF (emphasis added),

(a) the contaminant may have an adverse effect on the health of persons; (b) the contaminant is known to occur in public water systems with a freque ncy and at levels of public health concern; andEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 542 of 1099 (c) in the sole judgment of the Administrator, re gulation of such contaminant presents a meaningful opportunity for health risk reduction for persons se rved by public water systems (73 FR 60264).

Based on these criteria, the EPA has presented their rationale in the determination not to set an NPDWR for perchlorate as it would not present "a meaningful opportunity for health risk reduction for persons served by public water systems." Th is decision was made based on the derivation of a Health Reference Level (HRL) for perchlorate and was calculated to be 15 ppb based on a relative source contribution (RSC) of 62% (73 FR 60276)..

Even a cursory review of the 50 years of perchlora te research shows that the weight of scientific evidence clearly supports EPA's decision.

The purpose of this document is to review the k ey scientific studies and how these studies support the EPA's findings in the proposed determination. We present a brief review of the National Research Council of the National Academy of Sc iences (NRC) assessment and update key studies

that have been added to the scientific literature.

Between 1997 and 2002, at least 13 toxicological st udies of perchlorate, all using EPA protocols, were conducted in animals; these include pha rmacokinetic studies, subchronic studies, developmental studies, immunotoxicology studies, and a multigenerational reproductive study. All studies were conducted over a range of doses and evaluated independently by EPA. Of the many results obtained from this work, the most sensitive target organ was the thyroid gland and its influence on the body. Studies of potential muta genic effects were conducted but no such effects were found (U.S. EPA, 2002). During the same ti me period, there were several clinical exposure studies in humans and a number of epidemiologic and ecological studies, some in occupational settings and some in populations exposed to perchl orate via the community drinking-water supply.

[Text Box: The body of science supports the Agen cy's decision not to establish a national primary drinking water standard as there is no meaningful opportunity for health risk reduction.]

Response: Please see the response to comment code 6110.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21079

EPA Comment Code: 6110

Comment: IV. CONCLUSIONS

The results of this assessment demonstrate that the RfD continues to be a conservative and healthprotective toxicity guideline value. As such, perchlor ate concentrations in drinking water at or below the HRL proposed by EPA pose no significant health risk to the most sensitive individuals consuming water on a daily basis over a lifetime. Since the release of the RfD, additional studies

have been conducted and continue to add to the scientific weight of evidence supporting the RfD (and HRL) as conservative estimates. The RfD and HRL include uncertainty spanning perhaps an order of magnitude, and estimate a daily oral ex posure to the human population (including sensitive subgroups) that is likely to be without an appreciab le risk of deleterious effects during a lifetime. TheEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 543 of 1099 EPA has further determined that perchlorate is not found in public water supplies at a frequency and a level that would cause public health concern. Based on this, the EPA has determined that there is not "a meaningful opportunity for health risk reduction for persons served by public water systems" by determining a NPDWR.

IV. REFERENCES

Amitai Y, Winston G, Sack J, Wasser J, Lewis M, Bl ount BC, Valentin-Blasini L, Fisher N, Israeli A, Leventhal A. 2007. Gestational exposure to high pe rchlorate concentrations in drinking waer and neonatal thyroxine levels. Thyroid 17:843-850.

Agency for Toxic Substances and Disease Registry (ATSDR). 2008. Toxicological Profiles for Perchlorate. American Thyroid Association (A TA). 2006. Update on the Question of Perchlorate Exposure and Potential Effects on the Thyroid: Response to CDC Report of Environmental Perchlorate Exposure. Accessed at http://www.thyroid.org/professionals/publicati ons/statements/06_12_13_perchlorat e.html.

American Water Works Association, 2008). Nationa l Cost Implications of a Potential Perchlorate Regulation, Jul. 2008, at 31).

Barr DB, Wilder LC, Caudill SP, Gonz alez AJ, Needham LL, and Pirkle JL. 2005. Urinary creatinine concentrations in the U.S. population: implications for urinary biologic monitoring measurements. Environ. Health Perspect. 113 (2):192-200.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasi ni L, Caldwell KL. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect. 114(12):1865-71.

Blount BC, Valentin-Blasini L, Osterloh JD, Maul din JP, Pirkle JL. 2007. Perchlorate exposure of the US population, 2001-2002. J Expo Sci Environ Epidemiol. 17(4):400-7.

Braverman LE, He X, Pino S, Cross M, Magn ani B, Lamm SH, Kruse MB, Engel A, Crump KS, Gibbs JP. 2005. The effect of perchlorate, thiocy anate, and nitrate on thyroid function in workers exposed to perchlorate long-term. J Clin Endocrinol Metab 90:700-706.

Braverman LE, Pearce EN, He X, Pino S, Seeley M, Beck B, Magnani B, Blount BC, Firek A. 2006. Effects of six months of daily low-dose perc hlorate exposure on thyroid function in healthy volunteers. J Clin Endocrinol Metab. 91(7):2721-4. Epub 2006 Apr 24.

Borak J. 2005. Adequacy of iodine nutriti on in the United States. Conn Med 69:73-77.

CDC 2006. National Health and Nutrition Exam ination Survey (NHANES). Centers for Disease
Control and Prevention. Accessed October 20, 2006.

Clewell RA, Merrill EA, Gearhart JM, Robinson PJ , Sterner TR, Mattie DR, Clewell HJ 3rd. 2007. Perchlorate and radioiodide kinetics across life stag es in the human: using PBPK models to predict dosimetry and thyroid inhibition and sensitive subpopulations based on developmental stage. J

Toxicol Environ Health A 70:408-28.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 544 of 1099 Crawford-Brown D, Raucher B, Harrod M. 2006. In tersubject variability of risk from perchlorate in community water supplies. Environ Health Perspect 114:975-979.

Dasgupta PK, Martinelangd PK, Jackson WA, An derson TA, Kang T, TDCK RW, Rajagopalan S. 2005. The Role of Naturally Occurring Perchlorat e: The Role of Atmospheric Processes. Environ

Sci Technol 39:1569-1575.

Dasgupta PK, Dyke JV, Kirk AB, Jackson WA. 2006. Perchlorate in the United States. Analysis of

Relative Source Contributions to the Food Chain Environ Sci Technol 40:6608-6614.

Das Gupta PK, Kirk AB, Dyke JV, Ohira S. 2008. In take of iodine and perchlorate and excretion in
human milk. Environ. Sci, Technol.

Dohan O, Portulano C, Basquin C, Reyna-Neyr a A, Amzel LM, Carrasco N. 2007. The Na+/I symporter (NIS) mediates electroneutral active trans port of the environmental pollutant perchlorate. PNAS 104(51):20250-5.

Furnee CA, van der Haar F, West CE, and Hautva st JG. 1994. A critical appraisal of goiter assessment and the ratio of urinary iodine to crea tinine for evaluating iodine status. Am J Clin Nutr.59 (6):1415-7.

Gibbs JP, Van Landingham C. 2008. Urinary perchl orate excretion does not predict thyroid function among pregnant women. Thyroid 18:807-808.

Ginsberg G, Rice D. 2005. The NAS Perchlorate Review: Ginsberg et al. Respond. Environ Health Perspect. 113:A730-A732.

Greer MA, Goodman G, Pleus RC, Greer SE. 2002 . Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect. 110(9):927-37 . Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732.

Kirk AB, Martinelango PK, Tian K, Dutta A, Smit h EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Environ Sci Technol. 39(7):2011-7.

Lamm SH, Hollowell JG, Engel A, Chen R 2008 Perchlorate, thiocyanate, and low iodine association not seen with low creatinine-adjusted urine iodine among women of childbearing age [abstract]. Thyroid. 17 Suppl (S51).

Merrill EA, Clewell RA, Robinson PJ , Jarabek AM, Gearhart JM, Sterner TR, Fisher JW. 2005.

PBPK Model for Radioactive Iodide and Perchlorate Kinetics and Perchlorate-Induced Inhibition of Iodide Uptake in Humans, Toxi cological Sciences 83:25-43.

Murray CW, Egan SK, Kim H, Beru N, Bolger PM. 2008. US Food and Drug Administration's Total Diet Study: Dietary intake of perchlorate an d iodine. J Expo Sci Environ Epidemiol. Jan 2, 2008. [Epub ahead of print]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 545 of 1099 National Research Council of the National Acad emies (NRC). 2005. Health Implications of Perchlorate Ingestion. Committee to Assess the Health Implications of Perchlorate Ingestion, Board on Environmental Studies and Toxicology, Division on Earth and Life Studies. Washington, D.C.:

The National Academies Press.

Pearce EN, Lazarus JH, Smythe PP, et al. 2007a. Th yroid function is not affected by environmental perchlorate exposure in first trimester preg nant women. Thyroid. 17 Suppl:S133-134.

Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin-Bla sini L, Steinmaus C, Miller MD, Howd R. 2007. Impact of smoking and thiocyanate on perchlorate and thyroid hormone

associations in the 2001-2002 national health an d nutrition examination survey. Environ Health Perspect. 115(9):1333-8.

Rajagopalan S, Anderson TA, Fahlquist L, Rainwa ter KA, Ridley M, Jackson WA. 2006. Widespread Presence of Naturally Occurring Perchlorate in Hi gh Plains of Texas and New Mexico. Environ Sci

Technol 40:3156-3162.

Strategic Environmental Research and Developm ent Program (SERDP). 2005. Alternative Causes of Widespread, Low-Level Perchlor ate Impacts to Groundwater.

Tellez RT, Chacon PM, Abarca CR, Blount BC, Va n Landingham CB, Crump KS, Gibbs JP. 2005. Longterm environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal period. Thyroid. 15(9):963-975.

Tonacchera M, Pinchera A, Dimida A, Ferrarini E, Agretti P, Vitti P, Santini F, Crump K, and Gibbs J. 2004. Relative potencies and additivity of perchlorate, thiocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the human sodium iodide symporter. Thyroid. 14 (12):1012-9.

U.S. Environmental Protection Agency (EPA). 1989. Risk Assessment Guidance for Superfund,
Volume 1, Human Health Evaluation Manual (PartA) (EPA/540/1-89/002). Interim Final. Washington, D.C. Office of Emergency and Remedial Response.

U.S. Environmental Protection Agency (EPA). 1999. Exposures Factor Handbook (EPA/600/C99/001). Washington, D.C.: Office of Research & Development.

U.S. Environmental Protection Agency (EPA). 19 98a. Perchlorate Environmental Contamination: Toxicological Review and Risk Characterization Based on Emerging Information, Review Draft (NCEA-1-0503). Washington, D.C.: Office of Research and Development. December 31.

U.S. Environmental Protection Agency (EPA). 2002. Perchlorate Environmental Contamination: Toxicological Review and Risk Characterizati on (NCEA-1-05-3), External Review Draft. Washington, D.C.: Office of Research and Development. January 16.

U.S. Environmental Protection Agency (EPA) Integ rated Risk Information System (IRIS). 2005. Perchlorate and Perchlorate Salts. Wartenberg D, buckler G. 2001. Invited commentary: Assessing latex sensitization using data from NHANES III. Am J Epidem 153.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 546 of 1099 Response: Please see the response to comment code 6110 . EPA estimates that at least 5.1 to 16.6 million people are served by PWSs, for which we have data, that have perchlorate contamination. EPA has determined that an NPDWR for perchlorate could reduce exposures for these populations to levels below the potential alternative HRLs that EPA has identified as levels of public health concern for perchlorate. EPA believes that this perchlorate exposure re duction presents a meaningful opportunity for the reduction of health risks for persons served by PWSs.

This determination is based on the best availabl e peer reviewed science and data collected in accordance with accepted methods related to pe rchlorate’s occurrence in drinking water, the presence of perchlorate in foods and the potential health effects of exposure to perchlorate, and EPA’s population exposure evaluation as described in more detail in the final regulatory

determination.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21089

EPA Comment Code: 6110

Comment: US Environmental Protection Agency Offi ce of Water Docket (Mailcode 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

November 10, 2008

Re: Comments in Response to EPA Notice Drinking Water: Preliminary Regulatory Determination on Perchlorate [EPA-HQ-OW-2 008-0692; FRL-8727-6].

The Perchlorate Study Group (PSG) is pleased to submit comments to the Environmental Protection Agency (EPA) on Docket ID No. EPA-HQ -OW-2008-0692, entitled Drinking Water: Preliminary Regulatory Determination on Perchlorate. As manufacturers and users of perchlorate, the PSG is committed to ensuring that the best avai lable science is provided in public debate and applied in the subsequent setting of regulatory standards. The member companies of the PSG include Aerojet, American Pacific Corporation (A MPAC), Alliant Techsystems (ATK), and Tronox.

For over ten years, the PSG has worked cooperative ly and effectively with the US Environmental Protection Agency (EPA) and other federal agencies, state governments, and water purveyors to:

* increase scientific and medical understanding of perchlorate's possible effects on human health;
and,

* assess the level of perchlorate in drinking water that is expected to pose no adverse effects to

human health.

We therefore appreciate this opportunity to submit these comments relating to EPA's preliminary

determination.

I. The EPA's Proposed Determination is Back ed by the Best Science and the StatuteEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 547 of 1099 The PSG agrees with EPA's preliminary determina tion that a Federal drinking water regulation

would not meet the SDWA criteria and that EPA has ample justification for this determination. EPA has an extraordinary wealth of comprehensive, authoritative scientific information relating to perchlorate's health effects, supplemented by ex tensive occurrence and exposure data. The Agency is therefore exceptionally well-positi oned to issue a well-considered regulatory determination. The best available scientific data supports a determination under the Safe Drinking Water Act (SDWA) that public water systems do not present a me aningful opportunity for risk reduction.

Response: Please see the response to comment code 6110.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21092

EPA Comment Code: 6110

Comment: Second, EPA has ample scientific and technica l data to make a final determination on or before the planned date of December 2008. As noted in the attached scientific summary, perchlorate

is one of the most well-studied chemicals with detailed information on the mechanism of action, dose-response, and health effects. This issue also is not new. EPA released its first draft risk assessment on perchlorate in 1998, followed by a second in 2002. The 2005 NAS report was a comprehensive review of the science. The animal and human studies that have been published since the NAS report reduce the uncertainty and reinforce the NAS panel's finding that there will not be any adverse health effects from perchlorate at environmentally-relevant concentrations.

New studies published since the NAS report increase the weight of evidence that the current RfD protects human health including the most sensitive members of our population. In addition, testimony by Congressional members and witnesses a like have discussed the lengthy amount of time that EPA has spent studying the health effects, urgi ng the agency to issue a determination as soon as practicable. We join them in urging EPA to issue the final determination promptly.

Response: Please see the response to comment code 6110.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0521

EPA Comment ID: 28474

EPA Comment Code: 6110

Comment: Please accept the attached comments. Thank-you ED THOMAS

Attachment

September 18, 2009

U.S. Environmental Protection Agency Offi ce of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 548 of 1099 RE: Drinking Water: Perchlorate Supplemental Request for Comments (Docket Number: EPA-HQOW-2009-0297)

To Whom It May Concern:

NRWA commends EPA for their proposed regulatory determination for perchlorate. We believe the Agency has relied on sound science and that a national standard for perchlorate would not result in a meaningful opportunity for health risk reduction.

Response: Please see the response to comment code 6110.

Commenter Name: Mark S. Mayer Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28478

EPA Comment Code: 6110

Comment: September 18, 2009

Comment Clerk Docket EPA-HQ-OW-2009-0297 U.S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

To Whom It May Concern:

Thank you for the opportunity to provide comment on the Perchlorate Supplemental Request as published in the August 19, 2009 (Volume 74, Numb er 159) Federal Register. We have reviewed the request and offer the comments found in the attachment.

We hope EPA will favorably consider our comments. Thank you again.

Sincerely, Mark S. Mayer, P.E. Natural Resources Administrator SD Drinking Water Program

cc: Jim Taft, Executive Director, Association of Sa fe Drinking Water Administrators Carol Rushin, Acting EPA Region 8 Administrator Jason Glodt, Se nior Policy Advisor, Governor's Office James,
Stone, Chair South Dakota Section of the American Water Works Association

Attachment

Perchlorate Supplemental Request Comments by So uth Dakota Department of Environment and Natural Resources (DENR)

General Comments:

- The South Dakota Department of Environmen t and Natural Resources (DENR) supports EPA's preliminary decision to not regulate Perchlorate, and finds no reason now to alter that decision. Based on the information obtained from the contaminant candidate list and UnregulatedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 549 of 1099 Contaminant Monitoring processes used by EP A to obtain occurrence data on unregulated contaminates, Perchlorate is not a drinking wa ter issue in South Dakota. Consequently, South Dakota does not support EPA establishing a new national regulation for Perchlorate. Such a new rule will become another regulatory burden for ou r drinking water systems, but it would have no positive health effects or benefits for their customers.

Response: Please see the response to comment code 6110.

Commenter Name: Julie L. Heckman Commenter Organization: American Pyrotechnics Association (APA)

EPA Document ID: EPA-HQ-OW-2009-0297-0522

EPA Comment ID: 28490

EPA Comment Code: 6110

Comment: The premature or excessive regulation of perchl orate absent full consideration of all the facts and all the science, particularly for so new a concern, would threaten the fireworks industry's ability to continue to serve the country. It would threaten the nation's ability to continue to respect the most patriotic of its traditions.

Response: Please see the response to comment code 6110. Today’s determination is based upon an

assessment of the best available science and information.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28556

EPA Comment Code: 6110

Comment: The PBPK modeling is useful in demonstrating that all identified lifestages are protected at the RfD level, and especially under the current HAL of 15 ppb perchlorate in drinking water as they are within the 10x intraspecies factor. Th e alternative methods of exposure assessment are informative but do not show that any deviation fr om EPA's typical risk assessment based on a 70 kg adult consuming two liters of water is warranted. As the occurrence of perchlorate in water supplies is sporadic and geographically discreet, the Ag ency has not provided sufficient information or explanation to justify using Bayesian analyses of water occurrence data. EPA has sufficient information to determine that perchlorate should not be regulated as a drinking water contaminant under the Safe Drinking Water Act and should main tain a recommended health advisory limit of 15 ppb.

Response: Please see the response to comment code 611 0. After further consideration of the peer review and public comments, EPA concludes that th e PBPK modeling analysis, in the context of the perchlorate regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. For example, the mode l indicates that a fetus may be seven times more sensitive to the effects of perchlorate than a pregnant woman. The model also allows for the estimation of the concentration of perchlorate in breast milk (thus breast-fed infant exposure) at various maternal perchlorate exposure levels. Howev er, because of the stated limitations, EPA has

decided the model does not dir ectly bear on the current decision regarding the need for a NPDWREPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 550 of 1099 for perchlorate. EPA is continuing to evalua te whether the model could be used in setting a NPDWR for perchlorate.

EPA believes that perchlorate contamination in dr inking water does not occur sporadically. The Agency analyzed occurrence data from the Unre gulated Contaminant Monitoring Rule (UCMR), which is nationally representative, and found that pe rchlorate occurred in 26 states and 2 territories.

EPA continues to evaluate the utility of the Bayes ian model(s) in the development of a NPDWR for perchlorate.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28557

EPA Comment Code: 6110

Comment: Attachment

The Environmental Protection Agency (EPA) has sufficient information to make a regulatory determination concerning perchlorate under the Safe Drinking Water Ac t (SDWA) - perchlorate does not meet the three criteria necessary for regu lation - therefore, the Administrator can determine that the EPA should maintain its guidance for a Health Advisory Limit (HAL) at 15 parts per billion (ppb) in drinking water and can decide not to regulate perchlorate under the SDWA. The Agency continues to waste public resources and time based on ill- informed critiques of the National Research Council (NRC) 2005 findings on perchlorate.

Response: Please see response to comment code 6110.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28562

EPA Comment Code: 6110

Comment: In summary, the PBPK modeling is useful in demonstrating that all identified lifestages are protected at the RfD level, and especially under the current HAL of 15 ppb perchlorate in drinking water as they are within the 10x intras pecies factor in terms of potential risk. The alternative methods of exposure assessment are informative but do not show that any deviation from EPA’s typical risk assessment based on a 70 kg adult consuming two liters of water is warranted. As the occurrence of perchlorate in water supplies is sporadic and geographically discreet, the Agency has not provid ed sufficient information or expl anation to justify using Bayesian analyses of water occurrence data. EPA has suffici ent information to determine that perchlorate should not be regulated as a drinking water co ntaminant under the Safe Drinking Water Act and should maintain a recommended health advisory limit of 15 ppb.

Response: Please see response to comment ID 28556 under comment code 6110.

Commenter Name: Sonia SalasEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 551 of 1099 Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28683

EPA Comment Code: 6110

Comment: Conclusion

Based upon the best available scientific evidence, including exposure and occurrence data developed since the National Academy of Sciences issued it s findings in January, 2005, the undersigned conclude that the regulatory thresholds contem plated in EPA's above referenced notice are not scientifically justified and are substantially more stringent than necessary to ensure protection of public health. Moreover, the US Food and Drug Administration's (FDA) food sampling data and total dietary survey, and the relative source contribution calculated by USEPA for its 2008 preliminary regulatory determination demonstrate c onclusively that total perchlorate exposure in the US population is well below established levels of human health concern for both the general public and sensitive subpopulations.

For the reasons articulated above, the California ag ricultural industry encourages USEPA to act on its October 10, 2008 preliminary regulatory determination for perchlorate, which the weight of scientific evidence demonstrates to be high ly health protective. We appreciate USEPA's

consideration of our comments and we remain committed to working with USEPA, USDA and FDA to preserve the safety and integrity of our prod ucts and their contribution to balanced, healthy

diets.

Sincerely, Agricultural Council of California Calif ornia Citrus Mutual California Cotton Ginners and

Growers Association California Farm Bureau Federa tion California Floral Council California Grape and Tree Fruit League Grower-Shipper Association of Central California Imperial Valley Vegetable

Grower Association Ventura Cou nty Agricultural Association Nisei Farmers League Ventura County Agricultural Association Western Growers Association Western Plant Health Association Western United Dairymen

Response: Please see the response to comment code 6110.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28716

EPA Comment Code: 6110

Comment: Introduction

These comments are provided in further su pport of EPA's preliminary determination that establishment of a perchlorate drinking water stan dard is not merited, and in reference to comments already posted by Jonathan Borak on Septembe r 21st under reference EPA-HQ-OW-2009-0297-

0209.1. Mr. Borak's comments refe r primarily to the Blount, et al., 2006 study regarding the association of low background levels of perchlor ate with thyroid hormone levels. Notwithstanding the many inconsistencies and contradictions in this study as noted by Mr. Borak and others, it isEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 552 of 1099 clear in reviewing other comments submitted under Docket EPA-HQ-OW-2009-0297, that the Blount study is still being heavily relied upon by supporters of perchlorate regulation, who point to this study as proof of the eff ect of low background levels of perchlorate on thyroid function.

Response: Please see the response to comment code 6110 . EPA did consider the data presented in the Blount et al., 2006 study as well as other in formation on perchlorate exposure. EPA will consider

the best available science and information as EPA develops the perchlorate regulation.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28841

EPA Comment Code: 6110

Comment: Please accept the attached comments on behalf of the American Water Works

Association.

Attachment

September 18, 2009

U.S. Environmental Protection Agency Offi ce of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Drinking Water: Perchlorate Supplement al Request for Comments Docket EPA-HQ- OW2009-0297

The American Water Works Association a ppreciates the opportunity to comment on the supplemental request for comments regarding perchl orate as detailed in the August 3, 2009 Federal Register notice (74 FR 41883). AWWA is an in ternational, nonprofit, scientific and educational society dedicated to the improvement of drinking water quality and supply. Founded in 1881, the Association is the largest organization of water supply professionals in the world. Our 57,000 members represent the full spectrum of the drinki ng water community: treatment plant operators and managers, environmental advocates, engineers, scientists, academicians, and others who hold a genuine interest in water supply and public health. Our membership includes more than 4,700 utilities that supply roughly 80 percent of the nation's drinking water. Based on this broad membership base, these comments should be consid ered as representative of the drinking water community in general.

These comments represent a restatement of the position submitted to the Agency in response to preliminary regulatory determination for perchlor ate as detailed in the October 10, 2008 Federal Register notice (73 FR 60262). Given the weight of evidence available at that time and AWWA's independent assessment of occurrence and exposure we concurred with Agency's preliminary determination that regulation of perchlorate woul d not present "a meaningful opportunity for health risk reduction for persons served by public water systems." We continue to support that preliminary

determination. Response: Please see the response to comment code 6110.

Commenter Name: Tom CurtisEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 553 of 1099 Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28857

EPA Comment Code: 6110

Comment: Conclusion

AWWA believes that the Agency's originally pr oposed decision not to regulate perchlorate is supported by the criteria established in the SDWA. Th e primary public health issue - as stated by the NRC and others including the Agency's Inspecto r General [FN22: Wilson, M. 2008. Scientific Analysis of Perchlorate. US Environmen tal Protection Agency, Office of Inspector General:Washington DC. Available at http://www. epa.gov/oigearth/repor ts/2009/20081230-2008- 0010.pdf] - is iodine deficiency. The SDWA is not an effective means or "tool" to manage a public health issue dominated by dietary issues. The public 's exposure to all sources of goitrogens due to

extensive contributions from other sources as demonstrated by the FDA food market assessment support the findings that regulation of drinking water would not have a meaningful impact on changing the nation's level of iodine deficiency. A precautionary approach is not justified by the available public health data that provides no indication of epidemic cretinism, goiter, or hypothyroidism, even given the loading of other goitrogens that far exceed potential contribution from perchlorate from all sources. A risk management approach that seeks to extract 100 percent of the risk reduction value from the smallest possible source is not only ineffective, but is a disservice to the mission of seeking the greatest protection of public health. The Agency should use the findings of this assessment to support a collaborative effort with the Department of Health and Human Services and Department of Agriculture to develop outreach materials that communicate the importance of proper dietary levels of iodi ne, specifically targeting sensitive subpopulations. Attempts have been made in the past to ensure the public received appropriate iodine levels.[FN23:
Medicine: Pass the iodized salt, in Time 1949, 19 September. Available at http://www.time.com/time/magazine/article/0 ,9171,800702,00.html] AWWA believes that remains a better approach for addressing the problem of iodine deficiency, instead of using the Safe Drinking Water Act to address this issue

AWWA appreciates the opportunity to comment on these important drinking water issues. If you have any questions about these comments, please f eel to call Kevin Morley or me in our Washington

Office at 202-628-8303.

Sincerely, Tom Curtis Deputy Executi ve Director-Government Affairs

cc: Peter Silva, OW Cynthia Doughter y, OGWDW Eric Burneson, OGWDW

Response: Please see the response to comment code 6110. EPA agrees that promoting iodide nutrition is good public health policy that has a ro le in reducing the adverse effects associated with exposure to perchlorate. However, the Agency is required to undertake the development of a national primary drinking water regulation if the provisions under section 1412(b)(1) of SDWA are satisfied. That is, if the three legislative criteria are met, EPA must undertake the development of a

NPDWR. EPA has determined that the three crit eria are met for perchlorate for the reasons outlined in today’s federal register notice.

Commenter Name:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 554 of 1099 Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28875

EPA Comment Code: 6110

Comment: EPA, based on a scientific assessment of th e literature in 2008, concluded that federal regulation of perchlorate in drinking water is unwa rranted. More than 50 years of scientific research and guidelines support the Agency's position.

I. INTRODUCTION

On August 19, 2009, the Environmental Protection Agency (EPA) issued a Federal Register (FR) notice requesting comments on additional approaches to analyzing data related to EPA's perchlorate regulatory determination (the Notice; U.S. EPA, 2009b). The Notice states that "these additional comments are sought in an effort to ensure consider ation of all the potential options for evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate through a national primary drinking water rule." This docu ment responds to EPA's request for comments on behalf of the Perchlorate Study Group (PSG).[F N1: The PSG member companies include Aerojet General Corporation, American Pacific Corporati on, ATK, and Lockheed Martin Corporation.]

EPA is required by the Safe Drinking Water Ac t (SDWA) to publish Maximum Contaminant Level Goals (MCLGs) and National Primary Drinking Wa ter Regulations (NPDWR) if all the following statutory requirements are met:

(a) the contaminant may have an adve rse effect on the health of persons;

(b) the contaminant is known to occur in public water systems with a frequency and at levels of public health concern; and

(c) in the sole judgment of the Administrator, re gulation of such contaminant presents a meaningful opportunity for health risk reduction for persons serv ed by public water systems (U.S. EPA, 1996).

EPA's statutory criteria for setting a standard are unmet in this case. At exposure levels anticipated under the drinking water program, the toxicologi cal literature for perchlorate has demonstrated no
adverse effect on human health. Second, data from EPA's first cycle of the Unregulated Contaminant Monitoring Rule (UCMR1) demonstrates that perchlorate does not consistently occur in public water systems at levels that may cause adverse effects in humans. Lastly, because the first two requirements are not met, there is no meaningfu l opportunity for health risk reduction, the third requirement.

In 2008, EPA concluded that perchlorate did not meet the SDWA requirements and released its preliminary regulatory determination on perchlor ate for public comment (U.S. EPA, 2008a). EPA decided not to set an NPDWR for perchlorate as it would not present "a meaningful opportunity for health risk reduction for persons served by pub lic water systems." This decision was based on a Health Reference Level (HRL) for perchlorate in drinking water of 15 ppb, calculated based on an assumed relative source contribution (RSC) for drin king water of 62% of the reference dose (RfD) (U.S. EPA, 2008a).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 555 of 1099 Data on perchlorate exposure in humans support EP A's preliminary regulatory determination. Any

chemical at a sufficient dose will cause an advers e effect. Since the inception of EPA's evaluation of perchlorate and its interim guidance, no evidence of adverse effects from exposure to perchlorate at environmental levels in the U.S. has been presented.[FN2: In 1992, EPA began to address "...concerns about the potential human health effects of perchlorate discovered in drinking water..." and the EPA Superfund Technical Support Center pr oposed a "provisional" RfD for perchlorate of 0.0001 mg/kg-d which translates to a drinking water equivalent level (DWEL) of 4 ppb (Dollarhide, 1992). In 1995 the provisional RfD was revised by EPA and the National Center for Environmental Assessment (NCEA) to a range that translates from a DWEL of 4 to 18 ppb (Dollarhide, 1995). EPA released a document detailing the derivation of a revised provisional RfD for perchlorate (U.S. EPA, 1998a). In this analysis, EPA focused on pot ential secondary effects of perchlorate exposure in the developing organism. In 1999, EPA issued was what is referred to as the "1999 Interim Guidance" (Noonan, 1999). EPA states, "...the Office of Research and Development (ORD) recommends that the Agency's risk assessors and risk managers continue to use the standing provisional RfD range of 0.0001 to 0.0005 mg/kg-d [4 to 18 ppb equivalent] for perchlorate-related assessment activities." At the same time, the EPA's Office of Water added perchlorate to the Contaminant Candidate List (CCL) and perchlorate was added to the UCMR (U.S. EPA, 1999). In 2003, EPA's Assistant Administrator issued a Memo randum stating, "...we are re-affirming this guidance with an added suggestion to carefully consider the low end of the provisional 4-18 ppb range."]

50 years of perchlorate toxicological research show s that the scientific weight- of-evidence decidedly supports EPA's preliminary regulatory determination on perchlorate.

A review of the 50 years of perchlorate toxicologi cal research shows that the weight of scientific evidence decidedly supports EPA's preliminar y regulatory determination on perchlorate. Furthermore, EPA requested manufacturers and users to fund specific scientific studies on the health effects of perchlorate. As a result, at le ast 12 animal studies that cover reproductive and developmental toxicity, carcinogenicity, endocrine effects, and other specific toxicological endpoints were funded and conducted.[FN3: For example, th e following animal studies were required by EPA to fill data gaps: Argus Research Laboratories, In c., 1998; Argus Research Laboratories, Inc., 1999; Kiel et al., 1998, 1999; Argus Research Laboratorie s, Inc., 2001; Primedica, 2001; Bekkedahl et al., 2000; BRT, 2000a, 2000b; Siglin et al., 2000; York et al., 2001a, 2001b.] The results of the studies were transmitted directly to EPA for analys is and without review from industry.

Response: Please see the response to comment code 6110.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28905

EPA Comment Code: 6110

Comment: In summary, EPA's existing, scientifica lly based RfD remains a conservative, healthprotective toxicity guideline value. Perchlora te concentrations in drin king water at or below the 15 ppb HRL set by EPA, along with its existi ng, preliminary determination, pose no significant
health risk, even to the most sensitive individu als consuming water on a daily basis over a lifetime.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 556 of 1099 Finally, the best available science establishes that none of the three requirements of the SDWA are met; therefore, there is no scientific justificat ion to regulate perchlorate under this statute.

IV. REFERENCES

Aboul-Khair SA, Crooks J, Turnbull AC, Hytten FE. 1964. The physiological changes in thyroid function during pregnancy. Clin Sci 27:195-207.

Amitai Y, Winston G, Sack J, Wasser J, Lewis M, Bl ount BC, Valentin-Blasini L, Fisher N, Israeli A, Leventhal A. 2007. Gestational exposure to high pe rchlorate concentrations in drinking water and neonatal thyroxine levels. Thyroid 17:843-850.

Agency for Toxic Substances and Disease Registry (ATSDR). 2008. Toxicological Profiles for

Perchlorate.

Argus Research Laboratories Inc. 1998. A Neur obehavioral Developmental Study of Ammonium Perchlorate Administered Orally in Drinking Water to Rats [report amendment: July 27]. Horsham, PA: Argus Research Laboratories, Inc., Protocol Number 1416-002.

Argus Research Laboratories Inc. 1999. Oral (Drinking Water) Two-Generation (One Litter per Generation) Reproduction Study of Ammonium Perc hlorate in Rats. Horsham, PA. Argus Research
Laboratories, Inc., Protocol Number 1416-001.

Argus Research Laboratories Inc. 2001. Hormone, Thyroid and Neurohistological Effects of Oral (Drinking Water) Exposure to Ammonium Perchlorate In Pregnant and Lactating Rats and In Fetuses and Nursing Pups Exposed to Ammonium Perchlorate During Gestation or Via Maternal Milk. Horsham, PA. Argus Research Laborator ies, Inc., Protocol Number 1416-003.

Barr DB, Wilder LC, Caudill SP, Gonz alez AJ, Needham LL, and Pirkle JL. 2005. Urinary creatinine concentrations in the U.S. population: implications for urinary biologic monitoring measurements. Environ Health Perspect 113:192-200.

Barzilai D, Sheinfeld M. 1966. Fatal complicati ons following use of potassium perchlorate in thyrotoxicosis. Israel Journal of Medical Science 2:453-456.

Bekkedal MY, Carpenter T, Smith J, Ad emujohn C, Maken D, and Mattie DR. 2000. A Neurodevelopmental Study of the Effects of Or al Ammonium Perchlorate Exposure on the Motor Activity of Pre-weanling Rat Pups. Wright-Patters on Air Force Base, OH: Naval Health Research

Center Detachment.

Belzer RB, Bruce GM, Peterson MK, Pleus RC. 2004. Using comparative exposure analysis to

validate low-dose human health risk assessment: The case of perchlor ate. Comparative Risk

Assessment and Environmental Deci sion Making. New York, Kluwer.

Bizhanova A, Kopp P. 2009. Minireview: The sodi um-iodide symporter NIS and pendrin in iodide homeostasis of the thyroid. En docrinology 150(3):1084-90.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 557 of 1099 Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasi ni L, Caldwell KL. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-71.

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Clewell RA, Merrill EA, Yu KO, Mahle DA, Ster ner TR, Mattie DR, Robinson PJ, Fisher JW, Gearhart JM. 2003b. Predicting fetal perchlorate dose and inhibition of iodide kinetics during gestation: a physiologically-based pharmacokinetic anal ysis of perchlorate and iodide kinetics in the rat. Toxicol Sci 73(2):235-55.

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Keil D, Warren A, Jenny M, EuDaly J and Dillard R. 1998. Effects of Ammonium Perchlorate on Immunotoxicological, Hematological, and Thyroid Parameters in B6C3F1 Female Mice. Charleston, SC. Medical University of South Carolina, Depart ment of Medical Laboratory Sciences. Report no. DSWA01-97-0008. September 30.

Keil D, Warren A, Jenny M, EuDaly J, Dillard R. 1999. Effects of Ammonium Perchlorate on Immunotoxicological, Hematological, and Thyroid Parameters in B6C3F1 Female Mice. Charleston, SC. Medical University of South Carolina, Depart ment of Medical Laboratory Sciences. Report no. DSWA01-97-0008. June 19.

Kirk AB, Martinelango PK, Tian K, Dutta A, Smit h EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Environ Sci Technol 39(7):2011-7.

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and iodide excretion in human milk. En viron Health Perspect 115:182-6.

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Lamm SH, Hollowell JG, Engel A, Chen R. 2008. Perchlorate, thiocyanate, and low iodine association not seen with low creatinine-adjusted urine iodine among women of childbearing age [abstract]. Thyroid 17 Suppl (S51).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 560 of 1099 Lawrence JE, Lamm SH, Pino S, Richman K, Brav erman LE. 2000. The effect of short-term lowdose perchlorate on various aspects of thyroid function. Thyroid 10:659-63.

Lawrence J, Lamm S, Braverman LE. 2001. Low dose perchlorate (3 mg daily) and thyroid function. Thyroid 11:295.

Life Sciences Research Office (LSRO), Federation of American Societies for Experimental Biology Prepared for the Interagency Board for Nutrition Monitoring and Related Research . 1995. Third Report on Nutrition Monitoring in the United States : Volume 1. U.S. Government Printing Office, Washington DC.

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Total T4 and TSH. Environ He alth Perspect 117:731-738.

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PBPK Model for Radioactive Iodide and Perchlorate Kinetics and Perchlorate-Induced Inhibition of Iodide Uptake in Humans. Toxi cological Sciences 83:25-43.

Murray CW, Egan SK, Kim H, Beru N, Bolger PM. 2008. US Food and Drug Administration's Total Diet Study: Dietary intake of perchlorate an d iodine. J Expo Sci Environ Epidemiol 18(6):571-

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The National Academies Press.

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Norden MM, Larsson F, Tedelind S, Carlsson T, Lundh C, Forssell-Aronsson E, Nilsson M. 2007. Down-regulation of the sodium/iodide symporter ex plains 131I- induced thyroid stunning. Cancer Res 67(15):7512-7.

Pearce EN, Lazarus JH, Smythe PP, et al. 2007a. Th yroid function is not affected by environmental perchlorate exposure in first trimester pr egnant women. Thyroid 17 Suppl:S133-134.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

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Steinmaus C, Miller MD, Howd R. 2007. Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 na tional health and nutrition examination survey. Environ Health Perspect 115(9):1333-8.

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APPENDIX A

SUPPLEMENTAL TABLES

Table 1. Comparison of body weights from Kahn and Stralka (2008) and NHANES 1996-2000 in lbs. [see PDF docket ID EP A-HQ-OW-2009-0297-0662]

Table 2. Alternative HRLs based on corrected water intake rates. [see PDF docket ID EPA-HQOW-2009-0297-0662]

Table 3. Comparison of daily water ingestion to blood volume. [see PDF docket ID EPA-HQ-OW2009-0297-0662]

Response: Please see the response to comment code 6110. EPA continues to support the RfD. EPA has determined that perchlorate meets the cr iteria for regulating a contaminant in Section 1412(b)(1)(A) of SDWA. As previously discussed in this notice, perchlorate may have an adverse effect on the health of persons and perchlorate is k nown to occur or there is a substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of public health concern. Moreover, in light of the discussion in this notice and the information available at this time, the Administrator finds that regulation of perc hlorate in drinking water systems presents a meaningful opportunity for health risk reduction for persons served by public water systems. Therefore, EPA will initiate the process of proposing a NPDWR for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 564 of 1099 

### EPA Comment Code: 6120 Comments urgi ng EPA to regulate perchlorate

Response to Code 6120 : EPA has determined that the following three SDWA criteria for regulatory determination have been met for perchl orate: (1) It may have an adverse effect on the health of persons; (2) It is known to occur or there is a substantial likelihood that perchlorate will occur with a frequency and at levels of public heal th concern in public water systems; and (3) In the sole judgment of the Administrator, regulation of perchlorate presents a meaningful opportunity for health risk reduction for persons served by public water systems. EPA is initiating the development of a proposed NPDWR for perchlorate. EPA intends to publish a proposed regulation and analyses required by SDWA for public review and comment within 24 months of this notice. EPA will consider the public comments and expects to prom ulgate a final regulation within 18 months of the proposal

Individual Comments

Commenter Name: B. Halper Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0080

EPA Comment ID: 19675

EPA Comment Code: 6120

Comment: Please regulate the contaminate perchlorate in out drinking water here in AZ to at least the same standards as CA has of 6ppb. The truth of the matter is that the standard should be set as 2 or 3 ppb, but I know this will never happen as long as the DEPT of Defense interferes with this matter and scientific data is tampered with. This current deregulation costs our country millions with medical problems associated with perchlora te and what this does to our children.

Response: See response to comment code 6120.

Commenter Name: Beatrice Williams-Rude Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0083

EPA Comment ID: 19676

EPA Comment Code: 6120

Comment: No downgrading drinking water! No! Not from any source or for any claimed reason.

Beatrice Williams-Rude

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0085

EPA Comment ID: 19677

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 565 of 1099 Comment: I believe the proposed decision is harmful to public health. Limits on perchlorate should

not be increased.

Response: See response to comment code 6120.

Commenter Name: Commenter Organization: Amherst Family Health Center

EPA Document ID: EPA-HQ-OW-2008-0692-0087

EPA Comment ID: 19678

EPA Comment Code: 6120

Comment: this is bad for my patients health.

Response: This is not a comment, no response needed.

Commenter Name: D.R. Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0089

EPA Comment ID: 19679

EPA Comment Code: 6120

Comment: I strongly oppose perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0090

EPA Comment ID: 19680

EPA Comment Code: 6120

Comment: I would like to see the EPA, an organization which my taxes support, regulate any chemicals deemed harmful to humans in our drinking water.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0091

EPA Comment ID: 19681

EPA Comment Code: 6120

Comment: If you don't protect our drinking water, you don't care about America. Bottom Line.

Response: This is not a comment, no response necessary.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 566 of 1099 Commenter Name: Nancy Zorn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0095

EPA Comment ID: 19682

EPA Comment Code: 6120

Comment: I am a private citizen protesting the high am ount of perchlorate now allowed n drinking water. I believe this level is unsafe for pregna nt women and young children and should not be allowed. I don't belong to any government organization and thought this was a puoblic forum. I am a retired public high school teacher. My name is Nancy Zorn and I live at 7121 N. Comanche Ave.,
Warr Acres, OK 73132-6629.

Response: See response to comment code 6120.

Commenter Name: Burton Jaffe, MD Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0096

EPA Comment ID: 19683

EPA Comment Code: 6120

Comment: As a physician I am very upset that the EPA does not fully protect me, my family, and all citizens from perchlorate in tap water. Yo u are the environmental protection agency, and I strongly urge you to protect us. Burton Jaffe, MD

Response: See response to comment code 6120.

Commenter Name: S Kornbluth Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0099

EPA Comment ID: 19684

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Please don't wait to regulate Perchlorate. We already know that it has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0101

EPA Comment ID: 19685

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 567 of 1099 Comment: We ordinary citizens rely on our government to keep us safe. Please regulate perchlorate

in our water.

Response: See response to comment code 6120.

Commenter Name: H Moseson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0103

EPA Comment ID: 19686

EPA Comment Code: 6120

Comment: Get rid of perchlorate in our water! Current levels are not safe for public health.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #1 - Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19687

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Perchlorate is found in drinking water in 35 st ates, and according to the EPA’s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.

Response: See response to comment code 6120.

Commenter Name: Mass Mailing #1 - Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0081

EPA Comment ID: 19687

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Perchlorate is found in drinking water in 35 st ates, and according to the EPA’s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 568 of 1099 Commenter Name: Apparent Mass Mailing #2 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19689

EPA Comment Code: 6120

Comment: The Environmental Protection Agency (EPA), supposedly protecting us against harmful chemicals in our air, water and food, has formally refused to set a drinki ng- water standard for perchlorate, a chemical in rocket fuel that has be en linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #2 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19689

EPA Comment Code: 6120

Comment: The Environmental Protection Agency (EPA), supposedly protecting us against harmful chemicals in our air, water and food, has formally refused to set a drinki ng- water standard for perchlorate, a chemical in rocket fuel that has be en linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #2 - Physic ians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0100

EPA Comment ID: 19691

EPA Comment Code: 6120

Comment: The Senate Environment and Public Works Committee has endorsed legislation requiring the EPA to set a federal standard for perc hlorate and to monitor levels of the chemical in

tap water.

Please regulate perchlorate in our drinking water: Yo ur current decision is harmful to public health.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0105

EPA Comment ID: 19692

EPA Comment Code: 6120

Comment: I would like for the EPA to regulate perchlorate to safe levels for all humans including
fetuses, babies and children.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 569 of 1099 Response: See response to comment code 6120.

Commenter Name: Larry Francis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0107

EPA Comment ID: 19693

EPA Comment Code: 6120

Comment: Please take another look at your decision to ignore the chemical perchlorate in our drinking water. It seems to me that the patrioti c thing to do is protect Americans from dangerous chemicals in the environment. Plus, it's your job. Please get to work and set a safe standard for perchlorate, certainly not less th an the standard set in 2002.

Hopefully, Larry Francis Applegate, Oregon

Response: See response to comment code 6120.

Commenter Name: Ann Watters Commenter Organization: Polarity Center of Salem

EPA Document ID: EPA-HQ-OW-2008-0692-0108

EPA Comment ID: 19694

EPA Comment Code: 6120

Comment: This level of Rocket fuel is not suitable for human health... Rocket Fuel should be filtered out of the water supply at its source. You are supposed to be protecting the people in this country from health hazards.. Do your job please.

Response: See response to comment code 6120.

Commenter Name: Alison Dalton Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0111

EPA Comment ID: 19695

EPA Comment Code: 6120

Comment: I believe this decision is harmful to public sa fety. No perchlorate in our drinking water!

Alison Dalton

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0114

EPA Comment ID: 19696

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 570 of 1099 Comment: Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Response: See response to comment code 6120.

Commenter Name: J.H. Gailey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0115

EPA Comment ID: 19697

EPA Comment Code: 6120

Comment: As a layman with a little background in ch emistry the word "perchlorate" scares me, especially since we are advising pe ople to restrict their use of such cleaners as Chlorox for home use. Perchlorate presents an excess of chlorine to rocket fuel as an oxidizer, but we do not need or want that in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0118

EPA Comment ID: 19699

EPA Comment Code: 6120

Comment: Please strongly consider the serious health implications of perchlorate and the risks of unregulated perchlorate levels in our drinking water. This issue affects millions of people and should not be taken lightly.

Response: See response to comment code 6120.

Commenter Name: N Wittenberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0120

EPA Comment ID: 19700

EPA Comment Code: 6120

Comment: I think this change shows how grossly negligent the EPA has become. Corporations have poisoned the EPA and I am personally sick and tired of sitting back and watching it happen!!!

Response: This is not a comment, no response necessary.

Commenter Name: Lila Williams Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0121

EPA Comment ID: 19701

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 571 of 1099 Comment: I think this decision to allow perchlorate in water is harmful to public health. Please do

not do it.

Thank you!

Lila

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0124

EPA Comment ID: 19702

EPA Comment Code: 6120

Comment: If my generation had enough Perchlorate, I don't think my children and grandchildren should get more than we had. NO MORE PERCHLORATE!

Response: See response to comment code 6120.

Commenter Name: Melissa Mandel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0125

EPA Comment ID: 19703

EPA Comment Code: 6120

Comment: When I recently moved from California to Phoenix Arizona I learned that the local water supply is contaminated with Perchlorate. The EPA had the responsibility to prevent such contamination at the time it was occurring. Sin ce that did not happen it must protect the public health by controlling the legal limit. Raising the limit does not make any sense given the onslaught of contaminants assaulting the public from all angles. If anything, it should be lowered (since cleanup is not possible).

Please at least do not raise the legal limit.

Melissa Mandel

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0127

EPA Comment ID: 19704

EPA Comment Code: 6120

Comment: Percholate is not a safe chemical. It is know n to cause thyroid problems. Drinking water standards for this chemical should be set by the EPA.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 572 of 1099 Response: See response to comment code 6120.

Commenter Name: B Gagnon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0128

EPA Comment ID: 19705

EPA Comment Code: 6120

Comment: Perchlorate is a dangerous chemical and harmful to women and children. It should actually be banned as it is now showing up in milk and lettuce across the nation.

Not strictly regulating this harmful chemical in our drinking water is totally unacceptable.

It is clear the the EPA has come under the contro l of industry. This outrageous decision to allow more and more perchlorate contaminants to be consid ered acceptable in our water is just too much.

EPA must remember why the taxpayers pay the sala ries of those who work there. The American people and the future generations must be protected from these kinds of exposures.

The Safe Water Drinking Act must be honored and EPA must act in good faith on behalf of the public.

You are killing the people.

Response: See response to comment code 6120.

Commenter Name: N Mayers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0129

EPA Comment ID: 19706

EPA Comment Code: 6120

Comment: EPA needs to regulate and protect our drinking water from perchlorate, a hazard especially to pregnant women.

Response: See response to comment code 6120.

Commenter Name: D Burnham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0182

EPA Comment ID: 19707

EPA Comment Code: 6120

Comment: I'm against ANY perchlorate in my water. It NEEDS to be filtered out. It should be

BELOW the EPA recommendations.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 573 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0185

EPA Comment ID: 19708

EPA Comment Code: 6120

Comment: The EPA must set a federal standard for perchlorate and to monitor levels of the chemical in tap water. Refusing to do so is harmful to public health. Thank you.

Response: See response to comment code 6120.

Commenter Name: T.O. Mellem Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0186

EPA Comment ID: 19709

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate has been linked to thyroid problems in pregnant women, newborns and young children. Regulation of this chemical in our dringking water is required or it will make the current credit crunch look like child's play. Please set a standard for perchlorate that will prevent a health risk for million of Americans. I urge you to do so in accordance with the Safe Drinking Water Act.

Response: See response to comment code 6120.

Commenter Name: W Fraser Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0187

EPA Comment ID: 19710

EPA Comment Code: 6120

Comment: Please make sure to set the acceptable perchlor ate limit based on the health of children.

Response: See response to comment code 6120.

Commenter Name: S McMillan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0188

EPA Comment ID: 19711

EPA Comment Code: 6120

Comment: I am a mother of three who breastfed each of my children. I had my breastmilk tested for perchlorate, and sure enough, it was present. Can you imagine what it is like to be a mother knowing that you are feeding your precious baby rocket fuel? Think about it... My middle son is autisitc. I beat myself up wondering why. What did I do wrong? I tried to be so healthy. Could it beEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 574 of 1099 because I fed him perchlorate? This is so wrong. Please do not allow this public health threat to

continue.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0190

EPA Comment ID: 19712

EPA Comment Code: 6120

Comment: PLEASE!!! We have ENOUGH pollutants at tacking us from every where, I have a GREAT idea, how about setting the limit to ZERO? Do we really NEED the extra chemicals in our drinking water, Sometimes I need a little pep, but not JET FUEL!!!!

Response: See response to comment code 6120.

Commenter Name: J Garner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0195

EPA Comment ID: 19713

EPA Comment Code: 6120

Comment: when you lower the standard of anything you go further into killing self. this is not an advisable thing to do. but since no one in government listens to the people i doubt you will lsiten or

care one iota to what i a citizen of America thinks.

Response: See response to comment code 6120.

Commenter Name: Sally Swithers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0196

EPA Comment ID: 19714

EPA Comment Code: 6120

Comment: You're supposed to PROTECT US! How ca n you not regulate Perchlorate in our

water?????????????!!!!!!!!!!!!!!! !!!!!!!!!!!!!!!!!!!!! Shame on you.

Sally Swithers Sarasota, Florida

Response: See response to comment code 6120.

Commenter Name: W White Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0132

EPA Comment ID: 19715

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 575 of 1099 Comment: Please keep perchlorate OUT of our drinking water. Thank you.

Response: See response to comment code 6120.

Commenter Name: Jon Olsen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0134

EPA Comment ID: 19716

EPA Comment Code: 6120

Comment: Regarding the allowance of 15 times the pr eviously allowed (safe amount???) quantity of percholate in drinking water sounds to me like a policy of criminal insanity. Both people an our nonhuman life forms need water as close to pure as we can get. Rocket fuel in our drinking water is an obscenity. Please think: would you want your baby or grandchild being unwittingly fed such stuff?

Jon Olsen, Maine

Response: See response to comment code 6120.

Commenter Name: David Sparling, M.D., F.A.A.P. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0135

EPA Comment ID: 19721

EPA Comment Code: 6120

Comment: In view of the clear evidence that perchlora te ingestion is associated with sjuppression of thyroid function, the increased susceptibility of the fetus, infant and young child to that suppression, the well known effects of bhypothyroidism on brain development and subsequent adult brain function, and the lack of data identifying any threshold level of perchlorate ingestion below which thyroid safety in the fetus, infant and young child can be assured, I make two

recommendations:

1) Until such data are available, published in p eer-reviewed journals and confirmed by subsequent
studies, there should be no increase in the allowabl e levels of perchlorate in public drinking water supplies, and

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0140

EPA Comment ID: 19723

EPA Comment Code: 6120

Comment: I'am a pulmonary and critical care physician in Florida. I want to express my deep concern about the EPA's decision on addressing perchl orate in water. This chemical is known to be harmful and exposure through water could pose a serious danger to public health.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 576 of 1099 Response: See response to comment code 6120.

Commenter Name: Dr Roberta Richardson, MD Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0147

EPA Comment ID: 19724

EPA Comment Code: 6120

Comment: This is a comment regarding the EPA's decisi on not to set a standard for perchlorate in drinking water.

Perchlorate, a component of rocket fuel, has been associated with thyroid disease in pregnant women, young children, and newborns. It has been found in the drinking water of over half the states. I believe it is necessary for the EPA to set a standard for this compound, for public health and safety. I urge you to reconsider your decision.

Dr. Roberta Richardson, MD

Response: See response to comment code 6120.

Commenter Name: Stephen Couche Commenter Organization: Community for Earth, First Unitarian Church

EPA Document ID: EPA-HQ-OW-2008-0692-0149

EPA Comment ID: 19725

EPA Comment Code: 6120

Comment: Our Church is in Portland, OR, and although I do not know if Perchlorate is a problem anywhere in this state, if it is water systems anyw here it is a problem and health risk. Based on the knowledge we have of what the effects of Perc hlorate exposure can have on people we feel that levels should be kept at the lower level and should not be raised - the health of the people of this country is to precious.

Sincerely, Stephen Couche Community for Earth First Unitarian Church Portland, OR

Response: See response to comment code 6120.

Commenter Name: J Mason Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0145

EPA Comment ID: 19726

EPA Comment Code: 6120

Comment: Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Perchlorate is found in drinking water in 35 st ates, and according to the EPA’s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 577 of 1099 Response: See response to comment code 6120.

Commenter Name: J Mason Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0145

EPA Comment ID: 19728

EPA Comment Code: 6120

Comment: My mother and myself are sufferring from thryoid disease.She also has a monoclonal gammopathy which doctors say is probably due to environmental exposure: 40+ years of water quality deterioration & contamination. My own ci ty says our exposure to carcinogens in our

"treated" water would affect ONLY those with prolonged exposure of 25 years or more- we lived,and drunk this water for 29 years! I am gravely concerned for my children who also have been exposed to these contaminents for nearly 20 years. Meanwhile,our pure,natural wells are being drained,and exploited by companies who profit; while we, meanwhile, are being poisoned! WHO is advocating for us? WHO will STOP this abuse? It is within your power and was mandated BY thePEOPLE,FOR the PEOPLE that your agency SERVE OUR INTERESTS AND HEALTHPLEASE DO SO! TIME IS OF THE ESSENCE.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0152

EPA Comment ID: 19729

EPA Comment Code: 6120

Comment: Perchlorate standards should not be allowed to risk unsafe levels in human water supplies. the weakened standards do pose real risks. The link to thyroid problems is documented and EPA failures to protect public health are just not acceptable

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0153

EPA Comment ID: 19730

EPA Comment Code: 6120

Comment: This decision is harmful to public health!

Response: See response to comment code 6120.

Commenter Name: G McDonald-Tune Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0155

EPA Comment ID: 19731EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 578 of 1099 EPA Comment Code: 6120

Comment: This chemical is dangerous--public health is at stake--it should be carefully monitored and regulated

Response: See response to comment code 6120.

Commenter Name: William W. Winship Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0157

EPA Comment ID: 19732

EPA Comment Code: 6120

Comment: I believe that the refusal to set a drinking -water standard for perchlorate reflects a wholesale abandonment of responsibility on the part of the Bush Administration EPA...and is blatantly harmful to public health. The Senate Environment and Public Works Committee has endorsed legislation requiring the EPA to set a federal standard for perchlorate and to monitor levels of the chemical in tap water. Please do so!

Respectfully, William W. Winship

Response: See response to comment code 6120.

Commenter Name: A Roth Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0160

EPA Comment ID: 19734

EPA Comment Code: 6120

Comment: I consider the amount of perchlorate in dr inking water a danger to public health

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0161

EPA Comment ID: 19735

EPA Comment Code: 6120

Comment: I find it irresponsible to remove the regula tion of perchlorate in sources or potential sources of the drinking water of U.S. residents. Ca n you demonstrate with data that there is no harm to individuals, including children, infants, and pregnant mothers and the fetuses they carry, from drinking water containing perchlorate at the leve ls that you have announced you intend to allow (about 15 times higher than the level of perchlora te that the EPA permitted in drinking water in 2002 )?

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 579 of 1099 Commenter Name: Linda Gurley Commenter Organization: Gurley Painting

EPA Document ID: EPA-HQ-OW-2008-0692-0162

EPA Comment ID: 19736

EPA Comment Code: 6120

Comment: Docket ID No. EPA-HQ-OW- 2008-0068

I was a resident of Falmouth, Massachusetts. We had to pay for bottled water as the ground water was polluted with fuel from the local Navy airbase. The area around the base is a cancer pocket for breast cancer, the cause being directly linked to th e ground polution from the jet fuel. Answer the questions of the women (if living) and their familie s, how dangerous ground water pollution from jet fuel can effect a population.

Response: This is not a comment, no response necessary.

Commenter Name: Wes Sanders Commenter Organization: Vermont Interfaith Power & Light

EPA Document ID: EPA-HQ-OW-2008-0692-0163

EPA Comment ID: 19737

EPA Comment Code: 6120

Comment: Raising the "safe" level of perchlorate in drinking water is a palpable danger to the public health.

Response: See response to comment code 6120.

Commenter Name: J Porter Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0164

EPA Comment ID: 19738

EPA Comment Code: 6120

Comment: this decision is harmful to public health!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0166

EPA Comment ID: 19739

EPA Comment Code: 6120

Comment: It is past time to make scientific decisions based on science rather than on expediency or political pressure. The people of this country do not want perchlorate in their water - your mission should be to protect us from this, not to make standards easier for industry or the military.

Response: This is not a comment, no response necessary.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 580 of 1099 Commenter Name: Ann Marie Nehme, M.P.H., M.D. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0168

EPA Comment ID: 19740

EPA Comment Code: 6120

Comment: I think this is harmful to public health. Ann Marie Nehme, M.P.H., M.D.

Response: This is not a comment, no response necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0169

EPA Comment ID: 19741

EPA Comment Code: 6120

Comment: I think that it is unsafe and a bad decision for the gov not to set a drinking water standard for the chemical perchlorate in our tap water. This is outrageous in this day and age, especially with all of the technology available in this country to make sure that our water is safe. To allow chemicals in our water which have known/ unknown bad consequences to our health is a travesty and cannot be tolerated. I ask you to recons ider this and make sure our water is free of any chemicals which don't belong. There is a reason for the epa..lets not forget what that is. Thank you. No, thank me..I pay the taxes that pay you to do your job for me and my neighbors...keeping our

water safe and chemical free!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0172

EPA Comment ID: 19742

EPA Comment Code: 6120

Comment: Thanks, but if its all the same to you, I don't want any perchlorates in my drinking water. In fact, I believe it's your responsibili ty to ensure this; so please, do your job.

Response: See response to comment code 6120.

Commenter Name: Cheryl Hall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0174

EPA Comment ID: 19743

EPA Comment Code: 6120

Comment: The current standards for perchlorate in dr inking water (with a maximum that is 15 times higher than what was declared safe in 20 02) are unacceptable! This decision does not protect

our health.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 581 of 1099 Cheryl Hall, citizen

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0280

EPA Comment ID: 19744

EPA Comment Code: 6120

Comment: Please keep drinking water safe for my son and our family by not allowing harmful

chemicals in excess.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0281

EPA Comment ID: 19745

EPA Comment Code: 6120

Comment: This was a poor decision, and will prove to be harmful to public health. I hope that this

is reconsidered.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0282

EPA Comment ID: 19746

EPA Comment Code: 6120

Comment: NO Perchlorate!!!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0289

EPA Comment ID: 19747

EPA Comment Code: 6120

Comment: This is a public comment on Docket ID EPA-HQ-OW-2008-0692, Drinking Water: Preliminary Regulatory Determination on Perchlorate.

As a physician experienced in environmental epidem iology, I urge you to regulate perchlorate under the Clean Water Act. Perchlorate has been adequa tely documented as a hazardous chemical withEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 582 of 1099 adverse thyroid effects in pregnant mothers and their offspring. Already an estimated 16 million people are exposed to hazardous levels. You must do your job and regulate exposure to this

chemical.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0290

EPA Comment ID: 19748

EPA Comment Code: 6120

Comment: Percholate should be regulated more stringen tly. It is known to cause thyroid problems

and it is unconscionable for the EPA to weaken this regulation. Why do you think there is so much

more cancer than there used to be. Start doin g your job and protect the American people not the corporations.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0291

EPA Comment ID: 19749

EPA Comment Code: 6120

Comment: Please regulate the perchlorate content of our water supply -- It is already 15 times that which was the supposedly safe limit several years ag o. Not regulating it according to the effect on the health of our citizens puts all of us at risk. People are more important than business profits.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0292

EPA Comment ID: 19750

EPA Comment Code: 6120

Comment: Please monitor perchlorate! I believe the job of the Environmental Protection Agency is PROTECTION, which means monitoring and preventi ng contaminated drinking water. Thank you.

Response: See response to comment code 6120.

Commenter Name: Greg Gerritt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0295

EPA Comment ID: 19751

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 583 of 1099 Comment: Increasing the amount of perchlorate in water is not a good idea. Do not do this. greg gerritt

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0296

EPA Comment ID: 19752

EPA Comment Code: 6120

Comment: I believe that allowing more rocket fuel in my drinking water will be harmful to my health and the health of my family.

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

Commenter Name: Douglas, J. Feldman, PE Commenter Organization: Office of Water Resources, Suffolk County Department of Health Services (SCDHS)

EPA Document ID: EPA-HQ-OW-2008-0692-0297

EPA Comment ID: 19754

EPA Comment Code: 6120

Comment: This department suggests that perchlorate is sufficiently prevalent on Long Island and in other jurisdictions to warrant regulation by estab lishing a maximum contaminant level. This would greatly assist in enforcing remedial action when necessary, as well as to require and encourage impacted properties to connect to a public water supply system when feasible. Thank you for the opportunity to comment on this subject.

Douglas J. Feldman, P.E. Principal Public Heal th Engineer Office of Water Resources SCDHS 360 Yaphank Ave. Yaphank, NY 11980 Tel (631) 852-5810 Fax (631) 852-5787

Response: See response to comment code 6120.

Commenter Name: Barbara Seiple Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0300

EPA Comment ID: 19755

EPA Comment Code: 6120

Comment: Please hear us, we the people we need regula tion for Perchlorate found in our drinking water. We know it can lead to thyroid problems. what is the hold-up 9n getting this regulated?

Barbara Seiple Philadelphia, PA.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 584 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0302

EPA Comment ID: 19756

EPA Comment Code: 6120

Comment: Public drinking water that is safe for hu man consumption is essential. Given that perchlorate has been noted as a causative agent fo r thyroid disease, especially in pregnant women and young children, the EPA must set more string ent standards that will foster risk reduction and protect the public health.

Response: See response to comment code 6120.

Commenter Name: B Boxer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0233

EPA Comment ID: 19757

EPA Comment Code: 6120

Comment: Go back to the stricter standard. Absence of adequate regulation in this area can lead to the same type of disaster we are experiencing in the economy. Damage to the health of our people and increased costs for health care in future years are likely to be the cost of lax standards.

Response: See response to comment code 6120.

Commenter Name: Craig Leman, M.D. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0234

EPA Comment ID: 19758

EPA Comment Code: 6120

Comment: Perchlorate is a harmful contaminant, and it is definitely in the national interest to find ways to detect and to limit its presence in the environment. Craig Leman. M. D.

Response: See response to comment code 6120.

Commenter Name: Trudi Ferguson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0235

EPA Comment ID: 19759

EPA Comment Code: 6120

Comment: My thoughts on the need to regulate perchlor ate in our drinking water is this. Never before in my life have I met more people with Thyroid problems. Including people in my own family. Perchlorate was once used by the medical practices to regulate a person's thyroid. Then it must be very important to keep this away heal thy bodies. Children are the most vulnerable and weEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 585 of 1099 don't need to add more chemicals into their systems. If we can prevent it, we should. An ounce of prevention is worth a pound of cure!

Sincerely, Trudi Ferguson

Response: See response to comment code 6120.

Commenter Name: Judith Gardiner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0238

EPA Comment ID: 19760

EPA Comment Code: 6120

Comment: Protect the general public before industry in terests. Please do not allow perchlorate in drinking water at concentrations so much higher than previously thought safe.

Judith K. Gardiner

Response: See response to comment code 6120.

Commenter Name: R. DeLauro Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0239

EPA Comment ID: 19761

EPA Comment Code: 6120

Comment: Allowing Perchlorate in drinking water isn't acceptable. So many people have compromised immune systems, and aren't yet aware of it. Allowing toxins in the water could be considered tantamount to slow, premeditated mu rder in auto immune cases. How can you allow

this?

No amount of poisons are safe in the body. None.

EPA, Environmental PROTECTION Agency. Are you protecting the public or the corporations?

Response: See response to comment code 6120.

Commenter Name: D.E. Wedge Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0244

EPA Comment ID: 19762

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate is a highly reactive oxidation agent an d has been shown to have significant biological activity damaging to both animals and humans.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 586 of 1099 I understand it has been detected in large numbers of drinking water sources in the United States, potentially affecting millions of Americans.

The Safe Drinking Water Act mandates that the EPA must set a standard for such substances, in order to protect the health of our citizens.

Thank you, D. E. Wedge 6591 Maplegrove St. Oak Park, CA 91377

Response: See response to comment code 6120.

Commenter Name: C. Curtin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0245

EPA Comment ID: 19763

EPA Comment Code: 6120

Comment: I believe like MDs for social respnsibility th at this would be injurious to health.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0248

EPA Comment ID: 19764

EPA Comment Code: 6120

Comment: This decision is harmful topublic health!

Response: See response to comment code 6120.

Commenter Name: T. Davis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0249

EPA Comment ID: 19765

EPA Comment Code: 6120

Comment: Your decision not to set a percholorate standard is harmful to the health of the citizens of the USA. By failing to set a standard, you have not lived up to your mission to product Americans from pollutants. This is shameful.

Response: See response to comment code 6120.

Commenter Name: M. Mandel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0250

EPA Comment ID: 19766

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 587 of 1099 Comment: Docket ID No. EPA-HQ-OW- 2008-0068 Dr inking Water: Preliminary Regulatory Determination on Perchlorate I recently moved to Phoenix Arizona and learned upon arrival that Perchlorate is a risk factor in the local water supply due to contamination of the ground water. Since the EPA did not protect this vital resource for our health and safety at the time the damage was done, it should at least protect us now and into the future. Raising the legal limit protects the interests of polluters, not the public health. Please do not approve such a change in the regulation of

this contaminant. M. Mandel

Response: See response to comment code 6120.

Commenter Name: J.B. Goss Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0251

EPA Comment ID: 19767

EPA Comment Code: 6120

Comment: Against ANY increase in pe rchlorate. How can you even consider such a thing?

JB Goss

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0254

EPA Comment ID: 19768

EPA Comment Code: 6120

Comment: This seems outrageous to me. We know perchlorate at current levels is harmful to human health -- why on earth do you refuse to regulate it? Thyroid disorders are serious and can compromise the health of this and future generations. Please take better action.

Response: See response to comment code 6120.

Commenter Name: P. Medeiros Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0256

EPA Comment ID: 19769

EPA Comment Code: 6120

Comment: Return regulations to safe levels of perchlorate in water supply and throughout the food

chain.

I have high levels I am now experiencing thyroid problems, I face removal of part of my thyroid as the only means to mitigate the signs and symptoms of my thyroid condition.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 588 of 1099 I see a direct correlation to excess ive levels of pe rchlorate being allowing into our water supply and

food chain.

It is your vested responsibility to oversee envir onmental conditions to prevent the American people

from diseases and conditions detrimental to thei r health and well being and this issue must be seriously addressed in good faith or you are failing in your responsibilities to citizens. Thank you

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0257

EPA Comment ID: 19770

EPA Comment Code: 6120

Comment: Please regulate perchlorate in drinkng water. Your decision to not regulate perchlorate is harmful to public health. It is 15 times higher th an in 2002 and millions of Americans are exposed to unsafe levels. Please do not put people's health at risk.

Response: See response to comment code 6120.

Commenter Name: D. Sawyer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0258

EPA Comment ID: 19771

EPA Comment Code: 6120

Comment: This is harmful to public health !!!!!

Response: This is not a comment, no response is necessary.

Commenter Name: D. Sawyer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0259

EPA Comment ID: 19772

EPA Comment Code: 6120

Comment: This decision is harmful to public health !

Response: This is not a comment, no response is necessary.

Commenter Name: Noel Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0260

EPA Comment ID: 19773

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 589 of 1099 Comment: Get Serious. The EPA is supposed to pro tect the health of the environment and US citizens, not aid business. I find this proposal to be appalling. Is there no shame in this
administration? Noel Smith, Auburn, Maine

Response: This is not a comment, no response is necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0261

EPA Comment ID: 19774

EPA Comment Code: 6120

Comment: Please regulate our water!

Response: See response to comment code 6120.

Commenter Name: Rick Sandlin Commenter Organization: Global Wellness and Nutrition

EPA Document ID: EPA-HQ-OW-2008-0692-0264

EPA Comment ID: 19775

EPA Comment Code: 6120

Comment: We are VERY CONCERNED ABOUT THE QUALITY OF OUR TAP WATER TODAY! EPA: Please, No Perchlorate in Our Tap Wa ter! This decision is harmful to public health!

Response: See response to comment code 6120.

Commenter Name: Commenter Organization: Alliance for Democracy

EPA Document ID: EPA-HQ-OW-2008-0692-0265

EPA Comment ID: 19776

EPA Comment Code: 6120

Comment: I keep hearing that tap water is safer than bottled. Then I get a notice that the EPA does not regulate perchlorate in the Nation's drinking wa ter. In my opinion, it is your major job to see that what people in the United States are eating or drinking are not negatively affected by substances being put into the environment by anyone - persons or corporations.

Response: This is not a comment, a response is not necessary.

Commenter Name: Renee Watkins Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0266

EPA Comment ID: 19777

EPA Comment Code: 6120

Comment: It's wrong to create major health problems for innocent people in order to protect the waste disposal practices of certain entities, public or private, who wish to avoid regulation. You mayEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 590 of 1099 think you are protecting economic welfare, but you are actually contributing to the decline of this country, in health and in safety. Renee Watkins

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0268

EPA Comment ID: 19778

EPA Comment Code: 6120

Comment: I feel this decision is harmful to public health!

Response: See response to comment code 6120.

Commenter Name: B. Cramer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0269

EPA Comment ID: 19779

EPA Comment Code: 6120

Comment: The EPA should reverse its decision and set a more stringent standard regulating the amount of perchlorate in drinking water. This da ngerous chemical is linked to thyroid problems in pregnant women, newborns and young children. Perc hlorate has been found in the drinking water in

35 states in the U.S.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0272

EPA Comment ID: 19780

EPA Comment Code: 6120

Comment: I disagree with the relaxation of perchlora te level standards in our drinking water supplies.

Response: See response to comment code 6120.

Commenter Name: Gerson T Lesser, MD Commenter Organization: Department of Geriatrics, Mt Sinai School of Medicine

EPA Document ID: EPA-HQ-OW-2008-0692-0277

EPA Comment ID: 19783

EPA Comment Code: 6120

Comment: Gentlemen,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 591 of 1099 Perchlorate in the water supply is a potential hazard, especially for thyroid disease, and especially in the very young and pregnancy. It would be unwise to loosen restrictions on content of this in drinking water.

G.T. Lesser, MD, Asst Professer

P.S. These comments are mine and not n ecessarily those of the Medical School.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0206

EPA Comment ID: 19784

EPA Comment Code: 6120

Comment: No perchlorate in my water!!!

Response: See response to comment code 6120.

Commenter Name: J Monson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0209

EPA Comment ID: 19785

EPA Comment Code: 6120

Comment: We need to tighten drinking water restricti ons, not loosen them. The general public is already exposed to far too many toxins in America' s water supply, from perchlorate to prescription drugs. Loosening the regulations is a bad idea. Pl ease don't change the perchlorate level that is acceptable in our water.

Response: See response to comment code 6120.

Commenter Name: Lisa Bromfield Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0211

EPA Comment ID: 19786

EPA Comment Code: 6120

Comment: Science gives us more and more examples of how the chemicals we are adding to the water and soil of our planet are being found in human bodies. We need LESS chemicals in the water

- not more!! Please consider the health of not onl y humans but the plants and animals with whom we share the planet and on whom we depend.

Sincerely, Lisa Bromfield Stephens City, VA

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 592 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0212

EPA Comment ID: 19787

EPA Comment Code: 6120

Comment: No perchlorate in my drinking water!

Response: See response to comment code 6120.

Commenter Name: Alexander N. Gunn II, M.D., FACS Commenter Organization: Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0213

EPA Comment ID: 19788

EPA Comment Code: 6120

Comment: I am deeply offended that you would consider allowing near-toxic levels of perchlprate in drinking water. This is a marked derogation of responsibility which is intolerable to the average American citizen. We demand that you reduce this ruling at once.

Sincerely, Alexander N. Gunn II, MD, FACS

Response: See response to comment code 6120.

Commenter Name: Don Thompson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0214

EPA Comment ID: 19789

EPA Comment Code: 6120

Comment: I cannot believe that the proposed level of Perc hlorate to be allowed in drinking water is safe. Our town was has just finished a very expensive water treatment facility to reduce the arsenic levels in our drinking water. It was an expenditur e which I felt was justified and I believe that the expenditures necessary to lower potentially harmful levels of Perchlorate should also be required.

Sincerely, Don Thompson

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0215

EPA Comment ID: 19790

EPA Comment Code: 6120

Comment: Perchlorate levels in drinking water su pplies should be reduced not increased. Perchlorate levels in water are currently unacceptable and should most definitely not have standards

that would increase allowable levels.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 593 of 1099 Response: See response to comment code 6120.

Commenter Name: S.T. Joyce Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0216

EPA Comment ID: 19791

EPA Comment Code: 6120

Comment: This standard is inadequate and unacceptable. When did the EPA become an organization that is not dedicated to protecting citizens?

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0218

EPA Comment ID: 19792

EPA Comment Code: 6120

Comment: I am an individual, living in Palo Alto, CA Perchlorate is KNOWN to be unhealthy. Therefore I consider it IMPERATIVE that regulations be made to limit it. Actually, if we were to use the Precautionary Principle, we would not allo w ANY AMOUNT in our water, until it could be proven that some amount was NOT unhealthy /damaging. However since we don't operate that way, and since without regulations, those who produ ce/ use perchlorate won't bother to be careful, we need a specified limit.

Response: See response to comment code 6120.

Commenter Name: Diana Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0219

EPA Comment ID: 19793

EPA Comment Code: 6120

Comment: EPA-HQ-OW-2008-0692

I think it is important to keep Perchlorate levels very low - at least to 2002 levels thank you.

Diana Smith

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0220

EPA Comment ID: 19794

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 594 of 1099 Comment: We need to keep our water as pure as possible. There should be NO perchlorate in tap

water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0222

EPA Comment ID: 19795

EPA Comment Code: 6120

Comment: A public comment concerning levels of Pe rchlorate in drinking water. Refusing to regulate this harmful chemical in our drinking water is unacceptable. I urge you to consider the health of the American public, most especially th ose of highest risk, pregnant women, children and

newborns.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0224

EPA Comment ID: 19796

EPA Comment Code: 6120

Comment: Please do not allow perchlorate to contaminate our drinking water. It is a safety hazard that is not necessary and harmful especially to children and pregnant women. Aren't we causing enough harm to our planet and our health with out adding a new harmful elememnt that we will need to clean up?

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0226

EPA Comment ID: 19797

EPA Comment Code: 6120

Comment: Please regulate perchulate in drinking water . Our health depends on it. We are exposed to UNSAFE levels of it in OUR drinking water.

Response: See response to comment code 6120.

Commenter Name: Glenn Shean, Ph.D. Commenter Organization: Hamptom Roads Counseling

EPA Document ID: EPA-HQ-OW-2008-0692-0307

EPA Comment ID: 19798

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 595 of 1099 Comment: Allowing increased levels of perchorate in ou r drinking water is a crime. who does the EPA work for industry or the citizens? For the recent past the rhetorical question must be answered

as INDUSTRY!

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0308

EPA Comment ID: 19799

EPA Comment Code: 6120

Comment: Perchlorate does not belong in our drinking water - period!

Response: See response to comment code 6120.

Commenter Name: Bonnie Mandell-Rice Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0310

EPA Comment ID: 19800

EPA Comment Code: 6120

Comment: Please do not allow perchlorate in our dr inking water. There already are too many chemicals and pharmaceuticals in the water supply. Even if in isolation one such thing would be "safe," we have no idea about how they all interact. We already know perchlorate is dangerous. Do

not allow it to be added to the mix.

Bonnie Mandell-Rice Broomfield,CO

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0311

EPA Comment ID: 19801

EPA Comment Code: 6120

Comment: No rocket fuel in my drinking water, please!

You morons shouldn't have to be TOLD something like this!

Nov. 4 couldn't come soon enough!!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 596 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0313

EPA Comment ID: 19802

EPA Comment Code: 6120

Comment: There should be no perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0314

EPA Comment ID: 19803

EPA Comment Code: 6120

Comment: Unless you're also going to approve inserti on of rocket engines into the large intestine, any level of Perchlorate in the water supply in unacceptable.

http://www.youtube.com/watch?v=1rAsoLm1Ges

Thanks for listening.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0317

EPA Comment ID: 19804

EPA Comment Code: 6120

Comment: Perchlorate levels need to be monitored as they can be harmful to the health of many

Americans.

Response: See response to comment code 6120.

Commenter Name: Dr. Thomas Clark Commenter Organization: Southern Appalachian Forestry Task Force (SAFTF)

EPA Document ID: EPA-HQ-OW-2008-0692-0318

EPA Comment ID: 19805

EPA Comment Code: 6120

Comment: The U.S. desperately needs clean water for the health of our children. Please help strengthen the regulations which affect our water supplies.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0319EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 597 of 1099 EPA Comment ID: 19806

EPA Comment Code: 6120

Comment: Why are we putting ourselves at risk when we don't have to??? As a thyroid cancer
survivor, I want to know that this chemical, which ha s been proven to affect the thyroid, is regulated at a safe level. It has been found in the drinking water of 35 states, so we need to do something. Right now we're behind where we were before, not ahead!!! The maximum safe level for perchlorate in drinking water is now 15 times higher than what the EPA declared safe in 2002. According to Physicians for Social Responsibility, under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at ri sk. It's time to start making us safer!

Response: See response to comment code 6120.

Commenter Name: Erik Lokensgard Commenter Organization: Division of the Biological Sc iences, University of Chicago

EPA Document ID: EPA-HQ-OW-2008-0692-0320

EPA Comment ID: 19807

EPA Comment Code: 6120

Comment: Concerning: EPA-HQ-OW-2008-0692 Docket Title Drinking Water: Preliminary Regulatory Determination on Perchlorate DocketType Nonrulemaking Document ID EPA-HQOW-2008-0692-0001

October 15, 2008

Dear Reader,

I am a fourth year biology major at the Universi ty of Chicago and am deeply concerned about the current dangerously high perchlorate allowance. I recommend that regulations be made immediately limiting the industrial output of perchlorate and perchlorate related compounds. Perchlorate interferes with iodide uptake in the thyroid, and th e news of significant levels being found in breast milk and elsewhere is disturbing. If a woman cann ot safely breastfeed her child, we are in dire straights indeed.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0321

EPA Comment ID: 19809

EPA Comment Code: 6120

Comment: Are you guys nuts! We don't want 15 times more Perchlorate that we had in 2002. A jet fuel! Shame on you! Do all you people drink bottled water and just think that what people don't know won't hurt them? I drink tap water because I thought I could trust the federal government! Please clean up our water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 598 of 1099 Response: See response to comment code 6120.

Commenter Name: Jennifer Sass, PhD Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2008-0692-0322

EPA Comment ID: 19811

EPA Comment Code: 6120

Comment:

October 17, 2008

Docket identification (ID): EPA-HQ-OW-2008-00692

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0323

EPA Comment ID: 19814

EPA Comment Code: 6120

Comment: EPA-HQ-OW- 2008-0068

Why would anyone want to drink anything that's in rocket fuel???

Would you?

Response: This is not a comment, a response is not necessary.

Commenter Name: Sarah Woodwide Gallagher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0324

EPA Comment ID: 19815

EPA Comment Code: 6120

Comment: Ladies/Gentlemen:

How in good conscience can you countenance endangering the health of Americans with this flawed regulation?

Most sincerely,

Sarah Woodwide Gallagher

Response: This is not a comment, a response is not necessary.

Commenter Name: Clif SteinbergEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 599 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0326

EPA Comment ID: 19816

EPA Comment Code: 6120

Comment: It is time to stop the madness. Perchlorate is among the many toxic contaminants that we have poisoned our environment with, and now rather than protect ourselves and clean up our mess we will just drink our own poison. Insanity! Maybe criminal.

-Clif Steinberg

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0331

EPA Comment ID: 19817

EPA Comment Code: 6120

Comment: I want my water regulated and I think that this decision is harmful to our health and needs to be changed.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0333

EPA Comment ID: 19819

EPA Comment Code: 6120

Comment: No... I don't need any more Perchlorate in my water or my atmosphere. I live next to

3M.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0335

EPA Comment ID: 19820

EPA Comment Code: 6120

Comment: I think this decision is harmful to public health!

Response: See response to comment code 6120.

Commenter Name: Stephen F. Lynch Commenter Organization: Granite Medical Group

EPA Document ID: EPA-HQ-OW-2008-0692-0336EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 600 of 1099 EPA Comment ID: 19824

EPA Comment Code: 6120

Comment: I am a practicing physician of Internal Medicine and Pediatrics. I have researched the issue of acceptable perchlorate levels in drinking water, and have concluded that the current levels are TOO HIGH, not too low. Allowing higher levels will adversely affect the health of US citizens, including yours! Do NOT raise the current levels.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0337

EPA Comment ID: 19825

EPA Comment Code: 6120

Comment: This is a public comment regarding perchlora te levels in drinking water. I urge you to set reasonable levels for acceptable perchlorate concen trations in drinking water. These levels should be at or below those deemed "safe" by the EPA itse lf in 2002. The American public has the right to safe drinking water.

Response: See response to comment code 6120.

Commenter Name: D Timmerman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0340

EPA Comment ID: 19826

EPA Comment Code: 6120

Comment: We ask that perchlorate not be added to water . It is a chemical that is very toxic and could lead to ailments to the population.

Response: Perchlorate is not added to water. EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: Edith A. Martin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0341

EPA Comment ID: 19828

EPA Comment Code: 6120

Comment: I am an educated consumer and an American citizen. I am against the current allowable level of perchlorate in our drinking water. This is just one more ruling that the EPA has not enforced properly to ensure that the public is protected from known toxins in our environment,

whether it is in our air or water. Please ensure the safety of our water in this case by adjusting the level of perchlorate.

Thank you, Edith A. MartinEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 601 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0343

EPA Comment ID: 19829

EPA Comment Code: 6120

Comment: Do not allow unsafe chemicals in our water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0344

EPA Comment ID: 19830

EPA Comment Code: 6120

Comment: You're not helping! Perchlorate levels in drin king water as approved by the Bush EPA is unacceptable!

Response: See response to comment code 6120.

Commenter Name: Thomas Armstrong Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0348

EPA Comment ID: 19831

EPA Comment Code: 6120

Comment: Dear EPA,

I do not want perchlorate in my drinking water.

Thomas Armstrong

Response: See response to comment code 6120.

Commenter Name: Lynn and Harrison Houston Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0349

EPA Comment ID: 19832

EPA Comment Code: 6120

Comment: Dear Sirs,

We need a drinking water standard. this is harmful to public health as these chemicals are toxic.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 602 of 1099 Sincerely, Lynn and Harrison Houston Satellite Beach, Florida 32937-3000

Response: See response to comment code 6120.

Commenter Name: C. Fletcher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0351

EPA Comment ID: 19833

EPA Comment Code: 6120

Comment: As a registered nurse, I am concerned that no standard regarding the currently allowable amounts of perchlorate in drinking water exists . Perchlorate affects the function of the thyroid gland, a gland that is essential to human health. Perchlorate is found in the water drunk by humans

in at least 35 states. It is essential that the EPA set standards for levels of perchlorate in drinking water in order to address the problem and promote public health.

Response: See response to comment code 6120.

Commenter Name: S. McCarthy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0355

EPA Comment ID: 19836

EPA Comment Code: 6120

Comment: This is an unsafe decision! Perchlorate in dr inking water must be limited or E- liminated. Reconsider this decision with its increased danger for our tap water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0359

EPA Comment ID: 19837

EPA Comment Code: 6120

Comment: As a concerned citizen, I urge you to set a cautious standard for regulating perchlorate in drinking water.

I worked at Rocketdyne in Canoga Park in the la te 1960's, where I began having thyroid problems for the first time and have subsequently develope d autoimmune issues and chemical sensitivities. Please consider that the human immune system can tolerate only a finite amount of toxicity from all sources before it begins to break down. Perchlor ate may be only one of many hazards in our water system but that does not make it insignificant enough to overlook.

The role of the Environmental Protection Agency is to protect us from harmful substances. Please exercise diligence in carrying out your role.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 603 of 1099 Commenter Name: Elizabeth Sheehan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0362

EPA Comment ID: 19838

EPA Comment Code: 6120

Comment: I am extremely concerned about the increase d risk of exposure to harmful toxins such as perchlorate in tap water. This is a significant public health issue, putting young children, pregnant women, unborn children at risk. I urge you to re -examine your standards of acceptance regarding perchlorate. I thank you for considering my comment and rethinking policies.

Sincerely, Elizabeth Sheehan

Response: See response to comment code 6120.

Commenter Name: M.E. Harte Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0363

EPA Comment ID: 19839

EPA Comment Code: 6120

Comment: please regulate perchlorate in drinking water! That is a known carcinogen and should be regulated. Would you like one of your kids drinking water contaminated with that stuff? Please regulate it. Thanks!

Response: See response to comment code 6120.

Commenter Name: Terrence L. Horan, D.D.S. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0365

EPA Comment ID: 19840

EPA Comment Code: 6120

Comment: EPA representatives, Perchlorate has been show to be detrimental to human health. That is reason enough to restrict its presence in drinking water. Whatever industry has to do to keep it out of our environment, they must be forced to do. Anything less is irresponsible.

Terrence L. Horan, D.D.S.

Response: See response to comment code 6120.

Commenter Name: Robert N. Milling Commenter Organization: Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0366

EPA Comment ID: 19841

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 604 of 1099 Comment: Regulate Pechlorate in drinking water

Response: See response to comment code 6120.

Commenter Name: H.N Hanna Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0367

EPA Comment ID: 19842

EPA Comment Code: 6120

Comment: I am dismayed that the EPA has refused to set an appropriate drinking water standard for perchlorate. This rocket fuel chemical has b een linked to thyroid problems in pregnant women, newborns and young children. The maximum safe level is now 15 times higher than what the EPA declared safe in 2002. The new standard puts 20 to 40 million of us at risk. I think the EPA should be doing a better job of protecting us; that is what it was set up to do, and that is what we taxpayers are paying for the EPA to do.

Response: See response to comment code 6120.

Commenter Name: Mary Beth Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0370

EPA Comment ID: 19843

EPA Comment Code: 6120

Comment: To Whom This May Concern:

I write to insist that the EPA do the job it was created to do, and REGULATE the lowest amount possible of perchlorate in water.

Response: See response to comment code 6120.

Commenter Name: Mary Beth Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0370

EPA Comment ID: 19845

EPA Comment Code: 6120

Comment: The EPA exists to PROTECT Americans from the predators that manipulate science; PROTECT our children from the chemicals that do them harm (indeed permanent damage). Career scientists at the EPA know the right thing to do on this issue. I beg you to have the courage to do the right thing. Leave politicians and well-funded lobbyists out of this decision.

Please, provide tight regulation on perchlorate.

While you're at it, demand that the polluters pay to clean up the mess they've made -- we all know they've taken an obscene amount of our tax dollars as profit!EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 605 of 1099 Sincerely, Mary Beth Sullivan 212 Centre Street Bath, Maine 04530 207 443 9502 mbsull@mindspring.com

Response: See response to comment code 6120. Requiring polluter payment is outside the scope of this rule; no response is necessary.

Commenter Name: K. Hannigan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0371

EPA Comment ID: 19846

EPA Comment Code: 6120

Comment: Please do not put Perchlorate in our water.

Response: Perchlorate is not added to water.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0372

EPA Comment ID: 19847

EPA Comment Code: 6120

Comment: So it's safe to drink rocket fuel? Really? And we're supposed to believe there are no politics in government science and that the EPA cares about the health of Americans? Really???

Perchlorate is unsafe. If you doubt that, please f eel free to administer it to members of your own

families but DON'T force citizens coun ting on clean water to drink it.

Don't become the Environmental Pollution Agency.

Response: This is not a comment, a response is not necessary.

Commenter Name: Judith Weiss Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0374

EPA Comment ID: 19848

EPA Comment Code: 6120

Comment: I understand that the EPA is considering rais ing the bar on "safe" levels of byproducts of rocket fuel in our drinking water. This is the kind of politically driven lack of concern for citizen health that we've come to expect from our government.

I object to this agency playing cancer roulette with my health and the health of the nation.

Until and unless each water contaminant is tested for safety by the Ames test or another reputable test you should NOT deem any levels of rocket fuel or its byproducts as safe in food water or drink.

Let's see some concern for the public good in your policies. Judith WeissEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 606 of 1099 Response: See response to comment code 6120.

Commenter Name: Sherrie Riggio Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0375

EPA Comment ID: 19849

EPA Comment Code: 6120

Comment: Please keep the levels of perchlorate in th e drinking water at the levels suggested by safety standards declared by the EPA in 2002. It seems like we are going backwards with safety issues instead of forward. The public's health must take priority over politics. Please. Sherrie Riggio.

Response: See response to comment code 6120.

Commenter Name: Peter Roloff Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0376

EPA Comment ID: 19850

EPA Comment Code: 6120

Comment: As a concerned citizen I can think of no permissible levels of Perchlorate that should be allowed in our fresh water sources, period, end of discussion. sin cerly, Peter Roloff

Response: See response to comment code 6120.

Commenter Name: J. Koss, MD Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0377

EPA Comment ID: 19851

EPA Comment Code: 6120

Comment: PERCHLORATE, LIKE ALL MAN MADE CHEMICALS POSE UNCERTAIN AND UNTESTED RISKS TO MY PATIENTS. EUROPE demands proof of safety to add chemicals to the environment, let alone drinking water.Adults, especially children, run risks potentially discoverable AFTER 10-20 years of exposure. WHAT WILL THE GOVERNMENT DO THEN? It will be too late for many victims by then.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0379

EPA Comment ID: 19852

EPA Comment Code: 6120

Comment: I would want to know drinking water was safe for my children and grandchildren. Wouldn't you?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 607 of 1099 Response: This is not a comment, a response is not necessary.

Commenter Name: M. Soule Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0381

EPA Comment ID: 19853

EPA Comment Code: 6120

Comment: No perchlorate in our drinking water!!! TOXIC AND HARMFUL!!!

Response: See response to comment code 6120.

Commenter Name: Edwards Mills Commenter Organization: Kidem Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-0383

EPA Comment ID: 19854

EPA Comment Code: 6120

Comment: Please implement a meaningful standard for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0385

EPA Comment ID: 19855

EPA Comment Code: 6120

Comment: Set a Federal standard for perchlorate! Protect the public health!

Response: See response to comment code 6120.

Commenter Name: Brian Dewhirst, MD Commenter Organization: Palmetto Primary Care Physicians

EPA Document ID: EPA-HQ-OW-2008-0692-0387

EPA Comment ID: 19856

EPA Comment Code: 6120

Comment: I am a family physician in South Carolina an d take care of both adults and children. I want to express my deep concern about the EP's decision on addressing perchlorate in water. This chemical is known to be harmful and exposure thro ugh water could pose a serious danger to public health. Sincerely, Dr. Brian Dewhirst, MD Palmett o Primary Care Physicians Charleston, SC

Response: See response to comment code 6120.

Commenter Name: B. Meyer Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 608 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0388

EPA Comment ID: 19857

EPA Comment Code: 6120

Comment: I am writing to support adding Perchlorate regulations under the Safe Water Drinking Act (Docket ID EPA-HQ-2008-0692 ) This chmeical, used in rocket fuel, is linked to thyroid problems in pregnant women, children and newborns. The EPA must regualte the chemical in drinking water.Millions are threatened, 16 million in 35 states. Protect our health.

Response: See response to comment code 6120.

Commenter Name: R. Sharp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0391

EPA Comment ID: 19858

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

This is a bad decision. Keep Perchlorate out of drinking water.

Response: See response to comment code 6120.

Commenter Name: D Camp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0392

EPA Comment ID: 19859

EPA Comment Code: 6120

Comment: Water is more precious than gold, and highly needed healthy water for all living things. All the things found in surface water ends up in our bodies, so stop harmful chemicals in water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0393

EPA Comment ID: 19860

EPA Comment Code: 6120

Comment: Hypothyroidism is insidious and not diag nosed in time to avoid developmental deficiencies in children and dementia in old people.Perchlorate intake by children must be prevented at any cost. The standard for perchlorate in drinking water must be tightened.

Response: See response to comment code 6120.

Commenter Name: S. KingEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 609 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0394

EPA Comment ID: 19861

EPA Comment Code: 6120

Comment: It is dangerous for the EPA to raise the amou nt of perchlorate allowed in public driking water. Keep the old standard and protect the health of U.S. citizens.

Response: See response to comment code 6120.

Commenter Name: M.M. Foxton Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0399

EPA Comment ID: 19862

EPA Comment Code: 6120

Comment: Please keep American drinking water safe.

Response: See response to comment code 6120.

Commenter Name: E. Heilman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0401

EPA Comment ID: 19863

EPA Comment Code: 6120

Comment: The EPA has a responsibility to protect the heal th of US citizens and is obligated to regulate and minimize the amount of perchlorate found in drinking water -- it is known to be harmful to pregnant women and children. Take responsibility now, do your job of protecting PEOPLE not companies, and regulate (minimize) the amount of perchlorate in American drinking water. Do the right thing.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0407

EPA Comment ID: 19864

EPA Comment Code: 6120

Comment: This is outrageous, I want to know that my drinking water is safe and free of anything harmful to my health. It's not acceptable to have un safe levels of perchlorate in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Tim Mathews Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0408EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 610 of 1099 EPA Comment ID: 19865

EPA Comment Code: 6120

Comment: I strongly believe that the percholate levels in drinking water should be restricted much more conservatively.

Thank You,

Tim Mathews

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0409

EPA Comment ID: 19866

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

At least six of my friends and family members have serious thyroid conditions, probably due to environmental exposures. This is epidemic, and it's no time to allow MORE perchlorate in drinking water, as it is something already known to help cause thyroid problems in pregnant women, newborns and young children.

You know how widespread perchlorate exposure is now in America. Setting a standard for it is a real step toward health risk reduction. Choosing not to re gulate is choosing more disease, particularly for

children.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0411

EPA Comment ID: 19867

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate is a dangerous chemical that is currently found in the drinking water of 35 states. I urge you to set a standard for perchlorate in accordance with the Safe Drinking Wa ter Act. Please protect

American's health.

Response: See response to comment code 6120.

Commenter Name: AnonymousEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 611 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0412

EPA Comment ID: 19868

EPA Comment Code: 6120

Comment: Fresh, healthy and pure drinking water is a human right, whether or not a government agency wants to accept that fact. A human right! No single source should be able to alienate the people from that right. Therefor it is the ob ligation of those of power--whom the people have elected to represent them--to protect the rights of th eir constituents. Please do whatever you can to keep perchlorate as well as other toxic subst ances from the People's drinking water.

Response: See response to comment code 6120.

Commenter Name: K. Dalby Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0417

EPA Comment ID: 19869

EPA Comment Code: 6120

Comment: perchlorate is unsafe for consumption -- please keep out of drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0418

EPA Comment ID: 19870

EPA Comment Code: 6120

Comment: I am outraged to learn that while perchlorate has been detected in the water supplies of two-thirds of the states, there is no plan to create a minimum

acceptable level of this chemical.

Response: See response to comment code 6120.

Commenter Name: P. Incao Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0419

EPA Comment ID: 19871

EPA Comment Code: 6120

Comment: Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 612 of 1099 Commenter Name: Masha Etkin MD, PhD Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0420

EPA Comment ID: 19872

EPA Comment Code: 6120

Comment: To EPA: Please regulate perchlorate in dr inking water in accordance with the Save Drinking Water Act.

Thank you, Masha Etkin MD, PhD

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0425

EPA Comment ID: 19874

EPA Comment Code: 6120

Comment: I find it criminally obscene that there is no re gulation of perchlorate in the water supply.

I find it convenient that the EPA has been repopu lated with corporate advocates instead of those truly wishing to serve the public.

Response: See response to comment code 6120.

Commenter Name: E. Manire-Gatti Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0426

EPA Comment ID: 19875

EPA Comment Code: 6120

Comment: EPA must regulate the amount of perchlorate in drinking water so that it does not cause harm. Perchlorate is known to cause throid pr oblems in pregnant women, newborns, and small children. This chemical can lead to delayed and altered development in children. It can lead to the development of tumors.

I understand that perchlorate is needed by the defe nse industry and its control will make its products more expensive. However, the health of the citizens of the United States is more important than spending more for weapons. Please remember our present and future generations when you consider the regulation of perchlorate.

Response: See response to comment code 6120.

Commenter Name: C. DiBenedetto Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0430

EPA Comment ID: 19876EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 613 of 1099 EPA Comment Code: 6120

Comment: Please do not poison the people of America and our children. The EPA should regulate perchlorate in our drinking water, and the standards should not be lower than they are today -- they should be higher, if anything.

Response: See response to comment code 6120.

Commenter Name: Dorothea Leicher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0431

EPA Comment ID: 19877

EPA Comment Code: 6120

Comment: This is written by Dorothea Leicher, at 2303 Delancey Pl, Philadelphia, PA, 19103, as a Public Comment regarding EPA's refusal to regula te Perchlorate under the Safe Water Drinking Act (Docker ID EPA-HQ-OW-2008-0692)

Perchlorate has been linked to thyroid problems in pregnant women, newborns and young children. As mother, this kind of risk to my daugh ter and her children is of great concern.

Perchlorate is found in the drinking water of 35 states, so that regulating it would provide a significant protection for the public.

Safe drinking water is an extremely important asset, and one that we will have to rely on increasingly as water becomes scarcer. the trust in tap water has already been assaulted by the bottled water industry and it is especially important now do ever ything to protect this public resource in the spirit of the Safe Water Drinking Act. Than k you for your time and attention.

Response: See response to comment code 6120.

Commenter Name: S. Carr Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0435

EPA Comment ID: 19880

EPA Comment Code: 6120

Comment: Perchlorate toxicity is proven beyond do ubt. Why is there a question about its' regulation? It is ridiculous to poison people on purpose although the U.S. chemical industry has been doing so for half a century. Most of the ca ncers, thyroid problems, and birth defects seem related to the chemical industry and the lack of proper regulation from the EPA. If the EPA cannot do better, they should start over with a new agen cy that can protect us and close this one down.

Response: See response to comment code 6120.

Commenter Name: B. Welsh Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0438EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 614 of 1099 EPA Comment ID: 19881

EPA Comment Code: 6120

Comment: Do not allow more Perchlorate in our drinking water! Our water continues to degrade in quality - in part by various pollutants which are vi rtually impossible to study in the combinations they'll actually appear in. These combinations are virtually impossible to study due to their large numbers, but evidence so far indicates that the total effect of these pollutants is worse than the sum of effects of the separate pollutants.

Clean water is critical for life - and it's far cheape r and more sensible to keep the water clean rather than to clean it up after it's polluted.

Response: See response to comment code 6120.

Commenter Name: G. Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0442

EPA Comment ID: 19882

EPA Comment Code: 6120

Comment: I don't think any substance should be in our drinking water, except what our Creator put there. As far as any perchlorate is concerned, they don't belong in our water supply. If there is no way to eradicate it, then it should be the sma llest amount possible. This seems like something the EPA should know without our input. There our so ma ny diseases now that I feel are caused by the chemicals in our atmosphere; consequently, we don't want to allow this chemical in our water supply, which would endanger th e health of our citizens.

I strongly urge the EPA to set a high standard for our drinking water.

Response: See response to comment code 6120.

Commenter Name: J. Rinker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0444

EPA Comment ID: 19883

EPA Comment Code: 6120

Comment: Perchlorate has a long history of use in ro cket fuel and its has been shown to disrupt iodine uptake, which can lead to endocrine abnormalities in our most susceptible populations including pregnant women, newborns and small children.

Given that it has been found in the drinking water of 35 states in the US, it is imperative that the EPA not only regularly review but regulate this chemical to protect our families and future heritage.

As an occupational and environmental medicine physician I strongly urge that the EPA set a standard for perchlorate in our drinking water in order to protect American's health. Don't lose this opportunity to set regulations for reducing our health risks from chemically contaminated drinking water in accordance with the Safe Drinking Water Act.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 615 of 1099 Response: See response to comment code 6120.

Commenter Name: A. R. Ehrlich, MD Commenter Organization: Group Health Cooperative Health Care

EPA Document ID: EPA-HQ-OW-2008-0692-0445

EPA Comment ID: 19886

EPA Comment Code: 6120

Comment: Perchlorate in drinking water should be limited. I understand that thus far the EPA has refused to do this, which puts millions of small children and pregnant women at risk from the harmful effects on the thyroid.

A R Ehrlich, MD

Response: See response to comment code 6120.

Commenter Name: Jeoffry B. Gordon, MD, MPH Commenter Organization: Ocean Beach Medical Group

EPA Document ID: EPA-HQ-OW-2008-0692-0448

EPA Comment ID: 19887

EPA Comment Code: 6120

Comment: As apractici8ng physician with a devotion to environmental health diseases, it is my opinion that the preponderance of the available eviden ce would indicate that it is important to have a margin of safety by reducing the proposed level of perchlorate in drinking water by a factor of 20.

Response: See response to comment code 6120.

Commenter Name: Ellen M. Imbody Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0450

EPA Comment ID: 19888

EPA Comment Code: 6120

Comment: As a retired public health comissioner, I urge you to regulate the Perchlorate which is now found in the drinking water in 35 states. Percholate is a dangerous chemical. Without regulation too many Americans risk being exposed to this

chemical. With control of this chemical, you will be protecting our citizens health.

