### LETTER_ID FILE_NAME DOCKET_NUMBER EPA_LETTER_ID

6502 

### EPA-HQ-OW-2007-1189-0048.pdf EPA-HQ-OW-2007-1189-0048 0048 6503 

### EPA-HQ-OW-2007-1189-0049.pdf EPA-HQ-OW-2007-1189-0049 0049 6081 

### EPA-HQ-OW-2007-1189-0051.pdf EPA-HQ-OW-2007-1189-0051 0051 6504 

### EPA-HQ-OW-2007-1189-0052.pdf EPA-HQ-OW-2007-1189-0052 0052 6505 

### EPA-HQ-OW-2007-1189-0053.pdf EPA-HQ-OW-2007-1189-0053 0053 6506 

### EPA-HQ-OW-2007-1189-0054.pdf EPA-HQ-OW-2007-1189-0054 0054 6533 

### EPA-HQ-OW-2007-1189-0055.pdf EPA-HQ-OW-2007-1189-0055 0055 6507 

### EPA-HQ-OW-2007-1189-0057.pdf EPA-HQ-OW-2007-1189-0057 0057 6508 

### EPA-HQ-OW-2007-1189-0058.pdf EPA-HQ-OW-2007-1189-0058 0058 6509 

### EPA-HQ-OW-2007-1189-0060.pdf EPA-HQ-OW-2007-1189-0060 0060 6510 

### EPA-HQ-OW-2007-1189-0061.pdf EPA-HQ-OW-2007-1189-0061 0061 6511 

### EPA-HQ-OW-2007-1189-0062.pdf EPA-HQ-OW-2007-1189-0062 0062 6561 

### EPA-HQ-OW-2007-1189-0063.pdf EPA-HQ-OW-2007-1189-0063 0063 6512 

### EPA-HQ-OW-2007-1189-0064.pdf EPA-HQ-OW-2007-1189-0064 0064 6513 

### EPA-HQ-OW-2007-1189-0065.pdf EPA-HQ-OW-2007-1189-0065 0065 6514 

### EPA-HQ-OW-2007-1189-0066.pdf EPA-HQ-OW-2007-1189-0066 0066 6515 

### EPA-HQ-OW-2007-1189-0067.pdf EPA-HQ-OW-2007-1189-0067 0067 6516 

### EPA-HQ-OW-2007-1189-0068.pdf EPA-HQ-OW-2007-1189-0068 0068 6517 

### EPA-HQ-OW-2007-1189-0069.pdf EPA-HQ-OW-2007-1189-0069 0069 6518 

### EPA-HQ-OW-2007-1189-0070.pdf EPA-HQ-OW-2007-1189-0070 0070 6519 

### EPA-HQ-OW-2007-1189-0071.pdf EPA-HQ-OW-2007-1189-0071 0071 6520 

### EPA-HQ-OW-2007-1189-0072.pdf EPA-HQ-OW-2007-1189-0072 0072 6521 

### EPA-HQ-OW-2007-1189-0073.pdf EPA-HQ-OW-2007-1189-0073 0073 6522 

### EPA-HQ-OW-2007-1189-0074.pdf EPA-HQ-OW-2007-1189-0074 0074 6523 

### EPA-HQ-OW-2007-1189-0075.pdf EPA-HQ-OW-2007-1189-0075 0075 6524 

### EPA-HQ-OW-2007-1189-0076.pdf EPA-HQ-OW-2007-1189-0076 0076 6082 

### EPA-HQ-OW-2007-1189-0077.pdf EPA-HQ-OW-2007-1189-0077 0077 6525 

### EPA-HQ-OW-2007-1189-0078.pdf EPA-HQ-OW-2007-1189-0078 0078 6526 

### EPA-HQ-OW-2007-1189-0079.pdf EPA-HQ-OW-2007-1189-0079 0079 6527 

### EPA-HQ-OW-2007-1189-0080.pdf EPA-HQ-OW-2007-1189-0080 0080 6530 

### EPA-HQ-OW-2007-1189-0083.pdf EPA-HQ-OW-2007-1189-0083 0083 6531 

### EPA-HQ-OW-2007-1189-0084.pdf EPA-HQ-OW-2007-1189-0084 0084 6532 

### EPA-HQ-OW-2007-1189-0085.pdf EPA-HQ-OW-2007-1189-0085 0085 6562 

### EPA-HQ-OW-2007-1189-0086.pdf EPA-HQ-OW-2007-1189-0086 0086 6083 

### EPA-HQ-OW-2007-1189-0087.pdf EPA-HQ-OW-2007-1189-0087 0087 6534 

### EPA-HQ-OW-2007-1189-0088.pdf EPA-HQ-OW-2007-1189-0088 0088 6535 

### EPA-HQ-OW-2007-1189-0089.pdf EPA-HQ-OW-2007-1189-0089 0089 6536 

### EPA-HQ-OW-2007-1189-0090.pdf EPA-HQ-OW-2007-1189-0090 0090 6537 

### EPA-HQ-OW-2007-1189-0091.pdf EPA-HQ-OW-2007-1189-0091 0091 6538 

### EPA-HQ-OW-2007-1189-0092.pdf EPA-HQ-OW-2007-1189-0092 0092 6563 

### EPA-HQ-OW-2007-1189-0093.pdf EPA-HQ-OW-2007-1189-0093 0093 6564 

### EPA-HQ-OW-2007-1189-0094.pdf EPA-HQ-OW-2007-1189-0094 0094 6539 

### EPA-HQ-OW-2007-1189-0095.pdf EPA-HQ-OW-2007-1189-0095 0095 6540 

### EPA-HQ-OW-2007-1189-0096.pdf EPA-HQ-OW-2007-1189-0096 0096 6541 

### EPA-HQ-OW-2007-1189-0098.pdf EPA-HQ-OW-2007-1189-0098 0098 6542 

### EPA-HQ-OW-2007-1189-0099.pdf EPA-HQ-OW-2007-1189-0099 00996586 

### EPA-HQ-OW-2007-1189-0100.pdf EPA-HQ-OW-2007-1189-0100 0100

6543 

### EPA-HQ-OW-2007-1189-0101.pdf EPA-HQ-OW-2007-1189-0101 0101 6544 

### EPA-HQ-OW-2007-1189-0102.pdf EPA-HQ-OW-2007-1189-0102 0102 6545 

### EPA-HQ-OW-2007-1189-0103.pdf EPA-HQ-OW-2007-1189-0103 0103 6546 

### EPA-HQ-OW-2007-1189-0104.pdf EPA-HQ-OW-2007-1189-0104 0104 6547 

### EPA-HQ-OW-2007-1189-0105.pdf EPA-HQ-OW-2007-1189-0105 0105 6565 

### EPA-HQ-OW-2007-1189-0106.pdf EPA-HQ-OW-2007-1189-0106 0106 6566 

### EPA-HQ-OW-2007-1189-0107.pdf EPA-HQ-OW-2007-1189-0107 0107 6567 

### EPA-HQ-OW-2007-1189-0108.pdf EPA-HQ-OW-2007-1189-0108 0108 6568 

### EPA-HQ-OW-2007-1189-0110.pdf EPA-HQ-OW-2007-1189-0110 0110 6569 

### EPA-HQ-OW-2007-1189-0112.pdf EPA-HQ-OW-2007-1189-0112 0112 6570 

### EPA-HQ-OW-2007-1189-0113.pdf EPA-HQ-OW-2007-1189-0113 0113 6548 

### EPA-HQ-OW-2007-1189-0114.pdf EPA-HQ-OW-2007-1189-0114 0114 6549 

### EPA-HQ-OW-2007-1189-0115.pdf EPA-HQ-OW-2007-1189-0115 0115 6550 

### EPA-HQ-OW-2007-1189-0116.pdf EPA-HQ-OW-2007-1189-0116 0116 6571 

### EPA-HQ-OW-2007-1189-0118.pdf EPA-HQ-OW-2007-1189-0118 0118 6551 

### EPA-HQ-OW-2007-1189-0119.pdf EPA-HQ-OW-2007-1189-0119 0119 6552 

### EPA-HQ-OW-2007-1189-0120.pdf EPA-HQ-OW-2007-1189-0120 0120 6553 

### EPA-HQ-OW-2007-1189-0122.pdf EPA-HQ-OW-2007-1189-0122 0122 6554 

### EPA-HQ-OW-2007-1189-0123.pdf EPA-HQ-OW-2007-1189-0123 0123 6572 

### EPA-HQ-OW-2007-1189-0124.pdf EPA-HQ-OW-2007-1189-0124 0124 6555 

### EPA-HQ-OW-2007-1189-0126.pdf EPA-HQ-OW-2007-1189-0126 0126 6556 

### EPA-HQ-OW-2007-1189-0127.pdf EPA-HQ-OW-2007-1189-0127 0127 6573 

### EPA-HQ-OW-2007-1189-0128.pdf EPA-HQ-OW-2007-1189-0128 0128 6557 

### EPA-HQ-OW-2007-1189-0129.pdf EPA-HQ-OW-2007-1189-0129 0129 6574 

### EPA-HQ-OW-2007-1189-0130.pdf EPA-HQ-OW-2007-1189-0130 0130 6575 

### EPA-HQ-OW-2007-1189-0131.pdf EPA-HQ-OW-2007-1189-0131 0131 6576 

### EPA-HQ-OW-2007-1189-0132.pdf EPA-HQ-OW-2007-1189-0132 0132 6558 

### EPA-HQ-OW-2007-1189-0133.pdf EPA-HQ-OW-2007-1189-0133 0133 6577 

### EPA-HQ-OW-2007-1189-0134.pdf EPA-HQ-OW-2007-1189-0134 0134 6578 

### EPA-HQ-OW-2007-1189-0135.pdf EPA-HQ-OW-2007-1189-0135 0135 6579 

### EPA-HQ-OW-2007-1189-0136.pdf EPA-HQ-OW-2007-1189-0136 0136 6580 

### EPA-HQ-OW-2007-1189-0137.pdf EPA-HQ-OW-2007-1189-0137 0137 6581 

### EPA-HQ-OW-2007-1189-0138.pdf EPA-HQ-OW-2007-1189-0138 0138 6084 

### EPA-HQ-OW-2007-1189-0139.pdf EPA-HQ-OW-2007-1189-0139 0139 6582 

### EPA-HQ-OW-2007-1189-0140.pdf EPA-HQ-OW-2007-1189-0140 0140 6583 

### EPA-HQ-OW-2007-1189-0141.pdf EPA-HQ-OW-2007-1189-0141 0141 6584 

### EPA-HQ-OW-2007-1189-0142.pdf EPA-HQ-OW-2007-1189-0142 0142 6585 

### EPA-HQ-OW-2007-1189-0145.pdf EPA-HQ-OW-2007-1189-0145 0145 6587 

### EPA-HQ-OW-2007-1189-0146.pdf EPA-HQ-OW-2007-1189-0146 0146 6588 

### EPA-HQ-OW-2007-1189-0147.pdf EPA-HQ-OW-2007-1189-0147 0147 6601 

### EPA-HQ-OW-2007-1189-0148.pdf EPA-HQ-OW-2007-1189-0148 0148 6602 

### EPA-HQ-OW-2007-1189-0149.pdf EPA-HQ-OW-2007-1189-0149 0149 6603 

### EPA-HQ-OW-2007-1189-0150.pdf EPA-HQ-OW-2007-1189-0150 0150 6604 

### EPA-HQ-OW-2007-1189-0151.pdf EPA-HQ-OW-2007-1189-0151 0151 6605 

### EPA-HQ-OW-2007-1189-0152.pdf EPA-HQ-OW-2007-1189-0152 0152 6606 

### EPA-HQ-OW-2007-1189-0153.pdf EPA-HQ-OW-2007-1189-0153 01536607 

### EPA-HQ-OW-2007-1189-0154.pdf EPA-HQ-OW-2007-1189-0154 0154

6608 

### EPA-HQ-OW-2007-1189-0155.pdf EPA-HQ-OW-2007-1189-0155 0155 6609 

### EPA-HQ-OW-2007-1189-0156.pdf EPA-HQ-OW-2007-1189-0156 0156 6610 

### EPA-HQ-OW-2007-1189-0157.pdf EPA-HQ-OW-2007-1189-0157 0157 6611 

### EPA-HQ-OW-2007-1189-0158.pdf EPA-HQ-OW-2007-1189-0158 0158 6612 

### EPA-HQ-OW-2007-1189-0159.pdf EPA-HQ-OW-2007-1189-0159 0159 6613 

### EPA-HQ-OW-2007-1189-0160.pdf EPA-HQ-OW-2007-1189-0160 0160 6614 

### EPA-HQ-OW-2007-1189-0161.pdf EPA-HQ-OW-2007-1189-0161 0161 6615 

### EPA-HQ-OW-2007-1189-0162.pdf EPA-HQ-OW-2007-1189-0162 0162 6616 

### EPA-HQ-OW-2007-1189-0163.pdf EPA-HQ-OW-2007-1189-0163 0163 6621 

### EPA-HQ-OW-2007-1189-0164.pdf EPA-HQ-OW-2007-1189-0164 0164 6641 

### EPA-HQ-OW-2007-1189-0165.pdf EPA-HQ-OW-2007-1189-0165 0165 8582 

### EPA-HQ-OW-2007-1189-0166.pdf EPA-HQ-OW-2007-1189-0166 0166 8583 

### EPA-HQ-OW-2007-1189-0167.pdf EPA-HQ-OW-2007-1189-0167 0167

### EPA_LETTER_ID LETTER_ID LINE_NUMBER



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CS Title: 0051 Company/group/association name: Comment:

The following comments are my personal opinions and do not represent my employer, the National Institutes of Health. As way of background, I am a practicing microbiologist with more than 30 years experience, the Editor-in-Chief of the ASM Manual of Clinical Microbiology, editor of Topley & W ilson's Microbiology and Microbial Infections, author of numerous books and scientific publications, formerly Professor of Pathology and Medicine at Washington University in St. Louis, and currently Chief of Microbiology at the NIH Clinical Center. I was also a member of the Advisory Board to the EPA that helped formulate the Drinking Water CCL-3. My committee of experts spent considerable time and effort working with the EPA to develop objective criteria for selecting the agents and classifying all potential candidate agents. The criteria that we developed are listed in Exhibits 13, 15, 16, and 17 of this document. This was not a trivial exercise and we had some difficulties with some agents that were included in the final list.