Sincerely,

Ellen M. Imbody Pinetop, AZ

Response: See response to comment code 6120.

Commenter Name: B. RegulinskiEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 616 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0451

EPA Comment ID: 19889

EPA Comment Code: 6120

Comment: The EPA needs to set a maximum level of p echlorate in drinking water. AS FAR AS I

AM CONCERNED THERE IS NO SAFE LEVEL FOR FOREIGN CHEMICALS IN DRINKING WATER. There is already a shortage of clean drinking water in the world. Water is essential to life, and I resent the contamination of the little that the world has. Many wells in my area

of Arizona have had to be closed because of chemicals from cleaning air plane engines and manufacture of computer chips.

There is no excuse for allowing manufacturers to dump their waste water into the supply of clean drinking water.

Response: See response to comment code 6120.

Commenter Name: R. Sheridan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0452

EPA Comment ID: 19890

EPA Comment Code: 6120

Comment: I would like to comment regarding EPA's refusal to regulate Perchlorate under the Safe Drinking Act (Docket ID EPA-HQ-OW-2008-0692.

I think perchlorate should be regulated because it is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. This harmful chemical should be regulated. It has been found in Alaska, as well as in 34 other states. According to the EPA's data

it has been shown that we are at risk of being exposed to this chemical.

I urge you to set a standard for perchlorate in accordance with the Safe Drinking Water Act.

Ruth Sheridan, Anchorage, AK

Response: See response to comment code 6120.

Commenter Name: Catherine Moore Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0453

EPA Comment ID: 19891

EPA Comment Code: 6120

Comment: Perchlorate is not something I can drink safe ly. I already have a huge problem with my thyroid which can cause heart failure and a number of other serious problems. Please find a way to monitor and clean up this toxic material which is finding its way into our drinking water.

Many thanks, Catherine Moore, OregonEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 617 of 1099 Response: See response to comment code 6120.

Commenter Name: Grace Goldberg, DO Commenter Organization: MidCoast Maine Cares (MCMC)

EPA Document ID: EPA-HQ-OW-2008-0692-0457

EPA Comment ID: 19892

EPA Comment Code: 6120

Comment: Please remember that you are the Environm ental Protection Agency. Please do not raise the acceptable level of perchlorates in drinking water. Thankyou

Response: See response to comment code 6120.

Commenter Name: David P. Kuter, M.D. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0458

EPA Comment ID: 19893

EPA Comment Code: 6120

Comment: As a physician, I have reviewed the evidence and believe that more stringent guidelines are wise for the presence of perchlorate in water supplies.

David P. Kuter, MD 3917 Regent Street, Madison, WI 53705

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0467

EPA Comment ID: 19896

EPA Comment Code: 6120

Comment: Protect our nation's drinking water for rock et fuel, protect the health interests of pregnant women and children.

Response: See response to comment code 6120.

Commenter Name: N. O'Byrne Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0468

EPA Comment ID: 19897

EPA Comment Code: 6120

Comment: We must regulate perchlorate in our drinking water to an acceptable standard that does not endanger public health.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 618 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0471

EPA Comment ID: 19900

EPA Comment Code: 6120

Comment: regulate perchlorate to the old standands.

Response: See response to comment code 6120.

Commenter Name: James R. and Mary Duplisea Palmer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0472

EPA Comment ID: 19901

EPA Comment Code: 6120

Comment: My wife (Mary Duplisea-Palmer) and I (James R. Palmer) live at 66 Albert Pt. in Stetson, ME. This is our public comment regarding EPA's refusal to regulate Perchlorate under the Safe Drinking Water Act: Please continue to regulate this chemical according to the standard that was in place before this proposed change. Clean drinking wa ter is so important to life, and, unfortunately, humankind has pollutted it too much already. Even using EPA's data, this chemical is wide-spread already. Continue to do the job your agency was created to do.

Response: Perchlorate is not regulated in drinking water. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0475

EPA Comment ID: 19902

EPA Comment Code: 6120

Comment: The Environmental Protection Agency has fo rmally refused to set a drinking-water standard for perchlorate, a chemical in rocket fu el that has been linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0475

EPA Comment ID: 19904

EPA Comment Code: 6120

Comment: Is there something wrong with th is picture? Why not help as an agency to be part of the Green Revolution by advocating for an entire n etwork of workers whose sole goal would be to screen out (phase out) every iota of perchlorate fr om our drinking supply? And let's get more honest
about flouride, too.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 619 of 1099 Response: See response to comment code 6120. The comment about flouride is outside the scope of this notice; no response is necessary.

Commenter Name: Melvyn C. Thorne Commenter Organization: Johns Hopkins University

EPA Document ID: EPA-HQ-OW-2008-0692-0482

EPA Comment ID: 19905

EPA Comment Code: 6120

Comment: The regulatory limits on perchlorate in drinking water have been set irresponsibly too high. This is yet another of the reckless endanger ments of public health produced by the Bush administration to pander to an unbalanced ideology of deregulation of industry.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0483

EPA Comment ID: 19906

EPA Comment Code: 6120

Comment: Please, please, please put our health and welfare first. No perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: O. Yourke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0485

EPA Comment ID: 19907

EPA Comment Code: 6120

Comment: I think this decision is harmful to public health. No perchlorate should b allowed in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0486

EPA Comment ID: 19908

EPA Comment Code: 6120

Comment: Regulate percholate in all of our nations water supply. Do your job and protect the

environment.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 620 of 1099 Commenter Name: Dave Weller, MPH Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0487

EPA Comment ID: 19909

EPA Comment Code: 6120

Comment: EPA staffers,

Please demand that all industrial chemicals be removed from our drinking water supply. Your current work in regulating perchlorate is esp ecially important. Remove them from our water.

Thank you, Dave Weller (MPH)

Response: See response to comment code 6120. The comme nt about other industrial chemicals is outside the scope of this notice; no response necessary.

Commenter Name: S. G. Gompf Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0490

EPA Comment ID: 19910

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPAâ €TMs refusal to regulate Perchlorate under the Safe Water Drinking Act (Doc ket ID EPA-HQ-OW-2008-0692):

Perchlorate is component of rocket fuel. It has been linked to thyroid disease in pregnant women, in newborns and young children. It is incomprehensib le, and indefensible, that the EPA has refused to regulate a dangerous chemical in the drinking water of American mothers and children.

Response: See response to comment code 6120.

Commenter Name: C. Gabriel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0492

EPA Comment ID: 19913

EPA Comment Code: 6120

Comment: Perchlorate is a known health hazard. The EPA's refusal to set standards for it is unconscionable, and an abrogation of it's charter.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0493

EPA Comment ID: 19914

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 621 of 1099 Comment: Public Comment Regarding Immediate need to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

As an physician and a mother I am quite concerned about the lack of regulation of Perchlorate, a chemical in rocket fuel, linked to thyroid problems in pregnant women, newborns and young children let alone other as of yet undetermined consequences.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0493

EPA Comment ID: 19916

EPA Comment Code: 6120

Comment: Please use foresight and help to protect ou r drinking water by setting a standard for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Jan L. Crean, M.D. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0494

EPA Comment ID: 19917

EPA Comment Code: 6120

Comment: I am writing to urge the EPA to control the contamination of our drinking water and, by extension, our food supply with regard to perchlorate. The following is medical information regarding this toxic chemical, per the EPA itself:

PERCHLORATE

The EPA has established an official reference dose (RfD) of 0.0007 mg/kg/day of perchlorate. This level is consistent with the recommended reference dose included in the National Academy of Science's January 2005 report. A reference dose is a scientific estimate of a daily exposure level that is not expected to cause adverse health effects in humans. Risk information about perchlorate and perchlorate salt.

Perchlorate is a man-made anion commonly associated with the solid salts of ammonium, potassium, and sodium. Ammonium perchlorate is th e mostly widely used perchlorate compound. It has also been found to occur naturally in certain highly arid environments. These salts are highly soluble in water, and because perchlorate adheres poorly to mineral surfaces and organic material, it can be very mobile in surface and subsurface aqueous systems. Also, since it is relatively inert in typical groundwater and surface water conditi ons, perchlorate contamination may persist for extended periods of time.

Perchlorate interferes with iodide uptake into th e thyroid gland. Because iodide is an essential component of thyroid hormones, perchlorate disr upts how the thyroid functions. In adults, theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 622 of 1099 thyroid helps to regulate the metabolism. In children, the thyroid plays a major role in proper development, in addition to metabolism. Impairme nt of thyroid function in pregnant mothers may impact the fetus and result in such effects as changes in behavior, delayed development and decreased learning capability. Drinking water contam inated with perchlorate is the most likely way that perchlorate can be ingested.

Recent studies conducted by the U.S. Depart ment of Agriculture (Nov. 2004) and the Environmental Working Group (Apr. 2003) have d etected perchlorate in samples of lettuce in California. Several other studies also detected perc hlorate in milk samples taken from California and Texas. Additional studies of perchlorate uptake in food crops are currently being conducted by the U.S. Food and Drug Administration.

Production of ammonium perchlorate first began in the United States in the mid- 1940s, primarily for use by the U.S. military. The most common use s for ammonium perchlorate are in explosives and rocket propellants, which have been widely used in military munitions items, such as mortars, grenades and flares and solid fuel rocket. Based on production data from two perchlorate manufacturers, it is estimated that 90 percent of perchlorate compounds are manufactured for use in defense activities and the aerospace industry. While occurring most frequently at domestic Air Force installations, ammonium perchlorate has been det ected at Army and Navy sites too. The National Aeronautics and Space Administration (NASA) and De partment of Energy (DOE) also have a small number of facilities with perchlorate (specific info rmation on known perchlorate releases in the U.S. (XLS) (PDF, 7 pages, 515KB), as of September 23 , 2004). In addition, ammonium perchlorate and the other perchlorate salts have been or are used in a wide range of applications, including pyrotechnics and fireworks, blasting agents, solid rocket fuel, matches, lubricating oils, nuclear reactors, air bags and certain types of fertilizers. Improper storage and/or disposal related to the uses mentioned above are the most typical route fo r perchlorate to enter into the environment.

The EPA has been working with states, federal ag encies, tribes, water suppliers and the private sector for several years to address perchlorate. In 1998, EPA released an Interim Assessment Guidance for Perchlorate (PDF, 4 pages, 224KB), which was then subject to peer review in 1999.

The external review draft of the revised docume nt "Perchlorate Environmental Contamination: Toxicological Review and Risk Characterization," (November, 2002) responds to those recommendations emanating from the peer review.

The National Research Council of the National Academies published its technical review of the Health Implications of Perchlorate Ingestion in January 2005. From this review, EPA has established an official reference dose of 0.0007 mg /kg/day of perchlorate. This level is consistent

with the recommended reference dose included in the National Academy of Science's report. A reference dose is a scientific estimate of a daily exposure level that is not expected to cause adverse

health effects in humans.

Thank you for your attention to this matter. As a practicing OB/Gyn, I am intimately concerned with your actions, on behalf of my patients and their children, both born and unborn.

Response: See response to comment code 6120.

Commenter Name: Richard F. Koch Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 623 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0495

EPA Comment ID: 19918

EPA Comment Code: 6120

Comment: This is a public comment on the matter of perchlorate content of drinking water.

I urge that the standard be returned at least to the level permitted by today's standard. Better yet, a

lower level should be mandated.

Richard F. Koch dickkoch88@gmail.com

Response: EPA does not regulate perchlorate in drin king water. See response to comment code

6120.

Commenter Name: Alison M. Russell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0498

EPA Comment ID: 19919

EPA Comment Code: 6120

Comment: As a private citizen who also works in the wate r field, I urge you to adopt a strict health standard for the regulation of perchlorate in drinking water. No water consumer should have to bear the furden of any of this chemical in their water.

Thank you.

Alison M. Russell 548 Sumner St. Santa Cruz, CA 95062

Response: See response to comment code 6120.

Commenter Name: Sister Mary Schmuck Commenter Organization: Sisters of Mercy

EPA Document ID: EPA-HQ-OW-2008-0692-0499

EPA Comment ID: 19920

EPA Comment Code: 6120

Comment: Letting perchlorate into water is very harmful to human health.

Please prohibit it!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0501

EPA Comment ID: 19921

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 624 of 1099 Comment: PERCHLORATES DAMAGE HEALTH IN ALL SENTIENT BEINGS!!! (THAT INCLUDES 'YOU' WAY PAST TIME TO INSTITUTE 'SAFE' LIMITS (I.E. NONE!) AS IT IS
IN OUR WATER SUPPLY AND AFFECTS EVERYTHING, GRAZING GRASSES, FOODS,

AND EVEN SHOWS UP IN OUR MILK PRODUCTS!!!

MY UNDERSTANDING IS THAT THE EPA IS 'SUPPOSED' TO KEEP TRACK OF SAFE

LIMITS OF BAD CHEMICALS AND MANDAT E THAT THESE LIMITS ARE ACTUALLY

ENFORCED.

TIME TO DO YOUR JOB................ YOU R BAD, LACK OF CONTROL, IS KILLING ALL

THINGS.

Response: See response to comment code 6120.

Commenter Name: Dr. L. Paull Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0502

EPA Comment ID: 19922

EPA Comment Code: 6120

Comment: The current levels of perchlorate idrinkin g water are alarmingly dangerous. The EPA must regulateee the practices that are creating this level.

Response: See response to comment code 6120.

Commenter Name: L. Peles, M.D. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0503

EPA Comment ID: 19923

EPA Comment Code: 6120

Comment: I think this is dangerous to our health.

Response: This is not a comment, a response is not necessary.

Commenter Name: Rhea Irvine Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0504

EPA Comment ID: 19924

EPA Comment Code: 6120

Comment: It's more than a shame that citizens of many European countries are protected from substances that *may* endanger health than citize ns of our own country. Among the many things that have declined under the current Republic an administration, health and environmental protections --and the ethics of protecting or not protecting---rank high. Clean air and clean water should not be things that need to be debated or lobbied for. I urge you to set standards for perchlorate in water that are supported by the best scientific research.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 625 of 1099 Thank you, Rhea Irvine

Response: See response to comment code 6120.

Commenter Name: Kristen E. Cain Commenter Organization: FACOG

EPA Document ID: EPA-HQ-OW-2008-0692-0505

EPA Comment ID: 19925

EPA Comment Code: 6120

Comment: As a physician specializing in hormonal disord ers, I cannot understand how this benefits any Americans. This compound may be linked to breast, ovarian, uterine, testicular and prostate cancers as well as infertility, birth defects, and is a documented offender in thyroid disease. Allowing an increase in levels of perchlorate in our tap wate r will increase disease, health care costs, usage of bottled water, energy costs for transport of bottl ed water and petroleum byproduct usage for the bottling of the water in a public attempt to avoid exposure to these pollutants. We need to be making our water safer! Kristen E. Cain, MD, FACOG

Response: See response to comment code 6120.

Commenter Name: J. Angelina Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0507

EPA Comment ID: 19927

EPA Comment Code: 6120

Comment: I believe this is dangerous to the public safety!

Response: See response to comment code 6120.

Commenter Name: Noel Rasor Commenter Organization: MUP

EPA Document ID: EPA-HQ-OW-2008-0692-0508

EPA Comment ID: 19928

EPA Comment Code: 6120

Comment: I urge the EPA to return to limit perchlorate levels in drinking water to its own 2002

recommendations on what can be considered safe . This chemical is known to be harmful and exposure through water could pose a serious danger to public health. Sincerely, Noel Rasor, MUP

Response: See response to comment code 6120.

Commenter Name: J. McPeek Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0510

EPA Comment ID: 19929

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 626 of 1099 Comment: Rocket fuel or anything like it in my tap water does nothing to enhance my health, and could damage it. Safe level my rear end! There is no such thing.

Response: See response to comment code 6120.

Commenter Name: Christine Lomaka Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0512

EPA Comment ID: 19930

EPA Comment Code: 6120

Comment: Hi. I am a citizen of Portland, Maine. I have learned of your determination to not regulate perchlorate in our drinking water, though the amount of perchlorate in our water has been on the rise. It has been found to cause thyroid pr oblems in pregnant women and in the youth of our country. These are among the very people this department has been created to protect. You should not support businesses at the expense of the people' s and the environment's health. Do your job for the effects are lasting.

Sincerely, Christine Lomaka CLonthroad@aol.co m 76 Monument St. Portland, ME 04101

Response: See response to comment code 6120.

Commenter Name: C. Steinberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0513

EPA Comment ID: 19931

EPA Comment Code: 6120

Comment: This is to support the positon of Physicia ns for Social Responsibility on the matter of minimum perchlorate residue in drinking water. I can't understand why EPA is backtracking on its minimum set years ago, proposing to more than double that minimum. In that major industrialized nations have perchlorate minima in drinking water even lower than the former EPA minimum, arewe in this country reverting to the safety gauges more consistent with those in some nonindustrialized lands? The proposed elevation of th e perchlorate minima for our drinking water is disgraceful.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0515

EPA Comment ID: 19932

EPA Comment Code: 6120

Comment: The function of the EPA is to promote health for the citizens of the United States as

well as the natural environment within the national borders. I am informed that the EPA's current acceptable minimum for perchlorate is 15 times the level that had been set in 2002. This is unacceptable, as scientific research has indicated the dangerous effects of perchlorate on pregnantEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 627 of 1099 women, new born and young children. I urge you to set a lower, mandatory safe minimum for perchlorate, because it should not be a part of our drinking water.

Response: See response to comment code 6120.

Commenter Name: T. Udall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0516

EPA Comment ID: 19933

EPA Comment Code: 6120

Comment: Allowing perchlorate in drinking water is akin to murder, slow and torturous death, with or without healthcare. Corporations who think they are superior to life or that they have the right to destroy life without legal consequences must be regu lated or there will come a time when there is no

life left.

Response: This is not a comment, a response is not necessary.

Commenter Name: H. Meyer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0517

EPA Comment ID: 19934

EPA Comment Code: 6120

Comment: Perchlorate in our drinking water is harmful. Our limit should be none allowed. This chemical has been shown to be dangerous to infants and children causing thyroid disease, which may be a lifelong problem costing the individuals to suffer increased insurance fees, medication costs and problems with schooling. As a pediatrici an I am appalled that the EPA has allowed an increase in the water levels of perc hlorate a most dangerous substance.

Response: See response to comment code 6120.

Commenter Name: T. Johnson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0518

EPA Comment ID: 19935

EPA Comment Code: 6120

Comment: This is found in Rocket Fuel people, RO CKET FUEL! Hello-this should be stopped NOW. Your actions affect the lives of people, their health and well being.

This should not be allowed and the EPA has the power to stop this nonsense.

So STOP allowing this in our drinking water!

Response: See response to comment code 6120.

Commenter Name: AnonymousEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 628 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0521

EPA Comment ID: 19936

EPA Comment Code: 6120

Comment: No individual anywhere has been given the right to poison our drinking water and food. Any individual or agent who willfully poisons our water is a criminal. Do no poison our water with poisons, inorganic or viral. You are not protecting our health or the environment by poisoning our water with deadly toxins.

Response: This is not a comment, a response is not necessary.

Commenter Name: Joyce Paape Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0524

EPA Comment ID: 19937

EPA Comment Code: 6120

Comment: Do not raise the amount of percolate in ou r drinking water- it would endanger more people than the present levels- especially pr egnant wome & children!! Dr. Joyce Paape

Response: Perchlorate is not regulated in drinking water. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0527

EPA Comment ID: 19939

EPA Comment Code: 6120

Comment: I believe that in this country we should be able to depend on our drinking water being
safe, the air we breathe, the food we eat. What is the problem that you people cannot insure that that happens in this country?

Response: This is not a comment, a response is not necessary.

Commenter Name: Jana Koth Commenter Organization: UNMC

EPA Document ID: EPA-HQ-OW-2008-0692-0528

EPA Comment ID: 19940

EPA Comment Code: 6120

Comment: Perchlorate is hazardous and needs to be elim inated. This is a dangerous public health

concern.

Response: This is not a comment, a response is not necessary.

Commenter Name: M. Huber Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 629 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0529

EPA Comment ID: 19941

EPA Comment Code: 6120

Comment: Drinking water is valuable and increasingly scarce. Please keep our free of chemicals.

Response: See response to comment code 6120.

Commenter Name: Rebecca Fletcher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0530

EPA Comment ID: 19942

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPAâ €TMs refusal to regulate Perchlorate under the Safe Water Drinking Act (Doc ket ID EPA-HQ-OW-2008-0692):

I'm very concerned about this. Please regulate the quantities of this dangerous chemical that are allowed to be present in drinking water. I know that perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is tota lly unacceptable. Perchlorate is found in drinking water in 35 states, and according to the EPAâ€TM s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0533

EPA Comment ID: 19944

EPA Comment Code: 6120

Comment: Set a drinking water standard for Perchlorate.

It's absurd for the EPA to refuse to set standard s for this harmful pollutant in drinking water.

It's the same as not regulating the amount of le ad or mercury allowed in public drinking water.

Do your job EPA. Protect the environment, pro tect the people. Set a rigorous standard for Perchlorate in drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0534

EPA Comment ID: 19945

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 630 of 1099 Comment: I believe perchlorate is harmful to the public health. It causes thyroid problems in pregnant woman, newborns, and young children. More over, the safe limit for perchlorate is 15 times greater than what EPA declared in 2002. Too many people are potentialy exposed to this dangerous

toxin.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0536

EPA Comment ID: 19946

EPA Comment Code: 6120

Comment: why on earth would you add harmful chemicals to our drinking water!?!!!

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0540

EPA Comment ID: 19947

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA's refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

The high level of perchlorate allowed in our current drinking water supply is shameful and unethical. Our government is the ONLY party that has the authority to regulate toxic industrial emissions in our environment, and yet our government continues to protect industry rather than people.

Please keep the health of ordinary americans safe . Please pass legislation that requires cities and industries to clean up contaminated water to stricter standards. The technology exists today to do this! Why is this not happening?

I urge you to create the strictest possible standards of perchlorate in our drinking water to keep future generations safe and healthy, in acco rdance with the Safe Drinking Water Act.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0541

EPA Comment ID: 19948

EPA Comment Code: 6120

Comment: Allowing perchlorate in drinking water is a health risk! This decision is hazardous to the American population.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 631 of 1099 Response: See response to comment code 6120.

Commenter Name: L. Abbott Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0542

EPA Comment ID: 19949

EPA Comment Code: 6120

Comment: As perchlorate is detected in municipal wa ter systems we need a strict standard to safeguard the public. We must always ere on the side of safety.

Response: See response to comment code 6120.

Commenter Name: Karen Ulring Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0543

EPA Comment ID: 19950

EPA Comment Code: 6120

Comment: The EPA must set a standard that regulates the amount of perchlorate in our drinking water. It s well documented that this chemical in our water is dangerous, especially to pregnant women, and to peoples health in general. Plea se act to ensure the health of US citizens.

Thank you, Karen Ulring

Response: See response to comment code 6120.

Commenter Name: C.M. Adams Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0545

EPA Comment ID: 19951

EPA Comment Code: 6120

Comment: I am VERY sure that the United States need s very specific regulations on the amount of perchlorate allowed in public drinking water. Strict Regulations.

The American public expect to be protected by the EPA and their government, not subject to policies that make it easy for pollution to remain in their

water and polluters to go unpunished. We need to change jet fuel if it pollutes water sources.

Do not let Americans down by allowing pollution that may cause Thyriod problems to remain in our water. There are at least 5 people i can name who have thryriod issues, many living in our tiny little town that is too small to have a post office.

my husband was diagnosed 2 months ago.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 632 of 1099 This is a VERY serious issue. Do not allow corporati ons to continue as they are, just because it's easy to avoid rocking the boat.

Thank you for your time and attention to this matter.

Response: See response to comment code 6120.

Commenter Name: Kenneth A. Popio Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0547

EPA Comment ID: 19952

EPA Comment Code: 6120

Comment: I think making levels of allowable perchlora te in drinking water is hazardous to public

health.

Kenneth A. Popio

Response: See response to comment code 6120.

Commenter Name: M. O'Brien Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0548

EPA Comment ID: 19953

EPA Comment Code: 6120

Comment: Perchlorate in their drinking water exposes 20 to 40 million Americans to the unnecessary risk of thyroid problems, according to independent analysis. Please see to it that the levels considered allowable are reduced signific antly and monitored. Refusing to regulate the chemical ignores a significant harm to public health.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0549

EPA Comment ID: 19954

EPA Comment Code: 6120

Comment: As a Registered Nurse, I am sickened by the lack of protection of our water supply when it comes to contaminants such as perchlorate. We know, beyond doubt, that there is no safe

limit of this chemical in water. We must demand that our government do what is right and protect unsuspecting citizens from chemicals that are pervasive in our environment.

Response: This is not a comment, a response is not necessary.

Commenter Name: T. C. Washburn Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 633 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0550

EPA Comment ID: 19955

EPA Comment Code: 6120

Comment: As a public health physician and a Pediatrician, I am very concerned about potential hazards of perchlorate in drinking water. There a ppears to be ample evidence of potential thyroid disease in newborns and young children.

Please strongly consider setting a standard for maximal allowable perchlorate levels in drinking

water.

Thank you for your consideration.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0554

EPA Comment ID: 19956

EPA Comment Code: 6120

Comment: please eliminate/ limit perchlorate from our drinking water.

Response: See response to comment code 6120.

Commenter Name: D. Burton Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0555

EPA Comment ID: 19957

EPA Comment Code: 6120

Comment: Please reevaluate your decision on perchlora te residue in drinking water. Our children need protection from a lifetime of such chemicals when possible.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0559

EPA Comment ID: 19958

EPA Comment Code: 6120

Comment: Even if the perchlorate itself posed no apparent harm, which I believe it does, there have been no adequate studies of how iut inter acts with othere chemicals or how sensitive individuals react to it. Additionally, how can the EPA or any group force American citizens to expose themselves to chemicals they believe they should not have in their systems?

Response: This is not a comment, a response is not necessary.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 634 of 1099 Commenter Name: L. Garvey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0571

EPA Comment ID: 19959

EPA Comment Code: 6120

Comment: Nix Perchlorate! Do your job-Protect our wa ter & health! You work for citizens, not industry! Discusted!

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0574

EPA Comment ID: 19960

EPA Comment Code: 6120

Comment: Given a pattern in recent years of the FDA caving in to pressures from an administration that is militantly anitscience (and pro- corporate profits), I do not trust that a relaxing of regulation of perchlorate is in the public's best interest.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0575

EPA Comment ID: 19961

EPA Comment Code: 6120

Comment: It is the mandate of the Environmental Protection Agency to protect U.S. residents from agents in our environment that are, or are potentially, harmful to our health. I thoroughly disagree with the proposal to stop regulating perchlorate in our water supply.

Response: See response to comment code 6120.

Commenter Name: David Myers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0577

EPA Comment ID: 19962

EPA Comment Code: 6120

Comment: Do not compromise the acceptable level of perchorate in drinking water. Drinking water standards should not exceed levels determined safe in your own study of 2002. Keep our

water safe.

Thank you.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 635 of 1099 David Myers

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0579

EPA Comment ID: 19963

EPA Comment Code: 6120

Comment: It is not safe that perchlorate in the drinking water is fit to drink.

Response: See response to comment code 6120.

Commenter Name: Karl J. Volk Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0582

EPA Comment ID: 19965

EPA Comment Code: 6120

Comment: I Karl J.Volk of 43 whittier blvd declare the EPA as not doing its job of protecing me against environmental issues in general and specifi cally against Perchlorate and "allowable " Levels . You are gettingmy Tax dollars andI want you to set limits on the prnicious fuel in the water aquivers. Shame on you God dam it

Karl J.Volk

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0583

EPA Comment ID: 19966

EPA Comment Code: 6120

Comment: Perchlorate is detrimental to human health. In particular, it disturbs thyroid functioning which in turn compromises immune functioning. It has been discovered to be present in the drinking water in at least 35 states. For these reas ons, it must be declared hazardous and regulated.

Response: See response to comment code 6120.

Commenter Name: E.L. Blair Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0584

EPA Comment ID: 19967

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 636 of 1099 Comment: I am writing to express my anger over the plan for the EPA not to regulate perchlorate in drinking water even though it has been found in water in 35 states. What part of Environmental PROTECTION do you not understand?

I would like to see the EPA do what it is mandated to do by regulating perchlorate. This is nothing but a give-away to the weapons-making industries.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0586

EPA Comment ID: 19969

EPA Comment Code: 6120

Comment: Is it not enough that the Senate Environment and Public Works Committee has endorsed legislation requiring the EPA to set a federal standard for perchlorate and to monitor levels of Perchlorate in tap water? The American pub lic deserves to be able to drink their water with confidence that it's safe. If it isn't we may as well move to some third world country where the first question is, "Can I drink the water?" For shame, EPA!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0592

EPA Comment ID: 19970

EPA Comment Code: 6120

Comment: Please stop poisoning the earth and all its inha bitants with your thirst for war profits. Stop building rockets and start saving lives.

Response: This is not a comment, a response is not necessary.

Commenter Name: Mary Sue Penn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0601

EPA Comment ID: 19972

EPA Comment Code: 6120

Comment: Please do not loosen standards for perchlorate. Our tap water is polluted enough! Go

back at least to 2002 standards! We want pure, clean water.

Thank you, Mary Sue Penn

Response: See response to comment code 6120.

Commenter Name: G. GrantEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 637 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0609

EPA Comment ID: 19973

EPA Comment Code: 6120

Comment: I am writing to express my concern regarding the EPA's failure to regulate perchorate, as well as the proposed reference level. The citizens of the USA neeed their health protected from

this toxin in our water. The health of our childre n need this protection. Thyroid disease has become too common and this autoimmune disease affects ones entire health. It is not a simple disease. It is not diaganosed and controlled easily as some seem to think. I request that the EPA take time for a complete and through evaluation, review the ever-changing scientif ic findings permitting the community time to evaluate and comment on the findin gs. Please do not rush a decision, one that could adversily affect the women and children of this great nation.

Response: See response to comment code 6120.

Commenter Name: L. Skipper Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0611

EPA Comment ID: 19974

EPA Comment Code: 6120

Comment: I would like to comment regarding the EPA's failure to regulate perchlorate in the drinking water. It can cause thyroid problems. Five years ago, I was diagnosed as hypothyroid and my life has been ruined since then. The thought of this happening to millions of other people because the government has decided to look the ot her way in safeguarding our drinking water is outrageous! We depend on the EPA to protect the public and require the strongest standards for our drinking water. The public is looking for high stan dards for their drinking water without perchlorate

in it.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0623

EPA Comment ID: 19975

EPA Comment Code: 6120

Comment: Given the nature of the epidemic of thyroi d dysfunction, and the increased health cost of treatment of such dysfunction, it is essential to set new, regulatory levels of Perchlorate in Drinking water to absolute lowest levels, with intention to eliminate sources of additional contamination in an urgent and immediate timely approach to safeguard further risk to public

exposure.

Further, all public schools must be equipped wi th appropriate filters on drinking water taps immediately.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 638 of 1099 Further, all public facilities = hospitals, restaurant s, should be strongly advised to obtain, through
tax relief measures, safe and reliable filters for all tap water sources.

The public has the right to be protected. The cost of prevention far out weighs the cost of

treatment.

Response: See response to comment code 6120.

Commenter Name: Margaret Baco Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0624

EPA Comment ID: 19976

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPAâ €TMs refusal to regulate Perchlorate under the Safe Water Drinking Act (Doc ket ID EPA-HQ-OW-2008-0692):

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Perchlorate is found in drinking water in 35 st ates, and according to the EPAâ€TMs own data, 16 million Americans are at risk of being exposed to th is dangerous chemical. The cost of treating this epidemic of thyroid dysfunction is beyond estimate.

Response: See response to comment code 6120.

Commenter Name: Judith DiBiase Bennis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0631

EPA Comment ID: 19981

EPA Comment Code: 6120

Comment: PLEASE ban perchlorate from our environm ent, especially water resources. The EPA must set very high regulation standards for this ch emical that is poisoning our children, and in my case, grandchildren.

Thank you.

Juidth DiBiase Bennis 32 Summit Pass Medford, NJ 08055

Response: See response to comment code 6120.

Commenter Name: Carole Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0632

EPA Comment ID: 19982

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 639 of 1099 Comment: Do not allow approve or in any way haveperc holate in any waters that we ultimately will

drink

Response: See response to comment code 6120.

Commenter Name: L.A. Coons Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0644

EPA Comment ID: 19986

EPA Comment Code: 6120

Comment: Perchlorate in our drinking water is not safe! Do your job and protect the public. -Lisa

A. Coons

Response: See response to comment code 6120.

Commenter Name: L. Segnitz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0645

EPA Comment ID: 19987

EPA Comment Code: 6120

Comment: as a physician, i ask you to please strongly consider regulating and monitoring perchlorate in tap water. there are significant heal th consequences of ingestion of this chemical. thank you.

Response: See response to comment code 6120.

Commenter Name: K. Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0646

EPA Comment ID: 19988

EPA Comment Code: 6120

Comment: I am appalled that the Environmental Protection Agency (EPA) has formally refused to set a drinking-water standard for perchlorate, a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children.

Response: See response to comment code 6120.

Commenter Name: K. Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0646

EPA Comment ID: 19990

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 640 of 1099 Comment: Under this new standard, more than 16 milli on Americans are exposed to unsafe levels of perchlorate in their drinking water, and indepe ndent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water in 35 states in the U.S. We should be working to protect our water and our environment; the fact that you are even considering raising these levels is unbelievable.

We cannot continue to pollute our tap water. Besides the fact that this is bad for the environment, (the entity that your agency is supposed to protect), this is becoming social justice issue as well.

Response: This is not a comment, a response is not necessary.

Commenter Name: Luis Olmedo Vélez Commenter Organization: omité Cívico del Valle, Inc.

EPA Document ID: EPA-HQ-OW-2008-0692-0652

EPA Comment ID: 19993

EPA Comment Code: 6120

Comment: Luis Olmedo Vélez Executive Director Com ité Cívico del Valle, Inc. 699 E Street Brawley, CA 92227 October 24, 2008

Eric Burneson Office of Ground Water and Drinki ng Water Standards and Risk Management U.S. Environmental Protection Agency

Dear Sir:

We are concerned that the EPA’s failure to regula te perchlorate, as well as its unprotective proposed health reference level, will adversely affect the he alth and development of hundreds of thousands, perhaps millions of American children. In addition, expecting mothers will run the risk of permanently damaging the development of their unborn children. Not only will unborn children be affected, but the elderly population as well. Elderly people with a history of medical conditions will have a difficult time fighting off the effects that perchlorate may have.

Response: See response to comment code 6120.

Commenter Name: Luis Olmedo Vélez Commenter Organization: omité Cívico del Valle, Inc.

EPA Document ID: EPA-HQ-OW-2008-0692-0652

EPA Comment ID: 19994

EPA Comment Code: 6120

Comment: Imperial Valley undergoes several environmental risks: The air is unclean. Pesticides are used regularly where people may come in contact wi th it. EPA’s inability to contain perchlorate will only add to the already unstable environment in the Imperial Valley.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 641 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0159

EPA Comment ID: 20015

EPA Comment Code: 6120

Comment: Please don't let more perchlorate into the drinking water.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #4 - Natu ral Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20016

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I urge you to set a drinking water standard fo r perchlorate that will pr otect pregnant women and babies nationwide. Perchlorate poses a risk for pregnant women, newborns and young children by interfering with thyroid hormone, which is critical for optimal development of the brain and nervous system. Perchlorate is found in drinking water in at least 26 states, and 20-40 million people could be exposed to this chemical.

Several states have set drinking water standards or guidelines for this chemical, but these standards vary widely, so it is critical for the EPA to set a national standard that is based on the best available science and that will protect public health. The EPA's own staff scientists have determined that your decision not to regulate perchlorate places some infants and young children above safe levels of exposure. The EPA's current draft scientific analys is should undergo independent scientific peer review and should be used as the basis for the regulation.

Response: The Agency believes that further review by the National Research Council would unnecessarily delay regulatory decision making for perchlorate. Therefore, EPA is not, at present, planning to request additional NRC review of issues related to perchlorate. Instead, EPA is issued a notice in August of 2009 seeking comments on a br oad range of alternative approaches to the interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking

water.

EPA has determined to regulate perchlorate in dr inking water. See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #4 - Natu ral Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-0687

EPA Comment ID: 20018

EPA Comment Code: 6120

Comment: Again, I urge you to reverse your decision an d to set a national drinking water standard for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 642 of 1099 Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #5 - Clean Water Fund/Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-0689

EPA Comment ID: 20019

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

* perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought;

* a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Additional Facts

* Perchlorate is a harmful chemical used in rocket fuel, flares, and explosives.

* Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism.

* Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

* EPA agrees that perchlorate has been found in 39 5 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Response: See response to comment code 6120.

Commenter Name: Pete McHugh Commenter Organization: Santa Clara County Board of Supervisors

EPA Document ID: EPA-HQ-OW-2008-0692-0681

EPA Comment ID: 20020

EPA Comment Code: 6120

Comment: October 15, 2008

Stephen L. Johnson, Administrator Environmental Protection Agency - Mail Code 2822T 1200 Pennsylvania Avenue, N .W. Washington, D.C. 20460

Re: Docket ID No. EPA-HQ-OW-2008-0692

Dear Mr. Johnson:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 643 of 1099 The Santa Clara County Board of Supervisors does not agree with the preliminary determination of the Environmental Protection Agency (EPA) to no t regulate perchlorate in drinking water at a

national level.

Response: See response to comment code 6120.

Commenter Name: Pete McHugh Commenter Organization: Santa Clara County Board of Supervisors

EPA Document ID: EPA-HQ-OW-2008-0692-0681

EPA Comment ID: 20022

EPA Comment Code: 6120

Comment: In September 2007, the State of California adopted a regulation to establish a maximum contaminant level (MCL) of 6 micrograms per liter for perchlorate in drinking water. However, a national standard is critical to safeguard water supplies throughout the nation and provide a baseline for enforcement by the EPA.

Community health is one of our Board's highest pr iorities. The protection of our residents through an enforceable drinking water standard for perchlorate is of paramount concern. It is for these reasons, the Santa Clara County Board of Supervisor s urges your reconsideration of the need for a national perchlorate standard, and requests the EPA to protect public health by setting a Federal drinking water standard at or below the 6 micr ograms per liter established in California.

Sincerely,

Pete McHugh Chair, Board of Supervisors

c: Santa Clara County Board of Supervisors Peter Kutras, Jr., County Executive Jerry Klepner, BKSH and Associate s Santa Clara County Congressional Delegation

COUNTY GOVERNMENT CENTER 70 WEST HEDDING STREET SAN JOSE,

CALIFORNIA 95110

TEL: (4O8) 299-5030 FAX: (4O8) 298-6637

Response: See response to comment code 6120.

Commenter Name: P. Grieman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0683

EPA Comment ID: 20024

EPA Comment Code: 6120

Comment: I'm responding as an individual, not an organi zation, to say that I am appalled that the EPA is refusing to regulate Perchlorate under th e Safe Water Drinking Act (Docket ID EPA-HQOW-2008-0692).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 644 of 1099 As is recognized in many countries outside the Un ited States, perchlorate is a harmful chemical in rocket fuel that has been linked to thyroid pr oblems in pregnant women, newborns and young children. Perchlorate is found in drinking water in 35 states, and according to the EPA's own data,

16 million Americans are at risk of bein g exposed to this dangerous chemical.

Not regulating this harmful chemical in our drin king water is unacceptable. I urge you to set a standard to protect Americans' health in acco rdance with the Safe Drinking Water Act.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0688

EPA Comment ID: 20025

EPA Comment Code: 6120

Comment: Please regulate Perchlorate

Response: See response to comment code 6120.

Commenter Name: Brittni Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0690

EPA Comment ID: 20026

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Please still regulate this. Thank you!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0691

EPA Comment ID: 20027

EPA Comment Code: 6120

Comment: reverse this decision.

Response: See response to comment code 6120.

Commenter Name: Karen ParmettEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 645 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0693

EPA Comment ID: 20028

EPA Comment Code: 6120

Comment: We must keep rocket fuel and related waste streams out of our public drinking water. Please keep perchlorate out of our drinking water!

yours sincerely,

Karen Parmett 86 Clark St. Belmont MA 02478

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0694

EPA Comment ID: 20029

EPA Comment Code: 6120

Comment: I request that the U.S. Environmental Pro tection Agency set a regulation for perchlorate in drinking water.

I have been concerned for some time about contam ination in our water supply and have researched and now use water purification for my personal home drinking, cooking and bathing

water.Perchlorate is one of the contaminants I am concerned about and try to control in our water supply.

I believe that perchlorate contamination is a nation wide problem and poses a general health risk if not regulated and monitored.

A national primary water regulation should include strict levels of perchlorate contamination that would protect the public health.

Please reconsider any decisions that reduce the control of perchlorate in our water supply.

Response: See response to comment code 6120.

Commenter Name: J. Brundage Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0696

EPA Comment ID: 20030

EPA Comment Code: 6120

Comment: Please regulate perchlorate in water. People drink that stuff!

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 646 of 1099 Commenter Name: Tricia Telesco Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0697

EPA Comment ID: 20031

EPA Comment Code: 6120

Comment: Perchlorate is a very harmful chemical and once ingested, even in minute amounts, will adversely effect the public's health and safety. I strongly urge the EPA reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Tricia Telesco

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0699

EPA Comment ID: 20032

EPA Comment Code: 6120

Comment: Keep perchlorate out of our drinking water

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0700

EPA Comment ID: 20033

EPA Comment Code: 6120

Comment: Please keep our drinking safe beyond any common sense doubt and regulate perchlorates.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0701

EPA Comment ID: 20034

EPA Comment Code: 6120

Comment: How can the EPA not want to regulate perchl orate? That's a rhetorical question - it's pretty blatantly clear someone is being paid off, again.

Whoever is making these decisions needs to go, so that the EPA can do its job. I for one will support any effort by the EPA employees to oust the corrupt political appointees killing us for

money.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 647 of 1099 Response: See response to comment code 6120.

Commenter Name: L.S. Johnson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0705

EPA Comment ID: 20035

EPA Comment Code: 6120

Comment: Please reverse your preliminary determinati on on setting a regulation for perchlorate in drinking water. Perchlorate shou ld be regulated. Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0708

EPA Comment ID: 20036

EPA Comment Code: 6120

Comment: Please regulate perchlorate. It can damage a person's thyroid gland. We have enough medical expenses in this country.

Response: See response to comment code 6120.

Commenter Name: Carol Klingsmith Commenter Organization: Workout for Wellness

EPA Document ID: EPA-HQ-OW-2008-0692-0709

EPA Comment ID: 20037

EPA Comment Code: 6120

Comment: I feel it is imperative to keep our drinking water clean and safe. Please no Perchlorate in

the water.

Response: See response to comment code 6120.

Commenter Name: S. Strohmeyer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0710

EPA Comment ID: 20038

EPA Comment Code: 6120

Comment: Why are you even considering this? Our government should be here to defend us from outside danger, but this is just one more way to hurt our people and our beautiful country. The EPA is supposed to protect us from harm not kill us from the inside.

Response: See response to comment code 6120.

Commenter Name: M. FioriniEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 648 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0712

EPA Comment ID: 20039

EPA Comment Code: 6120

Comment: Perchlorate, at any level, should not be a llowed into our drinking water. It is a shame that you have to hold a public response to determine that we should not be drinking perchlorate.

There are many scientific reports that determine perchlorate is unsafe to drink and one does not

have to be a rocket scientist to know that rocket fu el is bad for humans and is also bad for all other living creatures. It should not be allowed in our dr inking water, regardless of the cost of removal. I know the government has spent more money on less worthwhile causes.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0715

EPA Comment ID: 20040

EPA Comment Code: 6120

Comment: I urge the Environmental Protection agency to do whatever it can to protect the drinking water supply in this country. It remains a highly vulnerable resource, critical to the health and well being of our entire population. Please work to regulate the effects of perchlorate in the water supply.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0717

EPA Comment ID: 20041

EPA Comment Code: 6120

Comment: It is imperative that the EPA regulate perchlorate (an ingredient of rocket fuel) and insist that it be kept ou t of our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0721

EPA Comment ID: 20042

EPA Comment Code: 6120

Comment: Perchlorate is Poison. Vote NO on Dock et ID: EPA-HQ-OW-2008-0692 Drinking Water: Preliminary Regulatory Determination on Perc hlorate Would you want to drink or bathe in

this?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 649 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0722

EPA Comment ID: 20043

EPA Comment Code: 6120

Comment: please do not allow perchlorate in the drinki ng water. If I wanted that in my water I would go out and get it. Try to keep our drinki ng water as pure as possible. Thank you from

someone who drinks a lot of water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0725

EPA Comment ID: 20044

EPA Comment Code: 6120

Comment: Please reconsider your position on perchola te, and set standards for it exclusion from drinking water.

Response: See response to comment code 6120.

Commenter Name: J. Rosalia Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0726

EPA Comment ID: 20045

EPA Comment Code: 6120

Comment: Keep PERCHLORATE OUT of the water. It is INSANE to even consider allowing it

in.

Response: See response to comment code 6120.

Commenter Name: Molly Lindner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0732

EPA Comment ID: 20046

EPA Comment Code: 6120

Comment: The drinking water in my locale, North Ca nton, Ohio, is still not drinkable, in my opinion, without filtering because it has chlorine in it and smells, tastes awful. Please regulate

Perchlorate and order local water control officers to purge this chemical from our drinking water.

Thank you.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 650 of 1099 Dr. Molly Lindner

Response: See response to comment code 6120.

Commenter Name: Luis Olmedo VÃ©lez
Commenter Organization: ComitÃ© CÃvico del Valle, Inc., Center for Health Education,
Prevention and Advocacy

EPA Document ID: EPA-HQ-OW-2008-0692-0736

EPA Comment ID: 20047

EPA Comment Code: 6120

Comment: Mr. Burneson, Tell EPA to extend the time comment period to 90 days. Thank you.

Luis Olmedo VÃ©lez Executive Director ComitÃ© CÃvico del Valle, Inc. 699 E Street Brawley,

CA 92227 October 24, 2008

Eric Burneson Office of Ground Water and Drinki ng Water Standards and Risk Management U.S. Environmental Protection Agency

Dear Sir:

We are concerned that the EPAâ€TMs failure to re gulate perchlorate, as well as its unprotective proposed health reference level, will adversely a ffect the health and development of hundreds of thousands, perhaps millions of American children. In addition, expecting mothers will run the risk of permanently damaging the development of their unborn children. Not only will unborn children be affected, but the elderly population as well. Elde rly people with a history of medical conditions will have a difficult time fighting off the effects that perchlorate may have.

Imperial Valley undergoes several environmental ri sks: The air is unclean. Pesticides are used regularly where people may come in contact with it. EPAâ€TMs inability to contain perchlorate will only add to the already unstable environment in the Imperial Valley.

Response: EPA announced on October 10, 2008, its preliminary regulatory determination that a national primary drinking water regulation for perchlorate would not present "a meaningful opportunity for health risk reduction for persons serv ed by public water systems." In response to requests from several stakeholde rs, EPA reopened the public comment period for an additional 15 days. Regarding EPA's determination to regulate perchlorate in drinking water, See response to

comment code 6120.

Commenter Name: D. Kaufer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0738

EPA Comment ID: 20049

EPA Comment Code: 6120

Comment: Please do not allow percholate in our drinking waterEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 651 of 1099 Response: See response to comment code 6120.

Commenter Name: G. Hansen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0741

EPA Comment ID: 20050

EPA Comment Code: 6120

Comment: The U.S. Environmental Protection Agency should reverse its preliminary determination on setting a regulation for perchlorate in drinking water.

There is no reason this country should allow these types of chemicals in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0744

EPA Comment ID: 20051

EPA Comment Code: 6120

Comment: Hello, It has come to my attention that th e EPA has made a preliminary decision NOT to regulate perchlorate, a rocket fuel, with resp ect to contamination of drinking water. Considering both the divergent and grave effects to humans upon exposure to this chemical as well as recent studies showing that the chemical is dangerous at lower levels than previous thought, it is outrageous that the EPA would make such a poor decision. Please reconsider in favor of regulating perchlorate for the sake of our health and especially the he alth of our babies and developing fetuses.

Response: See response to comment code 6120.

Commenter Name: K. Minissale Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0746

EPA Comment ID: 20052

EPA Comment Code: 6120

Comment: Even though percholate is only found to affect a very small percentage of the population (by geographical location), a national health standard should be set in light of the fact that all people, even minority groups, deserve pro tection of their basic health condidtions and that having a national standard in place can only benefit others in the future should greater affected areas

be discovered.

Response: See response to comment code 6120.

Commenter Name: R. Cubberly Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0747

EPA Comment ID: 20053EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 652 of 1099 EPA Comment Code: 6120

Comment: Keep Perchlorate out of our drinking wa ter!! Please reverse your decision!

Response: See response to comment code 6120.

Commenter Name: V. Hollen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0748

EPA Comment ID: 20054

EPA Comment Code: 6120

Comment: I urge the EPA to reverse its preliminar y determination on setting a regulation for perchlorate in drinking water. It has several potenti al health consequences: impaired thyroid gland, child developmental impairment including mental reta rdation, deficits in motor skills... Please be the clarion to declare the the US government is going to protect its citizens from contaminated water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0749

EPA Comment ID: 20055

EPA Comment Code: 6120

Comment: Water is our most precious resource. I think the EPA needs to rethink its decision and start better protecting our water supply by regula ting the amount of percholate in our drinking water. We should all be comfortable drinking fr om the tap in our homes, not constantly worrying about what contaminate has now found its way into our wells and water supplies. No one trusts the water as can be seen by the rise in purchasing of bottled water. It's your job to keep our water safe.

Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought. A national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 6120.

Commenter Name: J. Traweek Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0752

EPA Comment ID: 20057

EPA Comment Code: 6120

Comment: We are very concerned that the EPA will not be exercising its regulatory authority and the statutory purpose for its existence if the EPA does not take the needed steps to safeguard America's water quality by regulating the contaminat ion of our water with perchlorate. Thank you

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 653 of 1099 Commenter Name: K. McDonald Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0754

EPA Comment ID: 20058

EPA Comment Code: 6120

Comment: I strongly urge this agency to reconsider it 's decision to allow unlimited polution of our drinking water supplies with Perchlorate. Remember yo u and your family is drinking this water too.

Response: See response to comment code 6120.

Commenter Name: Raymon A. Baldoni Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0755

EPA Comment ID: 20059

EPA Comment Code: 6120

Comment: I have survery several dozen people in my neighberhood and 100% are against the EPA's tentative decision not to regulate perchlorate in drinking water. This decision is not in the best interests of the public and appears to be complete fiscally motivated. Our health and the health of our children is not negotiable and should not be relaxed to "reasonable care" standards. The EPA needs to be aggressive in setting all air and water standards to a best practice standard and deamnd funding to enable the agressive enforcement of these standards.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0757

EPA Comment ID: 20060

EPA Comment Code: 6120

Comment: I URGE YOU TO RECONSIDER YOUR DECISION NOT TO REGULATE

PERCHLORATE IN DRINKING WATER. I AM CONCERNED ABOUT THE HEALTH
IMPACTS, PARTICULARLY ON INFANTS A ND CHILDREN. PLEASE TAKE ACTION TO

PROTECT OUR WATERS AND THE PUBLIC HEALTH. THANK YOU.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0761

EPA Comment ID: 20061

EPA Comment Code: 6120

Comment: ALL chemicals that can get into our drinking water should be monitored and regulated. I am curious as to why you would NOT monitor and regulate such things.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 654 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0762

EPA Comment ID: 20062

EPA Comment Code: 6120

Comment: Please continue to regulate Perchlorate and all the chemicals which may be harmful in our drinking water. I urge you to reve rse your preliminary decision on this.

Response: Perchlorate is not regulated in drinking water. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0767

EPA Comment ID: 20063

EPA Comment Code: 6120

Comment: You must work to regulate rocket fuel in ou r drinking water. This is not optional, we need all the safeguards in place to make sure our safe drinking water, which is becoming ever more precious and scarce, remains so. It could be improved in so many ways, but certainly this is an easy one to regulate. Thank you!

Response: See response to comment code 6120.

Commenter Name: G. E. Andrews Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0769

EPA Comment ID: 20064

EPA Comment Code: 6120

Comment: Perchlorate in our drinking water is unaccepta ble. We need your leadership to make the right decision immediately to protect human health.

Response: See response to comment code 6120.

Commenter Name: Roger N. Carlsten Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0770

EPA Comment ID: 20065

EPA Comment Code: 6120

Comment: I strongly urged the EPA to take any action necessary to eliminate percholates from our national drinking water. Not just because I already suffer from hypothyroidism, but how it adversely affects all citizens, especially developing fetuses and young children.

Sincerely,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 655 of 1099 Roger N. Carlsten, D.D.S.

Response: See response to comment code 6120.

Commenter Name: Anita Burns Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0771

EPA Comment ID: 20066

EPA Comment Code: 6120

Comment: What is it that makes you think I want to have water with this chemical in it! There

should be criminal action taken to those that dis posed this chemical into the water system & they should have to pay to clean up this mess!. Our health is more important than letting this chemical stay in the water. I am strongly opposed to having this chemical in the water!!!!! Perchlorate is a harmful chemical used in rocket fuel, flares, and explosives. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills. Anita Burns ...bosburns@wowway.com

Response: See response to comment code 6120.

Commenter Name: H. Passas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0772

EPA Comment ID: 20067

EPA Comment Code: 6120

Comment: I wish to urge the EPA to reconsider the preliminary decision not to regulate perchlorate in drinking water. This is a harm ful substance that can damage the thyroid, thus affecting growth, development and metabolism at mi nute exposure levels, especially in babies in small children. Perchlorate has already been found in the drinking water consumed by millions of US citizens. I think it is unconscionable for the government agency that has the obligation to protect

the environment which sustains us all to fail in it s task of regulating dangerous substances!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0774

EPA Comment ID: 20068

EPA Comment Code: 6120

Comment: Please protect our health and well-being through the regulation of perchlorate in drinking water. It is a lethal contaminant not fo r consumption. Your responsibility is to protect the environment, not damage it and its inhabitants.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 656 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0776

EPA Comment ID: 20069

EPA Comment Code: 6120

Comment: It is the responsibility of the EPA to regula te perchlorate in drinking water. I urge you, the U.S. Environmental Protection Agency, to reve rse your preliminary determination on setting a regulation for perchlorate in drinking water . Here are a few facts on perchlorate:

* perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought;

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0776

EPA Comment ID: 20071

EPA Comment Code: 6120

Comment: I know perchlorate is found in drinking wa ter and drinking water source areas because I

worked on the assessment and remediation of contam inated and potentially contaminated properties in New England that had perchlorate. The people of the US depend on you to protect their drinking water. You must take the lead in establishing and enforcing a drinking water perchlorate regulation.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0778

EPA Comment ID: 20076

EPA Comment Code: 6120

Comment: Keep perchlorate out of our drinking water supply.

Response: See response to comment code 6120.

Commenter Name: Richard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0780

EPA Comment ID: 20077

EPA Comment Code: 6120

Comment: The regulation or perchlorates in drinking water should be established as soon as possible. this harmful chemical poses a threat to humans and should be dealt with accordingly..EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 657 of 1099 thank you. Richard

Response: See response to comment code 6120.

Commenter Name: Linda D. Hrushanyk Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0782

EPA Comment ID: 20078

EPA Comment Code: 6120

Comment: After reading some of the facts on perchlor ate and the potential health problems the chemical can cause, don't you think regulating the amount of perchlorate would prevent some health problems?

linda d. hrushanyk

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0783

EPA Comment ID: 20079

EPA Comment Code: 6120

Comment: Keep ariplane fuel out of our water, perchlor ate does not belong in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0784

EPA Comment ID: 20080

EPA Comment Code: 6120

Comment: Please do not lower the standards for clean water. As a member of the public I would prefer my drinking water to be free of rocket fuel. Thank you

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0785

EPA Comment ID: 20081

EPA Comment Code: 6120

Comment: Please regulate perchlorate in drinking water. I am sure the science exis ts to filter it so

we should use it.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 658 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0787

EPA Comment ID: 20082

EPA Comment Code: 6120

Comment: Regulate Perchlorate in our drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0788

EPA Comment ID: 20083

EPA Comment Code: 6120

Comment: Perchlorate has leaked into our water supplie s everywhere, though particularly in the western and southwestern United States. It has turned up in our lettuce!

Ingredients of rocket fuel do not belong in our wa ter. And if our tap water isn't clean, we're paving the way for the privatization of water, which means only the rich people will have water and the rest of us will have to fight each other for it.

Keep the water clean and get perchlorate out of our water. This one's a no- brainer.

Response: See response to comment code 6120.

Commenter Name: Mary Green Commenter Organization: Eleventh Street Family Health Service Center

EPA Document ID: EPA-HQ-OW-2008-0692-0789

EPA Comment ID: 20084

EPA Comment Code: 6120

Comment: q-OW-2008-0068To: Councilman Curtis J. Jones 4th District Room 404 Phila. PA

19107

In regard to contamination of our water and the water regulations please support identified as Water regulations Docket ID No. EPA- HQ-OW-2008-0068. The EPA will ma ke final determinations on this health advisory for percholorate of contaminat ion into our water supply and the regulation of it. Please consider looking inot this. thank you. Mary Green MSN, RN . Eleventh Street Family Health

Service Center 850 11th Street Phila. PA 1912 3 Attachments [see PDF of Docket ID EPA-HQOW-2008-0692-0789]

EPA-HQ-OW-2008-0692-0789.1 Comme nt attachment submitted by Curtis J. Jones, Philadelphia City CouncilEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 659 of 1099 Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0790

EPA Comment ID: 20085

EPA Comment Code: 6120

Comment: We don't need rocket fuel in our drinking water. If you are planni ng to join Bush and company on a remote island after looting the treasury, you might think that you're safe from it, but you're not. And if you're an alcoholic that denies being in a water-based environment, clear your thinking for a moment and figure out that everythin g that you eat has water in it. Tap water, for the most part. No, even living on bottled water won't g et you away from perchlorate, as most plastic bottles have perchlorate in them. It won't do anyone good to relax rules that are there to protect all of us. Just don't change the rules!

Response: See response to comment code 6120.

Commenter Name: L. Thorp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0791

EPA Comment ID: 20086

EPA Comment Code: 6120

Comment: Please regulate Perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0792

EPA Comment ID: 20087

EPA Comment Code: 6120

Comment: Please make sure that the standard for drinki ng water in the USA is one that does not allow for perchlorate. Thank you

Response: See response to comment code 6120.

Commenter Name: C. Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0798

EPA Comment ID: 20088

EPA Comment Code: 6120

Comment: There is no reason or excuse not to regulate Pe rchlorate that affects our drinking water.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 660 of 1099 Commenter Name: Pamela Love Koepf Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0801

EPA Comment ID: 20089

EPA Comment Code: 6120

Comment: Please do not allow our water to be unregulated for Perchlorate. We need any and all help to monitor all innappropriate invasives in our drinking and open water supply. If you guys don't do it, who will? Please reverse this important decision for the sake of all of us!

Pamela Love Koepf Bellevue, WA

Response: See response to comment code 6120.

Commenter Name: C. P. Gabelman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0804

EPA Comment ID: 20090

EPA Comment Code: 6120

Comment: I believe the mandate of the EPA is to pr otect our nation's citizens - not our nation's corporations. So please, get out of political mo de and get back into protection mode and start carrying out your mandate to provide a safe environment for me, my children, my grandchildren and beyond. Perchlorate has no business being in our drinking water supply. Please quit waiting for a crisis to develop before you have the backbone to do your job.

Response: See response to comment code 6120.

Commenter Name: C. Springer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0805

EPA Comment ID: 20091

EPA Comment Code: 6120

Comment: We don't know how to do it. We trust that drinking water and water that is home to aquatic animals will be protected from rocket fuel. thank you for your work.

Response: See response to comment code 6120.

Commenter Name: Tana Moore Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0807

EPA Comment ID: 20092

EPA Comment Code: 6120

Comment: To the U.S. Environmental Protection Ag ency - please reverse your preliminary determination on regulating perchlorate in drinking water. This is a substance known to causeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 661 of 1099 thyroid damage. The public and wildlife need protection from such substances in our water. Thank

you.

Tana Moore 21472 Wallace Drive Southfield MI 48075

Response: Please See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0811

EPA Comment ID: 20093

EPA Comment Code: 6120

Comment: No Perchlorate in the drinking water, please!

Response: See response to comment code 6120.

Commenter Name: R. Stevenson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0812

EPA Comment ID: 20094

EPA Comment Code: 6120

Comment: Please don't let our drinking water be cont aminated by Perchlorate. Clean water is becoming more and more rare and you are risking th e future by allowing this chemical to enter our lakes and streams. Please ask yourself if you wo uld be okay with letting your children or grand

children consume water or fish in a stream with Pe rchlorate in it. Thank you for your consideration

in this matter.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0813

EPA Comment ID: 20095

EPA Comment Code: 6120

Comment: Please regulate perchlorate. It's meant for rockets not people.

Response: See response to comment code 6120.

Commenter Name: D. and A. M. Wahl Edwards Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0816

EPA Comment ID: 20096

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 662 of 1099 Comment: Keep perchlorate out of our water supply vi a regulation. Please protect our future by protecting the fetuses carried in our mothers' wombs.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0819

EPA Comment ID: 20097

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. We need to maintain good quality drinking water and regulate poisons such as this. Please continue to regulate this poison for

the welfare of US citizens.

Response: Perchlorate is not regulated in drinking water. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0822

EPA Comment ID: 20098

EPA Comment Code: 6120

Comment: Please regulate amounts of perchlorate in America's drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0823

EPA Comment ID: 20099

EPA Comment Code: 6120

Comment: There is no reason to believe perchlorate is harmless.Since there is more evidence it is

harmful to our health does it not make sense for the EPA to be proactive in regulating it rather than risking our health? Scientific studies that are without influence of any industry need to become the standard so that your agency can function with so me degree of integrity.The US was once a leader in

environmental issues and we need to get back to that level.

Response: See response to comment code 6120.

Commenter Name: Adam Nation Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0825

EPA Comment ID: 20100

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 663 of 1099 Comment: Dear Sir/Madam:

It has come to my attention that the EPA, unde r the leadership of President Bush, has refused to regulate the presence of perchlorate in American drinking water. I urge the Agency to reconsider

this decision. Perchlorate is a chemical that has been linked to numerous deleterious health effects in humans (and other animals)-- including serious changes in the thyroid gland, and a potential impact on cognition and normal fetal development.

For these reasons, I urge the EPA to regulate perchlorate very strictly.

Cordially,

Adam Nation Pittsburgh, PA

Response: See response to comment code 6120.

Commenter Name: Dina C. Greenway Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0827

EPA Comment ID: 20101

EPA Comment Code: 6120

Comment: As we look hopefully toward a new attitude about our environment, we look to the EPA to set sound policy. Father Bush is waving go odbye. And the American people look forward to greater ease as you work to protect our health an d give a second chance to an environment now on life support.

Let your first act be to reverse to research and regulate for PERCHLORATE in our drinking water.

I thank you, and do a landslide majority of your constituents.

:) :) :) :) dina

Response: See response to comment code 6120.

Commenter Name: D. Toolanen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0828

EPA Comment ID: 20102

EPA Comment Code: 6120

Comment: Please forbid any perchlorates to enter any water systems. The costs and suffering of it are carried by the innocent victims, people, anim als, insects, birds, whose physiology will be negatively impacted by these unnatural and toxic chemicals.

Response: See response to comment code 6120.

Commenter Name: Nikki BlackEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 664 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0829

EPA Comment ID: 20103

EPA Comment Code: 6120

Comment: Every day I seem to hear about friends and loved ones dealing with often fatal illnesses or struggling with conditions that come from our po lluted environment. It is extremely disturbing to read that perchlorate, found in studies to impair the thyroid gland as well as the development of infants, has been found in our drinking water and the epa is not requiring that it be eliminated. How can we not protect something so essential as drinking water and make it as pure as possible? I firmly believe the epa should do whatever is possible to eliminate the existence of perchlorate in our drinking water.

Nikki black michigan

Response: See response to comment code 6120.

Commenter Name: L.W. DeLap Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0830

EPA Comment ID: 20104

EPA Comment Code: 6120

Comment: The evidence is clear that perchlorate is toxic. Contamination is widespread. Federal regulation of the level of perchlorate in public drinking water is needed to protect the US population.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0831

EPA Comment ID: 20105

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to rise above the political machinations surrounding this issue and reverse its preliminary determination on setting a regulation for perchlorate in drinking water. It is important that the American public can rely on the EPA making decisions based solely on scientifically dete rmined health risks rather than on potential risks to special interest groups.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0833

EPA Comment ID: 20106

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 665 of 1099 Comment: We want clean safe drinking water s houldn't that be obvious, don't you?

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0838

EPA Comment ID: 20107

EPA Comment Code: 6120

Comment: Please control percholorate in drinking water- humans are part of the environment and we too need protection. We already have had thyr oid cancer in our household, and since this chemical attacks the thyroid, we do not want to again deal with this issue.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0841

EPA Comment ID: 20109

EPA Comment Code: 6120

Comment: Any and all contaniments must be regulated in our public drinking water, no matter how

small the threat.

Response: See response to comment code 6120.

Commenter Name: Anne Hall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0847

EPA Comment ID: 20110

EPA Comment Code: 6120

Comment: Keep perchlorate out of our drinking water! Its a dangerous chemical and all Americans deserve to at least trust that the major substance that we all need to stay alive is safe to drink! It is ridiculous to even call yourselves the "Environmen tal Protection" Agency if this is the kind of contamination you would consider allowing.

I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Sincerely, Anne Hall Austin, TX

Response: See response to comment code 6120.

Commenter Name: Marjorie Curtiss Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0850

EPA Comment ID: 20111EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 666 of 1099 EPA Comment Code: 6120

Comment: To Whom This May Concern;

In my opinion this is "everyones" concern!

Please do not relax any regulations on drinking water safety, ever. Do we really have to keep bringing topics like this to the attention of the Federal Government? This is a "no brainer" fella's...YOU are the EPA! Sincerely, Marjorie Curtiss

Response: EPA is not "relaxing any regulations on drinking water saf ety," rather EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: S. Spencer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0852

EPA Comment ID: 20112

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. We must be able to provide clean, safe water to Americans and perchlorate contamination is a serious issue. Please take the responsible action and reverse this decision.

Response: See response to comment code 6120.

Commenter Name: Susan Luberto Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0853

EPA Comment ID: 20113

EPA Comment Code: 6120

Comment: I feel we have to protect our drinking water from any problems that could harm us now and later in life, please follow up and check on th e Perchorate that is in the water to make sure it does not stay there.

Thank you.Susan Luberto

Response: See response to comment code 6120.

Commenter Name: L. Thorp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0858

EPA Comment ID: 20114

EPA Comment Code: 6120

Comment: Please no perchlorate in the water. What will be allowed next?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 667 of 1099 Response: See response to comment code 6120.

Commenter Name: Kathleen Abke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0861

EPA Comment ID: 20115

EPA Comment Code: 6120

Comment: I believe it is a mistake to not regulate perchlorate in our drinking water. Please reverse your decision.

Kathleen Abke Grosse Pointe Woods, MI

Response: See response to comment code 6120.

Commenter Name: T. Harris Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0862

EPA Comment ID: 20116

EPA Comment Code: 6120

Comment: I urge the EPA to reverse its decision not to regulate perchlorate in drinking water supplies. This is a nasty chemical that I certainly do not want in my water, regardless of the impacts such legislation might have on industry. People's he alth should always come before any economic implications.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0864

EPA Comment ID: 20117

EPA Comment Code: 6120

Comment: Nobody wants rocket fuel in their drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0867

EPA Comment ID: 20118

EPA Comment Code: 6120

Comment: This should be an easy decision; do you wa nt your grandchildren drinking water tainted with perchlorate? Do you think anyone in this country wants that? I can only think that the makers of perchlorate would not object to such a contaminat ion but in someone else's water, not their own.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 668 of 1099 Since you should be concerned with the public's health it is confusing that you would even consider such a thing.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0871

EPA Comment ID: 20119

EPA Comment Code: 6120

Comment: please do not allow perchlorate in drinking water

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0873

EPA Comment ID: 20120

EPA Comment Code: 6120

Comment: I urge the U. S. Environmental Protection Agency to reverse its peliminary detemintion on setting a regulation for perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Commenter Organization: Bethlehem Area School District

EPA Document ID: EPA-HQ-OW-2008-0692-0874

EPA Comment ID: 20121

EPA Comment Code: 6120

Comment: Why is this even an issue? If perchlorate is used in jet fuel...it does NOT belong in our drinking water. Let's just clean up our act regarding water instead of adding more chemicals to it to kill whatever is in there already! Water should not be an issue as far as priority. Please get it cleaned up the correct way. (Floride is next...it was used to k ill rats...and it's in many water systems, ugh!!!)

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0875

EPA Comment ID: 20122

EPA Comment Code: 6120

Comment: To Whom it May Concern,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 669 of 1099 Please reverse your preliminary determination in rega rd to regulating perchlorate in drinking water. Even small amounts can affect our public health and th at of our children. Please take your role as a protector of our environment seriously.

LL Franklin, MA

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0876

EPA Comment ID: 20123

EPA Comment Code: 6120

Comment: I am not from a government agency or an official representative. But what I do represent is my family and most importantly, my children. Our drinking water needs to be safe for the American people and considering to not regula te possible contaminants such as perchlorate is very detrimental to all of our health and well being. Please reconsider this docket and do not pass it. We need our drinking water regulated.

Thank You.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0877

EPA Comment ID: 20124

EPA Comment Code: 6120

Comment: No rocket fuel in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0879

EPA Comment ID: 20125

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: C. H. Lynt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0880EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 670 of 1099 EPA Comment ID: 20126

EPA Comment Code: 6120

Comment: As an Engineer with an advanced degree, and an attorney, I am hereby urging the EPA (U.S. Environmental Protection Agency) to reve rse its preliminary decision not to regulate perchlorate in drinking water.

My reasons include the following:

It is well established that perchlorate contam ination is a nationwide problem. Perchlorate contamination has been shown (citations omitted) to have health effects at lower levels than previously understood.

A nationwide standard for primary drinking wa ter regulation would provide an important and meaningful opportunity to protect the public health.

Perchlorate is a harmful chemical used, for exam ple, in rocket fuel, flares, and explosives.

In small amounts, perchlorate can impair the thyroid gland, which regulates growth, development

and metabolism.

It is well known that developing fetuses, infant s and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

The EPA has evidence that perchlorate has been found in at least 395 sites in 37 states, including 153 public water systems serving over 20 million people. Many reliable estimates suggest an even

wider contamination.

This is an important public health issue that needs to be addressed in a responsible manner.

Response: Please see the response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0881

EPA Comment ID: 20127

EPA Comment Code: 6120

Comment: No Perchlorate in our drinking water. If ther e aren't already enough worries about what is already allowed in our drinking water, why this too?

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0882

EPA Comment ID: 20128

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 671 of 1099 Comment: Please reverse your decision. We do NOT wa nt perchlorate in our drinking water! It needs to be regulated.

Response: See response to comment code 6120.

Commenter Name: Elizabeth A. Carapico Commenter Organization: Arrowroot Natural Foods, LLP

EPA Document ID: EPA-HQ-OW-2008-0692-0888

EPA Comment ID: 20129

EPA Comment Code: 6120

Comment: To the EPA Personnel:

Your very name indicates your obligation to pro tect the environment and the vegetation and animal life (including people) depend ent on that environment.

Knowingly allowing a dangerous contaminant into the water supply is paramount to putting it there with your own hand; and thus the dangerous ramn ifications are on your shoulders personally.

Anything that has a negative effect should be regulated to the nth degree.

Perchlorate falls into this catagory.

I urge you to keep perchlora te out of our drinking water.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Shanoah LaPatka Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0894

EPA Comment ID: 20130

EPA Comment Code: 6120

Comment: Explain to me why perchlorate is not bein g regulated. It should be banned. Anything that is not naturally found in water should not be added to it. With all the facts how can you even be questioning it. Because of the added expense to remove it or not put it there at all? We can't live

without clean water! This is a no brainer!

Thank you, Shanoah LaPatka

Response: See response to comment code 6120.

Commenter Name: Elise Roman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0895EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 672 of 1099 EPA Comment ID: 20131

EPA Comment Code: 6120

Comment: It is important to do everything possible to provide to keep our drinking water clear of Perchlorate. It is outrageous to think that any levels would be acceptable for consumption by anyone, let alone the sick, elderly, young an d those with compromised immune systems.

This is a nationwide problem that needs to be addre ssed. It is more costly to deal with the adverse affects of Perchlorate in our drinking water th an to deal with health effects on our general populations.

Please regulate and ban this substance from our drinking water.

Elise Roman

Response: See response to comment code 6120.

Commenter Name: P. Nardizzi Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0899

EPA Comment ID: 20132

EPA Comment Code: 6120

Comment: Protection Agency to reverse its preliminar y determination on setting a regulation for perchlorate in drinking water. Committee for peop le who don;t want to die. Bring back the

American Indian

Response: See response to comment code 6120. The Americ an Indian is outside the scope of this

notice.

Commenter Name: James Gambucci Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0903

EPA Comment ID: 20133

EPA Comment Code: 6120

Comment: Hello.

Please keep Perchlorate out of our water!!

Thank you.

-James Gambucci

Response: See response to comment code 6120.

Commenter Name: John Porzondek Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 673 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0904

EPA Comment ID: 20134

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Nothing should be in water except WATER.

Please stop it for our children's and future's sake.

Thank you, John Porzondek 790 Lake Street Saugatuck, MI 49453-9435

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0910

EPA Comment ID: 20135

EPA Comment Code: 6120

Comment: Please keep poison out of the water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0913

EPA Comment ID: 20136

EPA Comment Code: 6120

Comment: a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0914

EPA Comment ID: 20137

EPA Comment Code: 6120

Comment: I support regulations and legislation that keep s perchlorate out of our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 674 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-0915

EPA Comment ID: 20138

EPA Comment Code: 6120

Comment: No perchlorate in our water!!! None!

Response: See response to comment code 6120.

Commenter Name: Jeffrey Ramsey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0920

EPA Comment ID: 20139

EPA Comment Code: 6120

Comment: I urge the US EPA to reconsider its posit ion on the regulation of perchchlorate in drinking water. This is a nationwide problem. Perc hchlorate-contaminated drinking water has been found to to have negative health impacts at lo wer levels than previously recorded, particularly affecting the thyroid gland of developing fet uses, infants and children. Our children deserve protection through regulation of this hazardous contaminant.

Please reverse your decision concerning perchchlorate regulation.

Kind regards, Jeffrey Ramsey 3315 He idelberg Drive Boulder, CO 80305

Response: See response to comment code 6120.

Commenter Name: G. MacCallum Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0923

EPA Comment ID: 20140

EPA Comment Code: 6120

Comment: You are insane to consider this. Fresh, clean water, so deeply necessary to all life, must be protected. Consideration of "acceptable" levels of any one chemical cannot exclude conscious study of how the myriad of other toxins and pharmaceuticals flowing into our environment in combination impact human life.

Response: See response to comment code 6120.

Commenter Name: Alex Milbank Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0924

EPA Comment ID: 20141

EPA Comment Code: 6120

Comment: Perchlorate is dangerous and should not be allowed in drinking water supplies. Please reverse your decision and protect humans and the en vironment. Thank you for your consideration.

Alex MilbankEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 675 of 1099 Response: See response to comment code 6120.

Commenter Name: Sarah Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0925

EPA Comment ID: 20142

EPA Comment Code: 6120

Comment: I don't want rocket fuel in my drinking wa ter. Please reverse your decision and regulate water for perchlorate. It is very harmful to human health and should not be in our drinking water.

Thank you,

Sarah Smith citizen Belmont, MA

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0929

EPA Comment ID: 20143

EPA Comment Code: 6120

Comment: If the government is aware of the presence of a potentially harmful contaminant in drinking water, it is their obligation to monitor it , study the health effects and fully understand the threat to the best of its ability. To do ot herwise, such as ignoring it, is negligent.

Please regulate perchlorate.

Response: See response to comment code 6120.

Commenter Name: M. Doyle Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0932

EPA Comment ID: 20144

EPA Comment Code: 6120

Comment: I do not understand why the EPA would allow anything in our drinking water that is not supposed to be there even if there is not â€ ̃â€ ̃a meaningful opportunity for health risk reduction for persons served by public water system s.â€TMâ€TM Please regulate the water so that we are not drinking Perchlorate!

Response: See response to comment code 6120.

Commenter Name: W. Petry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0933EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 676 of 1099 EPA Comment ID: 20145

EPA Comment Code: 6120

Comment: Plaese continue to regulate perchl orates in our drinking water.

Response: EPA does not currently regulate perchlor ate in drinking water; however, EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: E. Ralph Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0934

EPA Comment ID: 20146

EPA Comment Code: 6120

Comment: We should not have perchlorate in our drinking water. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought. The last months of a presidency is not the time to be rushing through controversial regulation.

Response: See response to comment code 6120.

Commenter Name: Roberta Masters-Cullen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0936

EPA Comment ID: 20147

EPA Comment Code: 6120

Comment: Dear Sir/Madam,

I strongly urge you to remember the envir onmental PROTECTION part of your agency's philosophy and ask you to please regulate perchlorate in our drinking water. Your department was founded to protect us - please don't let an ingredient that's used in rocket fuel go unregulated in our drinking water.

Roberta Masters-Cullen Alexandria, Virginia

Response: See response to comment code 6120.

Commenter Name: D. Fahrmann Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0938

EPA Comment ID: 20149

EPA Comment Code: 6120

Comment: As with all chemicals in the water...you know it will affect animals and humans in a negative way. You don't need to spend millions to figure it out -just attack the problem in any way you can to reduce the levels of the chemical.

At a minimum, the EPA needs to regulate Perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 677 of 1099 Response: See response to comment code 6120.

Commenter Name: W. Calvert Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0941

EPA Comment ID: 20150

EPA Comment Code: 6120

Comment: Dear EPA,

Please control the amount of perchlorate in our drinking water. This substance is harmful to human health. Not only is it your duty to do this , it is the morally correct thing to do.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0942

EPA Comment ID: 20151

EPA Comment Code: 6120

Comment: Please keep drinking water clean for everyone

Response: This is not a comment, no response is needed.

Commenter Name: Elizabeth Saunders Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0943

EPA Comment ID: 20152

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Ag ency to regulate perchlorate in drinking water. The preliminary determination to refrain from setting such a regulation is irresponsible.

Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought. As someone with an impair ed thyroid gland I do not like considering the possibility that my drinking water might at any time contain a chemical known to cause thyroid damage. I hate to think (not that I will ever know) that this might be the cause, or that drinking contaminated water would worsen my health.

To ignore this problem and avoid setting a stan dard for perchlorate in drinking water is inappropriate. We citizens count on our government agencies to protect our water and our health and this is one example of where that is necessary.

Please reverse the determination.

Sincerely, Elizabeth Saunders Dorchester, MA 02122EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 678 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0945

EPA Comment ID: 20153

EPA Comment Code: 6120

Comment: I am writing to urge the EPA to please regu late perchlorate in our drinking water. I type medical reports for an Oncology Center. Cancer ra tes are skyrocketing in this country. We don't

need another contaminant to make the situation worse.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0948

EPA Comment ID: 20154

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: G. Breese Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0949

EPA Comment ID: 20155

EPA Comment Code: 6120

Comment: It is vitally important to the health and saf ety of all Americans, particularly children and developing fetuses, that the EPA reverse its findin g and regulate perchlorate to keep it out of our drinking water! Such chemicals in our daily drinki ng water can do more long and short term damage than any terrorist could ever hope to do. Please reverse your decisions and keep Americans strong and healthy -- don't contribute to weakening our country just to save a few dollars. Thank you.

Response: See response to comment code 6120.

Commenter Name: M. Roberts Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0951

EPA Comment ID: 20156

EPA Comment Code: 6120

Comment: Please DO regulate the perchlorate in drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 679 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0952

EPA Comment ID: 20157

EPA Comment Code: 6120

Comment: Perchlorate needs to be regulated.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0954

EPA Comment ID: 20158

EPA Comment Code: 6120

Comment: We need to keep our water clean! I hope you will reverse this decision and regulate this

chemical.

Response: See response to comment code 6120.

Commenter Name: Jerise Fogel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0957

EPA Comment ID: 20159

EPA Comment Code: 6120

Comment: What is the EPA for, if not to regulate i tems such as this? I have no idea why adding Perchlorate to the list of regulated chemicals that should not be added to drinking water would be a sticking point for my Environmental Protecti on Agency, unless some large producer(s) of Perchlorate who habitually let them leach into ou r drinking water is/are paying someone off.

EPA, please do your job. Regulate Perchlorate!

Sincerely,

Jerise Fogel

Response: See response to comment code 6120.

Commenter Name: Angela Christman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0960

EPA Comment ID: 20160

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 680 of 1099 Comment: Reverse this decision!! This is a bad decision which is bad for the environment and for

our health! Reverse it now!

Angela Christman Catonsville, MD 21228

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0964

EPA Comment ID: 20161

EPA Comment Code: 6120

Comment: How can anyone imagine any amount of perchl orate is tolerable or safe in drinking water? It must also be banned in water for irrigation of crops and for animals. This chemical is toxic,
toxic, toxic!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0965

EPA Comment ID: 20162

EPA Comment Code: 6120

Comment: Reverse your finding and regulate perchlorate in drinking water!!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0967

EPA Comment ID: 20163

EPA Comment Code: 6120

Comment: Please ban Perchlorate from drinking water!! Nobody wants to drink that, just so the companies who produced it have an easier way of getting rid of it!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0970

EPA Comment ID: 20164

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 681 of 1099 Comment: I URGE THE U.S. ENVIRONMENTAL PROTECTION AGENCY TO REVERSE

ITS PRELIMINARY DETERMINATION ON SETTING A REGULATION FOR

PERCHLORATE IN DRINKING WATER.

Response: See response to comment code 6120.

Commenter Name: Philip Katz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0971

EPA Comment ID: 20165

EPA Comment Code: 6120

Comment: I am a strong supporter of regulations main taining clean air and water. Therefore I ask that you regulate the amount of percholate in our water supply. I ask that you make the level as scientifically possible.

Thank you,

Philip Katz Citizen 37 Kensington Ave. We st Newton, Ma 02465 philkatz@rcn.com

Response: See response to comment code 6120.

Commenter Name: Kristin Flora Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0973

EPA Comment ID: 20166

EPA Comment Code: 6120

Comment: Please regulate Percholarate in our water. We know that certain levels of this chemical have been found to be harmful. Why would you want to intentionally ignore the levels of this

harmful chemical in the water that we drink? Please reconsider your decision concerning the regulation of this harmful checmical.

Kristin Flora South Riding, VA

Response: See response to comment code 6120.

Commenter Name: S. Picciuca Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0976

EPA Comment ID: 20167

EPA Comment Code: 6120

Comment: Water uncontaminated is the right of all liv ing beings on this planet.Our security begins with safe water and nothing supercedes it.Please do your duty.

Response: This is not a comment, a response is not necessary.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 682 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0977

EPA Comment ID: 20168

EPA Comment Code: 6120

Comment: Why on earth would you allow Perchlorate in my drinking water? This is not acceptable.

Please fix this!

Response: See response to comment code 6120.

Commenter Name: J. V. Blargan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0983

EPA Comment ID: 20169

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. In California, perchlorate contamination in the groundwater has literally poisoned wells, and now it's okay, somehow?

Studies are already showing health impacts at lower levels than previously imagined and threatens of water supply. We need a national primary drinking water regulation to protect public health.

Bisphenol-A and Perchlorate are in a class of endo crine disrupters that impair the thyroid gland, which controls growth, metabolism, and development, especially in fetuses, infants and children.

EPA agrees that perchlorate has been found in 39 5 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0984

EPA Comment ID: 20170

EPA Comment Code: 6120

Comment: I can't believe there would even be a questi on as to whether or not to regulate the amount of perchlorate in water. What could possibly be a plausible reason? For the sake of children
alone, this should be a no-brainer. The fact that th ere is even a question is frankly disgusting to me. Our government at work looking ou t for our best interest, obviousl y. I hope no one at the EPA has a pregnant wife or children gulping down the cont aminated water. Do what's right, no matter what the cost!! We are talking about people's health here!

Response: See response to comment code 6120.

Commenter Name: B. SteinmetzEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 683 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0991

EPA Comment ID: 20171

EPA Comment Code: 6120

Comment: Please. I urge the U.S. Environmental Pr otection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Nothing is more important than public heath.

Response: See response to comment code 6120.

Commenter Name: Richard Lee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0994

EPA Comment ID: 20172

EPA Comment Code: 6120

Comment: I can't believe that anyone actually has to write to express their concern against not regulation a poison in our drinking water. What is going on here? Please reverse this reckless and devastating decision before more people are poisoned.

Thank you for your consideration. Richard Lee, Berkley, MI

Response: See response to comment code 6120.

Commenter Name: D. Edwards Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0995

EPA Comment ID: 20173

EPA Comment Code: 6120

Comment: EPA must regulate Perchlorate in drinking water ! It is too dangerous for public health.

Response: See response to comment code 6120.

Commenter Name: T. Coutinho Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0998

EPA Comment ID: 20174

EPA Comment Code: 6120

Comment: Our water must be protected..

..........................

Response: This is not a comment, a response is not necessary.

Commenter Name: L. C. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1000EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 684 of 1099 EPA Comment ID: 20175

EPA Comment Code: 6120

Comment: I urge the EPA to reconsider their decision not to regulate perchlorates in the drinking

water.

Perchlorates can have a negative effect on the thyroid gland which impacts the development and growth of born and unborn children. We need to protect our drinking water and our health.

Thank you. L.C.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1004

EPA Comment ID: 20176

EPA Comment Code: 6120

Comment: Please, NO rocket fuel allowed in the water!!!!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1005

EPA Comment ID: 20177

EPA Comment Code: 6120

Comment: As a citizen and a volunteer leader for the Boy Scouts of America, this just doesn't sound right to me. I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Water is the essence of life on Earth, let's keep it clean!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1011

EPA Comment ID: 20178

EPA Comment Code: 6120

Comment: take the rocket fuel out of our fuckin drinking water

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 685 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1013

EPA Comment ID: 20179

EPA Comment Code: 6120

Comment: I urge the EPA to carefully examine the health effects of any level of Perchlorate in the nation's drinking water.

Response: See response to comment code 6120.

Commenter Name: P. & T. Lyon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1014

EPA Comment ID: 20180

EPA Comment Code: 6120

Comment: PLEASE regulate perchlorate contaimination in drinking water. We are deeply disappointed in this administration's conserva tion and environmental record AND WE VOTED FOR YOU. At the least, our government needs to address the qualiity of water and protect future generations. The damage in the last century in th e Great Lakes is now dama ge forever and becoming acceptable. IT IS NOT ACCEPTABLE.

I HATE MORE REGULATIONS BUT REGULALTE PERCHLORATE. The job of the federal government is to protect our nation, do it.

Response: See response to comment code 6120.

Commenter Name: Miguel A. Diaz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1015

EPA Comment ID: 20181

EPA Comment Code: 6120

Comment: This is a request to ask you, to please K eep perchlorate out of our drinking water.

Thank you,

Miguel A. Diaz

Response: See response to comment code 6120.

Commenter Name: Ed Olmstead Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1016

EPA Comment ID: 20182

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 686 of 1099 Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water perchlorate contamination is a nationwide problem.

I do not, nor do I know if anyone can prvoe beyond a thin shadow of a doubt that perchlorate is harmful to life. However, when it comes to public good and the health of the country the fact that perchlorate is likely to be harmful in ways we know and don't know at this time is more than enough evidence to regulate this contaminant.

The job of the EPA is to protect the environm ent. The job the EPA is not to protect the corporations and the obscene corporate profits and practices that have led this country into a disastorous position financially and politically. I str ongly urge you to work for the public good and give up the policies of the last eight years of pro tecting military/industrial complex at the expense of the US citizenry. A effective military does not have to be maintained at the expense of poisoning our own people. Do the right thing and regulate this poison in the environment.

Ed Olmstead 43 Stilson Ave Florence, MA 01062

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1018

EPA Comment ID: 20183

EPA Comment Code: 6120

Comment: The EPA is becomming a spot on this na tions system. Instead of protecting the eniroment, they're safeguarding ways to further pollute our waters. When is this madness going to stop?

Response: This is not a comment, a response is not necessary.

Commenter Name: L. M. Maloney Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1021

EPA Comment ID: 20184

EPA Comment Code: 6120

Comment: I am not an organization. I am a mother and grandmother. I don't want my grandchildren drinking perchlorate. It is essent ial that the EPA maintain standards for drinking water that will protect our next generation from th e kind of disasters we see happening in China. Can we preserve an environment fit for our children? Yes we can!

Response: See response to comment code 6120.

Commenter Name: Richard R. Quick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1028EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 687 of 1099 EPA Comment ID: 20185

EPA Comment Code: 6120

Comment: I support the regulation of perchlorate in dr inking water. It should have happened a long time ago and the agencies responsible for allowing it into the water supply should have been stopped and disciplined a long time ago.

Why would anyone want the by products or components of rocket fuels in their water?

Richard R. Quick 15150 Warwick Detroit, Mi 48223

Response: See response to comment code 6120.

Commenter Name: Beth Robelia Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1033

EPA Comment ID: 20187

EPA Comment Code: 6120

Comment: To whom it may concern:

Your decision not to regulate perchlorate is irre sponsible and will have tragic consequences for pregnant women and young children.

The 153 public water systems that are affected by th is contamination will impact the lives of over 20 million people.

Please reconsider your decision. None of us would want to leave this sort of contamination for our children. I am sure none of the EPA personnel involv ed would want their children or grandchildren drinking water contaminated with perchlorate and you should not pretend that it would be OK for "other people."

Thank you for reconsidering your decision,

Beth Robelia, Ph.D.

Response: See response to comment code 6120.

Commenter Name: S. Randolph Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1034

EPA Comment ID: 20188

EPA Comment Code: 6120

Comment: I understand that the U.S. EPA issued a preliminary determination not to regulate perchlorate in drinking water. I urge you to reverse this determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 688 of 1099 The health risks particularly to the thyroid gland of children of even small amounts of perchlorate are severe enough to demand regulation.

Perchlorate contamination is not a rare event bu t has been found to be a nationwide problem.

Given the adverse health impacts of even lower levels than previously found problematic, it is essential that this contaminate be regulated to protect the public's health.

Response: See response to comment code 6120.

Commenter Name: P. Turner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1036

EPA Comment ID: 20189

EPA Comment Code: 6120

Comment: NO PERCHLORATE in PUBLIC WATER ! ! !

How many ways can you spell poison?

Response: See response to comment code 6120.

Commenter Name: Anne Felosak Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1038

EPA Comment ID: 20190

EPA Comment Code: 6120

Comment: To those responsible for keeping our dr inking water as healthy and free from contaminants as possible: I strongly urge you to reconsider letting any chemicals be given a pass as safe in our drinking water and even in the environm ent. We have to be more careful than ever about upsetting the balances in nature. Please keep our water as pure as possible. Anne Felosak

Response: See response to comment code 6120.

Commenter Name: S. Denmark Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1039

EPA Comment ID: 20191

EPA Comment Code: 6120

Comment: I am a private citizen and urge you to revers e the decision to not regulate perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Sara Dovre Wudali Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 689 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1047

EPA Comment ID: 20192

EPA Comment Code: 6120

Comment: Hi,

I am concerned about perchlorate in drinking water. I would like to have faith that my tap water is as clean as we can make it. I'm worried about the potential health problems and growth problems linked to percholorate. Please consider regulating it.

Thanks, Sara Dovre Wudali St. Paul, MN

Response: See response to comment code 6120.

Commenter Name: Katie Giddings Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1051

EPA Comment ID: 20193

EPA Comment Code: 6120

Comment: My family and I drink tap water rather th an bottled water because of the harmful environmental effects of plastic bottles and the wasted energy of shipping water in bottles. Please do not endanger our health by allowing poisons in to our precious drinking water. I ask the EPA to regulate perchlorate in drinking water, along with any other substances that can cause harm and might be found in our water. The Environmental Protection Agency needs to begin living up to its name again rather than being the ag ency to eliminate needed protections.

Thank you.

Katie Giddings 27 Turner St #2, Salem MA

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1052

EPA Comment ID: 20194

EPA Comment Code: 6120

Comment: no no no! what is the matter with you people? do your job please, which is to protect me, not put me at risk.

thank you

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 690 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1054

EPA Comment ID: 20195

EPA Comment Code: 6120

Comment: Dear EPA:

I've been working with communities over the past eight years to reduce pollutants in stormwater as required by Phase II of the Clean Water Act. Countless hours and dollars later, communities are making headway in cleaning up our surface waters. My region of the county gets its drinking water from the Detroit River, where I'm sure the industri al history of the area has deposited perchlorate into the Detroit River. Please join communities in protecting our water resources and regulate this dangerous chemical in our drinking water. You have required communities to minimize pollutants in our lakes and streams. Now please do your part in continuing our progress in protecting our drinking water.

Thank you.

Response: See response to comment code 6120.

Commenter Name: D. Knutson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1055

EPA Comment ID: 20196

EPA Comment Code: 6120

Comment: Keep perchlorate out of drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1057

EPA Comment ID: 20197

EPA Comment Code: 6120

Comment: To the decision makers at the EPA:

Perchlorate laced drinking water. Would YOU drink this? Would you let your KIDS drink this? PLEASE: DO YOUR JOB. If Bush prohibits you from doing it, please make HIM drink this.

Thanks.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1061

EPA Comment ID: 20198

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 691 of 1099 Comment: Please don't allow Perchlorate in our Drinking Water: Preliminary Regulatory

Determination on Perchlorate

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1065

EPA Comment ID: 20199

EPA Comment Code: 6120

Comment: I am writing to urge you to regulate the allowable limits of perchlorate in this nation's drinking water. With many safety questions still outstanding, this is a necessary step not only to protect the public health, but also to bolster public confidence in the ability of government regulators to take a stand against the interests of industry and act first in the best interest of the citizens of this country. Thank you.

Response: See response to comment code 6120.

Commenter Name: Fran Sugarman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1066

EPA Comment ID: 20200

EPA Comment Code: 6120

Comment: We are very concerned by the recently announced decision of the EPA to not regulate perchlorate in our drinking water. Perchlorate is an extremely harmful chemical used in rocket flares and explosives. We do not want to see our children exposed to this contaminant.

In the spirit of our new President- please listen to our concerns -and what parents want and reverse your decision.

Sincerely Fran Sugarman

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1067

EPA Comment ID: 20202

EPA Comment Code: 6120

Comment: May you suffer from the toxins which you permit in our drinking water.

Response: See response to comment code 6120.

Commenter Name: B. McCollumEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 692 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1068

EPA Comment ID: 20203

EPA Comment Code: 6120

Comment: The U.S. Environmental Protection Agency should reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Isn't this what your mission is about-- To protect the public and the environment from harmful contamination and pollution? Perchlorate contamination is a national problem and has severe health impacts that affect us all, especially the most vulnerable among us.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1072

EPA Comment ID: 20204

EPA Comment Code: 6120

Comment: What is the thinking here? Please act i mmediately and regulate Perchlorate in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Peggy Rinard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1075

EPA Comment ID: 20206

EPA Comment Code: 6120

Comment: Please reverse the EPA decision not to regulate perchlorate in drinking water.

Peggy Rinard 4469 Evergreen Drive St. Paul, MN 55127

Response: See response to comment code 6120.

Commenter Name: Patrick L. Doss-Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1076

EPA Comment ID: 20207

EPA Comment Code: 6120

Comment: To whom it may concern,

Please reconsider the EPA's preliminary determination concerning regulation of Perchlorate levels in our drinking water. I am particularly concerne d about potential damage to the thyroid in a developing fetus. As you may know, damage duri ng development can lead to serious problems such as retardation, loss of hearing, etc. These sorts of issues are devastating to the individuals affectedEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 693 of 1099 and costly to our society. We must not let short term profits harm the long term health and well being of the ecosystem and subsequently, us. We need stronger regulation of Perchlorate.

Respectfully,

Patrick L. Doss-Smith

Response: See response to comment code 6120.

Commenter Name: B Seng Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1080

EPA Comment ID: 20208

EPA Comment Code: 6120

Comment: Please take action to regulate perchlorate in drinking water. At the very least you must have programs in place to measure the amounts in public drinking water systems so that consumers can know whether or not they are pr otected. This action will also spur water filter manufacturers to come up with solutions for consumers.

Response: See response to comment code 6120.

Commenter Name: B Ferguson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1081

EPA Comment ID: 20209

EPA Comment Code: 6120

Comment: Keep rocket fuel out of our drinki ng water. Reverse this decision.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1082

EPA Comment ID: 20210

EPA Comment Code: 6120

Comment: When are you going to stop killing us? We need drinkable water. Why are you doing

this?

Response: This is not a comment, no response necessary.

Commenter Name: James W. Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1083

EPA Comment ID: 20211

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 694 of 1099 Comment: We must not allow Perchlorate in our water. This chemical is harmful and must be regulated from all water used by our citizens. Thank you.

Sincerely, James W. Smith 821 Heritage Point Chesapeake, VA 23322

Response: See response to comment code 6120.

Commenter Name: E Paulson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1087

EPA Comment ID: 20212

EPA Comment Code: 6120

Comment: Please regulate the amount of perchlorate in our drinking water. It is harmful to the thyroid, the thyroid effects not only our metabolism, but our heart. My cousin a middle aged man of 52 has a heart which is only functining at 25%, because of damaged sustained from a dysfunctioning thyroid. The thyroid damage and heart damage has affected his life and family. Perchlorate is a highly reactive compound and considering the other organic chemical componds in our water, what other products will they be forming which will be effecting our bodies? Please reconsider and regulate this compond in our water. Thank you.

Response: See response to comment code 6120.

Commenter Name: E.E. Jumikis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1090

EPA Comment ID: 20213

EPA Comment Code: 6120

Comment: The recent decision by the Environmental Protection Agency not to issue standards for perchlorate in drinking water is a profligate flight from its regulatory responsibility. As a victim of oral cancer which has fried my thryroid, I am very sensitive to the effects of perchlorate on thyroid function and development. I understand how a lack of prescience can lead to disastrous consequences. As our children proliferate mental afflictions like ADHD, autism and other mental impairments, EPA must not abandon its responsib ility to regulate perchlorate and other proven harmful chemicals in our drinking water.

Response: See response to comment code 6120.

Commenter Name: John Ganapes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1093

EPA Comment ID: 20214

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 695 of 1099 Comment: I am writing to urge you to limit levels of Perchlorate in our drinking water to extremely low numbers. As a parent I am concerned about th e health of my children and will not tolerate any

risk to them at all.

John Ganapes Minneapolis MN 55407

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1095

EPA Comment ID: 20215

EPA Comment Code: 6120

Comment: EPA agrees that perchlorate has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. Thus perchlorate contamination is a na tionwide problem--and has health impacts at lower levels than previously thought.

Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development, and metabolism. Developing fetuses, infants, and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech, or deficits in motor skills.

As a mother and as an American, I urge the U. S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. This is not the time to take an unwarranted, dangerous step away from the mission of the Environmental Protection Agency to safeguard our citizens, young an d old, from harmful containments in one of our country's most critical resources.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1096

EPA Comment ID: 20216

EPA Comment Code: 6120

Comment: SInce we say we care about our environment, lets do what we say and take action to deal with this toxin before it gets too late.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1097

EPA Comment ID: 20217

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 696 of 1099 Comment: This is a request for the U.S. EPA to reverse its preliminary decision not to regulate perchlorate in drinking water. Perchlorate can impa ir the thyroid gland and cause significant health
risks to fetuses, infants and children. Perchlorate has been found in numerous water sources in the U.S. and the EPA should do its job and protect the public from such contamination.

Response: See response to comment code 6120.

Commenter Name: M. Hoover Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1098

EPA Comment ID: 20218

EPA Comment Code: 6120

Comment: Please reverse your preliminary determinati on regarding regulations for perchlorate in drinking water.

Perchlorate contamination is a problem across the country. It negatively impacts our health at lower levels that thought previously - with possible impair ment to the thyroid. Of special concern is the impact on healthy thyroid function in fetuses, in fants and children. Possible negative outcomes include mental retardation, hearing, speech and motor deficits.

Perchlorate contamination has been found in hundreds of sites, more than 35 states and over a 150 public water systems.

Regulation by the EPA provides a necessary mechanism to protect our health.

Response: See response to comment code 6120.

Commenter Name: Chris Jones Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1100

EPA Comment ID: 20219

EPA Comment Code: 6120

Comment: We do not want Perchlorate in our drinking water. If ground water has potential to be

contaminated with Perchlorates then we need it monitored and evaluated.

Thank you Chris Jones

Response: See response to comment code 6120.

Commenter Name: H. Kitrosser Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1104

EPA Comment ID: 20220

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 697 of 1099 Comment: I am against your preliminary decision not to regulate perchlorate in drinking water. Please reconsider and keep our drinking water safe.

Response: See response to comment code 6120.

Commenter Name: Solo Greene Commenter Organization: Nez Perce Tribe

EPA Document ID: EPA-HQ-OW-2008-0692-1106

EPA Comment ID: 20221

EPA Comment Code: 6120

Comment: Water is one of the most sacred things to Native Americans, and without clean, quality water, we as a people aren't going to be here very much longer. The animals, birds, fish, vegetation and natural resources are already suffering because of contaminated water, and we don't need any more of it entering our water ways, especially when we can avoid it. Please do not allow this to happen.

Response: See response to comment code 6120.

Commenter Name: J. Blakeley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1110

EPA Comment ID: 20222

EPA Comment Code: 6120

Comment: Let's keep this pollutent out of our water!

Response: See response to comment code 6120.

Commenter Name: L.A. and S. Warner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1115

EPA Comment ID: 20223

EPA Comment Code: 6120

Comment: Perchlorate does not belong in water, and it should be a right of every American to have drinking water free of chemical contamination. My family is suffering from autoimmune issues. We notice more and more people who are dealing with chronic health issues and strongly believe that our country's loose use of synthetic products co uld be to blame. Keeping perchlorate out of drinking water is a no brainer. Why don't we start here!

Response: See response to comment code 6120.

Commenter Name: M.A. Baier Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1116

EPA Comment ID: 20224

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 698 of 1099 Comment: no perchlorate in the drinking water/ regulate rocket fuel

Response: See response to comment code 6120.

Commenter Name: George Hasapidis Commenter Organization: Cumberland Grange

EPA Document ID: EPA-HQ-OW-2008-0692-1120

EPA Comment ID: 20225

EPA Comment Code: 6120

Comment: Please protect humans and other animals from the harm that drinking perchlorate does. This is a known toxin, and it is the EPA's responsibility to protect us from it.

Response: See response to comment code 6120.

Commenter Name: J. Fredrick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1121

EPA Comment ID: 20226

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

I live in Michigan and believe that perchlorate is in my drinking water. I have a thyroid problem that I suffer with for the last 2 1/2 years. I have no insurance and have to pay for specialist and perscriptions out of pocket.

Is your purpose in Washington to help save our viable drinking resources and the citizen's with which you represent?!

Response: See response to comment code 6120.

Commenter Name: Laurie Dixon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1123

EPA Comment ID: 20227

EPA Comment Code: 6120

Comment: To whom it may concern,

It is crucial to my family as well as everyone I know that every measure be taken to protect our groundwater.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 699 of 1099 Living in Michigan, we have watched for deca des upon decades as our environment has been decimated with toxic pollutiion. Everyone in this area lives near a "superfund" site.

This is a huge issue for citizens, probably more than any government agency realizes. Cancer has become a plague in southeast Michigan.

Please do everything possible, setting up whatever measures are needed to stop the contamination our water supply.

Sincerely, Laurie Dixon

Response: See response to comment code 6120.

Commenter Name: Renee Kaiser-Muelken Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1124

EPA Comment ID: 20228

EPA Comment Code: 6120

Comment: I strongly encourage the U.S. Environm ental Protection Agency to reverse its preliminary determination on setting a regula tion for perchlorate in drinking water.

The EPA knows that perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought, and that a national primary drinking water regulation would provide a meaningful opportunity to protect public health. And we must be responsible to protect the most vulnerable in our society, the children - our future.

Thank you, Renee Kaiser-Muelken

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1125

EPA Comment ID: 20229

EPA Comment Code: 6120

Comment: The EPA must stop now the Bush administ ration's poisoning of our water, our environment, our lives. I am sure the appointed polit ical leaders of the EPA can make a last gasp effort to enrich corporate leaders and others w ho benefit financially if the EPA allows percholate and other poisons in our water, but it will be a s hortlived decision, and we will remember for a long time those who tried to slip one by us on their wa y out the door. For those of you who might allow this to happen, goodbye and good riddance.

Response: See response to comment code 6120.

Commenter Name: J. DreifusEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 700 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1127

EPA Comment ID: 20230

EPA Comment Code: 6120

Comment: I think the EPA needs to reverse its position on regulating perchlorate. How can it not regulate this chemical?

Response: See response to comment code 6120.

Commenter Name: S. Eckes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1128

EPA Comment ID: 20231

EPA Comment Code: 6120

Comment: Please, no perchlorate in drinking water.

Thanks.

Response: See response to comment code 6120.

Commenter Name: Phillip Lamoureux Commenter Organization: Michigan State University

EPA Document ID: EPA-HQ-OW-2008-0692-1129

EPA Comment ID: 20232

EPA Comment Code: 6120

Comment: Please regulate perchlorate levels in drinki ng water, and work to prevent groundwater perchlorate contamination from industrial and government sources. We need very low, safe standards for this pollutant.

Sincerely, Phillip Lamoureux Biochemist and Cell Biologist Michigan State University

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0655

EPA Comment ID: 20233

EPA Comment Code: 6120

Comment: As a pediatrician, I think it is unwise to increase the allowed amount of perchlorate in the drinking water. The fetus and he growing child ar e more sensitive to toxins than adults and need protecting.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 701 of 1099 Commenter Name: T.J. Blair Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0656

EPA Comment ID: 20234

EPA Comment Code: 6120

Comment: It defies logic and common sense to dump toxic rocket fuel into or near drinking water sources. This practice will be especially harmful to people living near military bases. I urge you to
SUPPORT OUR TROUPS, our children and others by NOT approving this regulation.

Thomas J. Blair 592 W. 2nd St. Winston-Salem, NC 27101

Response: EPA is not dumping toxic rocket fuel into or near water sources. Rather, EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: Lynn Nadeau Commenter Organization: HealthLink

EPA Document ID: EPA-HQ-OW-2008-0692-0657

EPA Comment ID: 20235

EPA Comment Code: 6120

Comment: Rocket fuel has no place in drinking water. Incidence of cancer rises as we allow our environment to be degraded. Please, EPA, protect us! Live up to your title!

Here in Massachusetts, we are well aware of the high rates of breast cancer on Cape Cod as well as the elevated amount of perchlorate in the water near the military base.

Response: See response to comment code 6120.

Commenter Name: Robin Mark Freeman Commenter Organization: Merritt College

EPA Document ID: EPA-HQ-OW-2008-0692-0662

EPA Comment ID: 20236

EPA Comment Code: 6120

Comment: Eric Burneson Office of Ground Water an d Drinking Water Standards and Risk Management U.S. Environmental Protection Agency

Dear Sir:

We the undersigned are concerned that EPA's fa ilure to regulate perchlorate, as well as its unprotective proposed health reference level, will adversely affect the health and development of hundreds of thousands, perhaps millions of Amer ican children. It has taken EPA years, with its
extensive resources, to come to its conclusions. Its findings are complex and controversial. We

cannot afford to have this decision rushed out the door, in the waning days of the current administration, without giving impacted co mmunities sufficient time to comment.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 702 of 1099 Commenter Name: L. L. Schumacher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0664

EPA Comment ID: 20238

EPA Comment Code: 6120

Comment: Oct. 8, 2008

Leonard L. Schumacher 16516 De nise Dr. Austin, Texas 78717

U .S. Environmental Protection Agency Attn: St eve Johnson, EPA Administrator Arei1 Rios Building 1200 Pennsylvania Ave. N .W. Washington, DC 20460 Dear Mr. Johnson,

I have read recently about the toxic rocket fuel ingredient (perchlorate) that has been found in public water supplies at 395 sites in 35 states, and that the EPA does not intend to rid it from the

water.

The levels found are high enough to affect thyroid function and pose developmental health risks, particularly for babies and fetuses acco rding to some scientists. Great!!!

Combine this toxin with all the other pesticides, insecticides, and the other many dangerous toxins and chemicals in our food supply, no wonder people are getting cancer.

Response: This is not a comment, a response is not necessary.

Commenter Name: B. Raimondo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0666

EPA Comment ID: 20240

EPA Comment Code: 6120

Comment: STop!!!! Perchlorate in the drinking water!!!

Response: See response to comment code 6120.

Commenter Name: Tatjana and Jeremy Thomas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0669

EPA Comment ID: 20241

EPA Comment Code: 6120

Comment: Can't believe this has been going on for years. Is rocket fuel more important than human life? Of course we will just take some drugs to cover up the symptoms and keep doing what we are doing best, COVER UP THE BAD STUFF! God Bless America.

Response: This is not a comment, a response is not necessary.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 703 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0671

EPA Comment ID: 20244

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPAâ €TMs refusal to regulate Perchlorate under the Safe Water Drinking Act (Doc ket ID EPA-HQ-OW-2008-0692):

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. The adverse effects of Perchlorate have not been extensively investigated. We do not know the full range of damage that this toxic chemical is having on our environment or our people. Nor have scientist looked at the synergistic effects of this poison, in combination with the thousands of other toxic substances known to be contaminating our drinking water. Not regulating this harmful chemical in our drinking water is unacceptable.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0671

EPA Comment ID: 20246

EPA Comment Code: 6120

Comment: How many more people must die or be severe ly impaired before EPA takes it's job of protecting the environment and the people of this country seriously. These harmful chemicals are poisons. Too many have already been harmed. It a ppears to those of us, who've been harmed by

toxic chemicals that the EPA has sold our lives an d health away to special interests and chemical companies. Too many people have already been ha rmed. It appears to those of us, who've been harmed by environmental and consumer by-product toxins that the EPA has sold our lives and health away to special interests and chemical companies. How is this any different than slave trafficking or child prostitution? Your failure to protect us indicates a wanton disregard for our lives!

I urge you to protect the environment, these current generations and the future generations of our country, in accordance with the Safe Drinking Water Act and protect all our health. Stop selling us

out!

Response: See response to comment code 6120.

Commenter Name: P. Morello Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0674

EPA Comment ID: 20247

EPA Comment Code: 6120

Comment: You MUST regualte perchlorate under the Safe water Drinking Act...please.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 704 of 1099 This chemical is found in rocket fuel & is a big safety issue for the public & our environment. It is a very dangerous chemical. What is wrong with you th at you are NOT outlawing this chemical to be found in America's drinking water?

Response: See response to comment code 6120.

Commenter Name: Judy F. Rosenblith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0675

EPA Comment ID: 20248

EPA Comment Code: 6120

Comment: As a retired Professor whose specialty wa s child development and whose research involved newborns, I am particularly shocked by any lowering of standards for perchlorate that should be tightened. The effects on pregnant wome n and newborns are particularly important in informing my views. Please reconsider the current proposal.

Sincerely, Judy F. Rosenblith Prof. Emerita, Whe aton College (MA) judyrosenblith@earthlink.net

Response: See response to comment code 6120.

Commenter Name: D. Manzullo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0676

EPA Comment ID: 20249

EPA Comment Code: 6120

Comment: How amazing that the health concerns of US Citizens continues to be put on the back burner by the Agencies that are supposed to be protecting us.

With tens of thousands of Thyroid Cancers diag nosed every year, how can we not be more proactive in protecting our youth from u nnecessary expense and health risks?

Response: This is not a comment, a response is not needed.

Commenter Name: Lisa Hampton Commenter Organization: Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0677

EPA Comment ID: 20251

EPA Comment Code: 6120

Comment: No perchlorate in my drinking water! This decision is harmful to public health, and the EPA's refusal to to set a drinking-water standard for perchlorate is deplorable. As you know, perchlorate has been linked to thyroid problems in pregnant women, newborns and young children. As someone who suffers from thyroid problems, exhaustion which stopped my life for the 13 years it took me to figure out what was going on, I ca n personally attest to how serious thyroid problems

can be.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 705 of 1099 Response: See response to comment code 6120.

Commenter Name: Lisa Hampton Commenter Organization: Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-0677

EPA Comment ID: 20252

EPA Comment Code: 6120

Comment: The Senate Environment and Public Works Committee has endorsed legislation requiring the EPA to set a federal standard for perc hlorate and to monitor levels of the chemical in tap water. This I heartily support. We need to reduce the maximum safe levels for perchlorate as opposed to allowing them to be 15 times higher than they were in 2002.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0678

EPA Comment ID: 20253

EPA Comment Code: 6120

Comment: I feel the stricter the standard on perchlora te levels in drinking water, the better. There is no ambiguity in the science that tells us that pe rchlorate is extremely harmful to the health of humans, especially to children.

Response: See response to comment code 6120.

Commenter Name: S. Smolen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0679

EPA Comment ID: 20254

EPA Comment Code: 6120

Comment: Dear Sir,

I am writing to you in response to the EPA's pre liminary descision not to set a national maximum contaminant level for perchlorate (Docket ID # EPA-HQ- OW-2008-0068). I am a former resident of the San Gabriel Valley, California, and US ci tizen whose family was exposed to contaminated groundwater containing perchlorate for a significant length of time. I was exposed to perchlorate at elevated levels through drinking water and also now suffer Hashimoto’s thyroid disease. Following discovery of the profound levels of contaminatio n in the San Gabriel Valley, I have been very discouraged and disappointed in the apparent la ck of concern for residents whose health has potentially been affected by long-term, historic, contamination. I appreciate the efforts that have since been made to clean up the toxins and to pr otect the drinking water of current residents, but that does nothing for residents that have already been exposed. In addition, I now reside in a state that does not have a MCL for perchlorate desp ite having known perchlorate releases. I am concerned for my children as well as the public's safety. It is for these reasons that I am very concerned about the EPA’s preliminary decision not to set a maximum contaminant level forEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 706 of 1099 perchlorate. I worry that we are fa cing another situation where we w ill be looking back wishing more appropriate safety measures had been implemented.

Response: See response to comment code 6120.

Commenter Name: Marcia Willhite Commenter Organization: Illinois Environmental Protection Agency

EPA Document ID: EPA-HQ-OW-2007-0068-0155

EPA Comment ID: 20257

EPA Comment Code: 6120

Comment: The Illinois Environmental Protection Agen cy ("EPA") recommends that the Agency reconsider its position of not regulating perchlora te, 2,4-dinitrotoluene, and 2,6-dinitrotoluene under the National Primary Drinking Water Regulation.

Response: This comment is outside of the scope of this action, no response necessary.

Commenter Name: Thomas Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0162

EPA Comment ID: 20267

EPA Comment Code: 6120

Comment: Perchlorate

Perchlorate is a very important issue for the drin king water community, and the perchlorate options detailed in the May 1st Federal Register notice rais e many complex issues. Perchlorate provides EPA with a critical opportunity to appropriately implem ent the standard setting provisions of the 1996 SDWA amendments and the CCL/UCMR process. A dditionally, there has been significant public interest generated by press coverage and subsequent interest by legislative bodies in certain states

and at the federal level.

Building upon our position previously communicate d to EPA in letters on February 2, 2005 and May 27, 2005, we recommend that EPA now make the decision to regulate perchlorate. AWWA believes that EPA has enough information to make a positive regulatory determination, and then to move forward with a proposed perchlorate regulati on consistent with the requirements of the Safe Drinking Water Act.

We make this recommendation for the following reasons, absent any one of which we might make a

different recommendation:

1. The National Research Council (NRC) and the Centers for Disease Control and Prevention (CDC) have found that perchlorate may have an adverse impact on the health of persons.

2. Perchlorate is known to occur in public water supplies in a number of states.

3. While occurrence data does not suggest that perchl orate occurs at levels of public health concern in the vast majority of public drinking water supplie s and the population at risk appears to be small,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 707 of 1099 that group does include a sensitive subpopulation (pregnant women and developing fetuses) of significant concern.

4. The Greer data and the Reference Dose (RfD ) recommended by the National Research Council (NRC) now make it possible for EPA to determine a protective level for perchlorate with a degree of confidence appropriate to a national primary drinking water regulation.

5. There are appropriate and reliable analytical m ethods for utilities and others to measure perchlorate concentrations in public water supplies, as documented by UCMR sampling, and laboratory capacity is not an issue.

6. A number of states are moving to regulate perc hlorate and a patchwork of different regulations will confuse the public and th e regulated community. And

7. Strong anecdotal data suggests that the lack of a perchlorate MCL has impeded a number of cleanups at hazardous waste sites. Cleanup at these sites could benefit public water suppliers, among

others.

Response: See response to comment code 6120.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0166

EPA Comment ID: 20275

EPA Comment Code: 6120

Comment: The notice also discusses perchlorate and does not provide a regulatory determination for this contaminant despite the availability of extensive data and high public concern. Because of the high public concern there is also high political interest. As local stewards of public health, we believe that if perchlorate presents a public health risk, then EPA should establish a maximum

contaminant level for it. AMWA be lieves strongly in the regulatory process outlined in the 1996 Amendments. In the case of perchlorate, AMWA believes that the information available to the agency clearly points to a determination to regulate.

It appears that the agency has deferred the decisi on on perchlorate based solely on wanting a more

accurate determination of the relative source contri bution that might be attributable to drinking
water. The notice states that, absent that inform ation, a determination whether setting a national primary drinking water standard would provide a meaningful opportunity to reduce risk for people served by public water systems cannot be made.

Response: See response to comment code 6120.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0166

EPA Comment ID: 20277

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 708 of 1099 Comment: At least nine states have addressed perchl orate through standards, health advisories, health based guideline levels, public advisories or other means. Utilities in states where no action has been taken face public perception and confidence problems at a minimum. EPA faces these same problems through continued inaction. A federal standard is needed in place of inconsistent state requirements.

AMWA urges EPA to keep in mind that a regulatory determination is the start of the regulatory process and not the end. Additional data is always gathered during the process. The final regulatory construct and requirements will be based on this da ta. All presently available data indicate that a positive determination is appropriate. Therefore AMWA believes that it is time for the regulatory process to begin. EPA can start this process ou tside the formal regulatory determinations and should do so. At minimum, a positive final determination should be made along with the determinations not to regulate 11 contaminants proposed in the present notice based on present data, and any additional information developed ov er the next several months while the agency’s regulatory determinations are finalized.

If you have any questions about our comments, plea se do not hesitate to contact me or Erica Brown

at 202-331-2820.

Sincerely, Diane VanDe Hei Executive Di rector Cc: Cynthia Dougherty, OGWDW

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1130

EPA Comment ID: 20290

EPA Comment Code: 6120

Comment: it is crucial to the health of our nation that we monitor perchlorate levels in our drinking

water!

Response: See response to comment code 6120.

Commenter Name: Glen Shull Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1132

EPA Comment ID: 20291

EPA Comment Code: 6120

Comment: I don't know how much percholate is in our water but if it is in it we should regulate it. We did not regulate sub-prime loans, allowed pe ople to submit loans to people who could not afford them and look what happened. If people are in danger of being sick from percholate, let's disallow it to be even close to illness causing levels. I teach tennis in Florida and drink a gallon of water a day, plus juices.

Glen shullEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 709 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1134

EPA Comment ID: 20292

EPA Comment Code: 6120

Comment: Do not permit perchlorate in water. Not healthful for babies, children or adults. If we are not to buy bottled water because of the envi ronmental impact of plastic bottles then we need clean safe tap water to drink.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1139

EPA Comment ID: 20293

EPA Comment Code: 6120

Comment: On October 10, the EPA announced its prelim inary decision not to regulate perchlorate in drinking water. EPA has request ed comments from the public before making a final decision. Ask

the Administration and the EPA to reverse this find ing and regulate perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1141

EPA Comment ID: 20294

EPA Comment Code: 6120

Comment: I am writing to urge the EPA to regulate perc horate in our drinking water supplies. This is a chemical that has been proven to cause heal th problems, particulary in young children, and it crucial that we regulate it.

Thank you very much

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1144

EPA Comment ID: 20295

EPA Comment Code: 6120

Comment: Do not allow perchlorate in our water!!EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 710 of 1099 Response: See response to comment code 6120.

Commenter Name: C. McFall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1147

EPA Comment ID: 20296

EPA Comment Code: 6120

Comment: Perchlorate is only one of a cascade of fo reign substances making its way into our drinking water. We are constantly learning of new, harmful substances whose interaction with our bodies and with other contaminates is unknown. The ONLY way we can preserve quality of our health as a nation is to ensure these foreign subst ances are not consumed by any of us. The EPA is supposed to PROTECT us from contamination, not fa cilitate it. This is our health, our future and our children we are talking about - not a group of hy pothetical 'percentage of exposure' risks. Please wake up and start seeing our environment for the mess we have made it and help us clean it up, not add to the problem because someone talked you into it.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1152

EPA Comment ID: 20297

EPA Comment Code: 6120

Comment: Please reverse decision to allow perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Amy Cobaugh Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1153

EPA Comment ID: 20298

EPA Comment Code: 6120

Comment: Please regulate perchlorates in our drinking water. As a citizen, I am very concerned about the health affects on my children, who are especially vulnerable to pollutants.

Thanks,

Amy Cobaugh San Mateo County, CA

Response: See response to comment code 6120.

Commenter Name: Rebecca Teal Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1157

EPA Comment ID: 20299EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 711 of 1099 EPA Comment Code: 6120

Comment: Please keep rocket fuel in my drinking wa ter. I like the way it makes my third eye glow. Regards, Rebecca Teal

Response: This is not a comment; no response is necessary.

Commenter Name: J. Vasconcellos Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1158

EPA Comment ID: 20300

EPA Comment Code: 6120

Comment: Its time to be proactive, as well as foresighted. Whats easier and more desirable to treat: perchlorate in our drinking water or askewed thyr oid disease in our children? Think the Future!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1162

EPA Comment ID: 20301

EPA Comment Code: 6120

Comment: We Minnesota voters just announced loud an d clear in yesterday's vote that we're willing to pay higher taxes in return for increased protecti on of our water, air, and other natural resources. Let's bring our regulatory protection up to speed. Monitor Perchlorates.

Response: See response to comment code 6120.

Commenter Name: G. A. Bagazinski Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1166

EPA Comment ID: 20302

EPA Comment Code: 6120

Comment: No Percholate in Drinking Water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1167

EPA Comment ID: 20303

EPA Comment Code: 6120

Comment: how about trying to keep perchlorate to a minimum level in our drinking water, like around none would be good, yes?EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 712 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1169

EPA Comment ID: 20304

EPA Comment Code: 6120

Comment: Don't see any reason that we should have Perchlorate in our water. Please consider limiting it.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1171

EPA Comment ID: 20305

EPA Comment Code: 6120

Comment: Reverse your ruling on perchlorate. No one wants to drink something that is tainted with fuel ingredients The environmental impact of increased bottled water consumption should be a factor in your consideration. Every effort should be made to increase the purity of our drinking water, so we can help reduce the environmentally damaging, excessive consumption of bottled

water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1177

EPA Comment ID: 20306

EPA Comment Code: 6120

Comment: I strongly believe the U.S. Environmental Protection Agency must reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Perchlorate is a serious concern health-wise, and I do not want it in the water I am drinking.

Response: See response to comment code 6120.

Commenter Name: Louise McEvers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1180

EPA Comment ID: 20307

EPA Comment Code: 6120

Comment: As a citizen with low thyroid, I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 713 of 1099 Perchlorate contamination is a national pr oblem that could impact many Americans.

Please reconsider your position.

Louise McEvers Austin, TX 78729

Response: See response to comment code 6120.

Commenter Name: K. Moreland Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1183

EPA Comment ID: 20308

EPA Comment Code: 6120

Comment: Percholate is a dangerous chemical and needs to be kept out of our drinking water. You must regulate this dangerous chemical

Response: See response to comment code 6120.

Commenter Name: Deb Arnason Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1184

EPA Comment ID: 20309

EPA Comment Code: 6120

Comment: Please do not allow percolate in our drinking water. Sadly. the EPA has deteriorated over the past 8 years. With our new President, I hope we can look forward to your PROTECTION that has been lacking by regulating this hazardous chemical as well as many others in our air, water and food supplies. Thank you for returning to sanity. Please help by doing the job we used to trust you for.

Deb Arnason 12 Dill St, Alva, FL 339 20 386-288-4454 diamondteldeb@aol.com

Response: See response to comment code 6120.

Commenter Name: W. Mcclure Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1190

EPA Comment ID: 20310

EPA Comment Code: 6120

Comment: Please reverse your decision and keep perchl orate out of the water supply. The public health takes precedence over business convenience and cost.

Response: See response to comment code 6120.

Commenter Name: C. RongstadEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 714 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1191

EPA Comment ID: 20311

EPA Comment Code: 6120

Comment: I ask the EPA to reverse its decision not to regulate perchlorate in drinking water. Why not regulate a chemical that has health impacts at low levels and is detectable in our drinking water?

Please consider the lack of regulation as harmful to the public and include perchlorate in drinking water regulations.

Response: See response to comment code 6120.

Commenter Name: T. J. Sanders Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1192

EPA Comment ID: 20312

EPA Comment Code: 6120

Comment: Let us do what it takes to save our envir onment and our planet. It is the only home we have. We are becoming over populated, and it is no l onger acceptable to add toxins to our ater and

air.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1195

EPA Comment ID: 20313

EPA Comment Code: 6120

Comment: Do not put perchlorate in our drinking water.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Frances Ann Leary Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1209

EPA Comment ID: 20314

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

A national primary drinking water regulation would provide a meaningful opportunity to protect public health.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 715 of 1099 Take the precautionary approach, or we will all pay la ter. It's harder to remove contaminants and try to make ammends with families impacted both emoti onally and financially by the ramifications of

toxics in their water. Now is the time to be a lead er on this and other critical environmental issues.

Sincerely, Frances AnnLeary

Response: See response to comment code 6120.

Commenter Name: L. Thorpe Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1221

EPA Comment ID: 20315

EPA Comment Code: 6120

Comment: Please keep chemicals out of our water. It is harming my families health and yours.

Response: See response to comment code 6120.

Commenter Name: Shawn Taylor Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1231

EPA Comment ID: 20335

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. I believe this is urgent for public safety.

Sincerely,

Shawn Taylor

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1232

EPA Comment ID: 20336

EPA Comment Code: 6120

Comment: As a concerned citizen with a family living by a major river and atop an already imperiled aquifer, I am distraught that EPA is even considering not regulating perchlorate levels in the water supply. How can my government be so unconcerned for its citizens' well-being? Perchlorate is a component in rocket fuel, and the sc ience shows that even in low amounts it can be

a threat to our health.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 716 of 1099 It is no favor to industry for the EPA not to set safety levels and monitor water for the presence of perchlorate. Should contamination at unsafe levels occur, the damage to the health of even a few citizens, much less to the large numbers who migh t be affected in any significantly populated area, would be a terrible blow to the industry as well.

It should be very clear that wise regulation is g ood for everyone. This is EPA's obligation, the very reason for your existence. This is not a quasi-market situation in which if one party fails, someone else will step in. EPA is our last best defense against man-made environmental hazards. We the citizenry are counting on you.

Response: See response to comment code 6120.

Commenter Name: Patricia A. Gozemba Commenter Organization: Salem Alliance for the Environment (SAFE)

EPA Document ID: EPA-HQ-OW-2008-0692-1234

EPA Comment ID: 20337

EPA Comment Code: 6120

Comment: We have seen our water supply for the City of Salem, MA jeopardized at Wenham Lake. We believe that the EPA should hold the line on weakening standards. I urge the U.S. Environmental Protection Agency to reverse its pr eliminary determination on setting a regulation for perchlorate in drinking water. Perchlorate cont amination is a nationwide problem and has health impacts at lower levels than previously thought; a national primary drinking water regulation would provide a meaningful opportunity to protect public health. The EPA should hold off on making

determinations such as this until the new administration takes office.

Dr. Patricia A. Gozemba

Salem, Massachusetts

Response: See response to comment code 6120.

Commenter Name: Tony Dewalt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1235

EPA Comment ID: 20338

EPA Comment Code: 6120

Comment: please remove rocket fuel, flare chemical from our waters. lets keep usa,s waters ahead of most of the worlds in drinking quality thank you tony dewalt

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1237

EPA Comment ID: 20339

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 717 of 1099 Comment: I have a chronic health condition and live not far from launch pads. The people of the community have long time wondered if the contam inants to which we are exposed are regulated or responsible for health issues. I am afraid as are those who read about perchlorates . We know they are not good for us! Please reverse the decision not to monitor this chemical and let us know you truly do care about the health of the public. It is critical to our childrens growth and the general health of our people.

Response: See response to comment code 6120.

Commenter Name: M. Musgrave Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1240

EPA Comment ID: 20340

EPA Comment Code: 6120

Comment: "Researchers at the Centers for Disease Control and Prevention (CDC) have just released findings that show that American women -- and especially women with low iodine intake -- are at risk of hypothyroidism due to common expos ure to the toxin perchlorate. " I'm not making this up. Check the facts. Perchlorate must be regulated to protect us--that's your job! If you want to keep it do it better and reverse this ruling. Our new administration will be sure to make you accountable for your responsibilities to The People!

Response: See response to comment code 6120.

Commenter Name: T. Lampert Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1241

EPA Comment ID: 20341

EPA Comment Code: 6120

Comment: No relaxing of standards for water pu rity. No percholates inthe water!!!!!!!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1246

EPA Comment ID: 20342

EPA Comment Code: 6120

Comment: I am concerned about rocket fuel being in our water supply and wouldn't like it to be in it, please.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 718 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1249

EPA Comment ID: 20343

EPA Comment Code: 6120

Comment: Please test for perchlorate in our drinking water!

Response: This regulatory action does not affect testin g requirements for perchlorate. Please See response to comment code 6120.

Commenter Name: Cara Cordoni Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1250

EPA Comment ID: 20344

EPA Comment Code: 6120

Comment: Please protect our drinking water. Test for and protect us from percholate! Jet fuel is
not food, not nutrition, not health and does not belong in our water or bodies. Please protect our babies, our children, our elderly. Do not make th e same kind of mistake the FDA made with the pesticide that is killing our bees - protect us from the beginning.

Cara Cordoni

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1262

EPA Comment ID: 20345

EPA Comment Code: 6120

Comment: 3M has been dumping this chemical and severa l others in our aquifer for years. At first they said there were no negative effects from it, bu t later I believe concerns about cancer, possibly,

have been raised.

At any rate, chemicals other than minerals supplie d naturally are not a desirable item in potable

water.

Please take care of this.

Thanks.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1264

EPA Comment ID: 20346

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 719 of 1099 Comment: What? Is not the the EPA the Environmen tal PROTECTION Agency? What is more important than monitoring and regulating what poisonous chemicals might enter our water sources? And what better motivation is needed than to protect our children? Our seeds of the future!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1265

EPA Comment ID: 20347

EPA Comment Code: 6120

Comment: Please do your job and keep our water sa fe. Keep Perchlorate out of the water

Response: See response to comment code 6120.

Commenter Name: N. Henderson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1266

EPA Comment ID: 20349

EPA Comment Code: 6120

Comment: As the mother of an infant, I urge the EPA to reconsider its position on the regulation of perchlorate in drinking water. Each and every contaminant in our public water supply jeopardizes the health of the citizens of this country, part icularly are most vulnerable population--infants and children. Ultimately, a decision not regulate a chemic al that we ingest has high financial cost when one 1 in 4 Americans will develop cancer during their lifetime. Please consider this factor when assessing this decision.

Response: See response to comment code 6120.

Commenter Name: Robert L. Oldershaw Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1268

EPA Comment ID: 20350

EPA Comment Code: 6120

Comment: Please get with the new program: empha sis on protecting the ENVIRONMENT rather than on protecting the excess profit s of influencial corporations.

Please ask yourselves whether you need to regain some integrity and self-esteem before you leave for new jobs.

Thanks,

Robert L. OldershawEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 720 of 1099 Response: See response to comment code 6120.

Commenter Name: Nancy B. Kurtz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1269

EPA Comment ID: 20351

EPA Comment Code: 6120

Comment: Coming from a family that has a tendency toward environmentally triggered diseases I want to tell you to take responsibility and manda te the perchlorate out of our drinking water. We have only begun to realize how many diseases are triggered by contaminants and need to nip this

track in the bud. This is a can of worms you don't want to be a part of opening.

Nancy B.Kurtz

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1271

EPA Comment ID: 20352

EPA Comment Code: 6120

Comment: I am speaking against the EPA's preliminar y decision not to regulate perchlorate in drinking water. I'd like to believe the EPA is workin g primarily to protect the public's health and not catering to big industry's concerns that regulati ons hamper their ability to make money. The USA needs to be a world leader in protecting th e environment with very stringent rules.

Response: See response to comment code 6120.

Commenter Name: Amy Rice-O'Rourke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1274

EPA Comment ID: 20353

EPA Comment Code: 6120

Comment: Dear Ones,

As a working Mother who grew up swimming and fishing in Lake St. Clair, & one who I takes our own kids there all summer, I am very concerned about these new laxxed regulationsabout the amount of perchlorate in our drinking water. Wha t is an exceptable amount of poisin? How long will it be until my children or their children show the effects of these pollutants? I urge the U.S. Environmental Protection Agency to reverse its pr eliminary determination on setting a regulation for perchlorate in drinking water. Perchlorate cont amination is a nationwide problem and has health impacts at lower levels than previously thought; a national primary drinking water regulation would provide a meaningful opportunity to protect public health. As you make these determinations, please bear in mind my 7 & 9 year old boys, their potential children and the hundreds of thousands ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 721 of 1099 other children who grow up all around the Great Lakes States & Canada and we deserve clean water to drink. We have to protect their legacy as well as their health.

Sincerely,

Amy Rice-O'Rourke

Response: See response to comment code 6120.

Commenter Name: J. M. Meyerson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1275

EPA Comment ID: 20354

EPA Comment Code: 6120

Comment: Please work hard keep contaminants like Perchlorate out of our drinking water. As citizens, we depend on you to protect us all.

Thank you,

Response: See response to comment code 6120.

Commenter Name: C. W. Doppler Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1280

EPA Comment ID: 20355

EPA Comment Code: 6120

Comment: Clean water is a basic human right and a basi c government responibility. As a citizen, I demand that you regulate perchlorate c ontamination in our drinking water.

Christina W Doppler

Crown Point IN

Response: See response to comment code 6120.

Commenter Name: Gary Kropilak Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1281

EPA Comment ID: 20356

EPA Comment Code: 6120

Comment: Gary Kropilak

16 Peek St

Rochelle Park, NJ 07662EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 722 of 1099 To whom it may concern,

Your decision to allow percholate to remain in our drinking water is unacceptable. Our limited supply of drinking water must be protected and fr ee of all harmful contaminates. Even miniscule amounts of percholate can threaten the health of f etuses, infants, teens and adults. I implore you to REVERSE your decision not to regulate percholate. Please protect us.

Thank You,

Gary Kropilak

Response: See response to comment code 6120.

Commenter Name: S. Brown Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1284

EPA Comment ID: 20357

EPA Comment Code: 6120

Comment: I'm writing to ask the agency to reconsider its decision on the need to regulate perchlorate levels in drinking water. Given its wi despread contamination (37+ states) and thyroid effects at low concentrations, particularly in utero, it is vital that the agency moves to protect public

health.

Response: See response to comment code 6120.

Commenter Name: G. Guthmiller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1285

EPA Comment ID: 20358

EPA Comment Code: 6120

Comment: Please regulate the perchlorate level in our drinking water. We do not need any chemicals dissolved in our water. We may find in th e future that this chemical has many hazardous risks for humans. Please don't poison our future generations. Thank you.

Response: See response to comment code 6120.

Commenter Name: Susan D. Snyder Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1288

EPA Comment ID: 20359

EPA Comment Code: 6120

Comment: Re: Drinking water standards & Perchlorate: I find it ironic that the agency responsible for the safety and protection of both the American public and the national environment would consider that any amount of perchlorate - which is not a naturally occurring chemical - has anEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 723 of 1099 acceptable level in the potable water of any mammal, whether human person or animal. To set any sort of standard/acceptable amount for percholorate presence is immoral, should never become legal and is, in the event, reprehensible. I understand that maintaining pure (perchlorate-free) water carries a cost: but it is nothing to the deep harm the chemical does to those who have no option but to drink it. Please, take the "high road" of consumer and environmental protection - in accordance with your mandate - and do not institutionalize th e further poisoning of our water system. I would appreciate a written acknowle dgment of my comment.

Susan D. Snyder 8628

Garfield Street

Bethesda, MD 208187

sue_snyder@verizon.net

Response: See response to comment code 6120. EPA acknowledges your request for a reply to your comment; however, EPA is unable to reply directly to all comments submitted.

Commenter Name: J. Kayle Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1291

EPA Comment ID: 20360

EPA Comment Code: 6120

Comment: Of course you need to regulate whether or not perchlorate is getting into our water supply! Don't be ridiculous. Please.

Response: See response to comment code 6120.

Commenter Name: Greg Swanson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1293

EPA Comment ID: 20361

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

On October 10, the EPA announced its preliminary decision not to regulate perchlorate in drinking water. I cannot understand why your agency would ev er consider not regulating this contaminate. The purpose of your agency is to be the watchga rd for the public in Protecting us from harmful substances. You need to side with the publics best interest in mind. If this causes manufacturers and industry to incur costs then they need to be responsible and include them in their cost of doing business just like all other repsonsible companies and manufactures.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 724 of 1099 Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; A national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Perchlorate is a harmful chemical used in rocket fu el, flares, and explosives. Perchlorate, even in small amounts, can impair the thyroid gland, wh ich controls growth, development and metabolism. Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills. EPA agrees that perchlorate has been found in 395 sites in 37 states, including 153 public water syst ems serving over 20 million people. Some estimates are even higher.

Reverse your preliminary determination and responsib ly regulate this potentially harmfull substance.

Thank You

Greg Swanson

Response: See response to comment code 6120.

Commenter Name: Kate Mendeloff Commenter Organization: University of Michigan, Ann Arbor

EPA Document ID: EPA-HQ-OW-2008-0692-1294

EPA Comment ID: 20362

EPA Comment Code: 6120

Comment: I am a private citizen who has great con cern about the potential pollution of our drinking water by perchlorate. Please be responsib le for the general welfare and make this illegal!

Kate Mendeloff, University of Michigan, Ann Arbor

Response: See response to comment code 6120.

Commenter Name: Lisa Stewart Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1300

EPA Comment ID: 20363

EPA Comment Code: 6120

Comment: Please reverse your decision and regulate perchlorate in drinking water. Isn't potable drinking water a priority?

You need to shed your "too little too late" imag e of post 911 and show Americans that you are doing your job to protect us from contam inates either in the air or water.

Your attention to the this is vital to the well being of countless Americans.

Most sincerely,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 725 of 1099 Lisa Stewart

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1301

EPA Comment ID: 20364

EPA Comment Code: 6120

Comment: I first read about perchlorate in the newspaper several years ago when it was discovered to be on organic lettuce grown in California! PLEASE reverse your preliminary determination on setting a regulation for perchlorate in drinking wa ter. This is a national problem - clean it up!

Response: See response to comment code 6120.

Commenter Name: J. Seegmiller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1302

EPA Comment ID: 20365

EPA Comment Code: 6120

Comment: Keep perchlorate out of our drinking water.

Response: See response to comment code 6120.

Commenter Name: Lisa Quartararo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1303

EPA Comment ID: 20366

EPA Comment Code: 6120

Comment: Perchlorate should be federally regulated just like any other chemical that has the potential to harm people or the planet. I don't understand what you are thinking!

Sincerely,

Lisa Quartararo

Colonia, NJ 07067

Response: See response to comment code 6120.

Commenter Name: Greta Mackenzie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1307

EPA Comment ID: 20367

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 726 of 1099 Comment: since my drinking water comes from a surfici al aquifer within a watershed affected by miami international airport, and concievable by the old aerojet facility, I would appeciate knowing it is safe to drink. Unfortunately the EPA dosnt inspire the confidence it used to under the Clinton administration. As far as I'm concerned, the mo re regulation on MCL's for water (and while we are at it air and food) the better!

greta Mackenzie PhD.

Response: This is outside of the scope of this effort, no response is necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1309

EPA Comment ID: 20368

EPA Comment Code: 6120

Comment: Please reverse your action to not regulate perchlorate in our drinking water. It's absurd that you would even consider allowing it in our drinking water----I mean you have to drink this

water as well. Lets use some common sense.

Response: See response to comment code 6120.

Commenter Name: L. Doggett Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1310

EPA Comment ID: 20369

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: M. Hough Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1312

EPA Comment ID: 20370

EPA Comment Code: 6120

Comment: I am deeply concerned with regard to articles I have read regarding perchlorate in our drinking water. This is an issue I feel needs to be addressed by the EPA. It clearly is a harmful chemical which can impair the thyroid gland and affect fetuses, infants and children. This is dangerous even in the smallest amounts. The EP A has decided not to move forward to regulate perchlorate in drinking water which possibly will be a big mistake. You have your findings and you must act accordingly. This contamination in drinki ng water is nationwide and not to take the proper measures to ensure the safety of our drinking wa ter would be harmful in the long run. Please reconsider and take the precautionary measures.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 727 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1313

EPA Comment ID: 20371

EPA Comment Code: 6120

Comment: I've been drinking water for a long time. My family drinks water. My pregnant daughter is passing the contents of the water she drinks on to her unborn child. Moreover, I believe the agents of our government responsible for water quality oversight drink water. In short, we all have a stake in keeping our water sources pure. Please keep faith with the trust we have put in you. Keep perchlorate out of our water (yours an d mine). Reverse this decision.

Response: See response to comment code 6120.

Commenter Name: A. Crane Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1317

EPA Comment ID: 20372

EPA Comment Code: 6120

Comment: Attention EPA Officials: I don't want perchlorate in our water systems. What would Ralph Nader say if he heard you were stopping your testing of this dreadfully harmful chemical in our drinking water? I think he'd say "get back on it!" Please help keep our waters safe for all the plants, animals and people who can't live without it.

Thank you,

A. Crane

Response: See response to comment code 6120.

Commenter Name: Christy Anderson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1318

EPA Comment ID: 20373

EPA Comment Code: 6120

Comment: To whom it may or may not concern,

I strongly urge the U.S. Environmental Protecti on Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought. It is unethical and inappropriate to allow toxic substances in our drin king water; however, a national primary drinking water regulation would provide a meaningful opportun ity to protect public health. Please protect our

health and the health of our children!!EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 728 of 1099 Christy Anderson

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1319

EPA Comment ID: 20374

EPA Comment Code: 6120

Comment: I urge the U.S. E.P.A. to reverse its pre liminary determination on setting a regulation for perchlorate in drinking water as this can be ve ry hazardous to large groups of our population and cannot be ignored.

Response: See response to comment code 6120.

Commenter Name: Heidi Washburn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1322

EPA Comment ID: 20375

EPA Comment Code: 6120

Comment: To the EPA, As a citizen, parent, grandparen t, and teacher, I strongly urge the EPA to reverse its decision NOT to regulate perchlorate, rocket fuel, in our nations water and drinking

water. Perchlorate is a harmful chemical whose de vastating effects on humans and animals will last generations. As a government organization created to protect our environment, I believe it is your moral duty to act now to insure that perchlorate does not make its way into the water. PLEASE

ACT NOW --- KEEP PERCHLORATE OUT OF AMERICA'S WATER.

Respectfully submitted,

Heidi Washburn

4615 Daventry Place

Valrico, FL 33596

Response: See response to comment code 6120.

Commenter Name: Frank Blaskowitz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1323

EPA Comment ID: 20376

EPA Comment Code: 6120

Comment: The EPA regulates a number potential health hazards. Perchlorate contamination is real and must be addressed. I urge the EPA to regula te this contaminant as quickly as possible.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 729 of 1099 Thank You,

Frank Blaskowitz

Response: See response to comment code 6120.

Commenter Name: Robert Prato Commenter Organization: Bucks County HIRT

EPA Document ID: EPA-HQ-OW-2008-0692-1327

EPA Comment ID: 20377

EPA Comment Code: 6120

Comment: I would strongly urge the EPA to reconsid er the perchlorate regulation for drinking water standards. I have experience with these ch emicals first hand (I am a Captain on a regional Hazardous Material response team), and I have a gr eat understanding of the short and long term effects of this type of chemical. Even minute amounts of this can cause harm to humans and animals alike. Please give due consideration to creating a standard for these chemicals.

Thank you.

Robert Prato Capt.

89-1 Bucks County

HIRT Bucks County, PA

Response: See response to comment code 6120.

Commenter Name: Maureen Roddy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1328

EPA Comment ID: 20378

EPA Comment Code: 6120

Comment: Keep rocket fuel out of our drinking wa ter!!! Our children are suffering from an epidemic of frontal lobe disorders -- autism is just one of them. Clean up our water and keep neurotoxins out. thank you.

Maureen Roddy

978 Van Auken Circle

Palo Alto, CA 94303

Response: See response to comment code 6120.

Commenter Name: AnonymousEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 730 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1329

EPA Comment ID: 20379

EPA Comment Code: 6120

Comment: Safe Drinking Water is one of the main in dicators of a developed country. Allowing percholate do go untested or regulated in our co untry's municipal waters is a mistake - one that every citizen will unknowingly make when they reach for a glass of tap water. With so much effort being made to turn people away from the fallacy of bottled water, why would we give people any

more reason to doubt their local water sources?

Please consider testing water for percholate and making sure levels are well below the permissible

amount!

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. Please see the response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1333

EPA Comment ID: 20380

EPA Comment Code: 6120

Comment: I urge the EPA to reverse its decision on Perchlorate. Thank you.

Response: See response to comment code 6120.

Commenter Name: John and Barb and family Harburg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1334

EPA Comment ID: 20381

EPA Comment Code: 6120

Comment: Please keep perchlorate out of the water.

Thank you

John and Barb Harburg and family

Response: See response to comment code 6120.

Commenter Name: Julie Seifert Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1336

EPA Comment ID: 20382

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 731 of 1099 Comment: Please urge tj=he EPA to reverse it's pre liminary determination on setting a regulation for permitting perchlorate in our drinking water. No levels are safe and we need to be protected!!!!!!!!!!!!!

Julie Seifert

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1337

EPA Comment ID: 20383

EPA Comment Code: 6120

Comment: Regulate Perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: D. Puyanic Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1339

EPA Comment ID: 20384

EPA Comment Code: 6120

Comment: You must regulate perchlorate - an ingredient in rocket fuel. You must reverse this finding and regulate perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Julia Burch Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1340

EPA Comment ID: 20385

EPA Comment Code: 6120

Comment: I do not want my drinking water standards loosened, especially when it comes to perchlorate. I understand that President Bush is trying to undo many important regulations that protect public health and our environment in his last few days in office. But EPA serves the American people, not just the President. EPA's j ob is to protect the public from harmful exposures whether acute or chronic. As well as to protect the environment for future generations. In the past eight years EPA has fallen down on this job. Regulati ons should be just as difficult to undo as they are to put in place to prevent politics and ind ustry from having inappropriate influence on our nation's environmental health. Keep perchlorate out of our water. In addition, EPA needs to develop standards for atrizine as well. Pesticides should not be in our water either. And if the technology does not exist to remove these chemic als from drinking water then they should be banned from use or production.

Private Citizen Julia Burch 846 32nd Street Sarasota, Florida 34234EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 732 of 1099 Response: Regarding regulation of perchlorate, See response to comment code 6120. Regarding regulation of atrazine, this is outside of the scope of this effort.

Commenter Name: Chip Thomas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1344

EPA Comment ID: 20386

EPA Comment Code: 6120

Comment: Please reverse the decision to not regulate perchl orate. It needs to be regulated due to its potential harm.

Chip Thomas Tampa, Fl 813-238-0437

Response: See response to comment code 6120.

Commenter Name: Aaron Smith Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1346

EPA Comment ID: 20387

EPA Comment Code: 6120

Comment: To Whom It May Concern:

The decision to put into place measures to regula te perchlorate in drinking water rest on the EPA's assessment of potential reduction of public health risk caused by the pollutant. It seems logical to me, and I hope to you, that if there exists ANY risk , or even the possibility of a risk to an population of American people, no matter how small, that re gulation is necessary. If the EPA concludes that even a small sub-population is affected by perchlorate, then the EPA is saying, in their opinion, it is okay to have polluted drinking water as long as it only hurts a few. I believe this is bad policy and hope that you would agree. Second , Drinking water is an extrem ely valuable resource, and will become more valuable in the coming decades. Wa ter tables all over the world are falling, climate change is causing drastic changes to our sour ces of drinking water, and skyrocketing world population is going to make drinking water more and more of a scare resource in the decades to come. It is imperative that we protect our drin king water against all possible contaminates.

Thank you for you time and attention to this issue.

Aaron smith aaronsmith@alumni.utexas.net

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1351

EPA Comment ID: 20388

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 733 of 1099 Comment: Please do not let perchlorate into our drinking water.

Response: See response to comment code 6120.

Commenter Name: Marilyn Alvey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1352

EPA Comment ID: 20389

EPA Comment Code: 6120

Comment: To Whom it may concern, Please strengthen standards for our drinking water. Why would anyone in their right mind allow toxic substan ces to be in water that US citizens are relying on to be safe and pure. We are the only civilized co untry that even puts chlorine in our drinking water, which is suspected of causing health problems, an d is being looked at as a major player in the

increase of breast cancer. We are so behind other nations in taking a proactive stance against toxins in our food, water and consumer goods. When ar e we going to wake up? Canada has just banned bisphenol A,as have most civilized countries, yet our government is still telling us that it is safeNOT! It is in liners of all canned goods, so how does one avoid it? We all can't grow and can our own food, we rely on the government to set safety standards and my government is sadly behind the curve. Please do not allow perchlorate in our drinking water. Sincerely, Marilyn Alvey

Response: See response to comment code 6120.

Commenter Name: Marni Hall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1353

EPA Comment ID: 20390

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protecti on Agency to reverse it's preliminary determination on setting a regulation for perchlorate in drinking water. It is irresponsible to ignore the fact that perchlorate has health impacts and if it is in our drinking water we are all at risk and suffer the impacts to our health. Please embrace th is opportunity to protect pu blic health. Sincerely,

Marni Hall

Response: See response to comment code 6120.

Commenter Name: S. M. Gagnon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1354

EPA Comment ID: 20391

EPA Comment Code: 6120

Comment: I am very unhappy with the EPA's preliminary decision not to regulate perchlorate in drinking water. The EPA must reverse this finding and regulate perchlorate in drinking water so as to protect the smallest, most vulnerable members of our society -- our babies and children. Clean, safe drinking water should be the right of every American.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 734 of 1099 Response: See response to comment code 6120.

Commenter Name: Francoise LaMonica Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1356

EPA Comment ID: 20392

EPA Comment Code: 6120

Comment: The health effects from ingesting low dosa ge perchlorate-contaminated water are not well known. But it's already known that it interferes with the body's iodine intake, causing an inhibition of human thyroid production. Regulation of this contaminent is clearly within the mission and mandate of your agency to protect humal health.

Further, since ammonium perchlorate which is used in solid rocket engine fuels has a limited shelf life and must periodically be replaced, a safe method of disposing of the chemical has to be designed and implemented. We cannot allow the buildup of perchlorate, notably in the Colorado Bassin, to

continue unabated.

I urge you to reconsider your agency decision not to regulate this chemical.

Sincerely,

Francoise LaMonica 944 Centre Street Newton, MA 02459

Response: Please see the response to comment code 6120. Regarding commenter’s statement “...since ammonium perchlorate which is used in solid rocket engine fuels has a limited shelf life and must periodically be replaced, a safe method of disposing of the chemical has to be designed and implemented”, proper disposal of ammonium pe rchlorate falls outside of the scope of this regulatory action, as the Safe Drinking Water Act’s authority is focused on whether or not the contaminant can be in public water systems.

Commenter Name: T. Greenlee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1357

EPA Comment ID: 20393

EPA Comment Code: 6120

Comment: I am appalled at the idea of drinking a rocket fuel additive. I implore you regulate Perchlorate strictly.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1365

EPA Comment ID: 20394

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 735 of 1099 Comment: Please protect our water from being contaminted by preventing perchlorate to be in our

water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1368

EPA Comment ID: 20395

EPA Comment Code: 6120

Comment: Are you retarded?

Anything and everything that is man made should be monitored, even it if is not adherently bad for people or the environment.

Please reconsider or the consequences will be dire.

Sincerely,

A concerned citizen

Response: See response to comment code 6120.

Commenter Name: Shannon No surname provided Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1371

EPA Comment ID: 20396

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. I personally do not want myself or my children to drink water that has a known contaminant that can effect thyroid function. I am actually not even sure why we would need to urge your decision in this direction as any chemical in our water system is alarming and should be regulated.

Thank you for your consideration.

Sincerely, Shannon

Response: See response to comment code 6120.

Commenter Name: Maureen Crossey Commenter Organization: Packard Manse, Inc.

EPA Document ID: EPA-HQ-OW-2008-0692-1372

EPA Comment ID: 20397

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 736 of 1099 Comment: Regulate Perchlorate. We need to convince Americans to trust their water supply. Stop using bottled water and filling the la nd with plastic waste. Maureen

Response: See response to comment code 6120. Regarding commenter’s statement about bottled water, the EPA does not have the authority to regu late bottled water and this statement is outside the scope of this regulatory action.

Commenter Name: J. Hammond Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1374

EPA Comment ID: 20398

EPA Comment Code: 6120

Comment: Please keep our drinking water safe -- the EPA needs to regulate perchlorate.

Response: Please see the umbrella response under 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1388

EPA Comment ID: 20399

EPA Comment Code: 6120

Comment: PLEASE NO ROCKET FUEL IN OUR DRINKING WATER.

I'M AN AMERICAN CONSUMER AND VERY CONCERNED ABOUT OUR DRINKING

WATER AND ITS CONTAMINANTS. IT'S NO WONDER ALL OF US ARE PUTTING IN

WATER PURIFIERS.

PLEASE PROTECT OUR WATER AND ELIMIN ATE ALL POISONS SO WE CAN DRINK

PURE WATER.

Response: Please see the umbrella response under 6120.

Commenter Name: Julia Earl Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1389

EPA Comment ID: 20400

EPA Comment Code: 6120

Comment: As a children's environmental health advocate, I urge the EPA to keep perchlorate out of US drinking water supplies. This harmful ch emical has no place in drinking water supplies. Special populations including pregnant women, infa nts, children and those of child-bearing age are particularly vulnerable. Therefore, I urge the U. S. Environmental Protection Agency to reverse its preliminary determination on setting a regula tion for perchlorate in drinking water.

Thank You, Julia Earl, MSEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 737 of 1099 Response: See response to comment code 6120.

Commenter Name: Alisa Novelli Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1392

EPA Comment ID: 20401

EPA Comment Code: 6120

Comment: Please do not allow any amount of perchlor ate in our drinking water It is a harmful chemical that can impair the thyroid gland whic h controls growth, development and metabolism.

Thank you, Alisa Novelli

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1397

EPA Comment ID: 20402

EPA Comment Code: 6120

Comment: NO Perchlorate in our drinking water!!!

Response: See response to comment code 6120.

Commenter Name: E. Granata Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1398

EPA Comment ID: 20403

EPA Comment Code: 6120

Comment: I urge you to reconsider your preliminary decision not to regulate the presence of perchlorate in drinking water. This is a public he alth hazard that can be remedied easily with standards set by EPA.

Response: See response to comment code 6120.

Commenter Name: L. Haas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1399

EPA Comment ID: 20404

EPA Comment Code: 6120

Comment: Please reverse your decision regarding the re gulation of perchlorate. It is the EPA's responsibility to regulate any and all substances in drinking water.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 738 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1401

EPA Comment ID: 20405

EPA Comment Code: 6120

Comment: please do not allow rocket fuels in our drinking water

Response: See response to comment code 6120.

Commenter Name: P. Leitzel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1403

EPA Comment ID: 20406

EPA Comment Code: 6120

Comment: I have been informed that perchlorate is in rocket fuel and may soon be in our drinking water. What is with the EPA? You're here to pr otect the public, not poison us. Please do not deregulate the use of this substance. Thank you

Response: See response to comment code 6120.

Commenter Name: J. and M. V. Shaw Kline Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1406

EPA Comment ID: 20407

EPA Comment Code: 6120

Comment: Please reverse your decision not to regulate perchlorate in our drinking water. We are very short sighted when we do not protect our drinking water.

My vote is to regulate perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Mary Mintz Commenter Organization: Northeast Organic Farming Association (NOFA)

EPA Document ID: EPA-HQ-OW-2008-0692-1407

EPA Comment ID: 20408

EPA Comment Code: 6120

Comment: It is obvious that we need to monitor as many pollutants as possible in our water supply for our health....need we say more?

Response: See response to comment code 6120.

Commenter Name: Mary MintzEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 739 of 1099 Commenter Organization: Northeast Organic Farming Association (NOFA)

EPA Document ID: EPA-HQ-OW-2008-0692-1408

EPA Comment ID: 20409

EPA Comment Code: 6120

Comment: Please consider reversing your decision to re gulate perchlorate.....isn't this very toxic?

Think future.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1410

EPA Comment ID: 20410

EPA Comment Code: 6120

Comment: Please reverse you decision on not regulating percholate in our water supply. There are so many destructive chemicals in our water now it is freightening. There is no reason to allow this harmful contaminate into the water supply. Allowing this chemical in our water supply will affect the health and safety of everyone. Please do the righ t thing for all of us. Regulate the admission of percholate now.

Response: See response to comment code 6120.

Commenter Name: Heather Morgan Commenter Organization: Morgan Holistic Health

EPA Document ID: EPA-HQ-OW-2008-0692-1411

EPA Comment ID: 20411

EPA Comment Code: 6120

Comment: We,as health professionals, believe that Pe rchlorate needs to be removed completely from drinking water and water should be constant ly monitored to insure no levels of this toxic

chemical are detected. There is a health crisis in Am erica, and part of this is due to environmental toxic exposure and we need to take action NOW to reverse the levels of exposure that are compiling from all forms of exposure which cause diseases in our bodies. Clean water, free of chemicals, is the most important thing we can do for our health.

Response: See response to comment code 6120.

Commenter Name: L. Huggins Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1416

EPA Comment ID: 20412

EPA Comment Code: 6120

Comment: Please, reconsider your decision, you MUST regulate perchlorate in drinking water as safety of population is extremely important for th e future of the country and its resources.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 740 of 1099 Response: See response to comment code 6120.

Commenter Name: S. Kagen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1417

EPA Comment ID: 20414

EPA Comment Code: 6120

Comment: I protest this lackadaisical response to poison in our drinking water.

Here's an idea. Put a few drops of perchlorate into everything you drink, and everything you boil, like potatoes or broccoli. Wait two years and then get back to me on how your health is doing.

This will be overtuned in a heartbeat in a couple of months.

Do the right thing.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1420

EPA Comment ID: 20415

EPA Comment Code: 6120

Comment: Please regulate perchlorate so it canno t be added to our drinking water.

Response: Perchlorate is not added to drinking water. EPA has determined to regulate perchlorate, See response to comment code 6120.

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20416

EPA Comment Code: 6120

Comment: November 3,2008 Stephen L. Johnson, Administrator United States Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C.. 20460 RE: Preliminary Regulatory Determination on Perchlorate; Docket ID No. EPA-HQ- OW-2008-0068

Dear Administrator Johnson:

The Children's Health Protection Advisory Commi ttee (CHPAC) has been closely monitoring the Agency's approach towards perchlorate as a drinki ng water contaminant. Our March 2006 letter to you recommended that the Agency develop a federal Maximum Contaminant Level (MCL) for perchlorate. This recommendation was based upon the ability of perchlorate to disrupt thyroid hormone synthesis, lowering circulating levels of thyroid hormone, and the critical importance of thyroid hormone to brain development. Our concer n over perchlorate has focused on in utero andEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 741 of 1099 postnatal development, particularly for neonates w hose exposures can be considerably greater than adults, and who lack stores of thyroid hormone. The life-long consequences of impaired brain development are sufficient to merit setting a protec tive MCL for perchlorate. Further, setting an MCL would mandate testing of public water su pplies, and allow discovery of hot spots of

contamination.

We are writing to you again on perchlorate because in the Preliminary Regulatory Determination on Perchlorate dated Oct 10, 2008, EPA decided agains t setting an MCL. This decision was based upon
the establishment of a flawed benchmark, a Health Risk Limit (HRL) of 15 ug/L. This benchmark is clearly too high for infants as the Agency's own ca lculations show that an HRL of 15 ug/L would allow daily exposures to infants that are 2-5 time s higher than the Reference Dose (RfD) (Federal Register, Vol 73, No.198, Octobe r 10, 2008, 60262-60282). The Rf D is meant to be applied to everyone, yet in the case of perchlorate it is applied to adults but not infants. This decision does not recognize the science which supports the exquisite sens itivity of the developing brain to even small drops in thyroid hormone levels and the fact that neonates have much diminished stores of thyroid hormone relative to adults. The Agency must ensur e that this life stage is adequately protected.

Response: See response to comment code 6120.

Commenter Name: Melanie A. Marty, Ph.D. Commenter Organization: Children's Health Protection Advisory Committee

EPA Document ID: EPA-HQ-OW-2008-0692-0962

EPA Comment ID: 20424

EPA Comment Code: 6120

Comment: In summary, the CHPAC believes that all thr ee conditions for setting an MCL are met and that the Agency must set an MCL for perchlor ate. We request further communication with you and your staff regarding the Preliminary Regulatory Determination on Perchlorate. This is a critical and timely issue given the concerns over endocrin e disruption by thyroid-active agents of various types and their potential to interact with other neur otoxicants to impair early life brain development. While many of these other neurotoxicants (heavy metals, pesticides, PCBs) have been aggressively targeted by USEPA, the lack of re gulation of perchlorate is an obvious oversight that can readily be addressed. Thank you for your attention to this matter.

Sincerely, Melanie A. Marty, Ph.D., Chair Ch ildren's Health Protection Advisory Committee

Cc: Benjamin Grumbles, Assistant Administarto r, OW Cynthia Dougherty, Director, OGWDW Eric Burneson, Chief, Targeting and Analysis Branch, OGWDW

References:

Blount BC, Pirkle IL, Osterlob JD, Valentin-Blasini L, Caldwell K.L. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-1871.

Greer MA, Goodman G, Piens RC, Greer SE (2002) Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 742 of 1099 MADEP, 2006 Perchlorate Monitoring Resul ts - Confirmed Above 1.0 ppb (Available at http://www.mass.govidep/water/drinlcing/percinfo.htm)

Response: See response to comment code 6120.

Commenter Name: Wenonah Hauter Commenter Organization: Food & Water Watch

EPA Document ID: EPA-HQ-OW-2008-0692-1259

EPA Comment ID: 20425

EPA Comment Code: 6120

Comment: November 7, 2008

Water Docket Environmental Protection Agency 12 00 Pennsylvania Ave., NW Washington, DC

20460

RE: Docket ID No. EPA-HQ-OW-2008-0692

Food & Water Watch, a Washington DC-based consumer advocacy organization, opposes the Environmental Protection Agency’s Preliminary Regulatory Determination on Perchlorate.

Food & Water Watch hopes that the EPA will rec onsider this preliminary determination and will issue a national primary drinking water regulati on for perchlorate in accordance with the Safe Drinking Water Act.

Perchlorate has been found in the drinking water supply of 35 states and the District of Columbia. Widespread human exposure to perchlorate was confirmed by the Centers for Disease Control’s NHANES study, which found that 100 percent of the 2,820 randomly selected study participants had detectable levels or perchlorate in their ur ine.[FNi: Blount, Benjamin C et al. "Perchlorate Exposure of the US Population, 2001-2002." Jo urnal of Exposure Science and Environmental Epidemiology. 17: 400-407, 2007.]

The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroid gland’s iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive

effects for those affected.

The EPA’s failure to regulate perchlorate in drin king water act places consumers - especially pregnant woman and children - at risk.

In response to this misguided determination, the EPA’s own Children’s Health Protection Advisory Committee has drafted a letter expressing its con cern with the EPA’s decision not to regulate perchlorate. Members of the co mmittee claim that EPA rushed a decision on perchlorate without taking time to review all the latest peer-reviewed studies.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 743 of 1099 Given the vital importance of fetal central nervo us development not only for long-term health and development of children, but also for the viability of fetuses, why would the EPA rush to a decision? Unfortunately the only conclusion we can draw is that the EPA has issued this determination to avoid strapping the Department of Defense with costs to clean-up near military bases, missile testing sites and chemical plants. While millions of consum ers’ health is jeopardized, it seems the budget concerns of the Pentagon or White Ho use are driving EPA’s decision.

This determination is clearly another instance of a regulatory agency shrinking from its responsibility to protect the American public. Instead of fulfillin g your obligations under the SDWA, the EPA has once again folded to pressure.

Sincerely,

Wenonah Hauter Executive Director

Response: Please see response to comment code 6120.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20430

EPA Comment Code: 6120

Comment: November 6, 2008

Water Docket U.S. Environmental Protection Agen cy Mailcode 2822T 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Docket ID No. EPA-HQ-OW-2008-06 92. Drinking Water: Preliminary Regulatory Determination

on Perchlorate

The Massachusetts Department of Environmen tal Protection (MassDEP) is submitting the following comments in response to the United St ates Environmental Protection Agency’s (EPA’s) request for comment on its preliminary determination not to regulate perchlorate in drinking water at a national level, Docket ID No. EPA- HQ-O W-2008-0692 entitled "Dri nking Water: Preliminary Regulatory Determination on Perchlorate". These comments were prepared by scientists in the MassDEP Office of Research and Standards (ORS ) including Carol Rowan West, MPH, Director, ORS; Tsedash Zewdie Ph.D., Senior Toxicologist , ORS; and C. Mark Smith Ph.D., S.M., Deputy
Director, ORS.

1. A Health Protective National Standard is Need ed. MassDEP disagrees with EPA’s draft decision not to regulate perchlorate at the national level and believes that a health protective national drinking water standard for perchlorate is both warranted an d necessary to protect the health of our nation’s
children. Overall, EPA’s assessment does not ad equately support its determination to not regulate perchlorate for a sizeable number of United State’ citizens, by disregarding elevated exposures and potential developmental effects in the neonate. This decision is inconsistent with basic precepts of public health protection.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 744 of 1099 Response: See response to comment code 6120.

Commenter Name: Carol Rowan West Commenter Organization: Massachusetts Department of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1422

EPA Comment ID: 20436

EPA Comment Code: 6120

Comment: In conclusion, EPA’s determination that a na tional drinking water is not warranted is based on an incomplete assessment of the data and will place many of the nation’s most vulnerable
citizens, our newborn children and fetuses at an early stage of development, at risk. MassDEP believes that there is compelling evidence to su pport a national drinking water standard for perchlorate at a value well below EPA’s HRL of 15 ppb.

For further information please conta ct Carol Rowan West at 617-292-5510 (Carol.RowanWest@state.ma.us) or C. Mark Smit h at 617-292-5509 (C.Mar k.Smith@state.ma.us).

References

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL (2006). Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-1871.

Burgi H, Benguerel M, Knopp J, Kholer H, and Studer H (1974). Influence of perchlorate on secretion of non-thyroxin iodine by the normal huma n thyroid gland . Europ J Clin Invest 4:65-69.

CA EPA (2004). Public Health Goal for Pe rchlorate in Drinking Water. Pesticide and

Environmental Health Hazard Assessment. Ca lifornia Environmental Protection Agency.

Dasgupta PK, Kirk AB, Dyke JV, and Ohira S-I (2008). Intake of iodine and perchlorate and

excretion in human milk. Environ Sci Technol 14:815-8121.

Ginsberg GL, Hattis DB, Zoeller RT, Rice DC (2007). Evaluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater: focus on exposure to nursing infants. Environ Health Perspect 115:361-369.

Ginsberg GL, Rice DC (2005). The NAS perchlora te review: questions about the perchlorate RfD. Environ Health Perspect 113:1117-1119.

Greer MA, Grim Y, Inoue K (1969). Fate of iodide de rived from intrathyroidal hydrolysis hydrolysis f thyroglobulin. Endo crinology 85:837-845.

Isaacs GH, Athans, JC, Rosenberg IN (1966). Eff ects of thyrotropin upon thyroidal iodide. Studies using thyroid venous cannulation and two ra dioiodine isotops. J Clin Invest 45:758

NRC (2005). Health Implications of Perchlor ate Ingestion. In. Washington D.C.: National

Academies Press.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 745 of 1099 MassDEP (2006). Update to Perchlorate Toxi cological Profile and Health Assessment. Massachusetts Department of Environmental Pro tection, Office of Research and Standards.

Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin -Blasini L, Braverman LE (2007). Breast milk iodine and perchlorate con centrations in lactating Boston-area women. J Clin

Endocrinol Metab 92:1673-1677.

Rosenberg IN, Athans JC, Behar A (1961). Thyrotropi n induced release of iodide from the thyroid. Endcrinology 69:438-455.

Sinha RA, Pathak A, Mohan V, Bandyopadhyay S, Rastogi L, Godbole MM (2008). Maternal thyroid ormone: a strong repressor of neuronal nitric oxide synthase in rat embryonic neocortex. Endocrinology 149:4396-4401.

Steinmaus C, Miller MD, Howd R (2007). Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 na tional health and nutrition examination survey. Environ Health Perspect 115:1333-1338.

Tellez R, Michaud Chacon P, Reyes Abarca C, Blount BC, Van Landingham CB, Crump KS, Gibbs JP (2005). Long-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the ne onatal period. Thyroid 15:963-975.

US EPA (2002). Perchlorate Environmental Cont amination: Toxicological Review and Risk

Characterization. United States Environmenta l Protection Agency, Office of Research and Development, NCEA-1-0503, External Review Draft.

Wolff, J. (1988). Perchlorate and thyroi d gland. Pharmacol Rev 50: 89-106.

Zoeller RT (2006). Collision of basic and applied appr oaches to risk assessment of thyroid toxicants.

Ann N Y Acad Sci 1076:168-190.

Zoeller RT, Rice DC (2004). Critical effect of pe rchlorate on neonates is iodide l Pharmacol 40:376- 377; author reply 378-379.

Response: See response to comment code 6120.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20447

EPA Comment Code: 6120

Comment: November 10, 2008

Water Docket Environmental Protection Agency Ma il Code: 2822T 1200 Pennsylvania Ave, NW Washington, DC 20460 RE: Dock et ID No. EPA-HQ-OW-2008-0068

To Whom It May Concern:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 746 of 1099 Thank you for the opportunity to provide comments on the Preliminary Regulatory Determination on Perchlorate in Drinking Water proposed by USEP A, which was published in the Federal Register of October 10, 2008 (73 Fed. Reg. 60262-82 (O ctober 10, 2008)). On October 7, 2005 the New Jersey Department of Environmental Protection ( NJDEP) received from the New Jersey Drinking Water Quality Institute (NJDWQI), a legislatively created public advisory body, a recommendation to establish an MCL for perchlorate of 5 ug/L . The Department plans to propose such an MCL including monitoring and compliance determination requirements before the end of 2008 with adoption later in 2009. The NJDEP believes that ha ving an MCL for perchlorate is good public health policy for both New Jersey and for the country as a whole.

There are two aspects of the propos al on which we would like to Comment: 1) the proposal of a health reference leve l (hrl) for perchlorate of 15 ug/l. It is our understanding that an hrl is a drinking water conc entration intended to protect individuals, including sensitive subgroups, from adverse effects resulting from a lifetime of exposure, similar to a lifetime health advisory or a maximum contaminant level go al. 2) The decision not to develop a regulatory standard (mcl) for perchlorate, and to develop guidance (a health advisory) instead, based on population exposed above the hrl.

Response: This is not a comment, a response is not necessary.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Dept. of Environmental Protection

EPA Document ID: EPA-HQ-OW-2008-0692-1526

EPA Comment ID: 20452

EPA Comment Code: 6120

Comment: Based on the above comments, we strongly ur ge USEPA to reconsider its conclusion that 15 ug/L is a health protective concentration fo r perchlorate in drinking water. We also strongly urge USEPA to reconsider its determination to not regulate perchlorate. The New Jersey Drinking Water Quality Institute recommendations regarding perchlorate can be found at http://www.nj.gov/dep/watersupply/perchlorate_mc l_10_7_05.pdf. For further information or clarification about our position, contact Dr. Eileen Murphy at 609-984-6070, or Eileen.murphy@dep.state.nj.us .

Sincerely,

Jeanne Herb, Director, Office of Policy and Planning

C: Michele Putnam, NJDEP Eileen Murphy, NJDE P Barker Hamill, NJDEP Sandra Krietzman, NJDEP Betty Boros-Russo, NJDEP Gloria Po st, NJDEP Perry Cohn, NJDHHS Mark Robson, Chair, New Jersey Drinking Water Quality Institute

Citations

Brown, R.S., Huang, S.A. and Fisher, D.S. (2004). The matura tion of thyroid function in the perinatal period and during childhood. In: The Th yroid. A Fundamental and Clinical Text. 9th Edition. Braverman, L.E. and Utiger, R.D., eds. , Lippincott Williams & Wilkins, Philadelphia.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 747 of 1099 NRC (2005). Health Implications of Perchlora te Ingestion. National Research Council Board on Environmental Studies and Toxicology. The Nati onal Academies Press, Washington, D. C. www.nap.edu

Van den Hove, M.F., et al. (1999). Hormone synthe sis and storage in the thyroid of human preterm and term newborns: effect of thyroxin e treatment. Biochimie 81:563-570.

Zoeller, R.T. and Rice, D.C. (2004). Critical e ffect of perchlorate on neonates is iodide uptake inhibition (Letter to the editor). Regulatory To xicology and Pharmacology, 40(3): 376-377.

Response: EPA has determined to regulate, See response to comment code 6120. Once the National Primary Drinking Water Regulation is fina l, EPA will consider revisions to the health advisory.

Commenter Name: Gregg Grunenfelder Commenter Organization: Washington State Department of He alth; and Oregon Department of

Human Services

EPA Document ID: EPA-HQ-OW-2008-0692-1529

EPA Comment ID: 20453

EPA Comment Code: 6120

Comment: November 10, 2008

Docket ID No. EPA-HQ-OW-2008-0692

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, Northwest Washington, DC 20460

To Whom It May Concern:

Recently, the US Environmental Protection Agency (EPA) solicited comments for an action notice placed on the Federal Register relating to a preliminary regulatory determination for perchlorate in drinking water. The agency stated that levels of perchlorate found in drinking water systems were

not at levels of concern and that there was no meaningful opportunity for health risk reduction through a national drinking water regulation. The Washington State Department of Health and the Oregon Department of Human Services disagree with EPA’s conclusion and recommend that EPA reconsider the need for a national drinking water standard for perchlorate.

Extensive use and improper disposal of this highly water-soluble compound has led to groundwater contamination throughout the United States. To da te, the extent of groundwater contamination has
not been well characterized. It is known, however, that here in the northwest low levels of perchlorate have been found in groundwater in some tested areas of eastern Washington and Oregon.

Response: See response to comment code 6120. Regarding commenter’s statement “...Extensive use and improper disposal of this highly wa ter-soluble compound has led to groundwaterEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 748 of 1099 contamination throughout the United States”, prope r disposal of perchlorate is required by EPA’s RCRA regulations and this subject matter falls outside of the scope of this regulatory action.

Commenter Name: James Barton Commenter Organization: Underwater Ordnance Recovery

EPA Document ID: EPA-HQ-OW-2008-0692-1531

EPA Comment ID: 20460

EPA Comment Code: 6120

Comment: Opposition to EPA's Decision to Not Regula te Perchlorate - A Threat to the Great

Lakes

James Barton, President - Underwater Ordnance Recovery jamesbarton@uwuxo.com Steve Pollack ESQ, - Director Blue Eco Legal Council steve@ecoesq.com

Removal of an estimated one million tons of unex ploded ordnance and bulk containers abandoned on the floor of the Great Lakes is unlikely if the US EPA decision to deregulate perchlorates stands. Perchlorates are the most persistent munitions constituent leaching from decaying military explosives abandoned in a marine environment. Al ready beginning to show up at certain lakefront municipal water treatment facilities on both the US an d Canadian sides, deregulation of perchlorates

threatens the essential rational for removal of these "point source" emitters of perchlorates, and sets the stage for irreversible and unnecessary perchlorate contamination of the Great Lakes.

Rocket fuel is commonly provided as the most lik ely source for perchlorate contaminated drinking water. While perchlorates are used for that pu rpose, they are also a major component of conventional military explosives. Prior to WWII, Ge rmany manufactured an entire class of civilian explosives based solely on perchlorates, and throughout WWII Russia manufactured numerous types of explosive filled projectiles containing up to 89% perchlorates by volume. The percent by volume of perchlorates used in period manufacture of US military explosives vary but 25% is a

conservative number overall.

Unaware of the impending threat to the United States and Canadaâ€TMs shared strategic asset
known as the Great Lakes, the US Environmenta l Protection Agency is said to have bowed to pressure from the Pentagon, according to US Senate Environmental Committee Chair, Senator Barbara Boxer (D-CA), adding; "To see the Bush EPA just walk away is shocking". Paul Yaroschak, Pentagon Deputy Director for Emerging Contaminants denies this, saying; "We have not intervened in any way", adding "The EPA decision was based on the Safe Drinking Water Act".

The EPA has identified over 400 land based active or formerly used defense sites across 35 states where perchlorates have already been detected at dangerous levels in local aquifers, affecting an untold number of adjacent communities. Most of th ese sites have had little exposure to rocket fuel, but do have a documented history of military high explosive use or manufacture. Soils contaminated with decadeâ€TMs worth of perchlorate laden high explosive residues have become "non- point" sources of pollution, and are as difficult and costly to remediate as the aquifers they continue to pollute every time it rains. By contrast, unexploded munitions and other defense wastes intentionally dumped and abandoned on the floor of the Great Lakes remain largely intact due to cold fresh waters, and fit the classic description of "point so urce" emitters of pollutants that can and must be

eliminated.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 749 of 1099 The most common critical pathway for perchlorate to enter the human body is through contaminated drinking water. It primarily attacks the thyroid gland where it slows metabolic rate, which is why it was once used to fatten livestock and poultry before being linked to breast and testicular cancer. The thyroid glands of children are most susceptible to perchlorates, which can also be transferred to the fetus maternally. Women ar e said to be ten times more susceptible to perchlorate uptake than men.

The incredible persistence of perchlorate gives it the ability to migrate far from its point of origin, including into crops. Because of this persistence, the technical and economic challenges involved in attempting to eliminate perchlorate once it has ente red an ecosystem illustrate that removal of point

sources is the most economical course of action. Mu ch of southern California for instance, is already forced to use perchlorate laced waters from the Colorado River, contaminated from a single DoD managed perchlorate manufacturing facility that used unlined retention ponds and operated in the
middle of the Nevada desert; miles away from the Colorado River.

Some might be surprised to learn the scope of the problem in the Great Lakes, and canâ€TMt imagine how or why it happened. The question is what we are going to do about it. Ask a Great Lakes resident and the answer is a foregone c onclusion; pull the munitions and related defense

wastes out of the Lakes before itâ€TMs too late. While few are aware that high explosive filled munitions provide a substantial source of perchlor ates, large numbers of munitions found elsewhere in a more advanced state of decay have been lin ked to a decline in fisheries. Where others were helpless to address such problems due to a lack of removal technology, we are not; but in fact are on the verge of choosing a similar fate.

The prime directive of the US Department of Defe nse is defending this nation against international strategic threats, and the projection of US influence and power; not long term domestic environmental threats, especially the ones they had a hand in creating. Allowing any waste originator into the decision making process regarding toxic waste clean up is a foolâ€TMs game; and the DoDâ€TMs dismal track record pertaining to unde rwater unexploded ordnance clean up bears this out. Where considerable resources are being devo ted to protect the health and economic viability of

individual communities from land based defense wa stes that you can see; the health and economic viability of a nation is being neglected for what you canâ€TMt.

Ask a US defense official what we are going to do about the defense wastes in the Great Lakes, and if you can get past the debate on whether the threat justifies remedial action, he will ask you who is going to pay for the clean up. At the upper levels in the Pentagon itâ€TMs all about the money, and how long you can delay spending a dime on anythi ng other than your prime directive. While that approach has worked well for them in the past, time is running out for the rest of us.

Deregulating perchlorate will not make it go away nor mitigate its harmful effects; using the Safe Drinking Water Act to justify it is an affront to our national identity; and its impact on the Great Lakes is a threat to our national security.

This action is clearly not the will of the men and women who proudly serve the US EPA, and does a disservice to the citizens whose interests they re present. Therefore, the decision to deregulate perchlorates must be delayed until after res ponsible leadership returns to the White House.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 750 of 1099 James Barton is an international expert on underwater ordnance, and regarded by some as the worlds leading expert on the subject.

Steve Pollack is the Director of Blue Eco Legal Council, specializing in environmental pollution at

federal facilities.

Response: See response to comment code 6120. EPA acknowledges commenter’s concern about the clean up of perchlorates in areas that serve as point source contamination to water, including The Great Lakes. The clean up of perchlorate contam ination in the United States is related to EPA’s CERCLA regulations and this subject matter falls outside of the scope of this regulatory action.

Commenter Name: J. Green Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0148

EPA Comment ID: 20461

EPA Comment Code: 6120

Comment: This is a Public Comment Regarding EPA’s refusal to regulate Perchlorate under the Safe Water Drinking Act (Docket ID EPA-HQ-OW-2008-0692):

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. Not regulating this harmful chemical in our drinking water is unacceptable.

Perchlorate is found in drinking water in 35 st ates, and according to the EPA’s own data, 16 million Americans are at risk of being exposed to this dangerous chemical.

Response: See response to comment code 6120.

Commenter Name: J. Green Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0148

EPA Comment ID: 20463

EPA Comment Code: 6120

Comment: Native Americans and Hispanics are especially vulnerable in New Mexico, as we have so many military weapons production facilities here. Perchlorates way beyond allowable parts per billion have been found in groundwater and streams. It is unacceptable to sacrifice the health of people and the environment for the sake of military-industrial profit. The EPA is our only recourse for protection from being poisoned to death by ou r own government. Please do your job EPA and enforce our clean water laws. Thank you.

Response: See response to comment code 6120.

Commenter Name: Vicky and Bll Clary Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0622

EPA Comment ID: 20464EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 751 of 1099 EPA Comment Code: 6120

Comment: Docket Identification (ID) Number: EPA-HQ -OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

I am writing to express my concern regarding the EPA's failure to regulate perchlorate, as well as the proposed reference level, which fails to pro tect - and will adversely affect -- the health and development of hundreds of thousands, perhaps millions of American children.

If the dangers we even only restricted to 17 milli on people alone that would be enough to take a more serious look at regulating, but the numbers of people affected is more like 20 to 40 MILLION + ! Already synthyroid is the number two prescribed medication in the country. This a drain on the insurance companies not to mention the devistation thyroid desease causes the patient. This chemical has been shown to cause thyroid problems. As a thyroid patient I can tell you every day is a struggle to keep control of my symptoms and I woul d not wish it on any one especially our children!

Response: See response to comment code 6120.

Commenter Name: Eric Keller Commenter Organization: Phi Alpha Delta, University of Detroit Mercy

EPA Document ID: EPA-HQ-OW-2008-0692-1428

EPA Comment ID: 20466

EPA Comment Code: 6120

Comment: The regulation of perchlorate in our nation's water ways is rationally needed. From our drinking water to storm drains; streams into lakes; swamps to our forests; our land to our produce; into our wildlife and livestock, even our families, friends, and children, this regulation is needed. Our
constitution demands this of us, and we must not be divided in makiong this stand; for our states,

for our nation.

The People, their representives, the courts, the administration, they all have a ligitimate use of authority to provide for and protect ourselves. It would be an unjustice to the american people in allowing this pollutent to contaiminate our nation, in this way, and amount, any longer. Halfmeasures have to be stopped. We must take a firm stand, here and now, to show the american people, individuals and businesses, government an d religion, neighbors and strangers, freinds and fowes, all over the world that the american government, its agencies, like the Environmental Protection Agency, are not going to stand idely by , and watch pollutants or contaiminates distroy our environment and severilly harm human beings and other inhabitants of this planet. We are reasonable,rationial, understanding, and forgiving, but we can not afford to be ignorant or blind, we can not afford to be walked over and abused any mo re, no matter in what situation, isuues, or relm.

Please take a stand, and strictly,within reasoning and speed, regulate perchlorate, (and other contaiminates and/or pollutants like) it is our duty to our posterity.

Thank you for your time, consideration, and civil service,

Respectfully,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 752 of 1099 Eric Keller Vice President, Phi Alpha Delta University of Detroit Mercy kelleree@students.udmercy.edu

Response: See response to comment code 6120.

Commenter Name: P. Pasles Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1431

EPA Comment ID: 20467

EPA Comment Code: 6120

Comment: I am writing to ask the EPA to reverse its preliminary decision that it will not regulate perchlorate in drinking water. I am the father of two small children, and I also have some professional training that allows me to understand the health issues (which have been established with the aid of statistical analysis-- I am a mathem atician). Even a small amount of perchlorate can affect growth, and can cause other long-term health problems as well. It is prevalent in our water supply all over this country, and the EPA needs to show leadership on this issue so that standards

are set at a national level.

Response: See response to comment code 6120.

Commenter Name: T. Novak Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1433

EPA Comment ID: 20468

EPA Comment Code: 6120

Comment: Just DO THE RIGHT THING!!!!!! Why in the world would you ever allow ANY rocket fuel into our drinking supply?

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1435

EPA Comment ID: 20469

EPA Comment Code: 6120

Comment: "I understand the dangers of perchlorate an d ask you to keep the testing requirement intact for our public drinking water supplies. Re moval of the testing requirement would eliminate detection of perchlorate in the case of accidental or intentional c ontamination of drinking water supplies, such as the Tewksbury Massachusetts contamin ation in 2004." . As a parent of 3 children, I feel it is vital to continue monitoring for this, and other contaminents. Thank you

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. See response to comment code 6120.

Commenter Name: D. WaggonerEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 753 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1440

EPA Comment ID: 20470

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: M. Sonnenblick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1441

EPA Comment ID: 20471

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills. As a public school educator we are seeing more and more children with educational deficits, including le arning disabilities, autism/Asperger's disorders, speech and language needs, and occupational therapy issues. These are expensive to remediate and often cause life-long struggles for the children and th eir families. We need to decrease the risk of babies developing these problems. Please regulate perchlorate and all other risky chemicals found in drinking water supplies.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1444

EPA Comment ID: 20472

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

As a registered nurse and a mother, I am concerne d about the effects of low levels of perchlorate contamination on human thyroid function, and the c onsequent harm to developing fetuses, infants

and children.

Response: See response to comment code 6120.

Commenter Name: G. Bastien Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1446

EPA Comment ID: 20473EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 754 of 1099 EPA Comment Code: 6120

Comment: Perchlorate should not be used in drinking water because of the threat to endocrine system. thyroid disruption is not something to be trifled with because of it overall impact on mood, general health, etc.. Mammalian studies have sent out warnings to public health officials giving us a choice to use greater filtration in better water tr eatment plants while we clean up our ground and

surface water.

I urge the EPA director to reverse the decision to allow the use of perchlorate in our water treatment plants.

Sincerely,

Greg Bastien 2709 E. Minnehaha Parkway Minneapolis, MN 55417

Response: See response to comment code 6120.

Commenter Name: Tom Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1450

EPA Comment ID: 20474

EPA Comment Code: 6120

Comment: Please regulate and limit Perchlorate emissions.

Perchlorate has been shown to damage the thyroid at very low concentrations, which in turn can lead to developmental problems, particularly in children.

Thank you. Tom

Response: See response to comment code 6120.

Commenter Name: M. J. Strawn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1451

EPA Comment ID: 20475

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. Perchlorate contamination is a nationwide problem which has health impacts at lower levels than previously thought.

EPA agrees that perchlorate has been found in 39 5 sites in 37 states, including 153 public water systems serving over 20 million people -- and othe r estimates of human perchlorate exposure are higher.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 755 of 1099 Even in small amounts, perchlorate can impair the thyroid gland, which controls growth, development, and metabolism. Developing fetuses, infants, and children with thyroid impairment may suffer mental retardation, loss of hearing and/or speech, or deficits in motor skills.

Exposure via drinking water occurs constantly, ever y day, for extremely long periods of time. EPA should not shirk its responsibilities to ensure the safety of twenty million people via this route.

Please regulate the amount of perchlorate in dr inking water. Twenty million Americans are counting

on you.

Response: See response to comment code 6120.

Commenter Name: J. Hudson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1454

EPA Comment ID: 20476

EPA Comment Code: 6120

Comment: I am concerned about the decision not to re gulate perchlorate in our drinking water. Since this agent is so widespread in our country-found in 37 states-it seems even more critical to both regulate and monitor its effect on such a huge segment of the population.

I hope the EPA will reconsider this decision for the he alth of all, but especially the very young and

the unborn.

Thank You

Jim Hudson

Response: See response to comment code 6120.

Commenter Name: M. Nolasco Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1464

EPA Comment ID: 20477

EPA Comment Code: 6120

Comment: I am writing to urge the US EPA to reverse its determination not to set a regulation for perchlorate in drinking water.

The health impact of percholate contamination is a nationwide problem.

Please keep this out of our drinking water.

M. Nolasco

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 756 of 1099 Commenter Name: T. Bell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1465

EPA Comment ID: 20478

EPA Comment Code: 6120

Comment: I am very concerned that we, as a country, are not doing more to insure clean and safe water standards. More and more compounds in our water have been found to have adverse effects in extremely small amounts that are currently legal. To relax or expand allowable amounts of trace poisons that hurt our children and county is just not right.

Response: See response to comment code 6120.

Commenter Name: Leslie McCollom Commenter Organization: O'Hanlon, McCollom & Demerath

EPA Document ID: EPA-HQ-OW-2008-0692-1467

EPA Comment ID: 20479

EPA Comment Code: 6120

Comment: My name is Leslie McCollom, and I am a priv ate individual who practises law in Austin,
Texas, at 808 West Avenue, Austin, Texas 78701 . I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. The reasons for my objections to your agency's preliminary determination is because perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought, according to research I have reviewed. I see no need to list all of the sources, since I am assuming that your agency has done its homework and reviewed all available data, research, and opinion on the effects of this chemical. A national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Perchlorate is a harmful chemical used in rocket fu el, flares, and explosives. Perchlorate, even in small amounts, can impair the thyroid gland, wh ich controls growth, development and metabolism. Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills as a result of consuming this chemical It is my understanding that the EPA agrees that perchlor ate has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. Under these circumstances, I believe the EPA has a legal duty to set a standard for this harmful chemical in drinking water, as well as in any an d all bodies of water that are subject to regulation

under the Clean Water Act.

Leslie McCollom O'Hanlon, McCollom & Demerath 808 West Avenue Austin, Texas 78701 (512)

494-9949

Response: See response to comment code 6120.

Commenter Name: SueAnn Hurley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1459

EPA Comment ID: 20480EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 757 of 1099 EPA Comment Code: 6120

Comment: To Whom it may concern: I urge the EPA to reverse your recent decision not to regulate perchlorate in public drinking water. It is too risky and dangerous. Thank you, SueAnn Hurley

Response: See response to comment code 6120.

Commenter Name: J. Egan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1455

EPA Comment ID: 20481

EPA Comment Code: 6120

Comment: Maintaining current standards for perchlorate content is needed to clean up existing ground water contamination and prevent future spills. Although the cost is significant, the degradation of our environment is more costly; in increased health care costs, loss of productivity,

and land value.

Response: This is not a comment. No response necessary.

Commenter Name: Richard, Alison, Henry Whittaker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1473

EPA Comment ID: 20482

EPA Comment Code: 6120

Comment: I am writing in support of maintaining high standards of water purity -- keeping perchlorate OUT of drinking water. Friends and family suffer from thyroid problems and perchlorate has been linked to thyroid problems. DO NOT RELAX any standards that would allow perchlorate in our drinking water. Richard, A lison & Henry Whittaker 103 Marin Street San Rafael

CA 94901

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1474

EPA Comment ID: 20483

EPA Comment Code: 6120

Comment: PLEASE reconsider your position on Perchl orate. While the pharmaceutical companies may like things just the way they are, we have to pr otect the public, especially children. With all the endocrine and other health problems plagueing this country, we need to reduce the amount of toxins that go into our bodies.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 758 of 1099 Commenter Name: Ann Galbraith Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1477

EPA Comment ID: 20484

EPA Comment Code: 6120

Comment: Good Day, I am writing to urge you to disallow perchlorate in drinking water sources because it can create more impacts on human health than previously recognized. Since it your mission to protect public health, it seems obvio us that you would act now to pull back on the decision to allow "safe" levels of this dang erous threat. Thank you, Ann Galbraith Miller

Response: See response to comment code 6120.

Commenter Name: Susan Dunham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1478

EPA Comment ID: 20485

EPA Comment Code: 6120

Comment: Please reconsider the consequences of not regulating perchlorate. Is this water you will be drinking? Is this water your family will be drin king? If it were, would you be making this decision knowing the harmful effects perchlorate can have on the health of the people who are exposed to it. We have had enough with the past administration l ooking the other way in other situations. Let's not

continue down the same road. You are the indi viduals that Americans hold responsible for our health and well being. If we can't count on you to do your jobs who can we count on? By choosing to support national regulations on public drinking water we know we can continue to trust you with health related issues. Please reverse your decision.

Sincerely, Susan Dunham

Response: See response to comment code 6120.

Commenter Name: T. Bramwell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1479

EPA Comment ID: 20486

EPA Comment Code: 6120

Comment: we need percholate testing in our water, and we need to move toward the banning of percholate that is enhanced by man- made action, or lack of action.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1480

EPA Comment ID: 20487

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 759 of 1099 Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: T. O'Brien Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1484

EPA Comment ID: 20488

EPA Comment Code: 6120

Comment: All possible steps need to be taken to elimina te or reduce to safe levels all contaminants in our drinking water. You need to protect our health.

Response: See response to comment code 6120.

Commenter Name: Molly P. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1486

EPA Comment ID: 20489

EPA Comment Code: 6120

Comment: To the U.S. Environmental Protection Agen cy: I am a normal 30 year old professional woman from MN and was shocked and disgusted to learn about the EPA decided to not regulate perchlorate in drinking water. Please reverse your preliminary determination on setting a regulation for perchlorate in drinking water! It should be the goal of the EPA to protect the health and welfare of Americans, not to gamble with our future by allowing the contamination of our nation's water supply! In Minnesota we are now seeing the cons equences of poor decisions like the one you are about to make. In many lakes and rivers it is no longer save to catch and eat fish, some waters are even unswimable. Consider the quality of limited resources you will be leaving for children and grandchildren. Do not take chances with somethin g as critically important as keeping our nation's drinking water clean!! Thank you for your consideration, Molly P.,Minneapolis, MN

Perchlorate FACTS: Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought;

a national primary drinking water regulation wo uld provide a meaningful opportunity to protect public health.

Perchlorate is a harmful chemical used in rocket fuel, flares, and explosives.

Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism.

Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 760 of 1099 EPA agrees that perchlorate has been found in 39 5 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1490

EPA Comment ID: 20490

EPA Comment Code: 6120

Comment: It is a generally acknowledged fact that our planet is suffering from the dangerous effects of human industrialization, most publicly understood as global warming. More and more people are working to become responsible stewards of the earth by consuming less, buying organic and recycling; all the while an insidious danger flows quietly beneath our feet.

Perchlorate is an environmental danger wide ly known amongst scientific communities and government agencies, yet virtually unheard by the public. So much research has been done on the existence of perchlorate contamination in our wate r, food and milk supplies, and yet nothing is being done to regulate it. Much worse than a passive lack of action, is the very active suppression by certain U.S. agencies to protect their very specifi c interests, at the great expense to our country's

environment and the health of those who inhabit it.

The EPA's website is full of information on how to contribute to the health of the environment from our classrooms to our beaches, from "pur chasing green" to reducing water waste. It's wonderful to see the EPA helping people to make a positive impact on an individual level.

Isn't it time for the EPA to take a responsible stand and make the decision to regulate perchlorate in drinking water? Please, help protect the health of our people, ecosystems and future. Without water, we are nothing.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1492

EPA Comment ID: 20491

EPA Comment Code: 6120

Comment: As someone who now suffers from thyroi d dysfunction after many years of normal thyroid function, I urge the EPA to reconsider th eir decision to allow perchlorate contamination in our drinking water.

Response: See response to comment code 6120.

Commenter Name: AnonymousEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 761 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1494

EPA Comment ID: 20492

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

1. As a consumer, I depend on the EPA to protect my health. 2. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; 3. Since even small amounts can impair development and metabolism, the EPA should err on the side of caution and keep perchlorate out of the water supply.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1495

EPA Comment ID: 20493

EPA Comment Code: 6120

Comment: If we cannot be assured of CLEAN drinking wa ter because of a lax EPA, this country is

in serious trouble!

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1500

EPA Comment ID: 20494

EPA Comment Code: 6120

Comment: All pollutants and contaminants to drinking water must be monitored and reported. Public interest demands this to protect the health of the public. Transparency is essential to good governance and to democracy itself. Perchlorate is in no way naturally found in water and is harmful to human health. The EPA must not lower standards. Its responsibility is to the public and not to particular industrial or corporate interests.

Response: See response to comment code 6120.

Commenter Name: R Cooper Jr. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1501

EPA Comment ID: 20495

EPA Comment Code: 6120

Comment: Any foreign substance in our drinking water is serious and is not acceptable. "Perchlorate," a jet fuel additive, is pure negligence to be tolerated in public drinking water that isEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 762 of 1099 consumed and used for cooking and bathing purpos es by innocent families and their children. We don't need deliberate health threats to our population to add to their already stressed state of health. Please consider the consequences and act on impr oving actions on this social issue. Every man, woman, and child is involved in this life threatening situation.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1502

EPA Comment ID: 20496

EPA Comment Code: 6120

Comment: I am dismayed at the EPA's preliminary deci sion not to regulate perchlorate in drinking water. Perchlorate has been shown to inhibit prope r function of the thyroid. As the father of a young son, and another child on the way, I am extremely concerned about dangerous chemicals present in our drinking water. Even a small reducti on in thyroid function results in a loss of IQ, and increased behavioral problems. The EPA was on a sensible course to limit exposure to this dangerous chemical around 2002. I am appalled that the safety of our children is being ignored due to political considerations. I have been extremely up set at the course the EPA has taken over the last 8 years, allowing the White House and politics to sway decisions that should be made based on science and for the health and safety of the American people.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1504

EPA Comment ID: 20497

EPA Comment Code: 6120

Comment: We need regulation of perchlorate in our drinking water.

Response: See response to comment code 6120.

Commenter Name: A.M. Guckin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1506

EPA Comment ID: 20498

EPA Comment Code: 6120

Comment: I am very concerned about the safety of US public water drinking water supplies. Keep the perchlorate out of the water. Test for it.

When contaminants are found, everyone in the region that uses that source for their household water needs to be informed and advised how to avoid consumption of the contaminants. We do not want to be forced to buy bottled drinking water - especially when we don't know what level of contaminants are permitted in the bottled water supply.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 763 of 1099 Thank you for your attention and please do all possible to insure that we have clean, safe drinking

water.

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. Please See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1507

EPA Comment ID: 20499

EPA Comment Code: 6120

Comment: I am asking the Environmental Protecti on Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. We need to PROTECT

OUR EARTH BECAUSE IT IS WHAT IS PROTECTING US. If we continue to violate and contaminate and pollute our earth, WE are the one s who suffer now and will suffer even more, until we make ourselves and other species totally extinct.

Response: See response to comment code 6120.

Commenter Name: D. Smythe Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1509

EPA Comment ID: 20500

EPA Comment Code: 6120

Comment: The determination of whether to control the level of perchlorate contaminates in drinking water supplies by the EPA has taken at le ast six years. Drinking water, groundwater or soil

in hundreds of locations in at least 43 states is polluted with perchlorates. In 2004, eight states had advisories for perchlorate in drinking water, ra nging from 1 to 18 parts per billion. Given the geographical magnitude of the problem and the diversi ty of current regulation, it is imperative that we have a Federal standard to protect ever yone in the United States equally.

That standard should recognize the scientific study that has gone on to determine a safe level, and should not be politicized or modifi ed to suit defense contractors.

Please set a standard of no more than 2 parts per billion.

Response: See response to comment code 6120.

Commenter Name: L. Brooks Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1512

EPA Comment ID: 20501

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 764 of 1099 Comment: Please make testing mandatory for Perchlora te in out drinking water. We need to be vigilent in maintaining our most valuable resources of fresh water vital to the good health of the general public.

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. Please see res ponse to comment code 6120.

Commenter Name: Nancy Stefanou Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1514

EPA Comment ID: 20503

EPA Comment Code: 6120

Comment: As a citizen, I ask you to remember your responsibilities to 'protect' (as in the Agency name) public interests. The umbilical cords of n ewborns are already show ing the presence of an alarming number of chemicals...pr eventing exposure is vastly preferable to damage control. Again, please remember who you serve.

Thank you, Nancy Stefanou 2582 Black Pine Trail Troy, Mi 48098

Response: This is not a comment, a response is not necessary.

Commenter Name: Lesley Cox Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1516

EPA Comment ID: 20505

EPA Comment Code: 6120

Comment: Perchlorate exposure recommended by Nationa l Academy of Sciences and adopted by EPA is an RfD of 0.7 μg/kg bw/day, this is daily exposure level over a lifetime that is not expected to cause adverse health effects. We already know perchlorate is in some public drinking water systems and in some foods. It makes no obvious se nse to ignore it. We have methods to test for detection, why not use them? EPA is our regulatory agency for protecting our country's drinking water. Do your job!!!!

Lesley Cox Carrabelle, FL

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1517

EPA Comment ID: 20506

EPA Comment Code: 6120

Comment: As a resident of Tewksbury, MA and a journalist, I urge that the EPA require perchlorate testing of drinking water. I know th e potential dangers of perchlorate to women and infants due to an corporate dumping of perchlorate into the Merrimack River in Massachusetts inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 765 of 1099 2004. That dumping went straight into Tewksbury's water supply, preventing residents from drinking the water for several weeks and costing the town a tremendous amount of money to locate the problem, stop the problem, and ensure the quality of the water. Testing public water supplies, particularly those drawn from rivers, ensures earl y detection of tainted water and early notification of at risk populations. Further, regular testing and ea rly detection helps identify polluters early and stop the pollution. Not testing for perchlorate in the wa ter supply is irresponsible from a public health and environmental perspective.

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. Please see the response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1519

EPA Comment ID: 20507

EPA Comment Code: 6120

Comment: we do not want perchlorate in our drinking water. it is clear we need to punish those in the federal govt who are not taking steps to protect americans. i note that the dept of defense of our own govt is one of the worst polluters. those in charge at this agency should go to jail for their lifetimes for poisoning fellow americans. no perchlor ate in our drinking water should be allowed.

Response: See response to comment code 6120.

Commenter Name: D.E. McKenney Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1524

EPA Comment ID: 20508

EPA Comment Code: 6120

Comment: In 2004, Tewksbury Massachusetts had a perchlorate contamination that prohibited the use of our tap water. I understand the dangers of perchlorate and ask you to keep the testing requirement intact for our public drinking water su pplies. Removal of the testing requirement would eliminate detection of perchlorate in the case of ac cidental or intentional contamination of drinking water supplies thereby endangering us all.

Response: This regulatory action does not affect test ing requirements for perchlorate in local jurisdictions. Please see the response to comment code 6120.

Commenter Name: Chris Christensen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1535

EPA Comment ID: 20509

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 766 of 1099 * perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; * a national primary drinki ng water regulation would provide a meaningful opportunity to protect public health.

Perc is still used in a majority of clothes cleane rs/laundries across the nation. I chose to switch cleaners as a result. It should not be part of our drinking water.

Chris Christensen 1160 N. Beverly Lane Arlington HTs, IL 60004

Response: See response to comment code 6120.

Commenter Name: Beatriz Bofill Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1536

EPA Comment ID: 20510

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought. A national primary drinking water regulation would provide a meaningful opportunity to protect public health.

If we do not learn from our past mistakes, we are doomed to repeat our failures over and over. Not protecting Americans from this contaminant will onl y cause greater problems further down the road.

Hopefully with the new administration, this will be a non issue and I won't have to waste my time writing about a no-brainer decision as to establish and enforce an MCL on perchlorate.

Sincerely, Beatriz Bofill

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1540

EPA Comment ID: 20511

EPA Comment Code: 6120

Comment: There are existing studies that prove exposur es to perchlorate have adverse effects on a woman's thyroid. How can we allow this toxin into our drinking water when it is known to be

harmful?

According to a 2006 study by researchers at the cen ters for disease control and prevention (cdc), it was concluded that american women, particularly those with low iodine intake, may have reduced thyroid function due to perchlorate exposure.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 767 of 1099 Please do not allow this harmful toxin to be unregulated when it comes to our drinking water.

Response: See the response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1541

EPA Comment ID: 20512

EPA Comment Code: 6120

Comment: There is sufficient evidence to warrant the regulation of perchlorate in drinking water. Please do so. Regards.

Response: See response to comment code 6120.

Commenter Name: Virginia Schulman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1542

EPA Comment ID: 20513

EPA Comment Code: 6120

Comment: I represent no organization, and no governme nt agency at any level. I am a concerned citizen, parent, and grandparent, and what's more, I care about my own health as well. Perchlorate does not belong in our drinking water. It needs to be regulated. How many toxins have we allowed into our environment only to say, years later, "Oop s! Now you have cancer. My bad!" We don't need to wait for years to say that perchlorate does not be long in our drinking water. We need to regulate it and keep it out of our water supplies. Doing nothing is not neutral; it's hostile to the people of the United States. In my book, that's treason. The EP A is supposed to protect us, not totally ignore our health on behalf of industry.

Virginia Schulman Northampton, Massachusetts

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1543

EPA Comment ID: 20514

EPA Comment Code: 6120

Comment: I agree that this substance should NOT be in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1545

EPA Comment ID: 20515EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 768 of 1099 EPA Comment Code: 6120

Comment: Rocket fuel in our water supply is domestic terrorism!

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1546

EPA Comment ID: 20516

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

The side effects of even a minor amount of this contaminate in our water supply can have serious effects on children and pregnant mothers. Please DO NOT let this opportunity pass to set up safe and effective regulations for our citizens

Response: See response to comment code 6120.

Commenter Name: Aaron J. Skoglund Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1547

EPA Comment ID: 20517

EPA Comment Code: 6120

Comment: I am concerned about the allowance of dangerous chemicals like perchlorate in our drinking water. I think that everything possible shou ld be done to keep our nation's drinking water pure and clean. I urge the EPA to reconsider its allowance of perchlorate in drinking water at any level. The citizens of this country need to know that our health and well being is the EPA's top priority. There should be next to no room for compromise on this principle.

Sincerely, Aaron Skoglund Amherst, MA

Response: See response to comment code 6120.