For example, Naegleria floweri is an uncommon agent associated with only a few cases of drinking water associated disease; however, disease caused by this organism (i.e., meningoencephalitis) is uniformly fatal. Thus, this parasite was included in our recommended list using the established selection criteria. It is my opinion that although we may have included some organisms where there was not uniform ageement, we did not exclude any organisms that we felt were appropriate for this. For that reason, I take exception at the inclusion of Helicobacter pylori and Entamoeba histolytica and the exclusion of Enterovirus and Rotavirus. The classification scores listed in Exhibit 17 do not reflect the opinion of the Expert Panel. H. pylori was given a score of 5.1 by the panel, E. histolytica as score of 7.1, Rotavirus a score of 7.2, and Enterovirus a score of 7.9. If the currently published list of Candidate Agents is to be retained, then justification for the variance from the panel's recommendations, particularly for inclusion of H. pylori and exclusion of Enterovirus, needs to be justifiedusing the stated selection criteria.

CS Title: 0077 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189 April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default-aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least20 additional patient homes are currently being studied and

compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.

Sincerely,

Philip Leitman President CS Title: 0087 Company/group/association name: Comment:

i do not agree with this letter writer who is employed by this company and of course writes for the companys profits. also it is my understanding that epa has approved every toxic chemical that went for approval before them for the past l7 years, hardly showing any regulatory action by this kind of blanket approval of all toxic chemicals, i also think 66 days for a toxic chemical to leave the soil is far far too long to be allowed. i do not appreciate dow chemical which has been involved in a sordid past, in my opinion. i think we need towatch toxic chemical companies far far more closely than we

have in the past. americans are carrying around l48 toxic chemicals in their bodies at present. something is desperately wrong with a system that allows that kind of invasion. our birds are dying. our fish are dying and turning up with pustules. something is attacking earth. we need to be much much more careful than epa has shown itself to be. CS Title: 0139 Company/group/association name: Comment:

May 21, 2008

Water Docket Docket ID No. EPA-HQ-OW-2007-1189 Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW . Washington, DC 20460

To W hom it May Concern:

In response to the notice in the Federal Register of February 21, 2008 (Volume 73, Number 35) the Association of State Drinking Water Administrators (ASDWA) would like to offer comments on the draft third Contaminant Candidate List (CCL3). ASDWA supports and represents the collective interests of the states, territories, and the Navajo Nation in their administration of national drinking water program requirements within their states or territories including regulatory development and the CCL. ASDWA appreciates the opportunity to prov ide the perspective of states on this important phase of the regulatory process.

* Perspectives on Overall Process to CCL: States fully endorse the regulatory development construct outlined in the 1996 SDWA amendments - a process based on sound science. Most states do not have the resources or capacity to conduct their own studies on the occurrence or health effects of contaminantsthat might need control in drinking water. They rely on EPA to

assess health risks and assemble occurrence data needed in order to determine whether or not contaminants warrant national regulations and, if so, at what levels. The CCL is the critical first step in this regulatory consideration and development process. We believe the existing process, including the CCL, is designed to capture the contaminants that have the greatest potential to pose a threat to water supplies, based on knowledge of their occurrence and their health risks. Webelieve this established protocol for evaluation of potential contaminants for regulation should be followed, rather than an ad hoc process.

* Need to Consider Synergistic Effects: States believe the current process has serious limitations because contaminants are typically considered indiv idually and not in mixtures/combinations. The health effects information from the Food and Drug Administration database on Maximum Recommended Daily Doses (MRDD) is derived based on the effects of single compounds; when in actuality, the compounds exist as mixtures in the environment. EPA should endeavor to address the cumulative and synergistic effects of these compounds as well.

* Comments on Pharmaceuticals and Personal Care Products: It is appropriate to add pharmaceuticals and personal care products (PPCPs) to the current and future CCL lists only as enough information becomes available to warrant consideration of these chemicals for possible regulation. We collectively need to avoid the "knee-jerk" reaction of calling for regulation of specific chemicals in response to media attention and instead, should continue to ensure that regulations be based on sound science. We urge EPA to continue to carefully

evaluate available health effect information on contaminants of concern. Pharmaceuticals, in particular, have a voluminous amount of data on health effects available as a result of FDA requirements associated with the use of these compounds. As a goal, it would be ideal to have none of these contaminants in the drinking water but practically, this is impossible. Thus, we should be guided by the premise that, if there is no observable health effect at levels found in drinking water (with an adequate margin of safety), then EPA should not set a standard. Resources could be better spent trying to prevent orminimize the amount of PPCPs that get into sources of drinking

water in the first instance. Manufacturers and those involved in the distribution of these products need to be engaged in efforts to keep these contaminants out of the environment and, in providing data and information about their health effects.

Nonetheless, public and legislative concern over pharmaceuticals and personal care products is not going away. EPA and the drinking water community need to get out ahead of the issue to avoid Congressional mandates prescribing a specific regulatory schedule. EPA should carefully review the data already evaluated in the CCL3 process and any new data reported in response to the February 21, 2008 Federal Register Notice to identify any contaminants in this group that could prov ide a meaningful opportunity for health risk reduction. If there is insufficient data on any of the PPCPs to warrant their inclusion on the CCL 3, EPA needs to identify these as candidates for additional study and consider including them in a future Unregulated Contaminant Monitoring Regulation.

* Comments on Specific Contaminants Warranting Further Consideration: Listed below are several categories of contaminants of concern to state drinking water programs. We do not have sufficient information about these contaminants to categorically recommend that they appear on CCL 3 or the Unregulated Contaminated Monitoring (UCM) list. However, we ask that the Agency pay particular attention to these contaminants, for the reasons mentioned, and consider them for possible current or future CCLs or for the UCM - applying the statutory tests for these lists to available data and information.

* Contaminants Warranting Further Analysis - Highly Prescribed Drugs: Water reuse is becoming an increasingly important tool as water systems stretch their water resources to meet growing demands. States want to ensure that EPA considers the most highly prescribed drugs and over-the-counter sales leaders for future health effects and occurrence study. Of particular concern are the antibiotics, due to the potential for eventual formation of resistant strains of bacteria.~ ACE inhibitors such as Lisinopril, Enalipril

~ Anti-anxiety such as Aprazolam, Lorazepam, Diazepam

~ Antiarrythmics such as Digoxin

~ Antibiotics such as Amoxicillin, erythromycin, Azithromycin, and Sulfamethoxazole

~ Anticoagulants such as Clopidogrel, warfarin

~ Anticonvulsants such as Gabapentin, carbamazepine, primidone

~ Antidepressants such as sertraline, Escitalopram, fluoxtine

~ Antihistamines such as pheniramine, bromopheniramine, chloropheniramine, clemastine, doxylamine, diphenylhydramine, triprolidine

~ Antihypertensives such as clonidine

~ Antiosteoporietics such as alandronate, risedronate

~ Antiulcer drugs such as esomeprazole, lansoprazole, pantoprazole

~ Bronchiodilators such as albuterol, salmeterol

~ Decongestants such as oxmetazoline, pseudoephredrine,xylometazoline, phenylpropylamine

~ Antiulcer (H-2 receptor antagonists) such as Ranatidine, cimeitidine, famotidine, nizatidine

~ Expectoratns such as guaifenesin

~ Glucocorticiods such as hydrocortisone

~ Antifungals such as haloprogin, miconazole, clotrmazole, butaconazole, tioconazole, terbinaifine

~ Antismoking aids such as nicotine, continine

* Contaminants Warranting Further Analysis -- Genotoxic Compounds: Genotoxic carcinogens, pharmaceuticals that are used for patients who, without the treatment would die, prov ide a benefit, but also may pose a health risk. The following compounds should be examined:

~Flutamide ~Methotrexate ~Carboplatin ~Ifosfamide ~Megestrol ~Cyclophosphamide ~Bleomycin A1 ~Topotecan ~Cisplatin ~Mitomycin ~Florouracil ~Docetaxel ~Mephalan ~Cyclosporine ~Procarbazine HCl ~Mercaptopurine ~Busulfan~Epirubicin

* Additional Contaminants or Contaminant Categories of Concern: In addition to the contaminants prev iously mentioned, states recommend the following specific compounds for further analysis and consideration:

~ Estrogenic Compounds including pro-estrogen chemicals and estrone

~ 17 alpha estradiol

[In addition to the contaminants previously mentioned, states recommend the following specific compounds for further analysis and consideration:] ~ Carbamazepine (most frequently detected pharmaceutical in numerous studies; it appears to be resistant to treatment removal technologies and tends not to break down in the

env ironment).

Thank you for your consideration of these comments. Please contact me at 703-812-9507 or jtaft@asdwa.org if we can prov ide additional information or if any clarification of these comments is needed.

Sincerely,

James D. Taft Executive Director CS Title: 0048 Company/group/association name: Comment:

In the ccl criteria table for long-term health effects from Legionella, the answer should be "YES" to the question "Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae?"There are many references. Here's a good one:

Thorax 1998;53:302-307 ( April ) Lung infections 4 Pathogenesis of lower respiratory tract infections due to Chlamydia, Mycoplasma, Legionella and viruses Author: Paul Andersen

A quote from the Abstract: "Long lasting sequelae such as bronchiectasis, lung fibrosis, and decreased lung function are seen after lower respiratory tract infections" CS Title: 0049 Company/group/association name: Comment:

If one of the criteria for placing a candidate chemical on the list is the liklihood of it being found in a PWS then there have been some exclusions that need to be considered.

More and more common pharmceuticals (metabolized and neat) have been showing-up in water testing results. Additionally, phthalates as a class of chemical and endocrine-disrupting chemicals such as bisphenol A and polyalkoxalated phenolics are being detected with regularity.

I urge you to consider broadening the list to include review and consideration of these contaminants.

Thank you. CS Title: 0052 Company/group/association name: Comment:

The Babylon Breast Cancer Coalition requests that all chemicals and pathogens on the Candidate Contaminant List become part of the standard contaminant list so that local water authorities and departments will receive directives to monitor theseadditional contaminants on a regular basis.

As an organization advocating a "better safe than sorry" approach to env ironmental, public and personal health policies, it is the epa's moral and public obligation to protect the health of consumers by broadening the drinking water contaminant list. CS Title: 0053 Company/group/association name: Comment:

Our organization urges the EPA to include all of the chemical contaminants (CCL3) to be included as an expanded standard list of contaminants for monitoring in our drinking water. Water districts throughout our country defer to the standard EPA list of contaminants for guidance and the current list is lacking. Chemicals like permethrin on the CCL3 have been found by a study at Mount Sinai Medical Center to have hormonal activity which can lead to breast cancer and other hormonal cancers. Formaldehyde, also on the CCL3, is listed on the NTP list of carcinogens as a probable carcinogen and PFOA has been catergorized by EPA as a likely carcinogen. Many of the pesticides on the CCL3 are probable or possible carcinogens as well. Thank you to the EPA for protecting public health by adding these additional CCL3 chemicals to your current standard list of chemicals to be monitored by all water departments throughout the United States. CS Title: 0054 Company/group/association name: Comment:

March 17, 2008

Water Docket Environmental Protection Agency Mailcode: 2822T 200 Pennsylvania Ave NW Washington, DC 20460This letter is to convey W isconsin Department of Agriculture,

Trade and Consumer Protection comments regarding Docket ID No. EPA-HQ-OW-2007-1189. Our comments are within two specific

areas.

First, we fully support the addition of the ESA and OA metabolites of alachlor, acetochlor and metolachlor to the Contaminant Candidate List. These are compounds that have repeatedly been detected in our drinking water supplies in Wisconsin. For instance, in 2001 we randomly sampled over 300 private drinking water wells throughout W isconsin and from that sampling we estimated the following detection frequencies: alachlor ESA - 27.8% of the wells, alachlor OA - 3.7%, acetachlor ESA - 2.6%, metolachlor ESA - 25.2% and metolachlor OA - 6.4%.

Second, we recommend the addition of dimethanamid and it's ESA and OA metabolites to the Contaminant Candidate List. Since this product became registered in the mid 90's we have been testing for the parent compound (dimethanamid) in monitoring wells at storage facilities throughout W I. We detect it in over 25% of the monitoring wells where we are conducting this long term monitoring.

If you have any questions or would like to learn more about the well sampling we have conducted in W isconsin, you can reach me at 608/224-4550.

Sincerely,

Lori G. Bowman Bureau Director Agrichemical Management Bureau CS Title: 0057 Company/group/association name: Comment:

Hi, As the mother of two young children and a recent breastcancer survivor, I'm concerned about hazards in drinking water.

My breast cancer was not estrogen fed nor has a heredity link been found to explain the cause of my cancer. Naturally, I've

very concerned about exposure to any cancer-causing agents and I do my best to avoid them, as well as eat right and exercise to be as healthy as I can be. Knowing that cancer-causing agents could be in my water is indeed upsetting. How am I to

avoid those? How are others to avoid them too?

Already, we have an epidemic of cancer in our country (and world); we must now step up to the plate and reduce the carcinogens around us. Though advances have been made in cancer treatments, far too many still die of the diseases. I know, they are my friends and acquaintances that are dying.

Please do your part and raise the bar for safer water. W ith global warming upon us, availability of water will certainly be a rising concern but if it's filled with cancer-causing agents, what's the point anyway?

Thank you. Kathy Finger of SC CS Title: 0058 Company/group/association name: Comment:

The Contaminant Candidate List (CCL) contains currently unregulated contaminants that are known or anticipated to occur in public water systems and which may adversely impact human health. Many of the chemicals on the list are known or probable carcinogens, such as acetochlor, 1,3-butadiene, and formaldehyde. The EPA needs to test for and regulate these contaminants. CS Title: 0060 Company/group/association name: Comment:

I want to see these contaminants tested for and regulated. CS Title: 0061 Company/group/association name:Comment:

As I understand it, this proposed list would include many contaminants that are currently unregulated - and KNOW N to be carcinogens or possible carcinogens. The fact that these chemicals are currently unregulated is downright frightening given their potential threat to public health and safety. These contaminants absolutely MUST be tested, limits imposed and strictly regulated.

J. Watkins Calistoga, CA CS Title: 0062 Company/group/association name: Comment:

April 13, 2008

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

These comments are being provided in response to USEPA's solicitation for comment in the notice [EPA-HQ-OW-2007-1189 FRL-8559-7] that appeared in Federal Register Volume 73, Number 35 on February 21, 2008.

Fenamiphos is listed on the draft CCL 3 as an organophosphate pesticide of concern to drinking water systems. Given its current label and registration status, it is hard to imagine that fenamiphos would be a candidate for the CCL 3 or carry a great degree of potential to occur in drinking water.

Please consider my comments in regards to fenamiphos and its appearance on the draft Contaminant Candidate List.

The Agency has incorporated elements of the National DrinkingWater Advisory Council (NDWAC) recommendations and adopted the

guiding inclusionary principles in developing the Drinking Water Contaminant Candidate List 3 (CCL3). The two guiding principles as suggested by the NDWAC are that chemical contaminants tend to be characterized by both the toxicological data principle and the occurrence data principle that can be modeled or estimated if measurement is not possible. Guided by these principles and using a multi-step process of identification, screening, and evaluation the Agency has developed a draft list consisting of 92 chemical contaminants so characterized by the potential occurrence and adverse health risks they may pose to consumers of public water systems (EPA, 2008). In the Fact Sheet: Third Drinking Water Contaminant List (CCL3) (EPA, 2008) the Agency has summarized the multi- step process as follows;

[The commenter summarized the steps of the CCL 3 process] 1. Identifying a broad universe of potential drinking water contaminants (called the "CCL Universe"). EPA evaluated 284 data sources that may identify potential chemical and microbial contaminants and selected a set of approximately 7,500 contaminants from these data sources for initial consideration.

[The commenter summarized the steps of the CCL 3 process] 2. Applying screening criteria to the CCL universe to identify those contaminants that should be further evaluated (the preliminary CCL or PCCL) based on a contaminant's potential to occur in public water systems and the potential for public health concern.

[The commenter summarized the steps of the CCL 3 process] 3. Identifying contaminants from the PCCL to include on the CCL based on more detailed evaluation of occurrence and health effects and expert judgment applied in a transparent reproducible manner.

[The commenter summarized the steps of the CCL 3 process] 4. Incorporating public input and expert review in the CCL process.

The Agency's incorporation of the NDWAC recommendations and the adoption of the guiding inclusionary principles in developing the CCL3 prov ides a solid framework and a logical approach forthe initial construction of this list. However, does the

process allow for the possibility or the necessity of re- screening draft listed CCL3 contaminants after the initial publication of the draft list? Could changes to the toxicological and/or occurrence data, resulting from changes in the registration status of a pesticide, be sufficient to warrant the re-screening of the contaminant? Specifically, would lowering of a contaminant's potential to occur in public water systems and the mitigation of adverse health risks brought about as a result of changes to the registration of the pesticide fenamiphos, be enough to elicit a re-screening of this contaminant in order to determine if it would still remain on the CCL3?

The Agency ultimately developed the Universe of chemicals relying on 39 of the initial 284 evaluated data sources (the "Universe of Data Sources"). The data sources are classified by whether they provided health effects data or occurrence data and produced a compilation of 25,980 unique substances (EPA, 2008 a).

The partitioning of contaminants from the universe of chemicals to the PCCL is determined by plotting the summation of the contaminants relative occurrence data elements against the summation of the contaminants relative health effects data elements as illustrated in Table 1 from the Contaminant Candidate List 3 Chemicals: Screening to a PCCL (EPA, 2008 b). A contaminant that is essentially passed to the PCCL is then

available to become a candidate for the draft CCL3.

Table 1, Partition for Screening to the Universe (EPA, 2008 b) [see PDF]

The toxicological data principle is described by the Agency for its screening purposes in the CCL 3 as essentially a health effect/toxicity categorization of contaminants (EPA, 2008 b). The health effect/toxicity data elements that provide toxicity information fall into two major categories (EPA, 2008 a):* Data elements that prov ide dose-response information

(potency)

* Categorical data elements on hazard (mostly related to carcinogenic potential)

The cumulative types of data elements that comprise this toxicity categorization or 'universe health effects' are; Maximum Recommended Daily Dose (MRDD), Lowest Observable Adverse Effects Level (LOAELs), No Observed Adverse Effect Level (NOAELs) Lethal Dose 50 (LD50), Tumorigenic Dose 50 (TD50) and Reference Doses and their equivalents (RfDs and RfD- eq). Some data sources only include descriptive data such as the positive, negative, or equivocal results from National Toxicology Program (NTP) studies or International Agency for Research on Cancer (IARC) carcinogen classifications (EPA, 2008 b). After the overall evaluation of the available data elements on a contaminant's universe health effects, the contaminant is partitioned into one of five categories of relative toxicity and designated as a Toxicity category 1 thru 5, with Toxicity category 1 considered to be most toxic.

Thirteen of the 92 chemical contaminants on the CCL3 are classified as Organophosphorus pesticides (OPs). Due to the relative acute toxicity of this class of compounds and the fact that there are a little over 100 Organophosphorus compounds in commercial use, it is understandable that the CCL take a special interest in this class of pesticides. It is generally accepted that OPs do not persist or bioaccumulate in the

env ironment, however they are acetylcholinesterase inhibitors that work primarily on the nervous system and their relative acute and chronic toxicity to aquatic species appears to be of great concern in the aquatic env ironment. Due to spray drift, runoff, and leaching concerns, OPs have the potential to find their way into public water systems (Temple and Smith, 1989). The OPs found on the draft list span an even distribution across the potential toxicity categories.

This would appear to indicate that using the multi-step process developed by the Agency, of identification, screening, andevaluation of chemical contaminants, has been successful at

encompassing a balanced scope as well as satisfying the inclusionary principle of toxicological data in the 'draft CCL' for the Organophosphorus class of compounds.

Fenamiphos, CAS 22224-92-6 (ETN, 2008), is one of the Organophosphorus chemicals that was screened using the elements of the Preliminary Contaminant Candidate List (PCCL) and selected to appear on the Draft CCL 3. Throughout the screening process, it was designated by the Agency as 'Category 2 toxicity' based on the whole of its cumulative Universe Health Effects data elements. Technical fenamiphos has a high acute oral toxicity with an LD50 (male/female) of 2.7/3.0 mg/kg. The endpoints for the dietary risk assessment are; acute dietary LOAEL 0.37 mg/kg/day and chronic dietary NOAEL 0.01 mg/kg/day and LOAEL 0.03 mg/kg/day. The Population Adjusted Dose (PAD) are 0.0012 and 0.0001 mg/kg/day for the acute and chronic dietary risk respectively. Both the acute and the chronic dietary risk from food are below the Agency's level of concern (EPA, 2002). In addition, fenamiphos is not classified as a human carcinogen by the American Conference of Governmantal Industrial Hygenists (2005). In the Interim Reregistration Eligibility Decision (IRED) for fenamiphos (EPA, 2002), the Agency indicates that if the manufacturer incorporates all the recommended changes to the label registration that were outlined by the decision, and that the use on extremely vulnerable soils is phased-out by May 31, 2005, then all current dietary risks will be mitigated. (EPA, 2002) This suggests that altering the current label use of the compound might have a mitigating effect on dietary risks and thus may influence or reduce the outcome of the Dose-Response Data element. The Agency went further and characterized the possible mitigated dietary risks for fenamiphos. The indications are that the dietary (acute and chronic) exposures from eating commodities treated with fenamiphos would be below the Agency's level of concern for the entire U.S. population, including infants and children. In addition, the mitigated dietary (drinking water) exposures would not be of concern for surface and ground water sources in soils that are not extremely vulnerable. However, exposure to shallow ground water sources of drinking water associated with soils that are extremely vulnerable would still exceed the Agency's level of concern (EPA, 2002). The sole manufacturer of fenamiphos hassince filed a notice to voluntarily cancel all registrations

for products containing fenamiphos instead of developing additional data as part of the risk mitigation proposal by the EPA (EPA, 2002).

However, the question remains valid. Would the registration status or label changes and possible resultant mitigated dietary risks have been sufficient to alter the determination of the overall fenamiphos potency distribution for the universe health effects (Toxicity 2 category)? Would this ultimately warrant that the contaminant be re-screened to the PCCL with updated data inputs that could possibly result in a fall from the draft universe CCL3? If the answer is no, then based on the toxicological data elements the Agency used for screening fenamiphos, and devoid of any other new input data, and/or until the tolerance reassessment process considers cumulative risks for the Organophosphate class of chemicals, fenamiphos would likely remain partitioned into the Category 2 toxicity for the screen to the PCCL.

The occurrence data principle is described by the Agency for its screening purposes in the CCL 3 as essentially an occurrence factor assigned to a contaminant. This occurrence factor is derived from the cumulative of its quantitative and descriptive data elements that characterize a contaminants potential to occur in drinking water. These data elements are categorized in CCL 3 Chemicals: Screening to a PCCL (EPA, 2008 b) and are as follows;

* Finished Water - measures concentration and frequency of detections

* Ambient Water - measures concentration and frequency of detections

* Total Releases in the Environment - measures pounds per year and number of states* Pesticide Application Rates - measures pounds per year and

number of states

* Production volume - measures pounds per year

Based on the changes to the registration status for fenamiphos, isn't it reasonable to assume that the potential of fenamiphos to occur in public water systems has drastically been reduced? The notice by the sole manufacturer to voluntarily cancel all registrations for products containing fenamiphos as of May 31, 2007 (EPA, 2002) would certainly translate to an immediate effect on the criteria for current total pesticide application rates and production volumes. In addition, some of the data element inputs used in the determination of the occurrence factor that were initially used during the screening process would continue to trend toward a reduction over the short term as the product stocks of fenamiphos are depleted. This includes the remaining occurrence categories of finished water, ambient water, and total releases in the environment. For instance, the Agency uses the most up to date production data that is available and reported under the Chemical Update System/Inventory Update Rule (CUS/IUR) and lists this as their input value for initial screening purposes (EPA, 2008 b). If we substitute a current 2008 production rate of zero as input into the criteria screen for production data, wouldn't this then indicate that fenamiphos would possibly be a candidate to move out of the PCCL, and in fact move back into the Universe CCL? Likewise, as depletion of existing stocks of fenamiphos progresses, wouldn't this also lower the value over time for the Total Environmental Releases (lbs/year)? Some of the

env ironmental release data used for fenamiphos in the PCCL screen came from the National Center for Food and Agricultural Policy (NCFAP). The most recent available version of this database reflects the last year of available data as of 1997 (NCFAP, 2008). The Agency indicates that they used this 1997 data as well as data reported from the 2002 Toxics Release Inventory (TRI) for evaluation of environmental release data category (EPA, 2008 b) in the determination of the occurrence factor. This occurrence factor determined for the screen to the PCCL doesn't accurately reflect fenamiphos' current registration and label use status. If the current occurrence data inputs were used for re-screening fenamiphos to the PCCL,it seems likely that fenamiphos would move from the PCCL back

to the CCL Universe of some 26,000 unique substances.

Although there are valid toxicological (Toxicity Category 2) and aquatic environmental concerns associated with fenamiphos, both the inclusionary principles of toxicological and occurrence data do not appear to be satisfied for this compound. Given its current label and registration status, it is hard to imagine that fenamiphos would be a candidate for the CCL 3 or carry a great degree of potential to occur in drinking water.

References:

(1) United States Environmental Protection Agency. (2008). Drinking Water Contaminant Candidate List 3--Draft [Federal Register: February 21, 2008 (Volume 73, Number 35)], [EPA-HQ- OW-2007-1189 FRL-8529-7], RIN 2040-AD99. Retrieved March 7, 2008, from Federal Register Online via GPO Access [wais.access.gpo.gov]: http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket. access.gpo.gov-/2008/E8-3114.htm.

(2) United States Environmental Protection Agency. (2008). Fact Sheet: Third Drinking Water Contaminant List (CCL3). EPA 815- F-08-001. Office of Water (4607M). February, 2008. Retrieved March 17, 2008), from EPA website via GPO Access [wais.access.gpo.gov]: http://www.epa.gov/OGW DW/ccl/pdfs/fs_ccl3.pdf

(3) United States Environmental Protection Agency. (2008 a). Contaminant Candidate List 3 Chemicals: Identifying the Universe. EPA 815-R-08-002. Draft. February, 2008. Retrieved March 17, 2008), from EPA website via GPO Access [wais.access.gpo.gov]: http://www.epa.gov/OGW DW/ccl/pdfs/report_ccl3_chemicals_univer se.pdf(4) United States Environmental Protection Agency. (2008 b).

Contaminant Candidate List 3 Chemicals: Screening to a PCCL. EPA 815-R-08-002. Draft. February, 2008. Retrieved March 17, 2008), from EPA website via GPO Access [wais.access.gpo.gov]: http://www.epa.gov/safewater/ccl/pdfs/report_ccl3_chemicals_sc reening.pdf

(5) Temple, Dr W .A. and Smith, Dr N.A. 1989. Organophosphorus Pesticides International Programme on Chemical Safety Poisons Information Monograph (Group Monograph) G001. Retrieved March 29, 2008, from the IPCS INCHEM website http://www.inchem.org/documents/pims/chemical/pimg001.htm

(6) Extension Toxicology Network. (2008). Pesticide Information Profiles. Retrieved March 17, 2008), from EXTOXNET Access [extoxnet.orst.edu]: http://extoxnet.orst.edu/pips/fenamiph.htm

(7) United States Environmental Protection Agency. (2002). Interim Reregistration Eligibility Decision (IRED)-Fenamiphos. Prevention, Pesticides and Toxic Substances (7508C). EPA 738- R-02-004. Retrieved March 29, 2008, from Federal Register Online via GPO Access [wais.access.gpo.gov]: http://www.epa.gov/oppsrrd1/REDs/fenamiphos_ired.pdf

(8) United States Environmental Protection Agency. (2002). Fenamiphos; Notice of Receipt of Request to Voluntarily Cancel All Product Registrations. [Federal Register: September 27, 2002 (Volume 67, Number 188)] Retrieved March 29, 2008, from Federal Register Online v ia GPO Access [wais.access.gpo.gov]: http://www.epa.gov/EPA-PEST/2002/September/Day-27/p24648.htm

(9) American Conference of Governmental Industrial Hygienists - TLVs and BEIs. (2002). Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices, p. 30. Retrieved March 29, 2008, via Access [wais.access.nlm.nih.gov]: http://toxnet.nlm.nih.gov/cgibin/sis/search/f?./temp/~Iy1iSo:1(10) The National Center for Food and Agricultural Policy

(NCFAP). (2008). NCFAP Pesticide Use Database. Retrieved March 29, 2008, via Access [ncsu.edu]: http://pestdata.ncsu.edu/ncfap/search.cfm CS Title: 0064 Company/group/association name: Comment:

I am a resident in a water service area which intends to use chloramine as a disinfectiant in my drinking water system. I understand that when monochloromine interacts with organic material many toxic byproducts are formed. Two of the most toxic byproducts of chloromine appear on your CCL 3, Hydrazine and N-Nitrosamines, specifically the most toxic, NDMA. Four other N- Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and NPYR also appear on the CCL3 list as likely disinfection byproducts.