Commenter Name: Thomas L. Schoaf Commenter Organization: Cities of Litchfield Park and Goodyear, AZ

EPA Document ID: EPA-HQ-OW-2008-0692-1552

EPA Comment ID: 20518

EPA Comment Code: 6120

Comment: November 5, 2008 Stephen L. Johnson, Ad ministrator U.S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvan ia Avenue, N.W. Washington D.C . 20460 Re:Preliminary Regulatory Determination on Perchl orate Docket ID No . EPA-HQ-OW-2008-0068

Administrator Johnson:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 769 of 1099 We, the undersigned, represent the cities of Goodyear and Litchfield Park. Our communities are located in the West Salt River Valley area of metropolitan Phoenix in central Arizona and are impacted or threatened by the Phoenix- Goodyear Airport (PGA) North federal superfund site. The PGA North federal Superfund Site is an area of groundwater that has been impacted by TCE and perchlorate and it is this perchlorate contamin ation that prompts us to request that the EPA reconsider its determination and establish a national maximum contaminant level for perchlorate.

By way of background, surface water supplies in Arizona are limited and are fully allocated. Thus, groundwater is a vital water resource in the arid southwest providing a reliable future municipal supply for our growing communities. It is of such im portance that Arizona classifies all aquifers as drinking water aquifers. Arizona, as with ma ny other states, adopts the federal maximum contaminant levels (MCLs) as it s own drinking water standards. Arizona also establishes aquifer water quality standards for the protection of its aquifers. Since Arizona's aquifers are classified as drinking water aquifers, the established aquifer water quality standards are generally equivalent to the

MCLs.

Response: See response to comment code 6120.

Commenter Name: Richard Mead Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1553

EPA Comment ID: 20521

EPA Comment Code: 6120

Comment: The refusal of the EPA to regulate perchlorate in drinking water is an abrogation of the EPA's responsibilities.

Perchlorate is known to cause health problems to in fants and adults that can be fatal or lead to permanent life-long disabilities.

Refusing to acknowledge this problem is tacit approval of those whose cause the pollution. The American tax payer is entitled to better protection than is currently provided, and should rightfully expect the EPA to manage this problem and hold the polluters accountable for cleaning up the problem and eliminating further contamination.

Richard Mead

Response: See response to comment code 6120.

Commenter Name: Crystal D. Lay Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1557

EPA Comment ID: 20522

EPA Comment Code: 6120

Comment: Comments submitted to Environmental Pr otection Agency regarding: Preliminary Regulatory Determination on Perchlorate in Drinking Water RIN 2040-ZA02EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 770 of 1099 I respectfully request EPAâ€TMs consideration of the following comment regarding RIN 2040-

ZA02:

I would urge EPA to reconsider setting a maximu m contaminant level for perchlorate in drinking

water for several reasons:

1. Perchlorate can interfere with the functioning of the thyroid gland causing serious health effects, especially in developing children.

2. If not regulated, the daily perchlorate intake can easily exceed the RFD of 0.7 Âμg/kg.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1565

EPA Comment ID: 20524

EPA Comment Code: 6120

Comment: Please regulate perchlorate in drinking water. This is a public health issue. This chemical can cause thyroid problems affecting growth and development.

Response: See response to comment code 6120.

Commenter Name: C. Kennedy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1569

EPA Comment ID: 20525

EPA Comment Code: 6120

Comment: I think that anything that is as harmfull as rocket fuel is to humans should be regulated in our drinking water no matter how many PPM are deemed acceptable. By not doing so there is a big loop hole where millions of americans are then subjected to something th at they are unaware of and may cause serious health hazards. First - on a personal note my mother had Non Hodgekings Lymphoma. Our family is unsure of what may have caused this. We had a well and if our water was

tested who knows what that test would find. Or fo r that matter when people are going through a healh crisis it is better to be sure nothing like th is would be introduced or reintroduced in their system. Second- Is it not better to try and regula te now and not in the future when there may be reason to have a huge multi person lawsuits. Does anyone really want to drink any persent of rocket fuel, maybe you folks at the EPA do but I don't! Thank you for your attention to this matter.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1570

EPA Comment ID: 20526EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 771 of 1099 EPA Comment Code: 6120

Comment: I urge the EPA to reverse it's decision re: pe rchlorate regulation. We now know that it has health impacts at lower levels than was previously recognized; with regulation public health could be protected. Thank you.

Response: See response to comment code 6120.

Commenter Name: Karen Cornelius Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1576

EPA Comment ID: 20527

EPA Comment Code: 6120

Comment: I am writing to urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. I think no doing so puts people's health at risk, even at low leve ls. It can impair the thyroid gland. This could be especially harmful to developing fetuses, infants and children with thyroid impairments. I heard it has been found in sites in 37 different states. This is way too many. (For me, anyone would be too many.) Please protect the health of vulnerable ci tizens. Thank you for your consideration. Karen

Cornelius

Response: See response to comment code 6120.

Commenter Name: M. Maguire Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1577

EPA Comment ID: 20528

EPA Comment Code: 6120

Comment: Please protect the American public and keep perchlorate out of our drinking water. Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1579

EPA Comment ID: 20529

EPA Comment Code: 6120

Comment: There shouldn't be any perchlorate in our dr inking water. Please r econsider the decision not to regulate this chemical.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 772 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1582

EPA Comment ID: 20530

EPA Comment Code: 6120

Comment: Please regulate Perchlorate levels in ou r drinking water...We don't need any more potentially hazardous chemicals in our life sustaining water.

Response: See response to comment code 6120.

Commenter Name: Josephine Primeau Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1583

EPA Comment ID: 20531

EPA Comment Code: 6120

Comment: Please, no Perchlorate in our drinking water! The risks to the public health far outweigh any argument to allow it. Please keep the well-be ing of the citizenry of the United States your priority rather than acting out of convenience.

Respectfully, Josephine Primeau

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1585

EPA Comment ID: 20532

EPA Comment Code: 6120

Comment: I have heard that the EPA is considering th e deregulation of perchlorate in our water systems. I do not know what to believe and cannot im agine that this is true. I know that many of us would like clarification. If this is true, I am against it. Thank you.

Response: On October 10, 2008 EPA published in the Federal Register a preliminary determination that a national primary drinking water rule wa s not necessary for perchlorate. However, EPA has now decided to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1587

EPA Comment ID: 20533

EPA Comment Code: 6120

Comment: Please do not deregulate PERCHLORATE in drinking water. We must protect our

water and our environment. Isn't that the function of the EPA protect our land and water? Isn't that why we the people created the EPA? Companies are not good at policing themselves.Just do the job you are suppose to do! Please do not go in the same direction as the Federal Reserve did with the banking!!EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 773 of 1099 Response: See response to comment code 6120.

Commenter Name: Amanda Forys-French Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1591

EPA Comment ID: 20534

EPA Comment Code: 6120

Comment: To Whom it Concerns: It is hard for me to believe that anyone in their right mind would allow a substance such as perchlorate to remain in our water. I urge you as a consumer of water to please regulate perchlorate for my sake, fo r the sake of my family and all of America. We have enough worries as to what may be in our food and water and this does not need to be another one. Please help! Thank you, Amanda Forys-French

Response: See response to comment code 6120.

Commenter Name: Robin M. Chambers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1592

EPA Comment ID: 20535

EPA Comment Code: 6120

Comment: I am hoping that the new administration will take more interest in providing me an healthy enviroment . The EPA has not done anything fo r the last eight years to further this cause . I am one of very many who does not want Perchlor ate in my drinking and more importantly in my childrens and grand childrens who will have have a long exposure to it .Ple ase do what the agency was set up to do that is provide us with a safe enviroment . Thank you Robin M Chambers

Response: See response to comment code 6120.

Commenter Name: A. White Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1596

EPA Comment ID: 20536

EPA Comment Code: 6120

Comment: please keep us safe from harmful cemicals..

Response: This is not a comment, a response is not necessary.

Commenter Name: Jan Bourdelle Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1597

EPA Comment ID: 20537

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 774 of 1099 Comment: Hello, please do not allow perchlorate contam ination in our water. I have thyroid issues as do many, many people. The medicine for it is a permanent life long commitment. As many of us
cannot afford healthcare, it will cause that much more of a financial burden on our citizens to support their impaired thyroids due to this chemic al's present in our drinking water. Thank you.

Jan Bourdelle, 458 Gail Dr., Nazareth PA 18064

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1598

EPA Comment ID: 20538

EPA Comment Code: 6120

Comment: no perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: B. A. Provost Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1603

EPA Comment ID: 20539

EPA Comment Code: 6120

Comment: Too many environmental protections have been lost in the last 10 or so years and we certainly can not afford to be further concerned about the safety of our drinking water. To allow something as hazardous to health as perchlorate in our water should call for anyone involved in EPA or the Bush administration orchestrating these cr iminal acts to be prosecuted in court. It is indeed a criminal act to allow an agent of death to be harbored in the water we must all have to survive. Governments have pursued the removal of trans-fats and nicotine from the public scene and turn around and let this go on. Such a travesty!

Response: This is not a comment, a response is not necessary.

Commenter Name: Van Landuyt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1608

EPA Comment ID: 20540

EPA Comment Code: 6120

Comment: No to perchlorate in tap water. Need a citizen ask?

Response: See response to comment code 6120.

Commenter Name: Anonymouos Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1610EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 775 of 1099 EPA Comment ID: 20541

EPA Comment Code: 6120

Comment: Every adult and child deserves to have clean drinking water. The health consequences of contaminants is not fully known so we need to be vigilant.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1612

EPA Comment ID: 20542

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. Perchlorate causes too many harmful effects to humans in even small amounts. As a tax paying and contributing citizen of this country I have a right to safe drinking water. In the future, as I decide to have a family, I want my children to have access to safe drinking water, not water that could cause them to have birth defects or negative consequences to their health. Please don't allow perchlorate in our water. Thank you for your time.

Response: See response to comment code 6120.

Commenter Name: Elise Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1613

EPA Comment ID: 20543

EPA Comment Code: 6120

Comment: Please limit the amount of percholate allowed in our water. As a family physician, I am concerned about medical effects, such as affecting thyroid function by this chemical. Thank you,
Elise Sullivan, M.D. Santa Rosa, CA

Response: See response to comment code 6120.

Commenter Name: S. L. Jackson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1614

EPA Comment ID: 20544

EPA Comment Code: 6120

Comment: I do NOT want perchlorate to be tolerated/ ignored in public drinking water supplies -- nor in water supplied to farms and animals.

For that matter, I don't want rocket fuel to be polluting the air I have to breathe, either, but I guess this battle against killer chemicals must be waged one painful step at a time. S.L. Jackson Randolph, NJEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 776 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1617

EPA Comment ID: 20545

EPA Comment Code: 6120

Comment: To not monitor and regulate potentially toxi c substances in drinking water endangers the well being of all organisms that ingest the sub stance. I urge the EPA to carry out its mandate protecting the health of the American People.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1618

EPA Comment ID: 20546

EPA Comment Code: 6120

Comment: Please regulate perchlorate in our drinki ng water!!! I'm very concerned with the pollutants found increasingly in our drinking water . Drugs, MTBE, perchlorate, pesticides.....how are our children going to survive all this? Are these chemicals harming our children, do we even know? Isn't it true that even in small amounts perc hlorate can cause thyroid impairment? Please do everything you can to provide this country with safe water to drink.

Response: The statement regarding drugs, MTBE, and pesticides fall outside the scope of this regulatory action. Regarding the remainder of the comment, please see the response to comment

code 6120.

Commenter Name: Denise F. Sipple Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1621

EPA Comment ID: 20547

EPA Comment Code: 6120

Comment: To: Stephen L. Johnson, Admini strator, EPA From: Denise F. Sipple, Rumson, NJ Re: Enforceable limits for perchlor ate in our drinking water

I recently lost my only child to cancer. Please pro tect the health of millions of American families and set enforceable limits for perchlorate in our drinking water. Specifically, I am writing to urge you reverse EPA's preliminary regulatory determination and set a protective drinking water standard for perchlorate as required by the Safe Drinking Water Act.

Perchlorate contamination in our food and water su pplies is too widespread, and its toxic effects too well known, for continued inaction on this problem.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 777 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1623

EPA Comment ID: 20549

EPA Comment Code: 6120

Comment: It is a failure in your role to protect the people of the US that you want to no longer regulate perchlorate. The point at which you will begin to regulate it again in the future will most likely be because of a tragic foreseen incident. We all know that awareness, prevention, and action now prevents future complications. Please do the right thing and act accordingly.

Response: See response to comment code 6120.

Commenter Name: D. Brown Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1624

EPA Comment ID: 20550

EPA Comment Code: 6120

Comment: Please keep Perchlorate out of our drinking water. It is known to be harmful in very slight concentrations, and has been found in numerous water systems throughout the country. I urge the EPA to honor its responsibility to protect th e public by regulating this substance.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1626

EPA Comment ID: 20551

EPA Comment Code: 6120

Comment: Please regulate perchlorate in our water. Your mandate is to protect the environment and the citizens of this country, and this kind of substance entering the bodies of children can't be permitted.

Response: See response to comment code 6120.

Commenter Name: Janet Ryan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1627

EPA Comment ID: 20552

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. Please consider the harm that this decision could have on the public's health. Thank you. Janet RyanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 778 of 1099 Response: See response to comment code 6120.

Commenter Name: M. A. Mulligan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1628

EPA Comment ID: 20553

EPA Comment Code: 6120

Comment: How can the EPA not regulate perchlorate in dr inking water? It is known to impair the thyroid gland, affecting growth, development and m etabolism, and it has been found in public water systems across the nation. I urge you to reverse this decision.

Response: See response to comment code 6120.

Commenter Name: J. Sprance Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1629

EPA Comment ID: 20554

EPA Comment Code: 6120

Comment: Why would you NOT regulate against Rocket Fu el in drinking water? I would like to understand what possible rationale there could be FOR allowing Rocket Fuel in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1429

EPA Comment ID: 20557

EPA Comment Code: 6120

Comment: Really - there are enough health problems that need addressing in this country - autisim is just one example (I had never even heard of it as a child, currently though it's statistically on the increase). So, when there are health issues that can be addressed, and whose numbers can be keep lower, deregulation makes no sense. I'd like to hear an yone of you explain it to your children if your grandchild had mental retardation, or any other bi rth deficit, from the neglect you had in casting your vote against deregulation. Our clean waters must always be protected. Make your vote count - for the future generations! It may be your child and your grandchild that will be thanking you.

Response: See response to comment code 6120.

Commenter Name: Kathryn Murray Commenter Organization: North Shore Unitarian Church

EPA Document ID: EPA-HQ-OW-2008-0692-1447

EPA Comment ID: 20558

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 779 of 1099 Comment: Keep our drinking water clean!

Response: This is not a comment, a response is not necessary.

Commenter Name: Nancy Yoke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0621

EPA Comment ID: 20559

EPA Comment Code: 6120

Comment: Water Docket Environmental Protection Ag ency Mailcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460

Docket Identification (ID) Number: EPA- HQ-OW-2008-0692 Preliminary Regulatory Determination on Perchlorate Re: Request for extension of comment period

I have a friend whose son was just diagnosed with Hashimoto's Disease, a disease of the thyroid. This is a potentially serious condition brought on by what? -- He is only 16! He has nodules on his thyroid -- something is causing this problem and si nce he lived on a naval base for several years, he has been exposed to this awful chemical Perchl orate in larger doeses. THIS IS SERIOUS AND WE

NEED OUR GOVERNMENT AGENCIES TO WAKE UP ! Quit protecting those at fault and do the right thing -- PROTECT OUR CHILDREN!!!!

Response: See response to comment code 6120.

Commenter Name: Samuel A. L. Perry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1604

EPA Comment ID: 20562

EPA Comment Code: 6120

Comment: Dear EPA Staff,

As a drinking water professional, I generally abhor new regulations, but a national MCL on perchlorate is one thing that makes sense to me. After all, it occurs in drinking water at levels of public health concern far more often than than nearly any other chemical regulated under the SDWA, the two notable exceptions are arsenic and nitr ate. If the same logic applied to perchlorate were applied to TCE, TCE would never have been regulated.

Response: See response to comment code 6120.

Commenter Name: James Hartman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1631

EPA Comment ID: 20575

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 780 of 1099 Comment: Industrial chemicals do not belong in our water supply. Obviously it is not possible to eliminate all traces of such from the public water supply, but electing to NOT regulate perchlorate is irresponsible and threatens public health. There is ample evidence that, unregulated, this chemical poses a significant risk to the public. Please reverse your preliminary decision on this matter.

Thank you,

James Hartman

Response: See response to comment code 6120.

Commenter Name: Marc H Lavietes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1633

EPA Comment ID: 20576

EPA Comment Code: 6120

Comment: Perchlorate is poison and should not be in drinking water.

Marc H Lavietes MD

Response: See response to comment code 6120.

Commenter Name: Andrea Kintree Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1635

EPA Comment ID: 20577

EPA Comment Code: 6120

Comment: To Whom It May Concern,

Please monitor and regulate/strictly limit the amount of perchlorate in the water. Only the government has the authority to keep an eye on th ese things. I look at what happens in other countries where things aren't regulated, or the go vernment people don't do their jobs, and the water situation is a mess. I don't want that to happen here.

Respectfully submitted, Andrea Kintree

Response: See response to comment code 6120.

Commenter Name: Gladys Poorte Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1636

EPA Comment ID: 20578

EPA Comment Code: 6120

Comment: I live in Austin, Texas and have learned that Texas is one of the states where perchlorate is found in the water. I have a 20 year old daugh ter that has recently developed thyroid problems.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 781 of 1099 There is no genetic history of thyroid problems in our family. Perchlorate, even in small amounts can impair the thyroid gland.

I've also learned that developing fetuses, infa nts and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

EPA agrees that perchlorate has been found in 39 5 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water.

Please, protect our children!!!

Gladys Poorte

Response: See response to comment code 6120.

Commenter Name: Edward Klutz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1638

EPA Comment ID: 20579

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Edward Klutz

Response: See response to comment code 6120.

Commenter Name: Janet Draper Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1640

EPA Comment ID: 20580

EPA Comment Code: 6120

Comment: Dear Sir:

I hope you will reverse the preliminary decision of th e EPA not to regulate perchlorate in drinking water. Such a decision does not protect me and mill ions of other Americans from a toxic substance. We rely upon you you to protect us.

Thank you for your consideration of my plea.

Sincerely,

Janet Draper 1825 Dunedin Ave. Duluth, MN 55803EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 782 of 1099 Response: See response to comment code 6120.

Commenter Name: Laura Reiley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1641

EPA Comment ID: 20581

EPA Comment Code: 6120

Comment: Please fight for the right to have regulations restricting what is allowed to be dumped into our water ways.

Perchlorate contamination in the drinking water is unexceptable at any level.

You are my voice and I am saying NO to perchlorate.

Kind Regards, Laura Reiley

Response: See response to comment code 6120.

Commenter Name: Janine Ambrose Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1645

EPA Comment ID: 20582

EPA Comment Code: 6120

Comment: My question?

Why do I even need to write you about putting rocket fuel in our water. We have elected you because of your intelligence and support of the peopl e. Please observe what is coming in front of you, and do what is best for the people!

Thanks for your time, Janine Ambrose

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1646

EPA Comment ID: 20583

EPA Comment Code: 6120

Comment: I urge the EPA to reconsider and reverse thei r decision about Perchlorate. It is harmful to our population's health and should not be allowed in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Beth AdamsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 783 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1648

EPA Comment ID: 20584

EPA Comment Code: 6120

Comment: Percholoriate must be regulated out of our drinking water and soon!

We all know the hazardous effects of this danger ous chemical. Let's ban its use and keep our water safe for all generations!

Thank you!

Beth Adams

Greenfield, MA

Response: See response to comment code 6120.

Commenter Name: Susan R. Kepner Commenter Organization: New Hampshire House of Representatives

EPA Document ID: EPA-HQ-OW-2008-0692-1653

EPA Comment ID: 20585

EPA Comment Code: 6120

Comment: As a state representative serving on th e Resources, Recreation, and Development commitee in the NH House, I am very concerned a bout the quality of our drinking water. I cannotunderstand your decision NOT to regulate the dangerous "perchlorate" in drinking water. Please rethink this and remember that YOU are supposed to be guarding the health and welfare of all Americans!! Rocket fuel is not healthy in any thing we drink!! Even low levels are a danger, especially to infants and fetuses! Who will benefit by this la ck of regulation? What big business or agency is

MORE IMPORTANT THEN THE HEALTH OF THE AMERICAN PUBLIC???? REGULATE

PERCHLORATE!!!!!!

Response: See response to comment code 6120.

Commenter Name: S. Broder Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1656

EPA Comment ID: 20586

EPA Comment Code: 6120

Comment: It's important to me that I can trust that our drinking water is clean and healthy, especially for my baby and small child, whose de veloping bodies are particularly vulnerable to

chemicals.

Response: See response to comment code 6120.

Commenter Name: L. ThorpEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 784 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1660

EPA Comment ID: 20587

EPA Comment Code: 6120

Comment: why can't we find a way for jet planes to remove excess fuel from their tanks without dumping the fuel on the ground? Sounds so simple, then we would not have dangerous levels of perchlorate in the ground water. I am apalled that th is practice goes on. Your inept ability to see that this is a very real concern for people also amazes me. Pardon my forwardness, but my husband died from something related to this, and I am concerned that others may die needlessly because regulations are not either followed, or not created fo r the military which is the largest polluter in this country, and largest contributor to superfund si tes throughout the country. My husband was an environmental engineer who worked on a superfund site, and I know first hand about groundwater contamination. His job was to clean up the sites! Please reconsider the measure that is being forwarded very seriously.

Response: See response to comment code 6120.

Commenter Name: Jimmy Spearow Commenter Organization: Sacramento Chapter, Physicians for Social Responsibility

EPA Document ID: EPA-HQ-OW-2008-0692-1672

EPA Comment ID: 20591

EPA Comment Code: 6120

Comment: We urge you to protect Americans' health by regulating perchlorate in drinking water in accordance with the Safe Drinking Water Act. Please set the MCL for perchlorate in drinking water at no greater than 1 ppb.

Several states, including New Jers ey, Massachusetts, and California ha ve already addressed the issue of perchlorate in drinking water by either already setting or planning to set a MCL that is far lower

than the current EPA recommendation. While none of these states have proposed a MCL as low as 1 ppb, their standards would still be far more pro tective of public health than the current EPA recommendation. But beyond these state borders, m illions of people drink perchlorate contaminated water and depend on the federal government to protect them. EPA must fulfill this responsibility. Please regulate perchlorate in drinki ng water at no greater than 1 ppb.

Sincerely,

Jimmy Spearow, Ph.D. Sacramento Chapter, Physic ians for Social Responsibility 911 Pennsylvania Place, #3 Davis, CA 95616 jlspearow@sbcglobal.net

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1673

EPA Comment ID: 20592

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 785 of 1099 Comment: This decision should be reversed. The public has the right to know what is in their drinking water. Think about our children and grandch ildren. I want them to be healthy and to be aware of what they are putting in their bodies. Keep our water safe.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1674

EPA Comment ID: 20593

EPA Comment Code: 6120

Comment: Hi, I am an ordinary citizen, but an educated one, and I am very dismayed at the idea that the EPA may not regulate perchlorate. I urge the EPA to continue to regulate this substance, which can be very detrimental to a human's thyroid gland and even more serious to children that are exposed. Keep our water clean! It's bad enough we have to deal with several exposures and pollutions.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1676

EPA Comment ID: 20594

EPA Comment Code: 6120

Comment: For heaven's sake, STOP THE MADNESS... ....D you honestly think that this is okay.......Clean it up please and then keep it cl ean....No perchlorate in out water and keep out the other cooties. Thank you

Response: See response to comment code 6120.

Commenter Name: J. Mosman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1682

EPA Comment ID: 20595

EPA Comment Code: 6120

Comment: Please re-consider your preliminary decision regarding perchlorate in drinking water. We need to protect our water resources; they are much more important than oil, gas, and coal! Without water of good quality, we will be faced with impossi ble problems, and it might be too late to correct them. Let's be pro- active, limit the amounts of pe rchlorate to an extremely tiny percentage, and not realize years from now there was a horrendous mistake made.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 786 of 1099 We definitely need to protect future generations fr om problems associated with perchlorate, which links have been proven to exist.

Please, do revise your position; water is essent ial, and it's been badly abused in the past. We definitely need to re-orient ourselves and protect ou r resources - our nation's well-being relies on it.

Response: See response to comment code 6120.

Commenter Name: N. Abercrombie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1685

EPA Comment ID: 20596

EPA Comment Code: 6120

Comment: Please enact legislation that will protect our freshwater system from contamination with pollutants.

Response: This is not a comment, a response is not necessary.

Commenter Name: J. Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1689

EPA Comment ID: 20597

EPA Comment Code: 6120

Comment: Please reverse your decision to not regulate perchlorate in drinking water. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought. I am concerned for my family and the environment.

Response: See response to comment code 6120.

Commenter Name: P. Paul Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1691

EPA Comment ID: 20598

EPA Comment Code: 6120

Comment: This request is to ask you to seriously consider reversing your decision not to consider regulating perchlorate in drinking water. Since perchlorate is used for rocket fuel and studies have shown trace amounts can destroy the thyroid gland as well as thyroid inhibition in fetuses, the longrange costs for health care is phenomenal. From a logical perspective, it makes more sense to regulate perchlorate in drinking water before it be comes a national health and environmental diaster.

Thank You

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 787 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1692

EPA Comment ID: 20599

EPA Comment Code: 6120

Comment: As a tax payer, I urge the government/EPA to continue the regulation of perchlorate in our drinking water. Our planet/bodies is already sub jected to enough unregulated contaminates..... keep our drinking water as pure/safe as possible!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1695

EPA Comment ID: 20600

EPA Comment Code: 6120

Comment: regulate perchlorate period.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1697

EPA Comment ID: 20601

EPA Comment Code: 6120

Comment: Rocket fuel (perchlorates) wasn't an original ingredient of water and shouldn't be in it now! You can add it to your own water if you wish. However, I'd greatly appreciate your leaving it out of mine. Your job is to help protect the public, NOT big business.

Response: See response to comment code 6120.

Commenter Name: Lesley LeFevre Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1698

EPA Comment ID: 20602

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. -Lesley LeFevre, PsyD

Response: See response to comment code 6120.

Commenter Name: Clark Sellars Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1699

EPA Comment ID: 20603

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 788 of 1099 Comment: I urge the EPA to Regulate Perchlorate in ou r drinking water. If you don't do it NOW, it will have to be in the future costing ten time s as much and many more water supplies degraded. Please think of the health of the public and the enviroment FIRST. Sincerly Clark Sellars

Response: See response to comment code 6120.

Commenter Name: L. Helfman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1700

EPA Comment ID: 20604

EPA Comment Code: 6120

Comment: You should regulate perchlorate in our water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1701

EPA Comment ID: 20605

EPA Comment Code: 6120

Comment: Gentlemen,

Higher perchlorate levels in drinking water? Yo u have got to be kidding. Rocket fuel does not belong in drinking water, at any level!

Perchlorate is proven harmful to developing fetuse s, infants and children and at lower levels than previously thought. Allowing perchlorate in drinki ng water is filfully negligent on your part.

Please fulfill your responsibility to the people and environment. Performing your duty under the law if a very important job; please do not shirk it now.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1702

EPA Comment ID: 20606

EPA Comment Code: 6120

Comment: I am very concerned about allowing any perchlorate into the water system. Please regulate this chemical and protect our water system. Thank you.

Response: See response to comment code 6120.

Commenter Name: AnonymousEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 789 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1703

EPA Comment ID: 20607

EPA Comment Code: 6120

Comment: I SUPPORT THIS COMMENT IN FULL. EPA HAS BEEN APPROVING FAR

TOO MANY TOXIC POLLUTANTS FOR THE LA ST 17YEARS, TURNING DOWN NONE

FOR APPROVAL. THAT SHOWS NO DISC RIMINATINO ON THE PART OF THIS

AGENCY AND NO PROTECTION FOR THE AMERICAN PUBLIC AND ITS CHILDREN.

Response: This is not a comment, a response it not necessary.

Commenter Name: Paul Einboden Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1704

EPA Comment ID: 20608

EPA Comment Code: 6120

Comment: Please reconsider the preliminary determina tion on setting a regulation for perchlorate in drinking water.

It is critical that harmful chemicals are not in th e public drinking water. (That perchlorate not work its way into further drinking water systems).

Thank you Paul Einboden St. Petersburg, FL

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1707

EPA Comment ID: 20609

EPA Comment Code: 6120

Comment: I respectfully request that the EPA regulate pe rchlorate levels in water. There are certain chemicals that are permissible in the water supply; this is not one of them.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1708

EPA Comment ID: 20610

EPA Comment Code: 6120

Comment: Please make the regulations stricter for the purity of our drinking water. There has been

a substantial increase in childhood autism and othe r ailments in the last 20 years. Studies are continuing to try and find the causes of this, but wh y wait for the results to show that higher levelsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 790 of 1099 of toxins in the drinking water ar e to blame. Please, please be proactive in keeping the health and

welfare of our children.

Response: See response to comment code 6120. Commenter 's statements are out of scope of this regulatory action.

Commenter Name: MattHew C. Ford, Jr. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1710

EPA Comment ID: 20611

EPA Comment Code: 6120

Comment: To Whom It May Concern,

Keep Perchlorate out of our drinking water.

Very truly yours,

MattHew C. Ford, Jr., M.P.A.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1713

EPA Comment ID: 20612

EPA Comment Code: 6120

Comment: No rocket fuel/Perchlorate in drinking water, please.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1716

EPA Comment ID: 20613

EPA Comment Code: 6120

Comment: We do NOT want perchlorate in our drinking water!!!!!!! PLEASE don't be responsible for it happening.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1719

EPA Comment ID: 20614

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 791 of 1099 Comment: Perchlorate is a chemical we know is harmful. Why would it be a lawful option to allow a chemical used in rocket fuel in drinking wa ter? The chemical can impact human development and
metabolism, even at low levels. Please consider our children and America's coming generations. Regulate Perchlorate in our drinking water and turn the decision to allow it around.

Response: See response to comment code 6120.

Commenter Name: S. Ultimo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1722

EPA Comment ID: 20615

EPA Comment Code: 6120

Comment: why is there any question on whether perchlora te should be regulated in drinking water

?

Response: This is not a comment, a response is not necessary.

Commenter Name: Carol Bigelow Commenter Organization: University of Massachusetts

EPA Document ID: EPA-HQ-OW-2008-0692-1427

EPA Comment ID: 20633

EPA Comment Code: 6120

Comment: Accordingly, docket ID No. EPA-HQ-OW-200 8-0692 should not form the basis for national primary drinking water regulation.

Considering these issues, we conclude that EPA has based its argument for not regulating perchlorate contamination in public water systems on a literature that is both limited and ill focused. We believe that EPA has not performed a sufficiently "thorough review" of the literature, that it has omitted important information, and that it has failed to perform its due diligence in the interpretation and analysis of the information that it did present. To correct this, EPA must employ the CDC study (Blount et al, 2006a) as the point of departure for RfD determination, and must

focus on the neonate and infant as the most sensitive population.

References

Andersen S, Pedersen KM, Bruun NH, Laurberg P (2002) Narrow individual variations in serum T(4) and T(3) in normal subjects: a clue to the understanding of subclinical thyroid disease. J Clin

Endocrinol Metab 87:1068-1072.

Andersen S, Bruun NH, Pedersen KM, Laurberg P (2003) Biologic variation is important for interpretation of thyroid functi on tests. Thyroid 13:1069-1078.

Auso E, Lavado-Autric R, Cuevas E, Escobar Del Rey F, Morreale De Escobar G, Berbel P (2004) A moderate and transient deficiency of materna l thyroid function at the beginning of fetal neocorticogenesis alters neuronal migrat ion. Endocrinology 145:4037-4047.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 792 of 1099 Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL (2006a) Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-1871.

Blount BC, Valentin-Blasini L, Osterloh JD, Mauldi n JP, Pirkle JL (2006b) Perchlorate Exposure of the US Population, 2001-2002. J Expo Sci Environ Epidemiol.

Chan S, Rovet J (2003) Thyroid Hormones in the f etal central nervous system development. Fetal

and Maternal Medicine Review 14:177-208.

Chopra IJ, Sabatino L (2000) Nature and sources of circulating thyroid hormones. In: The Thyroid:
A Fundamental and Clinical Text, Seventh Editi on (Braverman LE, Utiger RD, eds), pp 136-173. Philadelphia: Lippincott-Raven.

Dohan O, Portulano C, Basquin C, Reyna-Neyr a A, Amzel LM, Carrasco N (2007) The Na+/I symporter (NIS) mediates electroneutral active trans port of the environmental pollutant perchlorate.

Proc Natl Acad Sci U S A 104:20250-20255.

Gilbert ME, Sui L (2006) Dose-dependent reductions in spatial learning and synaptic function in the dentate gyrus of adult rats following developmental thyroid hormone insufficiency. Brain Res

1069:10-22.

Gilbert ME, Sui L (2008) Developmental exposure to perchlorate alters synaptic transmission in hippocampus of the adult rat. Environ Health Perspect 116:752-760.

Ginsberg G, Rice D (2005) The NAS Perchlorate Review: Questions Remain about the Perchlorate RfD. Environ Health Perspect 113:1117-1119.

Ginsberg GL, Hattis DB, Zoeller RT, Rice DC (2007) Evaluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater: focus on exposure to nursing infants. Environ Health Perspect 115:361-369.

Goodman JH, Gilbert ME (2007) Modest Thyroid Hormone Insufficiency During Development Induces a Cellular Malformation in the Corpus Callosum: A Model of Cortical Dysplasia. Endocrinology.

Greer MA, Goodman G, Pleus RC, Greer SE (2002) Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.

Herbstman J, Apelberg BJ, Witter FR, Panny S, Goldman LR (2008a) Maternal, infant, and delivery factors associated with neonatal thyroi d hormone status. Thyroid 18:67-76.

Herbstman JB, Sjodin A, Apelberg BJ, Witter FR, Halden RU, Patterson DG, Panny SR, Needham LL, Goldman LR (2008b) Birth delivery mode mo difies the associations between prenatal polychlorinated biphenyl (PCB) and polybrominate d diphenyl ether (PBDE) and neonatal thyroid

hormone levels. Environ Health Perspect 116:1376-1382.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 793 of 1099 Heyerdahl S, Oerbeck B (2003) Congenital hypothyro idism: developmental outcome in relation to levothyroxine treatment variab les. Thyroid 13:1029-1038.

Kirk AB, Dyke JV, Martin CF, Dasgupta PK (2007) Temporal patterns in perchlorate, thiocyanate, and iodide excretion in human milk. Environ Health Perspect 115:182-186.

Lavado-Autric R, Auso E, Garcia-Velasco JV, Aruf e Mdel C, Escobar del Rey F, Berbel P, Morreale de Escobar G (2003) Early maternal hypothyroxi nemia alters histogenesis and cerebral cortex cytoarchitecture of the progeny. J Clin Invest 111:1073-1082.

Lewander WJ, Lacouture PG, Silva JE, Lovejoy FH (1989) Acute thyroxine ingestion in pediatric patients. Pediatrics 84:262-265.

NRC (2005) Health Implications of Perchlor ate Ingestion. In. Washington D.C.: National

Academies Press.

Oerbeck B, Sundet K, Kase BF, Heyerdahl S (2003) Congenital hypothyroidism: influence of disease severity and L-thyroxine treatment on intellectual, motor, and school-associated outcomes in young

adults. Pediatrics 112:923-930.

Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin -Blasini L, Braverman LE (2007) Breast milk iodine and perchlorate con centrations in lactating Boston-area women. J Clin

Endocrinol Metab 92:1673-1677.

Rovet JF (2002) Congenital hypothyroidism: an analys is of persisting deficits and associated factors. Child Neuropsychol 8:150-162.

Scinicariello F, Murray HE, Smith L, Wilbur S, Fowler BA (2005) Ge netic factors that might lead to different responses in individuals exposed to pe rchlorate. Environ Health Perspect 113:1479-1484.

Selva KA, Harper A, Downs A, Blasco PA, Lafr anchi SH (2005) Neurodevelopmental outcomes in congenital hypothyroidism: comparison of initial T4 dose and time to reach target T4 and TSH. J

Pediatr 147:775-780.

Selva KA, Mandel SH, Rien L, Sesser D, Miyahi ra R, Skeels M, Nelson JC, Lafranchi SH (2002) Initial treatment dose of L-thyroxine in congen ital hypothyroidism. J Pediatr 141:786-792.

Sharlin DS, Tighe D, Gilbert ME, Zoeller RT (2008) The Balance between Oligodendrocyte and Astrocyte Production in Major White Matter Tracts Is Linearly Related to Serum Total Thyroxine. Endocrinology 149:2527-2536.

Steinmaus C, Miller MD, Howd R (2007) Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 na tional health and nutrition examination survey. Environ Health Perspect 115:1333-1338.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 794 of 1099 van den Hove MF, Beckers C, Devlieger H, de Ze gher F, De Nayer P (1999) Hormone synthesis and storage in the thyroid of human preterm and term newborns: effect of thyroxine treatment.

Biochimie 81:563-570.

Zoeller RT, Rovet J (2004) Timing of thyroid horm one action in the developing brain: clinical observations and experimental findin gs. J Neuroendocrinol 16:809-818.

Response: EPA has determined to regulate perchlorate in drinking water (See response to comment code 6120). For further information about the RfD for perchlorate, please see the response to comment ID 28927 under comment code 2110. Regarding the comment for EPA to focus on the neonate and infant as the most "sensitive popula tion," EPA published a Federal Register notice on August 19, 2009 seeking comments on additional a pproaches to analyzing data related to EPA's perchlorate regulatory determination. These comments were sought in an effort to ensure consideration of all the potential options for ev aluating whether there is a meaningful opportunity for human health risk reduction of perchlorate thro ugh a national primary drinking water rule which

included neonates and children.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20652

EPA Comment Code: 6120

Comment: We hereby petition EPA to rethink their alle ged health-protective level for perchlorate, and their proposed decision not to regulate it in drinking water. Thank you for consideration of our

comments.

Sincerely yours,

Robert A. Howd, Ph.D. Senior Toxicologist

References

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. (2006). Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 114:1865-1871.

Clewell RA, Merrill EA, Gearhart JM, Robinson PJ , Sterner TR, Mattie DR, Clewell HJ. (2007). Perchlorate and radioiodide kinetics across life stag es in the human: using PBPK models to predict dosimetry and thyroid inhibition and sensitive subpopulations based on developmental stage. J

Toxicol Environ Health Part A. 70:5 408-428.

Greer MA, Goodman G, Pleus RC, Greer SE. (2002) . Health effects assessment for environmental perchlorate contamination: The dose-response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 795 of 1099 Kahn HD, Stralka K. (2008). Estimated daily averag e per capita water ingestion by child and adult age categories based on USDA's 1994-1996 and 19 98 continuing survey of food intakes by individuals. J Expo Sci Environ Epidemiol May 14. [Epub ahead of print]

NAS. (2005). Health implications of perchlorate in gestion. National Academy of Sciences, National Research Council. January 2005.

OEHHA. (2004). Public Health Goal for perchlor ate in drinking water. Office of Environmental
Health Hazard Assessment, California Environm ental Protection Agency, Oakland and Sacramento,

CA.

Steinmaus C, Miller MD, Howd R. (2007). Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 Na tional Health and Nutrition Examination Survey. Environ Health Perspect 115(9):1333-1338.

U.S. EPA. (2004). Estimated Per Capita Water Ingest ion and Body Weight in the United States - An Update. U.S. Environmental Protection Agency, Washington, D.C. EPA-822-R-00-001.

U.S. EPA. (2005). Guidance on Selecting Age Gr oups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants. U.S. Environmental Protection Agency, Washington, D.C. EPA/630/P-03/003F.

U.S. EPA. (2008). Inhibition of the Sodium-Iodid e Symporter by Perchlorate: An Evaluation of Lifestage Sensitivity Using Physiologically-Based Pharmacokinetic (PBPK) Modeling. EPA/600/R08/106A. Docket No. EPA-HQ-OW-2008-0692-0076.

Response: See response to comment code 6120.

Commenter Name: Mic Stewart Commenter Organization: Metropolitan Water District of Southern California

EPA Document ID: EPA-HQ-OW-2008-0692-1784

EPA Comment ID: 20662

EPA Comment Code: 6120

Comment: In 2004, California's Office of Environmental Health Hazard and Assessment (OEHHA) adopted a public health goal (PHG) for perchlorate of 6 ppb. In October 2007, the California Department of Public Health (CDPH, formerly the Department of Health Services) adopted a primary drinking water standard (maximum contaminant level, MCL) of 6 ppb.

Although California has its own MCL for perchlorate, a national drinking water standard would assist in the clean-up of hundreds of U.S. Depa rtment of Defense facilities in Southern California and around the country. Since the detection of pe rchlorate contamination throughout the southwest Region and in hundreds of local groundwater wells, Metropolitan, its member agencies, and the drinking water community have called on the EPA to make a regulatory determination on perchlorate consistent with the tenets of the Safe Drinking Water Act.

Metropolitan wishes to offer the following comments:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 796 of 1099 * Regulatory Determination - With EPA's determina tion not to regulate perchlorate and therefore not set a drinking water MCL, Metropolitan is c oncerned that without Federal regulation potential clean-up efforts of contaminated surface and groundwater sites throughout the region and other parts of the Country may be impaired.

Response: See response to comment code 6120.

Commenter Name: Stephen A. Owens Commenter Organization: Arizona Department of Environmental Quality

EPA Document ID: EPA-HQ-OW-2008-0692-1785

EPA Comment ID: 20666

EPA Comment Code: 6120

Comment: Numerous environmental, health and medical agencies, including the National Academy of Sciences, have documented and agreed that ingesting perchlorate through contaminated water, food and human breast milk may interfere with the production of thyroid hormones. This interference occurs because perchlorate "competes" wi th the uptake of iodide in the thyroid gland. Adding to this concern is EPA's own finding that th e risk to infants is greater even when they have ingested low levels of perchlorate. Finally, th e Centers for Disease Control found that ingesting perchlorate contaminated food and water may pose even a greater health threat for those women who have lower iodine intake levels to begin with.

Based upon the known occurrences of perchlorate in Arizona's water supply coupled with known human health concerns at detected levels, ADEQ disagrees with EPA's preliminary decision not to regulate perchlorate and strongly encourages EPA to reconsider the determination.

Thank you in advance for your consideration of these comments

Sincerely, Stephen A. Owens Director

Response: See response to comment code 6120.

Commenter Name: Ann Ell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1522

EPA Comment ID: 20668

EPA Comment Code: 6120

Comment: To Whom it May Concern, As a Mother of two small children who had to deal with this problem recently, I urge you to take a good look at the regulations and make them as forceful as possible. sincerely, Ann M. Ell Tewksbury MA

Response: See response to comment code 6120.

Commenter Name: P. Impink Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1434

EPA Comment ID: 20675EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 797 of 1099 EPA Comment Code: 6120

Comment: Our whole town was not able to drink the water for 6 months when perchlorate was detected from discharge from another community. I was pregnant at the time. Please require municipal water suppliers to test for perchlorate. We just don't know the long term health effects of

these contaminants.

Response: See response to comment code 6120.

Commenter Name: Sandra Clifford Teeple Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1730

EPA Comment ID: 20677

EPA Comment Code: 6120

Comment: I am deeply concerned by the EPA's decision to allow perchlorate in public drinking water. While allowing this substance to remain ma y be an initial cost- saving issue for some businesses, in the long term, perchlorate COSTS Am erica a great deal of money, time, effort, and resources. The damage to infants and small children is incalculable; the costs to medically care for and to remedially educate the children damaged by de liberate pollution, such as perchlorate, are also

incalculable.

Prevention is always CHEAPER than restoration and remediation! Please do not permit the pollution of our drinking water. Thank you for listening to my concerns.

Sandra Clifford Teeple jsteep@aol.com

Response: Please See response to comment code 6120.

Commenter Name: Karen A. Vilandry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1734

EPA Comment ID: 20680

EPA Comment Code: 6120

Comment: Dear Mr. Johnson,

With respect to the decision in Massachusetts to lower the perchlorate standard in drinking water, it only makes sense to do the same nationwide. http://www.boston.com/news/local/massachusetts/articles/2006/07/28/massachus etts_sets_state_standard_for_perchlorate/?p1=email_to_a_friend

Drinking water needs to be in its purest form to protect public health. Please keep in mind, that already two thirds of the country is using hydr ofluosilicic acid, (fluoride), a hazardous waste byproduct of the phosphate industry, in drinking wa ter. By allowing another toxic chemical in the drinking water, it only exacerbates the problem ev en further creating quite a toxic cocktail of

chemicals that humans don't need in their water source. Please act on behalf of all, protect the population and keep the water clean.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 798 of 1099 Thank you! Karen A. Vilandry "Wasted Away"

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1738

EPA Comment ID: 20682

EPA Comment Code: 6120

Comment: Please reverse your decision on allowing the rocket fuel addative to be allowed in our drinking water.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Denis Orpen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1739

EPA Comment ID: 20683

EPA Comment Code: 6120

Comment: I have learned the dangers of perchlorate and ask you to help keep the requirement intact for our drinking water.Removal of the testing would eliminate detection in case of contamination. We in Tewksbury still recall the contamination of our water in 2004.

Denis Orpen 51 Nina Dr Tewksbury

Response: This regulatory action does not address any existing testing requirements for perchlorate in local jurisdictions. Please see response to comment code 6120.

Commenter Name: L. Kuegler Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1740

EPA Comment ID: 20684

EPA Comment Code: 6120

Comment: The testing of water for perchlorate is very important. As a resident of Tewksbury,MA I was subject to contaminated perchlorate drinki ng water and during that time I contracted hyperthyroidism. This has affected my life drastically.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1744EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 799 of 1099 EPA Comment ID: 20686

EPA Comment Code: 6120

Comment: testing for perchlorate is very important and should not be discontinued. I live in Tewksbury, Ma. We were unable to drink our water for months because of high levels of perchlorate. I have young children so my concern is for them.

The side effects of perchlorate are scary so plea se do what is right and continue to test!

Response: This regulatory action does not address tes ting requirements for perchlorate in local jurisdictions. Please see res ponse to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1745

EPA Comment ID: 20687

EPA Comment Code: 6120

Comment: Although perchlorate levels have perhaps droppe d to neglible levels in water supplies as a whole, in 2004 the tap water in Tewksbury, Ma ssachusetts could not be consumed because of elevated perchlorate levels. In fact, this cond ition was ultimately isolated to dumping by a manufacturing facility upstream on the Concord Rive r, which merges with the Merrimack River, from which Tewksbury's water is drawn. It has sin ce been addressed, but consider the implications for residents of Tewksbury, and specifically for children, had the condition not been detected, I

don't believe this is a reasonable risk to assume. I certainly would not want my three small children to be harmed by such a decision.

Thank you.

Resident of Tewksbury

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1746

EPA Comment ID: 20688

EPA Comment Code: 6120

Comment: Please continue to test for Perchlorate and other chemicals in our drinking water. Right around the time the perchlorate was found, my ne ighbor was very sick with thyroid problems (in her 40s) and I had to have chemotherapy at age 41 from a molar preganancy turned choriocarcinoma.

People's health is nothing to mess around with. Health is wealth and we can't afford not to have

clean air in water. Please be sure to test our water!

MANY THANKS.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 800 of 1099 A concerned citizen of Tewksbury

Response: This regulatory action does not address tes ting requirements for perchlorate in local jurisdictions. Please see res ponse to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1747

EPA Comment ID: 20689

EPA Comment Code: 6120

Comment: umm how about we tighten water safety standards rather than making them more lax. Don't be [expletive] retarded.

Response: This is not a comment, a response is not necessary.

Commenter Name: S. Franzeen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1753

EPA Comment ID: 20690

EPA Comment Code: 6120

Comment: Perchlorate is a nasty little chemical. I'm not sure what the EPA's motivation is to not regulate the threat of perchlorate in our drinking water, but please add my voice in opposition to such a notion. Perchlorate must be regulated.

Response: See response to comment code 6120.

Commenter Name: E. Cruz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1755

EPA Comment ID: 20691

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. I live near a plant which releases perchlorate into the environment every da y, and it is an ongoing concern for me and my family.

Response: See response to comment code 6120.

Commenter Name: Bruce P. Boxer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1756

EPA Comment ID: 20692

EPA Comment Code: 6120

Comment: Please keep our water safe to drink. Regulate Percholates. Please Thanks, BruceEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 801 of 1099 Response: See response to comment code 6120.

Commenter Name: Ylana Stewart Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1757

EPA Comment ID: 20693

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Perchlorate is used in rocket fuel, flares, and explos ives. How can we possibly allow it to exist in our drinking water? The same water that our children drin k. It is horrifying to think that the EPA does not consider regulation extremely important. Perchl orate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Please protect us from this hazard. Sincerely, Ylana Stewart - Rockland, Massachusetts

Response: See response to comment code 6120.

Commenter Name: D.L. Humes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1759

EPA Comment ID: 20694

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on not regulating for perchlorate in drinking water.

There is enough evidence showing a strong corre lation between perchlorate and health problems. Please do the job your department was created for and protect the citizens of this country and the environment instead of large corporations and bow ing to special interests that influence your department either directly or through congressmen who have been bribed through campaign funds. Pass regulations that will protect us today and tomorrow.

Response: See response to comment code 6120.

Commenter Name: Lynn Brown Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1760

EPA Comment ID: 20695

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary decision on perchlorate levels in drinking water. This st uff has health impacts even at low levels.

Young children would be especially be at risk. Plea se protect the public health. Let's move forward...

not backward.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 802 of 1099 Lynn Brown 18 Foxcroft Rd. Niantic, CT

Response: See response to comment code 6120.

Commenter Name: Heather Hesse-Stromberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1763

EPA Comment ID: 20696

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Heather Hesse-Stromberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1763

EPA Comment ID: 20698

EPA Comment Code: 6120

Comment: As the mother of a 4 year-old, this kind of potential hazard frightens me to the core. There are enough threats to her good health and normal development without adding the one thing she is most encouraged to do (drink lots of water) to the list...

Please reconsider your decision to not regulate perc hlorate in the drinking water - the health of the next generation depends on it!

Heather Hesse-Stromberg Rochester, NH

Response: See response to comment code 6120.

Commenter Name: D. Peters Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1764

EPA Comment ID: 20699

EPA Comment Code: 6120

Comment: I am writing to urge the EPA to protect pu blic health by increasing regulation of perchlorate in drinking water. Contamination can put may children and adults at risk for serous health problems.

Response: See response to comment code 6120.

Commenter Name: Agnes Merrick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1771EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 803 of 1099 EPA Comment ID: 20700

EPA Comment Code: 6120

Comment: To the EPA,

I am deeply concerned over your unethical attitude towards allowing perchlorate to contaminate our drinking water. If one of your own family me mbers suffered a life-threatening disease or an incurable deformity from ingesting Rocket Fuel- tain ted water, you would have to live with the fact that your moral laziness was the precipitating cause.

Sincerely, Agnes Merrick 519 Yarmouth Rd. Baltimore, Md. 21286

Response: This is not a comment, a response is not necessary.

Commenter Name: N. Thakur Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1772

EPA Comment ID: 20701

EPA Comment Code: 6120

Comment: ban perchlorate in drinking water

Response: See response to comment code 6120.

Commenter Name: S. Blackard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1774

EPA Comment ID: 20702

EPA Comment Code: 6120

Comment: As a citizen of the United states I count on the EPA to set regulations that keep our drinking water clean and healthy. Please set regu lations to keep perchlorate and other potentially toxic chemicals out of our drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1777

EPA Comment ID: 20703

EPA Comment Code: 6120

Comment: Clean drinking water is a limited natural resource - fought over in some regions - and is worthy of the full protection by the EPA. We must ensure that all business enterprises and municipalities are held to the highest siting and ope rating standards necessary to safeguard our water supplies. Of particular concern to me is the possi bility of water contamination by perchlorate - an ingredient in rocket fuel. This must not be allowed to take place and the EPA must set strict contamination and testing guidelines.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 804 of 1099 Response: See response to comment code 6120.

Commenter Name: Becky Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1778

EPA Comment ID: 20704

EPA Comment Code: 6120

Comment: I am concerned about keeping our water safe and about allowing perchlorate intoour water supply. I believe that we should not have any perchlorate in our water. Becky

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #7 – Group Unidentified

EPA Document ID: EPA-HQ-OW-2008-0692-1518

EPA Comment ID: 20705

EPA Comment Code: 6120

Comment: I understand the dangers of perchlorate an d ask you to keep the testing requirement intact for our public drinking water supplies. Re moval of the testing requirement would eliminate detection of perchlorate in the case of accidental or intentional c ontamination of drinking water supplies, such as the Tewksbury Ma ssachusetts contamination in 2004.

Response: See response to comment code 6120.

Commenter Name: Daniel Green Commenter Organization: Green Machine Consulting, LLC

EPA Document ID: EPA-HQ-OW-2008-0692-1783

EPA Comment ID: 20706

EPA Comment Code: 6120

Comment: This is a dumb rule. Please reject it.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1790

EPA Comment ID: 20707

EPA Comment Code: 6120

Comment: Test for and keep perchlorate out of our drinking water.

Response: See response to comment code 6120.

Commenter Name: L. McPhedran Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 805 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1791

EPA Comment ID: 20708

EPA Comment Code: 6120

Comment: Please do not allow perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Karen Parelhoff Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1793

EPA Comment ID: 20709

EPA Comment Code: 6120

Comment: I do not understand why you would not insist on regulating perchlorate in our water. I do not want rocket fuel in my drinking water in an y amount, truthfully. At the very least I want it monitored and regulated. We know that there are health concerns associated with it especially for the unborn. Please put country first that means the health and well-being of our children and the rest of us should be your first concern. It irks me that I need to write this as it seems like such a nobrainer. Protect our water. Protect our health.

Karen Parelhoff 6803 Glenmont St. Falls Church, Va. 22042

Response: See response to comment code 6120.

Commenter Name: L. Astur Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1803

EPA Comment ID: 20711

EPA Comment Code: 6120

Comment: I urge the EPA to protect public health by regulating perchlorate in drinking water.

This substance has been found in public drinking water supplies nationwide and is a serious threat
the the health of fetuses, children, and adults.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1808

EPA Comment ID: 20712

EPA Comment Code: 6120

Comment: I hope you do not deregulate the amount of pe rchlorate in drinking water. The drinking
water should be clean to drink, not have trace amounts of rocket fuel in it.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 806 of 1099 Commenter Name: Ed O. Travis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1810

EPA Comment ID: 20713

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. Perchlorate is a dangerous
chemical, and the EPA owes citizens a decision base on the best available scientific data, with a margin of safety added to ensure pr otection of the public health in situations where there is not a

consensus.

Ed Travis Austin, TX

Response: See response to comment code 6120.

Commenter Name: Sierra Club Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1811

EPA Comment ID: 20714

EPA Comment Code: 6120

Comment: Please re-visit. No perchlorate in water!

Response: See response to comment code 6120.

Commenter Name: Elanne Palcich Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1812

EPA Comment ID: 20715

EPA Comment Code: 6120

Comment: As a citizen living within the U.S.A., I prefer not to have perchlorate in my water. I hope the EPA doesn't think it's ok to have perchlorate leaching into our water supplies. There must be some sort of EPA policy guidelines in place to protect citizens from toxic chemicals such as this. The issue seems to be following through with your mandate.

Thanks. Elanne Palcich 29 SE 5th St. Chisholm, MN 55719

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1813

EPA Comment ID: 20716

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 807 of 1099 Comment: Allowing such things as percolate, fluoride, drugs and other toxins in the water is rediculous. Do your job and protect the populous from these and other toxins.

Response: Regarding regulating perchlorate in drinking water, see response to comment code 6120. Regarding regulation of "fluoride, drugs and other to xins in the water," no response is necessary as it is outside of the scope of this action.

Commenter Name: Laurie Meisenheimer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1814

EPA Comment ID: 20717

EPA Comment Code: 6120

Comment: Please, do as you need to and protect the environment for the people of the United States. That is your job. You need to reverse yo ur decision not to regulate percholate. It would be negligent not to try to keep our waters free of th is known dangerous chemical. As a teacher, I see many children who are not funtioning as they should . We need to do our best to keep them whole and healthy. Regulate percholate- keep us safe. That is what the EPA is for, and we all look to you to do what is right.

Laurie Meisenheimer First Grade Teacher

Response: See response to comment code 6120.

Commenter Name: T. Morris Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1815

EPA Comment ID: 20718

EPA Comment Code: 6120

Comment: On October 10, the EPA announced its prelim inary decision not to regulate perchlorate in drinking water. Please reverse this decision and keep our water clean!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1817

EPA Comment ID: 20719

EPA Comment Code: 6120

Comment: Even if at any point in time percolate isn't much of a threat it is possible that someone somewhere could have access to it and if it ends up in the water, not only would everyone want it detected but also somebody could be caught for illegal activity.

Response: No response necessary, this is not a comment.

Commenter Name: Regina EppEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 808 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1820

EPA Comment ID: 20720

EPA Comment Code: 6120

Comment: To whom it may concern:

Regarding the allowance of perchlorate in drinki ng water--Please note that this substance affects metabolism at much lower levels that previously thou ght. I strongly urge you to protect our drinking water supply, which is quickly deteriorating in quali ty, from further contamination. My family and I are putting our faith in our government's asserti on that the needs of ordinary people will not suffer when balanced with the desires of corporations.

Sincerely,

Regina Epp

Response: See response to comment code 6120.

Commenter Name: Noel Anderson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1822

EPA Comment ID: 20721

EPA Comment Code: 6120

Comment: This is in regards to allowing percholate in our drinking water and not regulating it. As a person who has thyroid problems, I am highly concerned that the government would allow a chemical into our drinking water that would fu rther compromise my health. For this reason I strongly urge you to ban percholate entirely from our water.

Sincerely,

Noel Anderson Quakertown, PA

Response: See response to comment code 6120.

Commenter Name: S. Elliott Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1823

EPA Comment ID: 20722

EPA Comment Code: 6120

Comment: NO PERCHOLATE in our drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 809 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1824

EPA Comment ID: 20723

EPA Comment Code: 6120

Comment: Please reverse your preliminary determination concerning the amount of perchlorate in our drinking water. Our children have enough to face due to our poor choices. The wellness of our generation and those that follow will be directly affected by this decision and those similar. It is time we stop adding any chemicals that are not absolutel y necessary to that which we ingest. There are other ways to solve these problems without exasperating our contribution to illness.

Response: See response to comment code 6120.

Commenter Name: Lois Fournier Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1825

EPA Comment ID: 20724

EPA Comment Code: 6120

Comment: As a nurse for 40 years, I am concerned about public health. Clean water and clean air are basic rights that MUST be protected for the he alth of all peoples. To allow toxic chemicals like perchlorate in our drinking water at levels that cause problems, especially to those who are most vulnerable, is criminal. We can't expect to have productive citizens whose health is compromised. And we will burden society even more with costly, lif elong medical bills. Please toughen the laws on acceptable levels of perchlorate for everyone's sake.

Lois Fournier Centerville, MA

Response: See response to comment code 6120.

Commenter Name: Robert A. Cloutier, Jr. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1832

EPA Comment ID: 20725

EPA Comment Code: 6120

Comment: Please regulate perchlorate in drinking water. I do not want rocket fuel in my drinking

water.

Thank you, Robert A. Cloutier, Jr.

Response: See response to comment code 6120.

Commenter Name: M. Killian Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1834

EPA Comment ID: 20726

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 810 of 1099 Comment: Please regulate our drinking water. Tell the EPA to keep perchloate out of the water. Do not allow jet fuel to seep into our supplies!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1837

EPA Comment ID: 20727

EPA Comment Code: 6120

Comment: Please regulate and monitor drinking wa ter for perchlorate contamination.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1839

EPA Comment ID: 20728

EPA Comment Code: 6120

Comment: We should be tightening the standards for drinking water, not loosening them. Americans deserve safe, potable drinking water.

Response: See response to comment code 6120.

Commenter Name: Michael Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1841

EPA Comment ID: 20730

EPA Comment Code: 6120

Comment: October 28, 2008 Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave., NW. Washington, DC 20460.

Dear Sir or Madam,

I live in Los Angeles, CA and like many who live here, I am greatly concerned with the level of perchlorate in our water supply due to rocket fuel spillage. These worries have doubled recently as my wife and I are now planning to have our first child.

While I understand there is conflicting evidence when it comes to the study of perchlorate, it is widely accepted that percholorate can negatively a ffect the thyroid in a mother which is essential for proper development of the fetal brain.

No woman in the United States should be scared to drink tap water because she thinks it might cause damage to her unborn child. Rocket fuel has no place in our drinking supply IN ANY LEVEL - and certainly not at an increased level from what we used to believe was acceptable.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 811 of 1099 I trust you to do the right thing and require those who spill harmful chemicals in our water to pay for proper cleanup - and to keep "acceptable" levels of perchlorate as low as humanly possible.

Sincerely yours, Michael Peterson

Response: Regarding regulating perchlorate in drinking water, see response to comment code 6120. Regarding "requiring those who spill harmful chemic als in our water to pay for proper cleanup," see response to comment code 6300.

Commenter Name: C. Rose Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1842

EPA Comment ID: 20731

EPA Comment Code: 6120

Comment: Please do whats right

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1843

EPA Comment ID: 20732

EPA Comment Code: 6120

Comment: It is always astonishing how the people that pledged to defend the American people, plan to allow toxins and carcinogens flow throug h our drinking water. For what? A favor? My first child is due at the end of April. When you go to sleep tonight, think about my child and the regulations you are attempting to abandon. I woul dn't allow anyone to ever poison your child, why would you allow the poisoning mine? Why do you want to poison children? How can you live with yourself? My child, crying, because he has been poisoned thanks to your support of deregulation policies.

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1844

EPA Comment ID: 20733

EPA Comment Code: 6120

Comment: I grew up on Redstone Arsenal in Alabama(Aka Rocket City) and know first hand how damaging this chemical can be. My mother has had thyroid problems ever since my family moved there in 1984. Even though we only lived there for 5 years, and have zero history of thyroid problems in the family, she is now on medication for thyroid problems, and will be for the rest of

her life.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 812 of 1099 To think that 20 years later, there is still zero regulation on Perchlorate is not only idiotic, but it is harming human health... The EPA has become a joke if you ask me under the Bush administration's last 8 years. It is their legal responsibility to pr otect American's from environmental harm, and yet here they are doing the exact opposite..

Why do i even pay taxes if this is what we get for our money? Should we honestly keep paying you

to harm our loved one's health?

This government needs to move back to being FOR the people, and NOT for the Corporations....

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1845

EPA Comment ID: 20734

EPA Comment Code: 6120

Comment: I'm going to keep this as short and simple as possible.

Americans as a whole are terribly overweight and have a tendency to put more than enough things into our bodies with a negative effect associated with them,

Why would we not want to clean up our water as much as we can, especially if we can remove a cause of tyroid problems in children, unborn children and their mothers.

It only makes sense to be willing to spend the time and money to better our water for the lives of

our children.

Response: No response necessary, this is not a comment.

Commenter Name: Kenneth C. Moore Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1846

EPA Comment ID: 20735

EPA Comment Code: 6120

Comment: Put the allowable limits of Perchlorate in drin king water back to what it was in 2002. I don't care what it costs to clean up; human bein gs, especially newborns, should not have to be exposed to the potential health reprocussions of th is matter. It shall be the U.S. Government's #1 priority to PROTECT and SERVE the citizens of the United States. Until the U.S. Government stops being persuaded by special interest groups, this country is NEVER going to see what it is truly capable of becoming; it will never see its TRUE potential.

Kenneth C. Moore

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 813 of 1099 Commenter Name: Dennis W. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1849

EPA Comment ID: 20738

EPA Comment Code: 6120

Comment: I think there should be stronger regulations on Perchlorate and a law that requires a clean up should be enacted.

I lived next to a military base for 5 years and my wife went through three different pregnancies at that time. My research shows that Perchlorate can cause thyroid problems in pregnant women. During my wife's last pregnancy she developed a thyroid problem. My wife has to deal with a thyroid problem and we have to pay for thyroid medi cation for the rest of our lives possible because the EPA doesn't know how to do their job. There n eeds to be stronger legislation on this chemical. At least regulate it to the point of what was considered safe in 2002.

Thank You Dennis W.

Response: See response to comment code 6120.

Commenter Name: M. Biro Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1850

EPA Comment ID: 20739

EPA Comment Code: 6120

Comment: It is very important the the Agency is fully aware of the risks of allowing substances to be disposed in our water. It is expected that, wh ile there is ANY doubt that harmful consequences may occur, the Agency void any additional permission. The Agency is supposed to always protect the interests of the population and never take any action for which the consequences are not fully understood, when authorizing the increase/release of chemicals on the en vironment. Therefore, based on your study, I do not believe the Agency ha s all the necessary elements to put this rule in effect, and it is the agency responsibility to void it.

Response: See response to comment code 6120.

Commenter Name: Charles Cronin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1852

EPA Comment ID: 20741

EPA Comment Code: 6120

Comment: In regards to the changes on rules regardin g perchlorate levels in drinking water, I believe the new changes should apply to only the area in and around Crawford, Texas, leaving the higher and safer standards for the bulk of the US citizenry!

Thanks, Charles CroninEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 814 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1853

EPA Comment ID: 20742

EPA Comment Code: 6120

Comment: Please stop your midnight regulations that harm the environment and people. Citizens are more important than lobbyists (they just have more money.) Please represent the little guys and

do what is best for us.

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1854

EPA Comment ID: 20743

EPA Comment Code: 6120

Comment: Perchlorate should be regulated at a level at or lower than the standard set in 2002, or at
the set standard in California, which ever is lo wer. Raising this level is counter productive.

Response: See response to comment code 6120.

Commenter Name: Mi Sunyn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1861

EPA Comment ID: 20745

EPA Comment Code: 6120

Comment: 11/06/08

Dear EPA,

Please clean-up our water supply by restricting perchlorates

Mi Sunyn 110 Roberts Ave #201 Alexandria, VA 22076

Response: See response to comment code 6120.

Commenter Name: J. Agee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1862

EPA Comment ID: 20746

EPA Comment Code: 6120

Comment: 11/06/08EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 815 of 1099 Dear EPA,

Please do not put harmful chemicals in our water.

J. Agee 850 N. Randolph St. Arlington, VA 22202

Response: EPA does not intend to put harmful chemicals into our water, instead EPA has determined that perchlorate should be regulated in public water systems. See response to comment

code 6120.

Commenter Name: Tony Frangello Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1863

EPA Comment ID: 20747

EPA Comment Code: 6120

Comment: 5 NOV 08

TO WHOM IT MAY CONCERN

I WOULD LIKE TO SUPPORT THE CLEAN WATER ACTION COMMITTEE EFFORTS

TO RID OUR LOCAL WATER SUPPLY OF PERCHLORATE.

TONY FRANGELLO 618 S. ROYAL ST. ALEXANDRIA, VA 22314

Response: See response to comment code 6120.

Commenter Name: D.O. Luttz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1864

EPA Comment ID: 20748

EPA Comment Code: 6120

Comment: 11/06/08

Dear EPA,

Please put a cap on perchlorates. Its polluting the and we don't need it.

D.O. Luttz 8004 Candlewood Dr. Alexandria, VA 22306

Response: See response to comment code 6120.

Commenter Name: Peter S. Toney Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1865

EPA Comment ID: 20749EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 816 of 1099 EPA Comment Code: 6120

Comment: To the EPA

To whom it may concern:

I am a Virginia voter and am concerned about dr inking water quality. Perchlorate is a dangerous chemical found in 37 states - we need to keep it out of our water supplies and it must be regulated.

Sincerely, Peter S. Toney

918 Green St. #1 Alexandria, VA 22314

Response: See response to comment code 6120.

Commenter Name: Jon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1866

EPA Comment ID: 20750

EPA Comment Code: 6120

Comment: 11/06/08

Dear EPA,

You guys need to keep perchlorate out of my drinking water. I water to live!!!

Jon 6500 Hillview Ave. Alexandria, VA 22306

Response: See response to comment code 6120.

Commenter Name: Richard D. Weaver Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1867

EPA Comment ID: 20751

EPA Comment Code: 6120

Comment: Water Docket, EPA, Mailcode 2822T 1200 Pennsylvania Ave Washington, D.C. 20460

* ATTN: Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern,

I believe that the EPA should institute strict regu lations on perchlorate in drinking water. I believe that there is strong evidence to suggest that it's pr esence in our drinking water is a significant risk to public health. There have not been sufficient routine tests on the effects of this chemical and it should be strongly regulated until such time as it is absolutely confirmed that it poses no significant health risk. Thank you.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 817 of 1099 Richard D. Weaver

Response: See response to comment code 6120.

Commenter Name: Robert S. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1869

EPA Comment ID: 20753

EPA Comment Code: 6120

Comment: 11/05/08

My drinking water

To Whom it May Concern @ the EPA. Please keep perchlorate out of my water: a nationwide primary drinking water regulation is needed to protect our public health. I support the clean water

action.

Robert S. [Surname Illegible] 823 So uth Royal St Alexandria VA 22314

Response: See response to comment code 6120.

Commenter Name: Susan Willes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1870

EPA Comment ID: 20754

EPA Comment Code: 6120

Comment: 11/07/08

Dear EPA,

I do not want perchlorate or harmful chemcial in our water

Susan Willes 110 Hume Ave Al ex VA 22310 703-548-7762

Response: See response to comment code 6120.

Commenter Name: Janice Hollman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1871

EPA Comment ID: 20755

EPA Comment Code: 6120

Comment: OW-2008-0692

Attention EPA:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 818 of 1099 I, Janice Hollman, am concerned with the chemical, perchlorate, in our water system. Please use alternative chemcials in rocket fuel and explosives. It is very important.

Sincerely, J Hollman 319 Hume Ave Alexandria, VA 22301

Response: See response to comment code 6120. Regarding regulating use alternative rocket fuels, that is beyond the scope of this action.

Commenter Name: Norman Howard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1872

EPA Comment ID: 20756

EPA Comment Code: 6120

Comment: Dear EPA,

I Norman Howard am very much apposed to harmfu l chemical and deposit in our water system.

Norman Howard 106 Hume Ave. Alex. VA 22301

Response: See response to comment code 6120.

Commenter Name: Margaret S. Guryan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1873

EPA Comment ID: 20757

EPA Comment Code: 6120

Comment: As a mother with an infant, I am very concerned about perchlorate in drinking water. Because of the harmful effects on children's development and fetuses, we need to limit this contamination in our drinking water. I urge the EPA to regulate this to keep our drinking water safe.

Margaret S. Guryan 221 E. Oxfo rd Ave Alexandria VA 22301

Response: See response to comment code 6120.

Commenter Name: Meghan Hendy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1874

EPA Comment ID: 20758

EPA Comment Code: 6120

Comment: November 5, 2008

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Avenue Washington, DC 20460

ATTN: Docket ID No. EPA-HQ-OW-2008-0692EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 819 of 1099 Dear Environmental Protection Agency:

I am very disappointed in your announcement to not regulate perchlorate in drinking water and respectfully ask you to reconsider this decision. Perchlorate has been proven to be a harmful chemical and can impair the thyroid gland, especially impacting fetuses and children. I urge you to establish a federal exposure standard.

Response: See response to comment code 6120.

Commenter Name: Meghan Hendy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1874

EPA Comment ID: 20760

EPA Comment Code: 6120

Comment: As a mother of a toddler and a women in her childbearing years this is very concerning to me. We need a better federal tracking system for perchlorate and a higher exposure standard to protect our youngest citizens. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought. It is imperative the the EPA implements a national primary drinking water regulation to protect public health.

Thank you for your consideration.

Sincerely, Meghan Hendy Alexandria, VA

Response: See response to comment code 6120.

Commenter Name: John Williams Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1875

EPA Comment ID: 20762

EPA Comment Code: 6120

Comment: I don't want perchlorate in may drinking water

John Williams 327 N. St. Asaph St. Alex., VA

Response: See response to comment code 6120.

Commenter Name: Sadea Ramsay Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1876

EPA Comment ID: 20763

EPA Comment Code: 6120

Comment: 11/7/08

To Whom it May Concern:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 820 of 1099 Perchlorate needs to be regulated by the EPA. Giving the federal government free reign to dump rocket fuel into our ground water is unacceptable. This is a huge threat to public health. This is a nationwide problem that needs to be addressed. Please put perchlorate contamination at the forefront of your drinking water regulations.

Thank you, SADEA RAMSAY 2406 CLYD E AVE APT #4 ALEXANDRIA, VA 22301

Response: See response to comment code 6120.

Commenter Name: Will Arttey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1877

EPA Comment ID: 20764

EPA Comment Code: 6120

Comment: EPA water Docket,

I work as a chef in VA, and I vote I believe that perchlorate is a dangerous chemical, since It has been found in 37 states, Presents a wide spread threat to our health, It get into water supply so It must be regulated.

Sincerely Will Arttey 216 East Bellef onte Apt 1 Alexandria VA 22301

Response: See response to comment code 6120.

Commenter Name: Andrew E. Stevenson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1878

EPA Comment ID: 20765

EPA Comment Code: 6120

Comment: EPA Water Docket

Dear Regulators:

I am writing to express my support for increased fe deral regulation of perchlorate. It has serious health consequences - especially in young children; and shouldn't be given "a pass" as was recently done by the Bush Administration in its deal with the manufacturer.

Response: See response to comment code 6120.

Commenter Name: J. Sestak Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1879

EPA Comment ID: 20767

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 821 of 1099 Comment: We need a national policy for regulating perchlorate in our drinking water. This chemical is dangerous to our youth in particular due to it's harmful effects on the thyroid gland.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1883

EPA Comment ID: 20768

EPA Comment Code: 6120

Comment: I am outraged that EPA has not yet done it s duty to protect the health of our families and communities from perchlorate pollution. This regulation must not be passed.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1886

EPA Comment ID: 20769

EPA Comment Code: 6120

Comment: regulate perchlorate now

Response: See response to comment code 6120.

Commenter Name: Tina Donze Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1887

EPA Comment ID: 20770

EPA Comment Code: 6120

Comment: Mr. Townsend,

As a concerned citizen and mother of two children, I am appalled at the fact that the EPA would allow a chemical such as perchlorate to be in our drinking water. There are enough chemicals in our drinking water and air that we should spend more time and money cleaning it up rather than deciding if we should allow current levels to stay as they are. I don't care if I have to pay more taxes to have regulations tightened on the amount of pollution and contaminants a company is allowed to release into our environment. We only have one pl anet and we are not doing enough to take care of it and it's people. Please make sure that my children and there children can grow up in a safe environment free from all the unnecessary chemicals. Thank you.

Sincerely, Tina Donze

Response: See response to comment code 6120.

Commenter Name: Rebecca DowneyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 822 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1888

EPA Comment ID: 20771

EPA Comment Code: 6120

Comment: Rebecca Downey 1211 Hazel St Charlottesville, VA 22902-4908

November 16, 2008

Administrator Stephen L. Johnson 1200 Pennsylvania Ave ., N .W. Rm. 1101A Washington, DC

20460

Administrator Johnson:

Dear Sir,

As a physician I am very concerned as to the EPA is considering not setting a federal drinking-water standard for perchlorate.

Response: See response to comment code 6120.

Commenter Name: M. Hoff Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1889

EPA Comment ID: 20775

EPA Comment Code: 6120

Comment: As a resident of northern New Mexico, in a region where high amounts of perchlorates have been found in certain water tables, especially those ajacent to Los Al amos National Laboratory, I strongly object to the EPA proposal not to regulate this poisonous substance. I realize the EPA has been seriously in decline during this current administration and systematically shedding responsibility left and right from protecting the Amer ican public from the depredations of out-ofcontrol industries. But pretending a problem is not there will not make it go away. The EPA's shirking of responsibility makes it morally responsib le for the health problems caused by its neglect. Please keep on regulating perchorates.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1890

EPA Comment ID: 20776

EPA Comment Code: 6120

Comment: Increasing the amount of pollution allowed in our drinking water has no positive benefits to the public, however, it has a great be nefit to industy and big business. Money, money, money they cry, in their smoked filled rooms, pollu tion is the name fo the game and big business areEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 823 of 1099 great at it. This rotten to the core president shou ld be forced to drink the waters produced by big business manufacturing processes.

Response: This is not a comment, no response necessary.

Commenter Name: V. Foxx Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1892

EPA Comment ID: 20777

EPA Comment Code: 6120

Comment: This type of action further illustrates how li ttle the government cares about the people they allegedly serve. The midnight rules are illustrati ve of carelessness, recklessness and a total lack of compassion. If I ever see George W. Bush in pers on, he WILL take the time to hear me out. If he is lucky, he'll still have all his teeth when we are done.

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1893

EPA Comment ID: 20778

EPA Comment Code: 6120

Comment: I am not really sure why in the world this one would even pass, other than the fact that someone is getting paid a lot of money. If we as the public have any say so if this one passes, I want to make it very clear that I appose this proposal. It 's not safe, it is putting innocent lives in danger, and it is uncalled for. If this is Bush's way of getting back at America, well then all I can say is, God help him.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1894

EPA Comment ID: 20779

EPA Comment Code: 6120

Comment: I believe the safety of all people, especially children and pregnant women should be the first factor in deciding what contaminate levels are acceptable in drinking water. Bearing that in
mind, I think all levels should be lowered never raised.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1895

EPA Comment ID: 20780EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 824 of 1099 EPA Comment Code: 6120

Comment: Our drinking water must be strictly regulated . Perchlorate is known to be harmful to one's health. How are you supposed to feel safe if you know your water could potentially contain harmful chemicals? Please regulate our water, and protect our parks and environment. You are doing a wonderful job as I can see, please keep it up. We are all counting on you.

Response: See response to comment code 6120.

Commenter Name: Tim Cranford Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1896

EPA Comment ID: 20782

EPA Comment Code: 6120

Comment: The proposed relaxation of this standard is hazardous to the health and safety of millions of Americans. Rather than relaxing the standard, it would be much more advisable to

decrease the "safe" levels of Perchlorate and brin g them back down to the 2002 standard. Barring that, leave them as they are. None of us want to be drinking higher levels of this component of rocket fuel, nor do we want to be drinking higher levels of any other chemical. Drinking water in America should be clean. Anything less is unaccepta ble and puts the health of millions of Americans at risk. ~ Tim Cranford, US Citizen and Taxpayer

Response: See response to comment code 6120.

Commenter Name: Joe K. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1897

EPA Comment ID: 20783

EPA Comment Code: 6120

Comment: One begins to question his/her faith in our government when money becomes more important than the well-being of those who reside within it's rule. I believe the correct choise is obvious and hope that any other leve l minded person would agree.

~Joe K Redding, CA

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1902

EPA Comment ID: 20784

EPA Comment Code: 6120

Comment: I agree with Clean Water Action. I want my water clean!

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 825 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1903

EPA Comment ID: 20785

EPA Comment Code: 6120

Comment: Please keep perchlorate out of our drinking water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1904

EPA Comment ID: 20786

EPA Comment Code: 6120

Comment: Aren't there enough documented cases of health problems caused by contaminants in our water supply? Please do NOT allow perchlorate into our drinking water! Do your job and protect us!

Response: See response to comment code 6120.

Commenter Name: B. Pearlman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1907

EPA Comment ID: 20787

EPA Comment Code: 6120

Comment: Please regulate to make perchlorate levels very low in the drinking water. These chemicals can have adverse effects on the thyroid gl and depressing it's function and causing obesity. We don't need more causes of obesity in this country.

Thank you.

Response: See response to comment code 6120.

Commenter Name: Amelia Kroeger Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1909

EPA Comment ID: 20788

EPA Comment Code: 6120

Comment: 6 November 2008

The U.S. Environmental Protection Agency should re verse its preliminary determination on setting a regulation for perchlorate in drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 826 of 1099 Perchlorate contamination is a na tionwide problem and clearly has health impacts at lower levels than previously thought;

Give we citizens more serious consideration - a national primary drinking water regulation would help protect public health.

Thank you.

Amelia Kroeger 65 Stubbs Bay Road Maple Plain MN 55359

Response: See response to comment code 6120.

Commenter Name: Charlotte Morton Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1913

EPA Comment ID: 20789

EPA Comment Code: 6120

Comment: To whom it may concern,

I am writing to urge the regulation of Perchlora te in our drinking water. We should not have such chemicals in our water ignored. Please keep our water clean and safe.

Sincerely, Charlotte Morton

Response: See response to comment code 6120.

Commenter Name: Lucy Margolis Commenter Organization: Educational Rights Advocates, Inc.

EPA Document ID: EPA-HQ-OW-2008-0692-1914

EPA Comment ID: 20790

EPA Comment Code: 6120

Comment: It is my understanding that the EPA has d ecided, as a preliminary decision, not to regulate perchlorate in drinking water. That being th e case, I am writing to request that you reverse that decision. I REQUEST THAT YOU REGULATE PERCHLORATE IN DRINKING

WATER.

It is my understanding that perchlorate is harmfu l to people - e.g., that it can impair the thyroid gland. As a person who has taken Rx Synthroid da ily for many years, I personally support regulation of perchlorate so that others won't have impaired thyroid function.

It is my understanding that developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech, or deficits in motor skills. As an educational
advocate for families of children with disabilities, I support regulation of perchlorate in order to reduce the potential number of children with special needs in the future.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 827 of 1099 It is my understanding that perchlorate has been foun d in at least 395 sites in 37 states, including 153 public water systems serving over 20 million people. That's a public health hazard that cannot be ignored. So, for these and other good and sufficient reasons, I REQUEST THAT YOU

REGULATE PERCHLORATE IN DRINKING WATER.

Thank you for your time and consideration.

Regards,

Lucy Margolis, President Educational Rights Advo cates, Inc. 10430 SW 99 Street Miami, Florida 33176 Phone (305) 279-8855 Fax (305) 279- 4880 Cell (305) 588-3858 Lucyedu@aol.com

Response: See response to comment code 6120.

Commenter Name: Joshua Squire Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1917

EPA Comment ID: 20791

EPA Comment Code: 6120

Comment: I am greatly concerned about our exposure to toxic chemicals, both for environmental and personal health issues. Limiting our exposur e can greatly increase our life-long health. Everything from household cleaners to beauty produ cts and now to our drinking water seem to be loaded with toxins. The American people sometimes rely on government agencies to help protect it's

constituents. It seems to me that if the EPA di d not regulate a known toxin in our drinking water, then they would not be doing the service that they were organized for in the first place. I urge the EPA to regulate Perchlorate in our drinking water.

Thank you, Joshua Squire

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1918

EPA Comment ID: 20792

EPA Comment Code: 6120

Comment: I am quite diturbed that the EPA is consid ering NOT regulating perchlorate in the environment. It is the EPAs duty and should be morally obligated to do what is right for the health

of the environment and citizens. Do not be pressured by other governement agencies or corporations and do what you were founded to do. Please...Do not risk the health of the

environment and it citizens.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 828 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1922

EPA Comment ID: 20794

EPA Comment Code: 6120

Comment: Please keep perchlorate out of my drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1923

EPA Comment ID: 20795

EPA Comment Code: 6120

Comment: I am appalled by the EPA's decision to NO T regulate perchlorate in drinking water. This is an astounding position for the agency to take since perchlorate can cause significant human health problems, even at levels much lower than previously thought. We and our children have enough insults to our health and immune systems each day without the EPA making it worse by working for corporations instead of the public at large. The EPA violates its fiduciary responsibility to the citizens of this nation by refusing to re gulate a known toxin. Please reverse this decision. Please make the people in the EPA do their j obs. Protecting the public from these kinds of contaminants is what the agency exists to do. If the EPA does not step in and do what they were created for, then possibly it is time to do away with the EPA and replace it with an agency that will do its job.

Response: See response to comment code 6120.

Commenter Name: Robert L. Darwin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1926

EPA Comment ID: 20796

EPA Comment Code: 6120

Comment: The EPA should do whatever they can to keep Perchlorates out of our drinking water.

Robert L. Darwin Alex andria, VA 703-548-3595

Response: See response to comment code 6120.

Commenter Name: R. Perla Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1929

EPA Comment ID: 20797

EPA Comment Code: 6120

Comment: Please keep harmful toxins like perc hlorate out of our drinking water.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 829 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1931

EPA Comment ID: 20798

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1932

EPA Comment ID: 20800

EPA Comment Code: 6120

Comment: Very simply, people shouldn't be forced to drin k water that is toxic. Perchlorate in water can be measured. It's toxicity can be determined. Therefore limits on allowable amounts in drinking water can be drafted and enforced. Just do it!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1935

EPA Comment ID: 20801

EPA Comment Code: 6120

Comment: Please reconsider regulating perchlorate in drinking water. The health risks warrant it.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1938

EPA Comment ID: 20802

EPA Comment Code: 6120

Comment: You must develop an MCL for perchlorate, along with MTBE, TBA, and 1,4-dioxane, among others. It is totally irresponsible for EPA to cave to DOD, the petroleum industry and others and not protect the public. You work for US.

Get a move on with doing your job!

Response: Regarding regulating perchlorate in drinking water, see response to comment code 6120. Regarding regulating MTB, TBA and 1,4-dioxane, th is is outside of the scope of this action.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 830 of 1099 Commenter Name: Yvonne Rost Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1946

EPA Comment ID: 20803

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. I don't want my children exposed to the effects of this chemical, nor would I wa nt any family or friends to be afflicted by it.

Yvonne Rost Ferndale, MI

Response: See response to comment code 6120.

Commenter Name: J. Coleman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1948

EPA Comment ID: 20804

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. It's difficult to believe that a "protection" agency would accept a chemical that has health impacts at lower levels than previously thought. We should have a national drinking water regulation to provide a meaningful opportunity to protect public health

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1954

EPA Comment ID: 20805

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchl orate in drinking water. When I learned that Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism, I was baffled by the EPA's even considering not to regulate it. It's used in rocket fuel and explosives and is a very harmful chemical. It should not be in drinking water,
but even the EPA has found it in 37 states, in cluding 153 public water systems serving over 20 million people. Some estimates are even higher. Not setting a regulation for percholate is not environmental protection. I urge you, once again, to reverse your preliminary determination.

Response: See response to comment code 6120.

Commenter Name: Jay Lees Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 831 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1957

EPA Comment ID: 20806

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlor ate in drinking water (Re: Document ID EPAHQ-OW-2008-0692-0001). Perchlora te contamination has health impacts at lower levels than previously thought by experts. Additionally, devel oping and instituting a national primary drinking water regulation would provide a meaningful opportuni ty to protect public health. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and child ren with thyroid impairment may suffer mental retardation, loss of hearing and speech or defici ts in motor skills. Our Governmental agencies should be in the business of passing regulations that help protect the health and livelihoods of all of the citizens of our great Country, and reversing the preliminary determination on Perchlorate contaminaltion levels in drinking water is one of many ways for a Government Agency to perform to its public charter. VR, Jay Lees, Lexington Park, Maryland.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1958

EPA Comment ID: 20807

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

* Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; * a national primary drinki ng water regulation would provide a meaningful opportunity to protect public health.

This is COMPLETELY ridiculous! I cannot believe th is is something that we have to be concerned about. In this country, in this time period, that I have to be worried about the water that I am drinking. You are the ENVIRONMENTAL PROTECTION AGENCY not the "let's make it easy for business to do whatever the hell they want " agency. PROTECT the environment and people! Honestly, what did you think you were supposed to be spending your time on when you applied at

the EPA?

I'm seriously disturbed and disappointed.

Response: See response to comment code 6120.

Commenter Name: Commenter Organization: The Night Move, LLC

EPA Document ID: EPA-HQ-OW-2008-0692-1960

EPA Comment ID: 20809

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 832 of 1099 Comment: Perchlorate contamination is a nationwide problem that can impact health at lower levels than previously thought. It is a dangerous ch emical that affects the thyroid gland, potentially impairing the body's regulation of growth, development and metabolism. The EPA has found perchlorate in at least 153 public water systems. Th is chemical is used in rocket fuel and explosives. The companies creating these products with ha rmful side effects obviously aren't concerning themselves with the impact they are having on our environment. The government is allowing this. Ultimately, a regulation on the use of perchlorate would be the best an swer to the health concerns of Americans. However, a national regulation of drin king water would also provide an opportunity to protect public health. Please, I urge the EPA to reverse its preliminary determination on setting a regulation for perchlorate in drinking water.

Thank you.

The Night Move, LLC

Response: See response to comment code 6120.

Commenter Name: George Ferguson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1961

EPA Comment ID: 20810

EPA Comment Code: 6120

Comment: We have enough problems with the water quality now, please do not allow more problems by not regulating percholate in our wa ter. There has to be a way of controlling water pollution.

Respectfully, George Ferguson

Response: See response to comment code 6120.

Commenter Name: Monica Juitt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1963

EPA Comment ID: 20811

EPA Comment Code: 6120

Comment: Dear Official,

I am contacting you today to request the U.S. Environmental Protection Agency reconsider its preliminary determination to not set a regulation fo r perchlorate in drinking water. Perchlorate is a harmful chemical used in rocket fuel, flares, and explosives and even in small amounts can have very serious health impacts to our citizens. These include deficits in hearing, speech, motor skills and mental capacity.

Please look at the facts and consider regu lating perchlorate in our drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 833 of 1099 Thank you,

Monica Juitt

Response: See response to comment code 6120.

Commenter Name: K. O'Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1965

EPA Comment ID: 20812

EPA Comment Code: 6120

Comment: Please do everything necessary to keep perchlorate out of our nation's drinking water.

Response: See response to comment code 6120.

Commenter Name: J. Nash Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1966

EPA Comment ID: 20813

EPA Comment Code: 6120

Comment: Your standards should be very tough regard ing perchlorate and other contaminants in water. It is amazing to me that you would even consider removing perchlorate from your surveillance. This only reinforces what most already believe about Republicans, which is that you are in the service of one or another large business, not the public. Goodbye and good riddance in January!

Response: See response to comment code 6120.

Commenter Name: Ricarda G. Black Commenter Organization: Welcome to Wellness

EPA Document ID: EPA-HQ-OW-2008-0692-1970

EPA Comment ID: 20814

EPA Comment Code: 6120

Comment: Please reverse your decision not to regular perchlorate.

Response: See response to comment code 6120.

Commenter Name: Barbara Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1976

EPA Comment ID: 20815

EPA Comment Code: 6120

Comment: Dear Sirs,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 834 of 1099 I always ask government agencies what their charge is. So, I wish to ask you what is your charge? Perchlorate is dangerous to human health and should thus be regualated. Government is to do for people what they cannot do for themselves. It is a great responsibility and yet a privilege to protect the people of this great nation. Not to regulate dangerous pollutants in our drinkng water seems like you have forgotten why this agency exists. Please answer your conscience when making decisions that impact our children.

Respectfull, Barbara Sullivan Citizen 2005 22nd Ave. NE Minneapolis, MN 55428

Response: See response to comment code 6120.

Commenter Name: Laurel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1977

EPA Comment ID: 20816

EPA Comment Code: 6120

Comment: please keep our drinling wa ter safe, no perchlorate

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1978

EPA Comment ID: 20817

EPA Comment Code: 6120

Comment: Please keep perchlorate out of drin king water, start regulating now.

Response: See response to comment code 6120.

Commenter Name: Dave Schaenzer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1979

EPA Comment ID: 20818

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

I do not want to drink perchlorate contamination in my water. This is a nationwide problem and has health impacts. I suggest that having a national primary drinking water regulation would provide a uniform standard that would protect public health at a federal level. This would save the cost of State by State regulations. This would also prevent l ong litigative process thru the individual states.

Thank You Dave Schaenzer

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 835 of 1099 Commenter Name: D. Nelson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1981

EPA Comment ID: 20819

EPA Comment Code: 6120

Comment: Perchlorate must be regulated in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1983

EPA Comment ID: 20822

EPA Comment Code: 6120

Comment: This chemical has been linked to thyroid problems in vulnerable populations of newborns, young children and pregnant women. The relaxation of this standard is harmful to public

health.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1984

EPA Comment ID: 20823

EPA Comment Code: 6120

Comment: I would like to know how this is in some way justified by President Bush?? This is drinking water for the very same infants that Mr. Bush and company supposedly try to "save" from abortion. I guess once they are out of the womb, thes e babies are no longer politically important and can be given poison. Where are all the right wing evangelicals that are so angry about abortion but never say a word in protest of infants being pr ovided poisoned water by our government?? What a conscience you must have Mr. Bush!! It is no wond er why you have been selected as one of the worst president's of our life time - I would say th e worst in our entire history as a country. 27% approval rating?? do you have any shame? and to make matters worse, at the last minute of the presidency when people think you can't go any lower; you push forward with these insane laws! Amazing how selfish you can be. The days till yo ur last day in office cannot come soon enough! Hope all your buddies with deep pockets are able to talk to your creator when its time for final judgement! Because from where I'm standing; you defi nitely have a long list of sins to account for!

Response: No response necessary, this is not a comment.

Commenter Name: Jasmin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1985

EPA Comment ID: 20824EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 836 of 1099 EPA Comment Code: 6120

Comment: 11/06/08

Dear EPA,

I also do not want perchlorate in my drinking water.

Jasmin 326 N. Royal St. Alex. VA 22134

Response: See response to comment code 6120.

Commenter Name: Ben Spriggs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1986

EPA Comment ID: 20825

EPA Comment Code: 6120

Comment: 11/06/08

Dear EPA,

Please cap perchlorate in my water resources.

Ben Spriggs 312 N. Royal St. Alexandria, VA 22134

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1991

EPA Comment ID: 20826

EPA Comment Code: 6120

Comment: Perchlorate needs to be reduced and or e limanted in the drinking water. This issue needs to be addressed and better regulated, not swept under the rug. This is a major health concern,
and as a woman, mother and citize n of the USA, I am astounded that this issue with Perchlorate contaminating the water that I drink exist.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1992

EPA Comment ID: 20827

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 837 of 1099 Comment: Pushing through this regulation is harmful to the general populous and should not be continued until an acceptable review period has been established. This kind of government regulatory process without adequate review and study is unacceptable and only panders to special

interest.

Response: EPA announced on October 10, 2008, its preliminary regulatory determination that a national primary drinking water regulation for perchlorate would not present "a meaningful opportunity for health risk reduction for persons serv ed by public water systems." In response to requests from several stakeholde rs, EPA reopened the public comment period for an additional 15 days.

Commenter Name: T. Dginazio Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1993

EPA Comment ID: 20828

EPA Comment Code: 6120

Comment: I am outraged by this last minute rule changing. Will phone White House Monday to protest under cutting the public trust. The maximum safe level for perchlorate in drinking water is now 15 times higher than what was declared safe in 2002. Under this new standard, more than 16 million Americans are exposed to unsafe levels of perchlorate in their drinking water, and independent analysis shows anywhere from 20 to 40 million Americans at risk. Perchlorate has been found in the drinking water in 35 states in the U.S. This chemical has been linked to thyroid problems in vulnerable populations of newbor ns, young children and pregnant women. The relaxation of this standard is harmful to public he alth. outraged by this last minute rule changing.

Response: See response to comment code 6120.

Commenter Name: Aaron Peterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1994

EPA Comment ID: 20829

EPA Comment Code: 6120

Comment: It has been shown that perchlorate greatly impacts human health by interfering with iodide uptake into the thyroid gland. Its greatest impact is on newborns, young children, and pregnant women. While small amounts of perchlor ate may not pose a serious threat, large amounts endanger human health and water resources. A la ck of regulation for perchlorate leaves me concerned for the developmental health of those most vulnerable to the chemical's effects.

-Aaron Peterson

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1995

EPA Comment ID: 20830EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 838 of 1099 EPA Comment Code: 6120

Comment: Enough chemicals in our drinking water. Th e evidence from reports on the EPA's page show that perchlorate is toxic and we should not be drinking water with it. It is even found in mother's milk. The government is the cause of the contamination and the study was done by industry. It is obvious that the EPA is not really protecting the citizens. Regulate perchlorate.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1996

EPA Comment ID: 20831

EPA Comment Code: 6120

Comment: Regulate perchlorate now!

Response: See response to comment code 6120.

Commenter Name: Mary Moore Commenter Organization: Lindon Park Neighborhood Association (LPNA)

EPA Document ID: EPA-HQ-OW-2008-0692-2002

EPA Comment ID: 20835

EPA Comment Code: 6120

Comment: EPA needs be moving toward the adoption of standards that protect the public from major health threats and not toward deregulation, especially when the primary exposure pathway for perchlorate is from contaminated drinking water.

Perchlorate is extremely persistent. Lack of regulati on will not diminish this health risk to the public. LPNA respectfully requests that EPA develop a lega l standard for perchlorate in drinking water.

Sincerely,

Mary Moore Lindon Park Neighborhood Association Phoenix, AZ

Response: See response to comment code 6120.

Commenter Name: Andy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2006

EPA Comment ID: 20836

EPA Comment Code: 6120

Comment: Dear Sir or Madaam,

I think clean water is a good idea. Please do all you can to make sure it is clean.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 839 of 1099 Thanks Andy

Response: See response to comment code 6120.

Commenter Name: Heather Mastroddi Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2008

EPA Comment ID: 20838

EPA Comment Code: 6120

Comment: Water Docket ID # EPA-HQ-OW-2008-0692

To Whom It May Concern,

I would like to see more research on also regulating the harmful chemical perchlorate in our water.

Thank you,

Heather Mastroddi 601 Poplar St. Catasaqu, PA 18032

Response: See response to comment code 6120.

Commenter Name: Kimberly Scherman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2009

EPA Comment ID: 20842

EPA Comment Code: 6120

Comment: Docket ID # EPA-HQ-OW-2008-0692

To whom it may concern:

Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought. It can impair thyroid gland which controls growth, developmental health impairment. Please regulate this substance!!!!

Sincerly,

Kimberly Scherman 640 S. 14t h St. Catasaqua, PA 18032

Response: See response to comment code 6120.

Commenter Name: Brenda Heininger Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2013

EPA Comment ID: 20845

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 840 of 1099 Comment: I feel primary drinking water regulation is needed to protect public health.

Perchlorate is a very harmful chemical which needs to be regulated.

Brenda Heininger 2317 Silo Dr. Easton, PA 18040

11/10/08

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2014

EPA Comment ID: 20847

EPA Comment Code: 6120

Comment: What could the EPA possibly be thinking? PLEASE, PLEASE.....regulate this chemical in our drinking water!!!!!

Response: See response to comment code 6120.

Commenter Name: E. Cuffari Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2015

EPA Comment ID: 20848

EPA Comment Code: 6120

Comment: Please reverse this decision on the regulati on of Perchlorate in our drinking water. The last thing we need is Another chemical doing harm to US and our children. Since this chemical has been found in 37 states drinking water , I feel it's important to regulate.

Response: See response to comment code 6120.

Commenter Name: Lynn Thorp Commenter Organization: Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-2017

EPA Comment ID: 20850

EPA Comment Code: 6120

Comment: Clean Water Action has been concerned a bout perchlorate contamination for many years and has worked with communities facing pe rchlorate contamination of their water supplies and in several states where drinking water standa rds have been considered and/or set. Drinking water is a priority area for the organization and we work on many aspects of Safe Drinking Water Act implementation.

Clean Water Action urges the Agency to reconsid er its preliminary determination NOT to set a Maximum Contaminant Level (MCL) for perchlorate at this time. With tens of millions of drinkingEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 841 of 1099 water consumers affected and given that perchlorate affects some of our most vulnerable people the most - infants and children - there is a meaningful opportunity for health risk reduction.

Response: See response to comment code 6120.

Commenter Name: Donna Wolsted Commenter Organization: Gleason Lake Improvement Association (GLIA)

EPA Document ID: EPA-HQ-OW-2008-0692-2018

EPA Comment ID: 20852

EPA Comment Code: 6120

Comment: We want to maintain the be st drinking water we can.

Please eliminate percholate from rocket fuels and explosives.

We have to be aware that the cancer and other di seases in U.S. have some strong contributing

factors that other countries do not have.

I am not willing to risk my health on having more chemicals in our food or water. because the gov. "thinks" it is safe. Donna Wolsted, GLIA

Response: See response to comment code 6120.

Commenter Name: Lenny Siegel Commenter Organization: Center for Public Environmental Oversight

EPA Document ID: EPA-HQ-OW-2008-0692-2019

EPA Comment ID: 20856

EPA Comment Code: 6120

Comment: If EPA were serious about protecting the heal th of America’s children, it would move forward with plans to develop a legal standard for perchlorate in drinking water. In the course of
that effort, it should consider how other c ontaminants might contribute to the problem.

Finally, over the past decade, our understanding of the perchlorate threat has changed. Large sources of perchlorate pollution, associated with rocket-fuel production and other industrial activity, remain. However, it appears that perchlorate exposure is wide spread at low levels also because of natural, agricultural, and incidental sources. To devel op a public health strategy that addresses such exposures, we need a drinking water standard that requires the sampling of our water supplies at the low levels found to be a potential problem by the Centers for Disease Control. Even if it turns out that other factors-such as low iodine consumption-play a key role in the manifestation of thyroid dysfunction, such sampling is essential to protect th e health of our children for decades to come.

Sincerely, (submitted electronically) Lenny Siegel Executive Director

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 842 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2022

EPA Comment ID: 20857

EPA Comment Code: 6120

Comment: It doesn't take a rocket scientist to know that drinking rocket fuel is unhealthy. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Is there any question that Perchlorate in our water needs to be

banned?

Response: See response to comment code 6120.

Commenter Name: Doug Bendele Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2025

EPA Comment ID: 20858

EPA Comment Code: 6120

Comment: I urge the EPA to regulate perchlorate in drinking water. Perchlorate contamination has been found to be a nationwide problem with potenti ally devastating medical effects. Please exercise the authority given to you to protect my children and yours.

Doug Bendele, human, father, husband, citizen, engineer

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2026

EPA Comment ID: 20859

EPA Comment Code: 6120

Comment: NO perchlorate in my water please regulate, accountability good - clean water best.

Response: See response to comment code 6120.

Commenter Name: E.D. Levinson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2036

EPA Comment ID: 20860

EPA Comment Code: 6120

Comment: It seems more than dangerous NOT to regulate perchlorate - please reconsider immediately.

Thank you.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 843 of 1099 Commenter Name: Hannah Durocher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2037

EPA Comment ID: 20861

EPA Comment Code: 6120

Comment: As a member of the general public, I was horri fied to hear that the EPA is considering NOT regulating perchlorate in drinking water. Th is chemical has been shown to be harmful to

human and animal health.

As someone with a thyroid problem who has seen the number of people with thyroid problems increase over the last few decades, I was appalle d to learn that the EPA has made a preliminary decision to not regulate a substance that has been shown to damage the thyroid gland.

In our time of bottled spring water for the wealthy, the failure to regulate perchlorate would disproportionately affect the health of the middle class and working poor. This is immoral and bad

for health care costs.

The purpose of the government is to serve the needs of the people--not the needs of industry without any consideration for the people. I urge the I urge the EPA to reverse its preliminary

decision and make a stand for moral steward ship of our nation's drinking water.

Hannah Durocher 1407 N. Kenilworth St. Apt. 3 Arlington, VA 22205

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2038

EPA Comment ID: 20862

EPA Comment Code: 6120

Comment: Dear EPA:

Please regulate the percholate in drinking water and protect public health. I understand the

contaminant can have harmful affects at levels lower than thought previously.

Thank you for your attention to this matter.

Response: See response to comment code 6120.

Commenter Name: M. King Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2041

EPA Comment ID: 20863

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 844 of 1099 Comment: You must regulate Perchlerate in Drinking water, We do not know the possible effects that ingestion of this toxic chemical can cause. Start Regulating it Now!

Response: See response to comment code 6120.

Commenter Name: R. James Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2044

EPA Comment ID: 20864

EPA Comment Code: 6120

Comment: Keep Perchlorate out of our Drinking Water.

Response: See response to comment code 6120.

Commenter Name: Gabriel Donovan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2046

EPA Comment ID: 20865

EPA Comment Code: 6120

Comment: To the EPA,

I write to petition for the regulation of Perchlor ate in America's water resources. As with all chemical ingredients in use today, Perchlorate is a mystery. A mystery in that we do not know the long term ramifications of exposure in humans an d to the environment. The preliminary findings point to ill effects in both regards. For this reason I strongly urge you to reconsider your position of non regulation. We the people of the United Stat es depend on your vigilant watch to protect us from the danger of industrial pollutants. Regulate Perchlorate.