It was my understanding that NDMA has already been determined to be a 'probable human carcinogen" by the USEPA. It is also my understanding that Hydrazine is genotoxic. Little is known about the effect of these byproducts in the levels they are formed in the drinking water system. However, peer reviewed studies would indicate that these emerging byproducts are possibly 100's of times more toxic than those of chlorine. I am a stage 4 breast cancer surv ivor, so I am obviously concerned

over the potential and unknown carcinogen effects this change in our drinking water may have, not only on my prognosis, but the prognosis of millions of other cancer surv ivors. Since I was diagnosed at the age of 34, with no family history or risk factors for the disease, I am convinced that environmental factors played a part in my contracting the disease. More studies need to be carried out on these Chloromine byproducts to determine their carcinogen effects before you move forward with the use of Chloromine in our water system.

Water systems across the country are using or are intending to use chloramine as a disinfectant in order to meet EPA's Stage 2 regulations regarding chlorine byproducts on the recommendation or suggestion of EPA. It is incumbent upon EPA then to study the byproducts of chloramine expeditiously in order to protectthe public health from byproducts far worse than those of

chlorine. I am asking not only for a study of these byproducts, but a moratorium on the use of chloramine until it's byproducts are studied and determined to be safe.

Thank you, Tricia J. Coniglio, Camp Hill, PA CS Title: 0065 Company/group/association name: Comment:

Attached documents contain new information on perchlorate toxicity and contamination. [See PDF for Attachment] CS Title: 0066 Company/group/association name: Comment:

COMMENT Docket Title Drinking Water Contaminant Candidate List 3 Docket ID EPA-HQ-OW-2007-1189 Document ID EPA-HQ-OW-2007-1189-0001

Jane Boisvert 95 Holmes Rd. S. Burlington, VT 05403

802-863-3331

To W hom It May Concern:

I am a resident in a water service area using or intending to use chloramine as a disinfectant in my drinking water system. I understand that when monochloramine interacts with organic material many toxic byproducts are formed. Two of the most toxic byproducts of chloramine appear on your CCL 3, Hydrazine and N- Nitrosamines, specifically the most toxic, NDMA. Four other N-Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and NPYRalso appear on the CCL3 list as likely disinfection byproducts.

It was my understanding that NDMA has already been determined to be a 'probable human carcinogen" by the USEPA. It is also my understanding that Hydrazine is genotoxic. Little is known about the effect of these byproducts in the levels they are formed in the drinking water system. However, peer reviewed studies would indicate that these emerging byproducts are possibly hundreds of times more toxic than those of chlorine.

Water systems across the country are using or are intending to use chloramine as a disinfectant in order to meet EPA's Stage 2 regulations regarding chlorine byproducts on the recommendation or suggestion of EPA. It is incumbent upon EPA then to study the byproducts of chloramine expeditiously in order to protect the public health from byproducts far worse than those of chlorine. I am asking not only for a study of these byproducts, but a moratorium on the use of chloramine until its byproducts are studied and determined to be safe.

I have personally experienced health problems due to the use of chloramine in our water system and hope you will take action to stop the use of chloramine.

Thank you.

Jane Boisvert CS Title: 0067 Company/group/association name: Comment:

As a support group leader of non tuberculous mycobacteria in the NY and Metropolitan Area, as well as leading a national group on-line, I am representing close to 200 patients in their quest for a cure. This disease can be devistating, and removing our project would be catastrophic for some patients.Comment on Proposed EPA

Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that: i) Mycobacterium avium remain on the CCL and that ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water. At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario, provides concrete

evidence that the prevalence of pulmonary NTM infections is much higher than prev iously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of SouthernCalifornia to provide a snapshot of the epidemiology of

pulmonary NTM in the United States.

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women. This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. I request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.Thank you for your attention and consideration in this matter.

Sincerely, Debbie Breslawsky breslaw1@gmail.com CS Title: 0068 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 29, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that: i) Mycobacterium avium remain on the CCL and that ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not- for-profit organization for pulmonary NTM infection, is currently funding a pilot study to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water. At least 20 additionalpatient homes are currently being studied and compared to

sputum.

Epidemiology - Increasing Prevalence A recent study from Toronto, Ontario, provides concrete evidence that the prevalence of pulmonary NTM infections is much higher than prev iously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to prov ide a snapshot of the epidemiology of pulmonary NTM in the United States.

Health Effects As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women. This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),I believe that removing M. avium from the CCL is not in the

public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. I request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.

Sincerely,

Andrea McMurrough (MAC/NTM patient) CS Title: 0069 Company/group/association name: Comment:

April 23, 2008

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue N.W . Washington D.C. 20460

RE: Federal Register Docket - EPA-HQ-OW-2007-1189

To W hom It May Concern:

Weare four law students attending New England School of Law and we write to you in support of adding perchlorate to the Safe Drinking Water Act (SDWA) contaminant list.

The EPA Administrator is obligated to publish a maximum contaminant level goal and promulgate a national primarydrinking water regulation for identified contaminants if the

Administrator makes three findings[FN1: 42 USC §300g-1(b)(1) (A)]: 1) 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[FN2: 42 USC §300g-1(b)(1)(A)(ii)]; 2) 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[FN3: 42 USC §300g-1(b) (1)(A)(iii)]; and 3) the contaminant may have an adverse effect on the health of persons.[FN4: 42 USC §300g-1(b) (1)(A)(i)]

This comment is organized around the three elements necessary for the Administrator to find that perchlorate is a contaminant, with a focus on the need for a national standardized maximum contaminant level.

I. Perchlorate is Known to Occur at a Level of Public Health Concern

It is well documented that perchlorate contamination is a dangerous and widespread occurrence, rising to the level of a significant public health concern. Contamination has been well documented in at least thirty-seven states and the District of Columbia.[FN5: Letter to James Inhofe, Anu Mittal, Government Accountability Office, September 16, 2005 at 1.] It has been estimated by some commentators that more than five hundred drinking water sources, serv ing approximately twenty million people, are affected by perchlorate contamination.[FN6: Exempting Department of Defense From Federal Hazardous Waste Laws : Resource Contamination as "Range Preservation"?, Caitlin Sislin, 32 ECGLQ 647, 653 (2005).]

One government report cataloged 395 separate sites where perchlorate was found in the soil, groundwater, surface water, or drinking water.[FN7: Perchlorate: A System to Track Sampling and Cleanup Results is Needed, Government Accountability Office, May 2005] Several of these sites had levels of perchlorate contamination in their drinking water many timesgreater than EPA's Drinking Water Equivalent Level (DW EL) of

24.5 parts per billion (ppb).[FN8: Id.] The City of Baldwin Park in California had a measured perchlorate level of 159 ppb in their drinking water, more than six times greater than EPA's DW EL; and the Atlantic Beach Water System in Duval County, Florida had a measured perchlorate level of 200 ppb, more than eight times the DW EL.[FN9: Id. at 33-34] In California alone, the Department of Health Services identified over 350 public drinking water sources that are contaminated with perchlorate. Further studies indicate that levels of contamination in California water wells range from 12 to 682,000 parts per billion.[FN10: 32 ECGLQ 647, 654-5 (2005)]

The federal government itself is responsible for many of these contamination sites as at least forty Department of Defense facilities have perchlorate contaminated groundwater or surface water.[FN11: http://www.miltoxproj.org/laws.htm.] For example, the Longhorn Army Ammunition Plant in Harrison County, Texas was found to have 320,000 ppb, the Redstone Army Arsenal in Alabama with 220,000 ppb, the Naval Surface Warfare Center in Indian Head, Maryland with 276,000 ppb; the Edwards Air Force Base, Jet Propulsion Laboratory in Kern County, California with 160,000 ppb; and the Army W hite Sands Missile Range near Alamogordo, New Mexico with 32,900 ppb.[FN12: 27 STENVLJ 43, FN 573 (2008).] A recent federal government report stated that at least eight contaminated Department of Defense facilities are contaminated at a "significant" level.[FN13: Perchlorate: A System to Track Sampling and Cleanup Results is Needed, Government Accountability Office, May 2005 at 29-44; 27 STENVLJ 43, FN 544 (2008)]

While EPA has yet to issue a nationwide regulation for perchlorate in drinking water, the prevalence of perchlorate and the dangers of allowing it to persist in drinking water have not escaped the courts. Under both the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) courts have had some ability to impose liability on those responsible parties for introducing perchlorate into the soil, groundwater, or drinking water.[FN14: 42 U.S.C. §690; 42 U.S.C. §9601] For example, in Castic Lake Water Agency v . Whittaker Corp. the United States District Court for theCentral District of California found that perchlorate was a

hazardous waste under RCRA.[FN15: Castic Lake Water Agency v . Whittaker Corp., 272 F.Supp.2d 1053 (2003)] The court found that although perchlorate is not a "listed" hazardous waste, it is subject to RCRA as a "characteristic" hazardous waste because perchlorate demonstrates the characteristic of ignitability by being an "oxidizer," meaning that the chemical "cause[s] or enhance[s] the combustion of other materials."[FN16: Id.; 49 CFR 173.127] This classification as a characteristic waste allowed for the court to hold that not only does RCRA apply to perchlorate, but that CERCLA also applies by v irtue of CERCLA being applicable to "hazardous substances" listed under various federal statutes, including RCRA.

Although the courts have applied RCRA and CERCLA to perchlorate and EPA has issued other guidance standards, neither these decisions nor these policies are legally binding and are not a sufficient substitute for a national standard. A case such as Castic Lake merely allows for the application of certain federal statutes to perchlorate, the court did not state specifically when the federal statute should apply. W ithout legally binding regulations from EPA, it is unclear how much perchlorate is truly safe to drink. The federal government has cataloged several hundred perchlorate sites, yet there is no guidance as to whether any of these sites possess enough perchlorate to bring a federal suit and require a cleanup for the sake of our nation's drinking water.

Massachusetts is a frontrunner in the regulation of perchlorate in the environment.[FN17: MassDeP, Addressing Perchlorate and other Emerging Contaminants in Massachusetts, available at http://www.mass.gov/dep/water/drinking/percfs77.htm] In July of 2006, Massachusetts implemented the first standards in the nation for perchlorate in drinking water and waste site cleanup.[FN18: Id.] The Massachusetts drinking water standard is 2 parts per billion and the s-1/gw-1 standard is 0.1 parts per million.[FN19: Final Changes to the Massachusetts Contingency Plan 310 CMR 40.0000 available at http://mass.gov/dep/cleanup/laws/perchlorate-310CMR40-07282006. pdf.] These standards have been inserted into the Massachusetts Contingency Plan and are codified at 310 CMR 40.0000.[FN20:Id.] W hile the standards that are explained here are the most

stringent because of the nature of exposure in drinking water and s-1/gw-1 locations, the complete set of standards that have been incorporated into the Massachusetts Contingency Plan are attached as Appendix A.[FN21: Id.] [See Appendix A in PDF]

II. There is a Meaningful Opportunity to Reduce Health Risks

The well established and significant public health risk of perchlorate, along with nonuniform standards among states, presents a meaningful opportunity for the Administrator to publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for perchlorate.

The statute is unambiguous in its mandate for the Administrator to establish national drinking water standards. The SDWA states that the Administrator "shall" publish such goals if the three factors outlined in this comment are found.[FN22: 42 USC §300g-1(b)(1)(A)]

In Massachusetts v . EPA, the Supreme Court determined that EPA refused to comply with a clear statutory command and instead offered a "laundry list of reasons not to regulate."[FN23: Massachusetts v . EPA, 127 U.S. 1438, 1462 (2007).] The court held that EPA's actions were "arbitrary, capricious,...or otherwise not in accordance with law."[FN24: Id. at 1463] This decision centered on the Court's determination that EPA offered no reasoned explanation for its refusal to decide whether greenhouse gasses cause or contribute to climate change.[FN25: Id.] In the case of SDWA and perchlorate, there is similarly no reasoned explanation not to publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for perchlorate. It is EPA's statutory mandate to regulate a contaminant that has adverse health effects and is known to occur at a frequency that gives rise to a public health concern. The time is ripe and a meaningful opportunity is presented for EPA to regulate perchlorate.

III. Adverse Health Risks of PerchloratePerchlorate is a compound that is both man-made and naturally

occurring.[FN26: U.S. Food and Drug Administration, Perchlorate Questions and Answers, available at http://www.cfsan.fda.gov/~dms/clo4qa.html#effects, (updated February 7, 2008).] Ammonium perchlorate is used as the primary component in solid propellant for rockets, missiles, and fireworks.[FN27: USACHPPM, Perchlorate in Drinking Water,

available at http://chppmwww.apgea.army.mil/documents/FACT/31-003-0502.pdf] Because of its short shelf life, ammonium perchlorate must periodically be replaced within the country's missile and rocket inventory. Since the 1950's this has resulted in large

volumes of the compound being discarded.[FN28: Id.] This disposal program has led to contamination of groundwater sources, and therefore drinking water is the easiest way to come in contact with perchlorate.[FN29: Environmental Protection Agency, Perchlorate, available at http:// www.epa.gov/fedfac/documents/perchlorate.htm]

Perchlorate presents a health risk because it interferes with the operation of the thyroid gland.[FN30: U.S. Food and Drug Administration, Perchlorate Questions and Answers, available at http://www.cfsan.fda.gov/~dms/clo4qa.html#effects, (updated February 7, 2008).] Because of this interference with thyroid function, it has been used medically to treat hyperthyroidism and iodine metabolism.[FN31: Id.] In adults, the thyroid controls metabolism, while in children it assists in development of the central nervous system.[FN32: Id.] Accordingly, pregnant woman and newborns are at significant health risk from exposure to perchlorate.[FN33: Id.]

To classify the health risk that perchlorate poses to the population, the National Academy of Sciences conducted a study and reached a recommended reference dose of 0.7 micrograms per kilogram of body weight per day as the amount of percholrate that an individual could be exposed to daily without adverse effects.[FN34; Id.] In February 2005, EPA adopted this reference dose of 0.7 micrograms per kilogram of body weight per day.[FN35: Id.] This translates to 24.5 parts per billion based on two liters of drinking water consumption per day byadults.[FN36: Id.]

With the current lack of EPA guidance in implementing legally binding federal standards, states have adopted a wide variety of drinking water standards. Listing perchlorate as a contaminant under the SDWA will resolve this ambiguity and ensure the nation's drinking water has the minimal amount of perchlorate that is safe for human consumption.

IV. Conclusion

Perchlorate is just one of many dangerous substances present in our nation's drinking water. For too long substances such as perchlorate have gone unregulated by EPA, and the public has been forced to suffer. Those fortunate enough to live in a state which regulates perchlorate, such as Massachusetts, should not be the only ones that are protected from being subjected to such a dangerous chemical in their drinking water. And conversely, residents in states that regulate perchlorate should not have to suffer from groundwater contamination from neighboring non-regulating states. The time is now to impose a national standard for the amount of perchlorate allowed in drinking water.

Sincerely,

Robert DeLong

Marlee Furman

Lane Goldberg

Terry Oznick CS Title: 0070 Company/group/association name: Comment:April 5, 2007

Dear Representative Michele Kupersmith,

In a recent phone call I mentioned the effects I have had from chloraminated water; they began in summer 2006. It was not until January 8th of 2007 that I became aware of Chloramine in our water and made the connection between my health issues and the water supply.

On that day I ceased using tap water...completely. This caused immeasurable inconvenience and aggravation, not to mention excessive cost. My energy level returned in 2-3 days and in a week my symptoms had totally disappeared. This was all the proof I needed to know chloramine is harmful. An expensive whole house filtration system had to be installed in order to return to using tap water. It is expensive to maintain and, to this day, I continue to buy expensive spring water for drinking and cooking.

I am gravely concerned about the long term effects of chloramine on the general population. This is a substance that has NEVER been studied, tested, or proven safe for human consumption. I am aware that there are no dermal, respiratory, or epidemiological studies on chloraminated water.

Please get chloramine (chlorine + ammonia) out of our water, NOW .

Respectfully,

Elaine Greenfield

The Canadian EPA has deemed Chloramine "toxic to theenv ironment" (CEPA 1999)

CS Title: 0071 Company/group/association name: Comment:

April 23, 2007

Dear Jim Fay,

In a recent email message I related to you how adversely I was affected by chloramine in our tap water, causing me to install a whole house filtration system, and, prior to that deal with the expense of bottled water, doctor's v isits, laundry and showers out of town.

Enclosed is only the first installment of my filtration system bill which will end up costing @ $2000. Added to this are other costs averaging @ $70 per month (doctors, bottled water, showers and laundry)

As a tax payer in South Burlington, I really object to the fact that I have been forced into this situation by the Champlain Water District. I am paying a premium for potable water in addition to what I must pay the city of So. Burlington for water supplied by the CW D. (see enclosed bill)

I firmly believe there should be some manner of compensation

available to people negatively impacted by the water supply.

Sincerely,

Elaine Greenfield CS Title: 0072 Company/group/association name: Comment:COMMENT

Docket Title Drinking Water Contaminant Candidate List 3

Docket ID EPA-HQ-OW-2007-1189

Document ID EPA-HQ-OW-2007-1189-0001

Name: Josephine M. Rakow, DO

Address: P.O. Box 6, Camp Hill, PA 17001

Phone: (717) 737-7643

I am a resident in a water service area using or intending to use chloramine as a disinfectant in my drinking water system. I understand that when monochloramine interacts with organic material many toxic byproducts are formed. Two of the most toxic byproducts of chloramine appear on your CCL 3, Hydrazine and N-Nitrosamines, specifically the most toxic, NDMA. Four other N-Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and NPYR also appear on the CCL3 list as likely disinfection byproducts.

It was my understanding that NDMA has already been determined to be a 'probable human carcinogen" by the USEPA. It is also my understanding that Hydrazine is genotoxic. Little is known about the effect of these byproducts in the levels they are formed in the drinking water system. However, peer reviewed studies would indicate that these emerging byproducts are possibly 100's of times more toxic than those of chlorine.Water systems across the country are using or are intending to

use chloramine as a disinfectant in order to meet EPA's Stage 2 regulations regarding chlorine byproducts on the recommendation or suggestion of EPA. It is incumbent upon EPA then to study the byproducts of chloramine expeditiously in order to protect the public health from byproducts far worse than those of chlorine. I am asking not only for a study of these byproducts, but a moratorium on the use of chloramine until it's byproducts are studied and determined to be safe.

Thank you. CS Title: 0073 Company/group/association name: Comment:

I want the chemicals and pathogens on the below Candidate Contaminant List to be part of the standard contaminant list so that our own local water departments will receive the directive to monitor these additional contaminants on a regular basis

Beyond Pesticides) EPA is seeking public comments on a proposed list of 104 possible drinking water contaminants that may need to be regulated in the future to ensure the continued protection of drinking water. Under the Safe Drinking Water Act, EPA includes on the draft Contaminant Candidate List (CCL) currently unregulated contaminants that are known or anticipated to occur in public water systems and which may require regulation. This draft CCL, which is the third such listing, lists 93 chemical contaminants or groups and 11 microbes, and describes the process and basis for selecting these contaminants."EPA is casting a broader scientific net for potential regulation of chemicals and microbes in drinking water," said Assistant Administrator for Water Benjamin H. Grumbles. "EPA's proposed list of priority contaminants will advance sound science and public health by targeting research on certain chemicals and microbes and informing regulators on how best to reduce risk."

The CCL process was established by the 1996 amendments to the Safe Drinking Water Act as a mechanism to determine if newregulations are needed to protect drinking water. Under this

process EPA conducted extensive research into the occurrence and health effects of the listed contaminants before issuing new regulations or standards.

In developing the draft CCL 3, the agency implemented a new approach for selecting contaminants which builds upon

evaluations used for prev ious lists and is based on substantial expert input early in the process and recommendations from a larger number of different groups including stakeholders, the National Research Council and the National Drinking Water Advisory Council.

The draft list includes chemicals used in commerce, pesticides, biological toxins, disinfection byproducts, and waterborne pathogens. The agency evaluated approximately 7,500 chemicals and microbes and selected 104 candidates for the final draft list based on their potential to pose health risks through drinking water exposure. The comment period is open for 90 days beginning the day of publication in the Federal Register, February 21, 2008 and ends May 21, 2008.

The CCL has expanded to include roughly 40 pesticides and pesticide degradates, and includes acephate, captan, permethrin, and ziram. The first CCL listed only 60 contaminants, which included less than 12 pesticides.

Research has shown that over 200 contaminants are present in drinking water across the U.S., and more than half of these are unregulated (See Daily News of January 9, 2006 and March 3, 2006). Exposure to these contaminants can cause serious adverse effects, including cancer, reproductive toxicity and birth defects. EPA has previously failed to enforce testing that would reveal the pollutants in tap water supplies and to set health-based limits for those found in tap water. EPA has also missed three mandatory Safety Drinking Water Act deadlines to set standards for unregulated contaminants.

For more information on the CCL 3 and the list of contaminantsvisit: http://www.epa.gov/safewater/ccl/ccl3.html . For

additional CCL 3 support documents and more detailed information on the contaminants, visit docket number EPA-HQ- OW-2007-1189. To submit a comment visit Regulation.gov and enter the above docket number. Comment period ends May 21, 2008.

EPA Contact: Dave Ryan, (202) 564-4355 / ryan.dave@epa.gov . CS Title: 0074 Company/group/association name: Comment:

#8 Buck Ridge Drive Wilmington, DE 19807

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008

As leader of a support group in W ilmington DE for men and women afflicted with non-tuberculosis mycobacteria pulmonary disease... and on behalf of that group... I am writing with the following request:

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculousmycobacteria, or NTM) are known water contaminants that are

currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates ofpulmonary NTM in the United States until completion of the

NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.Sincerely,

Jolly Clarkson-Shorter CS Title: 0075 Company/group/association name: Comment:

Colorado State University

College of Veterinary Medicine and Biomedical Sciences

Department of Microbiology, Immunology and Pathology Fort Collins, Colorado 80523-1677 Telephone: (970) 491-6136 FAX: (970) 491-1815 http://www.cvmbs.colostate.edu/microbiology/

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.M. avium and related strains of mycobacteria (nontuberculous

mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any otheragency, it is difficult to assess the mortality rates of

pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.Sincerely,

Diane Ordway, PhD Assistant Professor Department of Microbiology, Immunology and Pathology Colorado State University CS Title: 0076 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for bettersurveillance and understanding of this disease. NTM Info &

Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study[FNi] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology -Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii] provides concrete

evidence that the prevalence of pulmonary NTM infections is much higher than prev iously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-termphysician intervention as initial treatment typically requires

18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. I request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter. I am a group leader with over 50 NTM patients primarily in the Dallas, Tx area. Most of us are patients of Dr. Richard Wallace at UT Health Center @ Tyler. I have led this support group for

over 5 years.

Sincerely,

Amy Cherrnay 2806 Lake Brook Ct Highland Village, TX 75077 972-318-8970 CS Title: 0078 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing PrevalenceA recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM caused illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing. My own case requires continuing treatment with 3-4 antibiotics, plus daily physical airway clearance using an electric v ibrating vest.

Aging Population at Greater RiskThere appears to be an increase in pulmonary NTM infection in

the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

I represent a support group of eight other patients in Minnesota and western W isconsin.

Thank you for your attention and consideration in this matter.

Sincerely,

Jean Ratchye 309 Ryan Ave. St. Paul MN 55102 CS Title: 0079 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008Pursuant to the proposed list of contaminants on the Federal

Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previouslyunderstood. A pilot study is currently in process by NAIAD and

Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx ]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),I believe that removing M. avium from the CCL is not in the

public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.

Sincerely,

Carole LaMontagne Support Group Leader of New England States I am representing 26 ladies and 1 man that have NTM disease CS Title: 0080 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits .

M. avium and related strains of mycobacteria (nontuberculousmycobacteria, or NTM) are known water contaminants that are

currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates ofpulmonary NTM in the United States until completion of the

NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.Sincerely,

Deanne York, patient/East Texas Support Group Leader 17335 Hidden Valley Lane Flint, TX 76752 Home phone 903-561-6672 Cell 713-417-6615 dsyork1@sbcglobal.net

PS. I am an NTM Support Group Leader from East Texas. I represent over 60 NTM patients. Most of those patients have MAC! !! MAI CS Title: 0083 Company/group/association name: Comment:

Please find attached a recent review publication on the risk assessment for human health associated to cyanotoxins exposure. E. Funari and E. Testai Human health risk assessment related to cyanotoxins exposure. Critical Rev . Toxicol., 38, 97-126 (2008). [See PDF for Attachment]

Hoping it could be useful to your evaluation

Sincerely yours

Emanuela Testai & Enzo Funari

Dr. Emanuela Testai Istituto Superiore di Sanità Environment & Primary Prevention Dept. Mechanisms of Toxicity Unit Viale Regina Elena, 299 00161 Roma (Italy) Tel. +39 06 49902920 Fax +39 06 49387139E-mail: emanuela.testai@iss.it

CS Title: 0084 Company/group/association name: Comment:

May 8, 2008

Via www.regulations,gov Docket ID No. EPA-HQ-OW-2007-1189

Water Docket U.S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue, NW Washington. DC 20460

Re: Dow AgroSciences Cormnents on EPA's Draft Drinking Water Contaminant Candidate List 3

To whom it may concern:

Dow AgroSciences LLC ("DAS") appreciates the opportunity to prov ide comments on the draft "Drinking Water Contaminant List 3" released by EPA on February 21, 2008 (EPA-HQ-OW-2007-118, FRL-8529-7). As the primary manufacturer of the chemical tebufenozide (CASRN 112410-23-8), DAS recommends that EPA remove tebufenozide from the draft list for regulation as a contaminant under the Safe Drinking Water Act (SDWA). A rationale for this recommendation is provided below.

1. Tebufenozide is a pesticide which is already adequately regulated by the U.S. EPA's Office of Pesticide Programs (OPP) under FIFRA and FEPCA.

Tebufenozide was registered for use by the U.S. EPA's Office of Pesticide Programs under auspices of the Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug,

and Cosmetic Act (FFDCA) as modified by the Food Quality Protection Act of 1996 after thorough evaluation of the potential env ironmental impacts and human safety associated with its use. Reports of more than 300 studies documenting the chemistry, environmental fate, toxicology and human safety of tebufenozide are on file with EPA's OPP and support the registered uses of the products as regulated under FIFRA and FEPCA.

In addition to Tebufenozide Technical (EPA Reg. No. 62719-419), registered for manufacturing use, approved products for use by farmers and pest management specialists include Confirm[FN*: Trademark of Dow AgroSciences] 2F (EPA Reg. No. 62719-420), Confirm 70WSP (EPA Reg. No. 62719-434), and Mimic[FN*: Trademark of Dow AgroSciences] 2LV (EPA Reg. No. 62719-439). Tebufenozide-containing products are sold for use through professional pest management dealers and distributors, and they are not marketed for retail consumer use in home yards or gardens. Labeling and use of tebufenozide-containing products are highly regulated by U.S. EPA as well as state lead pesticide regulatory agencies. Precautions to prevent entry of tebufenozide to surface or ground waters are included on each product label:

* Do not cultivate within 10 feet of aquatic areas so as to allow growth of a vegetative filter strip.

* For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark, except under forest canopy when aerially applied to control forest pests.

* Do not contaminate water when disposing of equipment washwaters and rinsate.

* Do not apply when weather conditions favor drift or runoff from areas treated.DAS believes existing regulation of tebufenozide by EPA under

FIFRA and FEPCA is adequate to protect the environment and human health, including drinking water, and does not believe additional regulation under SDWA is warranted.