Sincerely,

Gabriel Donovan Texas

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2047

EPA Comment ID: 20866

EPA Comment Code: 6120

Comment: Our healthcare system needs reform and Soci al Security is straining and will get worse. The health problems brought on by not regulating perc olate can be prevented. It is irresponsible to ignore this element and deem it as harmful.

Please reverse your decision.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 845 of 1099 Response: See response to comment code 6120.

Commenter Name: Kathryn S Taylor Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2048

EPA Comment ID: 20867

EPA Comment Code: 6120

Comment: Please, please, please reconsider this decision to allow perchlorate in our drinking water. We are facing enough cancer and other health i ssues because of chemicals in our water and soil.

For health, Kathryn S Taylor 154 SE Lincol n Circle North St. P etersburg, FL 33703

Response: See response to comment code 6120.

Commenter Name: Della R. Post Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2053

EPA Comment ID: 20868

EPA Comment Code: 6120

Comment: I am appealing to you in the interest of all citizens who drink water (everyone, including you) to reverse your decision not to regulate the amount of Perchlorate in our water supplies. Too many studies have found clear danger allowing this contaminent to remain in our water. To allow it to continue harming us is irres ponsible behavior from an organization whose job is to protect the American people.

Sincerely, Della R. Post 154 Villa ge Circle Oakdale, PA 15071

Response: See response to comment code 6120.

Commenter Name: Justin White Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2058

EPA Comment ID: 20869

EPA Comment Code: 6120

Comment: Can anyone come up with one good reason to put Perchlorate in the drinking water? Aside from the obvious one, which is that it is the cheapest, and sneakiest, way for a corporation/government to get rid of a danger ous byproduct. As was done with fluoride, a byproduct of aluminum smelting, and ammonium, which killed all of my fish and thus, can't be all that good for you.

Adding Perchlorate to our drinking water is a ri diculous notion and everyone knows it. Wouldn't it be nice if people were truthful and responsible and took accountability for their actions?

Concerned Citizen, Justin WhiteEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 846 of 1099 Response: Perchlorate is not added to drinking water . There are three principal sources of the perchlorate in the environment: its use as an ox idizer (rocket propellants, fireworks, flares and explosives), its presence in Chilean nitrate fert ilizer, and formation via atmospheric processes.

Commenter Name: Margaret Tait Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2062

EPA Comment ID: 20870

EPA Comment Code: 6120

Comment: I have lived with thyroid disease for 13 years . It makes every day harder and has effected every aspect of my health and life. Without regulati on, sadly, industry does not often take the action needed to protect the public from contaminants. It makes no sense to accept any risk to our children's health. We must regulate perchlorate's presence in our water.

Margaret Tait Brighton, Michigan

Response: See response to comment code 6120.

Commenter Name: Pamela Rogow Commenter Organization: Eco Impresario Services

EPA Document ID: EPA-HQ-OW-2008-0692-2063

EPA Comment ID: 20871

EPA Comment Code: 6120

Comment: News of the EPA's impending reversal of it s initial determination to protect drinking water from perchlorate contamination is a great mist akes. Please protect the public from this danger.

Response: See response to comment code 6120.

Commenter Name: Susie Bryan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2065

EPA Comment ID: 20872

EPA Comment Code: 6120

Comment: Please do not contaminate the water with one more chemical. We have a daughter affected with autism and is not able to detoxify he rself very well due to low glutathione levels. This is common with children affected by autism. Whether or not the EPA finds that there is a safe amount that does not cause long-term affects on "people" doesn't speak to the large population of people that are having a hard time processing a ll the chemicals that are CURRENTLY out there.

Please hear our voices and don't add any more chemicals to the water that do (in some part) have a toxicity level (even though they haven't shown to have a large effect). Any toxi city is a lot of toxicity for a child on the spectrum!

Susie BryanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 847 of 1099 Response: Perchlorate is not added to drinking water . There are three principal sources of the perchlorate in the environment: its use as an ox idizer (rocket propellants, fireworks, flares and explosives), its presence in Chilean nitrate fert ilizer, and formation via atmospheric processes.

Commenter Name: J. and D. Dietz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2066

EPA Comment ID: 20873

EPA Comment Code: 6120

Comment: Pls. do not allow rocket fuel to remain in our water. You may say it is not harmful but what is causing our sicknesses and cancers? Water s hould be clean and have no man made or natural

substances in it which could cause harm. Who knows wh at we will find out in the future concerning our digesting rocket fuel. This is preposterous!! Filter it out of our water!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2068

EPA Comment ID: 20874

EPA Comment Code: 6120

Comment: We need cleaner water. Please protect us from chemicals like perchlorate!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2069

EPA Comment ID: 20875

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation fo r perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Donna Levin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2070

EPA Comment ID: 20876

EPA Comment Code: 6120

Comment: Please change your decision on percholate, and regulate its presence in drinking water. We depend on you. Thank you.

Donna Levin Elkins Park, PennsylvaniaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 848 of 1099 Response: See response to comment code 6120.

Commenter Name: Susan S. Merrill Commenter Organization: Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-2073

EPA Comment ID: 20877

EPA Comment Code: 6120

Comment: Greetings:

Please reverse the deregulation of perchlorate, a ch emical found in rocket fuel, from drinking water in the United States. Americans need clean drinking water and should be protected from contaminants in it such as perchlorate.

Thank you for making this change in the law.

Sincerely,

Susan S. Merrill Member, Clean Water Action

Response: See response to comment code 6120.

Commenter Name: Caryn Mandelbaum Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2076

EPA Comment ID: 20878

EPA Comment Code: 6120

Comment: Why bother having an EPA when it is unw illing to carry out its purpose-- to secure clean water (all water), air and land? Specifically, by denying its responsibility to regulate perchlorate in drinking water, the EPA is offending the lead ers that chartered the institution and all people affected by its irresponsibility.

Perchlorate contamination is a problem nationwide. A small amount of this pernicious chemical poses a massive threat to our freshwater resour ces-- groundwater. There are communities, like some near me in California, that are nearly entire ly dependent on groundwater. They can only expect to suffer grave health impacts from drinking perc hlorate-laden groundwater . All the EPA has done here is to declare a Superfund site. That is unacceptable.

The EPA was created in order to be responsible for the government and government-sanctioned industrial pollution to our natural resources. Perc hlorate found its way into our drinking water supply as a result of the Department of Defenses contracts with the aerospace industry. It sounds like paranoia, but I know the industry's and government's protective measures or accountability

could not be further from the truth.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 849 of 1099 If you are not going to stand up to your responsibility, stop wasting my tax dollars and get out of a regulatory regime. If you are going to continue to pretend to be the department that secures clean water, air and land, then set perchlorate standards and clean-up superfund sites.

By all means, I expect a response-- both national and personal.

Sincerely, Caryn Mandelbaum, carynm5@gmail.com

Response: Regarding regulating perchlorate, see response to comment code 6120. Regarding cleaning up Superfund sites, see response to comment code 6300.

Commenter Name: Theresa Quigley-Uhl Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2077

EPA Comment ID: 20879

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlora te in drinking water. Please keep our water free from harmful chemicals. Keep our children healthy.

Thank you, Theresa Quigley-Uhl 1134 Sn yder avenue philadelphia,PA 19148

tajuhl7@aol.com

Response: See response to comment code 6120.

Commenter Name: Robin Porter Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2078

EPA Comment ID: 20880

EPA Comment Code: 6120

Comment: I urge the EPA to reconsider its regulation of perchlorate in our drinking water. This chemical can cause serious health issues in developi ng fetuses and children, and it's long-term effects

are not known. We shouldn't risk the lives of our children to find out! Please keep our drinking
water clean, safe and free of harmfu l chemicals such as perchlorate.

Thank you, Robin Porter Concerned citizen

Response: See response to comment code 6120.

Commenter Name: Michael Doxy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2079

EPA Comment ID: 20881

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 850 of 1099 Comment: 11/5

To Whom it May Conern

I would like to support the Clean Water Action Commi ttees efforts to rid our local water supply of perchlorates.

Michael Doxy 706 S. Royal St Alexandria, VA 22314

Response: See response to comment code 6120.

Commenter Name: Teresa Jordan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2080

EPA Comment ID: 20882

EPA Comment Code: 6120

Comment: 3152 Shad Court Simi Valley, CA 93063 November 26, 2008

Water Docket US EPA Mailcode: 2822T 1200 Penns ylvania Avenue, N.W. Washington, DC 20460

Re: DOCKET ID No. EPA-HQ-OW-2008-0692 (Preliminary Regulatory Determination on Perchlorate--Reopening of Public Comment Period (November 28, 2008 Deadline)).

Dear Mr. Grumbles, and Mr. Burneson:

I just read through the Santa Susana Field La boratory's Perchlorate Work Plan, the State Water Resources Control Board's Proposed Recycled Water Policy Staff Report, and after mulling through my recent letters addressing the State Water Resources Control Board's proposed review of California's Anti-Degradation Policy (Resolution 68-16), I am convinced more than ever that it is of the utmost importance the USBPA initiates development of a national regulation for perchlorate in drinking water ASAP because if the types of d ecisions on water quality issues made by California's State and Regional Water Quality Control Boards are in dicative of trends in the other 49 States such state of affairs significantly impact Americans nationwide.

Sincerely, Mrs. Teresa Jordan

Enclosures:

November 19, 2008, Letter to the State Water Reso urces Control Board; Anti- degradation Policy. (3 Pages) [See PDF Docket ID EPA-HQ-OW-2008-0692-2080]

November 20, 2008, Letter to the State Water Reso urces Control Board; Anti- degradation Policy. (5 Pages) [See PDF Docket ID EPA-HQ-OW-2008-0692-2080]

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #8 - Food and Water WatchEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 851 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1805

EPA Comment ID: 20883

EPA Comment Code: 6120

Comment: Dear Administrator Johnson,

I am writing to urge you to reconsider EPA's pr eliminary determination not to regulate perchlorate in drinking water.

Perchlorate has been found in the drinking water supply of 35 states and the District of Columbia. Widespread human exposure to perchlorate was co nfirmed by the Center for Disease Control’s NHANES study, which found that 100 percent of the 2,820 randomly selected study participants had detectable levels of perchlorate in their urine.

The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroid gland’s iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive

effects for those affected.

EPA’s failure to regulate perchlorate in drinking water places consumers - especially children and pregnant women - at risk.

In response to this misguided determination, EPA’s own Children’s Health Protection Advisory Committee has drafted a letter expressing its c oncern with EPA’s decision not to regulate perchlorate. Members of the co mmittee claim that EPA rushed a decision on perchlorate without taking time to consider all the latest peer-reviewed studies.

Given the vital importance of fetal central nervo us development not only for long-term health and development of children, but also for the viability of fetuses, why would EPA rush to a decision? Unfortunately, the only conclusion we can draw is that EPA has issued this determination to avoid strapping the Department of Defense with costs to clean up near military bases, missile testing sites and chemical plants. While millions of consumers’ health is jeopardized, it seems the budget concerns of the Pentagon or White Ho use are driving EPA’s decision.

This determination is clearly another instance of a regulatory agency shirking its responsibility to protect the American public. Instead of fulfillin g its obligations under the SDWA, EPA has once again folded to pressure.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #6 - Earth Justice

EPA Document ID: EPA-HQ-OW-2008-0692-0972

EPA Comment ID: 20884

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 852 of 1099 Comment: Administrator Stephen L. Johnson 1101 A EPA Headquarters 1200 Pennsylvania Avenue, NW, Ariel Rios Building Washington, DC 20460

Subject: Protect Our Drinking Water From Perchlorate Contamination

Dear Administrator Johnson,

I am writing to urge you reverse EPA's prelimin ary regulatory determination and set a protective drinking water standard for perchlorate as required by the Safe Dr inking Water Act.

Perchlorate contamination in our food and water su pplies is too widespread, and its toxic effects too well known, for continued inaction on this problem.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1799

EPA Comment ID: 20887

EPA Comment Code: 6120

Comment: I cannot believe that this is something that is even being debated. The idea of allowing an ingredient that is in rocket fuel to even be present in any percentage in our drinking water is utterly ridiculous.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1884

EPA Comment ID: 20888

EPA Comment Code: 6120

Comment: This is crazy. Why would this administration go against the SCIENCE of this action? Are you trying to scheme your way into making the public FEAR tap water in order to boost the sales of bottled water by your best friends and co rporate companies while putting the public health at risk? Wow, so there is actually movements be ing created around the support of tap water and against corporate giants. You're afraid of the people g etting this right. Do the right thing in your last days in office. I really fear for the world you are leaving your children. Does that EVER cross your mind? Greed never solved any problems in our country. Grow up.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1891

EPA Comment ID: 20889

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 853 of 1099 Comment: For Bush to pass something as absurd as this is pretty low of him. I would expect this out of a Republican, however. Most Republicans are only out for themselves or others who can provide top dollar. Perchlorate keep increasing in the drinking water. What will happen when they increas again? Will there be another determination of how safe the water is? Will the water still be

declared 'safe'? I bet that if Bush and the rest of his administration had to drink the water, they would not pass such a thing. When will there be anyone in any sort of political office/setting who will care about the average American? Congress and the rest of capital know this, I am sure, but if the average American were to stand up and not take any of the [expletive] that was being fed to us, the people would actually be able to take charge of this country like it should be. The United States is becoming a [expletive] due to things (this docket) like this, and is alos why China is the next 'Land of Opportunity'. The U.S.A. is now the 'Land of Degregation and No Hope'.

Thanks for the terrible job everyone on Capital Hill. I hope you enjoy destroying this once great

country.

Response: No response necessary, this is not a comment.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1921

EPA Comment ID: 20890

EPA Comment Code: 6120

Comment: Someone better change the regulations on what is acceptable. 0% There is enough crap in the drinking water that EPA say is acceptable. Is it accep table to POISON us? Let's regulate something that matters. I don't care if it's PPM or PPB the perchlorate levels are still unacceptable.

Response: See response to comment code 6120.

Commenter Name: D'Lanie Blaze Commenter Organization: TheAeroSpace

EPA Document ID: EPA-HQ-OW-2008-0692-0641

EPA Comment ID: 20891

EPA Comment Code: 6120

Comment: To Whom It May Concern:

I am very concerned that the EPA is poised to walk away from monitoring perchlorate in our drinking water. Given the documented risk this c ontaminant poses to public health, this decision contradicts the purpose for which this agency was designed.

Southern California's main industries during the 1950's and 1960's were atomic energy and aerospace. Santa Susana Field Laboratory (SSFL) was home to over 30,000 rocket engine tests and the worst nuclear accident in US history. During the Cold War and Space Race, the Atomic Energy Commission (AEC) and Department of Energy (DOE) encouraged rampant environmental pollution in the name of production and experiment ation, resulting in massive contamination to ground and surface water. Presently, SSFL languish es in a state of contamination. PerchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 854 of 1099 remains a concern within our community; it has repe atedly tested beyond "safe" levels in drinking water, and thyroid issues are staggering in the neighborhoods surrounding SSFL. This is a nationwide concern, especially in communities that border military bases with a history of missile development.

The DOE continues to evade accountability for environmental crimes, which spanned decades. The EPA's cavalier approach to public safety rega rding perchlorate sets a dangerous precedent.

Predictably, the public has been inadequately informed and provided with little time to offer educated comment before the opportunity to take pa rt in the decision-making process expires. The EPA's attempt to rush this decision before admi nistrative change - and while meeting only the minimum requirements for public participation (whi ch are inept at best) - is very telling. The decision to cease monitoring for perchlorate in drinking water likely augurs trouble on the horizon for our citizens, the majority of which blindl y trust agencies like the EPA to fulfill their responsibilities in an ethical, if not logical, fashion.

Sadly, the opportunity to access information and b ecome involved in decisions like this one are difficult. Conversely, the public is bombarded with pharmaceutical ads which announce the availability of a wide variety of medication which is arguably necessary as a result of our routine exposure to a variety of toxins and pathways. Thyroid issues are steadily rising, and yet the government body tasked with this issue is willing to walk away from it. This does nothing but give rise to the possibility of collusion between EPA an d pharmaceutical corporations. What is the payoff for walking away from perchlorate? This is certainly not a decision motivated by commitment to public safety.

Response: See response to comment code 6120.

Commenter Name: Brie Brigham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1436

EPA Comment ID: 20893

EPA Comment Code: 6120

Comment: Brie Brigham 118 South Gill Street Sta te College, PA 16801 October 29, 2008

Office of Ground Water and Drinking Water (4601 ) Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, DC 20460-0003

To Whom It May Concern,

I support the EPA's decision to regulate the con centration in drinking water, but believe the perchlorate contamination level considered safe should be lowered. Perchlorate occurs both naturally and through manufacturing, and is found in rocket fuel, fireworks, and airbags. Perchlorate enters United States drinking water from improper di sposal by test sites, military bases, and chemical plants. A 2005 report by the EPA stated that the chemical compound polluted soil, groundwater, and drinking water in 35 states and has contaminated 153 public water systems in 26 states. The report also estimated that 16.6 million Americans ar e exposed to perchlorate at levels scientistsEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 855 of 1099 consider unsafe. Perchlorate contamination in drinking water can have devastating effects, particularly on fetuses, newborns, and children.

Response: See umbrella response under 6120.

Commenter Name: Brie Brigham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1436

EPA Comment ID: 20896

EPA Comment Code: 6120

Comment: In conclusion, I applaud the EPA's decision to regulate perchlorate concentrations in drinking water. However, I believe the contaminati on level should be lowered so that fetuses, newborns, and children are not exposed to levels that are unsafe.

Sincerely, Brie Brigham

Response: Please see the response to comment code 6120.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20898

EPA Comment Code: 6120

Comment: EPA’s Preliminary Regulatory Determination on Perchlorate is an embarrassment to the agency. It marks the next step in a long journey away from sound science, impartiality, and public health protection towards biased decisions where the agency no longer even attempts to hide its partiality towards industry interests.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20902

EPA Comment Code: 6120

Comment: The combined effect of these multiple layers of corruption has been to make perchlorate look safe when it is not, and to make EPA appear as though it is simply servicing perchlorate polluters, which it is. The agency’s pr oposed action is nothing less than pandering to perchlorate polluters who would be made to clean up the tap water of 40 million people in 27 states if the agency were to conduct an honest assessmen t of the human health risks of perchlorate.

This assessment makes a mockery of everything EPA stands for. It must not be adopted.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 856 of 1099 Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20908

EPA Comment Code: 6120

Comment: The scientific evidence clearly points to the need for EPA to set a health protective drinking water standard for perchlorate - that is, a standard lower than the level shown to be associated with altered thyroid hormone levels in American women with low iodine intake. Unfortunately, EPA has relied on questionable scien ce, an even more questionable computer model, and circular logic to justify its proposal to not regu late this harmful contaminant at all in our nation’s drinking water. This is inexcusable.

EWG urges EPA to overhaul its poorly crafted assessment according to the points described in detail below and to live up to its mandate of protecti ng public health by setting a stringent drinking water standard for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20917

EPA Comment Code: 6120

Comment: Conclusion

As outlined above, EPA’s preliminary regulatory determination on perchlorate is rife with errors, omissions, and wrong assumptions. EPA relies on a computer model that was generated using the now discredited Greer study. In addition, EPA c hooses to ignore the valuable data from human studies like the Blount study that show potential health risks to millions of U.S. residents from perchlorate exposures much lower that the propos ed HRL of 15 ppb. EPA also disregards the vulnerability of breast fed infants and young childre n, in whom current perc hlorate exposures could potentially result in decreases in thyroid hormone le vels that have long-term adverse effects on brain development and growth. Perhaps most egregi ous is EPA’s finding that protecting 30,000 pregnancies annually is not a sufficient reason to regulate this dangerous contaminant in drinking

water.

Response: See response to comment code 6120.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group

EPA Document ID: EPA-HQ-OW-2008-0692-1432

EPA Comment ID: 20919

EPA Comment Code: 6120

Comment: In the meantime, EWG calls on EPA to fix the numerous glaring errors in its assessment and to quickly move to set a health prot ective drinking water standard for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 857 of 1099 Sincerely,

Dr. Anila Jacob, MD, MPH Senior Scie ntist Environmental Working Group

References:

Amitai Y, Winston G, Sack J, Wasser J, Lewis M, Bl ount BC, Valentin-Blasini L, Fisher N, Israeli A, Leventhal A. 2007. Gestational Exposure to High Perchlorate Concentrations in Drinking Water and Neonatal Thyroxine Levels . Thyriod 17(9): 843-50.

Blount BC, Valentin-Blasini L, Osterloh JD, Maul din JP, Pirkle JL. 2006a. Perchlorate Exposure of the US population, 2001-2002. Journal of Expo sure Science and Environmental Epidemiology 17(4): 400-07.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell LK. 2006b. Urinary Perchlorate and Thyroid Hormone Levels in Adolescent and Adult Men and Women living in the United States. Environmental Health Perspectives 114(12): 1865-71.

Dasgupta PK, Kirk AB, Dyke JB, Ochira S. 2008. Intake of Iodine and Perchlorate and Excretion in

Human Milk. Environmental Science and Technol ogy. 9/17/2008: epub ahead of print.

EPA. 2008. Drinking water: Preliminary Regulatory Determination on Perchlorate. http://www.epa.gov/safewater/ccl/r eg_determine2.html#perchlorate

EWG. 2006. Thyroid Threat. http://w ww.ewg.org/reports/thyroidthreat

EWG. 2008. FDA Food Testing Shows Widespread Rocket Fuel Contamination of Commonly Consumed Foods and Beverages. www.ewg.org/node/25875

GAO. Testimony before the Subcommittee on Invest igations and Oversight, Committee on Science and Technology, House of Representatives: Chemical assessments. www.gao.gov/new.items/d08810t.pdf

Greer MA, Goodman G, Pleuss RC, Greer SE. 200 2. Health Effect Assessment for Environmental Perchlorate Contamination: the Dose Response for Inhibition of Thyroidal Radioiodide Uptake in Humans. Environmental Health Perspectives (110): 927-37.

Kirk AB, Martinelango PK, Tian K, Dutta A, Smit h EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Environmental Science and Technology 39(7) 2011- 17.

Kirk AB, Dyke JV, Martin CF, Dasgupta PK. 2007 . Temporal patterns in Perchlorate, thiocyanate, and Iodide Excretion in Human Milk. Environmental Health Perspectives 115(2) 182-86.

MassDEP. 2006. Update to "Perchlorate Toxico logical Profile and Health Assessment". http://www.mass.gov/portal/gog_cache.jsp?q=cache:DvvnPHJtRYwJ:www.mass.gov/dep /toxics/perchlorate-toxicity-061206.pdf+G reer&access=p&output=xml_no_dtd&ie=UTF8&client=mgov&site=EOEAxDEPx&proxystylesheet=mgov&oe=UTF-8EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 858 of 1099 Murray WM, Egan SR, Kim H, Beru N, Bolger PM. 2008. US Food and Drug Administration's Total Diet Study: Dietary Intake of Perchlora te and Iodine. Journal of Exposure Science and Environmental Epidemiology 2008 (1-10)Epub ahead of print.

Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Valentin-Blasini L, Braverman LE. 2007.

Breast Milk Iodine and Perchlorate concentrati ons in Lactating Boston Area Women. Journal of Clinical Endocrinology and Metabolism 92(5):1673-7

Response: See response to comment code 6120.

Commenter Name: Lucy Allen Commenter Organization: Pacific Institute

EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 20925

EPA Comment Code: 6120

Comment: November 5, 2008

Administrator Stephen L. Johnson Water Dock et, Environmental Protection Agency 2822T, 1200 Pennsylvania Ave., NW Washington, D.C. 20460

RE: Drinking Water: Preliminary Regulatory D etermination on Perchlorate, Federal Register October 10, 2008, (73 FR 60262) (FRL-872 7-6) Docket Number: EPA-HQ- OW-2008-0692

Dear Mr. Stephen Johnson,

The Pacific Institute would like to formally submit the following comments on the Environmental Protection Agency’s (EPA) Drinking Water Prelimin ary Regulatory Determination on Perchlorate. After reviewing the Preliminary Determination and relevant literature, we do not agree with the EPA’s determination that regulating perchlorate pr esents no "meaningful opportunity for health risk reduction for persons served by public water sy stems." While we recogniz e that the science upon

which the determination is based has been contes ted, our comments address a number of further concerns, including the protection of vulnerable populations; the impacts that the determination will have on remediation efforts and future monitoring; and the criteria for what is considered to be a "meaningful opportunity" for protection of public health.

Response: This is not a comment, a response is not necessary.

Commenter Name: Lucy Allen Commenter Organization: Pacific Institute

EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 20928

EPA Comment Code: 6120

Comment: Ongoing monitoring of drinking water is needed to safeguard public health. The EPA’s preliminary decision to not regulate perchlorate wa s contingent on the fact that a relatively small number of public water systems currently contain le vels of perchlorate at unsafe levels. While thisEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 859 of 1099 may be true today, it may change, as perchlorate is widely used and easily leached. With uncertainties surrounding the extent of current contamination, and continued use of perchlorate,[FN11: Both Trumpolt et al. and Aziz et al. identify uncertainties in how current uses of perchlorate, e.g. in road flares and fireworks affect groundwater perchlora te levels. See footnotes 12,13.] the EPA should set a Primary Drinking Water Regulation to make ongoing monitoring mandatory.

According to GAO 2007, federal and state agencies have found perchlorate in groundwater, surface water, soil, or public drinking water systems at almost 400 sites in 37 states, in concentrations ranging from 4 ppb to more than 3.7 million ppb. The GAO contends that "it is difficult to determine the extent of perchlorate in the United St ates or the status of any cleanup actions because EPA does not centrally track or monitor perchlor ate detections, environmental releases, or cleanup

activities."

Many potential sources of perchlorate contamin ation in the U.S. exist, including munitions manufacture and disposal, use of explosives in ro ck blasting, manufacture and use of fireworks, manufacture and use of safety flares, and use of Ch ilean nitrate fertilizers.[FN12: Trumpolt, C., M. Crain, G. Cullison, S. Flanagan, L. Siegel, and S. Lathrop. (2005). Perchlorate: Sources, Uses, and
Occurrences in the Environment. Retrieved Oct 27, 2008 from http://yosemite.epa.gov/r10/CLEANUP.NSF/PH /Arkema+Technical+Documents/$FILE/Perc hlorate-Sources-Occurance-In-The-Environment.pdf.],[F N13: Aziz, C., R. Borch, P. Nicholson, and E. Cox. (2006). Alternative Causes of Wide-Spr ead, Low Concentration Perchlorate Impacts to Groundwater. GeoSyntec Consultants, Guelph, ON, Canada. Retrieved Oct 27, 2008 from http://www.springerlink.com/content/p8m017624280 752w/.] In addition to these ongoing uses of perchlorate, there may be environmental contamin ation from historic releases, for example from manufacture and disposal. This widespread use is lik ely to lead to further water contamination, as perchlorate is readily leached from soil into ground water due to its high solubility and persistence in

the environment.

Response: See response to comment code 6120.

Commenter Name: Lucy Allen Commenter Organization: Pacific Institute

EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 20929

EPA Comment Code: 6120

Comment: The EPA determined that regulating perchlor ate in drinking water does not pose a meaningful opportunity to protect public health-even as its report recognizes that 900,000 people will remain exposed to perchlorate at levels that co uld exceed the health reference level, up to 30,000 of which are pregnant women at any given time. Protecti ng the health of these individuals, even if it is a small group, is significant, and the federal government has the capacity and responsibility to do

so.

Response: See response to comment code 6120.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 860 of 1099 EPA Comment ID: 20931

EPA Comment Code: 6120

Comment: In its preliminary determination, EPA has tentatively decided not to promulgate maximum contaminant levels (MCL's) for perchlor ate under the federal Safe Drinking Water Act (SDWA), 42 U.S.C. [sections] 300f to 300j-26. Th e Environment Department strongly urges EPA to reconsider this preliminary determination and to pr omulgate an MCL for perchlorate at a level that will protect human health, including the health of subgr oups at greater risk of adverse health effects.

Response: See response to comment code 6120.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20941

EPA Comment Code: 6120

Comment: Comments from Environmental Defense Fund on the Preliminary Regulatory Determination on Perchlorate Docket EPA-HQ-OW- 2008-0692 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008

Prepared by Caroline Baier-Anderson, Ph.D. Senior Health Scientist

Submitted to Docket: November 28, 2008

On behalf of Environmental Defense Fund, a non-profit, non-partisan, non- governmental environmental organization that combines law, po licy, science and economics to find solutions to today's most pressing environmental problems, we offer the following comments on the Preliminary Regulatory Determination on Perchlorate.

Environmental Defense Fund would like to express our strong disagreement with the Environmental Protection Agency's (EPA) Preliminar y Regulatory Determination on Perchlorate, as presented in the Federal Register / Vol. 73 , No. 198 / Friday, October 10, 2008. EPA has determined that a national primary drinking water regulation for perchlorate would not present a meaningful opportunity for health risk reduction. We believe that this decision is predicated on a flawed reference dose, and the incorrect applicat ion of a physiologically based pharmacokinetic model, leading to the derivation of a faulty health reference level. Below we lay out the details of our criticism, and offer alternative views that justify pr omulgation of a stronger standard for perchlorate.

Response: Regarding promulgating a perchlorate stan dard, see response to comment code 6120. Regarding the perchlorate reference dose, see response to comment 28863 under comment code 2110; regarding application of the PBPK model, see responses to comment codes 2400 and 2410; and regarding derivation of the health reference le vel, EPA derived potential alternative HRLs for 14 life stages (age groups) using the RfD and life st age-specific exposure information in the August 9, 2009, notice (74 FR 41883; USEPA 2009b). These levels range from 1 μ g/L to 47 μ g/L and are the concentrations of perchlorate in drinking water th at may result in total perchlorate exposures (from food and water) greater than the RfD for individual s at each life stage. These HRLs are calculated based on individuals who consume an average am ount of perchlorate from food (except forEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 861 of 1099 pregnant women where EPA used a 90 th percentile dietary intake estimate), but who consume equal or more water on a per body weight basis than 90 percent of their cohorts.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20954

EPA Comment Code: 6120

Comment: EPA Can Reduce Health Risk by Prom ulgating a Perchlorate Standard

In summary EPA has an opportunity to significantly reduce risks to human health by promulgating a perchlorate standard, providing that the refere nce dose is based on CDC data, taking into consideration sensitive subpopulations, including wome n of child-bearing age that are not receivingsufficient iodine, and the fact that hypothyroidism in the US is not only prevalent, but underdiagnosed and under-treated. All else follows from th is initial calculation, as a reference dose based on the appropriate consideration of these factors will result in a more realistic estimate of the number of US citizens potentially impacted by perc hlorate in drinking water. Such an analysis, based on more realistic assumptions, and newer, more accurate data, will provide concrete support for

EPA action.

References

Andersen S, Pedersen KM, Bruun NH, Laurberg P. 2002. Narrow individual variations in serum T4 and T3 in normal subjects: a clue to the understanding of subclinical thyroid disease. J Clin

Endocrinol Metab 87:1068-1072.

Aoki Y, Belin RM, Clickner R, Jeffries R, Phillip s L, Mahaffey KR. 2007. Serum TSH and total T4 in the United States population and their association with participant characteristics: National Health and Nutrition Examination Survey (NHANE S 1999-2002). Thyroid 17:1211-1223.

Blount BK, Pirkle JL, Osterloh JD, Valentin-Blasi ni L, Caldwell KL. 2006. Urinary perchlorate and thyroid hormone levels in adolescent and adult me n and women living in the United States. Environ Health Perspect 115:1865-1871.

Blount BC, Valentin-Blasini L, Osterloh JD, Maul din JP, Pirkle JL. 2007. Perchlorate exposure of the US Population, 2001-2002. J Expo Sci Environ Epidemiol 17(4):400-7.

Caldwell KL, Jones R, Hollowell JG. 2005. Urinary iodine concentration: United States National

Health And Nutrition Examination Su rvey 2001-2002. Thyroid 15:692-699.

Crump KS, Gibbs JP. 2005. Benchmark calculati ons for perchlorate from three human cohorts. Environ Health Perspect 113(8):1001-8.

Dasgupta PK, Kirk AB, Dyke JV, Ohira S-I. 2008. Intake of Iodi ne and Perchlorate and Excretion

in Human Milk. Environ Sci Technol 42: 8115 - 8121.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 862 of 1099 Greer MA, Goodman G, Pleus RC, Greer SE. 2002 . Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans. Environ Health Perspect 110:927-937.

Haddow JE, Palomaki GE, Allan WC, Williams JR , Knight GJ, Gagnon J, et al. 1999. Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. N Engl J Med 341:549-555.

Kirk AB, Martinelango PK, Tian K, Dutta A, Smit h EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Envi ron Sci Technol 39:2011-2017.

Kirk AB, Dyke JV, Martin CF, Dasgupta PK. 2007 . Temporal patterns in perchlorate, thiocyanate and iodide excretion in human milk. Environ Health Perspect 115:182-186.

Kohrle J. 2008. Environment and endocrinology: th e case of thyroidology. Ann Endocrinol (Paris) 69(2):116-22.

Mage DT, Allen RH, Gondy G., Smith W., Barr D.B. , and Needham L.L. 2004. Estimating pesticide dose from urinary pesticide concentration data by creatinine correction in the Third National Health and Nutrition Examination Survey (NHANES-III). J Expo Anal Environ Epidemiol 14:457-465.

Morreale de Escobar G, Obregon MJ, Escobar del Rey F. 2000. Is neuropsychological development related to maternal hypothyroidism or to materna l hypothyroxinemia? J Clin Endocrinol Metab

85:3975-3987.

Pirkle J. 2007. CDC's Perchlorate Biomonitoring A ctivities and Study Results. Statement of James Pirkle, M.D., Ph.D. Deputy Director for Science Na tional Center for Environment Health Centers for Disease Control and Prevention U.S. Departme nt of Health and Human Services, Testimony, Committee on Energy and Commerce, Subcommi ttee on Environment and Hazardous Materials, United States House of Representatives Wednesday, April 25, 2007.

Pop VJ, Brouwers EP, Vader HL, Vulsma T, van Baar AL, de Vijlder JJ. 2003. Maternal hypothyroxinaemia during early pregnancy and subsequent child development: A 3-year follow-up study. Clin Endocrinol (Oxf) 59:282-288.

Stanbury JB, Wyngaarden JB. 1952. Effect of perc hlorate on the human thyroid gland. Metab Clin Exp 1:533-539.

Tellez RT, Chacon PM, Abarca CR, Blount BC, La ndingham CB, Crump KS, et al. 2005. Long-term environmental exposure to perchlorate through drinking water and thyroid function during pregnancy and the neonatal pe riod. Thyroid 15:963-975.

Tonacchera M, Pinchera A, Dimida A, Ferrarini E, Agetti P, Vitti P, Ferruccio S, Crump K, Gibbs J. 2004. Relative potencies and additivity of perc hlorate, thiocyanate, nitrate and iodine on the inhibition of radioactive iodine uptake by the huma n sodium iodine symporter. Thyroid 14:1012-19.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 863 of 1099 Tran N, Valentin-Blasini L, Blount BC, McCu istion CG, Fenton MS, Gin E, Salem A, Hershman JM. 2008. Thyroid-stimulating hormone increases acti ve transport of perchlorate into thyroid cells. Am J Physiol Endocrinol Metab 294(4):E802-6.

Woodruff TJ, Zeiss L, Axelrad DA, Guyton KZ, Jan ssen S, Miller M, Miller GG< Schwartz JM, Alexeef G, Anderson H, Birnbaum L, Bois F, Cog liano VJ, Crofton K, Euling SY, Foster PMD, Germolec DR, Gray E, Hattis DB, Kyle AD, Luebke RW, Luster MI, Portier C, Rice DC, Solomon G, Vandenberg J, Zoeller RT. 2008. Meeting Report: Moving Upstream-Evaluating Adverse Upstream End Points for Improved Risk A ssessment and Decision-Making. Environ Health Perspect 116:1568-1575.

Wyngaarden JB, Wright BM, Ways P. 1952. The ef fect of certain anions upon the accumulation and retention of iodide by the thyroid gland. Endocrinol 50:537-549.

Response: Regarding promulgating a perchlorate stan dard, see response to comment code 6120; regarding the basis for the RfD, see response to comment code 2110; regarding consideration of sensitive subpopulations, see responses to comment codes 5225, 5230, and 5240,

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20979

EPA Comment Code: 6120

Comment: November 28, 2008

U.S. Environmental Protection Agency Offi ce of Water Docket (Mailcode: 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

Comments from the NATURAL RESOURCES DEFENSE COUNCIL on the Drinking Water: Preliminary Regulatory Determination on Perchlorate

Docket EPA-HQ-OW-2008-0692 Federa l Register / Vol. 73, No. 198 / Friday, October 10, 2008

SUMMARY

On October 10, 2008, EPA announced a preliminar y regulatory determination not to set a healthprotective standard perchlorate in drinking water.[ FN1: 73 Fed. Reg. 0262 (Oct. 10, 2008).] The Federal Register notice states that: "The Agency has determined that a national primary drinking water regulation (NPDWR) for perchlorate would not present 'a meaningful opportunity for health risk reduction for persons served by public wa ter systems.'" EPA soug ht comments on whether setting a national primary drinking water standa rd for perchlorate would provide a meaningful opportunity for health risk reduction for persons serv ed by public water systems, on the scientific data and supporting analyses for this determination, and on its use of a revised physiologically-based pharmacokinetics (PBPK) model. With this FR No tice, EPA has proposed a health reference level (HRL) of 15 ppb as the maximum contamination leve l of perchlorate that could be in drinking water, and still keep daily human consumption levels from exceeding the reference dose (RfD) of 0.7 ug/kg/day.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 864 of 1099 After careful review of these documents, NRDC concludes that EPA's determination is legally flawed. EPA must regulate a contaminant if it may have an adverse effect on human health, if it is known to occur (or there is a substantial likelihood that the contaminant will occur) in public water systems with a frequency and at levels of public he alth concern; and if its regulation would present a meaningful opportunity for health risk reduction for persons served by public water systems.[FN2: 42 U.S.C. [section] 300g-1(b)(1)(A).] For perchlorate, each of these three requirements are met, and therefore, underscore that EPA must regulate its presence in drinking water. First, EPA's preliminary regulatory determination acknowledg es that perchlorate may adversely affect human health.[FN3: 73 Fed. Reg. 60275 (Oct. 10, 2008).] S econd, as explained in more detail below, despite EPA's contention, perchlorate is known to contam inate the drinking water systems serving millions of people at levels where adverse human health e ffects occur. And third, setting an appropriately stringent MCL will lead to lower levels of perchlora te ingested by hundreds of thousands of infants, thereby offering a concrete and meaningful reduction in human health risks.

Procedurally and scientifically, EPA has made th is preliminary determination in an arbitrary and capricious manner. Procedurally, the FR Notice announcing EPA's preliminary determination was issued for public comment even before EPA ha d received the peer review report on the PBPK model, which EPA used to justify the HRL. Moreov er, it is our understanding that EPA is still awaiting peer review comments on the proposed HRL itself. The preliminary determination also

fails to address the recommendations of the Science Advisory Board Drinking Water Committee (SAB DWC). Scientifically, the basis for EPA's dete rmination fails to appropriately incorporate data demonstrating population level effects at environmentally relevant levels of exposure. In effect, this data severely undercuts EPA's conclusion that ther e would not be a sufficient benefit for protecting public health by setting a drinking water standard for perchlorate. The agency’s apparent decision to ignore relevant scientific information, in reachi ng a decision not to regulate this dangerous and widespread drinking water contaminant is not a pr oper exercise of EPA's decision-making process. Instead of rushing forward without the benefit of full consideration of the most recent scientific evidence (and scientific advice), EPA should care fully review and analyze the results of the peer review of the PBPK model and the HRL, allow the public an opportunity to review and analyze those results, and request an SAB DWC review prio r to making a determination on how to address perchlorate contamination. EPA's failure to fully consider the existing data on the effects of perchlorate on vulnerable sub-populations, and short- circuit the process of peer review and public comment on the models upon which their determina tion is based, is arbitrary and capricious. Furthermore, EPA’s conclusion regarding the potential health benefits of setting a drinking water standard for perchlorate is in error, and its prelim inary decision not to set a regulatory standard for perchlorate, if finalized, would viol ate the Safe Drinking Water Act.

Response: EPA has reversed its October 2008 preliminar y determination not to develop an NPDWR for perchlorate and now concludes, based on the analysis presented in the final regulatory
determination, that there is a substantial likeli hood that perchlorate will occur in public water systems with a frequency and at levels of public health concern. The Ag ency has determined that regulation of perchlorate presents a meaningful oppor tunity to reduce health risk for persons served by public water systems.

Please see the response to comment code 6120. EP A disagrees with the comme nter’s statement that procedurally and scientifically, the preliminary re gulatory determination for perchlorate was made inEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 865 of 1099 an arbitrary and capricious manner. EPA consider s the best available science when developing drinking water standards, as required by the 1996 amendments to the Safe Drinking Water Act. In applying these principles, "best available" usually refe rs to the availability at the time an assessment is made. In the August 2009 notice, EPA stated that it was re-evaluating how best to incorporate the PBPK modeling analysis into its evaluation of perc hlorate — if at all. The Agency sought comments on ways to use the PBPK modeling analysis to inform the regulatory determination. Regarding the commenter’s concern about the peer review of the PBPK model, please see the response to comment code 6400. Additionally, EPA discussed the k ey scientific issues raised by external peer reviewer commenters on the Interim Drinking Water Health Advisory for perchlorate in the August 2009 notice and in today’s notice. A summary of peer review comments and EPA responses on the Interim Drinking Water Health Advisory are ava ilable in the docket for today’s notice (Docket ID No. EPA–HQ–OW–2009–0297) at http://www.regula tions.gov. EPA has further considered peer reviewer and public comments regarding the use of the PBPK model to inform today’s regulatory determination for perchlorate, please see response to comment ID 20432 in comment code 5220 for

a more detailed discussion.

EPA disagrees that the PBPK model should have been reviewed by the SAB because the model and draft report underwent a formal external peer re view by eight experts in accordance with EPA guidance (see response to comment code 6400). Additionally, per SDWA, EPA will consult with the SAB prior to proposal of the perchlorate maximum contaminant level goal and NPDWR.

Please see the response to comment code 5220 fo r a further discussion of EPA’s determination that regulation of perchlorate in drinking water system s presents a meaningful opportunity for health risk reduction for persons served by public water systems.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20982

EPA Comment Code: 6120

Comment: Based upon the evidence in the record, as discussed in greater detail below, NRDC urges EPA to reverse course, and set a national prim ary drinking water standard for perchlorate that is protective of sensitive sub-populations. EPA shou ld not set a HRL at 15 ppb; rather, given the
most current data available, NRDC believes that that a truly health protective standard would fall below 1 ppb.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20988

EPA Comment Code: 6120

Comment: NRDC strongly objects to EPA's preliminar y determination on perchlorate because the conclusions are not based on a comprehensive review of the best available science (as explained in more detail below) and are not supported by the PBPK model findings, or by EPA's expert scientificEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 866 of 1099 advisors on the Children's Health Protection Ad visory Committee.[FN22: Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] In fact, drinking water that is contaminated with perchlorate at the HRL would leave infants and young children exposed to excessive and unsafe levels of this toxic chemical.

Response: Please see the response to comment ID 20979 under comment code 6120.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21003

EPA Comment Code: 6120

Comment: CONCLUSION

EPA should not finalize its preliminary determination not to regulate perchlorate.

Response: See response to comment code 6120.

Commenter Name: Rebecca Connolly Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1882

EPA Comment ID: 21036

EPA Comment Code: 6120

Comment: Dear EPA,

Please stop allowing perchlorate to filter into our drinking water.

Thank you.

Sincerely, Rebecca Connolly 116 Hume Ave. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Michael Suttles Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1880

EPA Comment ID: 21037

EPA Comment Code: 6120

Comment: EPA Water Docket

To Whom it May Concern:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 867 of 1099 I'm a student and a voter in Virginia and I'm concerned about water quality. Perchlorate is a dangerous chemcial often found in water and has been discovered to be present in 37 states. Therefore, it must be regulated in order to protect our health.

Sincerely, Michael Suttles 411A E Ho well Ave. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Maggie Geist Commenter Organization: Association to Preserve Cape Cod (APCC)

EPA Document ID: EPA-HQ-OW-2008-0692-2083

EPA Comment ID: 21104

EPA Comment Code: 6120

Comment: November 26, 2008

Water Docket Environmental Protection Agency Ma il Code: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460 RE: Dock et ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

The Association to Preserve Cape Cod (APCC) is a non-profit environmental organization dedicated to the preservation of Cape Cod's natu ral resources and quality of life. Founded in 1965 and currently representing over 5,500 members, APCC is the oldest and largest environmental organization on Cape Cod.

On behalf of APCC, I am pleased to submit comments on the Preliminary Regulatory Determination on Perchlorate in Drinking Water proposed by USEPA. APCC urges USEPA to reconsider its determination to not regulate perchl orate. There are a significant number of water resources across-the country that contain perchlora te; 35 states have dete cted dangerous levels of perchlorate in drinking water. The full extent of the pervasiveness of perchlorate is still unknown. In addition to drinking water, it is also found in pr oduce and dairy products, likely coming from water used to irrigate crops and water lives tock. Perchlorate is also extremely persistent, meaning it has the potential to migrate far from the source of contamination, polluting entire watersheds.

The health consequences of ingesting perchlorate ar e significant, largely impact infants, and can be transferred maternally to a fetus. Perchlorate cause s a reduction of the thyroid hormone production. The thyroid hormone is critical for muscle and br ain development. Where protecting the health and development of children is of paramount importan ce, such risks from perchlorate are unacceptable. Establishing a regulatory limit on perchlorate in drin king water is an important step in reducing this

risk nationwide.

Sincerely,

Maggie Geist

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 868 of 1099 Commenter Name: Peggy Shiffrin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2084

EPA Comment ID: 21105

EPA Comment Code: 6120

Comment: Peggy Kobacker Shiffrin 2811 Chesterfi eld Place, NW Washington, DC 20008

November 20, 2008

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Avenue, NW Washington, DC 20460

Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern:

I urge you to reverse your decision and set a federal limit n perchlorate in drinking water. Perchlorate is a nationwide problem and has health impacts at lower levels than previously thought. Please protect public health, especially infant s and children, by regulating perchlorate.

Thank you,

Peggy Shiffrin

Response: See response to comment code 6120.

Commenter Name: Teresa Jordan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2086

EPA Comment ID: 21107

EPA Comment Code: 6120

Comment: 3152 Shad Court Simi Valley, CA 93063 November 16, 2008

Water Docket USEPA Mailcode: 2822T 1200 Penns ylvania Avenue, N.W. Washington, DC 20460

Re: DOCKET ID No. EPA-HQ-OW-208-0692 (Preliminary Regulatory Determination on Perchlorate -- Reopening of Public Comment Period (Novemeber 28, 2008 Deadline)).

Dear Mr. Grumbles, and Mr. Burneson:

I am writing to ask that the Agency initiate development of a national regulation for perchlorate in drinking water.

Mr. Grumbles and Mr. Burneson, as a concerned ci tizen who has followed the significant impacts to people's and animals' health from water, soil, and air contamination due to DOW, NASA, and Rockwell International/Boeing Company rocket engines and nuclear reactors testing, lasers and

other activities on the Santa Susana Field Laborat ory (the SSFL, located in Simi Hills, in VenturaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 869 of 1099 County, California) for 19+ years, I was shocke d when I read that the Agency would not be regulating perchlorate in drinking water sys tems around the Nation beacuse the determination significant ramifications for the County of Ventura, and, most especially, the City of Simi Valley!!!

Mr. Grumbles and Mr. Burneson, if I ever thought th ere was hope to finally have the SSFL included in the USEPA's Superfund List because of the Agency's cumulative findings, such grave news -- this determination coming years after perchlorate was included on the first (March 2, 1998) and second (February 24, 2005) Contaminant Candidate Lists (CCLs) -- just snuffed out the small light at the end of this very long tunnel! What travesty for the public trust, and the environmental justice program!!!

Mr. Grumbles and Mr. Burneson, this determi nation will allow the Ventura Countrywide MS4 NPDES Permit, and the municipal NPDES permits for the Cities of Thousand Oaks and Simi Valley, and the Camarillo Sanitary District waste water treatment plants to breeze through the Los Angeles Regional Water Control Board (LARWQCB ) public review and comment period, and public hearing next time around -- no wond er the two subjects dropped off the radar.

Response: See response to comment code 6120.

Commenter Name: Frederick Behnke Jr. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2087

EPA Comment ID: 21110

EPA Comment Code: 6120

Comment: November 24, 2008

Water Docket, EPA Mail Code 2822T 1200 Penns ylvania Ave Washington DC 20460 Attention: Docket No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

Please keep our drinking water safe by regulating the amount of perchlorate allowed in our drinking water. There has been scientific proof that perchl orate can lead to thyroid problems in pregnant women, newborns, and infants. A primary drinking water regulation is needed to protect the public health. Sincerely,

Frederick E Behnke, Jr. 1470 Mordor Lane Hanover MD 21076

Response: See response to comment code 6120.

Commenter Name: Anne Eberhardt Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2088

EPA Comment ID: 21111

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 870 of 1099 Comment: Water Docket, EPA Mail Code 2822T 1200 Pennsylvania Ave Washington, DC 20460 Attn: DOcket ID EPA-HQ-OW-2008-0692

To Whom it May Concern

It has come to my attention that the EPA has announced its intention to not regulate perchlorate in drinking water.

Please reverse that decision immediately. Do not ruin our drinking water which has always been good. Please regulate it.

Anne Eberhardt 1213 Tacoma St Allentown, PA 18109

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2089

EPA Comment ID: 21112

EPA Comment Code: 6120

Comment: Perchlorate contamination is a nationwide problem which needs to be addressed. Perchlorate has health impacts at lower levels th an previously thought. A National Primary drinking water regulation is needed to protect ou r drinking water from pollutants.

The Food and Drug Administration found perchlor ate in 74% of foods it tested. We don't need more perchlorate coming from our drinking water.

For the health of everyone something need to be done, so please keep perchlorate out of our drinking water.

Sincerely

Response: See response to comment code 6120.

Commenter Name: Tina, Mona, and Ahmed Saleh Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2090

EPA Comment ID: 21113

EPA Comment Code: 6120

Comment: Water Docket, EPA Mail Code 2822T 1200 Pennsylvania Ave. Washington, DC 20460

Attn: Docket ID No. EP A-HQ-OW-2008-0692

To Whom it May Concern,

We need good, clean, purified water to keep this nation healthy. My mother has been going to the Doctor's for a whole year now because the area of her kidney has been bothering her and theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 871 of 1099 Doctor's say it's due to the unhealthy, unpuri fied water she has been drinking. Perchlorate contamination is a worldwide problem and has health impacts at lower levels than previously thought. Its already effecting 37 states. 37 states! That 's more than half of the U.S. We need to stay healthy, we need cleaner water.

Sincerely, Tina Saleh Mona Saleh Ahmed Saleh 16 35 E. Greanleaf St. Allentown, PA 18109

Response: See response to comment code 6120.

Commenter Name: Ellen Blaschinski, M.B.A., R.S. Commenter Organization: Regulatory Services Branch, Connecticut Department of Public Health

EPA Document ID: EPA-HQ-OW-2008-0692-2091

EPA Comment ID: 21117

EPA Comment Code: 6120

Comment: EPA's opportunity to address perchlorate is substantial from a public health perspective given the risks this chemical can pose to early lif e development and its potential for occurrence in public water supplies. Sensitive test methods exist as do practical treatment options. Therefore, we urge EPA to reconsider its decision to not regula te perchlorate. In that reevaluation, EPA should utilize methodologies that ensure protection of all potentially sensitive receptors from the antithyroid effects of this chemical.

Please let us know if you would like additional information regarding the Connecticut Department of Public Health's comments on this important matter.

Sincerely, Ellen Blaschiriski, M.B.A., R.S. , Chief, Regulatory Services Branch

Response: See response to comment code 6120.

Commenter Name: Bonnie Ludwick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2092

EPA Comment ID: 21118

EPA Comment Code: 6120

Comment: OW-2008-0692=

To Whom It May Concern

Please regulate Perchlorate out of our drinking water now! Thanks Bonnie S. Ludwick 30 W. High
St Hellertown, PA 18055

Water Docket, EPA, Mailcode 2822 T 1200 Pennsylvania Ave. Wash ington, DC 20460 Attn: Docket ID No. EPA-HQ-OW-2008-0692

Response: See response to comment code 6120.

Commenter Name: (illegible)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 872 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2093

EPA Comment ID: 21119

EPA Comment Code: 6120

Comment: -OW-2008-0692 11/13 Dear EPA,

Learning of the side effects of perchlorate cont aminations (thyroid issues, birth deffects, loss of [illegible] etc) that come from military bases, fir eworks, construction sites, and so on. If you could do a regular water check (weekly or daily)....Just to make sure the water that your fellow citizens consume daily even babies OR at least inform us ASAP that the levels are high so we could at least use bottled water (while you filter the water ) it would prevent so many problems.

Thank you, high school student nurses aid

Response: See response to comment code 6120.

Commenter Name: Juanita Velez Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2094

EPA Comment ID: 21120

EPA Comment Code: 6120

Comment: 631 Oakcrest Wyoming MI 49508

Stephan Johnson,

Clean Water is important to every living thing and its important to keep the water safe + pure for the future generations. To help regulate green house gas emissions under the Clean air act.

thank you Juanita Velez

Response: This is not a comment, no response is needed.

Commenter Name: Clair Edwards Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2095

EPA Comment ID: 21121

EPA Comment Code: 6120

Comment: Dear EPA,

Please keep toxins out of our water these are harmful to our kids!!!

Thank you Clair Edwards 2422 Taylor Ave Alex. VA 22302

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 873 of 1099 Commenter Name: John Hall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2096

EPA Comment ID: 21122

EPA Comment Code: 6120

Comment: To: EPA

Perchlorate is unsafe -- hurts kids, toxic.

Please stop.

John Hall 213 Woodland Ter Alexandria VA 22303

Response: See response to comment code 6120.

Commenter Name: Andrew Freed Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2097

EPA Comment ID: 21123

EPA Comment Code: 6120

Comment: U.S. Environmental Protection Agency,

My name is Andrew Freed and I am writing you in re gards to an issue that has been brought to my attention recently. A young lady I encountered informed me of the epidemic surrounding perchlorate in drinking water. She educated me on the concerns and factors if we do not regulate the amounts of perchlorate in our drinking water.

One of the concerns she brought up is that perc hlorate contamination is a nationwide problem. Not only does this effect my drinking water personally but this concerns me because, coming from a larger family, we are spread nationwide and their heal th is just as important to me as my own.

Another concern is that the EPA is ignoring the fact that lower levels of perchlorate in our drinking water does have impacts on health, more than they previously thought. One of the risks is impairment to the thyroid gland. Many people aren't aware of the importance of that gland. It not only controls growth it also controls development and metabolism. When tampered with, these impacts are especially harmful to children and fetuses.

And a factor that really stuck home is the lack of concern for our nation from the EPA. In our world today, we have to start somewhere in, orde r to make change. Our newly appointed president wants to make change and this might be a step in the right direction. A national primary drinking water regulation is needed to protect public health. Citizens of the United States are not aware of many of the risks they face everyday. We rely on go vernment agencies to ensure our safety when it comes to everyday exposure to things we take for granted like the water:we drink and the air we

breathe.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 874 of 1099 All I am asking for is that you take a look at the concerns and think to yourself would you or your

loved ones want to drink water that is contaminated?

Thank you for your time. Sincerely, Andrew Freed

Response: See response to comment code 6120.

Commenter Name: Edward and Colleen Flok Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2098

EPA Comment ID: 21124

EPA Comment Code: 6120

Comment: Water Docket, EPA Mail Code 2822T 1200 Pennsylvania Ave Washington, DC 20460

Attn: Water Docket ID No . EPA-HQ-OW-2008-0692

To Whom It May Concern

Perchlorate is a widespread contaminate. It is a nationwide problem, that has health impacts at lower levels than previously thought. Perchlorate contamination threatens public health. Traces of Perchlorate have been detected in people , the foods we eat, and groundwater.

I am now aware the United States Environm ental Protection Agency (EPA) has announced its intention not to regulate Perchlorate in drinking wa ter. I am writing this letter to ask that the EPA reverse there decision. A national primary drinking water regulation is needed to protect public

health.

Thank you. Respectfully, Dr. Edward Flok 1335 Jefferson Street Hellertow n, Pa. 18055 610-838- 4851 Email: eddieflok57@gmail.com

Respectfully, Colleen M. Flok 1335 Jeffe rson Street Hellertown, Pa. 18055 Email: colleenf58@aol.com

Response: See response to comment code 6120.

Commenter Name: Ann Mowrey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2099

EPA Comment ID: 21125

EPA Comment Code: 6120

Comment: November 20, 2008 To Whom It May Concern:

I am concerned with keeping Perchlorate out of ou r drinking water. Perchlor ate contamination is a nationwide problem and has health impacts at lo wer levels than previously thought. A national primary drinking water regulation is needed to protect public heath.

Thank you Ann Mowrey 136 Roth Ave. Hellertown, PA 18055EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 875 of 1099 Water Docket, EPA Mail Code 2822T 1200 Pennsyl vania Ave Washington, DC 20460 Attn: Water Docket ID No. EPA-HQ-OW-2008-0692

Response: See response to comment code 6120.

Commenter Name: Kristin Verrastro Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2100

EPA Comment ID: 21126

EPA Comment Code: 6120

Comment: U.S. Environmental Protection Agency,

My name is Kristin Verrastro and I am writing you in regards to the recent concerns of regulating perchlorate in our nations drinking water. I am a resident of Pennsylvania and have been recently informed about this growing problem.

I am not sure if you are aware of the dangers of the perchlorate bein g in our drinking water but it does not just affect a specific area. It is a na tionwide problem and impacts health issues at lower levels than previously thought. One of the health problems that perchlorate can impair is the thyroid gland. As a person who deals with thyroid issues personally this has raised a red flag in my life. If you are not aware, the thyroid glad controls growth, development and metabolism, which can be extremely harmful if tampered with to children and fetuses.

Also speaking as a human being needing water to survive everyday life, the excessive amounts of perchlorate in our drinking water needs to be re gulated to protect public health. I am 26 years old woman and some day would like to have children and the risk that they may become sick because of something that we as a nation could have fixed is also something that raises a red flag in my life.

All I am asking for is that you take a look at the concerns and think to your self, would you or your

loved ones want to drink water that is contaminated?

Thank you for your time.

Kristin E. Verrastro

Water Docket, EPA Mail Code 2822T 1200 Pennsyl vania Ave Washington, DC 20460 Attn: Water Docket ID No. EPA-HQ-OW-2008-0692

Response: See response to comment code 6120.

Commenter Name: Kemmerer Family Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2101

EPA Comment ID: 21127

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 876 of 1099 Comment: Water Docket, EPA Mail Code 2822T 1200 Pennsylvania Ave Washington, DC 20460

Attn: Water Docket ID No . EPA-HQ-OW-2008-0692

To the US Environmental Protection Agency,

You need to reverse your decision and regula te perchlorate in drinking water. Perchlorate contamination is a nationwide problem and has he alth effects at lower levels than previously thought. A national primary drinking water regula tion is needed to protect public health. Please reconsider your decision. This is a big health issue.

The Kemmerer Family

Response: See response to comment code 6120.

Commenter Name: Katie and Frank Nemeth Hummer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2102

EPA Comment ID: 21128

EPA Comment Code: 6120

Comment: November 13, 2008

Water Docket, EPA Mail Code 2822T 1200 Pennsyl vania Ave Washington, DC 20460 Attn: Water Docket ID No. EPA-HQ-OW-2008-0692

Attention: U.S. Environmental Protection Agency (EPA):

I am writing to inform you of some recent information I have obtained from an outside source. Did you know that perchlorate is a nationwide problem and has health impacts at lower levels than previously thought? Did you know that a national primary drinking water regulation is needed to protect public health?

It is your duty to take close investigation on th is matter that we, as th e people, have support and protection in this issue. Please take this informat ion and investigate solutions on this serious issue concerning something we all need for survival.

Cordially, Katie Hummer Frank Nemeth

Response: See response to comment code 6120.

Commenter Name: Sandra Hoag Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2103

EPA Comment ID: 21129

EPA Comment Code: 6120

Comment: 11/18/08EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 877 of 1099 Sandra L. Hoag 806 Crescent Drive Alexandria, VA 22302

Water Docket, EPA, Mailcode 2822T 1200 Pennsyl vania Ave. NW Washington, DC 20460 Docket ID No. EPA-HQ-0W 2008-0692

To Whom it May Concern:

I urge you to reverse your decision and set a fe deral limit for perchlorate in drinking water. Perchlorate is a nationwide problem and has greater health impacts at lower levels than previously thought. Please protect public health, especially in fants and children, by regulating perchlorate.

Sincerely, Sandra Hoag

Response: See response to comment code 6120.

Commenter Name: April Verlo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2104

EPA Comment ID: 21130

EPA Comment Code: 6120

Comment: 11/18/08

To: EPA Water Docket

I am an environmental scientist and concerned about perchlorate. It affects children and is widespread. Please see that it is regulated.

April Verlo 401 Tennessee Alexandria, VA 22305

Response: See response to comment code 6120.

Commenter Name: Elizabeth Johnson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2105

EPA Comment ID: 21131

EPA Comment Code: 6120

Comment: Elizabeth Johnson 2704 Davis Avenue Alex andria, VA 22302 November 19, 2008

Water Docket, EPA, Mailcode 2822T 1200 Pennsyl vania Avenue, NW Washington, DC 20460 Re: Docket ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

I urge you to reverse your decision and set a fe deral limit for perchlorate in drinking water. Perchlorate is a nationwide problem and has health im pacts at lower levels than previously thought.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 878 of 1099 Please protect public health, especially the health of infants and children, by regulating perchlorate. With five grandchildren I am particularly concerned about the impact of your decision on the standards set for the water they drink.

Sincerely, Elizabeth Johnson

Response: See response to comment code 6120.

Commenter Name: Toni Soule Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2106

EPA Comment ID: 21132

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate toxins in our drinking water, especially perchlorate, which is dreadful!

Sincerely, Toni Soule 2400 Clemson Mills Rd Alex., VA 22302

Response: See response to comment code 6120.

Commenter Name: Lorraine Keir Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2107

EPA Comment ID: 21133

EPA Comment Code: 6120

Comment: 3307 Elmore Drive Alexandria, VA 22302

November 16, 2008

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Avenue, NW Washington, DC 20460 Docket ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

I urge you to reverse your decision and set a federa l limit for perchlorate in drinking water. I have a

small child and am concerned about the effects of perchlorate on her health and development. Please protect public health, especially those of infants and children like my daughter, by regulating perchlorate.

We have a right to clean drinking water and the government should do all in it's power to ensure our water is safe. Thank you for your consideration.

Sincerely,

Lorraine P. KeirEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 879 of 1099 Response: See response to comment code 6120.

Commenter Name: J.B. Poersch Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2108

EPA Comment ID: 21134

EPA Comment Code: 6120

Comment: Dear EPA,

Regulate perchlorate. Its too big a risk for my family.

Sincerely J.B. Poersch 608 Woodland Tr. Alexandria, VA 22302

Response: See response to comment code 6120.

Commenter Name: Laura Ahehan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2109

EPA Comment ID: 21135

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate perchlorate and other harmful to xins. Our neighborhood knows it is dangerous for

our children.

Laura Ahehan 2414 Davis Ave. Alexandria, VA 22302

Response: See response to comment code 6120.

Commenter Name: Michael Aldanli Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2110

EPA Comment ID: 21136

EPA Comment Code: 6120

Comment: Dear EPA,

As a concerned citizen, I believe perchlorate should be eliminated from the environment to the

maximum extent feasible.

Michael Aldanli 3400 Alabama Ave. Alexandria, VA 22305

Response: See response to comment code 6120.

Commenter Name: George B.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 880 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2113

EPA Comment ID: 21954

EPA Comment Code: 6120

Comment: Nov. 20, 2008

E.P.A.

Please work to regulate or better yet eliminate perchlorate from everyone's drinking water.

Thanks,

George B. [illegible] 1044 Springhill Way Gambrills, MD 21 054 301-621-7881

Response: See response to comment code 6120.

Commenter Name: Ron W Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2114

EPA Comment ID: 21956

EPA Comment Code: 6120

Comment: Nov. 17, 2008

Dear EPA

I urge you to regulate the amount of perc hlorate in our drinking water supply.

Sincerely,

Ron W [illegible] 3324 [illegible ] Lane Brookeville, Md 20833

Response: See response to comment code 6120.

Commenter Name: T Siegel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2115

EPA Comment ID: 21958

EPA Comment Code: 6120

Comment: EPA Water Docket:

I am a Wash DC voter. Perchlorate is a dangerous ch emcial found in 37 states - it gets into water and therefore must be regulated.

T. Siegel 1383 28th St NW Wash DC 20007EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 881 of 1099 Response: See response to comment code 6120.

Commenter Name: Matt Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2116

EPA Comment ID: 21965

EPA Comment Code: 6120

Comment: To All Readers,

Perchlorate is a harmful chemical found in our drinking water. It is used in Rocket fuel and explosives. Every day, citizens ingest thousands of gallons nationally. If something is not done soon, This great country will be left a barren wasteland wi th no humans to care for it and all our efforts

will have been wasted. Perchlorate can cause massi ve problems both physically and mentally to any human that ingests it.

Response: See response to comment code 6120.

Commenter Name: Matt Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2116

EPA Comment ID: 21967

EPA Comment Code: 6120

Comment: This country strives not on its technological booms, but the minds that drive them. If we do not act now, it'll soon be too late and what use will these technological advances be to us then. Without the bright minds of our citizens, what use is a government who wouldn't act when it

had the chance.

If the EPA does not do something to prevent further problems now, then there is no point in allowing them to stay as a federal agency anymor e. The EPA has a responsibility to act now and as such should proceed with all haste. No Bureaucratic procedure or code should stop them. No effort should be made to stop them from proceeding to fulfill their duty to this great country.

There are many sources of perchlorate contamin ation including many military bases, fireworks manufacturers, and blasting at construction sites. If there were more routine testing then perhaps the problem could be more properly identified. Currently perchlorate has been found in 37 states, and in public water systems serving over 20 million people.

Respectfully, Matt Lewis

Response: See response to comment code 6120.

Commenter Name: Christine Wojciechowski Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2118

EPA Comment ID: 21987

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 882 of 1099 Comment: November 14, 2008

To Whom It May Concern:

Perchlorate is a harmful chemical that can cause he alth problems if ingested. This chemical should not be in our drinking water. We need regulation to protect public health.

Thank you, Christine Wojciechowski

Response: See response to comment code 6120.

Commenter Name: John Sherry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2120

EPA Comment ID: 21990

EPA Comment Code: 6120

Comment: Water Docket, EPA Mailcode 2822T, 1200 Pe nnsylvania Ave., Washington, D.C. 20460

We live very close to a military base and to dump site. We need routine testing and a drinking water regulation

Thank you John Sherry

Response: See response to comment code 6120.

Commenter Name: Eugene A. Smell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2122

EPA Comment ID: 21998

EPA Comment Code: 6120

Comment: 20 November 2008

To: EPA

Please continue to regulate pe rchlorate in drinking water.

Thank you

Eugene A. Smell

Response: See response to comment code 6120.

Commenter Name: Barbara A. Smell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2123EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 883 of 1099 EPA Comment ID: 21999

EPA Comment Code: 6120

Comment: November 20, 2008

EPA

To whom it may concern:

Please continue to regulate pe rchlorate in drinking water.

Barbara A. Smell

Response: See response to comment code 6120.

Commenter Name: Sarah Favrao Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2124

EPA Comment ID: 22011

EPA Comment Code: 6120

Comment: November 11. 2008

To whom it may concern:

I am writing to urge the EPA to reverse their decision to not regulate perchlorate in our drinking

water. Studies have shown that this it is a nati onwide problem with ground water contamination,
and has detrimental health effects for all, but es pecially fetuses and young children. From what I have read from Clean Water Action's literature, I believe perchlorate should be regulated, to protect my health and my family's health.

Sarah Favrao

Response: See response to comment code 6120.

Commenter Name: Robert J Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2125

EPA Comment ID: 22012

EPA Comment Code: 6120

Comment: 11-10-08

To: Water Docket EPA, mailcode 2822T 1200 Penn. Ave Wash DC, 20460 ATTN: Docket ID No EPA-HQ-OW-2008-0692

Dear Sirs,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 884 of 1099 I believe perchlorate contamination is a national probl em and has health impacts at lower levels than previously thought.

A national primary drinking water regulation is needed to protect the public health.

Regards Robert J [illegible] 103[illegible] Askewton Road Seve rna Park, MD. 21146

Response: See response to comment code 6120.

Commenter Name: Elaine Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2127

EPA Comment ID: 22013

EPA Comment Code: 6120

Comment: November 17, 2008

EPA,

I am a concerned Alexandria Virginia resident.

I learned about your decision not to regulate perchlorate and am upset with this decision

It is a threat to human health and I asking you to reconsider and regulate.

Thank you Elaine [illegible]

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2128

EPA Comment ID: 22014

EPA Comment Code: 6120

Comment: To whom it may concern:

Perchlorate is not something I want in my water. For the sake of our nation's young people, please consider regulating this threat to our DC water supply!

Sincerely, [illegible] 3609 N Street Washington, DC 20007

Response: See response to comment code 6120.

Commenter Name: Anna Sannes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2129

EPA Comment ID: 22015EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 885 of 1099 EPA Comment Code: 6120

Comment: Dear EPA,

I'd just like to take this opportunity to remind yo u how important it is that we keep perchlorate out of our water systems. As a daycare worker, I spend most of my time with children, and the thought of them being hurt developmentally, by water, is frightening. Please help keep our children safe; keep perchlorate out of the water.

Thanks, Anna Sannes LXR 217 Georgetown Univ ersity Box 578853 Washington, DC 20057

Response: See response to comment code 6120.

Commenter Name: Katherine Rogers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2130

EPA Comment ID: 22016

EPA Comment Code: 6120

Comment: To EPA -

Please don't put perchlorate in our water.

3263 O St, NW Washington, DC 20007

Katherine Rogers

Response: EPA does not put perchlorate into water. EPA has determined that perchlorate in drinking water requires regulation. See response to comment code 6120.

Commenter Name: Courtney Stonestreet Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2131

EPA Comment ID: 22017

EPA Comment Code: 6120

Comment: 12 November 2008

Courtney Stonestreet 3378 Martha Custis Drive Alexandria, Virginia 22302

Dear EPA -

We need clean, healthy water in Virginia! Perchlora te needs to be labeled as a harmful toxin and kept out of our drinking. Please do you part with the public's health in mind and keep this chemical out

of the water.

Sincerely, Courtney StonestreetEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 886 of 1099 Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2132

EPA Comment ID: 22018

EPA Comment Code: 6120

Comment: To: EPA Water Docket

I am a Virginia voter and a grandmother concerned about the state of the planet our grandchildren

will inherit.

Perchlorate is a dangerous chemical found in 37 sta tes. Therefore, since affects children when it gets into water, it should be regulated.

Sincerely,

[illegible] 1510 Dogawood Drive Alexandria, VA 22302

Response: See response to comment code 6120.

Commenter Name: Lani Weatherhead Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2133

EPA Comment ID: 22019

EPA Comment Code: 6120

Comment: 11/12/08

Dear EPA,

Please don't put perchlorate in my water. It will hu rt my baby. Please regula te what you are allowing to get into the water.

Thank you,

Lani Weatherhead 3755 Gunston Alexandria, VA 22302

Response: EPA is not putting perchlorate into your water. EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120.

Commenter Name: Jackie Draghi Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2134

EPA Comment ID: 22020

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 887 of 1099 Comment: 1/22/08

Dear EPA,

Please regulate perchlorate and do routine testing for it.

Sincerely, Jackie Draghi 3775 Gu nston Road Alexandria, VA 22302

Response: See response to comment code 6120.

Commenter Name: William Webner Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2135

EPA Comment ID: 22021

EPA Comment Code: 6120

Comment: November 2008

To: EPA Water Docket -

I am a voter and DC resident. Perchlorate is a dang erous chemical found in 37 states. It msut be regulated because it gets into water.

William Webner 1237 30th Street Wash, DC 2007

Response: See response to comment code 6120.

Commenter Name: Gladys Billups Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2136

EPA Comment ID: 22022

EPA Comment Code: 6120

Comment: TO: EPA From: Gladys Billups

To Whom It May Concern,

As a citizen concerned about passing a stringent and decisive clean water act by congress, I request that you work with the organization Clean Water Action to ban the use of per chlorate. We as a

nation should have access to clean and safe water without toxic chemicals.

Respectfully, Gladys Billups

Response: See response to comment code 6120. Banning the use of perchlorate is outside the scope of this regulatory determination.

Commenter Name: Kimberly Feeney Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 888 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2140

EPA Comment ID: 22023

EPA Comment Code: 6120

Comment: November 10, 2008

Environmental Protection Agency 1200 Penns ylvania Avenue Washington, D.C. 20460

Re: Perchlorate Contamination of Drinking Water

To Whom It May Concern:

Perchlorate contamination of drinking water is a public health issue. Until each state, in the United States, addresses perchlorate contamination, I believe the EPA must regulate national primary drinking water.

Perchlorate contamination of drinking water is unacceptable.

Sincerely, Kimberly Feeney

Response: See response to comment code 6120.

Commenter Name: Deborah Honecker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2141

EPA Comment ID: 22024

EPA Comment Code: 6120

Comment: Nov. 6, 2008

To Whom It May Concern,

Please consider the risks involved with perchl orate contamination. Citizens expect the EPA to monitor water quality and locate sources of water c ontamination. The military, industry, and other interests have proven themselves unwilling or inep t at self-monitoring, which makes your work that much more important. The health and safety of m illions of citizens are dependent on actions taken by the EPA.

Thank you, Deborah Honecker 521 Evergreen Rd. Severna Park, MD 21146

Response: See response to comment code 6120.

Commenter Name: Linda L Ferguson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2142

EPA Comment ID: 22025

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 889 of 1099 Comment: Dear EPA,

I urge you to regulate the amount of perc hlorate in our drinking water supply.

Sincerely, Linda L. Ferguson 602 Pers immon Ct Severna Park, MD 21146

Response: See response to comment code 6120.

Commenter Name: Ellie Milleker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2143

EPA Comment ID: 22026

EPA Comment Code: 6120

Comment: Ellie Milleker 112 A Askewton Rd Severna Park, MD

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, D.C. 20460

Re: Docket ID No. EPA-HQ-OW-2008-0692

I am writing to voice my strong opposition to not put regulations on perchlorate in drinking water.

Perchlorate contamination is a na tionwide problem. A national primar y drinking water regulation is needed to protect public health.

Sincerely, Ellie Milleker

Response: See response to comment code 6120.

Commenter Name: Kimberly & Justin Vance Carter Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2144

EPA Comment ID: 22027

EPA Comment Code: 6120

Comment: November 20, 2008

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, DC 20460 ATTN: Docket ID No. EPA-HQ-0W-2008-0692

Dear Sir/Madam:

I understand that the EPA does not intend to regulate perchiorate in drinking water. I understand that perchlorate is a human health hazard causing damage to the thyroid gland. I also understand that perchlorate is currently detected in 37 states and in public drinking water thus affecting over 20 million Americans. This is unacceptable.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 890 of 1099 I urge the EPA to rethink it's position on this i ssue. The U.S. is the wealthiest nation on the planet and there is no excuse for Americans to be exposed to this toxin by simply drinking a glass of water. Thank you in advance for your prompt attention to this matter.

Sincerely, Kimberly Carter & Justin Vance

Response: See response to comment code 6120.

Commenter Name: Breona Keller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2145

EPA Comment ID: 22028

EPA Comment Code: 6120

Comment: Dear EPA,

I think you should try to cleanse the water that we wash and drink in. If we want our world back to normal we have to sacrifice a lot of things. As I was reading the sheet, it said perchlorate is a harmful chemical used in rocket fuel and explosives. And it impacts are especially harmful to children and fetuses. Stop doing harm to our planet and to the human beings that live in it. Just take it out of our

water.

Thank You, Breona Keller

Response: See response to comment code 6120.

Commenter Name: Linda E. Lozier Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2146

EPA Comment ID: 22029

EPA Comment Code: 6120

Comment: November 6, 2008 U.S. Envi ronmental Protection Agency

Sir / Ma'am,

It is my understanding that the EPA intends not to regulate the levels of Per chlorate in our drinking water. I urge you to reconsider this position. A standard must be set. Per chlorate is a harmful chemical that is used in rocket fuel and explosives. It should not be present in our children, or ourselves. Per chlorate affects the thyroid gland an d may severely impair growth and development of fetuses and children. With this said, regulation is a must. This should not be allowed to go unmonitored. Please reconsider your position, for yourself, and our future. Thank you for your time

and consideration.

Respectfully yours, Linda E. Lozier

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 891 of 1099 Commenter Name: E. Breem Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2147

EPA Comment ID: 22030

EPA Comment Code: 6120

Comment: November 10, 2008

To U.S. EPA,

Please keep perchlorate out of drinking water!

Help protect our children from the harmful chemical!

Thank you, E. Breem 103 Askewton Rd. Severna Park, MD 21146

Response: See response to comment code 6120.

Commenter Name: John Vernon Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2148

EPA Comment ID: 22031

EPA Comment Code: 6120

Comment: 11/9/08

To the EPA -

I strongly urge reconsideration of the decision not to regulate perchlorate in drinking water. This is an important public health issue, regardless of the simple minded tree huggers. Feel free to have the new Administrator give me a call or drop me a line, any time. Keep up your good work!

Sincerely, John Vernon 107 Askewton Rd. Severna Park, MD 21146

Response: See response to comment code 6120.

Commenter Name: Katie Milleker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2149

EPA Comment ID: 22032

EPA Comment Code: 6120

Comment: Katie Milleker 112A Askewton Rd. Severna Park, MD 21146

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, D.C> 20460

Re: Docket ID No. EPA-HQ-OW-2008-0692EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 892 of 1099 I am writing to implore you to overturn your decision regarding not regulating perchlorate in drinking water! I am a lifelong resident of Maryla nd and I am a holistic healthcare practitioner. Health and nutrition is a priority in my family an d while I can control what we eat, I have always assumed we have safe and clean drinking water. Since I believe that perchlorate is a harmful chemical, it is the responsibility of the EPA to re gulate specific levels of this chemical in our drinking water. By being proactive in this regard we shall avoid future health problems and save not only countless dollars for health care but more importantly, citizens health and well-being.

Sincerely, Katie Milleker

Response: See response to comment code 6120.

Commenter Name: Nancy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2150

EPA Comment ID: 22034

EPA Comment Code: 6120

Comment: 11/11/08

To the powers that be,

I write as a concerned citizen regarding perchlorate contamination. I understand that it may be present in our water supply, especially near milit ary installations. I live in Anne Arundel Country, Md. - home to Ft. Meade, as well as mercury contamination sites. And for 35 years, I have worked in the field of early childhood disabilities.

Whatever control we may have over harmful substances in our environment is worth achieving. Please consider the safety cautions related to perchlorate contamination.

Thank you Nancy [illegible]

Response: See response to comment code 6120.

Commenter Name: Taylor M. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2151

EPA Comment ID: 22041

EPA Comment Code: 6120

Comment: Dear EPA,

I believe that it is important to keep our water safe and healthy. Having perchlorate is not healthy at all. I'd rather not have my body damaged just beca use I drank some water. Please fix this problem!

Thank you Taylor. M. [no surname]

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 893 of 1099 Commenter Name: Lewis W. Billups Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2152

EPA Comment ID: 22044

EPA Comment Code: 6120

Comment: TO: EPA From: Lewis W. Billups

To Whom It May Concern,

As a citizen concerned about passing a stringent and decisive clean water act by congress, I request that you work with the organization Clean Water Action to ban the use of per chlorate. We as a

nation should have access to clean and safe water without toxic chemicals.

Respectfully, Lewis W. Billups

Response: See response to comment code 6120.

Commenter Name: George Cooper Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2153

EPA Comment ID: 22045

EPA Comment Code: 6120

Comment: Dear EPA,

I support imposing a standard on the regulation of perchlorate in drinking water.

Sincerely, George Cooper 3612 Ov al Dr Alexandria, VA 22305

Response: See response to comment code 6120.

Commenter Name: Laura Ricard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2154

EPA Comment ID: 22057

EPA Comment Code: 6120

Comment: To Whom It May Concern

As a concerned citizen who cares deeply about envir onmental issues I urge you to list perchlorate as a chemical sufficiently toxic to limit its presence in drinking water. Given our recent change in leadership I am hopeful that you will feel embolde ned to take a stronger stance to protect our

environment.

Regards, Laura Richard, PA C 516 Tennessee Ave Alexandria, VA 22305EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 894 of 1099 Response: See response to comment code 6120.

Commenter Name: Sheila C Joy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2155

EPA Comment ID: 22070

EPA Comment Code: 6120

Comment: 11/17/08

To: EPA Water Docket

I am a Virginia voter, perchlorate is a dangerous ch emical which should be regulated. It occurs in 37 states and adversely affects children.

Sincerely, Sheila C Joy 3418 Old Dominion Blvd Alex VA 22305

Response: See response to comment code 6120.

Commenter Name: Kelsey Ogburn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2156

EPA Comment ID: 22072

EPA Comment Code: 6120

Comment: 11/13/08

EPA

You must continue to regulate perchlorate in our drinking water.

Please help!

Kelsey Ogburn 805 Redwood Trail Crownsville MD 21032

Response: See response to comment code 6120.

Commenter Name: William J. Shaw Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2157

EPA Comment ID: 22087

EPA Comment Code: 6120

Comment: Dear EPA,

I urge you to regulate the amount of perchlorate in our drinking water supply. This issue is vital to

our future.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 895 of 1099 Sincerely, William J. Shaw 299 Aston Forest Ln Crownsville, MD 21032

Response: See response to comment code 6120.

Commenter Name: J Savage Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2158

EPA Comment ID: 22088

EPA Comment Code: 6120

Comment: Jomi Savage

We don't want harmful chemicals in our drin king water! They serve no usefull purpose and only impair our well being. So please for god sa ke, STOP PUTTING THAT [expletive] IN OUR

WATER!!

Thank you.

Response: See response to comment code 6120.

Commenter Name: Gary Elson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2159

EPA Comment ID: 22089

EPA Comment Code: 6120

Comment: November 13, 2008

Water Docket, EPA Mailcode 2822T 1200 Penns ylvania Avenue Washington, DC 20460

Attn: Docket ID# EPA-HQ-OW-2008-0692

I support the regulation of perchlorate in drin king water and the stri ct enforcement of its prohibition. Perchlorate contaminations is a na tionwide problem and the protection of the public health requires such regulation on a nationwide basis.

Gary Elson 409 Kyle Rd. Crownsville, MD 21032

Response: See response to comment code 6120.

Commenter Name: Elaine & George Anderson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2160

EPA Comment ID: 22090

EPA Comment Code: 6120

Comment: 11/17/08EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 896 of 1099 To: EPA Water Docket,

I am a Virginia voter, and a kayaker and interested in preserving our waters. Perchlorate is a dangerous chemical found in 37 states. Since it can get into water and children's thyroids are vulnerable, it needs to be regulated.

Elaine Anderson George Anderson

Response: See response to comment code 6120.

Commenter Name: Molly J. Hall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2163

EPA Comment ID: 22093

EPA Comment Code: 6120

Comment: November 11, 2008

Dear EPA,

It is time you take the health and safety of our dr inking water seriously. We need a federal law that will keep the chemical, perchlorate out of our drinking water.

Please move swiftly on this matter. The health an d safety of your constituents depends on your quick action.

Molly J. Hall Arnold, MD

Response: See response to comment code 6120.

Commenter Name: Cather Pauly Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2164

EPA Comment ID: 22094

EPA Comment Code: 6120

Comment: Dear EPA,

From a concerned Virginia resident, as a hopeful mom to be, I urge you to reconsider your decision not to regulate perchlorates, which could potentially harm not only me and my pets, but also my

future children. This is a serious matter for all of our health & welfare. Please help keep us safe.

Thank you Cather Pauly 3108 Wellington Rd Alexandria VA 22302

Response: See response to comment code 6120.

Commenter Name: Teresa Avery Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 897 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2165

EPA Comment ID: 22095

EPA Comment Code: 6120

Comment: Dear EPA,

I urge you to regulate the amount of perc hlorate in our drinking water supply.

Sincerely, Teresa Avery 1246 Ti mber Turn Arnold, Md. 21012

Response: See response to comment code 6120.

Commenter Name: Jean Sengelaub Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2166

EPA Comment ID: 22096

EPA Comment Code: 6120

Comment: To: EPA

I urge you to regulate the amount of perchlorate in our drinking water to a maximum of 2 ppb.

Sincerely, Jean Sengelaub 1289 Terrace Lane Arnold, MD 21012 11-10-08

Response: See response to comment code 6120.

Commenter Name: Jean Sengelaub Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2166

EPA Comment ID: 22097

EPA Comment Code: 6120

Comment: To: EPA

I urge you to regulate the amount of perchlorate in our drinking water to a maximum of 2 ppb.

Sincerely, Jean Sengelaub 1289 Terrace Lane Arnold, MD 21012 11-10-08

Response: See response to comment code 6120.

Commenter Name: Claire Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2167

EPA Comment ID: 22098

EPA Comment Code: 6120

Comment: EPA,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 898 of 1099 We all should have drinking water free of substance s like perchlorate. Please take another look at regulation. Its impact could be more harmful than we know now - affecting the thyroid gland.

Thank you, Claire [illegible]

Response: See response to comment code 6120.

Commenter Name: Mark Milleker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2168

EPA Comment ID: 22099

EPA Comment Code: 6120

Comment: Mark Milleker 112 Askewton Rd Severna Park MD 21146

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Ave Washington, D.C. 20460

November 10, 2008

Re: Docket # EPA-HQ-OW-2008-0692

Not allowing the EPA to regulate perchlorate in drinking water makes no sense. Hopefully the

Obama administration will overturn all executive or ders that harm our environment and the people

that drink water.

A national primary drinking water regulation is need ed right away. Think of the cost savings we will achieve with a healthier population.

Make the right choice.

Mark Milleker Drinking Wa ter Advocate 410 647-7264

Response: See response to comment code 6120.

Commenter Name: Jennifer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2169

EPA Comment ID: 22100

EPA Comment Code: 6120

Comment: November 12, 2008

Dear EPA,

I urge you to seriously consider regulating perchlorate in drinking water.

Sincerely, Jennifer [illegible] 211 St An drews Road Severna Park, Md 21146EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 899 of 1099 Response: See response to comment code 6120.

Commenter Name: Georgette A Irwin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2170

EPA Comment ID: 22221

EPA Comment Code: 6120

Comment: November 20, 2008

EPA -

Please work to regulate or eliminate PERCHLORATE from all drinking water.

Yours truly, Georgette A. Irwin 1044 Springhi ll Way Gambrills MD 21054 301-621-7881

Response: See response to comment code 6120.

Commenter Name: Bonita K Patterson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2171

EPA Comment ID: 22228

EPA Comment Code: 6120

Comment: Nov. 20, 2008

ATTN: EPA Water Docket

I am writing to ask you to please regulate perchlorate in drinking water.

This is a very harmful chemical and our water is already filled with plenty of other harmful

chemicals.

I have lived in our house for 38 yrs. and had brea st cancer 10 yrs. ago. We stopped using tap water @ that time. We now use reverse osmosis water filters.

I truly believe are water is one of the main reasons we have so much [illegible] in our development.

Listen to the people crying out for safe drinking water.

Bonita K. Patterson 867 Frost Valley Cir Gambrills, MD

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2173

EPA Comment ID: 22252EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 900 of 1099 EPA Comment Code: 6120

Comment: 11-6-08

To whom it may concern,

Drinking water should be tested for perchlorate because children and adults could be harmed by

these chemicals.

Thank you, (illegible)

Response: See response to comment code 6120.

Commenter Name: Rachelle Stanley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2174

EPA Comment ID: 22323

EPA Comment Code: 6120

Comment: Water Docket EPA Mail code 2822T 1200 Pennsylvania Avenue Washington, DC

20460

ATTN: Docket ID No: EPA-HQ-OW-2008-0692

As someone who trusts the Government to protect me from "The Axis of Evil", I also trust that
same Government to ensure I have safe, clean drin king water available to myself and my children. I recently learned that the EPA is intending to not regulate the amount of perchlorate in drinking water, and I find that frightening.

I strongly encourage you to reconsider this d ecision; as it will affect my two young children.
Perchlorate has been linked to mental retardation, loss of hearing and speech or deficits in motor skills in children with thyroid problems. My childre n are genetically predisposed to thyroid disease, so this is very worrisome for me.

We have enough to worry about in this country: terrorism, education, health care, the economy, using less oil and reducing our carbon footprints. I d on't want to have to worry about the water that crosses my children's lips too.

Sincerely, Rachelle Stanley 2607 Ap ril Dawn Way Gambrills, MD 21054

Response: See response to comment code 6120.

Commenter Name: Kaii Heward Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2175

EPA Comment ID: 22329

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 901 of 1099 Comment: 11/19/08

Dear Fellow American,

I am writing you concerning our water supply. Among all of the other contaminates in our drinking water, there is the issue of perchlorate and I hear the EPA does not intend to regulate this chemical. It is inconceivable to me that it is not already being monitored considering how it affects thyroids, motor skills, development and other kinds of mental health. It impacts our children the most. I feel that perchlorate should be part of the mandatory tes ting done for our water supply. The health of all American citizens is crucial. Basically, failure to remove perchlorate's effects is consciously neglectful. We need to lock after our own welfare and be our own advocates. Monies used to protect ourselves from this chemical are just that: Monies. Our health is priceless. Please vote to make the regulation of perchlorate mandatory for all states.

Thank you for your time,

Kaii Heward

Response: See response to comment code 6120.

Commenter Name: Carrie Allen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2176

EPA Comment ID: 22330

EPA Comment Code: 6120

Comment: My family and I would like the EPA to contin ue to regulate Perchlorate levels in our water supply. We have read that it can ne gatively affect our health in low levels.

Thank you Carrie Allen 2516 Viva ldi Ln Gambrills MD 21054

Response: See response to comment code 6120.

Commenter Name: Anna Hyde Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2177

EPA Comment ID: 22331

EPA Comment Code: 6120

Comment: To whom it may concern:

As a mother to be and the wife of a doctor, I am consistently troubled by what contaminants are contained in our drinking water, especially after seve ral recent studies that have raised alarm. I urge you to reverse your decision and set a federal limit for perchlorate in drinking water. It can have disasterous health impacts, especially for infants and children.

Sincerely, Anna HydeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 902 of 1099 Response: See response to comment code 6120.

Commenter Name: Andrea Leidolf Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2178

EPA Comment ID: 22332

EPA Comment Code: 6120

Comment: Nov 17, 2008

Dear epa,

I would like to see a limit set on perchlorate in drinking water.

Sincerely, Andrea Leidolf 909 N Ov erlook Dr Alexandria VA 22305

Response: See response to comment code 6120.

Commenter Name: Harrison B. Williams Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2179

EPA Comment ID: 22333

EPA Comment Code: 6120

Comment: To: the US Environmental Protection Agency

I strongly urge you to reverse your decision to NOT regulate perchlorate in drinking water. Because perchlorate does not readily dissipate and can cont aminant drinking water for years after it is
released into the environment, I believe it is imperative that it be regulated by the EPA.

Harrison B. Williams 3617 Oval Drive Alexandria, Va 22305

Response: See response to comment code 6120.

Commenter Name: Karl Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2180

EPA Comment ID: 22334

EPA Comment Code: 6120

Comment: 11/12/08

To All Concerned at the EPA:

Please keep perchlorate out of our drinking water.

If there are other solutions for getti ng rid of this please explore.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 903 of 1099 Thank you, Sincerely Karl Hutchinson 3761 Gunston Road Alexandria, VA 22302

Response: See response to comment code 6120.

Commenter Name: Kevin & Lita Yates Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2181

EPA Comment ID: 22335

EPA Comment Code: 6120

Comment: November 18, 2008

18801 Breeze Way Circle Olney, MD 20832

To Whom It May Concern:

We are very concerned about the EPA announcin g its intention NOT to regulate perchlorate in drinking water. Perchlorate has been found in 37 st ates, and in public water systems serving over 20 million people. As parents of three growing children, we are especially concer ned about the presence of perchlorate in our drinking water since it is a harmful chemical that can impair the thyroid gland, which controls growth, development and metabolism.

We need our government agencies to regulate harmful chemicals. This is the purpose of the EPA, to protect citizens from harmful pollution. Please protect the citizens of the United States by regulating the harmful chemical perchlorate in drinking water.

Thank you, Kevin and Lita Yates

Response: See response to comment ID 19873 under comment code 5220.

Commenter Name: Hillary Collyer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2182

EPA Comment ID: 22372

EPA Comment Code: 6120

Comment: 11/12/08

Dear EPA,

Perchlorate occurs widely. There are many sources of perchlorate contamination. Because there has not been routine testing, we do not know the full extent of contamination. I ask that you act quickly to perform appropriate tests and implement adequate regulation.

Thank you for your attention to this important matter.

Regards, Hillary Collyer 3775 Gunston Rd. Alexandria, VA 22302EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 904 of 1099 Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2183

EPA Comment ID: 22377

EPA Comment Code: 6120

Comment: EPA Washington, DC 20005

To Whom It May Concern:

Please address the issue of perchlorate in our DC drinking water, and protect us from the problems that can occur from over exposure. It is to that end that I fully endorse the efforts of the Clean Water Action organization and their efforts to rid ou r drinking water of this dangerous and harmful

chemical.

Thank you for your interest in this matter.

Sincerely (illegible) 3507 Nst NW Was., DC 20005

Response: See response to comment code 6120.

Commenter Name: M. Jane Schumacher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2185

EPA Comment ID: 22379

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate perchlorate because it impacts the he alth of children; fetuses, as well as adults.

The regulation of this substance in our drinking water is very important to me and to all others who

are aware of this.

Please reconsider and make this an important regulation.

Thank you, M. Jane Schumacher

Response: See response to comment code 6120.

Commenter Name: Tina Carroll Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2189

EPA Comment ID: 22380

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 905 of 1099 Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I am a concerned citizen of Maryland. I have r ecently learned of your decision to choose not to regulate perchlorate levels in our drinking water. In Maryland we have several known facilities that distribute perchlorate:

Aberdeen Proving Ground Alliant Tech Systems Naval Surface Warfare Center New Jersey Fireworks Thiokol Corporation

Response: This is not a comment, no response needed.

Commenter Name: Diego Bank Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2190

EPA Comment ID: 22383

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I hope that our drinking water contaminants can be regulated, so that people aren't affected by the negative effects of perchlorate.

Thanks.

Sincerely, Diego Bank Kingston

Response: See response to comment code 6120.

Commenter Name: Brenda Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2191

EPA Comment ID: 22390

EPA Comment Code: 6120

Comment: To All Readers,

Perchlorate is a harmful chemical found in our drinking water. It is used in Rocket fuel and explosives. Every day, citizens ingest thousands of gallons nationally. If something is not done soon, This great country will be left a barren wasteland wi th no humans to care for it and all our efforts

will have been wasted. Perchlorate can cause massi ve problems both physically and mentally to any human that ingests it.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 906 of 1099 Response: This is not a comment, no response necessary.

Commenter Name: Brenda Lewis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2191

EPA Comment ID: 22392

EPA Comment Code: 6120

Comment: This country strives not on its technological booms, but the minds that drive them. If we do not act now, it'll soon be too late and what use will these technological advances be to us then. Without the bright minds of our citizens, what use is a government who wouldn't act when it

had the chance.

If the EPA does not do something to prevent further problems now, then there is no point in allowing them to stay as a federal agency anymor e. The EPA has a responsibility to act now and as such should proceed with all haste. No Bureaucratic procedure or code should stop them. No effort should be made to stop them from proceeding to fulfill their duty to this great country.

There are many sources of perchlorate contamin ation including many military bases, fireworks manufacturers, and blasting at construction sites. If there were more routine testing then perhaps the problem could be more properly identified. Currently perchlorate has been found in 37 states, and in public water systems serving over 20 million people.

Respectfully, Brenda Lewis

Response: See response to comment code 6120.

Commenter Name: James Kirk Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2192

EPA Comment ID: 22399

EPA Comment Code: 6120

Comment: To whom it may concern:

My family and I are greatly concerned that the EPA is considering not to regulate perchlorate in our drinking water.

We fully support a national primary drinking water regulation to protect future generations.

Thanks James Kirk 2482 Red Fall Ct Gambrills, MD 21054

Response: See response to comment code 6120.

Commenter Name: Leigh E Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2193

EPA Comment ID: 22408EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 907 of 1099 EPA Comment Code: 6120

Comment: 11-20-08

Dear EPA

If you are truly an agency that protects the environment you will understand that perchlorate contamination is a nationwide problem and that it has health impacts at lower levels than previously thought.

Many people can not afford either bottle water or to filter their water. I have a thyroid problem. Could it be from drinking perchlorate? We need a national primary drinking water regulation to protect all of us.

Sincerely Leigh E [illegible]

Response: See response to comment code 6120.

Commenter Name: Georgia Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2194

EPA Comment ID: 22409

EPA Comment Code: 6120

Comment: Dear EPA Folks,

Perchlorate in the water is a terrible thing for our nation's children, and to think it's allowed in the DC water is awful. Please think about regulating this!

Thank you, Georgia [illegible] 3519 Prospect St NE Was., DC 2007

Response: See response to comment code 6120.

Commenter Name: Ben Richeda Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2204

EPA Comment ID: 22410

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Seriously,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 908 of 1099 The US has the best drinking water in the world. I should know, I've been around. However, implicit in this assumption is the trust that the EP A is doing a good job. Don't mess this up for the

rest of us who can't afford bottled water or filters.

Sincerely, Ben

Sincerely, Ben Richeda 1160 Camino Cruz Blanca Santa Fe, NM 87505

Response: See response to comment code 6120.

Commenter Name: Sarah Beth Cassel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2205

EPA Comment ID: 22411

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I think it is obvious to protect our future generati ons. My boyfriend is a father of a young one and and hope one day to be a mommy. I already have to worry about mercury levels in my fish... and now i have this to be concerned about. We are poisoning our earth and rightfully we are the ones paying for it, but protect the innocents. let us beco me a nation that is ecologically intelligent and looking into the future and no be so selfish. please.

Again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

it is that important.

Sincerely,

Sarah Beth Cassel 115 N. Beechwood Ave. Catonsville, MD 21228

Response: See response to comment code 6120.

Commenter Name: Dixie Walker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2210

EPA Comment ID: 22412

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 909 of 1099 I urge you to set a drinking water standard for perc hlorate. Perchlorate is found in drinking water in at least 26 states, and 20-40 million people could be exposed to this chemical. Businesses and Individuals appreciate "Standards" and "Standards fo r safe drinking water" is something the average U.S. citizen believes the EPA provides. They have no idea that the upmost is not being done to protect the countries supply of clean water. Do the right thing for the multitude of taxpayers who are busy making a living and raising a family. THEY TRUST that the EPA is looking out for their health - Honor their confidence in you by insuring that perchlorate is regulated throughout the

U.S.A.

I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

Sincerely, Dixie Walker 214 Chase Dr Pelham, AL 35124

Response: See response to comment code 6120.

Commenter Name: Anita Brightman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2211

EPA Comment ID: 22413

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I urge you to set a drinking water standard for perchlorate. I live near Aberdeen Proving Ground and have countless friends who suffer with thyr oid disease. While working on Post, I too was diagnosed with thyroid problems and took synthr oid for 10 years. Once I stopped drinking that water and changed jobs, I could not get my thyroid regulated. They eventually took me off the medicine because my thyroid function was in normal ranges.

This is an important issue and warrants attention and more study.

Sincerely, anita brightman 210 arch er street bel air, MD 21014

Response: See response to comment code 6120.

Commenter Name: Andrea Link Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2216

EPA Comment ID: 22415

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 910 of 1099 Dear Administrator Johnson and EPA staff,

I am writing to urge you to keep out water clean. It should be mandated that toxic chemicals be kept out of our water. There should be no question about this subject. Why on earth would you even consider not taking care of the health of our people?

Please keep our water clean.

Sincerely, Andrea Link 4028 S. Delaware Englewood, CO 80110

Response: This is not a comment, no response necessary.

Commenter Name: Andy Burgess Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2217

EPA Comment ID: 22416

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I cannot believe you have decided not to set a dr inking water standard for perchlorate that will

protect pregnant women an d babies nationwide.

There is no excuse for this decision - no financial, statistical, or political rationale can offset the moral obligation you have to protect the citizens of the USA from dangerous exposure to chemicals we recognize and understand how to abate.

Response: See response to comment code 6120.

Commenter Name: Andy Burgess Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2217

EPA Comment ID: 22418

EPA Comment Code: 6120

Comment: Again, I urge you to reverse your decision an d to set a national drinking water standard for perchlorate.

Sincerely, Andrew Burgess 2615 6th Street Boulder, CO 80304

Response: See response to comment code 6120.

Commenter Name: Neil and Pam Ackerman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2219EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 911 of 1099 EPA Comment ID: 22419

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Keep perchlorate OUT of our drinking water, PLEASE!

Sincerely, Neil and Pam Ackerman 8500 Falmouth Ave #3313 Beachport Complex Playa Del Rey,

CA 90293-8727

Response: See response to comment code 6120.

Commenter Name: Amy Geffre Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2223

EPA Comment ID: 22420

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Hello.

As a student of toxicology and a mother, I urge yo u to set a drinking water standard for perchlorate that will protect pregnant women and babies nation wide. I know you must already understand the potential health problems perchlorate can cause, so I will not lecture, but please take note of what I

say.

My son is just older than newborn; tap water goes into his formula and that of many other small children that I know and do not. Their nervous systems are fragile yet as they develop; when there is even the most minute chance of harming or stunting so precious a part of them, I feel that it is cause for strict, non-discriminate regulations to be put in place concerning such potentially harmful agents.

"Perchlorate is found in drinking water in at le ast 26 states, and 20-40 million people could beexposed to this chemical." This statement worries me. I see my son developing, making cause-andeffect relationships, beginning to comprehend color, beginning to respond to me with smiles. It makes me feel fulfilled beyond anything else I've felt. I can't imagine how horrible it would be for a mother to look at her child and know that her baby couldn't do such things because of exposure to a

harmful chemical.

I am aware that the problem of this compound's pr esence in drinking water is not necessarily so bad as to cause such heavy retardation in a child, but I worry about the potential for the situation to fastEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 912 of 1099 become as such, thus I write to you to consider making a blanket regulation preemptively to ensure drinking water will never have harmful levels of perchlorate.

Problems are best avoided by ensuring that they can' t happen to begin with. Please consider this. I urge you to. Please reverse your decision and s et a national standard on perchlorate. Children are depending on us to keep them safe and healthy. Let's not make them lose their faith in us.

Sincerely, Amy Geffre 131 N Clark St Apt. B Forest City, IA 50436

Response: See response to comment code 6120.

Commenter Name: Kim Leerdam Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2224

EPA Comment ID: 22421

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Are you serioussssssssssss?????????????????

Be logical.

Again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

I hope Robert Kennedy Jr takes over the EPA an d you all get fired for being so insincere.

Sincerely, Kim Leerdam 410 N. Rossmore Ave #405 Los Angeles, CA 90004

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2226

EPA Comment ID: 22422

EPA Comment Code: 6120

Comment: EPA Water Docket

I am a student and I'm studying Biology. Perchlor ate is a dangerous chemical and in the water. We need to protect children so it must be regulated.