2. Tebufenozide is a pesticide product being promoted by EPA as a preferred alternative to existing products, and further regulation under the SDWA would be counterproductive to this aim.

Tebufenozide was first registered for use as a pesticide by U.S. EPA during 1995 under its "reduced risk" program. This program expedites the approval of conventional pesticides that the Agency believes pose less risk to human health and the

env ironment than existing alternatives. Subsequent to its initial classification and registration as a reduced risk product by EPA for use in walnuts during 1995, tebufenozide was classified as reduced risk and gained registration approval for uses including pecans (1998), leafy vegetables, brassica

vegetables, fruiting vegetables, cranberry, forestry, ornamentals, berries, mint, pome fruit, cotton, turnip, canola (1999), tree nuts (2000), citrus fruits, grapes, and tuberous and corm vegetables (2004).

In addition, tebufenozide received a Presidential Green Chemistry Challenge Award in 1998 from U.S. EPA. The aim of this program is to promote pollution prevention and industrial ecology as well as the principles of green chemistry in chemical design, manufacture and use. In conferring the award, EPA noted that tebufenozide (trade name Confirm) "...effectively and selectively controls important caterpillar pests in agriculture without posing significant risk to the applicator, the consumer, and the ecosystem. It will replace many older, less effective, more hazardous insecticides..."

Both of these programs have promoted the use of tebufenozide as a reduced risk, green chemistry alternative and further regulation under the SDWA by the EPA Office of Water would be at odds with this clear intent of the Agency.3. Tebufenozide does not have an environmental fate profile

that would make it a high priority for regulation in drinking water.

Based on studies conducted according to EPA OPP guidelines (Dong et. al., 2000) and on file with the Agency, tebufenozide has a dissipation half-life in soil of 7 to 66 days under aerobic laboratory conditions and a half-life of 31 to 53 days in soil under field conditions. These degradation rates indicate that tebufenozide will not accumulate or persist in the soil env ironment. Moreover, tebufenozide has an average sorption coefficient (Koc) of 572, which indicates that it is not highly mobile. Given its rapid degradation in soil and favorable Koc, it is unlikely to enter surface or ground water

env ironments via runoff or leaching.

Tebufenozide has not been listed by the U.S. Geological Survey's National Water Quality Assessment Program or the U.S. Department of Agriculture's Pesticide Data Program as a priority ground or surface water contaminant for monitoring purposes.

*Dong, L.; Hazelton, G.A.; Fernandes, J.M.; Lisk, D.C.; Long, l.W. (2000) "Contirm 2F and Contirm 70WSP Agricultural Insecticides - Reduced Risk Rationale - Citrus", Report OOR-1029, 134 pages (MRID 45141001).

4. Tebufenozide does not have a toxicological profile that would that would make it a high priority for regulation in drinking water. Maximum contaminant levels (MCLs) under SDWA are established by the U.S. EPA for those "chemicals that are thought to pose the most serious risk." A review of the toxicological database for tebufenozide reveals and supports a low hazard toxicological profile and as such, there would appear to be little scientific basis for including tebufenozide as a candidate for MCL development.Tebufenozide is of low acute toxicity, with no mortality or

significant clinical signs following doses as high as 5000 mg/kg/day by oral and dermal routes of exposure. Tebufenozide represents a low hazard v ia inhalation as well. It is not a skin or eye irritant and is not associated with dermal sensitization. Tebufenozide is rapidly absorbed by the body and eliminated quickly, with limited tissue distribution and metabolism. It is not bioaccumulative.

In studies using oral exposure in laboratory animals ranging from 28 to 52 weeks in duration, tebufenozide was generally well-tolerated at dose levels up to regulatory limit doses. There are established NOAELs and LOAELs for all short and long- term studies involving tebufenozide. Tebufenozide showed no indication of genotoxicity in a variety of in vitro and in vivo studies including gene mutation, clastogenicity, and unscheduled DNA synthesis. Metabolites of tebufenozide that have been evaluated also show no indication of genotoxic or mutagenic potential. In standard guideline-compliant oncogenicity studies, tebufenozide was devoid of carcinogenic potential and showed no signs reflective of chronic toxicity. Tebufenozide has been evaluated in two multigeneration reproduction studies and there is no indication that it poses a specific reproductive hazard. Similarly, it is not a specific developmental toxicant and is not teratogenic as evaluated in two species. In an assessment of neurotoxicity following single high doses, tebufenozide was devoid of findings indicative of neurotoxic potential. An acceptable daily intake (ADI) value of 0.02 mg/kg bw/day has been proposed based upon an NOAEL (hematological effects) of 2 mg/kg bw/day obtained in a 52-week dog study.

In summary, tebufenozide represents a low-hazard compound with no sentinel toxicological effects or critical endpoints that drive the need for establishment of an MCL in drinking water.

5. Tebufenozide does not have a current or future use profile that would make it a high priority for regulation in drinking water.When introduced onto the market as a pesticide product in the

mid-1990's, tebufenozide was initially widely used in fruit,

vegetable, and row crop agriculture. As manufacturers including DAS have introduced newer insecticide products during the intervening years, many uses of tebufenozide have been replaced by these newer products. Thus, use of tebufenozide has declined significantly during the past several years, and more than 90% of product use is now associated with sugarcane agriculture in the Southern U.S. where it continued to have an excellent fit with integrated pest management programs. DAS anticipates that use of tebufenozide on a niche market basis will continue for the foreseeable future in U.S. agriculture but will not expand significantly as newer alternatives continue to be introduced. Thus, the volume of current and projected tebufenozide use in the U.S. would not seem to merit serious consideration for regulation under the SDWA as a priority contaminant.

Kenneth D. Racke, Ph.D. Regulatory Manager - Insecticides U.S. Regulatory and Government Affairs CS Title: 0085 Company/group/association name: Comment:

On behalf of Breast Cancer Action and our 20,000 members, we urge you to adopt the Contaminant Candidate List (CCL 3) to ensure that drinking water is properly monitored for toxic chemicals. Breast Cancer Action is very concerned about the link between env ironmental exposures and breast cancer. Many of the contaminants on the CCL 3 are associated with breast cancer and other diseases, and should be properly monitored and regulated. Wealso want to ensure that perchlorate is federally regulated, as it is in California.

Thank you for giving us the opportunity to comment on drinking water standards.

Sincerely,Barbara A. Brenner

Executive Director Breast Cancer Action CS Title: 0055 Company/group/association name: Comment:

I urge you to include the chemicals and pathogens on the Candidate Contaminant list as part of EPA's standard contaminant list. I believe this is essential for protectionof public health. This refers to Docket #EPA-HQ-OW-2007-1189-0001. CS Title: 0088 Company/group/association name: Comment:

Attached you will find comments from the Methanol Institute encouraging the Agency not to include methanol on the final Contaminant Candidate List 3.

May 15, 2008

Water Docket Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, N.W . Washington, D.C. 20460

Docket ID No. EPA-HQ-OW-2007-1189

Comments of the Methanol Institute Regarding Drinking Water Contaminant Candidate List 3 - Draft

The Federal Register notice of February 21, 2008, published for public review and comments a draft list of contaminants that are currently not subject to any proposed or promulgated national primary drinking regulations, that are known or anticipated to occur in public water systems, and which mayrequire regulation under the Safe Drinking Water Act. This

notice included methanol as a candidate chemical for listing. Webelieve that methanol does not pose a risk to drinking water and would therefore not be an appropriate candidate for a national primary drinking water standard.

The Methanol Institute serves as the trade association for the global methanol industry. Methanol is an essential chemical building block used to manufacture a wide range of products including building materials, plastics, adhesives, solvents, paints, textiles, refrigerants, windshield wash and anti- freeze, and fuels. In 2008, the U.S. is expected to consume 6.7 million metric tons (or 2.2 billion gallons) of methanol. Our industry's commitment to product stewardship helps ensure that methanol is used in a safe and responsible manner.

In considering whether to include methanol in the draft CCL 3 listing, the Agency s own evaluation team assigned methanol to the "L?-L" model decision category. This means that the

evaluation team found methanol to be close to the boundary for a List-Not List decision, and "leaned" towards listing. Clearly, the evaluation team itself questioned a listing for methanol, and in reviewing the "Attribute Score" for methanol we can see why methanol was on the boundary.

Methanol was assigned a potency score of "3," on a "1" to "10" range indicating that low doses of methanol are not a significant concern for adverse health effects. In terms of

severity, methanol scored a "6" on a nine point range as hav ing health effects that may be "significant, irreversible, non- lethal conditions or disorders." In terms of severity, methanol was not considered a risk for developmental or reproductive effects, tumors or disorders likely leading to death, or death. These scores are based on a reference dose (U.S. EPA 1986), which is considered the richest supporting data set.

The preliminary CCL3 suggests a severity grade of "6" for methanol toxicity, "significant, irreversible, nonlethal conditions or disorder". The data from the selected study (the basis for the EPA RfD) indicated altered organs weights andincreased serum enzymes indicative of liver toxicity, but no

liver pathology was present. Therefore, there is no indication from these data that the effects were irreversible. On the contrary, one would expect these effects to disappear following

a recovery period without methanol exposure. Based on the data,

a severity grade of "5" (significant reversible effects) is more appropriate.

Methanol's consideration for listing is likely not based on these health effects attributes, but simply because methanol scores highly on the occurrence attributes. Methanol scored a "10" for both prevalence (how widespread the occurrence) and magnitude (quantity). In assessing occurrence, there were no findings of methanol in finished water systems or in ambient water, which form the top of the hierarchy for assessing actual occurrence in drinking water. Methanol is a high production chemical, which accounts for its high occurrence ranking, even if its has not actually been found in drinking water. For magnitude, methanol releases reported under the Toxics Release Inventory, must account for its "10" ranking. Again, since no methanol was identified in finished or ambient water, there are no median values, which are at the top of the hierarchy for measuring magnitude. Persistence and mobility make up the lower end of the magnitude hierarchy. Here methanol is identified as a chemical that "biodegrades fast," so it is not considered a persistent contaminant. Methanol is completely miscible in water.

Wecan understand the apprehension the evaluation team may have had when considering to list methanol. It would appear that methanol was included in the draft list only because it is a high production volume chemical. The occurrence data does cite 201,697,278 lbs/year in total releases according to the 2004 TRI report, but when you examine the TRI report in detail, a different picture emerges. First, total TRI on-site and off- site reported "disposed or otherwise released" figures have consistently fallen for the past 15 years, with 178,319,830 pounds reported in the 2006 TRI Report. Of this total, more than 83% are fugitive or point source air emissions and deposition to water bodies is not a factor. Only 0.022% of the total methanol is represented by "total off-site disposal or other releases." Further, the total quantity disposed of orotherwise released on-and off-site, represents just 0.07% of

the total production-related waste managed for methanol, with the vast majority of methanol recycled or treated on-or off- site. By these metrics, there is only a minimal concern for methanol entering surface or ground-water resources.

In 1999, the Methanol Institute commissioned a study by Malcolm Pirnie, Inc. entitled "Evaluation of the Fate and Transport of Methanol in the Env ironment" (available at www.methanol.org). The purpose of this report was to summarize the existing information through a literature review of over 100 reports, as well as the use of computer modeling, to determine the fate of methanol in the environment. The researchers also explored three conceptual release scenarios, including tank truck or rail car release, barge release, and release from underground storage tanks at a refueling facility. This study found:

"The physical and chemical properties of methanol help to further define the fate and transport of this chemical in the

various environmental media in the context of each of the conceptual release scenarios. The dominant mechanisms of methanol loss from subsurface soil and groundwater are expected to be biodegradation and advection (dispersion and diffusion) with little loss from adsorption on soils due to its high solubility and low retardation factor. In surface water, the infinite solubility of methanol will result in rapid wave-, wind-, and tide enhanced dilution to low concentrations (< 1%). Once concentrations have been diluted below toxic levels the dominant mechanism of methanol loss is expected to be biodegradation. Compared to other loss mechanisms identified, including volatilization and chemical degradation, biodegradation is expected to be the dominant process controlling the fate of methanol in the soil, groundwater, and surface water environments. In addition, the biodegradation of methanol can occur under both aerobic (oxygen present) and anaerobic (oxygen absent) conditions.

Therefore, following any of the three conceptual release scenarios presented, methanol is not likely to persist in soil or water due to its rapid biodegradation. Methanol is miscible in water and consequently will dissolve quickly and be dilutedto low concentrations in the event of a surface water spill. In

groundwater, methanol concentrations are highly dependent on the nature and the magnitude of the release, but will likely fall to low concentrations once complete dissolution has occurred. In both surface and ground waters, methanol will likely be easily biodegraded under a wide range of possible water quality conditions."

These findings are consistent with the EPA's Evaluation Team's notation the methanol "biodegrades fast," and is generally considered to be env ironmentally benign. Further, over 200 wastewater treatment plants inject methanol into the treatment process for denitrification with no significant residual methanol in the effluent. W ith many of the nation's most sensitive estuaries being harmed by high nitrogen loading, methanol is playing an increasingly important role in helping to prevent and reverse the spread of "dead zones."

The Malcolm Pirnie study also addressed human health effects finding: "Methanol s properties and toxicity are well understood, an the ocular toxicity and metabolic acidosis that are effects of acute high doses of methanol are well-known. Methanol is neither mutagenic, nor carcinogenic. W hile methanol produces toxic effects on humans and animals, the current

evidence suggests that these effects only occur at high doses."

This report also focused on the potential use of methanol as a transportation fuel in comparison with gasoline and stated, "In conclusion, the fate and transport of methanol in the

env ironment is well understood. Methanol spills to the soil, groundwater, and surface water will quickly biodegrade under both aerobic and anaerobic conditions and, consequently, methanol is not expected to persist. Methanol exhibits a lower toxicity to both humans and indigenous microbes then

conventional gasoline. Therefore, based on this analysis, methanol appears to be a more environmentally benign fuel compared to conventional gasoline."

In conclusion, we would encourage the Agency not to include methanol on the final Contaminant Candidate List 3. TheAttribute Score for methanol - when explored in detail - would

indicate that methanol has a low risk for human health impacts and that there is very little concern that methanol would impact finished water systems or ambient water. W hile methanol is an essential chemical for the U.S. economy, a detailed

review of the Toxics Release Inventory demonstrates that methanol does not pose an env ironmental threat. Since the half- life for methanol in groundwater and surface water is just one to seven days, methanol is not a persistent contaminant. We appreciate this opportunity to prov ide our comments, and would be pleased to address any questions you may have regarding this statement.