Sincerely, [illegible]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 913 of 1099 1721 Crestwood Dr. Alexandria, Va 22302

Response: See response to comment code 6120.

Commenter Name: Malcolm Herstand Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2227

EPA Comment ID: 22423

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Please!

Set a limit for perchlorate levels in water.

Your report talks about doses over months. But people live and drink from their water supply for

decades.

Maximum levels would be enforceable by encouraging reduction and containment of perchlorate use in fireworks and battery manufacturing.

As a hydrologist for Montana State, I understand that groundwater contamination is receiving increased attention, and citizens are becoming more educated about it.

Don't become known as the

Sincerely, Malcolm Herstand 1625 W. Kagy Bozeman, MT 59715

Response: See response to comment code 6120.

Commenter Name: Mary Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2229

EPA Comment ID: 22424

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I urge you to reverse your decision and to set a national drinking water standard for perchlorate. Protecting our drinking water is b ecoming a greater problem, and it needs to be addressed. I believeEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 914 of 1099 we have an obligation to protect people, especially pregnant mothers and children from dangerous

chemicals in the water.

Thank you.

Sincerely, Mary Miller 417 Akers Drive Wilmore, KY 40390

Response: See response to comment code 6120.

Commenter Name: Marie Maccabee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2240

EPA Comment ID: 22425

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I urge you to set a drinking water standard for pe rchlorate that will protect life here on earth. I think it is necessary for your agency to set a national st andard that is based on the best available science and that will protect public health. It would be litterally insane and completely unhuman for this group of yours to ignore your own staff scientists ' reasonings about the dangers of this chemical. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity

for health risk reduction."

Again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

Sincerely, marie maccabee 103 woodside ave thurmont, MD 21788

Response: See response to comment code 6120.

Commenter Name: Tigris Powers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2244

EPA Comment ID: 22426

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Perchlorate should NOT be anywhere near our nati on's pregnant women, infants, children, or our drinking water supply. It's difficult to believe that th is is an issue that has to be questioned, when it poses a health threat to to 20-40 million people nation wide.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 915 of 1099 When the health of young children is being put to the test, aren't we better off being SAFE than sorry?

Perchlorate poses a risk for pregnant women, ne wborns and young children by interfering with thyroid hormone, which is critical for optimal development of the brain and nervous system.

Today 1 in 159 children are diagnosed with autism, a di sorder that is directly related to the brain and nervous system. Could there be a connection? Is it worth risking? I don't think so.

Response: See response to comment code 6120.

Commenter Name: Rose Lernberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2246

EPA Comment ID: 22428

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Please reverse your decision and set a national dr inking water standard for perchlorate that will

protect pregnant women an d babies nationwide.

Perchlorate interferes with the thyroid hormone, wh ich is critical for optimal development of the brain and nervous system. it is present in drinki ng water in at least 26 states, and 20-40 million people could be exposed to this chemical. This especially poses a risk for pregnant women, newborns and young children.

It is urgent that you set a national standard, base d on the best available science, to protect public health. Several states have set standards or guide lines for perchlorate, but these vary widely. Your own staff scientists say that not regulating perc hlorate means some infants and young children will receive unsafe levels of exposure. The current draf t scientific analysis should undergo independent scientific peer review and be used as the basis for the regulation.

All Americans deserve healthy and clean drinking water.

Response: See response to comment code 6120.

Commenter Name: Anna Kovach Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2247

EPA Comment ID: 22476

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 916 of 1099 Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I currently am working for a State Assemblywoman in New York. I have recently been doing alot of research about what goes into public drinking water, namely pharmecuticals. Along with these, which affect everything from microbacterium to sma ll fish and amphibians, there are also a whole slew of chemicals from everywhere else too. Please make sure you regulate what goes into the water.

I don't want anything worse to happen to my planet!!!

I urge you to set a drinking water standard fo r perchlorate that will pr otect pregnant women and babies nationwide. Perchlorate poses a risk for pregnant women, newborns and young children by interfering with thyroid hormone, which is critical for optimal development of the brain and nervous system. Perchlorate is found in drinking water in at least 26 states, and 20-40 million people could be exposed to this chemical.

Again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

Sincerely, Anna Kovach 124 Prosp ect Ave Apt 5 Binghamton, NY 13901

Response: See response to comment code 6120.

Commenter Name: Roman Berka Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2249

EPA Comment ID: 22477

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Thanks for doing nothing about perchlorate - great job.

Signed, The American People

Sincerely, Roman Berka 1260 Hillside Vw Algonquin, IL 60102

Response: This is not a comment, no response necessary.

Commenter Name: Rhona Schwartz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2251

EPA Comment ID: 22478EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 917 of 1099 EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

For heaven's sakes, don't we have enough trouble with our imported food supply! What the heck is perchlorate doing in our water!

You're supposed to help keep Americans safe. Ge t perchlorate banned and ba nished before all hell

breaks loose.

Sincerely, Rhona Schwartz 315 First Av e. W., #210 Seattle, WA 98119

Response: See response to comment code 6120.

Commenter Name: William McGhee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2266

EPA Comment ID: 22479

EPA Comment Code: 6120

Comment: WILLIAM MCGHEE 5 ROSENEATH COURT OLNEY MD 20832

U.S. ENVIROMENTAL PROTECTION AGENCY

E.P.A. Please take time to reconsiders the announ ced intention not to regulate per chlorate into our water system. I personally think this could provide a problem not only to my self but also to my children and my neighbors children. I did grow up in a time when you could drink from a water hose, but it was from a well. I have had the problem with broken water lines pollute our water system enough, to make me want to pop a well in th e city. Please look at all options to regulate my and my families drinking water, for the future of my children and yours.

Thank You, William Mcghee

Response: See response to comment code 6120.

Commenter Name: T., Craig, Sophie & Ian Brouillette Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2268

EPA Comment ID: 22480

EPA Comment Code: 6120

Comment: November 24, 2008

To the EPA:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 918 of 1099 As a mother of two small children and a firm advo cate of drinking plenty of water every day, my family and I are deeply disturbed to hear that the EPA has decided NOT to regulate perchlorate in our drinking water.

Perchlorate contamination is a nationwide probl em that must be addressed and remedied. The effects of unsafe levels of perchlorate on the th yroid gland currently known that can have adverse impacts on health are devastating.

We want the EPA to regulate perchlorate levels in our drinking water, and a Nation primary drinking water regulation is needed.

Sincerely, The Brouillette Family of Mary land [illegible] Craig Sophie Ian

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2269

EPA Comment ID: 22481

EPA Comment Code: 6120

Comment: EPA,

I don't think I have to highlight the importance of the environment and the effect it has on people and more important children and animals, so I write this letter to illustrate my passion for the welfare and health of all human when I say please lets learn from the past of ignorance and please test and regulate Perchlorate.

Respectfully, Concerned Citizen

Response: See response to comment code 6120.

Commenter Name: Glenn M. Phillips Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2270

EPA Comment ID: 22482

EPA Comment Code: 6120

Comment: November 24, 2008

Glenn M. Phillips 7778 Kidwell Dr. Hanover, MD 21076

Water Docket, EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, DC 20460

ATTN: Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 919 of 1099 Perchlorate is harmful and needs to be regulated in our water supply. This is a nation-wide problem and carries health impacts to everyone. Please review your choice not to regulate perchlorate in drinking water and amend your decision, as is only proper.

Sincerely, Glenn M. Phillips

Response: See response to comment code 6120.

Commenter Name: Debbie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2274

EPA Comment ID: 22483

EPA Comment Code: 6120

Comment: Dear EPA:

Perchlorate is harmful and needs to be tested in our water. Please take action to resolve the matter.

Debbie [illegible] 788 Sunny Chapel Rd Odento Md 21113

Response: See response to comment code 6120.

Commenter Name: Mary Ogburn Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2275

EPA Comment ID: 22484

EPA Comment Code: 6120

Comment: 11/13/08

EPA

You must continue to regulate perchlorate in our drinking water. Please help.

Mary Ogburn 805 Redwood Tr ail Crownsville MD 21032

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2276

EPA Comment ID: 22485

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate our drinking water. Help us keep our water safe and clean.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 920 of 1099 Response: See response to comment code 6120.

Commenter Name: Jessica Gillengerten Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2277

EPA Comment ID: 22486

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

hello.

i am curious about this disinterest in regulating national drinking water.

why wouldn't we want to continue to maintain he althy standards for our primary necessity in life?

i spent many years in quebec, and enjoyed the be nefit of seeing the true sources of the water supplies to their entire city.

it's remarkable to note the difference, between florida sulphur water... carolina mountain water... new york city tap water... chicgao re-filtered lake michigan water...hawaiian lava rock filtered water,

and canadian melted snow.

of course there are geographic diffe rences that create natural filtration variances, but why should we be sacrificing anything when it comes to keeping our water clean?

we are capable of doing great things. we have boundless technology, and plenty of educated people looking to work...

why not set a noble task, and pursue excellent standards?

Perchlorate does not sound like a natural part of H2 0. and since my tap water does not come with a list of ingredients, save for a once a year particulat e analysis, i would really prefer to know the EPA was doing a fine job keeping an eye on what was coming into my glass.

the japanese are doing incredible things with wate r filtration. and as i have said, i was also very impressed with the great effort the canadians have put into protecting the pristine sources of their drinking water.

why shouldn't we take pride in a precious commodity? last i heard, it was a costly item in jordan, where people were standing in line to get a limited amount of clean bottled water issued to them.

and we painfully pollute, and waste...when we have the ability to improve.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 921 of 1099 again, I urge you to reverse your decision and to set a national drinking water standard for perchlorate, and to raise our standards overall.

clean water is a deciding factor for where i choose to liv e in this world. it's amazing to think that it is something the EPA could possibly be taking for granted. thank you.

Sincerely, jessica gillengerten 3407 ge rhardt st sarasota, FL 34237

Response: See response to comment code 6120.

Commenter Name: Linda Yow Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2293

EPA Comment ID: 22488

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

Please set a protective drinking water standard fo r perchlorate as required by the Safe Drinking Water Act, reversing EPA's preliminary regulatory determination and doing what is right. Our food and water supplies are widely polluted with perchl orate and its toxic effects are well known, so action on this problem is urgent.

Exposure to perchlorate in the U.S. population ex ceeds the reference dose set by EPA, so EPA needs to incorporate the protective methodology for the sake of the millions of U.S. families exposed to dangerous levels of perchlorate contamination.

Thank you for your attention.

Sincerely, Linda Yow Route 1 Box 1650 Glen Allen, MO 63751

Response: See response to comment code 6120.

Commenter Name: James Pierson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2296

EPA Comment ID: 24977

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 922 of 1099 For the good of our country, it is critical for the EPA to set national standards, based on the best available science, to protect public health. The EP A's scientists have determined that your decision not to regulate perchlorate places some infants an d young children above safe levels of exposure. The EPA's current draft scientific analysis should undergo independent scientific peer review and should be used as the basis for regulations relative to perchlorate.

I urge you to reverse your decision and to set a national drinking water standard for perchlorate.

Sincerely, James Pierson 1079 Yorktown Drive Charleston, SC 29412

Response: The Agency believes that further review by the National Research Council would unnecessarily delay regulatory decision making for perchlorate. Therefore, EPA is not, at present, planning to request additional NRC review of issues related to perchlorate. Instead, EPA is issued a notice in August of 2009 seeking comments on a br oad range of alternative approaches to the interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking

water.

EPA has determined to regulate perchlorate in dr inking water. See response to comment code 6120.

Commenter Name: Kraig Erickson Commenter Organization: RMC Water and Environment (RMC)

EPA Document ID: EPA-HQ-OW-2008-0692-2299

EPA Comment ID: 24978

EPA Comment Code: 6120

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

I urge you to set a drinking water standard fo r perchlorate that will pr otect pregnant women and babies nationwide. Perchlorate poses a risk for pregnant women, newborns and young children by interfering with thyroid hormone, which is critical for optimal development of the brain and nervous system. Perchlorate is found in drinking water in at least 26 states, and 20-40 million people could be exposed to this chemical.

Several states have set drinking water standards or guidelines for this chemical, but these standards vary widely, so it is critical for the EPA to set a national standard that is based on the best available science and that will protect public health. The EPA's own staff scientists have determined that your decision not to regulate perchlorate places some infants and young children above safe levels of exposure. The EPA's current draft scientific analys is should undergo independent scientific peer review and should be used as the basis for the regulation.

Response: The Agency believes that further review by the National Research Council would unnecessarily delay regulatory decision making for perchlorate. Therefore, EPA is not, at present, planning to request additional NRC review of issues related to perchlorate. Instead, EPA is issued a notice in August of 2009 seeking comments on a br oad range of alternative approaches to theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 923 of 1099 interpretation of the scientific data relevant to a regulatory determination for perchlorate in drinking

water.

EPA has determined to regulate perchlorate in dr inking water. See response to comment code 6120.

Commenter Name: Roland Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2300

EPA Comment ID: 24981

EPA Comment Code: 6120

Comment: Dear EPA

Please regulate perchlorate. This is harmful to our drinking water.

Roland [illegible] 16 W. [illegible] Ave Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: J. Elizabeth Callis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2301

EPA Comment ID: 24982

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate perchlorate

Thank you for paying attention

J Elizabeth Callis 19 W. Caton Ave. Alexandria, VA. 22301

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2302

EPA Comment ID: 24983

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate perchlorate!

[illegible] 437 E Luray Ave Alexandria, VA

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 924 of 1099 Commenter Name: Shannon O'Donnell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2303

EPA Comment ID: 24984

EPA Comment Code: 6120

Comment: DEAR EPA,

PLEASE REGULATE PERCHLORATE & TOXINS . IT CAUSES BIRTH DEFECTS AND IT

IS SOMETHING THAT CONCERNS ME.

SINCERELY, SHANNON O'DONNELL

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2304

EPA Comment ID: 24985

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate perchlorate in our water system. It is harmful to children and pregnant women.

Sincerely, [illegible] 2406 Sanf ord St. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Daisy and G. Hickson Howell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2305

EPA Comment ID: 24986

EPA Comment Code: 6120

Comment: Dear Epa Water Docket

- please regulate perchlorate that harmful to children.

Daisy Howell G. Hickson 612 N [ illegible] St Alexandria VA

Response: See response to comment code 6120.

Commenter Name: John Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2306

EPA Comment ID: 24987EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 925 of 1099 EPA Comment Code: 6120

Comment: Dear EPA Water Docket,

Please regulate perchlorate.

Thanks,

John [illegible]

Response: See response to comment code 6120.

Commenter Name: Heidi Mayor Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2307

EPA Comment ID: 24988

EPA Comment Code: 6120

Comment: 3614 Jenifer St., NW Washington, DC 20015 November 21, 2008

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Ave., NW Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2008-0692

Dear Environmental Protection Agency:

I am writing to urge, beg and even cajole you to set a federal limit for percholate in drinking water. Percholate is a nationwide probmem with significant health impacts. While I am fortunate enough to be able to afford to pay money to filter my drin king water, I believe that clean drinking water is a fundamental right of every American, including t hose who cannot afford to spend extra money to obtain it. Please regulate perchola te. We will be a healthier, weal thier and wiser nation for your

efforts.

With kind regards, Heidi Mayor

Response: See response to comment code 6120.

Commenter Name: C. Foni Bissessar Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2308

EPA Comment ID: 24989

EPA Comment Code: 6120

Comment: Please regulate perchlorate It's harmful to children and the environment

C. Foni Bissessar 610 N. Ripl ey St. Alexandria, VA 22304

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 926 of 1099 Commenter Name: Cam Schaedel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2309

EPA Comment ID: 24990

EPA Comment Code: 6120

Comment: Dear EPA

Please regulate perchlorate to keep our water safe for children.

Sincerely, Cam Schaedel 5336 Tha yer Ave. Alexandria, VA 22304

Response: See response to comment code 6120.

Commenter Name: Jeremiah Marsh Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2311

EPA Comment ID: 24992

EPA Comment Code: 6120

Comment: EPA Water Docket

Please regulate perchlorate, it harms kids in development.

Jeremiah Marsh Medical School Student Howard University

Response: See response to comment code 6120.

Commenter Name: Caroline Schaffer Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2312

EPA Comment ID: 24994

EPA Comment Code: 6120

Comment: November 24, 2008

Dear EPA Water docket

Please regulate perchlorate. It harms childrens development.

Caroline Schaffer 5347 Holms Run Parkway Alexandria VA 22304

Response: See response to comment code 6120.

Commenter Name: Thomas Blackwood Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2313EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 927 of 1099 EPA Comment ID: 24995

EPA Comment Code: 6120

Comment: 11/21/08

EPA Water Docket

I am a virginia fisherman/voter and wish to d eclare perchlorate as a dangerous chemical with negative health effects, especially for children. Since it is widespread and gets into water it should be regulated.

Thomas Blackwood 801 Ramsey St Alex VA 22301

Response: See response to comment code 6120.

Commenter Name: David Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2314

EPA Comment ID: 24996

EPA Comment Code: 6120

Comment: 11/24/08

To EPA water docket

I'm a Virginia voter and supporter of Virginia en vironment. Perchlorate is a dangerous chemical found in thirty seven states and affects the health of children. Since it gets into water we must call for it to be regulated.

Sincerely, David [illegible] 4909 Rutland Pl. Alexandria, VA 22304

Response: See response to comment code 6120.

Commenter Name: Melanie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2315

EPA Comment ID: 24997

EPA Comment Code: 6120

Comment: As a concerned member of our area & a vo ter I wish to see that perchlorate be regulated because it gets into water supplies & has negative health effects, especially for children.

Sincerely, Melanie [illegible] 602 [ illegible] St. Alexandria VA 22308

Response: See response to comment code 6120.

Commenter Name: Robert A. Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 928 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2316

EPA Comment ID: 24998

EPA Comment Code: 6120

Comment: 11/20/08

EPA Water Docket

I am a long term Virginia resident. Perchlorate is a dangerous chemical. Since it gets into water & harms children, it should be regulated.

Robert A. [illegible] 406 Highland Pl Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: David Uhl Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2317

EPA Comment ID: 24999

EPA Comment Code: 6120

Comment: 11/20/2008 David Uhl

Water Docket, EPA, Mailcode 2822T 1200 Pe nn. Ave NW Docket ID No. EPA-HQ-OW-2008-

0692

To whom it may concern:

Given our current problems with deregulation, I urge the EPA to reverse its decision and set a federal limit for perchlorate in drinking water.

Sincerely David Uhl, MPA

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2318

EPA Comment ID: 25000

EPA Comment Code: 6120

Comment: Dear EPA

I would like it if you find a better way to clean the water and not harm it or other people. I wish you

take this in consideration. We need at least one good thing to happen in the world right now. Start by removing perchlorate water.

(p.s. why are you trying to clean the water this way?) (good luck)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 929 of 1099 [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2319

EPA Comment ID: 25001

EPA Comment Code: 6120

Comment: To whom it may concern,

I learned there is a horrible chemical in our world. This chemical is called Perchlorate. Perchlorate can affect the thyroid gland, which controls gro wth, development and metabolism. This is very
harmful to children and babies. This chemical has been found in 37 states. Therefore, WE NEED

TO KEEP PERCHLORATE OUT OF DRINKING WATE R!!!!!! Please help us keep our water safe by keeping Perchlorate out of our drinking water!

Sincerely, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2321

EPA Comment ID: 25002

EPA Comment Code: 6120

Comment: To Whom it may concern:

I learned that chemicals are in our water. I want to grow up healthy and strong so can you please make a law to keep perchlorate out of our water.

from, [comment from patron under the age of 13]

Hi there Girls Rule!

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2322

EPA Comment ID: 25003

EPA Comment Code: 6120

Comment: Water Docket EPA Mail code 2822T 1200 Pennsylvania Avenue Washington, DC 20460 ATTN: Docket ID No: EPA-HQ-OW-2008-0692EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 930 of 1099 My name is [comment from patron under the age of 13]. I am six. I want to drink clean water. My mom says I should write to you to tell you test for Perchlorate. She's usually right about that kind of stuff. Please reconsider your decision to not test for Perchlorate. My future depends on it.

Thank you, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2323

EPA Comment ID: 25004

EPA Comment Code: 6120

Comment: Dear EPA,

I think it is inportant to have clean water. Perchlorate should be filterd because it can inpair the thyroid gland. The thyroid gland controls groth, develope ment and metabolism. These prodlems are most likely to occur in kids like me. Please help us Fix this prodlem.

Thank you

Sincerely, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2324

EPA Comment ID: 25005

EPA Comment Code: 6120

Comment: Date 11/0/08

Dear EPA,

Please pass laws to keep perchlorate contaminatio n out of our water. This is drinking water so we want to keep it clean. We don't want kids, parent s, or babys to get sick. Also we don't want it to come to our water because we don't want our people to get sick too. So lets all try to keep our water CLEAN and save the people.

from, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 931 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2325

EPA Comment ID: 25006

EPA Comment Code: 6120

Comment: November 21, 2008 [comment from patron under the age of 13]

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Ave. NW Washington Dc 20460 Docket ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

Please reverse your decision and set a federal limit for perchlorate in our drinking water. I may just be an 11 year old but I have a lot of years of water in my future so please protect my health and that of my families. Remember you dr ink and use this water too!

Kindly, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2326

EPA Comment ID: 25007

EPA Comment Code: 6120

Comment: 11/24/2008 [comment from pa tron under the age of 13]

To Whom it May Concern:

I urge you to reverse your decision and set a fe deral limit for perchlorate in drinking water. Perchlorate is a nationwide problem and has health impacts at lower levels than previously thought. Please protect public health, especially infant s and children, by regulating perchlorate.

Sincerely, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Donna Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2328

EPA Comment ID: 25008

EPA Comment Code: 6120

Comment: 11/19/2008

To: EPA Water Docket

I am a Virginia voter and work supporting environmental organizations and issues.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 932 of 1099 Perchlorate is a dangerous chemical and is widesp read in water supplies with especially negative

effects in children. Therefore it is extremel y important to see that it is regulated.

Sincerely, Donna [illegible] [illegible] W [illegible] Avenue Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: R. Travers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2330

EPA Comment ID: 25010

EPA Comment Code: 6120

Comment: To EPA Water Docket

Please regulate perchlorate, it is harmful to most living things and doesn't belong in water.

R. Travers 432 E Luray Ave Alex. Va 22301

Response: See response to comment code 6120.

Commenter Name: Carl Wall Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2331

EPA Comment ID: 25011

EPA Comment Code: 6120

Comment: Attention EPA Water Docket,

I am extremely unhappy with the fact that perchlorate is an unregulated substance which pops up in water. This stuff can hurt children and in today's world we need to raise healthy Americans. Action needs to be taken so our country has safe standards.

Thanks, Carl Wall 513 E [illegible] Alex. VA 22301

Response: See response to comment code 6120.

Commenter Name: Emerson Tom Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2332

EPA Comment ID: 25012

EPA Comment Code: 6120

Comment: November 21, 2008 Emerso Tom 3615 Ingomar Place, NW Washington DC 20015

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Ave. NW Washington Dc 20460 Docket ID No. EPA-HQ-OW-2008-0692EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 933 of 1099 To Whom It May Concern:

Please reverse your decision and set a federal limit for perchlorate in our drinking water. I may just be a 13 year old but water is important to me an d everyone I know. Please protect my health and that of my family. Remember you drink and use this water too!

Kindly, Emerson Tom

Response: See response to comment code 6120.

Commenter Name: Michelle Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2333

EPA Comment ID: 25013

EPA Comment Code: 6120

Comment: Dear EPA Water Docket

Please regulate perchlorate in our water systems. The DoD already has a substitute to keep rockets flying.

Regards Michelle [illegible] 542 E [ illegible] Ave Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Tracie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2334

EPA Comment ID: 25014

EPA Comment Code: 6120

Comment: Dear EPA,

Please regulate toxins from rocket fuel. They are harmful to children.

Thanks, Tracie [illegible]

Response: See response to comment code 6120.

Commenter Name: Dennis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2335

EPA Comment ID: 25015

EPA Comment Code: 6120

Comment: Nov. 20, 2008EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 934 of 1099 Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Av, NW Washington, DC 20460 Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern:

Please reverse your recent decision on perchlorate in drinking water by setting a federal limit.

Perchlorate is a national problem that requires a Federal solution.

Sincerely, Dennis Stout

Response: See response to comment code 6120.

Commenter Name: M.L. Lang Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2336

EPA Comment ID: 25016

EPA Comment Code: 6120

Comment: To EPA

Regards perchlorate - absolutely not to be dumped in our waters. Please encourage known substitute

for rocket fuel.

M.L. Lang 14 W. Rosemont Ave.

Response: Perchlorate is not being dumped into our waters.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2338

EPA Comment ID: 25018

EPA Comment Code: 6120

Comment: 11/24/2008 [comment from pa tron under the age of 13]

To Whom it May Concern:

I urge you to reverse your decision and set a fe deral limit for perchlorate in drinking water. Perchlorate is a nationwide problem and has health impacts at lower levels than previously thought. Please protect public health, especially infants and children, by regulating perchlorate.

Sincerely, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 935 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2339

EPA Comment ID: 25019

EPA Comment Code: 6120

Comment: Dear E.P.A,

I want clean drinking water. Please help all states provide their citizens with clean drinking water. I don't want people getting sick.

Sincerely, [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2340

EPA Comment ID: 25020

EPA Comment Code: 6120

Comment: To Whom it may concern

There are bad chemicals in our water. Please make a law that keeps perchlorate out of the water so we can grow up healthy and strong.

From [comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2320

EPA Comment ID: 25036

EPA Comment Code: 6120

Comment: Water Docket EPA Mail code 2822T 1200 Pennsylvania Avenue Washington, DC 20460 ATTN: Docket ID No: EPA-HQ-OW-2008-0692

My name is [comment from patron under the age of 13] and I am three. I want to drink clean water just like my brother. My mom says I should write to you to tell you test for Perchlorate. She's usually right about that kind of stuff. Please reconsider your decision to not test for Perchlorate. My future depends on it.

[comment from patron under the age of 13]

Response: See response to comment code 6120.

Commenter Name: Olivia Butler Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 936 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2329

EPA Comment ID: 25037

EPA Comment Code: 6120

Comment: Dear EPA Water Docket

Please regulate perchlorate it's harmful to childre n, and can be replaced with other chemicals for

rocket fuel.

Olivia Butler 423 E Juray Ave Alexandria, Va. 22301

Response: See response to comment code 6120.

Commenter Name: T.C. Nelson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2341

EPA Comment ID: 25038

EPA Comment Code: 6120

Comment: Dear EPA

Please regulate perchlorate - it is da ngerous to our family and future

Sincerely, T.C. Nelson 15 W. [illegible] Alexandria VA 22301

Response: See response to comment code 6120.

Commenter Name: Julia Goldstein Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2342

EPA Comment ID: 25039

EPA Comment Code: 6120

Comment: Dear EPA,

Perchlorate is bad for people to consume. Limits should be set on how much is in our drinking

water source.

Julia Goldstein 4201 Massachusetts Av e, NW 8008E Washington, DC 20016

Response: See response to comment code 6120.

Commenter Name: Diane Millard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2343

EPA Comment ID: 25040

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 937 of 1099 Comment: Diane Millard 3503 Valley Dr. Alexandria, VA 22302

Dear EPA;

Please ban/regulate perchlorates in the drin king water in the DC/Northern VA area. These chemicals have been proven to cause disabilities in children, specifically affecting the thyroid.

Please take the action to rid this toxic pollutant from our water and environment. I and generations to follow will greatly appreciate that action be taken now.

Sincerely, Diane Millard

Response: See response to comment code 6120.

Commenter Name: JoAnn Tom Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2344

EPA Comment ID: 25041

EPA Comment Code: 6120

Comment: November 21, 2008 JoAnn Tom 3615 In gomar Place, NW Washington DC 20015

Water Docket, EPA, Mailcode 2822T 1200 Penns ylvania Ave. NW Washington Dc 20460 Docket ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

Please reverse your decision and set a federal limit for perchlorate in our drinking water. Please protect our health and that of our families. Remember you drink and use this water too!

Kindly, JoAnn Tom

Response: See response to comment code 6120.

Commenter Name: Joan Kennan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2345

EPA Comment ID: 25042

EPA Comment Code: 6120

Comment: November 10, 2008

Water Docket, EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, DC 20460

ATTN: Docket ID No. EPA-HO-OW-2008-0692

In reference to EPA's intention not to regulate perchlorate in drinking water, I urge you to reconsider this position:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 938 of 1099 Perchlorate can impair the thyroid gland which controls growth, development and metabolism. These impacts are especially harmful to children and fetuses.

I do believe that a national primary drinking water regulation is needed to protect public health.

Sincerely, Joan Kennan 3143 O Street, NW Washington, DC 20007

Response: See response to comment code 6120.

Commenter Name: Teresa Kelley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2346

EPA Comment ID: 25043

EPA Comment Code: 6120

Comment: To whom it may concern,

I am writing to keep perchlorate out of my drinking water.

This is a problem for everybody including elderly, children and pets, also it can cause problems for people taking medications, like my family.

Please take this letter into consideration when you vote on this subject.

Thank you, Teresa Kelley 3109 Holly St. Alexandria, VA 22305

Response: See response to comment code 6120.

Commenter Name: Deborah Classman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2347

EPA Comment ID: 25044

EPA Comment Code: 6120

Comment: To: Water Docket, EPA, Mailcode 2822T 1200 Penn. Ave NW Washington DC 20460 Docket ID No EPA-HQ-OW-2008-0692

From: Deborah Classman 5240 Nebraska Ave NW Washington DC 20015

Nov. 21, 2009

Please reverse your decision to set a federal limite for perchlorate in drinking water. This chemical had deleterious effects on national health, even in very small amounts. Your job is to protect public health. Please do so and regulate perchlorate.

Deborah ClassmanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 939 of 1099 Response: See response to comment code 6120.

Commenter Name: Joseph (illegible) Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2348

EPA Comment ID: 25045

EPA Comment Code: 6120

Comment: Dear Department of Environmental Protection,

As an uncle of 13 children and a father-to-be I fi nd it at the minimum troubling, and at most a travesty of justice that your body has decided not to regulate perchlorate in drinking water. It has been brought to my attention that even low levels of this chemical can have adverse health effects. The lack of care and disregard for what is right, good, and just, I find personally appalling. I propose that you and your body seriously reexamine your po licies and your morals. I thank you for your time and courtesy in hearing me voice my complaints. I trust that in the end you will make the right

decision.

Yours truly, Joseph [illegible] M.D.

Response: See response to comment code 6120.

Commenter Name: Wesley Thomas Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2349

EPA Comment ID: 25046

EPA Comment Code: 6120

Comment: EPA Water Docket

Perchlorate, a substance found in solid rocket fuel s has no place in water. This substance needs to be kept out of the environment in order that it not stunt the growth of children like my daughter

Victoria.

Wesley Thomas 405 East Luray Avenue Unit A Alexandria, VA 22301- 1603 (202) 412-2926

Response: See response to comment code 6120.

Commenter Name: Enn Ki Janz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2350

EPA Comment ID: 25047

EPA Comment Code: 6120

Comment: Dear EPA Water Docket

Please regulate perchlorate. Harms children developmentEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 940 of 1099 Enn Ki Janz 5331 Holmes Run Pkwy Alexandria VA 22304

Response: See response to comment code 6120.

Commenter Name: Mary Cianningin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2351

EPA Comment ID: 25048

EPA Comment Code: 6120

Comment: EPA Water

Please regulate perchlorate its a harmful substance.

Mary Cianningin 540 E. Lura y Ave. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Mary Cianningin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2351

EPA Comment ID: 25049

EPA Comment Code: 6120

Comment: EPA Water

Please regulate perchlorate its a harmful substance.

Mary Cianningin 540 E. Lura y Ave. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2352

EPA Comment ID: 25050

EPA Comment Code: 6120

Comment: EPA:

PLEASE REGULATE PERCHLORATE - IT IS A HARMFUL SUBSTANCE.

[illegible] 10 E. Rosemont Alex, VA 22301

Response: See response to comment code 6120.

Commenter Name: Selma Munden Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 941 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-2353

EPA Comment ID: 25051

EPA Comment Code: 6120

Comment: EPA Water Docket

Please regulate perchlorate its a harmful substance.

Selma Munden 508E Luray Ave. Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Christine Kulinski Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2354

EPA Comment ID: 25052

EPA Comment Code: 6120

Comment: DEAR EPA REPRESENTATIVE -

PLEASE ENSURE OUR CITIZENS ARE NOT EXPOSED TO PERCHLORATE IN OUR

WATER.

THANK YOU, CHRISTINE KULINSKI

Response: See response to comment code 6120.

Commenter Name: Leslie Durs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2355

EPA Comment ID: 25053

EPA Comment Code: 6120

Comment: Dear EPA representative,

Please ensure our children are not exposed to perchlorate in our waters.

Thank you, Leslie Durs 128 E Ro semont Ave Alexandria VA 22301

Response: See response to comment code 6120.

Commenter Name: Jeannie Sharp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2356

EPA Comment ID: 25054

EPA Comment Code: 6120

Comment: Dear EPA,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 942 of 1099 Perchlorate is a dangerous chemical and I believe we should set a limit on it.

Jeannie Sharp 906 N. Overlook Dr. Alexandria, VA 22305

Response: See response to comment code 6120.

Commenter Name: Avis Rana Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2357

EPA Comment ID: 25055

EPA Comment Code: 6120

Comment: Portland, Oregon November 4, 2008

Environmental Protection Avenue NW Washington DC 20460

Re: Docket EPA-HQ-OW-2008-069 2 Drinking Water Preliminary Regulatory Determination

This letter is to request that your agency set a dr inking water standard for perchlorate, consistent with the legislation endorsed by the Senate Environment and Public Works Committee, and that you monitor levels of the chemical in tap water.

Perchlorate is a chemical in rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children. The maximum safe level now established in drinking water is 15 times higher than what the EPA declared safe in 2002. Under this new standard, more than 16 million Americans would be exposed to unsafe levels of perchlorate in their drinking water, placing

more than 16 million Americans at risk. Perchlor ate has been found in the drinking water in 35

states in the U.S.

I hope you will set a federal standard establishing sa fe levels for perchlorate in drinking water and will make provision for monitoring which will assur e that Americans can be assured their drinking water is free from this dangerous chemical.

Sincerely, Avis Rana

Response: See response to comment code 6120.

Commenter Name: Laura Milleker Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2358

EPA Comment ID: 25056

EPA Comment Code: 6120

Comment: Laura Milleker 112 A Askewton Rd S.P., M.D. 21146

Water Docket EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, D.C. 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 943 of 1099 Re Docket ID No. EPA-HQ-OW-2008-0692

I am writing to voice my strong opposition to not put regulations on perchlorate in drinking water.

Perchlorate contamination is a na tionwide problem. A national primar y drinking water regulation is needed to protect public health.

Sincerely, Laura Milleker

Response: See response to comment code 6120.

Commenter Name: Kathryn L. Jacobson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2359

EPA Comment ID: 25057

EPA Comment Code: 6120

Comment: Kathryn L. Jacobson 3306 Holly Street Alexandria, VA 22305

Water Docket Environmental Protection Agen cy Mailcode 2822T 1200 Pennsylvania Avenue Washington, D.C. 20460

ATTN: Docket ID No. EPA-HQ-OW-2008-0692

To Whom It May Concern:

I am writing regarding percholate contamination, which is a nationwide problem and has health impacts at lower levels than previously thought. Please reverse your previous decision and provide a national primary drinking water regulation to prevent percholate contamination and protect the public health.

Thank you for your attention.

Sincerely, Kathryn Jacobson

Response: See response to comment code 6120.

Commenter Name: Leslie Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2360

EPA Comment ID: 25058

EPA Comment Code: 6120

Comment: 11/24/08

To EPA Water Docket,

I am a Virginia voter. Perchlorate is a dangerous chemical found in 37 states. It gets into water and effects the health of children, so it should be regulated.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 944 of 1099 Sincerely, Leslie [illegible] 602 N. Pickett St Alexandria, Va 22304

Response: See response to comment code 6120.

Commenter Name: Lewis Tara Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2363

EPA Comment ID: 25059

EPA Comment Code: 6120

Comment: EPA Water Docket,

Please regulate perchlorate! I have two young girls an d would love to know that our water is as safe as possible!

Sincerely, Tara Lewis 522 E Luray Ave Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2364

EPA Comment ID: 25060

EPA Comment Code: 6120

Comment: Dear EPA

Please regulate perchlorate. This is a harmful substance with known substitutes.

[Illegible] 12 W. Rosemont Ave Alexandria, VA 22301

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0036

EPA Comment ID: 28336

EPA Comment Code: 6120

Comment: I support EPA including Perchlorate on the National Primary Drinking Water List. I am especially concerned that it is not included to date as a pregnant woman. Small changes in maternal thyroid hormone levels during pregnancy have be en associated with reduced IQs in children and high levels of perchlorate in the water could lead to mental retardation in children of mothers who consumed contaminated water. This is not just a health concern for fetuses and infants, but for anyone in our country suffering any kind of thyroid problems. Which considering how unhealthy Americans are, there are probably plenty of peopl e who suffer from thyroid issues. Perchlorate allowed in the drinking water will only d ecrease the health of our population.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 945 of 1099 California has already taken steps to regulate this contaminant, EPA should too. EPA guideline of 1 part per billion for its public drinking water standard should be enforceable, not just a recommendation. EPA should be protecting human health and the environment, not industry. I sincerely hope and pray that EPA will go back to its mission statement and ignore industry influences. Fight for us and the environment, regu late Perchlorate in the drinking water today!

Response: See response to comment code 6120.

Commenter Name: W. Cucinotta Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0038

EPA Comment ID: 28339

EPA Comment Code: 6120

Comment: d. EPA should regulate all exposures from these types of chemicals as we know little about the harm they cause when exposed to or mixed with different medicines or the multiple other chemicals in our bodies or in individual water sys tems. Because there is not enough data about our exposures to these chemical "soups" to assure pr otection for the American people and until there is more data assuring our safety from mixing perchlor ates with other drugs an d chemicals, EPA should aim to control all exposure.

Response: See response to comment code 6120.

Commenter Name: Kathryn Taylor Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0041

EPA Comment ID: 28340

EPA Comment Code: 6120

Comment: Please consider our lives and our health and set a reasonable limit to perchlorate in drinking water. Our lives and our future depend on you. Don't be swayed by those with money and power. You are in your position to protect others.

Sincerely, Kathryn Taylor

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0043

EPA Comment ID: 28341

EPA Comment Code: 6120

Comment: I live in NJ and already face a multitude of pollution issues, so I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 946 of 1099 Response: See response to comment code 6120.

Commenter Name: Deborah Roney Commenter Organization: Clean Water Action

EPA Document ID: EPA-HQ-OW-2009-0297-0045

EPA Comment ID: 28342

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billi on for perchlorate. Perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought;

To assist in keeping down health care costs to our country, protecting infants and children against this polutant is critical. A national primary drin king water regulation would provide a unique preemptive opportunity to protect public health. One that our government is responsible to do.

Thank you for taking action to protect our health and our economy.

Deborah Roney

Response: See response to comment code 6120.

Commenter Name: L. Obara Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0051

EPA Comment ID: 28343

EPA Comment Code: 6120

Comment: PLEASE KEEP PERCHOLATE OUT OF OUR DRINKING WATER! WE RELY

ON YOU TO SET HEALTHY STANDARDS FOR A LL OF US! Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyr oid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

Response: See response to comment code 6120.

Commenter Name: A.J. Melman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0058

EPA Comment ID: 28344

EPA Comment Code: 6120

Comment: Please regulate Perechlorate in drinking water. It does not belong in our water and it is your mandate to protect citi zens from contaminates in our public water supplies.

Response: See response to comment code 6120.

Commenter Name: C. ErnstEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 947 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0063

EPA Comment ID: 28345

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billi on for perchlorate. perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. a national pr imary drinking water regulation would provide a meaningful opportunity to protect public health. Why limit perchlorate?

Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 m illion people. Some estimates are even higher. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills

Response: See response to comment code 6120.

Commenter Name: Beth Appelbaum Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0064

EPA Comment ID: 28346

EPA Comment Code: 6120

Comment: Please take perchlorate out of our drinkiin g water! I already have thyroid issues and do not need any other problems nor want youing children to have issues. beth appelbaum

Response: See response to comment code 6120.

Commenter Name: Toula J. Halperin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0066

EPA Comment ID: 28347

EPA Comment Code: 6120

Comment: I urge the EPA to limit Perchlorate to 1 part per billion in our drinking water. This is especially important for the health and well being of young children. Yours sincerely, Toula J. Halperin 18 Watchung Road Short Hills, NJ 07078

Response: See response to comment code 6120.

Commenter Name: Samuel Fuller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0071

EPA Comment ID: 28348

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 948 of 1099 Comment: Dear EPA

Your job is to protect US citizens- and the envir onment. Given the article in today's Sunday NY Times your incompetence and inertia is inexcusable. Please wake up to the tragedy before you and ban rocket fuel from our drinking water.

Fr Samuel Fuller

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0072

EPA Comment ID: 28349

EPA Comment Code: 6120

Comment: Being a student of the medical field I can tell you that perchlorate must be limited and should NOT be in our drinking water in random am ounts! Please take whatever actions necessary to limit this highly effective and in large amounts, toxic substance in our country's drinking water supply.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0074

EPA Comment ID: 28351

EPA Comment Code: 6120

Comment: I believe we need to set a limit on the allocated amount of perchlorate in our country's drinking water. This chemical/ compound in known to be harmful to humans if ingested. We can not allow this problem to persist into the water s of our united states citizens any longer.

Response: See response to comment code 6120.

Commenter Name: J. Nadeau Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0086

EPA Comment ID: 28352

EPA Comment Code: 6120

Comment: Keep perchlorate out of my drinking water!

Response: See response to comment code 6120.

Commenter Name: Robert J. O'Connell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0092EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 949 of 1099 EPA Comment ID: 28354

EPA Comment Code: 6120

Comment: To Whom It May Concern: Please take action to STOP PERCHLORATE from entering our water systems. Recent studies seem to indicate that the threshhold levels at which

serious harm to a fetus and onset of mental retard ation, among other dangers, are lower than the originally predicted. Thank you for all you do to protect our health and our environment. Yours truly, Robert J.O'Connell

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0097

EPA Comment ID: 28355

EPA Comment Code: 6120

Comment: No rocket fuel in our drinking water!!

Response: See response to comment code 6120.

Commenter Name: B. Beckel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0112

EPA Comment ID: 28356

EPA Comment Code: 6120

Comment: Please set a minuscule amount of Perchhlor ate allowable in our drinking water. We believe reports that indicate many health problems and especially effects on the unborn from exposure to small amounts of Perchlorate. Now is th e time for us to take charge of how our societal penchant for war and the profits of war affect our environment.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0113

EPA Comment ID: 28357

EPA Comment Code: 6120

Comment: A national primary drinking water regulation would send a message to the rest of the world that the United States practices what it preaches, but more importantly woul dprotect this country's citizens. Therefore I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

Response: See response to comment code 6120.

Commenter Name: L. TouzeauEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 950 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0121

EPA Comment ID: 28359

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billi on for perchlorate. perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical.a national prim ary drinking water regulation would provide a meaningful opportunity to protect public health.

Why limit perchlorate? Perchlorate is a harmful ch emical that EPA claims has been found in 395 sites in 37 states, including 153 public water syst ems serving over 20 million people. Some estimates are even higher.Perchlorate, even in small amount s, can impair the thyroid gland, which controls growth, development and metabolism.Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

Response: See response to comment code 6120.

Commenter Name: L. Kier Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0123

EPA Comment ID: 28360

EPA Comment Code: 6120

Comment: Please keep percholate out of our drinking water. It is afffecting my thyrois and my daughter's speech.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0127

EPA Comment ID: 28362

EPA Comment Code: 6120

Comment: Please,I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate. Do it for your children

Response: See response to comment code 6120.

Commenter Name: B. Harris Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0135

EPA Comment ID: 28364

EPA Comment Code: 6120

Comment: Please keep perchlorate out of our drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 951 of 1099 Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #10 - Group Unidentified

EPA Document ID: EPA-HQ-OW-2009-0297-0039

EPA Comment ID: 28365

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought;

protecting infants and children is critical.a nati onal primary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: See response to comment code 6120.

Commenter Name: J. Capozzelli Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0088

EPA Comment ID: 28366

EPA Comment Code: 6120

Comment: The U.S. Environmental Protection Agency (EPA) has still not decided whether to set a drinking water standard, a limit for perchlorate, an ingredient in rocket fuel that is contaminating

water nationwide. Perchlorate is a harmful chemical that the EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills. I urge the U.S. Environmental Protection Agency to mo ve forward with a drinking water standard of no higher than one part per billion for perchl orate because berchlorate contamination is a nationwide problem and has health impacts at lo wer levels than previously thought. A national primary drinking water regulation would prov ide a meaningful opportunity to protect public health.Thank you.

Response: See response to comment code 6120.

Commenter Name: Noreen P. Cullen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0136

EPA Comment ID: 28367

EPA Comment Code: 6120

Comment: Dear Sir/Madam;EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 952 of 1099 Perchlorate has been shown to be dangerous to human health and should not be ingested by anyone, especially by children. We need to do everything we can to remediate the waters that currently contain perchlorate and do even more to prevent further intrusion of perchlorate into the waters in our country.

Noreen P. Cullen 30 Delmar Rd Glastonbury, CT 06033 noreen@faeryspirit.com

Response: See response to comment code 6120.

Commenter Name: D. Browder Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0140

EPA Comment ID: 28368

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate. - perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. - a national primary drinking water regulation would provide a meaningful opportunity to protect public health. If perchlorate is affecting the thyroid as substantially as indicated, it could also be contri buting to the obesity of our nation. It could be slowing down the metabolism for those who would ot herwise burn calories much more easily but because of a chemical issue going on in their body, it is slowed down significantly.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0146

EPA Comment ID: 28369

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of NO parts per billion for perchlorate.

- perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. - a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

I mean, think about it. This affects YOUR water too!

Response: See response to comment code 6120.

Commenter Name: Joe Parrish Commenter Organization: US Environmental Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0148

EPA Comment ID: 28370

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 953 of 1099 Comment: I very urgently ask the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher th an 1 part per billion for perchlorate.

Perchlorate contamination is a nati onwide problem and has health impacts at far lower levels than previously thought; without this protection, infants and children will be damaged.

Perchlorate in concentrations above 1 PPB will im pair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment will suffer mental retardation, loss of hearing and speech and deficits in motor skills.

A national primary drinking water regulation at 1 PPB for perchlorate is absolutely essential to protect public health.

Do not delay adopting this esse ntial limit for perchlorate.

Sincerely, Dr. Joe Parrish US Environmental Watch 300 E. 56th Street Suite 2B New York, NY

10022

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0152

EPA Comment ID: 28371

EPA Comment Code: 6120

Comment: As one who individually and whose children ha ve been severely negatively impacted by Agent Orange (Dioxin), I can not imagine how anyone could be persuaded to allow Perchlorate reach our drinking water.

Response: See response to comment code 6120.

Commenter Name: Susanne Emerick Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0155

EPA Comment ID: 28372

EPA Comment Code: 6120

Comment: It is time to pass safer water regs. Keep perchlorate out of our drinking water.

Susanne Emerick

Response: See response to comment code 6120.

Commenter Name: Albert A. Bartlett Commenter Organization: University of Colorado at Boulder

EPA Document ID: EPA-HQ-OW-2009-0297-0161EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 954 of 1099 EPA Comment ID: 28374

EPA Comment Code: 6120

Comment: Dear Friends,

Please do all you can to keep perchlorate out of the drinking water systems.

With thanks and best wishes, I am,

Sincerely yours, Albert A. Bartlett Professor Emeritus of Physics, University of Colorado at Boulder.

Response: See response to comment code 6120.

Commenter Name: Beth Robelia Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0162

EPA Comment ID: 28375

EPA Comment Code: 6120

Comment: To whom it may concern:

Please set a standard to limit perchlorate in water. Data indicates it is hazardous to human health and should not be consumed by children or preg nant women. Limiting consumption by setting limits seems the most prudent course of action.

Regards, Beth Robelia

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0168

EPA Comment ID: 28377

EPA Comment Code: 6120

Comment: No more than one part per billion of perchlorate in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0171

EPA Comment ID: 28378

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 955 of 1099 Response: See response to comment code 6120.

Commenter Name: Patrick Iannone Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0172

EPA Comment ID: 28379

EPA Comment Code: 6120

Comment: Dear Sirs/Madams,

As an industrial research scientist, I urge the U.S. Environmental Protection Agency to adopt a drinking water standard of no higher th an 1 part per billion for perchlorate.

As we've seen over the past decade or more, the lack of strict government oversight in critical areas (such as the public health, banking, etc) leads to ab uses by large corporations. Please continue your role in protecting infants and children from contaminated drinking water.

Regards, Patrick Iannone, Ph.D 146 Davis Lane Red Bank NJ, 07701

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0173

EPA Comment ID: 28380

EPA Comment Code: 6120

Comment: I urge the Environmental Protection Agency to set the drinking water standard for perchlorate to no more than 1 part /billion.

Although there are a number of he alth concerns with this chemical, I am especially concerned about the mischief it causes in thyroid function. As a federal government, we can take on the expenses of life-long medical care or we can fulfill our preem ptive responsibilities to protect American citizens from a lifetime of disability. Please be strong and say "no" to relaxed standards for Perc.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0174

EPA Comment ID: 28381

EPA Comment Code: 6120

Comment: I am a concerned citizen and would like to fa cilitate change in my world. I don't like being killed with pollution by people and companies th at are taking advantage of all of us. I have zero tolerance for pollution, greed and ignorance! Pl ease get help get our world livable again. Stop perchlorate in water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 956 of 1099 Response: See response to comment code 6120.

Commenter Name: Linc Cole Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0175

EPA Comment ID: 28382

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

Linc Cole 120 Cutlass Ln Cudjoe Key, FL 33042

Response: See response to comment code 6120.

Commenter Name: Bob Vaughan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0178

EPA Comment ID: 28383

EPA Comment Code: 6120

Comment: please set a national limit on the amount of the harmful chemical perchlorate allowed in our nation's drinking water.

thank you, Bob Vaughan Tampa,Florida

Response: See response to comment code 6120.

Commenter Name: R. Van Aken Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0180

EPA Comment ID: 28385

EPA Comment Code: 6120

Comment: The continual revelations regarding chemical s in our drinking water suggest we err on the side of caution regarding permissible limits. As we know the effects this chemical has on human beings I urge you to set the limit as low as feas ible to prevent serious the serious health problems possible from inadvertent consumption of this chemical.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0187

EPA Comment ID: 28386

EPA Comment Code: 6120

Comment: Please set a high standard for limiting this chemical in our drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 957 of 1099 Response: See response to comment code 6120.

Commenter Name: Maureen Lattimore Commenter Organization: Robert Bair Services

EPA Document ID: EPA-HQ-OW-2009-0297-0195

EPA Comment ID: 28388

EPA Comment Code: 6120

Comment: We need stronger legislation on keeping our water clean. There is only so much water and every day there is more data about that fact sh owing up and letting us know that the situation is getting worse. Please take strong action to keep our drinking water free of Perchlorate and other

hazardous chemicals.

Response: See response to comment code 6120.

Commenter Name: Peggi Sturmfels Commenter Organization: New Jersey Environmental Federation (NJEF)

EPA Document ID: EPA-HQ-OW-2009-0297-0204

EPA Comment ID: 28389

EPA Comment Code: 6120

Comment: I am a program organizer for NJ Envir onmental Federation as well as a mom and grandmother.

My deep concern about perchlorate in our waterways is growing. Particularly in regards to NJ which is now becoming a superfort by combining FT Di x, Mcquire Air Force Base and Lakehurst Navel Air Station. As a results, military air traffic has increased from 8000 to 80,000 over Centerl Jersey,

which is home to the headwaters of the Metedec onk and Toms River and the Kirkwood Cohansey aquifer that supply most of the drinking water for central and South Jersey. Added to that, this area is less than 50 miles in any direction from a major commercial airport.

Setting standards for perchlorate at one part per billion is the only reasonable action that can be taken protect the children and residents of this area. Sadly you may be too late.

Response: See response to comment code 6120.

Commenter Name: K. Cunningham Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0218

EPA Comment ID: 28391

EPA Comment Code: 6120

Comment: Gentlemen;

I have read for a number of years about the infilt ration of perchlorate mostly from some federal (or Federal contractor) facilities through ground wa ter or other discharges into surface waters. Perchlorate contamination is found (for example) in the Colorado River system and in irrigation andEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 958 of 1099 domestic water supplies drawing on it. Many of the California vegetables which millions of Americans enjoy have some perchlorate contaminat ion. People with some knowledge of chemistry often assume that perchlorate is, like sulfate, fair ly inert and innocuous at low concentrations. However, I understand that there is evidence that pe rchlorate has effects on thyroid health, even at sub-ppm concentrations, and it is known that its br omine analog, bromate, is to be avoided due to its toxic effects at low concentrations (one of th e reasons that ozonation is not a viable drinking water treatment when bromide ion is present). For these reasons, and because the sources of perchlorate contamination are fairly limited, I would ask that EPA begin to regulate this chemical more stringently in discharges and in drinking water supplies, perhaps down to the 1 ppb level in the latter. Thank you for your consideration of this opinion.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0223

EPA Comment ID: 28392

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

Perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical.

a national primary drinking water regulation wo uld provide a meaningful opportunity to protect public health.

5 years ago, I developed hypothyroidism. There is no family history of this. I know many others. I can't help but wonder if perchlorate in the water used to grow vegetables in the western U.S. states is partly responsible. At age 51, the health concerns for me are nothing compared to those of children exposed to this. Please take action to help protect our health. Thank You.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0234

EPA Comment ID: 28393

EPA Comment Code: 6120

Comment: Common sense dictates that we keep our water supplies clean of pollutants. Why is that so hard to commit to? Please keep perchlora te and other contaminants out of the water.

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 959 of 1099 Commenter Name: Nancy Kuecke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0238

EPA Comment ID: 28417

EPA Comment Code: 6120

Comment: I strongly recommend setting a limit NOW on the amount of perchlorate allowed in our drinking water!

Thank you for your time and effort.

Nancy Kuecke

Response: See response to comment code 6120.

Commenter Name: Merryl Gladstone Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0245

EPA Comment ID: 28419

EPA Comment Code: 6120

Comment: As a mother and a concerned citizen, I am writing in support of regulations restricting perchlorate in America's drinking water. It is dangerous and not what we as American citizen deserve in our drinking water. Listen to the scientific evidence and do write by people NOT industry. You are our voice.

Response: See response to comment code 6120.

Commenter Name: Patricia McPeak-La Rocca Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0255

EPA Comment ID: 28420

EPA Comment Code: 6120

Comment: I am a Certified Nurse- Midwife, and I write on behalf on pregnant women, their
unborn fetuses, babies, children, families and in dividual citizens,who do NOTwant the inclusion of any amount of perchlorate in our drinking water . We rely on the EPA to protect our water sources and prevent public health problems. This is a substance known to be harmful in the scientific literature. We must be willing to protect our most vu lnerable citizens who are not yet of age: babies

and children. This is also a case of The Precuat ionary Principal; safety must be proven and not

assumed.

I urge the U.S. Environmental Protection Agen cy to move forward and limit the amount of perchlorate in water to no greater than 1 part per billion.

Sincerely, Patricia McPeak- La Rocca, CNM Amherst, MAEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 960 of 1099 Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0256

EPA Comment ID: 28421

EPA Comment Code: 6120

Comment: I urge you to set regulations banning perchlorate of concentrations higher than 1 part per billion in drinking water. Perchlorate (even in sm all amounts) is linked to thyroid damage, which, in fetuses and children, can lead to intelligence disability (mental retardation), loss of hearing and speech, or motor impairment. It is unconscionable to allow the levels or perchlorate in drinking water to go unpunished and untreated.

Response: See response to comment code 6120.

Commenter Name: Walter McClure Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0265

EPA Comment ID: 28422

EPA Comment Code: 6120

Comment: On August 19, the U.S. Environmental Protection Agency (EPA) requested public comments related to setting a limit for perchlorate in drinking water. Last year EPA appeared poised

to announce that it would not set a limit but is now reviewing scientific and other information to make a decision about moving forward with a regulation now.

Why limit perchlorate. It is a harmful chemical th at EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism.

Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Nancy T. Miller Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0266

EPA Comment ID: 28423

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 961 of 1099 Comment: I urge the EPA to set a standard on perchlor ate of one part per billion to ensure safe drinking water for everyone. -- Nancy T. Miller, Winona MN

Response: See response to comment code 6120.

Commenter Name: Thomas Clark Commenter Organization: Clark Chiropractic Health Center, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0267

EPA Comment ID: 28424

EPA Comment Code: 6120

Comment: We must keep this and so many other chem icals out of our drinking water. We must move ahead towards more pure water, not "tolerable" levels.

Thomas Clark, D.C. St. Petersburg, FL

Response: See response to comment code 6120.

Commenter Name: Kathryn C. Westman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0268

EPA Comment ID: 28425

EPA Comment Code: 6120

Comment: As a concerned citizen and registered nurse, I feel it is important for the US EPA to set a limit on Perchlorate in public drinking water, limiiting it to a standard of no higher than 1 part/billion.

We must protect the population - especailly childre n and infants- from the impairment on the thyroid gland that higher limits might cause. Please take this step to protect our public health.

Sincerely, Kathryn C. Westman 104 S. Harleston Dr. Pittsburgh, PA 15237

Response: See response to comment code 6120.

Commenter Name: Susan van Asch van Wyck Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0275

EPA Comment ID: 28427

EPA Comment Code: 6120

Comment: We cannot understand why you would want to allow ANY perchlorate in our drinking water!! It is no wonder so many millions of Americ ans die of cancer. We are all at risk every day because of lax governmental control, as we had during the Bush years. Please do not extend these dangers during the Obama administration. Thank you.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 962 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0281

EPA Comment ID: 28428

EPA Comment Code: 6120

Comment: please keep perchlorate ou t of our drinking water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0282

EPA Comment ID: 28429

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

Health impacts of perchlorate are well documented and present serious problems, especially in

children and infants.

Another reason why I RO filter all my water. But not everyone does or can afford to do so.

Response: See response to comment code 6120.

Commenter Name: Karen Parelhoff Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0291

EPA Comment ID: 28431

EPA Comment Code: 6120

Comment: We need perchlorate-free drinking water. Please regulate this harmful chemical to no more than one parts to a billion for our drinking water. We look to you to take care of us and protect our health from harmful chemicals in our soil, water, and air.

Karen Parelhoff

Response: See response to comment code 6120.

Commenter Name: Elaine Kampmann Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0295

EPA Comment ID: 28432

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 963 of 1099 Comment: I can't really imagine why there is much to debate here. I don't know if the agency has gotten stuck in some bureacreatic muddle, but ou r drinking water is becoming more and more contaminated and is already non-potable in areas of my city because of tri-chlor, per-chlor, etc.

Keep it out of the water!!!!

Thank you, Elaine Kampmann 2531 Wilkinson Rd. Sarasota FL 34231

Response: See response to comment code 6120.

Commenter Name: Pamela Hosler Commenter Organization: Hawthorn Children's Psychiatric Hos pital, Missouri Department of

Mental Health

EPA Document ID: EPA-HQ-OW-2009-0297-0307

EPA Comment ID: 28435

EPA Comment Code: 6120

Comment: I urge the U.S. EPA to set a national limit on perchorlate in drinking water. It has been found in the public water systems that serve 20 million people. Small amounts affect the thyroid gland, which, in turn, can cause health problems.

A national standard allowing no more than 1 ppb pe rchorlate in drinking water would prevent many many health problems.

Response: See response to comment code 6120.

Commenter Name: Mark Knight Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0309

EPA Comment ID: 28437

EPA Comment Code: 6120

Comment: I urge EPA to move forward with an appropriate drinking water standard for perchlorate. The reason is simple: Perchlorate cont amination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical.

Mark Knight Arlington, VA

Response: See response to comment code 6120.

Commenter Name: Linda Jeub Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0316

EPA Comment ID: 28438

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 964 of 1099 Comment: The U.S. Environmental Protection Agency must move forward to protect our drinking water with a standard of no higher than 1 part pe r billion for perchlorate. How rocket fuel gets into our drinking water is beyond me.

From what I have heard, perchlorate contaminatio n is showing up nationally, and has health impacts at lower levels than previously thought putting infants and children at risk.

We are at a point in our environmental history th at requires paying attention to the basics and drinking water is about as basic as it gets. A na tional primary drinking water regulation would be a meaningful step in protecting public health.

Thank you, Linda Jeub

Response: See response to comment code 6120.

Commenter Name: Robert H. Michels Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0317

EPA Comment ID: 28439

EPA Comment Code: 6120

Comment: Please do not allow perchlorate into the drinking water in this country!!

Sincerely, Robert H. Michels 9 17-991-1367 rmichels57@yahoo.com

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0318

EPA Comment ID: 28440

EPA Comment Code: 6120

Comment: Please ensure that perchlorate is kept put of our drinking water. This is critical.

Response: See response to comment code 6120.

Commenter Name: Greg Black Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0320

EPA Comment ID: 28442

EPA Comment Code: 6120

Comment: About proposed regulations on Perchlorate in our water:

I am adamantly oppsed to allowing this chemical to continue to be dumped into my water. The U.S. Environmental Protection Agency should enforce a drin king water standard of no higher than 1 part per billion for perchlorate (I would prefer a more strick standard.).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 965 of 1099 Also, whant are we going to see some movement on Mercury Standards for coal powered plants?

We voted for change, and I want to see it now in EPS enforecement.

Most Sincerely,

Greg Black

Response: The issue of mercury standards for coal power ed plants is outside the scope of this action. For your comment on perchlorate, see response to comment code 6120.

Commenter Name: Pauline DiBella Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0321

EPA Comment ID: 28443

EPA Comment Code: 6120

Comment: Nobody wants rocket fuel in their drinking water.

Why limit perchlorate????

- Perchlorate is a harmful chemical that EPA cl aims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. - Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. - Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills.

Sample Letter

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

- perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. - a national primary drinking water regulation would provide a meaningful opportunity to protect public health. Please act now to regulate perchlorate and protect our water supply.

thank you.

Pauline DiBella Devon, Pennsylvania

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0330

EPA Comment ID: 28444EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 966 of 1099 EPA Comment Code: 6120

Comment: Please keep perchlorate out of drinking wa ter. The safety of the public is vital!

Response: See response to comment code 6120.

Commenter Name: A. Crane Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0331

EPA Comment ID: 28445

EPA Comment Code: 6120

Comment: Let's keep our water safe! Please! I recentl y attended an Herbalists Festival and the attendance was double what the organizers had ex pected and many of the attendees were there to learn about caring for the lymphatic system. If it is proven and known that the perchlorate found in rocket fuel is bad for the thyroid and causes birth defects and has been found in 37 states then I hope and pray you get busy on regulating the presence of this chemical in our water ways, all of
them - rivers, lakes, streams, wetlands and our city water systems. Who want s the rain to bring us cancer? I don't. Please work to stop the polluting , dumping and excess production of this hazardous substance. Thank you. Sincerely, A. Crane

Response: See response to comment code 6120.

Commenter Name: M. Dougherty Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0334

EPA Comment ID: 28446

EPA Comment Code: 6120

Comment: I am very concerned about Perchlorate contaminating our drinking water. Please set

standards to eliminiated this threat to our he alth and the health of future generations.

Response: See response to comment code 6120.

Commenter Name: Damon J. Brinson Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0340

EPA Comment ID: 28448

EPA Comment Code: 6120

Comment: I am writing to urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher th an 1 part per billion for perchlorate.

Perchlorate contamination of drinking water is a serious problem across our nation. The chemical impacts people's health at lower levels than previo usly thought. It is critical to protect infants and

children from this toxic chemical.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 967 of 1099 I firmly believe that a federal drin king water regulation, with a stan dard of <= 1 PPB of perchlorate, would protect public health. Please support this standard.

Thank you, Damon J. Brinson 4860 Dona Lane Golden Valley, MN 55422

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0346

EPA Comment ID: 28450

EPA Comment Code: 6120

Comment: Nobody wants rocket fuel in their drinking water.

Response: See response to comment code 6120.

Commenter Name: R. Oliver Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0347

EPA Comment ID: 28451

EPA Comment Code: 6120

Comment: Nobody wants rocket fuel in their drinking water.

Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills.

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

Response: See response to comment code 6120.

Commenter Name: R. Oliver Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0356

EPA Comment ID: 28453

EPA Comment Code: 6120

Comment: Nobody wants rocket fuel in their drinking water.

Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 milli on people. Some estimates are even higher.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 968 of 1099 Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills.

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

Response: See response to comment code 6120.

Commenter Name: G. Spring Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0361

EPA Comment ID: 28455

EPA Comment Code: 6120

Comment: Please. No perchlorate in our water. Water is life.

Response: See response to comment code 6120.

Commenter Name: K. Stote Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0366

EPA Comment ID: 28457

EPA Comment Code: 6120

Comment: Please don't allow perchlorate to be present in our drinking water without any limits, we need to set a maximum allowance amount. Do it for our future generations, cause once it's done, there's not a hell more we do to change it.

Thank you.

Response: See response to comment code 6120.

Commenter Name: W. Brunkhorst Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0375

EPA Comment ID: 28460

EPA Comment Code: 6120

Comment: The EPA has yet to set standards for perchora te,a component of aircraft fuel. It is critical to take action now,before perchlorate is detected in drinking water. Prevention is much cheaper than spending millions correcting a problem that is bound to occur.

Response: See response to comment code 6120.

Commenter Name: Susan Marie Frontczak Commenter Organization: Storysmith

EPA Document ID: EPA-HQ-OW-2009-0297-0377EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 969 of 1099 EPA Comment ID: 28461

EPA Comment Code: 6120

Comment: Thyroid impairment, mental retardation, loss of hearing and speech, and motor skill deficits are all problems that can result from perc hlorate contamination of drinking water. While the health care reform debate rages, let's make so me common sense choices so that fewer people need health care or disability income. I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Janice Church Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0378

EPA Comment ID: 28462

EPA Comment Code: 6120

Comment: Please make a scientific, not a political, decision regarding the allowable levels of percholate in our drinking water.

Your decision will impact your children, my child ren, and our grandchildre n. Please make your

decision based on the best scientific evidence availabl e. Please leave politics out of your equation as best you can.

Thank you. Janice Church New Tennessee resident

Response: See response to comment code 6120.

Commenter Name: Michael Rice Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0386

EPA Comment ID: 28463

EPA Comment Code: 6120

Comment: * Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. * Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. * Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills.

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.

* perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. * a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Thank you for hearing my concerns Sincerely, Michael RiceEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 970 of 1099 Response: See response to comment code 6120.

Commenter Name: Jeff Franklin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0388

EPA Comment ID: 28464

EPA Comment Code: 6120

Comment: Dear EPA,

Please make our water safe from Perchlorate. NO amount is truly safe. Please think about your children and grandchildren drinking the water you approve.

Be well, Jeff Franklin 720-570-2923

Response: See response to comment code 6120.

Commenter Name: L. Thorp Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0391

EPA Comment ID: 28465

EPA Comment Code: 6120

Comment: PLEASE KEEP ROCKET FUEL OUT OF OUR DRINKING WATER,I DON'T

WANT TO IMBIBE A GLASS OF IT AND "TAKE OFF" THANK YOU FOR YOUR

ATTENTION TO THIS MATTER

Response: See response to comment code 6120.

Commenter Name: R. Downing Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0396

EPA Comment ID: 28466

EPA Comment Code: 6120

Comment: The EPA should set a drinking water standard of no higher than 1 part per billion for perchlortae. This chemical does pose health risks and must be kept to a minimum.

Response: See response to comment code 6120.

Commenter Name: Sharon Biondi Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0401

EPA Comment ID: 28467

EPA Comment Code: 6120

Comment: Dear Sirs,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 971 of 1099 Please limit the chemical perchclorate in our water supplies to a safe level. The cumulative effect on our young and future generations is dangerous at the present level.

Thank you, Sharon Biondi

Response: See response to comment code 6120.

Commenter Name: Vorcelia Oliphant Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0410

EPA Comment ID: 28470

EPA Comment Code: 6120

Comment: Please do not permit these substances in our drinking water.

Thank you Vorcelia Oliphant

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0420

EPA Comment ID: 28472

EPA Comment Code: 6120

Comment: Please keep our water safe by eliminating use of perchlorate.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0435

EPA Comment ID: 28473

EPA Comment Code: 6120

Comment: Please no Perchlorate in our water supply. None.

Response: See response to comment code 6120.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.

EPA Document ID: EPA-HQ-OW-2009-0297-0528

EPA Comment ID: 28511

EPA Comment Code: 6120

Comment: From: Lenny Siegel To: Eric Burneson/DC/USEPA/US@EPA Cc: Andria Ventura Date: 09/18/2009 01:29 AM Subject: Re: Docket ID No. EPA-HQ-OW-2009-0297EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 972 of 1099 Eric,

Please find attached a letter from community activists across the country calling upon EPA to regulate perchlorate and set a standard protective of ALL Americans.

Lenny Siegel

--

Lenny Siegel Executive Director, Center for Public Environmental Oversight a project of the Pacific Studies Center 278-A Hope St., Mountain View, CA 94041 Voice: 650/961-8918 or 650/969-1545
Fax: 650/961-8918

http://www.cpeo.org

Attachment

September 4, 2009

Mr. Eric Burneson Office of Ground Water and Dr inking Water Standards and Risks Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW, Mailcode 2822T Washington, D.C. 20460

Re: Docket ID No. EPA-HQ-OW-2009-0297

Dear Mr. Burneson,

On behalf of our various organizations and ou r tens of thousands of members throughout the United States, we are writing to express our belief th at the potential health impacts from exposure to perchlorate through drinking water are signific ant and that they warrant prompt regulation to protect public health and safety. Setting a dr inking water standard will provide the U.S. Environmental Protection Agency (EPA) with a "m eaningful opportunity for health risk reduction for persons served by public water systems." Conse quently, EPA should move as quickly as possible to establish a more protective reference dose for perchlorate and then to promulgate a maximum contaminant level (MCL) for perchlorate that is no higher than one part per billion (ppb). We base this view on the scope of the contamination in dr inking water supplies, exposure of the American population through other pathways, including food, and the most recent scientific studies that
demonstrate serious health threats, even at low levels, to a larger portion of the population than previously recognized. These studies are based up on a much larger exposure data set than the studies upon which the current reference dose, and thus the entire regulatory regime, is based.

Response: Regarding "establishing a more protective reference dose for perchlorate," see response to comment code 2110. Regarding EPA's decision to regulate perchlorate, see response to comment

code 6120.

Commenter Name: Andria Ventura Commenter Organization: Clean Water Action et al.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 973 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0528

EPA Comment ID: 28517

EPA Comment Code: 6120

Comment: A perchlorate drinking water standard of no higher than 1 ppb would protect a large share of the American population currently at risk. Given the scope of the perchlorate contamination nationally, the multiple exposure pathways and other environmental contaminants impacting thyroid function and development, and the data demonstrating a serious health threat to a significant part of the country's population, EPA is obligated to establish such a drinking water standard. We applaud the agency's considerati on of how to move forward to regulate this contaminant and urge you to take steps to es tablish a protective MCL as soon as possible.

Sincerely,

Andria Ventura Program Manager Clea n Water Action San Francisco, CA

Lenny Siegel Executive Director Center for Public Environmental Oversight Mountain View, CA

Jeanne Rizzo, R.N. President Breast Cancer Fund San Francisco, CA

Debra Hall Founder Hopewell Junction Citizens for Clean Water Hopewell Junction, NY

Peter Strauss President PM Strauss & Associates San Francisco, CA

Pamela King Palitz Environmental Health Advocate and Staff Attorney Environment California San
Francisco, CA

Ansje Miller Policy Director Center for Environmental Health Oakland, CA

Jerry Bowling III Behr VOC Area Leaders Dayton, Ohio

Brian Moench, MD President Utah Physicians for a Healthy Environment

David W. Campbell Secretary-Treasurer USW Local 675 Carson, CA

Steven B. Pollack, Attorney Executive Dir ector Blue Eco Legal Council Northbrook, IL

Stephen M. Brittle Don't Waste Arizona Phoenix, AZ

Dvija Michael Bertish Rosemere Neig hborhood Association Vancouver, WA

Luis Olmedo Velez Executive Director Comi te Civico del Valle, Inc. Brawley, CA

Kent Slowinski Environmental Health Group Washington, D.C.

Laura Olah, Executive Director Citizens for Safe Water Around Badger Merrimac, WI

Miriam Torres Environmental Justice Coalition for Water Santa Monica, CAEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 974 of 1099 Chris Nidel, M.S., J.D. Nidel Law, PLLC

Jane Horton Mountain View, CA

Dave Ness, Jr Bayport, MN

John Yelenick SSAB - Rocky Mountain Arsenal Denver, CO

Stephanie Smolen Former resident San Gabriel Valley, CA

Barry Kissin, Esq. Member Fort Detrick Re storation Advisory Board Frederick, MD

Gail Shephard Norwalk, CA

Bruce Oldfield Professor, Geology Br oome Community College Binghamton NY

Bob Spiegel Executive Director Edison Wetlands Association Edison, NJ

Robert Stewart Rural Community Assistance Project Washington DC

Response: See response to comment code 6120.

Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28541

EPA Comment Code: 6120

Comment: October 7, 2009

Mr. Eric Burneson Office of Ground Water and Drinking Water Standards and Risks Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW, Mailcode 2822T Washington, D.C. 20460 Re: Dock et ID No. EPA-HQ-OW-2009-0297

Dear Mr. Burneson,

On behalf of The Alliance of Nurses for Healthy Environments, we are writing to express our belief that the potential health impacts from exposure to perchlorate through drinking water are significant and that they call for prompt regulation to protect the public's health and sa fety. Setting a drinking water standard will provide the U.S. Environmen tal Protection Agency (EPA) with a "meaningful opportunity for health risk reduction for persons se rved by public water systems". EPA should move as quickly as possible to establish a more pr otective reference dose for perchlorate and then to promulgate a maximum contaminant level (MCL) for perchlorate that is no higher than one part per billion (ppb).

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 975 of 1099 Commenter Name: Kathy Curtis Commenter Organization: Alliance of Nurses for Healthy Environments (ANHE)

EPA Document ID: EPA-HQ-OW-2009-0297-0651

EPA Comment ID: 28546

EPA Comment Code: 6120

Comment: A perchlorate drinking water standard of no higher than 1 ppb would protect a large share of the American population currently at risk. Given the scope of the perchlorate contamination nationally, the multiple exposure pathways and other environmental contaminants impacting thyroid function and development, and the data demonstrating a serious health threat to a significant part of the country's population, we beli eve EPA is obligated to establish such a drinking water standard. We applaud the agency's consideration of how to move forward to regulate this contaminant and urge you to take steps to es tablish a protective MCL as soon as possible.

We look forward to following the EPA response on this critical health issue.

Sincerely, Kathy Curtis and MaryJane Williams , RN, PhD Co-chairs, Policy Workgroup For the Alliance of Nurses for Healthy Environments

Response: See response to comment code 6120.

Commenter Name: Rebecca O'Donnell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0436

EPA Comment ID: 28581

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 pa rt per billion perchlorate, if that!

Sincerely, Rebecca O'Donnell Boyertown, PA

Response: See response to comment code 6120.

Commenter Name: Raymond Sowiak Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0440

EPA Comment ID: 28582

EPA Comment Code: 6120

Comment: I urge the EPA to adopt a limit of 1 PPB W perchlorate in U.S. drinking water. I understand recent studies show perchlorate to be more harmful than previously thought, especially to infants and young children. It may cause mental retardation, loss of hearing and speech, and poor development of motor skills.

EPA's own data show perchlorate to be present in drinking water in 37 states, including public water systems serving more than 20 million people.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 976 of 1099 I understand that perchlorate, like any harmfu l chemical, probably affects different people to different degrees, but I also believe the EPA should err on the conservative side until more data can be amassed regarding the effects of these chemic als on a decent statistical basis. Big business will always have powerful advocates and lobbyists pr esenting gloomy scenarios of high costs and dubious benefits, but who advocates for the average guy here in the U.S.?

Response: See response to comment code 6120.

Commenter Name: Ron Harden Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0441

EPA Comment ID: 28583

EPA Comment Code: 6120

Comment: It is imperative that our drinking water be protected in every possible way. It us unconsciensionable that perchlorate would be allowed to enter it, and unconsciensionable of an industry to seek to be able to place the com pound in ground water. Please issue the appropriate regulation to disallow perchlorate from being placed into our water supplies.

Response: Perchlorate is not being placed into wa ter systems. EPA has decided to regulate perchlorate. See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0445

EPA Comment ID: 28584

EPA Comment Code: 6120

Comment: Let's go! Complete this drinking water standard.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0446

EPA Comment ID: 28585

EPA Comment Code: 6120

Comment: Please set limits for perchlorate in drinking wa ter. It surprises me that it would even be considered not to have regulated and enforced standards to protect our citizens.

Thank you!

Response: See response to comment code 6120.

Commenter Name: Eva Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0453EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 977 of 1099 EPA Comment ID: 28586

EPA Comment Code: 6120

Comment: Dear Trusted employees at Environmen tal Protection Agency of the USA,

The citizens of this country trust you to analyze every single substance that comes at all in contact with our living environment, and to determine wh at amounts we can tolerate and still be healthy. We, including industry, needs to know that, so we can act accordingly.In your spare time you need to do that. But since you don't have any spare time ... then prioritize! and do the ones that are

obvious first!

Perchlorate is one of the very obvious ones that need to be done now! And please remember, that if you wait till a chemical is at the top of the priority lis t, then your analysis is more likely to be tainted by politics or industry pressures. It's better to get it done early, while no one is paying attention, so you can make a true impact analysis .... and please , always err on the side of human safety .... better to be safe than sorry. Thanks kindly ... we're counting on you to protect us. Eva in Denver, CO

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0466

EPA Comment ID: 28589

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a primary drinking water standard for perchlorate that priori tizes potential and proven risks to public health and ecosystems over risks to industries that use perchlorate.

Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher. Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearin g and speech or deficits in motor skills.

Response: See response to comment code 6120.

Commenter Name: Daniel Sullivan Commenter Organization: Foil The Three Productions

EPA Document ID: EPA-HQ-OW-2009-0297-0474

EPA Comment ID: 28590

EPA Comment Code: 6120

Comment: Keep this perchlorate, this ingredient of rocket fuel, out of people's drinking water. Everyone has a right to be uncontaminated, especially children, who need to develop well. This stuff can retard their ability to build a g ood life in this changing world.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 978 of 1099 Commenter Name: Donna Cirillo Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0475

EPA Comment ID: 28591

EPA Comment Code: 6120

Comment: To Whom It May Concern,

I don't understand what the debate is about. We k now that Perchlorate affects the thyroid, so limit it's usage. How many people need to be harmed before you take action?

Very concerned citizen. Donna Cirillo

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0476

EPA Comment ID: 28592

EPA Comment Code: 6120

Comment: Please take action to limit perchlorate in drinking water.

Nobody wants rocket fuel in their drinking wa ter. However, the U.S. Environmental Protection Agency (EPA) has still not decided whether to se t a drinking water standard - a limit - for perchlorate, an ingredient in rocket fuel that is contaminating water nationwide.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0479

EPA Comment ID: 28593

EPA Comment Code: 6120

Comment: Please Regulate our water more effectively and efficiently.

Response: See response to comment code 6120.

Commenter Name: Cici Hallberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0481

EPA Comment ID: 28594

EPA Comment Code: 6120

Comment: Please keep perchlorate out of our drinki ng water. It has been determined to be carcinogenic. We don't need any more contaminates in our drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 979 of 1099 Response: See response to comment code 6120.

Commenter Name: Belina Reisman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0483

EPA Comment ID: 28595

EPA Comment Code: 6120

Comment: Please protect us from another pollutant. Please set limits on percholate in our water.

Just today, I've come across two items that highlig ht our need to keep water safe and available, which requires regulatiion.

The first, a news article, addressed peoples' need for dental work due to the damaging pollutants in

the water.

The second was a documentary shown on TV - Flow: For the Love of Water. I came away from the show recognizing we need to work now for protection of our water resources.

Then, Clean Water Action sent me an email on the percholate issue.

Response: See response to comment code 6120.

Commenter Name: Lynn surname not provided Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0487

EPA Comment ID: 28596

EPA Comment Code: 6120

Comment: Please make sure that percholate does not g et into our water.It affects everyone. Keep

us safe.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0488

EPA Comment ID: 28597

EPA Comment Code: 6120

Comment: Please remain true to your name: the Environmental Protection Agency. That means something. This is not a conditional protection you offer, as in when you get special interest money to loosen controls, etc. You are charged with protecting the environment UNCONDITIONALLY. Please do your job. Keep our drinking water clean. Keep perchlorate out.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 980 of 1099 Commenter Name: Keitha Kinne Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0489

EPA Comment ID: 28598

EPA Comment Code: 6120

Comment: I strongly urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate. For too long we have put the interest of unbridled growth ahead of th e health of our people and our environment. We must recognize that we cannot continue down this path and the EPA must become a strong voice for preserving our environment.

It is evident that perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants an d children is critical. A national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Please take this important step to limit perchlor ate contamination. Respectfully yours. Keitha Kinne, 129 Picketts Ridge Road, Redding CT 06896

Response: See response to comment code 6120.

Commenter Name: William Connor Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0490

EPA Comment ID: 28599

EPA Comment Code: 6120

Comment: Please prohibit perchlorate out of potable water. Thank you

Response: See response to comment code 6120.

Commenter Name: Sasha Rickard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0503

EPA Comment ID: 28601

EPA Comment Code: 6120

Comment: Dear EPA,

I am strongly in favor of puting a standard of no mo re than 1 part per billion for perchlorate as it is a risk to public health.

Sincerely, Sasha Rickard

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 981 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0508

EPA Comment ID: 28602

EPA Comment Code: 6120

Comment: I ask you, please, U.S. Environmental Protection Agency, to put a limit on the amount of perchlorate in our drinking water to no higher than 1 part per billion.

The public, of all ages, deserves to have their heal th protected by drinking water that does not cause health problems. If we as citizens do not have our health, we do not have much at all.

Response: See response to comment code 6120.

Commenter Name: Barbara Mc Ellen Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0512

EPA Comment ID: 28603

EPA Comment Code: 6120

Comment: iam a single voter in bergen county new jersey who is recovering from cancer. please get the pollutants out of our water..including rocket fuel!!!!

Response: See response to comment code 6120.

Commenter Name: Ryan Tomazin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0520

EPA Comment ID: 28605

EPA Comment Code: 6120

Comment: I am an environmental protection science/chemistry graduate, and I constantly argued with professors, guests from ALCOSAN in Pittsbu rgh and everyone else that would listen about chemical levels in water and what was acceptable in drinking water. Water is essential to all life, and there should not be an acceptable level of rocket fu el in water. There should be NO rocket fuel, or PCBs or heavy metals, etc., in our water. The water authorities should not have to super- chlorinate our water, like it is in Pittsburgh, to give us someth ing that is essential to our life. Stand up and be the Environmental Protection Agency, and not th e Chemical Subsidiaries Protection Agency. You were supposed to be on our side. How many cancer deaths do we have in the US, compared to 30 or 50 years ago? Clean air and water is necessary, not optional. We are paying you, and this is what

we want.

Thank you for your time,

Ryan Tomazin Bridgeville, PA

Response: See response to comment code 6120.

Commenter Name: Alexandra Grabbe Commenter Organization: Chez Sven Bed & BreakfastEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 982 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0524

EPA Comment ID: 28606

EPA Comment Code: 6120

Comment: I run a green bed & breakfast in Wellfleet on Cape Cod and often comment about the state of water on our fragile sandbar. I am very wo rried about percholorate in water supplies, since I have traveled on airplanes that dumped rocket fuel into the ocean, and sincerely hope you will do something to control percholorate. Please set a st andard and improve regulations regarding drinking water in general. Thank you for your attention.

Response: See response to comment code 6120.

Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28607

EPA Comment Code: 6120

Comment: Dear Administrator Jackson,

Attached you will find an official statement from Food and Water Watch regarding EPA-HQ-OW2009-0297. Additionally, we have included over 6, 000 activist letters supporting our statement.

We urge you to make a national primary drinking water rule for perchlorate. EPA's failure to regulate perchlorate in drinking water places consum ers, especially children and pregnant women, at risk. We recommend that EPA use the regulation of perchlorate as an opportunity to protect our waterways and make our drinking water safe for all.

Thank you for your consideration,

Kathy Dolan Triclosan Campaign Advocate Food and Water Watch

Attachment

Administrator Jackson USEPA Headquarters Ariel Ri os Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460

September 18, 2009

Dear Administrator Jackson,

I am writing, on behalf of Food and Water Watch, to urge you to make a national primary drinking water rule for perchlorate.

Response: See response to comment code 6120.

Commenter Name: Kathy Dolan Commenter Organization: Food and Water Watch (FWW)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 983 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28612

EPA Comment Code: 6120

Comment: The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroid glands iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive

effects for those affected.

EPA's failure to regulate perchlorate in drinking water places consumers, especially children and pregnant women, at risk. We urge the EPA to consider the regulation of perchlorate as an opportunity to protect our waterways and make our drinking water safe for all.

Sincerely,

Kathleen Dolan Triclosan Campaign Advocate

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0535

EPA Comment ID: 28613

EPA Comment Code: 6120

Comment: I have lived on the "space coast" for over 40 years. I have an immune illness and

wonder how much all those launches and resulti ng rocket fuel in my air and water may have contributed to my chronic illness. I will never have good health again. I don't want others to go through this miserable life. We must clean our air and water and this includes getting perchlorate out

of our environment.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28614

EPA Comment Code: 6120

Comment: Administrator Jackson USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460

September 18, 2009

Dear Administrator Jackson,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 984 of 1099 I am writing, on behalf of Food and Water Watch, to urge you to make a national primary drinking water rule for perchlorate.

Perchlorate has been found in the drinking water supply of 35 states and the District of Columbia. Widespread human exposure to perchlorate was co nfirmed by the Center for Disease Control's NHANES study, which found that 100 percent of the 2,820 randomly selected study participants had detectable levels of perchlorate in their ur ine. And according to your request for comment notice, dated August 5, 2009, the number of people served by water contaminated with high levels of perchlorate ranges between 53.4 and 16.8 million people.

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #11 - Food and Water Watch

EPA Document ID: EPA-HQ-OW-2009-0297-0526

EPA Comment ID: 28618

EPA Comment Code: 6120

Comment: The widespread exposure of the population to some level of perchlorate raises serious health concerns. Perchlorate can inhibit the thyroid glands iodine uptake, potentially leading to hypothyroidism. Severe hypothyroidism during pregnancy can lead to abnormal fetal cognitive development, and even mild hypothyroidism during pregnancy is associated with subtle cognitive defects in children. Thus, perchlorate could alter f etal brain development, having lifelong cognitive

effects for those affected.

EPA's failure to regulate perchlorate in drinking water places consumers, especially children and pregnant women, at risk. We urge the EPA to consider the regulation of perchlorate as an opportunity to protect our waterways and make our drinking water safe for all.

Response: See response to comment code 6120.

Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28710

EPA Comment Code: 6120

Comment: Metropolitan's Concerns

Perchlorate contamination entering the Colorado Ri ver from the Las Vegas Wash area represents the largest extent of perchlorate contamination in the country. Water from the Colorado River downstream of the Las Vegas Wash supplies drin king water for over 23 million people throughout Nevada, California, and Arizona. Any effort to regulate perchlorate would ensure some degree of public health protection for this source of water su pply. Metropolitan believes that federal regulation of perchlorate would provide a meaningful opportunity for health risk reduction for the public water systems as described in the Safe Drinking Water Act.

Response: See response to comment code 6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 985 of 1099 Commenter Name: Mic Stewart Commenter Organization: Water Quality Section, Metropolitan Water District of Southern

California

EPA Document ID: EPA-HQ-OW-2009-0297-0496

EPA Comment ID: 28714

EPA Comment Code: 6120

Comment: Since the 1996 amendments to the Safe Drin king Water Act, no new contaminant has met EPA's three criteria for national primary drinki ng water regulation. Metropolitan believes that a determination by EPA not to regulate perchlora te in drinking water could adversely influence cleanup efforts along the Colorado River and other contaminated sites.

Metropolitan appreciates this opportunity to pr ovide comments on scientific approaches to analyzing scientific data related to perchlorate in drinking water and requests that EPA carefully consider these comments. Please contact me at (213 ) 217-5696 if you have any questions, or if I can provide additional information.

Very truly yours, Mic Stewart, Ph. D. Manager, Water Quality Section

Response: See response to comment code 6120.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28737

EPA Comment Code: 6120

Comment: The Network believes that the potential health impacts from exposure to perchlorate through drinking water are significant and that th ey warrant prompt regulation to protect public health and safety. Setting a drinking water stan dard will provide the U.S. Environmental Protection Agency (EPA) with a "meaningful opportunity for heal th risk reduction for persons served by public water systems".

Consequently, EPA should move as quickly as possible to establish a more protective reference dose for perchlorate and then to promulgate a maximum contaminant level (MCL) for perchlorate that is no higher than one part per billion (ppb). We base this view on the scope of the contamination in drinking water supplies, exposure of the Americ an population through other pathways, including
food, and the most recent scientific studies that demonstrate serious health threats, even at low levels, to a larger portion of the population than previously recognized. These studies are based upon a much larger exposure data set than the st udies upon which the current reference dose, and thus the entire regulatory regime, is based.

Perchlorate has been found in more than 400 dr inking water sources in 26 states, potentially affecting tens of millions of peopl e. EPA’s own data say that nearly 17 million people receive their water from public water systems where perchlorate has been found at levels exceeding 4 ppb. Were sampling routinely conducted with a detection limit of 1 ppb, that number would be much higher-EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 986 of 1099 particularly considering the estimated 20 million pe ople in the Southwest who receive drinking water

from the Colorado River.

Response: See response to comment code 6120.

Commenter Name: Nsedu O. Witherspoon Commenter Organization: Children's Environmental Health Network

EPA Document ID: EPA-HQ-OW-2009-0297-0674

EPA Comment ID: 28742

EPA Comment Code: 6120

Comment: A perchlorate drinking water standard of no higher than 1 ppb would protect a large share of the American population currently at risk. Given the scope of the perchlorate contamination nationally, the multiple exposure pathways and other environmental contaminants impacting thyroid function and development, and the data demonstrating a serious health threat to a significant part of the country's population, EPA is obligated to establish such a drinking water standard. We applaud the agency’s considerati on of how to move forward to regulate this contaminant and urge you to take steps to es tablish a protective MCL as soon as possible.

Sincerely,

Nsedu O. Witherspoon, MPH Executive Director

Response: See response to comment code 6120.

Commenter Name: Dan Delventhal Commenter Organization: MowGreen.US

EPA Document ID: EPA-HQ-OW-2009-0297-0270

EPA Comment ID: 28758

EPA Comment Code: 6120

Comment: Folks, we have to be proactive and precautionary and stand up as stewards to protect the masses from poisons in the air and water we survive on. You know the links to disease and reproductive related compromises. It would retarded to fail to prevent retardation in future generations. Limit Perchlorate!

Response: See response to comment code 6120.

Commenter Name: Karen Ceci Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0287

EPA Comment ID: 28759

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate. Please give our children and their children a chance at a healthy life.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 987 of 1099 Karen Ceci 11 Chalfont Rd Chalfont, PA 18914

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0536

EPA Comment ID: 28760

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billi on for perchlorate. Perchlorate contamination is a nationwide problem and has health impacts.

The US needs national primary drinking water regu lations to protect public health not only from perchlorate but from chemicals used in hydraulic fr acturing and other industrial practices currently unregulated as a result of the Bush administrati on. The EPA MUST take action NOW--what in the world are you waiting for? Surely in this administration the PEOPLE have rights to health?

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. Regarding the need for drinking water regulations for contaminants used in hydraulic fracturing and other industrial practices, a respons e is not necessary because it is outside of the scope of this action.

Commenter Name: Rita Valent Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0547

EPA Comment ID: 28761

EPA Comment Code: 6120

Comment: I can't think of any reason why perchlorate shou ldn't be limited. Of course it should be limited...it's dangerous, it hurts people. What other reason do we need?

Response: See response to comment code 6120.

Commenter Name: John M. Huff Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0549

EPA Comment ID: 28763

EPA Comment Code: 6120

Comment: I strongly request that the U.S. Environmen tal Protection Agency proceed with setting the drinking water standard for perchlorate at no high er than 1 part per billion, for the best interests of public health, particularly on behalf of infants and children. Thank you.

Response: See response to comment code 6120.

Commenter Name: Myrna PotichaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 988 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0552

EPA Comment ID: 28764

EPA Comment Code: 6120

Comment: Please act vigorously to curtail the level of perchlorate in drinking water. Our drinking water supplies should be maintained at the highes t level of purity, and exotic substances such as perchlorate have no place there, unless and until th ey are absolutely proven to be safe.Myrna Poticha

Colorado

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0559

EPA Comment ID: 28766

EPA Comment Code: 6120

Comment: Rocket fuel: KEEP IT OUT OF OUR WATER SUPPLIES!!!

Response: See response to comment code 6120.

Commenter Name: Kevin Hammond Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0560

EPA Comment ID: 28767

EPA Comment Code: 6120

Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate.

perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical.a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Although I am not sure if 1 ppb (part per billion) is a realistic level, the current level of air travel is only increasing warranting serious review of safe levels . We owe it to our children (and their's) to, at the very least, set a realistic regulatory level th at is 1.) not cost-prohibitive, 2.) safe and 3.)

maintainable.

Thank you for attention to this matter.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0563

EPA Comment ID: 28769EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 989 of 1099 EPA Comment Code: 6120

Comment: Perchlorate, like all other man-made substances , should be filtered from all public water

systems.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0567

EPA Comment ID: 28770

EPA Comment Code: 6120

Comment: eriously limit perchlorate in water, please. Thank you.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0574

EPA Comment ID: 28772

EPA Comment Code: 6120

Comment: please remove perchlorate from our drinking water keep our children safe from harm

Response: See response to comment code 6120.

Commenter Name: Carol Leventhal Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0583

EPA Comment ID: 28773

EPA Comment Code: 6120

Comment: It is inconceivable that the United States wa ter supply is contaminated by perchlorate, to a degree that threatens health and well being. Please reduce perchlorate in the water to no more than 1 part per billion.

Carol Leventhal 9219 Manchester Road Silver Spring, MD. 20901

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0584

EPA Comment ID: 28774

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 990 of 1099 Comment: I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate. * perchlorate contamination is a nationwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical. * a national pr imary drinking water regulation would provide a meaningful opportunity to protect public health.

Recently, a defense analysis postulates that the wo rld will be competing for water resources. in the light of this we cannot afford to further pollute our sources of fresh water with any more chemicals. Further we must hold the polluters responsible for any cleanup of known harmful chemicals in our water supplies.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0585

EPA Comment ID: 28775

EPA Comment Code: 6120

Comment: Perchlorate in drinking water is a public health problem.Even in small amounts, it can impair the thyroid gland, which controls growth, development and metabolism. Developing fetuses, infants and children with thyroid impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

I urge the U.S. Environmental Protection Agency to establish and enforce a drinking water standard for perchlorate of no higher than 1 part per billion.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0591

EPA Comment ID: 28776

EPA Comment Code: 6120

Comment: Bearing in mind the mission the EPA should stri ve to fulfill: protecting our air, soil, and water......I implore you to determine how the perchl orate is contaminating our water and to stop it.If stopping it is too lofty a goal for now, please limit the amount we are unknowingly exposed to every day. That's why we have your de partment - to protect citizens.

Response: See response to comment code 6120.

Commenter Name: Cathy Ellis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0597

EPA Comment ID: 28777

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 991 of 1099 Comment: I urge the Federal government to set a perc olate standard of no more than 1 part per billion. Clean drinking water should be a right of every American. Contaminants hurt the smallest and weakest the most and can be very harmful to fetuses and infants. These helpless citizens need the government to protect them over before it pr otects the rights of corpor ate America. Cathy Ellis West Chazy, NY

Response: See response to comment code 6120.

Commenter Name: Jim Tate Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0607

EPA Comment ID: 28779

EPA Comment Code: 6120

Comment: EPA: Please establish a standard for the volume of perchlorate permitted in our drinking water. And it should be extrememly low! Enough scientific data exist to convince EPA that perchlorate is hazardous to the health of anyone living in the US.

Response: See response to comment code 6120.

Commenter Name: Neeka Stanley Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0611

EPA Comment ID: 28781

EPA Comment Code: 6120

Comment: I drink tap water and I don't want a dose of perchlorate with it! It's a ridiculous waste to buy bottled water- I need my tap water to be sa fe and clean. I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part per billion for perchlorate. I work with kids with special needs and see the constant strain it puts on the kids, their families, and our community as we care for these kids. We need to do everything we can to limit exposure to toxic chemicals that could lead to even more kids with special needs. Thank

you.

Response: See response to comment code 6120.

Commenter Name: Joanne R. Hand Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0613

EPA Comment ID: 28782

EPA Comment Code: 6120

Comment: As a concerned citizen and supporter of Clean Water action I want to express my concern that the EPA limit the levels of perchlora te in drinking water to a standard of no higher than 1 part per billion for perchlorate

Joanne R. Hand 41 Gregory Te rrace Bloomfield New Jersey 07003EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 992 of 1099 Response: See response to comment code 6120.

Commenter Name: James Griffin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0618

EPA Comment ID: 28783

EPA Comment Code: 6120

Comment: I am writing to condemn the idea of allowing perchlorate in drinking water. In considering standards for water purity I urge you disallow this carcinogen in our water.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0619

EPA Comment ID: 28784

EPA Comment Code: 6120

Comment: However, the U.S. Environmental Pro tection Agency (EPA) has still not decided whether to set a drinking water standard - a limit - for perchlorate, an ingredient in rocket fuel that is contaminating water nationwide.

Clean Water Action members can help make sure the EPA takes action to limit perchlorate in drinking water.

On August 19, the U.S. Environmental Protection Agency (EPA) requested public comments related to setting a limit for perchlorate in dr inking water. Last year EPA appeared poised to

announce that it would not set a limit but is now re viewing scientific and other information to make a decision about moving forward with a regulation now.

Why limit perchlorate?

Perchlorate is a harmful chemical that EPA claims has been found in 395 sites in 37 states, including 153 public water systems serving over 20 million people. Some estimates are even higher.

Perchlorate, even in small amounts, can impair the thyroid gland, which controls growth, development and metabolism.

Developing fetuses, infants and children with thyroi d impairment may suffer mental retardation, loss of hearing and speech or deficits in motor skills.

Sample Letter

I urge the U.S. Environmental Protection Agency to move forward with a drinking water standard of no higher than 1 part pe r billion for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 993 of 1099 perchlorate contamination is a na tionwide problem and has health impacts at lower levels than previously thought; protecting infants and children is critical.a national primary drinking water regulation would provide a meaningful opportunity to protect public health.

Response: This is not a comment, a response is not needed.

Commenter Name: Lucy Rogers Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0621

EPA Comment ID: 28785

EPA Comment Code: 6120

Comment: Keep perchlorate out of our drinking water.

Response: See response to comment code 6120.

Commenter Name: Barbara B. Tacy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0623

EPA Comment ID: 28786

EPA Comment Code: 6120

Comment: To Whom It May Concern; As an individual liv ing in a highly populated area I am very aware of the critical need to pr otect what clean water we have left . Please act now to restrict the introduction of perchlorate into all of our wa ter systems. Thank you, Dr. Barbara B. Tacy

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0624

EPA Comment ID: 28787

EPA Comment Code: 6120

Comment: make this happen, we should not have to drink this

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0629

EPA Comment ID: 28788

EPA Comment Code: 6120

Comment: I don't understand how it is acceptable fo r any perchlorate to be in any water in America. I do not feel that the government has the people's best interest in mind when they allow these chemicals into homes. During the presidential campaign, I noticed there was a lot of talk about preventative care for health. I feel this goes in wi th that. If we were to take care of the roots ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 994 of 1099 sickness and disease, then the tree would die off as well. The government has a responsibility to the people of America, and I feel that it is about ti me that the government steps up and fulfills those responsibilities.

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0630

EPA Comment ID: 28789

EPA Comment Code: 6120

Comment: I don't understand how it is acceptable for an y amount of perchlorate to be in any water in America. During the presidential campaign, ther e was a lot of talk about preventative care. If we prevented the public from consuming harmful chemical, we would also be preventing the public from becoming ill. The government has a responsibility to the American people. I think it is about time the government steps up and fulfills those responsibilities.

Response: See response to comment code 6120.

Commenter Name: Brad Heinz Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0631

EPA Comment ID: 28790

EPA Comment Code: 6120

Comment: From 1962-1977, I was raised in West Covin a, California, a city whose drinking water supply was later determined to be contaiminiated by perchlorate. In late 1977, after I left for college, I was diagnosed with thyroid disease. The disease made it very difficult to pu rsue my studies, forcing me to drop classes. It also significantly intefered with my social integration during my freshman year. When later I learned about the contamination of the water supply in West Covina, I was angry to think how that might have contributed to the disease. It wrecked my life for the period leading up to diagnosis and treatment. I'm still c oncerned about the longterm health effects. Please strictly regulate this chemical in our drinking water.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28792

EPA Comment Code: 6120

Comment: September 19, 2009

U.S. Environmental Protection Agency Offi ce of Water Docket (Mailcode: 2822T) 1200 Pennsylvania Avenue, NW Washington, DC 20460EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 995 of 1099 Submitted via www.regulations.gov

Comments from the NATURAL RESOURCES DEFENSE COUNCIL

on the Drinking Water: Perchlorate Supplemental Request for Comments

Docket EPA-HQ-OW-2009-0297 Fede ral Register / Vol. 74, No. 159/ Wednesday, August 19,

2009

SUMMARY

On August 19, 2009, the U.S. Environmental Pr otection Agency (EPA) issued a Federal Register (FR) notice[FN1: 74 Fed. Reg. 41883 (August 19, 2009).] re questing comments on additional approaches to analyzing data related to its perc hlorate preliminary determination as detailed in its October 10, 2008 FR Notice.[FN2: 73 Fed. Reg. 60 262 (October 10, 2008).] In that previous notice, EPA made a preliminary regulatory determinati on not to set a health-protective standard for perchlorate in drinking water.[FN3: Id.] It st ated, "The Agency has determined that a national primary drinking water regulation (NPDWR) for perchlorate would not present 'a meaningful opportunity for health risk reduction for persons se rved by public water systems.'" EPA also proposed a health reference level (HRL) of 15 parts per billion (ppb) as the maximum contamination level of perchlorate that could be in drinking water and still keep daily human consumption levels from exceeding the reference dose (RfD) of 0.7 ug/kg/day.

In response to the October 10, 2008 FR notice, NR DC provided comments to EPA concluding that EPA's determination was legally flawed. EPA must re gulate a contaminant if it may have an adverse
effect on human health, if it is known to occur (or there is a substantial likelihood that the contaminant will occur) in public water systems wi th a frequency and at levels of public health concern; and if its regulation would present a meaningful opportunity for health risk reduction for persons served by public water sy stems.[FN4: 42 U.S.C. [Sec] 300g-1 (b)(1)(A).] For perchlorate, each of these three requirements are met, and therefor e, underscore the need for EPA to regulate its presence in drinking water. First, EPA's prelimin ary regulatory determination acknowledges that perchlorate may adversely affect human health.[FN5: 73 Fed. Reg. 60275 (Oct. 10, 2008).] Second, as explained in more detail below, despite EPA's contention, perchlorate is known to contaminate the drinking water systems serving millions of pe ople at levels where adverse human health effects occur. And third, setting an appropriately stringent MCL will lead to lower levels of perchlorate ingested by hundreds of thousands of infants, children, and pregnant women, thereby offering a concrete and meaningful reduction in human health risks.