Sincerely,

John Lynn President & CEO CS Title: 0089 Company/group/association name: Comment:

May 14, 2008

Via E-Mail

Water Docket U.S. Environmental Protection Agency Mail Code 2822T 1200Pennsylvania Avenue, NW Washington, DC 20460

Re:Docket No. EPA-HQ-OW-2007-1189 -- Drinking Water Contaminant Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21, 2008)

Dear Sir/Madam:The Olefins Panel (Panel) of the American Chemistry Council

submits these comments, together with the appended technical document, on the U.S. Environmental Protection Agency's (EPA) February 21,2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA). The Panel, which consists of companies[FN1: Panel member companies include Chevron Phillips Chemical Company, LP, The Dow Chemical Company, Eastman Chemical Company, Equistar Chemicals LP, ExxonMobil Chemical Company, Huntsman Corporation, INEOS Olefins & Polymers USA, NOVA Chemicals Inc., Shell Chemical Company, and Texas Petrochemicals, Inc.] that manufacture, use, or process 1,3- butadiene, one of the chemical contaminants included on the draft CCL 3, has a strong interest in the list and the approach that EPA utilized to develop it.

As discussed in the appended comments, the Panel urges EPA not to include 1,3-butadiene on the final CCL 3 for the following

reasons:

* 1,3-butadiene is a highly volatile gas that is expected to partition predominantly to air, and thus is very unlikely to be found in drinking water.

* In making CCL 3 decisions, EPA inappropriately used total TRI releases to determine l,3-butadiene's potential to occur in drinking water.

* EPA should define 1,3-butadiene's potential to occur in drinking water based on its minimal surface water releases, which are the most relevant data for characterizing potential drinking water occurrence.

The Panel appreciates the opportunity to submit these comments. For the reasons included in the attached comments and noted above, the Panel urges EPA not to include 1,3-butadiene on the final CCL 3. If you have any questions, please contact Dr. Elizabeth Moran, the Olefins Panel Manager, at Elizabeth_Moran@americanchemistry.com or (301) 924-2006.Sincerely,

Sharon H. Kneiss Vice President, Products Division

Attachments

BEFORE THE U.S. ENVIRONMENTAL PROTECTION AGENCY

COMMENTS OF THE OLEFINS PANEL OF THE AMERICAN CHEMISTRY COUNCIL

ON

DRINKING WATER CONTAMINANT CANDIDATE LIST 3-DRAFT

Drinking Water Contaminant Candidate List 3-Draft 73 Fed. Reg. 9628 (Feb. 21, 2008) Docket No. EPA-HQ-OW-2007-1189

Elizabeth J. Moran, Ph.D. Manager, Olefins Panel

Saeda A. Siam, Esquire Olefins Panel Counsel

Of Counsel: Lynn L. Bergeson, Esquire Ira Dassa, Esquire Bergeson & Campbell, P.C. 1203 Nineteenth Street, N.W . Suite 300 Washington, D.C. 20036-2401AMERICAN CHEMISTRY COUNCIL

1300 W ilson Boulevard Arlington, VA 22209

May 14, 2008

EXECUTIVE SUMMARY

The Olefins Panel (Panel) of the American Chemistry Council submits these comments, together with the appended technical document, on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA). The Panel, which consists of companies that manufacture, use, or process 1,3-butadiene, one of the chemical contaminants included on the draft CCL 3, has a strong interest in the list and the approach that EPA utilized to develop it

The Panel urges EPA not to include 1,3-butadiene on the final CCL 3 for the following reasons:

* In making CCL 3 decisions, EPA must use the most relevant data for 1,3-butadiene.

* 1,3-butadiene is a highly volatile gas that is expected to partition predominantly to air.

* EPA should define 1,3-butadiene s potential to occur in drinking water based on its minimal surface water releases, which are the most relevant data for characterizing potential drinking water occurrence.

TABLE OF CONTENTSEXECUTIVE SUMMARY ..........................................i

TABLE OF CONTENTS......................................... ii INTRODUCTION............................................... 1

I. 1,3-BUTADIENE SHOULD NOT BE INCLUDED ON THE FINAL CCL 3. 2

A. In Making CCL 3 Decisions, EPA Must Use the Most Relevant Data for 1,3-Butadiene..................................... 3

B. 1,3-Butadiene Is a Highly Volatile Gas That Is Expected to Partition Predominantly to Air............................. 5

C. EPA Should Define 1,3-Butadiene s Potential to Occur in Drinking Water Based on Its Minimal Surface Water Releases, Which Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence.................................. 7

CONCLUSION................................................. 8

INTRODUCTION

The Olefins Panel (Panel) of the American Chemistry Council submits these comments, together with the appended technical document, on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA).[FN1: 73 Fed. Reg. 9628 (Feb. 21, 2008).] The Panel, which consists of companies[FN2: Panel member companies include Chevron Phillips Chemical Company, LP, The Dow Chemical Company, Eastman Chemical Company, Equistar Chemicals LP, ExxonMobil Chemical Company, Huntsman Corporation, INEOS Olefins & Polymers USA, NOVA Chemicals Inc., Shell Chemical Company, and Texas Petrochemicals, Inc.] that manufacture, use, or process 1,3-butadiene, one of the chemical contaminants included on the draft CCL 3, has a strong interest in the list and the approach that EPA utilized to develop itUnder Section 1412(b)(1)(B) of the SDWA, as amended, EPA is

required to publish every five years "a list of contaminants which, at the time of publication, are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation under [the SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I). For a contaminant to be regulated under the SDWA, EPA must make three findings: (1) the contaminant may have an adverse effect on the health of persons; (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 presents a meaningful opportunity for health risk reduction for persons served by public water systems. Id. § 300g-1(b)(1)(A)(i)-(iii).] Congress made it clear that in selecting unregulated contaminants for this list, known as the CCL, EPA must "consider the [National Contaminant Occurrence Database (NCOD)] established under section [1445(g) of the SDWA]"[FN4: Id. § 300g-1(b)(1)(B)(i) (I).] and "select contaminants that present the greatest public health concern."[FN5: Id. § 300g-1(b)(1)(C).] Inclusion of a contaminant on the CCL means that the contaminant, at a later date, may become subject to an EPA determination to regulate.[FN6: Id. §§ 300g-1(b)(1)(B)(ii), (E).] Once listed, there is no procedure set forth in the SDWA, short of a determination not to regulate, for a contaminant's removal from the particular CCL on which it appears.[FN7: See 70 Fed. Reg. 9071, 9073 (Feb. 24, 2005) (a regulatory determination not to regulate a particular contaminant serves to "remove that contaminant from the CCL"), available at http://www.epa.gov/fedrgstr/EPA- WATER/2005/February/Day-24/w3527.htm; but see 63 Fed. Reg. 10273, 10275 (Mar. 2, 1998) (stating that EPA is "not precluded from modifying the CCL prior to the due date of the next CCL"),

available at http://www.epa.gov/fedrgstr/EPA- WATER/1998/March/Day-02/w5313.htm.]

I. 1,3-BUTADIENE SHOULD NOT BE INCLUDED ON THE FINAL CCL 3The Panel's comments focus entirely on EPA's inclusion of 1,3-

butadiene on the draft CCL 3. For the reasons discussed more fully below, 1,3-butadiene does not warrant inclusion on the final CCL 3, and the Panel urges EPA to remove it from the list.

EPA based 1,3-butadiene's "potential to occur in drinking water" on the total 2004 reported releases to the env ironment pursuant to the Toxics Release Inventory (TRI) program and the number of states in 2004 having those TRI-reported releases.[FN8: 73 Fed. Reg. at 9637, 9640.] Because, however, 1,3-butadiene is a highly volatile gas and thus, as EPA itself recognizes, is expected to partition predominantly to the atmosphere, the Panel urges EPA instead to consider the minimal level of surface water releases in determining whether 1,3- butadiene should be listed. Such a consideration shows that 1,3-butadiene is not "known or anticipated to occur in public water systems,"[FN9: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I).] and that it does not present "a substantial likelihood [of occurrence] in public water systems..." such that it can be regulated under the SDWA.[FN10: Id. § 300g-1(b)(1)(A)(ii).] Likewise, these data support the conclusion that 1,3-butadiene cannot be considered to present one of "the greatest public health concern[s]" from drinking water exposure.[FN11: Id. § 300g-1(b)(1)(C).] Consequently, 1,3-butadiene does not meet the statutory standard for inclusion on the CCL.

A. In Making CCL 3 Decisions, EPA Must Use the Most Relevant Data for 1,3-Butadiene

Under the screening approach that EPA used to narrow the universe of CCL 3 contaminants to a Preliminary CCL (PCCL), all chemical contaminants that were categorized in Toxicity Category 1, including 1,3-butadiene, "were captured [in the PCCL] regardless of their occurrence category."[FN12: 73 Fed. Reg. at 9638; EPA, Contaminant Candidate List 3 Chemicals: Screening to a PCCL, at 16, 19 (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0044.] In the subsequent classification process through which the 532 PCCL chemical contaminants were further evaluated, modeled, and narrowed to the draft CCL 3 on which EPA seeks comment, EPA sought to ensure, inter alia, a"meaningful basis for classification" as well as the

"incorporati[on] [of] relevant data." As EPA explained, "[t]he classification process...must consider the potential for occurrence in water," and "[t]he most relevant data used for the classification process include health effects data that are appropriate for drinking water exposures, and occurrence data that indicate the nature and spatial extent of potential occurrence in drinking water."[FN13: EPA, Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCL, at 2 (Feb. 2008 Draft) (classification of the PCCL to CCL), available at EPA-HQ-OW-2007-1189-0046. Of course, in implementing Section 1412 of the SDWA, EPA is required to use "the best available, peer-rev iewed science and supporting studies conducted in accordance with sound and objective scientific practices." 42 U.S.C. § 300g-1(b)(3)(A).]

As with most other chemical contaminants, EPA utilized the occurrence attributes of "prevalence" and "magnitude" to define 1,3-butadiene's actual or potential occurrence in drinking water.[FN14: Classification of the PCCL to CCL at 18.] Importantly, 1,3-butadiene is not known to occur in drinking water, and indeed, neither the NCOD that EPA is required to consider in its development of the CCL nor any other source of finished water or ambient water occurrence data reflects any detections of 1,3-butadiene.[FN15: See EPA, Contaminant Information Sheets for the Draft CCL 3 Chemicals, at 12 (Feb. 2008 Draft) (Information Sheets), available at EPA-HQ- OW-2007-1189-0042.] This fact should be taken into greater account in the CCL process. The process that EPA utilized treats chemicals known to occur in drinking water the same as those for which there is no ev idence of occurrence. Regardless of how toxic a particular chemical may be, if it is not found or anticipated to be found in public water systems, then inclusion on the CCL is neither warranted nor legally appropriate. Thus, there needs to be a way to remove from consideration those chemicals with little or no potential to occur in drinking water. To the extent that EPA purported to do this, the use of TRI total environmental release data is inappropriate, as can be seen in the case of 1,3-butadiene.

B. 1,3-Butadiene Is a Highly Volatile Gas That Is Expected to Partition Predominantly to AirEPA used the prevalence and magnitude attributes as the basis

for evaluating 1,3-butadiene's potential to occur in public water systems, with magnitude corresponding to the total on- and off-site disposal or other releases of 1,3-butadiene (i.e., 1,964,956 pounds) reported under the TRI for 2004, and prevalence corresponding to the number of states (34) with releases.[FN16: Id.] Reliance on TRI release data without considering 1,3-butadiene's physical properties and fate has led, however, to the erroneous conclusion that 1,3-butadiene might occur in drinking water.[FN17: In crafting the CCL 2, EPA explained that "[a] contaminant was considered to have the potential to occur [in drinking water] if, using the TRI, the release to surface water was in excess of 400,000 pounds per year and the physical-chemical properties indicated persistence and mobility of the contaminant." 69 Fed. Reg. 17406, 17409 (Apr. 2, 2004) (emphasis added), available at http://www.epa.gov/fedrgstr/EPAWATER/ 2004/April/Day-02/w7416.htm. For some contaminants, then, physical-chemical properties played a distinct role in the CCL 2 process. In the CCL 3 process, EPA considered chemical and physical properties, but only in those cases where production data under the Toxic Substances Control Act Chemical Update System/Inventory Update Rule constituted the sole measure of occurrence. See 73 Fed. Reg. at 9640-41. Certainly for 1,3- butadiene, chemical and physical properties also must play a distinct role in determining whether inclusion on the CCL 3 is appropriate.]

EPA, in contravention of its intent to incorporate "[t]he most relevant data," did not account for 1,3-butadiene's well-known physical properties.[FN18: The expert panel that EPA convened to provide input on EPA s approach to the draft CCL 3 recommended that "the physical properties of each chemical, especially gases, should be analyzed to determine if model results would change if surface water release information was used instead of total release data." EPA, Chemical Expert Input and Rev iew for the Third Contaminant Candidate List, at 8 (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0038.] As EPA's most recent health assessment of the chemical states, 1,3- butadiene "is very slightly soluble in water" and "a highly

volatile gas [that] is expected to partition predominantly tothe atmosphere and then undergo rapid destruction by

photoinitiated reactions."[FN19: EPA, Health Assessment of 1,3- Butadiene, at 2-1 (Oct. 2002) (IRIS Assessment), available at http://www.epa.gov/ncea/iris/supdocs/buta-sup.pdf; see also Agency for Toxic Substances and Disease Registry, Toxicological Profile for 1,3-Butadiene, at 59 (July 1992) (ATSDR Profile),

available at http://www.atsdr.cdc.gov/toxprofiles/tp28.pdf.] Moreover, "[b]ased on its physical properties, rapid

volatilization of 1,3-butadiene from either soil or water to [the] atmosphere is expected to dominate over all other potential env ironmental processes."[FN20: IRIS Assessment at 2-1; ATSDR Profile at 59.] In sum, quantities of 1,3-butadiene that are released to air, which are the vast majority of the total environmental releases, do not end up in drinking water, and any quantities that are released to other media partition to the atmosphere.[FN21: According to the TRI Explorer Chemical Report for 2004, of the total quantity of 1,3-butadiene released to the env ironment, more than 96 percent was in the form of fugitive and point source air emissions. See TRI Explorer Chemical Report for 2004, available at http://www.epa.gov/triexplorer/.] The appended technical comments soundly demonstrate both that 1,3-butadiene partitions primarily to the air -- 99.99% is removed via atmospheric processes -- and that any 1,3-butadiene that is released to water will partition significantly into the air. In the unlikely event that any 1,3-butadiene remains in surface water entering a treatment facility, standard water treatment practices have been shown to remove it.