The U.S. population is about 300 million people with about 6.8%, or 20 million, under 5 years old.
Therefore, based on EPA estimates that 16.6 million people are served by public water system with at least one detection of perchlorate over 4 ppb, th ere are, therefore, likely more than one million children in each year of life (from zero to five) who may be exposed to perchlorate levels that may adversely affect their health.[FN6: This value is derived by multiplying 1 6.6 million by 0.068. Please see below for further explanation about the appropriate perchlorate level to set for the health reference level.] Thus, the evidentiary record does not support EPA's proposed determination. Rather, the evidentiary record makes clear that regulating these exposures do represent "a meaningful opportunity for health risk reduction for persons served by public water systems."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 996 of 1099 Based upon the evidence in the record, as discussed in greater detail below, NRDC urges EPA to reverse course, and set a national primary drinking water standard for perchlorate that is protective of sensitive sub-populations. EPA should not set a HRL at 15 ppb; rather, given the most current data available, NRDC believes that to truly pro tect the public health, EPA should set an enforceable maximum contaminant level (MCL) as authorized by the Safe Drinking Water Act below 1 ppb.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28796

EPA Comment Code: 6120

Comment: NRDC strongly objected to EPA's preliminary determination not to regulate perchlorate

because the conclusions are not ba sed on a comprehensive review of the best available science (as explained in more detail below) and are not suppor ted by the PBPK model findings, or by EPA's expert scientific advisors on the Children's Health Protection Advisory Committee.[FN23: Letter from Melanie Marty to Administrator Johnson rega rding Preliminary Regulatory Determination on Perchlorate (November 3, 2008, PDF) http://yosemite.epa.gov/ochp/ochpweb.nsf/c ontent/perchlorateletter.htm/$file/Per chlorateLetter.pdf] In fact, drinking water that is contaminated with perchlorate at the proposed HRL of 15 ppb would leave infants and young child ren exposed to excessive and unsafe levels of

this toxic chemical.

Response: See response to comment ID 20988 under comment code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28812

EPA Comment Code: 6120

Comment: ADDITIONAL COMMENTS

Regulating Perchlorate Represents a Meanin gful Opportunity for Health Risk Reduction

NRDC notes that there is enough information for the Agency to make a final regulatory determination to promulgate a national primary dr inking water standard for perchlorate. The evidence about the impact of perchlorate contamina ted drinking water shows that it satisfies the requirements for promulgating a drinking water st andard under the Safe Drinking Water Act: (1) perchlorate is know to have an adverse effect on th e health of persons; (2) perchlorate is known to occur in public water systems with a frequency an d at levels of public health concern, and (3) regulating perchlorate presents a meaningful opportunity for health risk reduction for persons served by public water systems. Therefore, EPA should set an MCL for perchlorate, rather than focus on setting an HRL.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 997 of 1099 In its October 10, 2008 preliminary determination not to regulate perchlorate, EPA acknowledged that perchlorate could have an adverse effect on human health.[FN65: 73 Fed. Ref. at 60275.] Second, based on just quarterly or semi- annual sampling along, EPA showed that 4 percent of drinking water systems have detections of perchl orate over 4 ppb. As explained in further detail below, this occurrence exposes hundreds of thousands of pregnant women, children, and infants to dangerous levels of perchlorate, giving rise to a public health concern.

In October, 2008, EPA determined that up to 28 ,000 pregnant women would be exposed to more than 15 ppb of perchlorate. However, at that time , EPA stated that reducing the risk that 28,000 pregnant women would be exposed to perchlora te would not provide a meaningful opportunity to

reduce health risks.

What that October 2008 announcement failed to ex plain is that EPA's own staff experts have provided data to show that at the proposed HRL of 15 ppb, infants and children would consume perchlorate on a daily basis that exceeded the reference dose.

As explained above, EPA's proposed model shows that there are over one million children under 5 years old who would exceed the daily reference dose; this is likely an underestimate of the highly exposed.

As noted above, NRDC believes that any amount of perchlorate in drinking water over 1 ppb may have adverse health impacts on vulnerable popula tions, meaning EPA's estimate of the number of pregnant women who would be exposed to excessi ve perchlorate would be much higher than 28,000. In fact, based on EPA's estimate, over 200,000 pregnant women could be exposed to perchlorate contamination over 4 ppb (the maximum d etection limit identified in EPA's estimates). As such, by any measure, a regulation that could protect up to over 200,000 pregnant women and a million children and infants would give rise to a meaningful opportunity to protect public health.

Response: See response to comment code 6120.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28816

EPA Comment Code: 6120

Comment: CONCLUSION

EPA should amend its preliminary determinati on on perchlorate. EPA should determine to promulgate a national primary drinking water standa rd for perchlorate, to protect public health. Existing data on perchlorate exposure and e ffects, especially on vulnerable subpopulations, demonstrates that setting a national primary drinki ng water standard for perchlorate would provide a meaningful opportunity for health risk reduction. EP A is therefore required to set such a standard under the Safe Drinking Water Act.

Furthermore, a maximum contaminant level below 1 ppb would afford reasonable protections to the health of the susceptible populations of pr egnant women and breast-fed infants.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 998 of 1099 Response: See response to comment code 6120.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28908

EPA Comment Code: 6120

Comment: NJ Environmental Protection's comment.

If problem looking, please call 609-292-5550, Heather Hansberry

Attachment

September 18, 2009

Water Docket Environmental Protection Agency Ma il Code: 2822T 1200 Pennsylvania Ave, NW Washington, DC 20460 RE: Dock et ID No. EPA-HQ-OW-2009-0297

To Whom It May Concern:

Thank you for the opportunity to provide co mments on USEPA's notice, "Drinking Water: Perchlorate Supplemental Request for Comments," wh ich was published in the Federal Register of August 18, 2009 (74 Fed. Reg. 41883-41893). On March 16, 2009, the New Jersey Department of Environmental Protection (NJDEP) proposed a drinking water Maximum Contaminant Level (MCL) of 5 ug/L, including monitoring and comp liance determination requirements, in accordance with the 2005 recommendation of the New Jersey Drinking Water Quality Institute (NJDWQI), a legislatively created advisory body. The NJDEP belie ves that having an MCL for perchlorate will be beneficial to public health both in New Jersey and in the country as a whole.

In comments submitted on November 10, 2008, we urged USEPA to reconsider its October 10, 2008 proposed determination to not regulate perchl orate in drinking water. Our comments stressed that USEPA's proposed Health Reference Level (HRL) of 15 ug/L is not pro tective of infants, who are a sensitive population for perchlorate's effects on thyroid function. We also commented that the occurrence analysis presented was flawed because it s use of an inappropriately high concentration, 15 ug/L, greatly reduced the size of the population predicted to be expos ed at levels of public health concern. We commend USEPA for its current decision to reconsider its proposal not to regulate perchlorate, based on the comments subm itted by us and by many others.

Response: This is not a comment, a response is not necessary.

Commenter Name: Jeanne Herb Commenter Organization: New Jersey Department of Environmental Protection (NJDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0527

EPA Comment ID: 28917

EPA Comment Code: 6120EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 999 of 1099 Comment: We also strongly urge USEPA to reconsider its determination to not regulate perchlorate. The NJDEP (2009) proposed rule rega rding the regulation of perchlorate in drinking water can be found at http://www.nj.gov/dep/rules/proposals/031609a.pdf. The New Jersey Drinking Water Quality Institute (2005) recommend ations regarding perchlorate can be found at http://www.nj.gov/dep/watersupply/perchlorate_mc l_10_7_05.pdf. For further information or clarification about this issue, please cont act Dr. Gloria Post at (609) 292-8497 or gloria.post@dep.state.nj.us.

Sincerely, Jeanne Herb Director Policy, Planning and Science

Scott Brubaker Acting Assistant Commissioner Land Use Management

C : Gary Buchanan, NJDEP Judy Louis, NJDEP Sandra Krietzman, NJDEP Betty Boros-Russo, NJDEP Gloria Post, NJDEP Perry Cohn, NJDHHS Mark Robson, Chair, New Jersey Drinking Water Quality Institute

Response: See response to comment code 6120.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28926

EPA Comment Code: 6120

Comment: Attached are EWG's comments on Docket ID no. EPA-HQ-OW-2009-0297 (Drinking Water: Perchlorate Supplemental Request for Comments). Thank you.

September 18, 2009

Mr. Eric Burneson Office of Ground Water and Dr inking Water Standards and Risk Management Division Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC

20460

Re: Docket ID no. EPA-HQ-OW-2009-0297

Dear Mr. Burneson:

The Environmental Working Group (EWG) stro ngly supports the Environmental Protection Agency (EPA) establishing a drinking water standard for the rocket fuel ingredient perchlorate. This compound contaminates drinking water supplies na tionwide at levels of concern for human health, providing the agency with a meaningful opportunity for human health risk reduction through a national primary drinking water rule:

- The EPA has reported finding perchlorate, a potent thyroid toxin, in public water systems in 28

states and territories and estima ted that nearly 17 million people may be served by public water systems with at least one perchlorate detection > 4 ppb - The Centers for Disease Control and Prevention (CDC) have found perchlorate in the ur ine of nearly 3,000 Americans who were tested as part of a national biomonitoring study, in dicating widespread exposure among the U.S.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1000 of 1099 population (Blount et al 2006a) - In infants and ch ildren, drinking perchlorate contaminated tap water can result in cumulative exposures that exce ed the EPA's reference dose (RfD), even at tap water concentrations as low as 1 part per billion (ppb).

Recommendations

- EPA's own analyses show that infants under six months of age are exposed to enough perchlorate via food that additional exposure to perchlorate via tap water concentrations as low as 1 ppb can result in combined exposures that exceed the RfD. To protect these highly vulnerable individuals, EPA must set an MCL of less than 1 ppb for perchlorate in drinking water.

Response: See response to comment code 6120.

Commenter Name: Anila Jacob Commenter Organization: Environmental Working Group (EWG)

EPA Document ID: EPA-HQ-OW-2009-0297-0499

EPA Comment ID: 28937

EPA Comment Code: 6120

Comment: Summary: There is a wealth of evidence from government and academic scientists that strongly suggests that infants and children not only have disproportionately high perchlorate exposure compared with adults, they are also mo re vulnerable to its toxic effects. Baseline perchlorate contamination of breast milk, powdere d infant formula, and commonly consumed foods and beverages ensures that almost every infant and child in the U.S. will have multiple, daily sources of perchlorate exposure during critical periods of growth and brain development. However, for those children who live in states with perchlor ate contamination of tap water, the additional exposure from the tap water can easily lead to cumu lative exposures that exceed the agency's RfD. A decision by the agency to set an enforceable ma ximum contaminant level (MCL) of less than 1 ppb

could benefit the health of millions of infants an d children by decreasing cumulative perchlorate

exposures.

Sincerely, Anila Jacob, M.D., M.P.H. Senior Scientist

Enc. Attachment 1

References:

Blount BC, Valentin-Blasini L, Osterloh JD, Maul din JP, Pirkle JL. 2006a. Perchlorate exposure of the US population, 2001-2002. Journal of Expo sure Science and Environmental Epidemiology 17(4): 400-07.

Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell LK. 2006b. Urinary perchlorate and thyroid hormone levels in adolescent and adul t men and women living in the United States. Environmental Health Perspectives 114(12): 1865-71.

CHPAC (Children's Health Protection Advisory Co mmittee). 2008. Letter from Melanie Marty to Administrator Johnson regarding Preliminary Regu latory Determination on Perchlorate. Available online at: http://74.125.155.132/search?q=EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1001 of 1099 cache:fgJhPl_tIOIJ:yosemite.epa.gov/ochp/ ochpweb.nsf/content/perchlorateletter.h tm/%24File/PerchlorateLetter.pdf+CHPAC+and +perchlorate&cd=3&hl=en&ct=clnk&gl=

us&client=firefox-a

EPA (Environmental Protection Agency) 2008. Child-s pecific exposure factors handbook. Available online at: http://cfpub.epa.gov/ncea /CFM/recordisplay.cfm?deid=199243

EWG. 2005. National tap water quality database. Available online at: http://www.ewg.org/tapwater/findings.php

EWG. 2008. FDA food testing shows widespre ad rocket fuel contamination of commonly consumed foods and beverages. Available on line at: http://www.ewg.org/reports/FDAFindsRocket-Fuel-(Perchlorate)-in-Food-and- Beverages

GAO (U.S. Government Accountability Office). 2005 . Perchlorate. A system to tract sampling and cleanup results is needed. GAO-05-462. 20 Available online at: www.gao.gov/new.items/d07797t.pdf

GAO (U.S. Government Accountability Office). 20 06. Breastfeeding. Some strategies used to market infant formula may discourage breastfeedin g: state contracts should better protect against

misuse of WIC name. GAO-06-282. Available online at: www.gao.gov/new.items/d06282.pdf

Ginsberg G, Rice D. 2005. The NAS perchlorate review: questions remain about the perchlorate

RfD. Environmental Health Pe rspectives 113(9): 1117-9.

Ginsberg G, Hattis DB, Zoeller RT, Rice DC . 2007. Evaluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater; focus on exposure to nursing infants. Environmental Health Perspectives 115(3): 361-69.

Greer MA, Goodman G, Pleuss RC, Greer SE. 200 2. Health Effect Assessment for Environmental Perchlorate Contamination: the Dose Response for Inhibition of Thyroidal Radioiodide Uptake in Humans. Environmental Health Perspectives (110): 927-37.

Haddow JE, Palomaki GE, Allan WC, Williams JR, Knight GJ, Gagnon J, O'Heir CE, Mitchell ML, Hermos RJ, Waisbren SE, Fair JD, Klein RZ. 19 99. Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. New England Journal of Medicine

341: 549-555.

Kirk AB, Martinelango PK, Tian K, Dutta A, Sm ith EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Environmenta l Science and Technology 39: 2011- 2017.

Kirk AB, Dyke JV, Martin CF, Dasgupta K. 2007 . Temporal patterns in perchlorate, thiocyanate,

and iodide excretion in human milk. Envir onmental Health Perspectives 115: 182-186.

MassDEP. 2006. Update to "Perchlorate Toxico logical Profile and Health Assessment". http://www.mass.gov/portal/gog_cache.jsp?q=cache:DvvnPHJtRYwJ:www.mass.gov/dep /toxics/perchlorate-toxicity-061206.pdf+G reer&access=p&output=xml_no_dtd&ie=UTF8&client=mgov&site=EOEAxDEPx&proxystylesheet=mgov&oe=UTF-8EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1002 of 1099 Meikle A. Endocrine Replacement Therapy in Clin ical Practice. New York: Springer-Valley, 2007.

Murray WM, Egan SR, Kim H, Beru N, Bolger PM. 2008. US Food and Drug Administration's Total Diet Study: Dietary intake of perchlora te and iodine. Journal of Exposure Science and Environmental Epidemiology 2008 (1-10)Epub ahead of print.

NAS (National Academy of Sciences). 2005. Health Implication of Perchlorate Ingestion. National Academies Press. Available online at: http ://www.nap.edu/catalog.php?record_id=11202

Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin -Blasini L, Braverman LE. 2007. Breast milk iodine and perchlorate c oncentrations in lactating Boston area women. Journal of Clinical Endocrinology and Metabolism epub Feb 2007.

Pop VJ, Kuijpens JL, van Baar AL, Verkerk G, va n Son MM, de Vijider JJ, Vulsma T, Wiersinga WM, Drexhage HA, Vader HL. 1999. Low maternal free thyroxine concentrations during early pregnancy are associated with impaired psychom otor development in early infancy. Clinical Endocrinology 50: 149-55.

Schier JG, Wolkin AF, Valentin-Blasini L, Belson MG, Kieszak SM, Rubin CS, Blount BC. 2009. Perchlorate exposure from infant formula and comparisons with the perchlorate reference dose. Journal of Exposure Science and Environmental Epidemiology, March 18 (Epub ahead of print).

Steinmaus C, Miller MD, Howd R. 2007. Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001-2002 na tional health and nutrition examination survey. Environmental Health Perspectives 115(9): 1333-8.

WHO (World Health Organization and Food an d Agriculture Organization). 1998. Vitamin and mineral requirements in human nutrition. Second edition. Available online at: http://whqlibdoc.who.int/publications/2004/9241546123.pdf

Attachment 1:

Centers for Disease Control and Prevention's Responses to Questions for the Record From House Committee on Energy and Commerce

Response: See response to comment code 6120.

Commenter Name: Apparent Mass Mailing #9 - Group Unidentified)

EPA Document ID: EPA-HQ-OW-2008-0692-2366

EPA Comment ID: 29116

EPA Comment Code: 6120

Comment: Water Docket, EPA, Mailcode 2822T 1200 Pennsylvania Ave., NW Washington, DC

20460

To Whom It May Concern:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1003 of 1099 I urge you to reverse your decision and set a fe deral limit for perchlorate in drinking water. Perchlorate is a nationwide problem and has health impacts at lower levels than previously thought. Please protect public health, especially infant s and children, by regulating perchlorate.

Response: Please see the response to comment code 6120.

Revisions: Page 3 (Comment ID 20759)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1004 of 1099 

### EPA Comment Code: 6125 Comments critical of preliminary determination (in the October 2008 FR Notice) specifi c to Washington Post article

Individual Comments

Commenter Name: J Richards Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0223

EPA Comment ID: 19835

EPA Comment Code: 6125

Comment: from Washington Post article

Last month, The Washington Post reported that White House officials had extensively edited the EPA's perchlorate rule-making documentation to re move scientific data highlighting some of the
risks associated with the chemical, which has b een found in water in 35 states. The Defense Department and Pentagon contractors who face legal liability stemming from rocket fuel contamination have lobbied for six years to avoid a federal drinking-water standard for perchlorate.

http://www.washingtonpost.com/wp- dyn/content/article/2008/10/03/AR2008100303280.html? nav=rss_business/government

This appears to be not only a medical but a political-moral issue.

Response: Please see the response to comment code 6110. EPA has reversed its October 2008 preliminary determination not to regulate perc hlorate based upon a more direct evaluation of exposure to infants and developing children. In ma king today’s final regulatory determination, EPA uses the criteria mandated by the 1996 SDWA Amendments. EPA has made its determination based upon a consideration of the best available peer reviewed science and data collected in accordance with accepted methods.

Commenter Name: Mary Beth Sullivan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0370

EPA Comment ID: 19844

EPA Comment Code: 6125

Comment: The Washington Post reported that "The GAO, which produced a 2005 report calling for a better federal tracking system for perchlorate, found that limited EPA data show the chemical compound has polluted the soil, groundwater and dr inking water in 35 states and the District and has contaminated 153 public water systems in 26 states." The fact that there are some infants and toddlers in this country who drink formula using water contaminated by perchlorate is sinful. I have thyroid disease. I know how sluggish and foggy my mind becomes. I know how hard this disease is to diagnose.

We spend so many dollars on the military and "hom eland security" to keep Americans "safe" from enemies. This perchlorate story is an example of the enemy within. The Washington Post also reports that, "A National Academy of Sciences panel prepared a risk analysis in 2005 that...cameEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1005 of 1099 under attack because two of the committee's members had financial ties to defense contractors that face legal liability because of perchlorate disposal." It seems to me that milit ary contractors run this country. We know they hand out big bucks to decision makers to prevent creating regulation requiring them to clean up the mess they make.

Response: Please see the response to comment code 6110. EPA has reversed its October 2008 preliminary determination not to regulate perc hlorate based upon a more direct evaluation of exposure to infants and developing children. In ma king today’s final regulatory determination, EPA uses the criteria mandated by the 1996 SDWA Amendments. EPA has made its determination based upon a consideration of the best available peer reviewed science and data collected in accordance with accepted methods.

Commenter Name: Meghan Hendy Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1874

EPA Comment ID: 20759

EPA Comment Code: 6125

Comment: As reported in the Washington Post on September 22, 2008:

In the EPA's proposed rule, the administration assumes that perchlorate contamination of 15 ppb is safe. But its regulatory document states that "b etween 16,000 and 28,000 pregnant women" and 900,000 to 2 million Americans could be exposed to higher levels. The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe -- 700 nanograms per kilo gram of body weight per day -- if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

Response: Please see the response to comment code 6110. EPA has reversed its October 2008 preliminary determination not to develop an NPDWR for perchlorate and now concludes, based on the analysis presented in this notice, that there is a substantial likelihood that perchlorate will occur in public water systems with a frequency and at le vels of public health concern. Finally, EPA has determined that regulation of perchlorate presen ts a meaningful opportunity to reduce health risk for persons served by public water systems. EPA is initiating the development of a proposed NPDWR for perchlorate.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1006 of 1099 

### EPA Comment Code: 6130 Miscellaneous comments on the preliminary determination not to regulate (in the October 2008 FR Notice)

Individual Comments

Commenter Name: David Sparling, M.D., F.A.A.P. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0135

EPA Comment ID: 19722

EPA Comment Code: 6130

Comment: 2) The sources of perchlorate contamination of those public drinking water supplies should be identified and plans developed for dec ontamination of these sources or the development of alternative water supply sources no t contaminated with perchlorate.

David Sparling, M.D., F.A.A.P. P.O. Box 88637 Steilacoom, WA 98388

dsparling@igc.org

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. EPA will seek comment on any specific regulatory requirements as part of a proposed national primary drinking water regulation.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0163

EPA Comment ID: 20273

EPA Comment Code: 6130

Comment: Finally, NRWA feels that the issues raised by the aforementioned papers are of sufficient importance that it would be premature fo r the Agency to proceed with any of the possible scenarios for arriving at a perchlorate determination until these issues are resolved. For example, it is pointed out in the discussion of the evaluation of occurrence data and populations exposed (Table 5, page 24047) that this evaluation is very sensitiv e to the choice of an RSC and presumably to the occurrence data also. If the existing levels of contaminants are not known to any better accuracy than plus or minus a factor of 2 or more as is suggested by reference 1 above, it would not be good science to proceed with an analysis that is known to be sensitive to the value of such numbers.

Further we would encourage the agency to cont inue using and collecting data to support a "meaningful opportunity for public health protection" wh en determining if there is a clear benefit of regulating perchlorate. It is NRWA's belief that there is a need for more data to support this determination. There remain many uncertainties about the relative source contribution and the levels of perchlorate in urinary excretions. We believe that these issues along with the issues of affordability and compliance data variability must be appropriately addressed prior to the EPA Administrator making a determination regard ing perchlorate, in accordance with Section 1412(b)(1)(A) of the 1996 SDWA Amendments, that "in the sole judgment of the Administrator, regulation of such contaminant presents a mean ingful opportunity for health risk reduction for persons served by public water systems."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1007 of 1099 We thank you for the opportunity to provide co mments regarding this important matter.

Sincerely, Ed Thomas Ed Thomas

Electronic Attachments: 1. Phillips compliance data variability final.pdf 2. Rubin trade off health risk final.pdf

Response: EPA has made its determination based upon a co nsideration of the best available peer

reviewed science and data collected in accordance with accepted methods related to perchlorate occurrence in drinking water, the presence of perc hlorate in foods, and the health effects of exposure to perchlorate. Regarding the comment encouraging EPA to collect additional data to support the determination and to consider the pa pers the commenter provided, EPA believes there

are sufficient data on which to evaluate the best available data to make the determination. EPA does not believe that affordability analysis is needed to make a regulatory determination. SDWA requires that EPA evaluate affordability for small systems and request comment at the time of proposing a national primary drinking water standard.

Commenter Name: Diane VanDe Hei Commenter Organization: AMWA

EPA Document ID: EPA-HQ-OW-2008-0692-1525

EPA Comment ID: 20444

EPA Comment Code: 6130

Comment: National Academy of Sciences Review

In 2003, EPA asked the National Research Council (NRC) of the NAS to: * Assess the current state of the science regarding potential adverse effects of disruption of thyroid function by perchlorate and * Determine whether EPA's findings in its 2002 draft risk assessment were appropriate.

AMWA believes that regardless of the outcome of the final determination on perchlorate, the agency should commit to placing a similar question before the NAS for an answer by 2011.

If EPA’s final decision is to regulate perchlorate, then the review of the science available since the 2005 NAS report should provide a good foundation on which to build a regulation. If the decision is not to regulate perchlorate for the present, then the review will either c onfirm the decision with respect to changes in the state of scientific knowle dge or possibly point to the need to reassess the HRL and the regulatory determination.

Retention on the CCL

AMWA recommends that perchlorate be retained on the CCL or that some similar but less formal administrative action be taken so that changes in th e science speaking to potential health effects and changes in occurrence continue to be captured and evaluated. AMWA recommends that in the final determination, EPA elaborate on how systems such as IRIS are used to keep risk and other pertinent contaminant information current and how it might be used to advantage in tracking any changes in perchlorate status.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1008 of 1099 Response: The Agency believes that a second review by the NAS would unnecessarily delay regulatory decision making for perchlorate. Ther efore, EPA did not request additional NRC review of issues related to perchlorate. EPA has assessed recent best available data and has determined that regulation of perchlorate in drinking water sy stems presents a meaningful opportunity to reduce health risk for persons served by public water systems and has decided to regulate perchlorate in drinking water. See response to comment code 6120.

Regarding your recommendation that EPA ensure that changes in science related to potential health effects and changes in occurrence continue to be captured and evaluated, and elaborate on how systems such as IRIS are used to keep risk and ot her pertinent contaminant information current in tracking any changes in perchlorate status, beca use EPA has decided to regulate perchlorate in drinking water. EPA has found that perchlorate may have an adverse effect on human health. EPA has reversed its October 2008 preliminary determi nation not to develop an NPDWR for perchlorate and now concludes, based on the analysis presented in the final regulatory determination notice, that there is a substantial likelihood that perchlorate w ill occur in public water systems with a frequency and at levels of public health concern. Finally , EPA has determined that regulation of perchlorate presents a meaningful opportunity to reduce health ri sk for persons served by public water systems. The Safe Drinking Water Act requires EPA to review each National Primary Drinking Water Regulation (NPDWR) at least once every six years an d revise them, if appropriate. The purpose of the review, called the Six-Year Review, is to identify those NPDWRs for which current health effects assessments, changes in technology, and/or other factors provide a health or technical basis to support a regulatory revision that will maintain or strengthen public he alth protection. EPA will address changes in the science and occurrence at that time.

Commenter Name: Laurence Scudder Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1581

EPA Comment ID: 20561

EPA Comment Code: 6130

Comment: I urge the U.S. Environmental Protection Agency to reverse its preliminary determination on setting a regulation for perchlorate in drinking water. It is my understanding that the effects of levels of perchlorate in our drinking water have not been fully researched. Until said testing has been performed, I believe it is inconc lusive to set a standardized acceptable level of perchlorate in our drinking water. Most of all b ecause perchlorate affects the thyroid gland almost exclusively. This fact targets our children and unborn children as their thyroids are responsible for their growth and development not just metabolism as in adults. Thank you for your time and strongly consider my plea. Sincerely, Laurence Scudder

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Samuel A. L. Perry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1604

EPA Comment ID: 20563

EPA Comment Code: 6130EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1009 of 1099 Comment: While I think perchlorate should be regulated, I would support a reduced monitoring framework for those water systems that have sample s less than half any MCL that eventually gets developed. I also understand that monitoring costs may drop significantly as new analytical platforms are developed.

Sincerely, Samuel A. L. Perry, P.E.

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. Specific regulatory requirements for pub lic water systems (including monitoring) will be presented for public comment with the proposed NPDWR.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Agencies

EPA Document ID: EPA-HQ-OW-2008-0692-1527

EPA Comment ID: 20634

EPA Comment Code: 6130

Comment: November 10, 2008

Comment Clerk Docket EPA-HQ-OW-2008-0692 Wa ter Docket Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW. Washington, DC 20460

Dear Sir:

In response to the notice in the Federal Register of October 10, 2008 (Volume 73, Number 198) the Association of State Drinking Water Administrato rs (ASDWA) is offering comments to the U.S. Environmental Protection Agency (EPA) on th e Preliminary Regulatory Determination on Perchlorate. ASDWA is the professional Association that represents the collective interests of the nation's state drinking water programs responsible for implementation of the Federal Safe Drinking

Water Act.

EPA’s regulatory development activities are very im portant to states. Although some states have the expertise and resources to conduct their own eval uations of contaminant risks and may set their own, more stringent regulatory controls, most states rely on the EPA to determine which contaminants should be regulated in drinking water and at what levels. It is critical that these

determinations are based on sound science and ac complished through a transparent process with appropriate input from all interested parties, especially states. This is especially true in the case of perchlorate, since this contaminant has garnered exten sive public and political interest in the last few

years.

ASDWA appreciates the opportunity to provide the perspective of states on the Agency’s preliminary determination for perchlorate. States are generally in favor of EPA’s decision not to regulate, but there are some states that do favor national regulation of perchlorate, especially those who have already set their own standard. The Ag ency should expect direct comments from some of

these states. We do have a few recommendations to offer related to the perchlorate decision about

tools and information that we believe would benefit to all states. These recommendations do not include a recommendation to regulate, but they do go beyond the norm.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1010 of 1099 Regardless of EPA’s regulatory decision, states w ill need to act - Even if EPA does not adopt a national regulation of perchlorate, the public will li kely demand a response to detections of elevated levels of perchlorate - particularly, in light of the notoriety associated with this contaminant. The occurrence data may not support regulation of perchl orate, but the data do show that there are a significant number of water sources where perchl orate was detected, and at least a few where the levels are a public health concern. Because the decision not to regulate was based on a low national

number of detects at levels of con cern and not a lack of health effects, there is still a need for action
in some cases, even if a national standard is not justified. In states where there are detections of perchlorate at levels of concern, drinking water programs need to be able to respond appropriately so that public health can be protected. At a mini mum, states will need to assist individual water systems with the specific actions needed to contro l perchlorate. Information is needed from EPA on risk characterization and risk management as we ll as treatment options and alternative control measures to support state efforts. In some cases, a state may decide that perchlorate is common enough in their source waters that they are inter ested in developing statewide control measures, whether it is a formal monitoring program or a st ate specific MCL. We believe the Agency has data and expertise that can help support these actions.

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. EPA will provide further risk characteriz ation and risk management information as part of the national primary drinking water standard.

Commenter Name: Lewis Zediana Commenter Organization: Tewksbury Water Department

EPA Document ID: EPA-HQ-OW-2008-0692-1670

EPA Comment ID: 20669

EPA Comment Code: 6130

Comment: Please find attached my comments on this subject.

Perchlorate should not be dropped from the list. M ontioring can be adjusted by allowing waivers while taking into consideration the surrounding ar ea and chances of contamination. However more protection can be afforded to the populace by expanding the monitoring program to the effluent of wastewater plants. Which as by our experience ca n release Perchlorate passed inot the system..

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. EPA intends to present specific regu latory requirements for public water systems (including monitoring) for public comment wi th the proposed NPDWR. This action does not address waste water discharges.

Commenter Name: Lyndsey Crum Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1732

EPA Comment ID: 20679

EPA Comment Code: 6130

Comment: While I support the EPA’s desire to not promulgate NPDWR for perchlorate for the
reason above, I am concerned about the health implications this will have for the sensitive subpopulations of infants, pregnant women and th ose likely to become pregnant. Although theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1011 of 1099 connection between perchlorate and thyroid related he alth and cognitive defects is not conclusion, the EPA presents evidence that suggest such a link could exists. The possibility should be sufficient to warrant clearer, quantitative research targeti ng these populations, particularly in industrial communities where perchlorate could enter the public water supply.

In addition to a targeted study, the agency should consider the costs of not regulated perchlorate versus the possible treatment costs associated with th yroid conditions. Regulatory cost saving should not outweigh the cost of prevention.

Although the EPA is not required to promulga te NPDWR for perchlorate, should it conduct additional research, in which that research produces a strong health risk concern; EPA should create a NPDWR to address regulation needs. The regulation could be enforcing only when the state health agency has not already passed a sufficien t state public drinking water regulation.

Lyndsey Crum lcrum10@law.du.edu

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment code 6120. To do so, EPA used the best available p eer-reviewed science and does not think that an additional targeted study is necessary at this point. EPA intends to develop a proposed NPDWR, at which time EPA will analyze, among other things , quantifiable and nonquantifiable health risk reduction benefits as well as costs of a rule, the effects of perchlorate on the general population and specific life stages, and other relevant factors with respect to the degree and nature of the risk. See 42 USC 1412(b)(3)(C). Because EPA has decided to regulate perchlorate in drinking water the Sa fe Drinking Water Act requires EPA to review each National Primary Dr inking Water Regulation (NPDWR) at least once every six years and revise them, if appropriate. The purpose of the review, called the Six-Year Review, is to identify those NPDWRs for which current health effects assessments, changes in technology, and/or other factors provide a health or technical basis to support a regulatory revision that will maintain or strengthen public health protection. EPA will evaluate changes in the science

and occurrence at that time.

Commenter Name: Richard Weaver Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1868

EPA Comment ID: 20752

EPA Comment Code: 6130

Comment: Management,

Clean Water Action:

Please consider offering surveyed citizens more comprehensive information on the perchlorate in drinking water. Please also offer them either a pr e-written form or guideliness on writing to the EPA on this issue. Thank you

Richard WeaverEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1012 of 1099 Response: EPA has provided comprehensive information through three Federal Register notices and has provided instructions on how to provid e comments. Furthermore, pursuant to 42 USC 300(b)(3)(B), EPA intends to publish a document in support of its NPDWR that specifies, to the extent practicable-- (i) each population addressed by any estimate of public health effects; (ii) the expected risk or central estimate of risk for th e specific populations; (iii) each appropriate upperbound or lower-bound estimate of risk; (iv) each si gnificant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty; and (v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies

in the scientific data.

Commenter Name: Rebecca Downey Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1888

EPA Comment ID: 20774

EPA Comment Code: 6130

Comment: I urge you to reconsider any decisions on this important matter until proper analysis of all studies, including those that contradict ind ustry studies, have been properly assessed and

considered.

Sincerely,

Rebecca Downey

Rebecca Downey sent this message via Congress.org, which uses the Capwiz.XC system. Congress.org is a free public service of Capitol Advantage and Knowlegis, LLC. You may access Congress.org here: http://congress.org

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120. This determination was based on anal ysis of the best available science.

Commenter Name: Lucy Allen Commenter Organization: Pacific Institute

EPA Document ID: EPA-HQ-OW-2008-0692-1770

EPA Comment ID: 20927

EPA Comment Code: 6130

Comment: Without an enforceable federal standard, the Department of Defense, which is a primary user of perchlorate in the U.S., will perf orm remediation efforts according to a patchwork of state and agency guidelines. According to th e EPA, approximately 90 percent of perchlorate produced in the United States is for defense a ctivities and NASA.[FN7: EPA (2007). Perchlorate. Environmental Protection Agency, Federal Facilitie s Restoration and Reuse. Retrieved Oct. 24, 2008 from http://www.epa.gov/fedfac/documents/perchlorate.htm.] Recognizing perchlorate

contamination is a defense-related hazardous waste issue with significant potential impact on human health, the Department of Defense (DOD) designated perchlorate as an emerging contaminant and has taken some action to clean up contamination, mostly in the form of responding to requests made by the EPA and states-requests that relied on piecing together statutes, regulations, and theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1013 of 1099 power of oversight agencies.[FN8: GAO (2007). Department of Defense Activities Related to Trichloroethylene, Perchlorate, and Other Em erging Contaminants. Government Accountability Office. July, 2007. Retrieved October 24, 2008 fr om http://www.gao.gov/new.items/d071042t.pdf.] While the DOD is responsible by law for remediati on of contaminants regulated by the EPA or the state, its responsibility for what it classifies as "emerging contaminants" is not clearly defined.

In 2006, the DOD adopted its own management poli cy in which they are to comply with state or federal standards, whichever is most stringent. Acco rding to this policy, in the absence of state or federal standards, the DOD will manage its cont rol action using 24 parts per billion (ppb) as the

level of concern. Because a federal standard has not yet been established, the DOD must use state regulations to guide its remediation efforts. But while a handful of states have nonregulatory perchlorate-level guidelines, only two states-Ma ssachusetts and California-have set enforceable perchlorate drinking- water standards (1 ppb and 6 ppb respectively). Perchlorate contamination and its potential adverse health impacts, however, is obviously a multistate issue.[FN9: GAO 2007 finds federal and state agencies have found perchlora te in groundwater, surface water, soil, or public drinking water systems at almost 400 sites representi ng over 37 states, in concentrations that ranged from 4 parts per billion (ppb) to more than 3.7 million ppb. http://www.gao.gov/new.items/d07797t.pdf] Without a federal standard, not only will the DOD have to overcome the difficult challenge of perf orming remediation efforts according to varied guidelines, but states that currently lack their ow n enforceable standards and have known sources of perchlorate may be left with re mediation efforts based on the DOD’ s 24 ppb management standard.

In the absence of a federal standard, remediati on efforts by EPA and state officials of public drinking water systems contaminated by perchl orate have been shown to be nonexistent. DOD

remediation efforts are not alone in their need for guidance from a federal perchlorate standardcleanup of perchlorate in public drinking water systems has been shown to be nonexistent without a federal standard. According to research done by the GAO, "EPA and state officials told us they had not cleaned up contaminated public drinking water systems, principally because there was no federal drinking water standard or specific federal requi rement to clean up perchlorate."[FN10: GAO. (2007). Perchlorate: EPA Does Not Systematically Track Incidents of Contamination. Retrieved Oct 27, 2008 from http://www.gao. gov/new.items/d07797t.pdf.]

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20989

EPA Comment Code: 6130

Comment: DETAILED COMMENTS

1. EPA has made a preliminary determination not to set a health standard for perchlorate without reviewing or considering peer review and public comments on key pieces of evidence which it relies upon for its determination.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1014 of 1099 As EPA announced in its preliminary determination on perchlorate, the Agency is planning to issue a final determination by December 2008. However, NRDC has learned that the PBPK peer review reports of the staff report have only recently been submitted to EPA and were not incorporated into EPA's analysis in making its regulatory determi nation. Furthermore, NRDC has learned that EPA has solicited peer review comments on the HRL itself , and to date, is still awaiting those comments. EPA should not proceed with any decision on perchlor ate until all the peer review reports have been submitted to EPA, reviewed by EPA scientific sta ff and managers, and made available for public scrutiny.

If EPA finalizes its preliminary determination, in the absence of strong state drinking water standards for perchlorate, the HRL will provide th e only guidance for Superfund cleanup levels and health advisories for perchlorate. The importa nce of the HRL if EPA chooses not to regulate perchlorate underscores the importance that it be fully peer reviewed and those comments be made available to the public before EPA finalizes its determination. There is no justification for EPA's apparent intent to race ahead with a decision not to set a health- standard for perchlorate, and to rely upon an inadequate health reference level, prior to receiving, considering, and responding to both peer review and public comment. Failing to give th ese comments sufficient c onsideration in making

its final determination would render EPA's final action arbitrary and capricious.

Response: All the peer review reports have been submi tted to EPA, reviewed by EPA, and made available for public scrutiny. EPA has considered th e results of the peer review reports in reaching the determination it announces today to regulate perchlorate in drinking water. See response to

comment code 6120.

Commenter Name: Dawn M. Lee Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2117

EPA Comment ID: 21968

EPA Comment Code: 6130

Comment: Dawn M. Lee 1219 Severnview Dr. Crownsville, MD 21032

Water Docket, EPA Mailcode 2822T 1200 Penns ylvania Ave. Washington, DC 20460

Re: EPA-HQ-OW-2008-0692

I am writing to express my concerns regarding the issue of perchlorate levels in our drinking water in the United States. I feel this chemical should be further studied and monitored in our drinking water and water tables, and eliminated as much as possible. For the future of our children and their children, please continue to study the effects of perchlorate do not allow this chemical to remain uncontrolled in our drinking water.

Thank you, Dawn M. Lee

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment
code 6120. To do so, EPA used the best available peer-reviewed science. EPA intends to present specific regulatory requirements for public water sy stems (including monitoring) for public comment with the proposed NPDWR.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1015 of 1099 Commenter Name: Carrie Manion Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2121

EPA Comment ID: 21997

EPA Comment Code: 6130

Comment: 2194 Dairy Farm Road Gambrills, MD 21054

November 20, 2008

Environmental Protection Agency Water Docket 1200 Pennsylvania Ave. Washington, DC

RE: EPA-HQ-OW-2008-0692

Dear Sirs/Madam:

A recent online review of information about perchl orate proved very interesting. It seems that several states are imposing limitations on the presence of perchlorate in water; however the

recommended "safe" levels are inconsistent.

I feel that in order for the public to be protected by the potential risks associated with ingesting perchlorate, the EPA should conduct further, in de pth studies into the actual ramifications of this

chemical.

Instituting a drinking water regulation cannot be done until accurate, authoritative research into the health impacts is conducted.

I look forward to seeing the results of such tests in a timely manner.

Carrie Manion Resident of Anne Arundel County, Maryland

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment
code 6120. To do so, EPA used the best available peer-reviewed science. EPA intends to conduct further analyses, pursuant to the requirements of 42 USC 300g-1(3)(C)(i), in promulgating the

NPDWR with a maximum contaminant level.

Commenter Name: Andy Burgess Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2217

EPA Comment ID: 22417

EPA Comment Code: 6130

Comment: All Americans deserve healthy and clean dr inking water. The EPA should not finalize this decision until the scientific review is compl ete and should make decisions that are consistent with the agency's own scientists. Contrary to your claims, protecting the health of young children is indeed a "meaningful opportunity for health risk reduction."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1016 of 1099 Response: All the peer review reports have been submi tted to EPA, reviewed by EPA, and made available for public scrutiny. EPA has considered th e results of the peer review reports in reaching the determination it announces today to regulate perchlorate in drinking water. See response to

comment code 6120.

Commenter Name: Rose Lernberg Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2246

EPA Comment ID: 22429

EPA Comment Code: 6130

Comment: Please do not finalize this decision until the scientific review is complete. Please make

decisions that are consistent wi th the agency's own scientists.

Sincerely, Rose Lernberg 831 Balr a Drive E1 Cerrito, CA 94530

Response: All the peer review reports have been submi tted to EPA, reviewed by EPA, and made available for public scrutiny. EPA has considered th e results of the peer review reports in reaching the determination it announces today to regulate perchlorate in drinking water. See response to

comment code 6120.

Commenter Name: Susanna Sayre Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2310

EPA Comment ID: 24991

EPA Comment Code: 6130

Comment: Water Docket Environmental Protection Agency Mailcode 2822T,1200 Pennsylvania Avenue Washington, DC 20460

ATTN: Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern:

Perchlorate contamination in drinking water is a nationwide problem. As noted recently by the EPA's own Scientific Advisory Board, perchlorate' s widespread occurrence in drinking water and its well-documented toxicity to humans make it vital to have the best scientific evidence available in making a determination as to whether or not perchlorate levels should be regulated. Given its potential for posing significant risks to human health, I urge the EPA to delay final action on its decision not to set a federal drinking-water stan dard for perchlorate. I support a national primary drinking water regulation governing perchlor ate levels to protect public health.

Yours sincerely, Susanna Sayre 1900 5 Bloomfield Rd. Olney, MD 20832

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Michael SayreEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1017 of 1099 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2327

EPA Comment ID: 25009

EPA Comment Code: 6130

Comment: November 10, 2008 Water Docket Envir onmental Protection Agency Mailcode 2822T, 1200 Pennsylvania Avenue Washington, DC 20460

ATTN: Docket ID No. EPA-HQ-OW-2008-0692

To whom it may concern:

Perchlorate contamination in drinking water is a nationwide problem. As noted recently by the EPA's own Scientific Advisory Board, perchlorate' s widespread occurrence in drinking water and its well-documented toxicity to humans make it vital to have the best scientific evidence available in making a determination as to whether or not perchlorate levels should be regulated. Given its potential for posing significant risks to human health, I urge the EPA to delay final action on its decision not to set a federal drinking-water stan dard for perchlorate. I support a national primary drinking water regulation governing perchlor ate levels to protect public health.

Yours sincerely, Michael Sayre 19005 Bloomfield Rd. Olney, MD 20832

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28496

EPA Comment Code: 6130

Comment: Atttached are the comments of the Associati on of State Drinking Water Administrators on the request for additional comments on the regu lation of perchlorate (FR Vol. 74, No. 159). Additional comments are being submitted directly by states.

Attachment

September 24, 2009 Comment Clerk Do cket EPA-HQ-OW-2009-0297 Water Docket Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW. Washington,

DC 20460

Dear Sir:

In response to the notice in the Federal Register of August 19, 2009 (Volume 74, Number 159) the Association of State Drinking Water Administrato rs (ASDWA) is offering comments to the U.S. Environmental Protection Agency (EPA) on the Pe rchlorate Supplemental Request for Comments. ASDWA is the professional Association that represen ts the collective interests of the nation's state drinking water programs responsible for implementa tion of the Federal Safe Drinking Water Act.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1018 of 1099 EPA's regulatory development activities are very im portant to states. Although some states have the expertise and resources to conduct their own eval uations of contaminant risks and may set their own, more stringent regulatory controls, most states rely on the EPA to determine which contaminants should be regulated in drinking water and at what levels. It is critical that these

determinations be based on sound science and ac complished through a transparent process with appropriate input from all interested parties, especially states. This is particularly true in the case of perchlorate, since this contaminant has garnered ex tensive public and political interest in the past few years. We appreciate that EPA is sharing its a ssessment of health risk and occurrence data and requesting additional comment as important regulatory decisions are considered.

As we noted in our comments on EPA's preliminary decision on perchlorate regulation in October 2008, states were generally in favor of EPA's prelim inary decision not to regulate, but there are some states that do favor national regulation of perchlor ate, especially those who have already set their own standard. In that response, we did recommend some tools and information that we believed would benefit all states. Our comments today will address some of the questions in the Agency's August 19th request for comments, but also reiter ate some of the recommendations in our previous letter, where appropriate.

Response: Please see the response to comment code 6110.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 28748

EPA Comment Code: 6130

Comment: In summary, the NDEP believes the EPA should develop a national primary drinking water standard for perchlorate using updated, appropriate, and complete data sets; defensible analysis; and scientific approaches. The States and general public place a tremendous amount of

trust in the EPA to make credible decisions. Consequently, we trust the EPA will thoughtfully consider our comments and those submitted by other entities during its current evaluation. Much more significant public health benefit is achievab le and at a much lower cost by targeting iodinedeficient individuals through existing public health programs and correcting the iodine deficiencies through adjusted diets, use of supplements, and implementation of educational programs. These concepts are not new, yet they ha ve not been addressed in a mean ingful way. Congress is capable of funding such programs and should be reque sted to do so in the near term.

Sincerely, Tom Porta, Deputy Administrator Ne vada Division of Environmental Protection

Tp/tjc cc Jennifer Carr, P.E., CE M, Chief, Bureau of Safe Drinki ng Water, Nevada Division of
Environmental Protection, 901 S. Stewart Street, Suite 4001, Carson City, NV 89701-5249 Darrel Osterhoudt, Regulatory Affairs Mana ger, Association of State Drin king Water Administrators, 1401 Wilson Blvd., Suite 1225, Arlington, VA 22209 Kay Brothers, Deputy General Manager, SNWA Engineering/Ops, Southern Nevada Water Authori ty, 100 City Parkway, Suite 700, Las Vegas, NV 89106 Dr. Mic Stewart, Manager, Water Quality Se ction, Metropolitan Water District of Southern California, 700 North Alameda Street, Los Angeles, CA 90012 Marie Pearthree, Assistant General Manager, Central Arizona Water Conservation Di strict, PO Box 43020, Phoenix, AZ 85080-3020EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1019 of 1099 Brenda Pohlmann, Environmental Programs Ma nager, City of Henderson, PO Box 95050, Henderson, NV 89009 Susan Crowley, Tronox, LLC, PO Box 55, Henderson, NV 89009 Jeff Gibson, AMPAC, 3883Howard Hughes Parkwa y, Suite 70, Las Vegas, Nevada 89109

Response: Please see the response to comment ID 28857 under comment code 6110.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28795

EPA Comment Code: 6130

Comment: However, even when basing its decision upon this unacceptably high RfD, EPA's preliminary determination not to regulate perchlorate would still expose hundreds of thousands of children and infants to unsafe levels of perchlorate.

Response: EPA has determined to regulate perchlorate in drinking water. See response to comment

code 6120. For further information about the RfD for perchlorate, please see the response to

comment ID 28927 under comment code 2110.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1020 of 1099 

### EPA Comment Code: 6140 Additional new literature and information for EPA to consider when making a regulatory determination

Individual Comments

Commenter Name: Bill Connick Commenter Organization: University of Cincinnati

EPA Document ID: EPA-HQ-OW-2009-0297-0190

EPA Comment ID: 28387

EPA Comment Code: 6140

Comment: Dear Sir,

We have developed a new method for detection of pe rchlorate in aqueous solution with remarkably high selectivity. The method is likely to be low- cost relative to exisiting approaches (e.g., thosedescribed at http://www.cluin.org/contaminantfocus/default.focus/sec/perchlorate/cat/Overview/) and suitable for field work. We are preparing a manuscript for submissi on to the Journal of the American Chemical Society describing the discovery. I expect the document will be submitted within 10 days.

The science described in that account is covered by a provisional patent. We have recently made some significant improvements which will greatly incr ease the sensitivity. If this sounds relevant, please feel free to contact me.

Professor Bill Connick University of Cinci nnati (513)-556-0148 bill.connick@uc.edu

Regards, Bill

Response: EPA cannot evaluate methods that have not been peer reviewed. However, EPA will evaluate the best available, peer reviewed literature as the NPDWR is developed.

Commenter Name: Richard Nieuwenhuis Commenter Organization: New Jersey Farm Bureau (NJFB)

EPA Document ID: EPA-HQ-OW-2009-0297-0665

EPA Comment ID: 28533

EPA Comment Code: 6140

Comment: October 8, 2009

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue Washington, DC 20460

RE: Perchlorate Supplemental Request for Comme nts (Docket ID No. EPA-HQ- OW-2009-0297)

Dear Sir/Madam:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1021 of 1099 The New Jersey Farm Bureau (NJFB) is a 13,000 member organization which represents New Jersey agricultural producers and enterprises at all levels of government. We thank the Environmental Protection Agency (EPA) for the opportunity to provide comments on the above referenced docket regarding alternative approaches to the interpretation of scientific data relevant to establishment of a national primary drinking water regulation for perchlorate.

We believe that the approaches EPA described in th e August 19, 2009 Federal Register deviate from long-established methods by which EPA has anal yzed scientific and technical data. We are concerned that development of an overly conservati ve standard for perchlorate, that is not based on comprehensive, peer- reviewed science and an appropriate risk-based assessment could unintentionally lead to unjustified food scares associated with a wide variety of agricultural

commodities. Food scares of this nature could deter people away from consuming foods which the Food and Drug Administration (FDA ) encourages people to eat more of due to their nutritional

benefits and which the FDA has deemed critical to the health and development of children.
Furthermore, we are concerned about the economic impacts associated with such food scares.

Response: SDWA requires the consideration of sensitive subpopulations in developing NPDWRs. EPA exposure assessment policy has evolved to provide tools and policies consistent with the concern for all life stages. See responses to co mments IDs 28813 and 28677 under comment code

6140.

Commenter Name: Stephen Haterius Commenter Organization: National Association of State De partments of Agriculture (NASDA)

EPA Document ID: EPA-HQ-OW-2009-0297-0664

EPA Comment ID: 28548

EPA Comment Code: 6140

Comment: We remain very concerned that the approaches EPA outlined in the August 19 Federal Register will significantly-and unnecessarily-impa ct American agricultural production and foreign trade. Because perchlorate is naturally occurring at lo w levels in a number of agricultural products, it is imperative that EPA's regulatory determination be based upon a sound scientific approach that protects public health without unnecessarily crea ting concerns about the safety of agricultural products that are vital to a healthy diet. This is part icularly important in light of the fact that the risks associated with perchlorate can be easily avoided by the consumption of sufficient iodine-rich foods or iodine supplements by a specific subset of the population.

As we detailed in previous comments, an overly conservative perchlor ate standard that is not based on sound, peer-reviewed science and an appropr iate risk-based assessment could unintentionally lead to unjustified food scares on a wide variety of fresh fruits, vegetables, and dairy products. Even though EPA's current action is intended only to expl ore alternative approaches to analyzing data, the

additional alternatives under consideration could re sult in health reference levels which are much

lower than the level identified in the October 2008 notice. NASDA is concer ned that this kind of standard would likely lead to inaccurate consumer perceptions and confusi on about perchlorate in agricultural products. The ramifications of this ki nd of food scare would have devastating impacts on agricultural producers and rural communities. Fo r example, a study by Arizona State University indicates that a prolonged food scare involving wi nter lettuce could result in a negative economic impact of over $5 billion.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1022 of 1099 Moreover, EPA's actions could have significant im pacts on American producers' access to foreign markets. The agricultural products impacted by th is issue represent nearly $70 billion in export opportunities. Because other countries frequently ci te food safety concerns as justifications to erecting trade barriers to American agricultural products, an overly conservative perchlorate standard that is not based on sound, peer-reviewed scienc e and an appropriate riskbased assessment would likely lead to the imposition of unfair and economic ally devastating trade restrictions by America's trading partners.

Response: See responses to comments IDs 28813 and 28677 under comment code 6140.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0653

EPA Comment ID: 28559

EPA Comment Code: 6140

Comment: Further conservatism (i.e. more stringent assumptions) concerning hazard or exposure beyond central tendencies in the existing data s ets is not justified. To follow a precautionary principal in setting further restrictions in this case is both arbitrary and capricious. Further, without a clear basis for protecting public health, the Agency will cause public and private water providers to expend energy to remove perchlorate from water supplies that already protect their consumers. The Agency has failed to estimate the carbon emissions an d cost that this unnecessary removal, probably through dedicated reverse osmosis systems, will cost the American public in higher water rates and carbon emissions. The Agency has provided no data on the feasibility of removing perchlorate below the preliminary guidance level. In doing so, costs must be estimated for both the construction capital costs and based on energy expenditures whic h are an ongoing annual cost rather than a onetime capital cost. Such ongoing costs must be considered for the life of the project.

Response: See response to comment ID 28813 under comment code 6140.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28677

EPA Comment Code: 6140

Comment: We are further concerned that the food scares which will follow from setting a regulatory threshold below the existing natural ba ckground level of perchlorate in the environment will significantly disadvantage agricultural exports . Agricultural commodities make up a significant portion of all U.S. food exports. Given the long history of our Asian trading partners taking retaliatory actions for what they deem to be U.S. protectionism -- we are particularly concerned in light of the Obama Administration's recent a nnouncement to impose tariffs on Chinese tire manufacturers -- a regulatory determination which do es not take into consideration the presence of naturally occurring perchlorate will provide an un fortunate opportunity for the Chinese government to make good on their threats to punish U.S. agricultural exports.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1023 of 1099 Response: EPA is aware of the need to communicate clearly the implications of the NPDWR that is developed. The NPDWR as currently envisioned assumes that no change will be required to the food supply. Adjustment to perchlorate exposur e will be made in the drinking water supply, assuming that the food supply remains in its cu rrent state with regard to perchlorate.

Commenter Name: Robert Callahan Commenter Organization: California Chamber of Commerce (CalChamber)

EPA Document ID: EPA-HQ-OW-2009-0297-0666

EPA Comment ID: 28693

EPA Comment Code: 6140

Comment: Please see the attached comment letter re garding the perchlorate supplemental request for comments. Thank you.

Robert Callahan California Chamber of Commerce

October 8, 2009

Ms. Lisa P. Jackson Administrator Environm ental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460

SUBJECT: EPA-HQ-OW-2009-0297, "Drinking Wa ter: Perchlorate - Supplemental Request for

Comments"

Dear Ms. Jackson:

The California Chamber of Commer ce (CalChamber) wishes to express our concern with the federal Environmental Protection Agency's (EPA) interpreta tion of the scientific data relevant to a regulatory determination for perchlorate in drinking wa ter. While it is imperative to set public health standards, especially where a specific threat exists, there is no rationale for establishing lower standards or for rushing to a regulatory deci sion unsupported by scientific information.

Perchlorate is found naturally throughout the water environment in the 0.5 to 15 parts per billion range. The United States Geological Survey and othe r researchers have also measured perchlorate in rain, geologic formations, and rivers and aquifers throughout the United States. Five decades of scientific investigation, including a landmark Nati onal Academy of Sciences review, result in a clear and consistent conclusion: low levels of perc hlorate are not dangerous to public health.

We strongly believe that an unnecessarily lower standard would limit the flexibility of the water supply system. Curbs on water supplies, especially during a water emergency, would impact local economies and job markets, as plans for new housi ng areas and business centers are postponed or

cancelled due to lack of available water. Current re sidential areas and businesses could also be forced to endure unnecessary water shortages, water rationing, rate hikes and other consequences.

In light of this, it seems clear that the alternati ves proposed by EPA are not justifiable considering the significant economic costs that would be in curred without corresponding benefits to public health. Please keep these considerations in mind as the EPA determines additional approaches to interpreting perchlorate level data.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1024 of 1099 Sincerely, Robert Callahan Policy Advocate RC:fg

Response: See response to comment ID 28813 under comment code 6140. As explained elsewhere in this response to comments document (comm ent ID 28863 under comment code 2110), EPA believes that the RfD derived by the NRC is the best health assessment available for assessing risk to perchlorate.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2009-0297-0647

EPA Comment ID: 28719

EPA Comment Code: 6140

Comment: Appendix 1

A first step towards a possible link perchlorate-organohalogens-TH

It has been shown that chlorine-based disinfectants such as those found in drinking water oxidize to perchlorate as a disinfection by-product (DBP). This is, for example, why Massachusetts doubled its MCL from 1 to 2 ppb, because otherwise health -protecting chlorination of drinking water and swimming pools with bleach would have to be curtaile d. Is this oxidation of perchlorate from bleach (hypochlorite and hypochlorous acid) and other chlo rine derivates significant in comparison with daily intake of perchlorate?

According to the Blount study (based on the NHAN ES survey data) the average urinary perchlorate level in the population is 2.84ug/l which is roughly e quivalent to an oral dose of 0.04 ug/kg-day. This corresponds with drinking water of 1.4 ppb. Massachusetts' MCL was based on data that showed that about 0.5 ppb perchlorate origina ted from bleach alone[FN16: -Massachusetts Department of Environmental Protection. Perchl orate: Draft Toxicological Profile and Health

Assessment. 2004. - Occurrence of Perchlorate in Sodium Hypochlorite, Journal American Water Works Association (AWWA), Nov. 2008.]. Therefor e about 1/3 of the average daily intake of perchlorate would be due to bleach oxidation alone, which is substantial and which shows that chlorine could be a significant so urce of low level perchlorate.

Bleach is used ubiquitously, as for example in wate r purification stations, paper mills, drinking water and for many other applications. Other potential so urces of perchlorate as a DBP are other chlorine derivates such as chlorine gas and chloramine. On the other hand other DBPs originate from the

reaction of chlorine based disinfectants with or ganic matter (waste) to form organochlorides[FN17: Gary A. Boorman, Vicki Dellarco, June K. Dunnick, Robert E. Chapin, Sid Hunter, Fred
Hauchman, Hank Gardner, Mike Cox, and Robert C. Sills. Drinking Water Disinfection Byproducts: Review and Approach to Toxicity Evaluation. En vironmental Health Perspectives Supplements, February 199, Volume 107, Number S1.]. What co uld be one of the possible pathways that link perchlorate to organochlorides such as PCBs via chlorine?

According to EPA the building block for organoc hlorides is chlorophenol, and chlorophenols are produced from the organic matter found in used water when it reacts with chlorinated disinfectants[FN18: Environmental Protection Ag ency, EPA/600/P-03/002F).An Inventory ofEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1025 of 1099 Sources and Environmental Releases of Dioxin- Li ke Compounds in the United States for the Years 1987, 1995 and 2000. Federal Register: December 1, 2006 (Volume 71, Number 231)] Page 69564- 69565] Occurrence of Perchlorate in Sodium Hypochlorite, Journal American Water Works Association(AWWA), Nov. 2008] (phenol is benzen e with a hydroxyl group and PCBs are basically 2 chlorinated benzene rings). Those DBPs are found back in the drinking water leaving the water purification plants.

Therefore, this is one example of the possible lin k between very low levels of perchlorate and TH affecting substances: chlorine based disinfectants such as bleach, Cl2 and chloramines evolve to perchlorate in one way and to phenols, PCBS an d other organochlorides including dioxin-like compounds in another way. [Chloramines, besides being an added disinfectant, can also be formed as a reaction product of bleach with ammonia, itse lf amply present in used water (see ref. 15 )].

Response: EPA is aware of the link between perchlora te and hypochlorite/hypochlorous acid. This issue, and those related to other possible transforma tion products, will be considered in the context of NPDWR development.

Commenter Name: Jennifer Sass Commenter Organization: Natural Resources Defense Council (NRDC)

EPA Document ID: EPA-HQ-OW-2009-0297-0412

EPA Comment ID: 28813

EPA Comment Code: 6140

Comment: A Final MCL Below 1 ppb is Both Technologically and Economically Feasible

U.S. EPA's Method 314 approved ion chromatogr aphy detection protocol, for example, routinely detects perchlorate pollution at levels of 0.2ppb and the State of Massachusetts has established a 'reportable concentrations level for perchlorate of 2 ppb.[FN66: Thorne, Philip G. Field Screening
Method for Perchlorate in Water and Soil, ERDC/CRREL Technical Report 04-8, 36 pp, Apr 2004.],[FN67: "Final Changes to the Massach usetts Contingency Plan -310 CMR 40.0000," downloaded from http://www.mass.gov/dep/clea nup/laws/perchlorate-31 0CMR40-07282006.pdf, November 2 2006.] Ion exchange technology is able to treat perchlorate contamination to levels considerably below 1 ppb. Treatment systems opera ting on perchlorate- impacted wells owned by Aquarion Water Company in Massachusetts, for ex ample, treat wells to below 1 ppb.[FN68: "US Filter Recovery Services," downloaded from www.usfilter.com, November 2 2006.]

Economically, the cost of complying with a perchlorate MCL less than 1 ppb for the City of Rialto - one of the most impacted water systems in Californi a - for example will be zero after cleanup costs are recovered from identified responsible parties. A complete economic feasibility study should also include an analysis of the costs associated with healthcare and lost work resulting from illnesses associated with perchlorate contaminated water.

Response: EPA agrees that analytical methods and tr eatment techniques are available to address increasingly smaller concentrations of perchl orate. As the NPDWR is developed, economic feasibility will be evaluated in support of identifying an MCL.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1026 of 1099 EPA Document ID: EPA-HQ-OW-2009-0297-0650

EPA Comment ID: 28824

EPA Comment Code: 6140

Comment: Document ID No. EPA-HQ-OW-2009-0297

Additional NDEP Comments to "Drinking Wa ter: Perchlorate Supplemental Request for Comments" noticed by the USEPA in th e August 19, 2009 Federal Register.

These additional comments focus on: (1) the lack of a demonstrative environmental or public health benefit being realized when an MCL is applied to existing well-managed remediation sysytems in the Las Vegas Valley if a low standard is developed that does not consider all of the recent epidemiological literature; and (2) analytical ch allanges associated with accurately measuring perchlorate in water with elevated EC.

October 8, 2009

U.S. Environmental Protection Agency Mailcode 2822T 1200 Pennsylvania Ave., NW. Washington,

DC 20460

Subject: Docket ID No. EPA-HQ-OW-0297

Reference: Drinking Water: Perchlorate Supplemen tal Request for Comments (Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices

The Nevada Division of Environmental Protection (NDEP) submits these additional comments in response to the referenced "Supplemental Re quest for Comments" noticed by the U.S. Environmental Protection Agency (EPA) in the August 19, 2009 Federal Register; Docket ID No. EPA-HQ-OW-2009-0297. These comments are sub mitted in addition to comments previously provided by the NDEP dated September 16, 2009. The comments are provided within the extended comment period and are designed to assist the EPA in their efforts in evaluating whether there is a meaningful opportunity for human health risk reduction of perchlorate to persons served by public water systems through promulgating a national pr imary drinking water rule for perchlorate.

The NDEP understands that in order to regulate a contaminant in drinking water [i.e., develop a maximum contaminant level (MCL)], EPA must determine that the contaminant meets the following three criteria:

1) The contaminant may have an adverse effect on human health;

2) The contaminant is known to occur (or there is a substantial likelihood that the contaminant will occur) in public water systems, with a frequency and at levels of public health concern; and

3) Regulation of such a contaminant presents a me aningful opportunity for health risk reduction for persons served by public water systems.

These additional comments focus on two primary elements:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1027 of 1099 * The lack of a demonstrative environmental or public health benefit being realized when a drinking water standard (maximum contaminant level [MCL)) is applied to permitted waste water discharges from existing well-managed remediation systems in the Las Vegas Valley if a low standard is developed that does not consider all of the recent epidemiological literature; and

* analytical challenges associated with accuratel y measuring perchlorate in water with elevated electrical conductivity (EC).

Lack of Benefit Realized and Difficu lties Applying a Very low MCL:

MCLs are used by States, Territory's, and the Fede ral government to determine when an action may be required (action level) as well as when re mediation may cease (remediation standard). Additionally, many regulatory agencies (including the NDEP) use MCLs, when they are available, for water quality criteria applicable to water quality perm its. Two principal permit programs overseen by the NDEP in the State of Nevada are the National Primary Discharge Elimination System (NPDES) program and the Underground Injection Control (UIC) program. Permits issued by these programs not only are used to regulate the water quality of was te water discharges from various industries and governmental entities; these permits are also used to regulate the water quality of discharges from environmental remediation systems. Use of MCLs to set discharge limitations in these permitting programs where drinking water is the designated beneficial use of the receiving water is typical throughout the US.

Two significant environmental remediation projects are actively remediating perchlorate-impacted groundwater within the Las Vegas Valley (NDEP 2009). Tronox (formerly Kerr-McGee) operates a Fluidized Bed Reactor (FBR) that treats approxima tely 1,000 gallons per minute (gpm) with a typical influent concentration of approximately 500 m illigrams per liter (mg/L) perchlorate. AMPAC operates an In-situ Bioremediation (ISB) system that treats approximately 200 to 300 gallons per minute with a typical influent concentration of 20 to 30 mg/L perchlorate. Both treatment systems additionally treat (destroy) large amounts of chlo rate and nitrate due to the advantageous use of bioremediation. Bioremediation of perchlorate is nonselective; hence significant environmental and human health benefits are realized through use of these technologies (FBR and ISB) to treat large volumes of water impacted with elevated concentrations of perchlorate.

Both the Tronox and AMPAC bioremediation syst ems are designed to operate with more electron donor provided than is necessary to destroy all of the nitrate, chlorate, and perchlorate present within the influent water. These treatment system s are designed this way because it would be incredibly difficult to precisely meter an amount only necessary for the required mass destruction given that small changes in influent concentrations (of perchlorate, chlorate, and nitrate) occur. As such, the treatment systems are designed and the actual operations are managed in ways that the treated water typically exhibits no detectable concentr ation of perchlorate. St ated another way, there is no advantage to operate these remediation sys tems in a manner that conserves electron donor but puts the permittee (Tronox and AMPAC) at risk of a NPDES or UIC permit violation.

The practical challenge is not one of treatmen t system design and operation, but rather of monitoring. Significant challenges exist in iden tifying and quantifying perchlorate in the Tronox NPDES permitted discharge and AMPAC UIC permitted discharge at values typically less than approximately 10 ug/L and 6 ug/L , respectively. Additionally, the actual environmental benefit that could be perceived to be present if the permit di scharge values were lowered significantly is in theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1028 of 1099 range of less than 1/2 pound per day mass loading to the receiving waters. The down side associated with placing a significantly lower standard on th e referenced permits is that the two treatment systems would be precariously positioned for permit exceedance. It makes little sense to the NDEP to effectively establish discharge permit conditi ons that increase potential for noncompliance with two very important and very successful perchlorate treatment systems and at the same time provide no measureable environmental benefit or public health risk reduction.

Analytical Challenges:

Most perchlorate remediation that occurs throughout the United States involves significantly lower concentrations of perchlorate particularly when higher amounts of water are treated. Additionally, the baseline water quality applicable to those re mediation projects is much different on those projects than for projects within the and Mojave Desert region of the southwestern United States including projects within the Las Vegas Valley. Total dissolved solids (TDS) concentrations of shallow groundwater within the Las Vegas Valley typically exceed 1,000 mg/L and often can be
measured between 3,000 and 10,000 mg/L. Electrical conductivity (EC) measurements (specific conductance) often are used in lieu of TDS measurements to permit rapid, cost-effective analysis of water quality when monitoring ground water, surface water, and NPDES and UIC permitted discharges. Although EC and TDS measurements are not identical, the two are well correlated.

It is important to note that the treated water di scharged from the Tronox FBR remediation system typically measures in the range of 10,000 mg/L. Similarly, it is helpful to know that the donoramended water injected via a UIC permit by AMPA C to allow for ISB of perchlorate typically measures in the range of 3,000 to 4,500 mg/LTDS. The analytical method routinely used to quantify perchlorate in water is EPA Method 314. 0 or 314.1. Both of these Ion Chromatography (IC) based methods do not provide reliable results when the water samples being tested are in the range (or exceed) approximately 7,000 us/cm (referen ce Table 1 and the related analytical summaries in Attachment A). Additionally, these methods are pr esumptive methods in that they do not provide a definitive determination that the detected analyte is perchlorate as can be seen in Table 1. The

influent water to the above referenced treatmen t systems additionally contain a number of other analytes that can co-elute or otherwise compromise the detection and quantification of perchlorate.

It is for these reasons that:

* Other methods have been developed for use particularly with saline samples;

* Mass spectrometry (MS) is used as the detector in more robust analytical methods that are preferred by many knowledgeable chemists and other professionals working with perchlorate identification, quantification, and remediation as these advanced methods provide superior results;

and

* It is very difficult to identify and quantitate pe rchlorate to very low concentrations (generally less than between 6 and 10 ug/L) in water that ex hibits elevated TDS and/or other confounding analytes.

In summary, the NDEP recommends EPA conduct a thoughtful review of all of the data and

literature at this time. EPA should consider the side-effects and unnecessary costs external to the Safe Drinking Water Program (SDWA) that are in volved with using the proposed methodologies to set an MCL at a level that is not readily attainab le nationally using available analytical methods andEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1029 of 1099 readily available equipment. Alternatively, EP A should demonstrate additional measureable environmental or public health benefit that wo uld justify these additional external costs. The selection of appropriate analytical methods for use in different applications (drinking water, waste water, treated water from remediation systems) is crucial to enable the collection of useable data. Additionally, the application, of a scientifically based defensible regulatory standard (Health Advisory, MCL, or other standard) throughout the perchlorate remediation and monitoring process is a critical component to successful remediation and monitoring of perchlorate in environmental

media.

We trust the EPA will thoughtfully consider our comments and those submitted by other entities during its current evaluation.

Sincerely, Tom Porta, Deputy Administrator Ne vada Division of Environmental Protection

Tp/tjc cc Jennifer Carr, P.E., CE M, Chief, Bureau of Safe Drinki ng Water, Nevada Division of
Environmental Protection, 901 S. Stewart Street, Suite 4001, Carson City, NV 89701-5249 Darrel Osterhoudt, Regulatory Affairs Mana ger, Association of State Drin king Water Administrators, 1401 Wilson Blvd., Suite 1225, Arlington, VA 22209 Kay Brothers, Deputy General Manager, SNWA Engineering/Ops, Southern Nevada Water Authori ty, 100 City Parkway, Suite 700, Las Vegas, NV 89106 Dr. Mic Stewart, Manager, Water Quality Se ction, Metropolitan Water District of Southern California, 700 North Alameda Street, Los Angeles, CA 90012 Marie Pearthree, Assistant General Manager, Central Arizona Water Conservation Di strict, PO Box 43020, Phoenix, AZ 85080-3020 Brenda Pohlmann, Environmental Programs Ma nager, City of Henderson, PO Box 95050, Henderson, NV 89009 Susan Crowley, Tronox, LLC, PO Box 55, Henderson, NV 89009 Jeff Gibson, AMPAC, 3883Howard Hughes Parkwa y, Suite 70, Las Vegas, Nevada 89109

Table 1: Comparison of Analytical Methods used for Measuring Perchlorate in Aqueous Samples [see PDF docket ID EPA-HQ-OW-2009-0297-0650]

Attachment A [see PDF Docket ID EPA-HQ-OW-2009-0297-0650]

References:

Federal Register, 2008, Final Update IV, SW-846, Volume 73, Number 2; (wais.access.gpo.gov ) [DOC ID:fr03ja08-36]

Interstate Technical Regulatory Council, 2005, Perchlorate: Overview of Issues, Status, and Remedial Actions, ITRC Document, September 2005

Magnuson, Matthew L., Urbansky, Edward T., an d Kelty, Catherine A., 2000, Determination of Perchlorate at Trace Levels in Drinking Water by Jon-Pair Extraction with Electrospray Ionization Mass Spectrometry, Analytical Chemistry, Vol. 72 No. 1, January 1, 2000

Nevada Division of Environmental Protection (N DEP), 2009, Response to Supplemental Request for Comments, noticed by the US Environmental Protection Agency in the August 19, 2009 Federal Register; Docket ID No. EPA-HQ- OW-2009-0297EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1030 of 1099 Sellers, Kathleen, Aslop, William, Clough, Stephen, Hoyt, Marilyn, Pugh, Barbara, Robb, Joseph and
Weeks, Katherine, 2007, Perchlorate: Environm ental Problems and Solutions; CRC Press, Boca Raton, FL. Chapter 3, pgs. 43 to 63

Shen-yi Yang, 2007, SW 846 Methods for The Anal ysis of Perchlorate in Various Environmental
Media, Power Point Presentation, USEPA Office of Solid Waste.

USEPA, 1999, Method 314.0, Determination of Perchlorate in Drinking Water Using Ion Chromatography, Rev. 1.0. Available at www.epa.gov/safewater/methods/source.html

USEPA, 2005a: Method 314.1, Determination of Perchlorate in Drinking Water Using Nine Column Concentration/Matrix Elimination Ion Chromatography with Suppressed Conductivity Detection, Rev. 1.0, Available at www.epa.gov/ safewater/methods/source.html. EPA Document

No. EPA 815-R-05-009.

USEPA, 2005b, Method 331.0, Determination of Perchlorate in Drinking Water by Liquid chromatography Electrospray Ionization Ma ss Spectrometry, Rec. 1.0. Available at www.epa.gov/safewater/methods/source.html . EPA Document No. 815- R-05-007.

USEPA, 2005c, Method 332.0, Determination of Perchlorate in Drinking Water by Ion Chromatography with Suppressed Conductivity an d Electrospray Ionization Mass Spectrometry. Available at www.epa.gov/safewater/methods/ souree.html. EPA Document No. EPA/600/R05/049.

USEPA, 2007, Method 6850, Perchlorate in Water , Soil and Solid Wastes Using High Performance Liquid Chromatography/Electrospray Ioniza tion/Mass Spectrometry (HPLC/ESI/MS or HPLC/ESI/MS/MS). Available at http://www.epa.gov/SW-846

USEPA, 2008, Method 314.2, Determination of Perchlorate in Drinking Water Using TowDimensional Ion Chromatography with Suppressed Conductivity Detection, Ver. 1.0. Available at www.epa.gov/safewater/methods/source.html . EPA Document No. 815-B-08-001

Response: EPA will continue to evaluate the available sc ience related to perchlorate, the feasibility of analytical methods, and the costs and benefits of regulation, as part of its decision making process to set an MCL for perchlorate. Please note, however, that SDWA excludes from EPA’s cost/benefit analysis the consideration of costs and benefits resulting from compliance with other regulatory programs. SDWA Section 1412(b)(3)(C). Please also see response to comment ID 28813 under

comment code 6140.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28855

EPA Comment Code: 6140

Comment: Consideration of Studies Published since EP A adopted the NAS RfD for perchlorateEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1031 of 1099 In addition to the noted epidemiological, expo sure assessment, and occurrence studies, AWWA would like to direct the Agency's attention to othe r references that should bear on the decision making process following this comment period.

- AWWA and Water Research Foundation. 2009. Hy pochlorite - An Assessment of Factors That

Influence the Formation of Perchlorate and Other Contaminants.

Considering that perchlorate has been under review for Federal regulation and is currently regulated in California and Massachusetts (proposed in New Jersey), this study was commissioned to quantify potential perchlorate contributions from hypochl orite sources. Sodium hypochlorite is a commonly used form of chlorine in drinking water and water reuse applications for its ability to disinfect and maintain a residual level of disinfectant throughou t the distribution system. Approximately 1/3 of all drinking water treatment plants (DWTPs) in the United States use bulk hypochlorite for disinfection. [FN21: AWWA Disinfection Commit tee. 2008. Committee Report: Disinfection Survey Part 2 - Alternatives, experience and future plans. Journal AWWA. 100:11.] Though the majority of liquid hypochlorite use is in the form of bulk hypochlorite delivered from regional manufacturers and/or distributors, and some use on-site hypochlorite generators (OSG).

The data set for this study was limited to 12 OSG sites, 6 bulk hypochlorite sites, and 1 calcium hypochlorite site. This sample set suggested no difference between bulk sodium hypochlorite solutions, OSG solutions, and calcium hypochlorite solutions with respect to chlorate and perchlorate ion concentration, with the excepti on being bromate formation. The analysis did demonstrate the potential to exceed some existi ng state standards and HRLs proposed by the Agency. Therefore, as more pressure is placed on utilities using gaseous chlorine to move towards alternative disinfection practices for security re lated reasons, the sector requires more detailed information to fully characterize potential differe nces (in terms of contaminant formation/dosing) between the available options to avoid unintende d future water quality consequences and proper

consideration of the risk- risk tradeoffs.

- Russell, C., Roberson, A., Chowdhury, Z., and M. McGuire. 2009. National Cost Implications of a Perchlorate Regulation. Journal AWWA. 101:3:54.

Recognizing a lack of available information on projected national costs associated with perchlorate treatment, a study was conducted to estimate the national cost implications of setting a federal maximum contaminant level (MCL) for perchlorate at different levels between 4 and 24 ug/L. At the most stringent potential MCL evaluated (4 ug/L), the national compliance cost was estimated to be between $76 and $140 million per year at a 3% discount rate. The relatively low national compliance cost for perchlorate reflects the small nu mber of public water systems (PWSs) expected to be affected (3.4% at a perchlorate MCL of 4 ug/L based on 90th percentile perchlorate concentrations). However, the cost impacts to an individual system installing perchlorate treatment would likely be significant. With operations and maintenance (O&M) costs for perchlorate treatment over a 20-year period comparable to the capita l costs for construction and with these O&M costs continuing in perpetuity, ratepayers could face a significant increase.

Response: As the NPDWR is developed, economic fe asibility will be evaluated in support of identifying an MCL. EPA will consider the best av ailable, peer reviewed literature on the full range of issues embodied in an NPDWR, including risk-risk tradeoffs.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1032 of 1099 Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28920

EPA Comment Code: 6140

Comment: Since approximately 1/3 of all drinking water treatment plants (DWTPs) in the United States use bulk hypochlorite for disinfection, hypo chlorite should be considered as a source of perchlorate contamination in finished drin king water.[FN2: AWWA and Water Research Foundation. 2009. Hypochlorite - An Assessment of Factors That Influence the Formation of Perchlorate and Other Contaminants.] Sodium hypoc hlorite is a commonly used form of chlorine in drinking water. Because the AWWA-WRF analysis demonstrated the potential to exceed some existing state standards and HRLs proposed by USEPA, the results of this study should be reviewed when finalizing the regulatory determination, and al so included in the discussion regarding existing and future drinking water disinfection practices.

Response: EPA is aware of this study and agrees that it should be considered in developing the

NPDWR.

Commenter Name: Commenter Organization: Intertox, Inc.

EPA Document ID: EPA-HQ-OW-2009-0297-0662

EPA Comment ID: 28938

EPA Comment Code: 6140

Comment: APPENDIX B

INITIAL REVIEW OF HOPONICK ET AL., 2009

Initial Review of: Hoponick JR, Melillo PR, Visse r NT and Henshel DS. 2009. "Examining the

Correlation between Perchlorate Concentrations in California Drinking Water and Low Birth Weight Percentage Using Population-Scale Regr ession Analysis," obtained from C. Matthews,
Contractor, US EPA, Office of Environmental Information, EPA Docket Center, EPA Docket
OW-2009-0297-0492, received via em ail on September 30, 2009.[FN1: http://www.regulations.govisearch/Regs/contentStreamer?objectld= 0900006480a27182&disposition= attachment&contentType=xml]

This document (Hoponick et al., 2009) appears to be a manuscript that has been submitted for publication. The study is an ecological epidemiological study, and is short in length. The authors

evaluate the association between the mean perchlorate concentration measured in groundwater wells in 13 counties in California (measured between 19 97 and 2004), and the percent of neonatal births with low birth weight (LBW), coded by zip code from 1993 to 2002. Zip code data sets for percent of births with LBW for each year were "averaged to the county level by averaging all data within each county." Based on this evaluation, the aut hors conclude that "log perchlorate data are significantly correlated with LBW for all years" and th at "the increase is relatively linear from the lowest detectable perchlorate levels (3.3 ppb) to about 10 ppb, where the response appears to saturate." They further conclude, "Log perchlorate da ta also significantly positively correlates with TSH level for 1998, the only year for which TSH data was available."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1033 of 1099 An initial analysis of the manuscript was conduc ted using information derived from the manuscript. The source of data and an analysis of the met hods and conclusions is provided below. Comments are divided into the following categories: data re lated to perchlorate concentrations in drinking
water, data related to LBW, data related to ne onatal TSH, and discussion of confounding factors.

EPA should review the scientific basis of this manusc ript to assure itself that the data are reliable. Upon request, additional information can be provided. What might be useful is to review a recently published paper which reports no effect on birth weight, head circumference, and body length associated with perchlorate exposure (Blount et al., 2009). Briefly, the following is noted regarding the manuscript.

Perchlorate Concentrations in Drinking Water

Hoponick et al. (2009) conducted statistical analyses using the mean concentrations of perchlorate in drinking water,[FN2: The paper alternatively calls the water source either "groundwater wells" or "drinking water wells."] collected between 1997 and September 9, 2004, and averaged across each of 13 counties. The authors present mean concentrati ons for any California county that "contained two or more perchlorate detections from at least one drinking water source since 1997." Data were obtained from the California Department of Health Services website: http://www.cdph.ca.govicertlic/drin kingwater/Pages/Perchloratehistory.aspx. A downloadable MS

Excel file of the data is here: http://www.cdph.ca.gov/certlic/drinkingwa ter/Documents/Perchlorate/Perchloratefo rwebearlyfindings.XLS.

Some observations about these data are as follows:

* The CDHS website only provides downloadable data for detects of perchlorate in water only. It is not clear from the manuscript whether the analysis considered nondetects in the calculation of mean perchlorate concentrations.

* Neither the CDHS website nor the manuscript indicate the analytical method that was used to measure perchlorate during this time. For example, a change in analytical method could impact the

concentration data.

* The manuscript does not indicate the range of concentrations detected in the wells, the number and percentage of wells or water systems in whic h perchlorate was detected in each county, or how frequently perchlorate was detected in specific wells.

* The data obtained from CDHS shows that many wells were sampled repeatedly. However, the manuscript does not indicate how multiple detections at the same location were considered in the calculation of the county average.

* The manuscript does not indicate the extent to which sampled wells contribute to drinking water for the public in a given county, or whether water from wells was treated prior to distribution (but after sampling).EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1034 of 1099 * Some of sample dates in the CDHS database cannot be discerned because they appear to be

miscoded.

* The manuscript does not indicate how the timing of sample collection was assumed to relate to the

association with LBW data.

* It appears that some average concentrations reported in the manuscript include data from wells designated in the CDHS database as "inactive" or "destroyed," and therefore would not contribute to drinking water that is distributed to the pub lic. It is not clear how inclusion of these data is assumed to provide reliable measures of exposure.

Percent of Neonatal Births with Low Birth Weight (LBW)

Hoponick et al. (2009) report that data on neonata l birth weights were obtained from the California Department of Public Health (CDPH) for the years 1993 to 2002. The authors define "low birth weight" as a birth weight less than 2,500 grams (5.5 lb s.). The link provided in the paper redirects to here: http://ww2.cdph.ca.gov/programs/deodc/Page s/default.aspx. Annual data by zip code for the years 1993 to 2002 are available.[FN3: 1993: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1993.xls 1994: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1994.xls 1995: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1995.xls 1996: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1996.xls 1997: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1997.xls 1998: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1998.xls 1999: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip1999.xls 2000: http://ww2.cdph.ca.gov/data/statistic s/Documents/birthzip2000.xls 2001: http://wv2.cdph.ca.gov/data/statisti cs/Documents/birthzip2001.xls 2002: http://ww2.cdph.ca.gov/data/statist ics/Documents/birthzip2002.xls]

Some initial observations of these data are as follows:

* %LBW is lowest in 1996 for six of 13 counties and highest in 2002 for eight of 13 counties. The manuscript does not discuss these differences, or how they might relate to perchlorate exposure. For example, might there have been a change in the me asurement or reporting method for birth weight?

* Sacramento County has 135 zip codes, but in 2002 (for example) the CDPH data only includes birth weight data for 49 zip codes. Further, the CDHS data includes only 34 water samples for perchlorate (from a total of 14 locations in five systems), after exclusion of data from inactive or destroyed wells. It is not clear how from the manuscript how data from these wells was extrapolated to assumed exposure across the county, or to sp ecific zip codes, and how birth weight data for missing zip codes was considered. It appears that all individuals in the co unty were assumed to be exposed to the average perchlorate concentration co mputed from the available samples, and that the county average %LBW was based on the 49 zip codes for which data were available.

Neonatal TSH DataEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1035 of 1099 The manuscript remarks "TSH data was obtained by contacting the CDHS directly, and 1998 was the only year CDHS provided." We were not able to find the data in the manuscript to support this

statement.

Confounding Factors

The manuscript states, "The confounding factors data from 2003 was obtained from the California Interview Survey (CHIS) Database, which is operated by the University of California Los Angeles Center for Health Policy Research, in cooperation wi th CDHS and the Public Health Institute." The CHIS database is available (http://www.chis.ucla.edu/getdata.html). The only confounding variables reportedly considered by the authors were race and percentage of uninsured individuals. However, the literature on low birth weight is extensive and many other factors are known to influence birth weight including maternal health status, maternal ag e, smoking, alcohol/ drug use, prenatal care,
maternal education level, and other socio-economic factors (Bailey and Byrom, 2007; Nobile et al., 2007). It appears that these factors were not evaluated.

References

Bailey BA, Byrom AR. 2007. Factors predicting birth weight in a low-risk sample: the role of modifiable pregnancy health behaviors. Matern Child Health J11(2):173-9.

Blount BC, Rich DQ, Valentin-Blasini L, Lashley S, Ananth CV, Murphy E, Smulian JC, Spain BJ, Barr DB, Ledoux T, Hore P, Robson M. 2009. Perinatal Exposure to Perchlorate, Thiocyanate, and Nitrate in New Jersey Mothers and Newborns. En viron Sci Technol [Epub ahead of print].

Nobile CG, Raffaele G, Altomare C, Pavia M. 20 07. Influence of maternal and social factors as predictors of low birth weight in Italy. MC Public Health 7:192.

Response: EPA will use the best available, peer reviewed science in preparing the NPDWR for perchlorate.

Commenter Name: Tom Porta Commenter Organization: Nevada Division of Environmental Protection (NDEP)

EPA Document ID: EPA-HQ-OW-2009-0297-0638

EPA Comment ID: 29100

EPA Comment Code: 6140

Comment: The August 19, 2009 Federal Register Notice indicates that EPA is considering using monitoring data from the State of Massachusetts to help characterize the distribution of very low perchlorate concentrations occurrences. Evidence needs to be provided to support the use of Massachusetts (or other discrete) monitoring da ta for the purpose indicated. EPA has not demonstrated how these data sets are representa tive of the nation as a whole. Model calibration should be conducted with robust data that are repr esentative of the nation's water supply systems to make informed decisions regarding a national pr imary drinking water standard. Consequently, the NDEP recommends collection of new data for perchlor ate in public water systems, coupled with the use of more sensitive analytical methods wi th greater specificity (EPA Method 331 or EPA Method 332). Newer, more sensitive analytical met hods will provide more reliable and robust data, rather than trying to estimate values (< 4 ug/L) th at are not part of the existing, outdated occurrenceEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1036 of 1099 data generated using a less sensitive analytical method (EPA Method 314). The referenced more

sensitive methods have several method refinement s (different column packing material, longer columns, mass spectrometry detectors) that lead to fewer false positives or false negatives and permit perchlorate analysis with reporting limit s (detection limits) at or below 1 ug/L. These newer data are more robust and capable of multiple uses without limitations inherent in estimated data.

Response: EPA agrees that newer analytical methods are more sensitive. Information from a variety of sources will be used in developing the NPDWR. EPA is required to use the best available, peer reviewed science in its deliberations. The strength s and limitations will be considered as those deliberations proceed.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1037 of 1099 

### EPA Comment Code: 6200 Comments rela ted to EPA’s health advisory

Individual Comments

Commenter Name: Kathy M. Kinsey Commenter Organization: Maryland Department of the Environment

EPA Document ID: EPA-HQ-OW-2008-0692-1421

EPA Comment ID: 20428

EPA Comment Code: 6200

Comment: A Health Advisory for Perchlora te Will Undermine Cleanup Efforts

The establishment of a uniform federal standard is especially important to eliminate potentially conflicting state standards, particularly in cases of cross-boundary contamination. Merely publishing a health advisory for perchlorate, as EPA has proposed, will undermine expeditious cleanup of contaminated sites and regulation of discharges to interstate surface waters used to supply drinking water. A health advisory is not binding or enfo rceable, and does not ensure a uniform nationwide standard. Rather, it leads to a patchwork of differ ent state standards and in the absence of a state standard, cleanup standards for individual sites th at must be established through negotiation on a case-by-case basis.

Response: See response to comment ID 28479 under comment code 6200.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association

EPA Document ID: EPA-HQ-OW-2008-0692-1424

EPA Comment ID: 20441

EPA Comment Code: 6200

Comment: Health Advisory

AWWA supports the EPA decision to issue a Health Ad visory for perchlorate at the timeof the final determination. Health advisories provide important technical guidance to Federal agencies, State governments, and other public health officials on health effects, analytical methodologies, and treatment technologies. EPA should, in parallel, issue are vision of the "Assessment Guidance for Perchlorate" released by the Office of Solid Waste and Emergency Response (OSWER) on January 26, 2006, which defines the remediation goal for perchlorate in accordance with National Oil and Hazardous Substances Contingency Plan (Nationa l Contingency Plan, NCP), 40 CFR Part 300. In addition, any potential remediation action should c onsider all applicable or relevantand appropriate (ARAR) requirements under federal environmental or state environmental or facility siting laws.

Response: See response to comment ID 28479 under comment code 6200. A Health Advisory will no longer be needed.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association

EPA Document ID: EPA-HQ-OW-2008-0692-1669EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1038 of 1099 EPA Comment ID: 20618

EPA Comment Code: 6200

Comment: Based on the occurrence, health risk, and re lated findings presented in the Agency’s analysis we also believe that a health advisory is appropriate. It is evident that perchlorate is a problem in specific targeted areas. A health advisory will provide the acceptable levels that are safe

for local communities with contaminated source water.

Response: See response to comment ID 28479 under comment code 6200. A Health Advisory will

not be needed.

Commenter Name: Paul J., P.E. Ponturo Commenter Organization: Long Island Water Conference

EPA Document ID: EPA-HQ-OW-2008-0692-1260

EPA Comment ID: 20624

EPA Comment Code: 6200

Comment: In the preliminary determination, EPA has indi cated that States that are known to have perchlorate concentrations at or above the HRL should develop their own regulations, and has stated its intent to provide the States with a Health Advisory Level at the same time it finalizes this

determination. We wish to state for the record that we will ask the State of New York for an enforceable MCL to be adopted. The Long Island Water Conference's member suppliers are fully supportive of science-driven regulations that are mo st protective of public health, and to that end have in some cases voluntarily installed treatmen t or modified operational practices to reduce the use of wells containing perchlorate.

Response: See response to comment ID 28479 under comment code 6200.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Agencies

EPA Document ID: EPA-HQ-OW-2008-0692-1527

EPA Comment ID: 20635

EPA Comment Code: 6200

Comment: A Health Advisory is step one - If the Agency is not going to develop a full national regulation, it needs to provide adequate support for those entities (water systems and states) that are going to respond at the local level. In the Federal Register notice, EPA committed to publishing a health advisory for perchlorate at the time of the final determination in order to provide information regarding potential health risks from perchlorate- contaminated drinking water. States fully support

this action and recommend that th e Agency provide the health advisory as soon as possible. While this may be enough to help states and water sy stems determine when perchlorate is approaching levels of health concern, it will not provide th e level of technical support necessary for states and water systems to address perchl orate contamination problems.

Response: See response to comment ID 28479 under comment code 6200.

Commenter Name: Mic Stewart Commenter Organization: Metropolitan Water District of Southern CaliforniaEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1039 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1784

EPA Comment ID: 20663

EPA Comment Code: 6200

Comment: * Public Health Advisory for Perchlorate - Metropolitan recommends that any public health advisory for perchlorate in drinking water issued by the EPA include language that provides the greatest possible public health protection, part icularly for pregnant women and other sensitive sub-populations (e.g., infants and children).

Response: See response to comment ID 28479 under comment code 6200. A Health Advisory will

not be needed.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1855

EPA Comment ID: 21102

EPA Comment Code: 6200

Comment: IX. EPA Should Make Conforming Changes to its Regulation and Policies Consistent

with this Determination

At the same time of its final determination, EP A should maintain its March 2006 guidance for use by EPA regions and states, but update it with the n ew Health Advisory, if the decision is made to set

one. The RfD is a conservative safe dose as ha s been noted throughout our comments. The current guidance allows state and local officials to factor in site-specific considerations and populations as opposed to making local decisions guidance data ba sed upon nationally representative exposure data.

Issuing a health advisory and revised guidance at the same time as the agency issues a final determination provides a strong clear message fr om EPA headquarters to EPA regions as well as state and local public health officials on the final federal policy related to perchlorate. It brings to close any uncertainty at the federal level on the issue , thereby providing state and local officials with regulatory certainty and allowing them to move fo rward in addressing site-specific contamination.

Response: See response to comment ID 28479 under comment code 6200. A Health Advisory will

not be needed.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0521

EPA Comment ID: 28475

EPA Comment Code: 6200

Comment: Based on the occurrence, health risk, and re lated findings presented in the Agency’s analysis we also believe that a health advisory is appropriate. It is evident that perchlorate is a problem in specific targeted areas. A health advisory will provide the acceptable levels that are safe

for local communities with contaminated source water.

Response: See response to comment ID 28479 under comment code 6200.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1040 of 1099 Commenter Name: Mark S. Mayer Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28479

EPA Comment Code: 6200

Comment: - Where Perchlorate is a problem, it is important that EPA provide resources to those states to appropriately and consistently respond. Th e first step should be for EPA to establish a health advisory that can be used to identify potential problems at the local level.

Response: EPA has determined the need to regulate pe rchlorate and will develop a NPDWR. As a result, a health advisory will not be necessary.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28505

EPA Comment Code: 6200

Comment: A Health Advisory is step one - If the Agency is not going to develop a full national regulation, it needs to provide adequate support for those entities (water systems and states) that are going to respond at the local level. In the Octo ber 2008 Federal Register notice, EPA committed to publishing a Health Advisory for perchlorate at the time of the final determination in order to provide information regarding potential health risk s from perchlorate- contaminated drinking water. States fully support this action and recommend that the Agency finalize the interim January 2009 health advisory as soon as possible. ASDWA also recommends that EPA prepare educational materials to help states and water systems use th e Health Advisory to educate the public about perchlorate in the systems where it is detected.

Thank you for your consideration of these comm ents. Please contact me at 703-812-9507 or jtaft@asdwa.org if we can provide additional informat ion or if any clarification of these comments is

needed.

Sincerely, James D. Taft Executive Director

Response: See response to comment ID 28479 under comment code 6200.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0494

EPA Comment ID: 28832

EPA Comment Code: 6200

Comment: In addition, if EPA chooses to update its he alth advisory, AMWA recommends that the agency take care to explain the difference bet ween perchlorate and other chemical compounds. Perchlorate is an endocrine disruptor an d in the words of one peer reviewer,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1041 of 1099 "However, as noted above, what is still needed at the beginning of the document is a brief overview of the toxicokinetics of perchlorate, iodine as an essential element for the synthesis of thyroid hormones, why thyroid hormone sufficiency is importan t, what homeostasis is - perchlorate affects a self-regulating system which has evolved numerous feedback mechanisms to compensate for deficiency induced by inadequate intake, iodine uptake inhibition, illness and that within the homeostatic range, which is robust in humans, this system is successful. [The same would be true for excess.] In other words, the biological impacts of perchlorate are very different from those for chemical compounds which have direct target or gan toxicity and/or do not directly affect the availability of an essential element for which hom eostasis occurs." (EPA, 2008. Comment- Response Summary Report. Peer Review of Drinking Water Health Advisory for Perchlorate, page 7).

Response: EPA agrees that this suggested information should be incorporated into support documentation for the impending NPDWR.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1042 of 1099 

### EPA Comment Code: 6210 Need for EPA to provide additional support to States and water systems

Individual Comments

Commenter Name: Paul J., P.E. Ponturo Commenter Organization: Long Island Water Conference

EPA Document ID: EPA-HQ-OW-2008-0692-1260

EPA Comment ID: 20625

EPA Comment Code: 6210

Comment: However we wish to point out that those States that need to develop their own standards, potentially as many as 26 according to the preliminary determination, will need to make other complex decisions beyond establishing an MCL. EPA knows the importance of a fully-formed regulation that is legally defendable. To that end decisions will need to be made as to acceptable analytical methodologies, best available treatm ent technology and treatment residuals disposal, minimum analytical frequencies, and perchlorate occu rrence processes. It should also be recognized that companion regulations will need to be developed to identify and restrict industrial applications and storage of chemicals containing perchlorate. Unmeasured perchlorate may exist in products in common use, yet the users may be unaware of a po tential concern. As previously stated, many perchlorate detections do not trace to known sources.

Therefore we do wish to state our concern that st ates may lack the resources to develop a robust regulatory response to their individual perchlora te issues. We would respectfully request that EPA's guidance to the states should also incorporate a Federal resource commitment to the other aspects of the regulatory problem that the states will have to face. EPA should also continue to be a clearing house of information on perchlorate and commit research dollars to encourage the development of economically viable treatment alternatives, and to better understand perchlorate occurrence.

The Conference appreciates your consideration of th ese comments and looks forward to seeing the continued development of this important regulation.

Very truly yours, Kenneth S. Claus Cha irman, Long Island Water Conference

Response: See the response to comment code 6120. EPA acknowledges commenter’s concern

about decisions that will need to be made as to ac ceptable analytical methodologies, best available treatment technology and treatm ent residuals disposal, minimu m analytical frequencies, and perchlorate occurrence processes. These issues are fa ctors that EPA will consider when developing a NPDWR for perchlorate. Upon promulgating a NPDW R, EPA will provide States and public water systems with information in regards to perchl orate treatment techniques. EPA acknowledges commenter’s statement “...It should also be recogn ized that companion regulations will need to be developed to identify and restrict industrial a pplications and storage of chemicals containing perchlorate.” However this subject matter pertains to EPA’s RCRA regulations and falls outside of the scope of this regulatory action.

Pursuant to SDWA section 1412(b)(4)(E), 42 US C 300g-1(b)(4)(E), when EPA publishes a NPDWR establishing an MCL, the Administrator must list technologies, treatment techniques, and other means that the Administrator finds feasible for meeting the MCL, and:EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1043 of 1099 The Administrator shall include in the list any technology, treatment technique, or other means that is affordable, as determined by the Administrator in consultation with the States, for small public water systems serving--

(I) a population of 10,000 or f ewer but more than 3,300;

(II) a population of 3,300 or fewer but more than 500; and

(III) a population of 500 or fewer but more than 25;

and that achieves compliance with the maximu m contaminant level or treatment technique, including packaged or modular systems and poi nt-of-entry or point-of- use treatment units.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Agencies

EPA Document ID: EPA-HQ-OW-2008-0692-1527

EPA Comment ID: 20636

EPA Comment Code: 6210

Comment: Provide additional guidance to support states and water systems - In addition to the health effects, systems will need to know what tr eatments are effective for various types of source water and levels of perchlorate. Systems will al so need information to help them evaluate nontreatment alternatives to perchlorate control (if available). ASDWA would be willing to work with EPA and other partners to determine what su pporting materials should be developed.

Thank you for your consideration of these comments. We feel that perchlorate is somewhat of a special case due to its high profile and potential for causing adverse health effects and therefore deserves something beyond just a health adviso ry to support state drinking water programs. We hope the Agency will be willing to take these addi tional steps and we are ready to help develop a reasonable plan. Please contact me at 703-812-9507 or jtaft@asdwa.org if we can provide additional information or if any clarificati on of these comments is needed.

Sincerely, James D. Taft Executive Director

Response: EPA agrees and has decided to regulate perc hlorate in drinking water. See response to

comment code 6120. Pursuant to statutory requirements, EPA intends to publish and seek public comment on technology, treatment techniques, and other means which the Administrator finds to be feasible for purposes of meeting the pr oposed maximum contaminant level. The proposed regulation will also include an assessment of alternative treatment techniques that EPA is considering.

Commenter Name: Tina Carroll Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2189

EPA Comment ID: 22382

EPA Comment Code: 6210EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1044 of 1099 Comment: I am deeply concerned that there known so urces of perchlorate contamination in our area and the EPA has chosen to do nothing a bout it. All Americans deserve healthy and clean drinking water and I urge you to reverse your deci sion and to set a national drinking water standard for perchlorate.

Sincerely, Tina Carroll 3253 Chestnu t Avenue Baltimore, MD 21211

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment

code 6120.

Commenter Name: Mark S. Mayer Commenter Organization: South Dakota Department of Environment & Natural Resources (DENR)

EPA Document ID: EPA-HQ-OW-2009-0297-0467

EPA Comment ID: 28480

EPA Comment Code: 6210

Comment: - Where Perchlorate is a problem, it is also important that EPA provide technical information on effective treatment options for vari ous source waters and levels of Perchlorate.

Response: EPA has determined that regulation of perchl orate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. This action initiates the process to establish a national primary drinking water regulation (NPDWR) for perchlorate. EPA will provide an evaluation of feasible treatment technologies and small system compliance techniques as part of the proposed NPDWR.

Commenter Name: James D. Taft Commenter Organization: Association of State Drinking Water Administrators

EPA Document ID: EPA-HQ-OW-2009-0297-0525

EPA Comment ID: 28504

EPA Comment Code: 6210

Comment: Additional issues - In closing, we would like to recap some of our previous comments related to the regulation of perchlorate. These are still valid points and need to be considered, regardless of what final determination is made.

Regardless of EPA's regulatory decision, states w ill need to act - Even if EPA does not adopt a national regulation of perchlorate, the public will li kely demand a response to detections of elevated levels of perchlorate - particularly, in light of the notoriety associated with this contaminant. In states where there are detections of perchl orate at levels of concern, drin king water programs need to be able to respond appropriately so that public health can be protected. At a minimum, states will need to assist individual water systems with the sp ecific actions needed to control perchlorate. Information is needed from EPA on risk characterization and risk management as well as treatment options and alternative control measures to support st ate efforts. In some cases, a state may decide that perchlorate is common enough in their source waters that they are interested in developing
statewide measures, whether it is a formal monitori ng program or a state sp ecific MCL. We believe the Agency has data and expertise that can help support these actions.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1045 of 1099 Response: EPA agrees and has decided to regulate perc hlorate in drinking water. See response to comment code 6120 and response to comme nt ID 20634 under comment code 6130.

Commenter Name: Danielle Blacet Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2009-0297-0208

EPA Comment ID: 28921

EPA Comment Code: 6210

Comment: 3) Colorado River implications

As USEPA is aware, much of Southern Califor nia depends on a reliable water supply from the Colorado River, and our members actively participa te with other Colorado River basin states to help ensure the delivery of a quantity and quality of wa ter that will meet our environmental, urban and agricultural needs. This situation has become even more critical with the recent droughts in the

Colorado River basin and California.

ACWA strongly recommends that during its science-based review and ultimate regulatory determination for perchlorate, USEPA remains cogn izant of the sources and impacts from interstate perchlorate contamination to all California utilitie s, particularly those that rely on the Colorado River. This especially is relevant to agricultur al use of Colorado River water and concentration of perchlorate in produce shipped nationwide. We wo uld like to work with USEPA on ways to address this very important issue.

Response: EPA has determined that regulation of perchl orate in drinking water systems presents a meaningful opportunity to reduce health risk for persons served by public water systems. See response to comment code 6120. This action initia tes the process to establish a national primary drinking water regulation (NPDWR) for perchlora te. In developing the proposed national primary drinking water standard, EPA will consider the de gree to which perchlorate is present in public water supplies in all systems throughout the U.S. EPA intends to publish the proposed NPDWR for public comment along with health risk reduction and cost analysis, feasibility analysis and other analyses required for regulatory development un der the SDWA. EPA will consider comments on the proposed NPDWR and then promulgate the final regulation.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1046 of 1099 

### EPA Comment Code: 6300 EPA's intentio n to revise guidance on clean-up levels (preliminary remediation goals)

Response to Code 6300 : While EPA recognizes that perchlorate has been a contaminant of

concern at a number of sites that have (or may in the future) require cleanup, it is not appropriate for the Agency to establish national primary drinking water regulations for the purpose of establishing cleanup levels at contaminated sites. Rather, the Safe Drinking Water Act specifies the criteria which compels regulation of a contamin ant. EPA must determine that the contaminant meets three criteria: 1) the contaminant may ha ve an adverse effect on human health, 2) the

contaminant is known to occur or there is a substan tial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern, and 3) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for the reduction of health risks from perchlorate for persons served by public water systems. We would note, however, that on January 8, 2009, EP A issued guidance that revised the preliminary remediation goal (PRG)[Footnote] for perchlorate in soil from 24.5 ug/L to 15/ug/L, which states that where no federal or state applicable or relevant and appropriate (A RAR) requirements exist under federal or state laws, 15 ug/L is recomme nded as the PRG for perchlorate when making CERCLA site-specific cleanup decisions where ther e is an actual or potential drinking water exposure pathway (http://www.epa.gov/fedfac/do cuments/perchlorate_memo_01-08-09.pdf). Depending on EPA's final decision regarding a national primary drinking water standard for perchlorate, the Agency ma y modify this guidance.

Footnote: PRGs are not cleanup levels, but ar e specific statements of desired endpoint concentrations or risk levels (55 FR 8713 (March 8, 1990)) that are conservative, default endpoint concentrations used in screening and initial development of remedial alternatives before consideration of information from the site-specific risk assessment.

Individual Comments

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0166

EPA Comment ID: 20276

EPA Comment Code: 6300

Comment: AMWA believes that factors other than those discussed in the notice need to be considered. The contamination of water supplies by perchlorate is on-going, since perchlorate is still in use at various DoD sites, airfields and rocket manu facturing facilities. In addition, because there is no cleanup standard, perchlorate that has entered the soil and contaminated aquifers will likely spread, leading to additional impacted sites.

When a contaminant is polluting drinking water su pplies and the lack of a standard is impeding pollution prevention and cleanup, then an appropria te course of action is needed. Several of the contaminants in the notice deemed appropriate fo r a determination not to regulate are pesticides that have not been produced or used for decades and have low and decreasing occurrence levels.
Perchlorate, on the other hand, is still in use and is expected to have increasing occurrence levels as contamination migrates from soils to ground wa ter aquifers, potentially resulting in impacts on increasing numbers of water systems - clearly a call for action.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1047 of 1099 Response: See response to comment code 6300. The Ag ency has determined that the three SDWA criteria for regulatory determination have been me t for perchlorate. See response to commend code

6120.

Commenter Name: Diane VanDe Hei Commenter Organization: AMWA

EPA Document ID: EPA-HQ-OW-2008-0692-1525

EPA Comment ID: 20445

EPA Comment Code: 6300

Comment: Cleanup Standards

AMWA agrees with the agency that guidance regarding perchlorate and cleanup levels under the National Oil and Hazardous Substances Continge ncy Plan (National Contingency Plan, NCP) should be revised downward from the present pr eliminary remediation goal (PRG) of 24.5 ppb. AMWA believes, however, that an appropriate PRG to protect drinking water and it users should

assume that contaminated water sources would be used as drinking water. Perchlorate contaminated sites should be cleaned up to some fraction of the HRL (such as two-thirds or 10 ppb) so that any levels consumed are reliably and consistently below the HRL.

Since the recommended PRG generally is the starti ng point for determining appropriate site-specific cleanup levels, AMWA believes it is appropriate to st art at levels that allow a margin of safety with respect to the HRL to account for the variable nature of continuing contamination and occurrence fluctuations. The level could then be adjusted up or down depending upon the site specifics. The PRG based on the HRL should not supplant more stringent state standards.

Response: See response to comment code 6300.

Commenter Name: Thomas L. Schoaf Commenter Organization: Cities of Litchfield Park and Goodyear, AZ

EPA Document ID: EPA-HQ-OW-2008-0692-1552

EPA Comment ID: 20555

EPA Comment Code: 6300

Comment: Historical industrial operations have impa cted the aquifer in the PGA North Superfund Site with TCE and perchlorate. The EPA Region 9 is currently overseeing a private party financed cleanup of the TCE impacted groundwater at the si te. The remedy consists of several independent groundwater pump-and-treat systems. The treated water is either used as an irrigation supply or reinjected into the aquifer. Future remedies bein g considered to address the currently expanding TCE plume may entail providing the treated water for drinking water purposes. Where groundwater is being reinjected to the aquifer, EPA Region 9 is requiring the private party to treat for perchlorate as well as TCE in order to avoid aquifer degradat ion in areas not impacted by the plume. However, no treatment is required for water used as an irri gation supply. Since perchlorate, unlike TCE, has no established standard, EPA 9 is relying on guidance and "To Be Considered" criteria to require treatment of reinjected water at the PGA-Nort h Superfund Site. Without the strength of a promulgated standard, we are concerned that EPA Re gion 9 will not be able to ensure that future remedies require perchlorate treatment. Further, gu idance levels and To Be Considered criteria mayEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1048 of 1099 not provide EPA Region 9 the necessary authority to require that the responsible party implements an effective remedy to address the historical pe rchlorate contamination in the aquifer-our future water supply.

Response: See response to comment code 6300.

Commenter Name: Mic Stewart Commenter Organization: Metropolitan Water District of Southern California

EPA Document ID: EPA-HQ-OW-2008-0692-1784

EPA Comment ID: 20664

EPA Comment Code: 6300

Comment: * Applicable or Relevant and Appropriate Requirements (ARARs) - While California has a drinking water MCL of 6 ppb for perchlorate, M etropolitan suggests that given any decision by the EPA not to regulate perchlorate, the ARARs called fo r in regulatory cleanup be set at the drinking water standard in states with an MCL for perchlorate. This would provide cleanup guidance for

contaminated sites.

* Site specific cleanup levels - EPA states that th e Health Advisory value can be used as a "to be considered value" for developing cleanup levels fo r perchlorate contaminated sites (i.e., Superfund). The Health Advisory value that should be stipulated in the final health advisory document will be set at a level to provide protection to the population. Si tes that are potential sources of drinking water, or impact sources of drinking water, should be required to treat to a level that protects the population. A "to be considered" criteria for clean-up levels is not adequate to provide protection to the public.

Metropolitan appreciates this opportunity to provide input on the proposed regulatory determination for perchlorate and asks that EPA carefully consider these comments before publishing the final rule. Please contact me at (2 13) 217-5696 if you have any questions, or if I can provide additional information.

Very truly yours, Mic Stewart, PhD Manager, Water Quality Section

Response: See response to comment code 6300. The Ag ency has determined that the three SDWA criteria for regulatory determination have been me t for perchlorate. See response to commend code

6120.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1049 of 1099 

### EPA Comment Code: 6310 Clean up as a solution

Individual Comments

Commenter Name: Kay Brothers Commenter Organization: Southern Nevada Water Authority

EPA Document ID: EPA-HQ-OW-2009-0297-0648

EPA Comment ID: 28495

EPA Comment Code: 6310

Comment: October 8, 2009

Water Docket Environmental Protection Agency Ma ilcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

SUBJECT: Comments on the Drinking Water: Pe rcholorate Supplemental request for Comments Docket ID No. EPA-HQ-OW-2009-0297

The Southern Nevada Water Authority (Authority) submitted detailed comments, dated September 17, 2009, on the preliminary regulatory determinati on for perchlorate as listed in the August 19, 2009 Federal Register (74FR41883). We would like to submit the following additional comments regarding the Authority's commitment to ensure that perchlorate clean-up efforts continue along the Las Vegas Wash (Wash) upstream from Lake Mead.

As outlined in our comments previously submitted, perchlorate clean-up efforts in the Wash have significantly decreased the levels of perchlorate in Lake Mead and the lower Colorado River system. Tronox, Inc., (Tronox) owns the facility in Hender son, Nevada that produced perchlorate from 1952-2002. The site is the source of perchlorate co ntamination of groundwater that enters the Wash (which empties into the Colorado River). Currently, the contaminated water is intercepted at the Wash, treated in a remediation system financed by Tronox, and discharged into the Wash. The system is operated at the direction of the Neva da Division of Environmental Protection (NDEP), which estimates the current annual cost of operation at $6,000,000 with a potential remediation span of 100 years. On January 12, 2009, Tronox filed a petition for reorganization in United States Bankruptcy Court for the Southern District of New York.

The Authority, in order to actively participate in the litigation and to protect its strong interest in continued groundwater remediation and eventual elimination of the source of perchlorate contamination, hired the New York City bankruptcy firm of Kramer Levin Naftalis & Frankel. The Authority has filed a proof of cl aim, is examining the terms of a proposed sale of the Henderson site, and is working in concert with the Metropo litan Water District of Southern California (MET)

and the Central Arizona Water Conservation Distri ct (CAP) to ensure that remediation efforts receive an adequate accounting and future funding.

To summarize, the Authority in concert with the NDEP and our partners, CAP and MET, are committed to ensuring the clean-up of perchlora te continues along the Wash. If you have any questions regarding our comments, please contact me directly at (702) 862-3707.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1050 of 1099 Sincerely, Kay Brothers Deputy General Manager Engineering and Operations

KB/df

cc: Jeffrey Kightlinger, General Manager - Metropolit an Water District of Southern California David Modeer, General Manager - Central Arizona Project

Response: No response necessary for this comment.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1051 of 1099 

### EPA Comment Code: 6400 EPA's decision to subject updated PBPK model to peer review during comment period (in the October 2008 FR Notice)

Response to Code 6400 : EPA reviewed, modified, and applied the perchlorate PBPK models, which were originally developed by Merrill et al. (200 5) for adults and Clewell et al. (2007) for other life stages, to estimate the iodide uptake inhibiti on in the thyroid for each life-stage (73 FR 60262). Estimated ingestion rates were then used to estimate the internal dose and resulting iodide uptake inhibition for several life stages, including suscep tible populations (e.g., pregnant women and their fetuses, as well as breast-fed and bottle-fed infants).

The draft report, “Inhibition of the Sodium-Iodid e Symporter by Perchlorate: An Evaluation of Lifestage Sensitivity Using Physiologically-based Pharmacokinetic (PBPK) Modeling,” underwent a formal external peer review by eight experts in accordance with EPA guidance concurrently with the public comment period. Based on the external peer review comments, the models and report were revised. The final report, peer review report, and a summary of peer review comments and EPA responses are available at http://cfpub.epa .gov/ncea/cfm/recordisplay.cfm?deid=199347.

In the August 2009 notice, EPA stated that it was re-evaluating how best to incorporate the PBPK modeling analysis into its evaluation of perchlor ate — if at all. The Agency sought comments on ways to use the PBPK modeling analysis to inform the regulatory determination.

After further consideration of the peer review and public comments, EPA concludes that the PBPK modeling analysis, in the context of the perchlorat e regulatory determination, is useful in examining which life stages are most susceptible to the effects of perchlorate. However, because of the stated
limitations, EPA has decided the model does not di rectly bear on the current decision regarding the need for a NPDWR for perchlorate. EPA is continuing to evaluate whether the model could be used in setting a NPDWR for perchlorate.

Individual Comments

Commenter Name: Diane VanDe Hei Commenter Organization: AMWA

EPA Document ID: EPA-HQ-OW-2008-0692-1525

EPA Comment ID: 20443

EPA Comment Code: 6400

Comment: November 10, 2008

Water Docket U.S. Environmental Protection Ag ency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Drinking Water: Preliminary Regulatory D etermination on Perchlorate; Docket EPA-HQ-OW2008-0068

Dear Water Docket:

AMWA appreciates the opportunity to comment on the preliminary regulatory determination for perchlorate as listed in the October 10, 2008 Fe deral Register (73 FR 60262). AMWA stronglyEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1052 of 1099 supports the process required by the 1996 Amendments of the Safe Drinking Water Act that places a strong emphasis on science and focuses on contaminants which: may have an adverse effect on humans, occur or are likely to occur at levels of public health concern and provide a meaningful opportunity for health risk reduction.

Members of Congress, the Administrator and the pub lic have all weighed in on the need to regulate perchlorate. Concern over the lack of a regu latory path forward coupled with differing interpretations of the available scientific informati on has led to significant controversy. In such an environment, decisions need to be supported by peer reviewedscience to garner general acceptance. Accordingly, AMWA has several recommendations for the agency concerning peer review, review by the National Academy of Sciences (NAS), retention on the Contaminant Candidate List (CCL), the need for a strong cleanup standard, and othe r considerations. The remainder of these comments

will address each in turn.

Peer-Review

In the Federal Register Notice, EPA expresses its intention to subject several key scientific points used in the decision process to peer-review before finalizing the determination. The agency notes that adjustments have been made to a pr eviously peer-reviewed physiologically based pharmacokinetic (PBPK) model for predicting iodi de uptake for several sensitive subpopulations. Additionally, the agency feels that it is pertin ent to have a peer-review panel consider the appropriateness of the model for addressing non-adult populations. AMWA agrees that such reviews are appropriate and necessary. However, th e agency should assure that peer review panel questions are posed so that the usefulness of the model is explored with specific regard to the most sensitive subpopulations. Specifically, detailed commen t should be solicited on whether the lack of data on early fetal radioactive iodide uptake i nhibition would be expected to affect the agency’s determination that a Health Reference Level (HRL ) of 15 ppb is protective of pregnant women and

fetuses.

Response: See response to comment code 6400.

Commenter Name: Robert Howd Commenter Organization: California Environmental Protecti on Agency, Water Toxicology

Section

EPA Document ID: EPA-HQ-OW-2008-0692-1671

EPA Comment ID: 20645

EPA Comment Code: 6400

Comment: FROM: Robert A. Howd California Envi ronmental Protection Agency, Office of

Environmental Health Hazard Assessment

November 7, 2008

Water Docket Environmental Protection Agency Ma ilcode: 2822T 1200 Pennsylvania Ave., NW Washington, DC 20460

Subject: Comments to Docket ID No. EPA-HQ-OW-2008-0068EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1053 of 1099 To Whom It May Concern:

Thank you for providing the opportunity to comm ent on the Federal Register announcement of Friday, October 10, 2008, titled "Drinking Water: Preliminary Regulatory Determination on Perchlorate" (FR 73, no. 198, pp. 60262- 82 ). These comments were prepared by the Water Toxicology Section of the California Office of Environmental Health Hazard Assessment.

II(D), p 60265. EPA states that its regulatory d etermination on perchlorate has been based in part on a PBPK model with adjustments made by EPA that have not been peer reviewed (U.S. EPA, 2008). Some of the adjustments, including perchlora te inhibition of fetal iodide uptake, are critical to the interpretation. We recommend that such a peerreview, plus opportunity for public comment on the model, be carried out before EPA publis hes its final determination on perchlorate.

Response: See response to comment code 6400.

Commenter Name: Deborah Swackhamer Commenter Organization: Science Advisory Board

EPA Document ID: EPA-HQ-OW-2008-0692-1749

EPA Comment ID: 20659

EPA Comment Code: 6400

Comment: November 5, 2008

The Honorable Stephen L. Johnson Administrato r U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Dear Administrator Johnson:

Thank you for your memorandum of October 20, 20 08, requesting that the Science Advisory Board (SAB) undertake a study to provide advice on how EP A can strengthen scientific assessments, better communicate the results of assessments, and integra te natural science assessment with economic and social assessments to support EPA decision maki ng. I had the opportunity to discuss the request with my colleagues this week at a public adviso ry meeting of the chartered SAB. We will undertake this effort with the goal of providing advice to the new EPA Administrator within a year.

At our public meeting on October 28, 2008, the chartered SAB also discussed a draft report from the SAB's Drinking Water Committee on EPA's Draft Third Drinking Water Contaminant Candidate List (CCL3). The Committee’s draf t report highlighted its recommendation that perchlorate is one of four chemicals that "should be a high priority for consideration by the Agency, because there is a higher degree of certainty abou t their toxicity, occurrence, and treatability."

The SAB is also aware that EPA published a Drin king Water: Preliminary Regulatory Determination on Perchlorate in the Federal Register on Oct ober 10, 2008 (73 FR 602 62-60282). That notice provides a preliminary determination that "a na tional primary drinking water regulation (NPDWR) for perchlorate would not present 'a meaningful opportunity for health risk reduction for persons served by public water systems' " and provides a thirty-day public comment period. The notice also states that EPA plans to issue a final regulatory determination by Decemb er 2008. It should beEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1054 of 1099 noted that this preliminary determination relies on the use of a dosimetric model which is now undergoing letter peer review, and thus, it s soundness will not be publicly vetted.

Given perchlorate's wide occurrence and well-docu mented toxicity to humans, the SAB strongly believes that there must be a compelling scientif ic basis to support a determination not to regulate perchlorate as a national drinking water contamin ant. The quality of the scientific foundation for EPA's decisions depends on peer review, which brings a variety of scientific perspectives to bear on critical components of EPA's decisions. Where sc ience assessments have been conducted with the benefit of external scrutiny, the end products have been better able to support the policy making process. This view is very much aligned with the perspectives expressed in your memorandum to the

SAB.

Response: Administrator Stephen Johnson replied to the SAB on January 9, 2009. The letter is available in EPA’s docket ID No. EPA-HQ-OW-2009 -0297 for this notice. which is located in docket EPA-HQ-OW-2008-0692.

Commenter Name: Lynn Thorp Commenter Organization: Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-2017

EPA Comment ID: 20851

EPA Comment Code: 6400

Comment: We are particularly concerned that the preliminary determination was issued before peer reviews of the physiologically-based pharmacokin etics (PBPK) model used to derive the health

reference level AND the health refe rence level itself were available. Given widely varying analysis of existing data, these peer reviews could shed impor tant light on the Agency’s deliberations. We urge the Agency to reconsider its determination and to ta ke the time necessary to fully consider setting a federal standard for perchlorate in drinking water.

I appreciate the opportunity to weigh in on this important decision and am happy to provide more information if required.

Sincerely, Lynn Thorp, National Campaigns Coordinator CC: Eric Burneson, OGWDW

Response: See response to comment code 6400.

Commenter Name: Caroline Baier-Anderson, PhD Commenter Organization: Environmental Defense Fund

EPA Document ID: EPA-HQ-OW-2008-0692-1797

EPA Comment ID: 20949

EPA Comment Code: 6400

Comment: The Post hoc Application of PD Modeling Inappropriately Allows the Exceedence of

the RfD

EPA has chosen to use a novel approach in setting a risk-based health risk level for perchlorate by using physiologically based pharmacokinetic modeli ng to justify the exceedence of the referenceEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1055 of 1099 dose at a level ranging from 2 - over 5%. In do ing so, EPA would allow perchlorate exposures to attain unacceptably high levels.

The model that EPA is using has not yet completed peer review, so that stakeholders have no assurance that the model design is appropriate for th e task at hand. EPA should wait until the peer review process is complete before applying this model for official purposes as the peer review process could uncover important limitations of the model. For instance, while the model reports that predicted perchlorate blood levels would be higher in the fetus, lactating women and neonates, it is not clear if the model includes new information regarding the impact of TSH on NIS uptake of perchlorate (e.g., Tran et al. 2008 is not cited in the EPA document describing the model, EPA/600/R-08/106A), nor is it known how this new information might affect the modeling results. A peer review panel would be in the best posit ion to weigh in on questions such as this one.

It is also not clear if the model has been valid ated using responses of sensitive populations that include sub-optimal iodine intake. Given the documented impact on response to perchlorate exposure, this is would be an important step in the validation process. The model extrapolations were reportedly compared to data from the Chile an population, which as noted above, was fully iodine sufficient. Considering the demographics of iodine insufficiency in the US, it is imperative that the model extrapolations also be compared with data from a population that is not iodine

sufficient.

Response: See response to comment code 6400.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20998

EPA Comment Code: 6400

Comment: Despite these conclusions, only one week later and without waiting for the report to be peer-reviewed and available for public comment , EPA announced that it would not regulate perchlorate in drinking water. Although the Federal Register notice does report the staff conclusions, it contradicts them concluding that "EPA believes drinking water with perchlorate concentrations at or below the HRL of 15 ug/L is protective of all subpopulations."[FN52: Id. at 60280]

Response: EPA has decided to regulate perchlorate in drinking water. See response to comment code 6120 and response to comment code 6400.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 21004

EPA Comment Code: 6400

Comment: First, such a determination is premature, si nce the Agency is still awaiting peer review comments on the HRL and has only just received peer review comments on the PBPK model.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1056 of 1099 Response: See response to comment code 6400.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1057 of 1099 

### EPA Comment Code: 6500 Comments on alte rnative risk reduction approaches

Individual Comments

Commenter Name: Richard T. Kloos Commenter Organization: American Thyroid Association (ATA)

EPA Document ID: EPA-HQ-OW-2009-0297-0635

EPA Comment ID: 28530

EPA Comment Code: 6500

Comment: We are writing on behalf of the American Thyroid Association (ATA) in response to your request for comments (Fed Reg 74:41883, 08 /19/09) regarding EPA's perchlorate regulatory determination. The ATA represents the largest and most established group of physicians dedicated to the study of the thyroid gland and its disorders.

Decreases in maternal thyroid hormone associated with even mild iodine deficiency may have adverse effects on the cognitive function of offsprin g.1,2,3 It has recently been suggested that mild iodine deficiency may also be associated with th yroid deficiency resulting in attention deficit and hyperactivity disorders in offspring.4 Iodine defi ciency affects over 2.2 billion individuals worldwide (38% of the world’s population), and iodine deficiency is the leading cause of thyroid failure causing preventable mental retardation worldwide.5

Over the last few decades, iodine intake in the Un ited States has declined.6 Although iodine intake remains sufficient for the general U.S. population, there have been concerns in recent years that some pregnant women and women in their childbear ing years may have inadequate iodine intake.7,8 For this reason, in 2006 the ATA published recomme ndations for iodine supplementation of all U.S. pregnant and lactating women.9 These guidelines have not been widely adopted, and the availability and frequency of use of iodine-containing prenatal multivitamin supplements among pregnant U.S. women remains suboptimal.10,11

Response: See response to comment ID 28842 under comment code 6500. As discussed in detail in the final regulatory determination, EPA has found that perchlorate may

have an adverse effect on human health.

Commenter Name: Richard T. Kloos Commenter Organization: American Thyroid Association (ATA)

EPA Document ID: EPA-HQ-OW-2009-0297-0635

EPA Comment ID: 28532

EPA Comment Code: 6500

Comment: We would strongly urge that, whatever the EPA determines about the need for regulation of perchlorate in drinking water, attenti on should be paid to ensuring adequate iodine nutrition in the U.S., particularly amon g women who are pregnant or lactating.

Thank you for this opportunity to comment upon and contribute to your regulatory determination for perchlorate. Clearly, there is more need for studie s in this area in order to obtain greater clarity.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1058 of 1099 Sincerely, Richard T. Kloos, M.D. Secretary/ Chief Operating Officer, American Thyroid
Association Co-Director, The Ohio State Univ ersity Thyroid Cancer Unit Divisions of Endocrinology and Nuclear Medicine Columbus, OH. 43210-1296 Richard.Kloos@OSUMC.edu

Terry F. Davies, MB.BS, MD, FR CP, FACE President, American Thyroid Association Florence and

Theodore Baumritter Professor of Medicine Moun t Sinai School of Medicine One Gustave Levy
Place, Box 1055 New York, NY 10029-6574

References

1 World Health Organization, United Nations Children’s Fund, and International Council for the Control of Iodine Deficiency Disorders. Assessment of iodine deficiency disorders and monitoring their elimination. A guide for programme manage rs, 3rd Edition. Geneva, Switzerland: World Health Organization, 2007. 2 Vermiglio F, Lo Presti VP, Castagna MG, Violi MA, Moleti M, Finocchiaro MD, Mattina F, Artemisia A, Trimarchi F. Increased risk of maternal thyroid failure with pregnancy progression in an iodine deficien t area with major iodine deficiency disorders. Thyroid 1999;9:19-24. 3 Morreale de Escobar G, Ob regon MJ, Escobar del Rey F. Iodine deficiency and brain development in the first half of pregnancy. Publ Health Nutr 2007;10:1554-70. 4 Vermiglio ZF, Lo Presti VP, Moleti M, Sidoti M, Tortorella G, Sca ffidi G, Castagna MG, Mattina F, Violi MA, Crisa A, Artemisia A, Trimarchi F. Attention deficit and hyperactivity disorders in the offspring of mothers exposed to mild- modera te iodine deficiency: A possible novel iodine deficiency disorder in developed countries. J Clin Endocrinol Metab 2004;89:60454-60. 5

International Council for Control of Iodine Defi ciency Disorders, www.iccidd.org 6 Hollowell JG, Staehling NW, Hannon WH, Flanders DW, Gunter EW, Maberly GF, Braverman LE, Pino S, Miller DT, Garbe PL, DeLozier DM, Jackson RJ. Iodine nutr ition in the United States. Trends and public health implications: iodine excretion data from National Health and Nutrition Examination Surveys I and III (1971-1974 and 1988-1991). J Clin En docrinol Metab 1998;83:3401-8. 7 Holowell JG, Haddow JE. The prevalence of iodine deficiency in wo men of reproductive age in the United States
of America. Publ Health Nutr 2007;10:1532-9. 8 Pearce EN. U.S. iodine nutrition: where do we stand? Thyroid. 2008 Nov;18(11):1143-5. 9 Becker DV, Braverman LE, Delange F, Dunn JT, Franklyn JA, Hollowell JG, Lamm SH, Mitchell ML , Pearce E, Robbins J, Rovet J. Iodine Supplementation for Pregnancy and Lactation-United States and Canada: Recommendations of the American Thyroid Association. Thyroid 2006;16:9 49-51. 10 Leung AM, Pearce EN, Braverman LE. Iodine content of prenatal multivitamins in th e United States. N Engl J Med 2009;360(9):939-40. 11 Gregory CO, Serdula MK, Sullivan KM. Use of suppl ements with and without iodine in women of childbearing age in the United States. Thyroid. 2009;19(9):1019-20. 12 Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell KL. Urin ary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environmental Health Perspectives 2006;114:1865-71.

Invited Editorial [see PDF docket ID EPA-HQ-OW-2009-0297-0635]

Response: See response to comment ID 28530 under comment code 6500.

Commenter Name: Stephen Haterius Commenter Organization: National Association of State De partments of Agriculture (NASDA)

EPA Document ID: EPA-HQ-OW-2009-0297-0664EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1059 of 1099 EPA Comment ID: 28549

EPA Comment Code: 6500

Comment: It is key to this discussion that exposure to perchlorate is only potentially problematic for individuals with iodine deficiency. There is no evidence[FN1: United States Food and Drug Administration. Perchlorate Questions and Answers. http://www.fda.gov/Food/FoodSaf ety/FoodContaminantsAdulteration/ ChemicalContaminants/Perchlorate/ucm077572.htm] that iodine deficiency is a widespread problem in the United States, and that only indi viduals who are on restrictive diets or purposely avoid iodine consumption are at risk for such a de ficiency. While there is no evidence that iodine deficiency is a widespread problem in the US, wo men of child-bearing age and pregnant women are theoretically more at risk for effects of perc hlorate consumption. Because inadequate iodine consumption during pregnancy can lead to negative birth outcomes, any further reduction uptake by the thyroid from exposure to perchlorate could pose a risk. While there is no evidence of widespread iodine deficiency in women of child-bearing age or pregnant women, this subpopulation could be targeted with education about diet during pregnancy and appropriate prenatal care that stresses the importance of adequate iodine c onsumption during pregnancy.

In conclusion, we point to the EPA Office of In spector General's (OIG) draft review[FN2: United States Environmental Protection Agency. Office Inspector General Scientific Analysis of Perchlorate. http://www.epa.gov/oig/repor ts/2009/20081230-2008-0010.pdf] of EPA's perchlorate assessment which emphasizes a number of important points that are relevant to this discussion. Specifically, the review points to the fa ct that other naturally occurring compounds found in food behave in a way that is similar to perchlorate. According to this review, regulating perchlorate in drinking water is unlikely to have any material impact on public health. We agree with the conclusion in OIG's draft that promoting ade quate iodine intake is a superior approach than regulating perchlorate as a drinking water contaminant.

Because the public health concerns associated with potential perchlor ate consumption can be addressed through education and dietary modifica tions in a small subset of the population, NASDA is very concerned that EPA not adopt an approach that would lead to consumer confusion, food scares, and potential financial devastation for American agricultural producers.

Sincerely, Stephen Haterius Executive Director

Response: See response to comment ID 28530 under comment code 6500. Perchlorate contamination is more widespread in foods than in drinking water; however, EPA does not believe that the widespread presence of perchlorate in f ood overrides the need for public health risk reduction for persons served by PWSs with perc hlorate contamination. The Agency presented an extensive evaluation of dietary exposure to pe rchlorate in the October 2008 and August 2009 notices (73 FR 60262; USEPA 2008a and 74 FR 41883; USEPA 2009b). EPA has used this dietary exposure data to account for the relative source contribution (RSC) of perchlorate from food to estimate the range of levels of public health concern. EPA reco gnizes that a drinking water regulation would not eliminate total perchlorate exposure, but believes that the reduction in perchlorate exposure in drinking water presents a meaningful opportunity for health risk reduction for persons served by PWSs contaminated by pe rchlorate. EPA agrees that promoting iodide nutrition is good public health policy and may have a positive influence in reducing the iodide uptake inhibition effects associated with exposur e to perchlorate. However, the Agency does notEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1060 of 1099 think it is appropriate to rely on the promotion of io dide nutrition in this case, especially since these

activities are outside of EPA’s SD WA authority. As a result, while the health concerns associated with perchlorate may be addressed through other me ans, it is the Administrator’s judgment that a standard limiting perchlorate in drinking water can re duce health risk, particularly to fetuses, infants

and children.

Regarding the OIG report, while EPA acknowledges that nitrate and thiocyanate have the same mode of action as perchlorate, and that the effects of combined exposure to perchlorate, nitrate, and thiocyanate are additive, EPA does not believe there are sufficient scientific data currently available

to assess and characterize the combined risk of these contaminants. EPA has committed to a drinking water strategy that outlines four principl es to expand public health protection for drinking water (USEPA, 2010b). One of these principles is to address contaminants as groups. However, EPA does not believe that regulatory action to address perchlorate should be further delayed. Therefore, EPA intends to develop a proposed rule for perchlorate. At such time as a NPDWR is promulgated, EPA is required to review and revise, as appropriate, its drinking water standards at least every six years. Any revision must at least ma intain or improve public health protection. When

there are sufficient scientific data to assess the cumulative risks of perchlorate and other
contaminants, EPA will review this information to evaluate whether any revisions of NPDWRs are appropriate. EPA has determined the need to regulate perchlor ate in drinking water. Care will be taken to communicate the implications of that regulation.

Commenter Name: John P Gibbs Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0636

EPA Comment ID: 28555

EPA Comment Code: 6500

Comment: Efforts to assure adequate iodine in prenatal vitamins and infant formulas as suggested by the draft OIG report offer the most reasonable and immediate protection from the presence of NIS inhibitors among the recognized sensitive subpopulations.

REFERENCES

Pearce EN, Spencer CA, Mestman J, Lee R, Be rgoglio LM, Mereshian P, He X, Leung AM, Braverman LE, 2008. Thyroid Function is Not Aff ected by Environmental Perchlorate Exposure in First Trimester Pregnant Women from California an d Argentina. Presentation at Annual Meeting of the Endocrine Society, San Francisco, CA, June 15-18, 2008.

Pearce EN, Lazarus JH, Smyth PPA, He X, Dall'Amico D, Parkes AB, Burns R, Smith DF, Maina A, Leung AM, Braverman LE, 2007. Thyroid functi on is not affected by environmental perchlorate exposure in first trimester pregnant women. Thyroid 17 (s1), S-133

Lamm, S.H., Hollowell, J.G., Engel, A., Chen, R., 20 07. Perchlorate, thyroxine, and low urine iodine association not seen with low creatinine-adjusted urine iodine among women of childbearing age. Thyroid 17 (s1), S-51.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1061 of 1099 Tonacchera M, Pinchera A, Dimida A, Ferrarini E, Agretti P, Vitti P, Santini F, Crump K, Gibbs J.Relative potencies and additivity of perchlorate, th iocyanate, nitrate, and iodide on the inhibition of radioactive iodide uptake by the human sodium io dide symporter. Thyroid. 2004 Dec;14(12):1012-9.

Braverman LE, He X, Pino S, Cross M, Magn ani B, Lamm SH, Kruse MB, Engel A, Crump KS, Gibbs JP. The effect of perchlora te, thiocyanate, and nitrate on th yroid function in workers exposed to perchlorate long-term. J Clin Endocr inol Metab. 2005 Feb;90(2):700-6..

Crump KS, Gibbs JP. Benchmark calculations for perchlorate from three human cohorts. Environ Health Perspect. 2005 Aug;113(8):1001-8.

Tellez Tellez R, Michaud Chacon P, Reyes Abarca C, Blount BC, Van Landingham CB, Crump KS, Gibbs JP. Long-term environmental exposure to pe rchlorate through drinking water and thyroid function during pregnancy and the neona tal period. Thyroid. 2005 Sep;15

Gibbs JP. A Comparative Toxicological Assessm ent of Perchlorate and Thiocyanate Based on Competitive Inhibition of Iodide Uptake as th e Common Mode of Action. Human & Ecological

Risk Assess. 2006 Feb 12:157-173

Gibbs JP, Van Landingham CB. Urinary perchlorate excretion does not predict thyroid function among pregnant women. Thyroi d 2008 Jul;18(7):807-8.

Lamm SH, Braverman LE, Li FX, Richman K, Pi no S, Howearth G. Thyroid health status of ammonium perchlorate workers: a cross-sectional occupational health study.J Occup Environ Med. 1999 Apr;41(4):248-60.

Amitai Y, Winston G, Sack J, Wasser J, Lewis M, Bl ount BC, Valentin-Blasini L, Fisher N, Israeli A, Leventhal A. Gestational exposure to high perc hlorate concentrations in drinking water and neonatal thyroxine levels. Thyroi d. 2007 Sep;17(9):843-50

Response: See response to comment ID 28530 under comment code 6500.

Commenter Name: Sonia Salas Commenter Organization: Western Growers Association on behalf of several California agriculture groups

EPA Document ID: EPA-HQ-OW-2009-0297-0652

EPA Comment ID: 28681

EPA Comment Code: 6500

Comment: For iodine, FDA found that each of the 14 age/sex groups, including infants, children, and women of childbearing age exceeded the averag e intake levels estimated by the NAS to meet requirements for healthy individuals.

In light of these findings, FDA continues to st and by its prior recommendation that consumers

should not alter their infants' and children's diets or eating habits. Indeed, many of the foods at issue are major dietary sources of iodine and other nutritionally essential substances.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1062 of 1099 EPA's Calculation of the Relative Source Contri bution for its 2008 Preliminary Regulatory Determination also Reveals that Perchlorate Exposur e from Food is Below any Meaningful Level of

Concern.

Response: EPA calculated potential alternative HRLs th at were included in the August 2009 notice. These values incorporate and estimate perchlorate from food, deriving the potential alternative HRL such that only the water contribution of perchlorate would require adjustment to attain a tolerable perchlorate exposure from all sources. The Agency presented an extensive evaluation of dietary exposure to perchlorate in the October 2008 and August 2009 notices (73 FR 60262; USEPA 2008a and 74 FR 41883; USEPA 2009b). EPA has used this dietary exposure data to account for the relative source contribution (RSC) of perchlorate from food to estimate the rang e of levels of public health concern. EPA recognizes that a drinki ng water regulation would not eliminate total perchlorate exposure, but believes that the reducti on in perchlorate exposure in drinking water presents a meaningful opportunity for health risk reduction for persons served by PWSs contaminated by perchlorate.

Commenter Name: Tom Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0415

EPA Comment ID: 28842

EPA Comment Code: 6500

Comment: AWWA also concurs with the Agency's In spector General [FN1: Wilson, M. 2008. Scientific Analysis of Perchlorate. US Envi ronmental Protection Agency, Office of Inspector General. Available at http://www.epa.gov/oige arth/reports/2009/20081230-2008-0010.pdf] in stating that regulatory action under the Safe Drin king Water Act (SDWA) is not the appropriate or effective way to address the overarching public health issue - iodide deficiency. The National Research Council (NRC) assessment [FN2: Na tional Research Council (NRC). 2005. Health Implications of Perchlorate Ingestion. National Academy Press, Washington, DC.] of perchlorate also recognized iodide deficiency as the larger public health issue.

Response: EPA based its final regulatory determination on a number of different factors including the careful consideration of public comments. Re garding correcting iodine deficiencies, the Food and Drug Administration and Centers for Disease Control generally conclude that there is sufficient iodine in the diet. Below are findings from FDA’ s Total Diet Study (2003-2004) that estimates the dietary intake of iodide for 14 age-sex groups (Murray et al., 2008) and CDC’s National Health and Nutrition Examination Survey that measured perchlor ate in the urine of study participants in (2003- 2004, no data on < age 6). FDA’s Total Diet Study fi ndings: - Infants, 6-11 months, exceeded their Adequate Intake - Children and adult age/sex gr oups exceed their relevant Estimated Average Requirement CDC’s National Health and Nutrition Examination Survey: - "This finding confirms the stability of the U.S. iodine intake and contin ued adequate iodine nutrition for the country in general." - "On the basis of median urinary iodi ne concentrations, iodine intake of women of childbearing age appears adequate."EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1063 of 1099 

### EPA Comment Code: 7000 Miscellaneous Comments

Response to Code 7000 : See response to comment code 61 20 for a discussion of EPA’s decision to regulate perchlorate in drinking water and initiate the development of a proposed national primary drinking water regulation. EPA receive d a number of comments in response to its preliminary regulatory determination for perchl orate(73 FR 60262, October 10, 2008) and the supplemental request for comment on the perchlorate regulatory determination (74 FR 41883, August 19, 2009) that were not directly related to the Agency’s decision to regulate perchlorate in drinking water. These comments are compiled in re sponse to comment code 7000 in this response to comment document. EPA is not directly addressi ng comments that do not relate to the Agency’s decision on whether or not the Agency should promulgate a national primary drinking water regulation (NPDWR) for perchlorate under the Safe Drinking Water Act (S DWA). SDWA provides EPA with the authority to regulate public water systems through national primary drinking water regulations. Under this authority EPA plans to propose and promulgate a regulation that public water systems will have to comply with throug h monitoring and potentially using treatment techniques to reduce the levels of perchlorate in th e drinking water they supply to their customers. The authority under SDWA does not apply to disc harges, improper disposal or other releases of perchlorate or other contaminants. EPA therefor e is not addressing comments related to these concerns under this action. EPA is also not addressing comments related to contaminants other than perchlorate or drinking water policies unrela ted to the perchlorate regulatory determination.

Individual Comments

Commenter Name: W Zielke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0332

EPA Comment ID: 19818

EPA Comment Code: 7000

Comment: We should be finding out how Perchlorates are getting into our water and take steps to prevent that from happening.

Response: See response to comment code 7000.

Commenter Name: Margaret Baco Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0624

EPA Comment ID: 19978

EPA Comment Code: 7000

Comment: Further, there is an urgent requirement to sa feguard public health through effective legal action requiring the provision of relia ble tap water filters in all public establishments, inclusive of tax relief measures. All public schools, hospitals and re staurants should be equipped with this safeguard immediately to reduce the risk of further exposure.

Further, new programs must be established to ensure that private homes are able to afford

installation of effective water filters.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1064 of 1099 Further, legal actions must be established to regulate and control the collection of appropriate disposal of such filters.

Sincerely,

Margaret Baco

Response: See response to comment code 7000. NSF In ternational, the Water Quality Association and other independent certification organizations have certified household treatment systems for perchlorate removal.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0839

EPA Comment ID: 20108

EPA Comment Code: 7000

Comment: PEACELOVE EARTHHEART

Response: This is not a comment, a response is not necessary.

Commenter Name: L. L. Schumacher Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-0664

EPA Comment ID: 20239

EPA Comment Code: 7000

Comment: And what about the highly toxic fumigant you approved for use on strawberries exactly 1 year ago, for one year. Are you going to make that permanent? I would venture to say yes because the "money grubbers" want it and you always rule in their favor.

You should change your name from the Envir onmental Protection Agency, to the Environmental Destruction Agency.

Yours truly, Leonard L. Schumacher

Response: See response to comment code 7000.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association

EPA Document ID: EPA-HQ-OW-2008-0692-1669

EPA Comment ID: 20621

EPA Comment Code: 7000

Comment: In closing we find it inexplicable that th e Agency was able to in terpret the statutory standard of what determines the "meaningful oppo rtunity for health risk reduction" and make a determination in a relative short period of ti me. But, on the other hand, the Agency has not been able to interpret nor make a determination on similar statuary standards of "unreasonable risk toEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1065 of 1099 health" (URTH) [42USC300g-5(a)(3)] or "protecti ve of public" [42USC300g-1(b)(15)(B)]. What we find inexplicable is that the determination EPA has failed to make heretofore is more pressing to community water supplies than the determination EPA recently made for perchlorate. We believe that EPA should identify the URTH levels and wh at constitutes "protective of public health".

We thank you for the opportunity to provide co mments regarding this important matter.

Sincerely,

Ed Thomas

Electronic Attachments: 1. Rubin tr ade off health risk final.pdf

Response: See response to comment code 7000.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-1748

EPA Comment ID: 20658

EPA Comment Code: 7000

Comment: Finally, if the SAB convenes any public meeting on perchlorate, the PSG would welcome an opportunity to present th e scientific literature and our public comments. For over 10 years, the PSG has worked cooperatively with EPA, states, and other Federal agencies to provide the best available scientific information on perchlorate to assist public agencies. We look forward to any such opportunity with the SAB.

Sincerely,

Mr. Michael Girard Chairman Perchlorate Study Group

Cc: Marcus Peacock, Deputy Administrator Benjamin Grumbles, Assistant Administrator, Office of Water Cynthia Dougherty, Director Office of Grou nd Water and Drinking Water Eric Burneson, Chief, Targeting and Analysis Branch Suhair Shallal, SAB Designated Federal Officer

Response: There will be future opportunities to provide input/submit comments during development of a proposed NPDWR for perchlorate.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1743

EPA Comment ID: 20685

EPA Comment Code: 7000

Comment: The perchlorate contamination in Tewksbury, MA a few years ago resulted in 75% of my household not being able to consume our municipally provided tap water. My two children (both under age 2) and my pregnant wife were in the 'high risk' group that were advised not to

consume or brush their teeth with the contaminat ed water. Standard commercially available waterEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1066 of 1099 filtration systems were either a) incapable of addr essing the contaminant or b) unable to remove perchlorate contaminants to any particular standa rdized safe level. The filtration systems reviewed included systems that used reverse osmosis filtration as their buy-in into the organization.

Response: See response to comment code 6120. NSF In ternational, the Water Quality Association and other independent certification organizations have certified household treatment systems for perchlorate removal.

Commenter Name: Y. Carbajal Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1847

EPA Comment ID: 20736

EPA Comment Code: 7000

Comment: It is in everyone's best interest that drink water be tested for containments. Failure to do so can lead to a catastrophic epidemic.

Response: See comment code 7000.

Commenter Name: R. Howard Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1848

EPA Comment ID: 20737

EPA Comment Code: 7000

Comment: UR KILLING US THANK FOR THE WONDERFUL 8YRS MR.PRES IHOPE UR

LIFE ISNT AS LONG AS THESE 8YRS HAVE BEEN

Response: This is not a comment, a response is not necessary.

Commenter Name: J Bennet Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-1860

EPA Comment ID: 20744

EPA Comment Code: 7000

Comment: 11/06/08

Dear EPA,

Please get toxins out of our water.

J. Bennet 211 Royal St. Alexandria, VA 22314

Response: See response to comment code 7000.

Commenter Name: Commenter Organization: The Night Move, LLCEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1067 of 1099 EPA Document ID: EPA-HQ-OW-2008-0692-1960

EPA Comment ID: 20808

EPA Comment Code: 7000

Comment: As a new business in Michigan, we have taken the initiative to show concern for the environment in every way we can. We collectively look for ways to reduce our negative impact on the environment and search for ways to improve it. The Night Move started on the premise to get people out of their cars and into public transportation, reducing the air pollution from car exhaust. Also, we run our bus on biodiesel to reduce our emissions. For the emissions we do put out, we have partnered with CarbonFund.org to neutralize our carbon footprint. We don't stop there. Our flyers and advertisements are printed on recycled paper, passenger trash is recycled, and we reuse
water to clean the bus. Of course, there are alwa ys ways to improve and we are always looking for them. We do this because we know what we do has an impact on the environment around us. This means we are impacting the people around us whethe r they use our services or not. We like to do our part to keep our environment clean and safe to live in, and we expect others to be just as courteous, especially our government.

Response: This is not a comment, a response is not necessary.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2007

EPA Comment ID: 20837

EPA Comment Code: 7000

Comment: DIRTY LAKES!! Don't do this!!!

CLEAN LAKES!!

Keep our Lakes Clean!!!

[See illustration in PDF EPA-HQ-OW-2008-0692-2007]

Response: See response to comment code 7000.

Commenter Name: Brien Beebe Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2011

EPA Comment ID: 20843

EPA Comment Code: 7000

Comment: 11/6/08

I WOULD LIKE TO BELIEVE THAT THE EPA WOULD FIGHT TO PROTECT FOR

CLEAN WATER AND "PROTECT OUR ENVIRONMENT."

BRIEN BEEBE 311 DUKE ST. ALEXANDRIA VA. 22314EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1068 of 1099 Response: See response to comment code 7000.

Commenter Name: B.K. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2012

EPA Comment ID: 20844

EPA Comment Code: 7000

Comment: 11/06/08

Dear EPA,

Toxins out of water.

BK 207 S. Royal Alexandria, VA 22134

Response: See response to comment code 7000.

Commenter Name: Lynn Thorp Commenter Organization: Clean Water Action

EPA Document ID: EPA-HQ-OW-2008-0692-2017

EPA Comment ID: 20849

EPA Comment Code: 7000

Comment: December 1, 2008

Stephen L. Johnson Administrator U.S. Envir onmental Protection Agency Washington DC 20460

Dear Administrator Johnson,

I am writing on behalf of Clean Water Action and it 's 1.2 million members. Due to clerical errors, our organization's signature was not affixed to comments on the Agency's preliminary determination on perchlorate which were prepared and submitte d by the Natural Resources Defense Council for the relevant docket. I want to draw your attenti on to our organization's support for these comments despite our signature not being on the official docket copy.

Response: The commenter's support for comments prepar ed by the Natural Resources Defense Council (comment letter ID EPA-HQ -OW-2008-0692-1988) is noted.

Commenter Name: Lenny Siegel Commenter Organization: Center for Public Environmental Oversight

EPA Document ID: EPA-HQ-OW-2008-0692-2019

EPA Comment ID: 20855

EPA Comment Code: 7000

Comment: This reminds me of O.J. Simpson’s criminal defense. He insisted that some third party or parties killed his wife and Ronald Goldman, but he showed little interest in finding the unknown

perpetrators.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1069 of 1099 Response: No response necessary to the information provided by the commenter.

Commenter Name: Ron Curry Commenter Organization: New Mexico Environment Department

EPA Document ID: EPA-HQ-OW-2008-0692-1796

EPA Comment ID: 20934

EPA Comment Code: 7000

Comment: In considering these comments, particularly this groundwater monitoring data, it is important for EPA to understand that New Mexico is very dependent on its groundwater resources for drinking water. New Mexico is an arid state, with relatively little surface water. New Mexicans obtain approximately 90 percent of their drinking water from groundwater aquifers.[FN11: Affidavit of William Olsen, Chief, Ground Water Quality Bu reau, N.M. Environment Dep't, at 3, In re Appeal of Supplemental Discharge Permit for Cl osure (DP-1341) for Phelps Dodge Tyrone, Inc. (N.M. Water Quality Control Comm'n July 9, 20 07) (Nos. WQCC 03-12(A) and WQCC 03-13(A)).] And New Mexico is growing and developing rapi dly, placing greater demands on its aquifers. According to the New Mexico State Demographe r at the University of New Mexico Bureau of Business and Economic Research, the population of N ew Mexico is expected to increase by 30 percent between 2005 and 2020, and by more th an 50 percent between 2005 and 2035.[FN12: University of New Mexico, Bureau of Business an d Economic Research, Population Projections for New Mexico and Counties, available at www.unm.edu/~bber. The information was confirmed in a telephone conversation with Adelamar N. Alcanter a, Ph.D., New Mexico State Demographer, on November 24, 2008.] We therefore assume that much of the State's groundwater will be used for drinking water in the future. Consequently, there is a substantial likelihood that this perchlorate contamination will occur in public wate r systems in the foreseeable future.

Response: See response to comment code 7000.

Commenter Name: Herwig Opdebeeck Commenter Organization: Opdebeeck Consulting

EPA Document ID: EPA-HQ-OW-2008-0692-1798

EPA Comment ID: 20955

EPA Comment Code: 7000

Comment: RE: Docket ID No. EPA-HQ-OW-2008-0068

Comments on the US Environmental Protection Agencyâ€TMs Preliminary Regulatory
Determination on Perchlorate November 28th, 2008

Comment on the USEPA Office of Waterâ€TMs Preliminary Regulatory Determination on

Perchlorate.

Comment subjects

1. Relative Source Contribution (RSC) EPAâ€TMs past RSC based on a "default" assumption versus EPAâ€TMs RSC used in this Preliminary Regulatory DeterminationEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1070 of 1099 2. The very particular case of perchlorate: Tota l effective equivalent perchlorate NOEL and RfD

3. Checking of some outcomes of this EPA pre liminary determination with those obtained trough

another road.

Response: This is not a comment, a response is not necessary.

Commenter Name: Jennifer Sass, PhD. Commenter Organization: Natural Resources Defense Council

EPA Document ID: EPA-HQ-OW-2008-0692-1988

EPA Comment ID: 20996

EPA Comment Code: 7000

Comment: E. A final MCL below 1 ppb is both technologically and economically feasible.

Technical Feasibility

U.S. EPA's Method 314 approved ion chromatogr aphy detection protocol, for example, routinely detects perchlorate pollution at levels of 0.2ppb and the State of Massachusetts has established a ‘reportable concentrations level for perchlorate of 2 ppb.[FN46: Thorne, Philip G. Field Screening
Method for Perchlorate in Water and Soil, ERDC/CRREL Technical Report 04-8, 36 pp, Apr 2004.],[FN47: "Final Changes to the Massach usetts Contingency Plan -310 CMR 40.0000," downloaded from http://www.mass.gov/dep/clea nup/laws/perchlorate-31 0CMR40-07282006.pdf, November 2 2006.] Ion exchange technology is able to treat perchlorate contamination to levels considerably below 1 ppb. Treatment systems opera ting on perchlorate- impacted wells owned by Aquarion Water Company in Massachusetts, for ex ample, treat wells to below 1 ppb.[FN48: "US Filter Recovery Services," downloaded from www.usfilter.com, November 2 2006.]

Economic Feasibility

The cost of complying with a perchlorate Maximum Contaminant Level of less than 1 ppb for the City of Rialto - one of the most impacted water sys tems in California - for example will be zero after cleanup costs are recovered from identified res ponsible parties. A complete economic feasibility study should also include an analysis of the costs associated with healthcare and lost work resulting from illnesses associated with pe rchlorate contaminated water.

Response: See response to comment code 6120. Feasib ility and health risk reduction and cost analyses will be performed in support of a propos ed National Primary Drinking Water standard.

Commenter Name: Michael Girard Commenter Organization: Perchlorate Study Group

EPA Document ID: EPA-HQ-OW-2008-0692-2082

EPA Comment ID: 21025

EPA Comment Code: 7000

Comment: Your letter also highlights states which have issued MCLs, including California, Massachusetts, and New Jersey (which has pr oposed, but not finalized a standard.)EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1071 of 1099 As your letter points out, several states have issued standards or taken other regulatory steps relating to perchlorate in drinking water.. That is a sepa rate issue from whether a national standard is

advisable.

The Association of State Drinking Water Administrators noted in their recently filed comments that "States are generally in favor of EPA’s decision not to regulate, but there are some states that do favor a national regulation on perchlorate, especially those who have already set their own standard."[FN7: Association of State Drinking Water Administrators, Letter to EPA Docket, Docket EPA-HQ-OW-2008-0692, Nov. 10, 2008.] The American Water Works Association, the largest organization of water suppl y professionals in the world, a nnounced its agreement with EPA’s preliminary determination, based upon the results of two independently commissioned assessments which support EPA decision. [FN8: American Water Works Association, Drinking Water: Preliminary Regulatory Determination on Perchl orate Docket EPA-HQ-OW-2008-0692; Nov. 10, 2008.]

Response: See response to comment code 7000.

Commenter Name: Teresa Jordan Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2086

EPA Comment ID: 21108

EPA Comment Code: 7000

Comment: Mr. Grumbles and Mr. Burneson, it is impera tive that the USEPA, in Federal Register notices and in the Agency's Website, provide a facsimile number for the interested persons to

submit written comments. I do not E-mail. I do no t always have transportation to get to the post office. Foot problems keep me from walking long di stances. Since I have a fax machine, I am able to submit comments not only to members of Congress, but State and Federal government elected officials, and agenices. All public comment submitt al tools must be made available. The USEPA by doing otherwise limits the public's right to comment on issues.

Mr. Grumbles and Mr. Burneson, I notice that the USEPA provides an avenue to help the hearing impaired population participate. How does th e USEPA help the visually impaired population participate in the public comment process?

Response: EPA acknowledges the commenter's request. In the future, written comments may be

submitted to EPA's Docket Center Public Readin g Room at the following fax number: 202-566- 9744. Please include the appropriate Docket ID No. with your submission.

Commenter Name: Philip Hoos Commenter Organization: Earthjustice

EPA Document ID: EPA-HQ-OW-2008-0692-2111

EPA Comment ID: 21137

EPA Comment Code: 7000

Comment: To whom it may concern,EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1072 of 1099 I would like the attached document to be posted in docket number EPA-HQ- OW-2008-0692. Please disregard my previous email where I provide the incorrect docket number. If you have any questions please feel free to email me.

Thank you for your time, Phil

Phillip Hoos Research Associate Earthjustice 426 17TH St., 5th Floor Oakland, CA 94612 T: 510- 550-6700 F: 510-550-6740 www.earthjustice.org

Because the earth needs a good lawyer

[please see attachment PDF Docket ID EPA-HQ-OW-2008-0692-2111]

Response: The attachment has been posted to do cket number EPA-HQ- OW-2008-0692.

Commenter Name: Charlotte L. Sherry Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2119

EPA Comment ID: 21989

EPA Comment Code: 7000

Comment: Water Docket, EPA Mailcode 2822T 1200 Penns ylvania Ave., Washington, D.C. 20460

We have lived in Gambrills area since 1969. Lately when I make coffee, hot tea, ice tea or something

similar it has an odor and taste of chorine in it.

The water line has broken twice in the same place in the last few years. All these pipes have to be old

and need to be checked for cracks that let contamination into our water.

Thank you, Charlotte L. Sherry

Response: See response to comment code 7000.

Commenter Name: David L. Louden Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2161

EPA Comment ID: 22091

EPA Comment Code: 7000

Comment: 21 November 2008

STATEMENT FOR THE RECORD

Subj: CLEAN WATER ACTION I CO DOCK ET ID NO. EPA-HQ-OW-2008-0692

Dear Sir/Madame;EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1073 of 1099 I wish it to be known that I support the testing, both routine and sustained, of water delivered by public, state or county for purposes of drinking , cooking, cleaning, bathing or their kind.

The Environmental Protection Agency operates as a public trust on be half of the citizens of the

United States. It is therefore both a custodial res ponsibility as well as a matter of good stewardship to perform all due diligence in the execution of the duties and responsibilities assigned to the EPA by the laws and directives of the United States. I wish you continued success as you carry out this mandate on behalf of your fellow citizens.

Kind regards, David L. Louden 7894 Ba stille Pl Severn, MD 21144 410 551 7866 davidlouden@hotmail.com

Response: See response to comment code 6120.

Commenter Name: John A. Forbes Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2162

EPA Comment ID: 22092

EPA Comment Code: 7000

Comment: November 18, 2008

Dear EPA Administrator Stephen Johnson

I write to your with an urgent request to regula te greenhouse gas emissions under the Clean Air Act.

Greenhouse gases are a serious threat to public heal th and people's welfare especially small children. The US must again take the lead on the issue at the Federal level.

The Supreme Court affirmed to EPA authority. I urge you to regulate by setting specific emission reduction standards for power plants, big factories, vehicles and fuels.

Please act John A Forbes III

Response: See response to comment code 7000.

Commenter Name: Thomas S Soell Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2184

EPA Comment ID: 22378

EPA Comment Code: 7000

Comment: 13 Nov 2008

To whom it may concern,

I fortunately live next to the Herald Harbor water tower in Crownsville, Maryland. Every year we get a report on the level of contaminants found in the drinking water supplied by this source. It wouldEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1074 of 1099 be interesting to at least know the level of perchl orates in the water. I have no idea how to test for perchlorates or what level is safe or not. If they are harmful, it would be nice to know what levels they are in our water.

Thanks for your attention to this matter!

Thomas S. Soell 485 Mountain Rd Crownsville, MD 21032

Response: See response to comment code 6120. You may wa nt to call your drinking water utility or state drinking water program to lear n the results of past monitoring or to find out if monitoring is required in your state. If there is no requirement for monitoring in your state, you can have your water analyzed by a laboratory that is certified for the analysis of perchlorate or similar compounds. An EPA website provides a list of st ate certification officers or links to certified laboratories in your

state.

Commenter Name: Sean Auth Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2212

EPA Comment ID: 22414

EPA Comment Code: 7000

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

As an idealistic youth, I like to believe that those who are in charge hold the interests of those it is their duty to protect above those of big business, in the face of the apathetic and corrupt. We already have to worry about enough epidemics a ffecting the women and children of this nation, please do your part to shorten the list, if not for my family then for yours.

Sincerely, Sean Auth 619 Bates College Lewiston, ME 04240

Response: See response to comment code 6120.

Commenter Name: Hal Hyman Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2280

EPA Comment ID: 22487

EPA Comment Code: 7000

Comment: Docket # EPA-HQ-OW-2008-0692 Envir onmental Protection Agency Mailcode: 2822T, 1200 Pennsylvania Ave., NW Washington, 20460

Dear Administrator Johnson and EPA staff,

The NRDC is a radical group who are for the destruction of the United States disguised as

environmentalism. It is Marxism.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1075 of 1099 BE AWARE AND DESTROY THEIR AGENDA

Sincerely, Hal Hyman 49 Price Avenue Erlanger, KY 41018

Response: This comment is not relevant to this action.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2085

EPA Comment ID: 24975

EPA Comment Code: 7000

Comment: Dear Water people,

I like clean water because we drink it. I would not like to drink dirty water. People in Africa have dirty water and are dying and they are not very happy.

Love, [comment from patron under the age of 13]

Response: See response to comment code 7000.

Commenter Name: Kraig Erickson Commenter Organization: RMC Water and Environment (RMC)

EPA Document ID: EPA-HQ-OW-2008-0692-2299

EPA Comment ID: 24980

EPA Comment Code: 7000

Comment: Currently my company, RMC, is working with Pasadena Department of Water and Power to address high percholate levels in the M onk Hill area. Windsor Reservoir is a potable water storage reservoir constructed in the early 1900s wi th a capacity of 4.75 million gallons. It went out of service due to high percholate levels in the grou ndwater from wells feeding the Reservoir. PWP is currently constructing a percholate treatment facility at Reservoir site. Please feel free to contact me if you would like more information regarding PWP's actions to address percholate plumes.

Kind regards, - Kraig Erickson Project Engineer RMC Water and Environment 2400 Broadway,
Suite 300 Santa Monica, CA 90404 P hone: 310-566-6460 Fax: 310-566-6461 KErickson@rmcwater.com http://ww.rmcwater.com Innovative Solutions for Water and the

Environment

Sincerely, Kraig Erickson 2400 Broadway Suite 300 Santa Monica, CA 90404

Response: See response to comment code 7000.

Commenter Name: Under 13 Commenter Organization:

EPA Document ID: EPA-HQ-OW-2008-0692-2337

EPA Comment ID: 25017EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1076 of 1099 EPA Comment Code: 7000

Comment: Dear E.P.A,

I want clean drinking water!

From, [comment from patron under the age of 13]

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0073

EPA Comment ID: 28350

EPA Comment Code: 7000

Comment: ARE YOU KIDDING????????THIS IS A NO BRAINER! DON'T WE HAVE

ENOUGH AUTO IMMUNE DISEASES AND CA NCER CAUSING SUBSTANCES IN OUR

LIVES? ISN'T THE WORD 'PROTECTION' IN THE ENVIRONMENTAL PROTECTION

AGENCY THE CLUE THAT YOUR AGENCY IS SUPPOSED TO PROTECT US FROM

ANY CONTAMINANTS??? PLEASE WAKE UP NOW!!!!!

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0090

EPA Comment ID: 28353

EPA Comment Code: 7000

Comment: PLEASE CONSIDER YOUR CHILDREN,GRANDCHILDREN, AND GREATGRAND CHILDREN WHEN TALKING ABOUT THIS CONTAMINATION OF OUR/THEIR DRINKING WATER. IT SHOULD BE SO ELEMENTARY OF A DECISION

NOT TO ALLOW THE CONTAMINATION OF DRINKING WATER REGARDLESS OF

MONETARY OR POLITICAL INFLUENCES . DO WHAT IS MORALLY JUST. PROTECT THE NATURAL RESOURCE WE WERE ENTRUSTED WITH;DON'T CONTAMINATE IT

AND HOPE IT WILL BE SATISFACTORY.

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0118

EPA Comment ID: 28358

EPA Comment Code: 7000

Comment: This has got to be a joke right? Plain and simple...would the EPA be drinkingEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1077 of 1099 Response: See response to comment code 7000.

Commenter Name: J. Clarke Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0125

EPA Comment ID: 28361

EPA Comment Code: 7000

Comment: this really seems like a no brainer. we need to start acting on simple things like this in order to protect our future. with the onset of droughts throughout the US, we need to begin protecting what we do have before it's too late.

thanks,j. clarke

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0134

EPA Comment ID: 28363

EPA Comment Code: 7000

Comment: Please keep our waters safe!

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0157

EPA Comment ID: 28373

EPA Comment Code: 7000

Comment: This is really angering me, I may not be 18 yet and a legal adult, but i have as much right as any to drink UNCONTAMINATED water! this isnt the only problem too with drinking water! It has recently been recognized as of sept. 12th (to day actually) in the new york times how all across the nation people can't even drink their tap water because there are contaminants from coal companies in them. The water has been found to c ontain barium, arsenic, lead, magenese, and other harmful chemicals. People get ugly and painful rashes just by letting it touch their skin and have to apply a special lotion after showing because it makes their skin BURN. A 6 year old boy was brought to the dentist and had to get metal caps on his teeth because the water had eaten away the

enamel from his molars!

Government needs to address this because it is a fundamental living need- water. if we could ensure safely in our tap water, we could stop spending 10 billion dollars a year BOTTLING the stuff and just have people use a reusable safe stainless steel or hard safe-plastic bottle and save our ocean lots of pollution. Hey government! have uy heard ther e is a GIANT dump in the middle of the pacific ocean, circulating at a growing size that is already twice the size of Texas?!EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1078 of 1099 Start addressing the things that really matter

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0165

EPA Comment ID: 28376

EPA Comment Code: 7000

Comment: AIRPLANES DUMP FUEL EACH TIME THEY LAND & USUALLY OVER
WATER ,INCLUDING DRINKING WATER . WE NEED TO PURIFY OUR DRINKING

WATER BETTER TO REMOVE CONTAMIN ATES LIKE "PERCHLORATE" .

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0179

EPA Comment ID: 28384

EPA Comment Code: 7000

Comment: Our water is more important than most of us know. Keeping polutants such as jet fuel out of the water is crucial. We have so many mo re cancers, birth defects, and illnesses than ever before, it's not a difficult stretch to believe our water quality is part of the problem. Please tighten water quality regulations today.

Response: See response to comment code 7000.

Commenter Name: Charyl Curry Gargel Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0216

EPA Comment ID: 28390

EPA Comment Code: 7000

Comment: I am a very concerned business owner and ci tizen that is very concerned about our drinking water.Documents are showing an extremely dangerous amounts of the agent PERCHLORATE going into our aquafiers.Please inve stigate and take remediation action to correct

this for the sake of our citizens.

Thank You Charyl Curry Gargel

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0240

EPA Comment ID: 28418EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1079 of 1099 EPA Comment Code: 7000

Comment: Hey, let's PROTECT the water supply and not bow to corporate interests that want to make money at the expense of public health.

Response: See response to comment code 7000.

Commenter Name: Terrence O'Brien Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0302

EPA Comment ID: 28433

EPA Comment Code: 7000

Comment: I have been involved in Pharmaceutical manu facturing for over 25 years. I, more than most people, appreciate the potential impact that even minute quantities of chemical compounds can have on peoples health. Please pursue polluter s and protect innocent consumers of this country. That is why your organization was created. I should n't have to worry about Perchlorate, MTBE or other industrial compounds in my drinking water.

Sincerely, Terrence O'Brien Louisville, CO

Response: See response to comment code 7000.

Commenter Name: Sandra Chamberlin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0306

EPA Comment ID: 28434

EPA Comment Code: 7000

Comment: What is more basic and necessary than to have safe, clean drinking water. We must do everything for ourselves and our children, to protect rather than pollute our water. No one should have the right to harm others! Drinking is not a choi ce, it is life itself. Please help reverse the damage

we've done and do not continue to contaminate.

Thank you , Sandra Chamberlin Montclair, NJ 07042 21 Edgewood Rd.

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0308

EPA Comment ID: 28436

EPA Comment Code: 7000

Comment: Keep our waters clean, for our children and families!

Response: See response to comment code 7000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1080 of 1099 Commenter Name: D. Reynaud Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0319

EPA Comment ID: 28441

EPA Comment Code: 7000

Comment: Please give us more strongly enforced protections for our nation's water supplies!

Response: See response to comment code 7000.

Commenter Name: John Bachalis Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0344

EPA Comment ID: 28449

EPA Comment Code: 7000

Comment: I don't understand why there should be an y question of whether we should keep any kind of poisons out of our drinking water. Don' t we all need water to live? I see no reason for harmful chemicals or any kind, governmental or commercial to be allowed in our waters.

Do your job, and keep our water, air and land free of poisons.

John Bachalis, Yardley, PA 19067-1617

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0351

EPA Comment ID: 28452

EPA Comment Code: 7000

Comment: It defys logic that this discussion is happening. Because it is poison it is driving medical costs. With 17% of GDP going to medical, and that has gone up 1% since I have been following the number over the last five years, where have you been? You need to be looking at Periodic Table metals to really solve societal issues, What are my taxes paying for, a debate on how poison is poison? Commen sense people, not hogwash is needed from people that I pay.

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0358

EPA Comment ID: 28454

EPA Comment Code: 7000

Comment: It is absolutely ludicrous to allow toxic poison in our drinking water.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1081 of 1099 Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0362

EPA Comment ID: 28456

EPA Comment Code: 7000

Comment: How does a harmful chemical that comes from rocket fuel get in so many public waterways? Where is this rocket fuel made? Why are we eventually bathing and drinking it?

Response: See response to comment code 7000.

Commenter Name: Larry Ladd Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0372

EPA Comment ID: 28458

EPA Comment Code: 7000

Comment: I have already submitted comment 80a1871f, and I would like that comment to be attributed to myself, Larry Ladd, rather than "a nonymous." I also would like to make a correction to

the above Comment: "with the parvovirus outbreaks in Dharan after Patriot missile deployment, Badr 2002 pmed 11938419," should read "with the parvovir us outbreaks in Dharan after Patriot missile deployment, Mallouh & Quda h 1995 pmed 7715986."

Larry Ladd 11064 Santiam River Court Rancho Co rdova CA 95670 http://www.perchlorate.org

Response: EPA has made these corrections.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0374

EPA Comment ID: 28459

EPA Comment Code: 7000

Comment: Please, we let so much garbage into our food supply; excrement in meat, pesticides, growth hormones, at least keep the water as pure as possible! Spare no expense to ensure it stays that way

Response: See response to comment code 7000.

Commenter Name: Ruth Neifeld Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0402

EPA Comment ID: 28468

EPA Comment Code: 7000EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1082 of 1099 Comment: I do not know if this note is addressed to the correct agency. I am writing to ask that you help all Americans by ensuring that our drinki ng water is safe. I have been reading of many instances where this is not the case. We need someone in government to take on this task.

Thank you for your interest. Ruth Neifeld

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0406

EPA Comment ID: 28469

EPA Comment Code: 7000

Comment: I support limiting chemicals in our drinking water.

Response: See response to comment code 7000.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2009-0297-0521

EPA Comment ID: 28477

EPA Comment Code: 7000

Comment: In closing we find it inexplicable that th e Agency was able to in terpret the statutory standard of what determines the "meaningful oppo rtunity for health risk reduction" and make a determination in a relative short period of ti me. But, on the other hand, the Agency has not been able to interpret nor make a determination on similar statuary standards of "unreasonable risk to health" (URTH) [42USC300g-5(a)(3)] or "protecti ve of public" [42USC300g-1(b)(15)(B)]. What we find inexplicable is that the determination EPA has failed to make heretofore is more pressing to community water supplies than the determination EPA recently made for perchlorate. We believe that EPA should identify the URTH levels and wh at constitutes "protective of public health".

We thank you for the opportunity to provide co mments regarding this important matter.

Sincerely,

Ed Thomas

Electronic Attachments: 1. Rubin tr ade off health risk final.pdf

Response: See response to comment code 7000.

Commenter Name: James Talbot Commenter Organization: Neverland Designs

EPA Document ID: EPA-HQ-OW-2009-0297-0456

EPA Comment ID: 28587

EPA Comment Code: 7000EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1083 of 1099 Comment: Please put people above industry and keep our water pure

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0457

EPA Comment ID: 28588

EPA Comment Code: 7000

Comment: Keep our water clean, when it's gone, it's g one! It's very simple, no water = no life. Stop playing to big business.

Response: See response to comment code 7000.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0513

EPA Comment ID: 28604

EPA Comment Code: 7000

Comment: Keep water clean!

Response: See response to comment code 7000.

Commenter Name: James Evangelos Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0548

EPA Comment ID: 28762

EPA Comment Code: 7000

Comment: To those in the EPA,

Why wouldn't you prevent this chemical from entering our waterways? How you could you think, that to some degree, this couldn't be harmful? Where are your standards? Frankly,would you want your own children exposed? Consider adopting a lif e of higher expectation; a life driven by the desire to do what is more difficult because IT IS THE RIGHT THING TO DO. The right thing to do hear is require perchlorate users responsible for the introduction into our water system to find a different way of disposing the chemical. Yes, th at means money spent on research and development in order to create a manageable discarding mechan ism. But is the alternative even thinkable: to expose our race to a chemical that could limit thyr oid gland activity, ultimately leading to infant retardation, among a host of other unforeseen effects. I ask you to talk to your soul, deep down and see if it FEELS right to do what you are doing.

Kinldly , James Evangelos

Response: See response to comment code 7000.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1084 of 1099 Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0557

EPA Comment ID: 28765

EPA Comment Code: 7000

Comment: I am concerned about perchlorate in my drin king water. Please help keep it clean!

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0561

EPA Comment ID: 28768

EPA Comment Code: 7000

Comment: It doesn't suprise me that you think perchlor ate is ok in drinking water when you think HsiF is ok despite your 7,000 EPA Uniion worker s asking for a moratorium on it. Despite the fact that you have no safety documentation on this pr oduct. Despite the 3 plus year review of recent science on fluoride with it's conslusion saying fluoridation should cease. When will you do the job you are being paid to do? Does the word INTEGRITY mean anything to you? Does SCIENCE mean anything to you? You have proven that thes e words don't enter into the decisions you make.

Response: See response to comment code 7000.

Commenter Name: Robert Scrima Sr. Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0569

EPA Comment ID: 28771

EPA Comment Code: 7000

Comment: It is essential that our drinking water is healthy.Perchlorate is known to be very damaging especially to fetuses and young children. It has been shown to be very destructive to all

humans.

In the past America maintained safe drinking water.The long term health costs to not doing so are enormous.The tragedy of illness caused by contam inates should be avoided at all costs.

Sincerely, Robert Scrima Sr. 727 Ca ssandra Lane Lakeland, FL 33809

Response: See response to comment code 6120.

Commenter Name: Peter Galvin Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0600

EPA Comment ID: 28778

EPA Comment Code: 7000EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1085 of 1099 Comment: As a former federal regulator, I would like to urge you to keep the requirements and purpose of the law in mind in making your decision on this matter. Too frequently in recent years we have delayed or watered down necessary health actions because of fear of junk science submitted by impacted industries. Our counsel fall victim to fe ar of the lawsuit, and our leaderships fall victim to fear of individual congressional members re sponding to pressure from business organizations. The public has given you a mandate to protect water quality, and you should not hesitate to fulfill that expectation.

Peter Galvin

Response: See response to comment code 6120.

Commenter Name: Anonymous Commenter Organization:

EPA Document ID: EPA-HQ-OW-2009-0297-0609

EPA Comment ID: 28780

EPA Comment Code: 7000

Comment: Mercury, perchlorate and raw sewage....wh at else? Why worry we will be under the Obama health plan!?

Response: See response to comment code 7000.

Commenter Name: Commenter Organization: Seeds of Hope

EPA Document ID: EPA-HQ-OW-2009-0297-0632

EPA Comment ID: 28791

EPA Comment Code: 7000

Comment: Clean up the water-that's why we're using th e healthcare system too much. We're sick

because of contaminated water.

Response: See response to comment code 7000EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1086 of 1099 

### EPA Comment Code: 7100 N/A May 2007 Comments

Response to Code 7100 : Prior to publishing its preliminary regulatory determination for perchlorate (73 FR 60262, October 10, 2008) an d its supplemental request for comment on the perchlorate regulatory determination (74 FR 41 883, August 19, 2009), the Agency published a summary of the available information relevant to th e perchlorate regulatory determination as part of its preliminary determination for 11 other contamin ants on the second contaminant candidate list (72 FR 24016, May 1, 2007). EPA did not make a determination for perchlorate in the May, 2007 notice but rather described the available information relevant to the perchlorate regulatory determination and the steps the Agency planned to take to gather the information needed to make a regulatory determination. EPA recei ved a number of comments related to perchlorate in response to this request. These comments are compiled in this section. See response to comment code 6120 for a discussion of EPA’s decision to regulate perchl orate in drinking water. EPA’s response to comments on the regulatory determinations for othe r contaminants under CCL 2 can be found at 73 FR 44251, July 30, 2008.

Individual Comments

Commenter Name: Marcia Willhite Commenter Organization: Illinois Environmental Protection Agency

EPA Document ID: EPA-HQ-OW-2007-0068-0155

EPA Comment ID: 20256

EPA Comment Code: 7100

Comment: 217/785-478 May 23, 2007 Walter Docket En vironmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave, NW., Washingt on DC, 20460 Docket ID No: EPA--HQ--W--2007--

0068

To Whom It May Concern:

Thank you for the opportunity to comment on the United States Environmental Protection Agency's ("Agency") Regulatory Determinations Re garding Contaminants on the Second Drinking Water Contaminant Candidate List - Preliminary Determinations notice. In the notice it indicates that the Agency is seeking comment on 11 preliminar y determinations. In addition, the notice stated:

While the Agency has not made a preliminary determi nation for perchlorate, this action provides an update on the Agency's evaluation of perchlora te. The Agency requests public comment on the information and the options that the Agency is considering in the evaluating Perchlorate and welcomes the submission of relevant, new information and/or data that may assist the Agency in its regulatory determination. (Emphasis added)

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Marcia Willhite Commenter Organization: Illinois Environmental Protection Agency

EPA Document ID: EPA-HQ-OW-2007-0068-0155

EPA Comment ID: 20259

EPA Comment Code: 7100EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1087 of 1099 Comment: Further, the two carcinogens, 2,4-dinitrot oluene, and 2,6-dinitrotoluene have been found in groundwater in numerous locations in Illi nois, including Joliet Army Ammunition Plant at 10,000 μg/l, and Savanna Army Depot at 58.8 μg/l, respectively. These chemicals have caused,
threatened, and allowed contamination of Class I: Potable Resource Groundwater in Illinois.

Thank you again for the opportunity to comment on this important matter. If you have any questions please contact Richard P. Cobb of my staff at the number referenced above.

Sincerely, Marcia Willhite,Chief Bureau of Water

Response: This comment is outside of the scope of this action, no response necessary. EPA’s response to comments on the regulatory determinati ons for other contaminants under CCL 2 can be found at 73 FR 44251, July 30, 2008.

Commenter Name: Peter King Commenter Organization: American Public Works Association (APWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0156

EPA Comment ID: 20260

EPA Comment Code: 7100

Comment: May 29, 2007 Water Docket US Environmental Protection Agency Mail Code 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460 DOCKET ID. NO: EPA-HQ-OW-2007-

0068

Dear Assistant Administrator Grumbles:

The American Public Works Association (APWA) appreciates this opportunity to file comments on the proposed Regulatory Determinations Regarding Contaminants on the Seeond Drinking Water Contaminant Candidate List - Preliminary Determinations (72 FR 24016 (May 1, 2007)) and we agree with the decision announced in this noti ce. These comments were developed through input from APWA's Water Resources Management Committee.

APWA supports the Environmental Protection Agency's (EPA) efforts in making sound

determinations as to whether or not a Nationa l Primary Drinking Water Regulation (NPDWR) should be developed for certain unregulated chemic al contaminants under the Safe Drinking Water

Act. The members of APWA's Resources Ma nagement Committee agree with the Agency's preliminary determination that a NPDWR is not appropriate for the eleven contaminants considered by EPA in this notice.

Response: No response is necessary to the inform ation provided by the commenter. EPA’s response to comments on the regulatory determinati ons for other contaminants under CCL 2 can be found at 73 FR 44251, July 30, 2008.

Commenter Name: Peter King Commenter Organization: American Public Works Association (APWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0156

EPA Comment ID: 20262EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1088 of 1099 EPA Comment Code: 7100

Comment: APWA represents 29,000 members who design, build, operate and maintain transportation, water supply, sewage and refuse disposal systems, public buildings, and other structures and facilities essential to the economy and way of life. Public works professionals serve a diverse range of local communities, municipalities, counties, townships, villages and districts, whether large or small, urban or rural. As stewa rds of public infrastructure, APWA members are dedicated to managing and operati ng water systems that provide safe and reliable service to their

communities.

Please do not hesitate to contact APWA's Washin gton Office if we can be of help to you in the

future.

Sincerely, Peter King Executive Director

Response: No response is necessary to the info rmation provided by the commenter.

Commenter Name: Krista Clark Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2007-0068-0157

EPA Comment ID: 20263

EPA Comment Code: 7100

Comment: June 11, 2007 Ms. Cynthia Dougherty Office of Groundwater and Drinking Water U.S. Environmental Protection Agency 1200 Penns ylvania Ave. NW Washington, DC 20460

Re: May 1st Federal Register Notice for Pre liminary Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List (EPA-HQ-OW-2007- 0068)

Dear Ms. Dougherty:

The Association of California Water Agencies (ACWA) would like to request an extension of the 60- day comment period on the May 1st Federal Register notice for the Preliminary Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate

List.

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: Krista Clark Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2007-0068-0157

EPA Comment ID: 20264

EPA Comment Code: 7100

Comment: Our request for an extension to 120 days is driven by the complexity of the issues, including perchlorate, and the large volume of supplementary information not included in theEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1089 of 1099 Federal Register notice that must be considered before any comments, if necessary, are submitted to the Agency.

Response: After careful review and consideration of the comments EPA received on the May 2007 notice, the Agency made a final determination in July of 2008 that no regulatory action was appropriate for any of the 11 CCL 2 contaminants. However, EPA has provided 2 opportunities for further comment on the perchlorate regulatory dete rmination (please refer to the following Federal Register Notices: 73 FR 60262, October 10, 20 08 and 74 FR 41883, August 19, 2009).

Commenter Name: Krista Clark Commenter Organization: Association of California Water Agencies

EPA Document ID: EPA-HQ-OW-2007-0068-0157

EPA Comment ID: 20265

EPA Comment Code: 7100

Comment: ACWA believes the Contaminate Candidate Li st (CCL) is a critical element in developing drinking water standards. There are extensive policy and science issues involved in crafting and implementing this list, and as such, any related regulatory determinations should be thoroughly and carefully reviewed.

If you have any questions, do not he sitate to call me at 916-441-4545.

Sincerely, Krista Clark Director of Regulatory Affairs

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: Thomas Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0162

EPA Comment ID: 20266

EPA Comment Code: 7100

Comment: July 2, 2007 U.S. Environmental Protecti on Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List-Preliminary Deter minations Docket EPA-HQ- OW-2007-0068

Dear Docket:

The American Water Works Association apprecia tes the opportunity to comment on the preliminary regulatory determinations from the second Contamin ant Candidate List (CCL2) as detailed in the May 1st Federal Register notice (72 FR 24016). A WWA is an international, nonprofit, scientific and educational society dedicated to the improvement of drinking water quality and supply. Founded in 1881, the Association is the largest organization of water supply professionals in the world. Our 60,000 plus members represent the full spectrum of the drinking water community: treatment plant operators and managers, environmental advocates, en gineers, scientists, academicians, and others who hold a genuine interest in water supply and public health. Our membership includes more thanEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1090 of 1099 4,700 utilities that supply roughly 80 percent of the nation's drinking water. Based on this broad membership base, these comments should be consid ered as representative of the drinking water community in general. These comments are divided into two major sections, starting with general comments, and then followed by comments on specific contaminants discussed in the May 1st Federal Register notice.

General Comments

As previously mentioned, AWWA appreciates the opportunity to comment on the above referenced preliminary regulatory determinations. The Cont aminant Candidate List (CCL) and subsequent regulatory determinations are the foundation for th e standardsetting process resulting from the 1996 Safe Drinking Water Act (SDW A) Amendments. These two co mponents are among the most important changes in EPA’s approach for developi ng national drinking water regulations since the SDWA was initially passed in 1974. Ensuring that the appropriate contaminant is selected for regulation is the critical first step in the deve lopment of national drinking water regulation that should subsequently be followed by setting the standard at the appropriate level for that

contaminant.

The May 1st Federal Register address the prelimin ary regulatory determinations from CCL2 and the CCL process and the subsequent regulatory determi nations are intertwined. AWWA has significant concerns with the parallel ongoing process for the third Contaminant Candidate List (CCL3) and those concerns will be sent in a separate let ter to Cynthia Dougherty upon submission of these

comments.

Section 1412(b)(1)(A) of the 1996 SDWA Amendmen ts details the criteria for identification of contaminants for potential regulation:

i. the contaminant may have an adverse effect on th e health of persons; ii. the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and iii. in the sole judgment of the Administrator, regulation of such contaminant pr esents a meaningful opportunity for health risk reduction for persons served by public water systems.

Another reform that is particularly applicable to this notice is found in Section 1412(b)(3)(A):

In carrying out this section, and, to the degree that an Agency action is based on science, the

Administrator shall use -

(i) the best available, peer-reviewed science an d supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted m ethods or best available methods (if the reliability of the method and the natu re of the decision justifies use of the data).

EPA's preliminary regulatory determinations for eleven contaminants on the second Contaminant Candidate List (CCL2) as published in the May 1s t Federal Register complies with these two sections of the SDWA. AWWA commends EPA for not regula ting contaminants purely for the sake of regulation, as was the case for some of the 83 contaminants listed in the 1986 SDWA Amendments. AWWA also commends EPA for using the best-availabl e, peer-reviewed science in these preliminary

determinations.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1091 of 1099 AWWA agrees with EPA's decision not to regu late these eleven contaminants. The occurrence levels are generally low based on national surveys such as the Unregulated Contaminant Monitoring Rule (UCMR), and regulation does not present an opportunity for significant risk reduction as mandated by the 1996 SDWA Amendments. These preliminary determinations follow the logic previously used in July 2003 for the first round of regulatory determinations and for the first six-year review (Roberson, 2005). AWWA believes that use of consistent logic in these two parallel regulatory efforts is important, contributing to a more transparent process, and commends EPA for proceeding in this manner. Based on the first roun d of regulatory determinations, a range of 0.02%-

3.2% for national occurrence could be considered as the minimum threshold for development of a new regulation. National occurrence estimates for these eleven contaminants are well below this threshold, with boron having the highest prevalence of occurrence, at 1.7% of systems sampled in the National Inorganics and Radionuclides Survey (NIRS). Based on the first six-year review, a range

of 0.53%-9.28% for national occurrence could be c onsidered as the minimum threshold for revising an existing regulation.

Some might consider the lack of new contamin ant regulations since the 1996 SDWA Amendments as an indication that this new regulatory development process is not working. AWWA disagrees with that viewpoint and believes, rather, that not regula ting trivial contaminants is a positive development for EPA. Thirteen previously regulated contaminants had zero violations according to SDWIS data. Despite the lack of contaminant occurrence at levels of health concern, as inferred from the absence
of violations for these contaminants, their re gulation was nevertheless mandated by 1986 SDWA listing (Roberson, 2003).

A further indication that the new regulatory development process is working properly is the successful collection of occurrence data, through the Unregulated Contaminant Monitoring Rule (UCMR), to support regulatory determinations. Four of the contaminants (2,6-Dinitrotoluene, EPTC, Fonofos, Terbacil) in the current notice have zero occurrence based on the monitoring results from the first UCMR (UCRM1). These four contaminants were considered to be of potential

concern based on the best information at the ti me back in 1998 when the first Contaminant Candidate List (CCL1) was published. UCMR1 monitoring results showed that these four contaminants were never detected in any of the more than 3,800 monitored systems.

AWWA recommends that EPA expand its discussion of the logic underlying the determinations for these eleven contaminants. The logic provided in the May 1st notice is not entirely clear. Generally, EPA needs to raise the level of transparency in its decision logic so that stakeholders can understand how data and information translate to determinations and to ensure consistency across the two parallel regulatory efforts (regulatory determina tions and six-year review). For example, in the

current notice there is no discussion about the rema ining 40 CCL2 contaminants, what data are needed to make regulatory determinations, and what is being done to collect those data. Stakeholders have no way of knowing if more information on health effects or occurrence is required, or whether analytical methods research is needed before health effects and/or occurrence data can be reliably obtained.

The integration of EPA's overall drinking water research agenda with the overall regulatory development process is not sufficiently explained in this notice. The research being done on the

balance of the contaminants from the second Cont aminant Candidate List (CCL2) is not discussed. The process for conducting the appropriate resear ch and then making the appropriate regulatoryEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1092 of 1099 decision for the 40 remaining contaminants needs to be clearly communicated to the drinking water community. For example, although national occurre nce data from over 3,800 systems exists for
acetochlor, molinate, and nitrobenzene, which were included in UCRM1 List 1, these three contaminants are not discussed at all in the May 1st Federal Register. It is unclear how the regulatory development process is driving EPA's research agenda.

AWWA recommends that, in the final notice, EP A develop a table on the information gaps for chemical contaminants similar to the table of pg. 24052 of the May 1st Federal Register for

microbial contaminants. The limited research info rmation in the current notice gives the appearance that little progress has been made since our 2002 comments on the first round of regulatory determinations. There is a strong need for appr opriately communicating the body of research on

CCL contaminants to the water sector.

AWWA wants to reiterate its concern that the 60-day comment period is not sufficient for adequately analyzing the complex issues surrounding perchlorate and for review, in general, of the associated background documentation. On May 22 nd, AWWA requested an extension of the public comment period to 120 days and this extensi on was not granted. Not granting the requested extension is unfortunate, as the short comment period does not allow for adequate review by the drinking water community of the background documentation and for adequate debate on the complex policy issues. Perchlorate has been on EPA’s regulatory agenda since its inclusion on the

draft of the first CCL in 1997. While EPA has ha d over a decade to work through the complex policy issues surrounding perchlorate, the drinki ng water community had only 60 days to sift through these issues and make the appropriate policy decision.

Response: No response is necessary to the specific recommendations regarding transparency and information gaps as these comments were addressed in the July 2008 notice (73 FR 44255, July 30, 2008). Regarding the comment about perchlorate, please see response to comment ID 20264 under

comment code 7100.

Commenter Name: Thomas Curtis Commenter Organization: American Water Works Association (AWWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0162

EPA Comment ID: 20269

EPA Comment Code: 7100

Comment: Metolachlor

AWWA does not have any additional occurrence data on metolachlor or its degradates, but believes

that more research is needed on the occurrence and health effects of many herbicides and pesticides and their degradates. The results of this resear ch then need to be appropriately included in regulatory decisions by the Office of Pesticide Programs (OPP) and the Office of Groundwater and Drinking Water (OGWDW).

For example, metolachlor was not included in OPP's Cumulative Risk Assessment (CRA) for the chloroacetanilides because it was not apparent from currently available data that it shares the same target site in the nasal tissue as acetochlor, alachlor and butachlor, even though it does distribute to the nasal turbinates and "might" metabolize to qui noneimine, the active agent (as do acetochlor, alachlor and butachlor). Propachlor was also excluded from the Cumulative Risk Assessment forEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1093 of 1099 similar reasons. EPA should promote further research to definitively determine whether or not metolachlor , a very widely used pesticide, is carc inogenic, as acetochlor, alachlor and metolachlor have very similar chemical structures.

The triazine herbicides are another example of the need to obtain the appropriate occurrence and health effects data of herbicides and pesticides and their degradates. AWWA has commented extensively in the past to OPP on the atrazine reregistration process. AWWA, through the Water Industry Technical Action Fund (WITAF) and a partnership with the Awwa Research Foundation (AwwaRF), has conducted extensive research on atrazi ne and its chlorinated metabolites. A listing of the published papers resulting from this research is enclosed as Appendix B.

The need for more occurrence and health effects data increases with the growing concern about potential reproductive and developmental effects from many herbicides and pesticides and their degradates. These new health endpoints will create monitoring and compliance challenges for water utilities, as the typical quarterly compliance monitori ng is likely not appropriate for these new health endpoints. Both metolachlor and atrazine are on EP A's recently released draf t list of 73 pesticides for Initial Tier 1 Screening as a potential endo crine disruptor under the Federal Food, Drug, and

Cosmetic Act.

Methyl tertiary-butyl ether (MTBE)

AWWA supports EPA's decision not to make a regulatory determination for methyl tertiary-butyl ether (MTBE) at this time as the risk assessment is currently being revise d. AWWA does not have any additional MTBE data to add to the topics listed in the May 1st Federal Register notice.

Microbial Contaminants

An information summary describing the state of the knowledge on the prevention, treatment, and health effects of cyanobacteria and its toxins would be useful for utilities and for state primacy agencies. The information should be concise and pr actical to ensure the document will be useful to water utility personnel. The summary should also include information on occurrence and conditions that might favor growth of algae and producti on of toxins. A strategy for communicating this information to utility customers should also be addressed. In addition to resources generated by EPA, the summary should include information of research funded by other organizations, particularly Awwa Research Foundation (AwwaRF).

Again, AWWA appreciates the opport unity to comment on these importa nt drinking water issues. If you have any questions about these comments, plea se feel to call Alan Roberson or me in our Washington Office at 202-628-8303.

Yours Sincerely, Thomas W. Curtis Deputy Executive Director

cc: Ben Grumbles - USEPA OW Cynthia Doug herty - USEPA OGWDW Audrey Levine - USEPA

ORD Brian Mannix - USEPA OPEI Alan Roberson Steve Via

P:\Regulatory\Comments\2007\ RegDet2 Comments JAR 7207.doc

[APPENDIX A - see PDF] [APPENDIX B - see PDF]EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1094 of 1099 Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: Ed Thomas Commenter Organization: National Rural Water Association (NRWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0163

EPA Comment ID: 20270

EPA Comment Code: 7100

Comment: July 2, 2007 U.S. Environmental Protecti on Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List-Preliminary Determi nations (Docket Number: EPA- HQ-OW-2007- 0068)

To Whom It May Concern:

NRWA commends EPA for it's caution in withhol ding regulatory action on the 11 contaminants

reviewed to date under the second contaminant cand idate listing process (CCL2) and concurs with EPA recommendations in this regard. NRWA's position concerning these 11 contaminants, as well as the remaining candidates on the list, is influenced primarily by two recent papers that bear directly

on the occurrence data and the risk evaluations th at are an integral part of the CCL review.

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: Diane VanDe Hei Commenter Organization: Association of Metropolitan Water Agencies (AMWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0166

EPA Comment ID: 20274

EPA Comment Code: 7100

Comment: July 2, 2007 U.S. Environmental Protecti on Agency Office of Water Docket (Mailcode 2822T) 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List-Preliminary Deter minations; Docket EPA-HQ-OW- 2007-0068

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the preliminary regulatory determinations for 11 contaminants as listed in the May 1, 2007 Federal Register (72 FR 24016). AMWA strong ly supports the process required by the 1996 Amendments to the Safe Drinking Water Act (S DWA) that identifies potential contaminants, gathers needed information to determine if a national regulation is needed, and presents a formal evaluation and determination on whether or not to regulate a given contaminant.

Prior to the 1996 Amendments, Congress required re gulation of specific contaminants based solely on the first step of the current process - the listing of potential contaminants. This lead to regulation of numerous contaminants that did not appear in dr inking water at levels of public health concernEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1095 of 1099 and wasted limited EPA and public resources. AMWA believes that this notice demonstrates that the 1996 process can work well in that the highes t priority contaminants are selected for evaluation

and that evaluation leads to informed decisions.

AMWA supports each of the 11 regulatory determinations made.

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Administrators (ASDWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0169

EPA Comment ID: 20284

EPA Comment Code: 7100

Comment: July 2, 2007 Comment Clerk Docket EPA-HQ-OW-2007-0068 Water Docket Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW. Washington,

DC 2046 0

Dear Sir:

In response to the notice in the Federal Register of May 1, 2007 (Volume 72, Number 83) the Association of State Drinking Water Administrato rs (ASDWA) would is offering comments to the U.S. Environmental Protection Agency (EPA) on the Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant List -- Preliminary Determinations; Proposed Rule. ASDWA is the professional Association that represents the collective interests of the nation's state drinking water programs res ponsible for implementation of the Federal Safe Drinking Water Act.

Although some states have the expertise and resources to conduct their own evaluations of contaminant risk and may set their own, more string ent regulatory controls, most states rely on the EPA to determine which contaminants should be regula ted in drinking water. It is critical that these

determinations are based on sound science and ac complished through a transparent process with adequate input from all interested parties, especia lly the states. States ex pect EPA to follow the process prescribed in the Safe Drinking Water A ct and we support the three statutory criteria for regulatory determinations:

(1) the contaminant may have an adverse effect on the health of persons;

(2) the contaminant is known to occur or there is substantial likelihood that the contaminant will occur in public water systems with a frequency an d at levels of public health concern; and

(3) in the sole judgment of the Administrator, re gulation of such contaminant presents a meaningful opportunity for health risk reduction for pers ons served by public water systems.

ASDWA appreciates the opportunity to provide the perspective of states on EPA's preliminary

determination of which contaminants from the se cond Contaminant Candidate List (CCL2) should be regulated. States are generally in favor of the regulatory decisions that EPA is proposing in this

notice but we do have a few comments to offer.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1096 of 1099 States generally agree there is no significant oc currence nor any "meaningful opportunity for health risk reduction" in regulating the 11 contaminants EPA has preliminarily decided not to regulate. One state indicated that dacthal and its degradates did appear in some drinking water system monitoring in their state but that it could be effectively managed in the absence of a federal regulation. Therefore, ASDWA supports EPA's decision not to regulate the 11 contaminants on the list in the May 1, 2007 proposal.

Response: See response to comment ID 20264 under comment code 7100.

Commenter Name: James Taft Commenter Organization: Association of State Drinking Water Administrators (ASDWA)

EPA Document ID: EPA-HQ-OW-2007-0068-0169

EPA Comment ID: 20288

EPA Comment Code: 7100

Comment: Metolachlor and Methyl tertiary-butyl-ether (MTBE):

As stated in the Federal Register notice, EPA's primary need here is for additional contaminant occurrence data to support its regulatory decisions. Monitoring conducted by water systems under UCMRI and coming under UCMR2 will provide a solid base of occurrence data for future determinations. Many states have assisted EPA in implementing the UCMR monitoring to help assure that systems monitor and report as required. We believe these new data will add significantly to EPA's knowledge of the occurrence of cont aminants on the Contaminant Candidate Lists and others considered for regulation.

Thank you for your consideration of these comm ents. Please contact me at 703-812-9507 or jtaft@asdwa.org if we can provide additional informat ion or if any clarification of these comments is

needed.

Sincerely, James D. Taft Executive Director

Response: See response to comment ID 20264 under comment code 7100.EPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1097 of 1099 

## Appendix 1 – Complete List of EPA Comment Codes

Comment

Code Comment Topics Comment Code

Used?

1000 General Comments Y

1100 SDWA requirements and the CCL and Regulatory Determinations

process Y

1200 EPA’s handling in the October 2008 FR Notice of perchlorate-related

comments that were submitted following the May 2007 RegDet2 FR

Notice N

1300 Length of the comment period follo wing the October 2008 FR Notice Y 1400 Supplemental Request for Comments 1500 EPA's handling of comments on the October 2008 FR Notice Y 1600 Length of the comment period following August 2009 FR Notice Y

2000 Perchlorate Health Effects Y 2100 NAS (NRC) review of perchlorate he alth effects and reference dose Y 2110 Regulatory determinat ion based upon the alre ady-established RfD Y

2150 EPA's decision not to seek further input from the NRC on issues related to perchlorate Y

2200 Use of NHANES biomonitoring data for health effe cts evaluation Y

2300 Use of PBPK models from Clewell et al (2007) and Merrill et al (2005)

to evaluate health effects Y

2400 Use of EPA’s PBPK model to evaluate health effects Y

2410 Use of PBPK model to select life-stage-specific HRLs Y

2420 Suggestions for alternative ways to use the PBPK model to inform the regulatory determination Y

2500 Other health effects studies, models, and data for EPA to consider (besides NAS/NRC report, NHANES biomonitoring data, and PBPK models already evaluated) Y

2600 Comments on expanding scope of ri sk assessment to include other goitrogens and/or dietary iodide deficiency Y

3000 Perchlorate Occurrence in Drinking Water Y 3100 UCMR 1 occurrence analysis Y 3110 UCMR 1 analytical methods and minimum reporting limits (MRL) N

3120 UCMR 1 statistical methodology and nationally representative sample of small systems Y

3130 UCMR 1 schedule and sampling plan N 3140 UCMR 1 entry-point-level estima tion of perchlorate exposure Y

3150 Potential use of a Bayesian model to estimate number of PWSs and population served at a range of thresholds Y

3160 Use of Census data to estimate populations that are in the sensitive life

stage Y

3170 Accounting for variation of perchlorate levels in public water systems

over time Y

3200 Supplemental drinking water occurrence data from California and

Massachusetts Y

3300 Other drinking water occurrence studies, models, and data for EPA to consider (besides UCMR 1 and Ca lifornia and Massachusetts data YEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1098 of 1099 Comment

Code Comment Topics Comment Code

Used?

already evaluated)

4000 Evaluation of Perchlorate Exposure from Sources Other than Drinking Water Y

4100 Dietary studies N 4110 Dietary studies -- FDA’s 2005-2006 total dietary study (TDS) Y

4120 Dietary studies -- FDA’s 2003-2005 exploratory survey data on perchlorate in food N

4130 Dietary studies -- other studies, models, and data (besides FDA’s 2005- 2006 TDS, and 2003-2005 exploratory data) Y

4200 Biomonitoring N

4210 Biomonitoring -- urinary data fr om the 2001-2002 NHANES study, and EPA/CDC’s NHANES-UCMR analysis Y

4220 Biomonitoring -- breast milk st udies discussed in the notice Y

4230 Biomonitoring -- other biomonitoring studies, models, and data for EPA to consider (other than NH ANES and breast milk studies discussed in the notice) Y

4300 Other perchlorate exposure studies, models, and data for EPA to consider (other than drinking water, diet, and biomonitoring) Y

5000 SDWA Criteria Y

5100 SDWA Criterion #1 -- EPA’s determination that perchlorate may have adverse effects on the health of persons Y

5200 SDWA Criterion #2 -- EPA’s determination that perchlorate occurs infrequently at levels of health concern in public water systems Y

5210 Derivation of the RSC Y

5220 Derivation of the HRL Y

5225 Use of alternative HRLs specific to sensitive life stages, as described in Table 2 of the August 2009 FR notice. Y

5230 Calculation of frequency of exposure above the HRL among pregnant

women Y

5240 Consideration of other sensitive subpopulations (e.g., infants, children, and persons with iodine deficien cy or thyroid disorders) when establishing the HRL Y

5300 SDWA Criterion #3 -- EPA’s determination that regulating perchlorate with a NPDWR would not represent a meaningful opportunity to reduce health risks for persons se rved by public water systems Y

6000 EPA Actions Y 6100 EPA’s preliminary determination not to regulate perchlorate Y 6110 Comments urging EPA not to regulate perchlorate Y 6120 Comments urging EPA to regulate perchlorate Y

6125 Comments critical of preliminar y determination (in the October 2008 FR Notice) specific to Washington Post article Y

6130 Miscellaneous comments on the preliminary determination not to regulate (in the October 2008 FR Notice) Y

6140 Additional new literature and information for EPA to consider when making a regulatory determination Y

6200 Comments related to EPA’s health advisory Y

6210 Need for EPA to provide additional support to States and water

systems YEPA-OGWDW Final Perchlorate EPA 815-R-10-005 Comment Response Document January 2011

Page 1099 of 1099 Comment

Code Comment Topics Comment Code

Used?

6300 EPA’s intention to revise guidance on clean-up levels (preliminary remediation goals) Y

6310 Clean-up as a solution Y

6400 EPA’s decision to subject updated PB PK model to peer review during comment period (in the October 2008 FR Notice) Y

6500 Comments on alternative ri sk reduction approaches Y

7000 Miscellaneous Comments Y 7100 N/A May 2007 Comments Y