C. EPA Should Define 1,3-Butadiene s Potential to Occur in Drinking Water Based on Its Minimal Surface Water Releases, Which Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence

In view of 1,3-butadiene's highly relevant physical properties, EPA should base its characterization of 1,3-butadiene's potential to occur in drinking water not on the total quantity released to the env ironment, but rather on the total quantity released to surface water. In 2004, this figure was a mere 493 pounds encompassing only eight states.[FN22: Information Sheets at 12.] This figure decreased by more than 50 percent in 2005, to 236 pounds, and by more than 50 percent yet again in 2006,to 113 pounds.[FN23: See TRI Explorer Chemical Reports for 2005

and 2006, available at http://www.epa.gov/triexplorer/.] This level of surface water release is quite minimal, and as noted above, any 1,3-butadiene so released rapidly volatilizes to the atmosphere.[FN24: As explained in the appended technical comments, any 1,3-butadiene that somehow finds its way into groundwater, which, given the chemical s volatility and sparing solubility in water, is likely to be an exceedingly small amount, would volatilize quickly or otherwise be removed during the drinking water treatment process.]

Thus, 1,3-butadiene does not meet the statutory standard for CCL listing, as it is not known or anticipated to occur in public water systems, nor is there a substantial likelihood of it occurring in public water systems.

CONCLUSION

The Panel appreciates the opportunity to submit these comments. For the reasons noted above, the Panel urges EPA not to include 1,3-butadiene on the final CCL 3.

Technical Comments on the U.S. Environmental Protection Agency's Inclusion of 1,3-Butadiene in the Draft Third Contaminant Candidate List under the Safe Drinking Water Act

The U.S. Environmental Protection Agency (EPA) has published a draft list of chemicals that are known or anticipated to be public water system contaminants that may require regulation under the Safe Drinking Water Act (SDWA) (Federal Register, 2008). W hen issued in final, the list will become the third Contaminant Candidate List (CCL 3) issued since EPA published the SDWA Amendments in 1996. EPA has asked for comments on the draft CCL 3, which includes 1,3-butadiene (BD).

The SDWA Amendments list three criteria used to identify chemicals requiring regulation:* 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 health concern; and

* 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.

Data presented in this document show that BD is very unlikely to be present in public water systems because of its physical properties and because manufacturing controls mitigate against its release into the env ironment. W ith regard to chemical fate, as measured by env ironmental models, the atmosphere is the primary modeling compartment to receive BD from its manufacture, In the air, specific fate processes result in BD's physical degradation. BD is rapidly degraded in air and has a calculated half-life that ranges from two to six hours. BD is not expected to be present in public drinking water based on physical processes that remove volatile substances used in water treatment facilities and on the outcome of modeling that considered these processes together with BD's physico-chemical properties.

1,3-Butadiene Emissions from Manufacturing

Total yearly emissions of BD are reported by industry to the EPA pursuant to the Emergency Planning and Community Right-to- Know Act. These data are made available to the public through the Toxics Release Inventory (TRI). The most recent data are from 2006, as reported in 2007, and listed in Table 1 (EPA, 2008). These data are used in the following sections to estimate the partitioning behavior of BD in the environment and its potential partitioning to drinking water.The TRI data indicate that industrial emissions of BD declined

by 69% during the years between 1988 and 2006 (the most recent reporting year), or from approximately 7.7 million pounds to 2.4 million pounds per year (EPA, 2008). Although the total emission of BD from the 2006 TRI was reported as 2.4 million pounds per year, only 1.6 million pounds was actually released to the environment and was reported within the following compartments (Table 1): point source and fugitive losses to air (1.498 million pounds), underground injection (0.102 million pounds), soil landfill both on- and off-site (685 pounds), and loss to surface water (113 pounds). The remaining 0.8 million pounds are classified as "storage" and not considered as an

env ironmental emission.

Table 1. 2006 TRI data (pounds) for 1,3-butadiene reported to EPA and normalized to a yearly emission rate (kg/hr/yr). [see PDF]

1,3-Butadiene Atmospheric Fate

The atmosphere is the main env ironmental compartment of interest when considering fate processes that impact potential exposure to BD. BD is a gas and will partition to the air upon entering the environment even at reduced temperatures. Its behav ior in the environment is largely explained by its vapor pressure, which has been reported as 856 mm Hg (1141 hPa) at -1.5 °C (Boublik et al., 1984) and 2110 mm Hg (2813 hPa) at 25 °C (EPA, 2000). Although BD's water solubility has been reported as 735 mg/L at 25 °C (McAuliffe, 1966), suggesting that it has a degree of solubility, its Henry's Law constant (HLC), a measure of a chemical's volatilization rate from water, shows that BD will preferentially partition to air from solution. The HLC for BD is calculated as 20,699 Pa-m3/mole using the water solubility and vapor pressure data for 25 °C. The dissolution of BD from water as facilitated in a drinking water treatment plant is discussed below.

BD that enters the environment will primarily partition to the atmosphere, which is the major manufacturing route of loss.Results from an environmental distribution model, EQC Level III

(Canadian Env ironmental Modelling Centre, 2004; Mackay, 2001; Mackay et al., 1996), support this assessment. The EQC Level III model, which represents a steady state unit regional

env ironment, is based on a number of default and user-selected parameters[FN1: EQC Level III fugacity model v2.02. Model input parameters from EPA (2000) for BD at 25 °C: molecular weight = 54.09; water solubility = 735 g/m3; vapor pressure = 281,300 Pa; log Kow = 1.99; melting point = -108.9 °C; air half-life (AOPW IN, v1.91) = 1.9 hours; water half-life (Mackay et al., 2006) = 42 hours (within the range of suggested values); soil and sediment half-life (Mackay et al., 2006) = 168 hours (within the range of suggested values and comparable to the Biowin 4 Primary Survey Model). Emission rates used in the model to soil, air, and water compartments are based on 2006 IUR data (Table 1).]. Using emission values from the 2006 IUR and physical-chemical and biological parameters from the EPI SuiteTM package of programs (EPA, 2000) and the Handbook of Physical-Chemical Properties and Env ironmental Fate for Organic Chemicals (Mackay et al., 2006), EQC predictions show the air compartment retaining 99.7% of the steady state mass of BD, with the remaining 0.3% residing in the water, soil, and sediment compartments. The mass balance calculation suggests that 97.32% of BD is reacted in the atmosphere. Another 2.67% is atmospherically advected from the defined unit environment (and will subsequently undergo atmospheric reaction outside the modelled system). Consequently, 99.99% of emitted BD is removed from the EQC model environment via atmospheric processes.

In spite of its water solubility, wet deposition of BD from the air is not likely to play a significant role in its atmospheric fate, once again because of repartitioning to the air, i.e., net loss to the atmosphere. Additionally, partitioning to the air from aqueous solution for BD that may be entrained in process waters will also contribute to the net transfer to the atmosphere.

In the air, BD participates in a range of chemical reactions that leads to its degradation and the production of stable reaction products. These reactions are mediated by a variety of reactive species, but the predominant route of degradation is photoxidation via hydroxyl radicals (OH-) (Atkinson, 1985;Atkinson, 1989). The rate at which an organic compound reacts

with OH- is a direct measure of its atmospheric persistence (Meylan and Howard, 1993). Atkinson (1985), in a review of reported kinetic data for BD, recommends the following rate constant:

k(BD) = 6.68 E-11 cm3 molecule-1 s-1 at 298 K (24.9 °C)

Using an average concentration of 5 E5 OH- cm-3, the calculated atmospheric half-life for BD is 5.76 hours. Atkinson (1985) from a review of the literature reports that OH- concentrations in the lower troposphere have been estimated at less than or approximately equal to 5E6 molecules cm-3, and suggests the use of a daily average concentration of approximately 5E5 molecules cm-3 for the northern hemisphere, as reported by Crutzen (1982).

EPA has developed a computer model that includes a calculation of the atmospheric oxidation potential (AOPW IN, v1.92, in EPA, 2000) as a result of OH- attack. AOPW IN estimates the rate constant for the atmospheric, gas-phase reaction between photochemically produced OH- and organic chemicals. The rate constants estimated by the program are then used to calculate atmospheric half-lives for organic compounds based upon an

average atmospheric OH- concentration of 1.5E6 molecule cm-3. AOPW IN uses the following rate constant:

k(BD) = 6.66 E-11 cm3 molecule-1 s-1 at 25 °C (298.15 K)

Since the reactions necessary for this degradative process only take place in the presence of sunlight, the model normalizes atmospheric half-lives to a 12-hour day. BD is calculated by this model to have an atmospheric half-life of 0.16 day (1.9 hours) as a result of photolysis by OH- attack.

Manufacturing processes result in air being the primary compartment to which BD will migrate upon release. The results of the two calculations, using the recommended rate constantscited by Atkinson and AOPW IN, show that the half-life for BD in

air is relatively short, ranging from approximately 2 to 6 hours, depending on OH- concentration. Because of its short air half-life, BD is not expected to be in air at sufficient concentrations to act as a potential source of contamination to drinking water. Additionally, concentrations of BD in surface water as a result of manufacturing processes will significantly dissipate to the air based on its relatively high HLC.

1,3-Butadiene Environmental Partitioning

As mentioned above, BD has a relatively high water solubility. Consequently, there are two relevant drinking water sources that may result in BD exposure. These include: surface water, with loadings from atmospheric deposition, soil runoff and direct water discharges; and groundwater, with loadings mainly from underground injection.

Using the EQC Level III model, as described above with 2006 emissions taken from Table 1, the role of surface water in the

env ironmental fate and exposure of BD was explored. Model results suggest that 0.15% of the overall steady state mass is found in surface water. Subsequently, based on these US emission rates applied over the EQC unit area of 105 km2 (10% of which is water surface area and the remaining 90% is soil area), the resultant surface water concentration is 0.0015 ng/L. Hence, based on these predictions, the amount of BD in surface water is negligible.

Underground injection represents 6.4% (102,000 pounds) of the total environmental emissions of BD. The main drinking water concern is dissolution into groundwater. Exposure of groundwater to the atmosphere will result in BD depletion similar to that described for surface water. In most cases, groundwater will also be treated before consumption. During this process, aeration or air stripping of the groundwater will be important to BD mitigation. EPA has indicated that air stripping is one of the best-available technologies for removing volatile organic compounds (VOCs) from groundwater (Dyksen, 2005). To simulate BD volatilization resulting fromaeration, the STP model (Clark et al., 1995) was used. This

model is generally used to predict the fate of chemicals in sewage treatment facilities, consisting in part of an aeration tank. By defining the model system as a single aeration tank and using typical water treatment facility properties, this process can be examined.

Aeration basins of water treatment facilities are usually between 3-5 m deep, 3-9 m wide, with a width:depth ratio of <=2 for optimal mixing, and the length is governed by the desired water detention time, usually between 10-30 minutes (Dyksen, 2005). The aeration rate for treatment is set between 0.0008-0.012 m3 air/L of water. For a water flow rate of 226.8 m3/h (upper range of typical values), aeration rates equate to 1812722 m3/h, and tank volumes of 37.8-113.4 m3, for detention times of 10-30 minutes, respectively. Assuming an aeration tank depth of 5 m, the subsequent tank area based on this water flow rate of 226.8 m3/h would be 7.56-22.68 m2. The mass transfer coefficients (MTC) used for this analysis were 23.46 m/h for air-side and 0.01 m/h for water-side (Mackay and Yeun, 1983), which represent relatively conservative values (i.e., higher MTC values would result in greater volatilization). Based on these inputs, model results indicate that between 86.2-98.9% of BD would be removed by volatilization in the defined water treatment aeration tank.

During the water treatment process, other implemented mitigation technologies would further decrease the amount of BD in water. The use of dissolved air flotation (DAF) units in the water clarification process can be another significant removal pathway for VOCs due to the introduction of air to the treatment water. Oxidation is yet another potential loss mechanism, especially in both the aeration and DAF processes. There also are sorption technologies applied that may help remove residual levels of BD that are aqueous dissolved. Consequently, after treatment it is unlikely that BD would be present in drinking water.

SummaryIn summary, BD is unlikely to be present in drinking water.

Emissions of BD from manufacturing facilities have decreased

over the period 1988-2006. Modeling shows that the air is the primary environmental compartment to receive BD from manufacturing because of its physical properties. In air, atmospheric fate processes result in its rapid degradation, with an atmospheric half-life of two to six hours. Any BD released to surface or groundwater from manufacturing, or that enters surface or groundwater through run-off, will subsequently partition significantly to air based on its physical properties. In the unlikely event that any BD remains in water entering a drinking water treatment facility, standard water treatment processes will likely remove it. Since BD is unlikely to be present in drinking water, EPA should remove it from the draft CCL 3.

References

Atkinson R (1985). Kinetics and mechanisms of the gas-phase reactions of the hydroxyl radical with organic compounds under atmospheric conditions. Chem. Rev . 85: 69-201.

Atkinson R (1989). Kinetics and mechanisms of the gas-phase reactions of the hydroxyl radical with organic compounds. Journal of Physical and Chemical Reference Data. Monograph No.1. In: Micromedex (1995) HSDB database.

Boublík T, Fried V and Hála E (1984). The Vapour Pressures of Pure Substances. Second Edition, pp. 972, Elsev ier Science Publishers, New York, NY, USA.

Canadian Env ironmental Modelling Centre (2004). Level III Fugacity Model, version 2.80, May 2004. Trent University, Peterborough, Ontario, Canada. Model website: http://www.trentu.ca/academic/aminss/envmodel/models/L3280new.h tml

Clark B, Henry J and Mackay D (1995). Fugacity analysis andmodel of organic chemical fate in a sewage treatment plant.

Environ. Sci. Technol. 29: 1488-1494.

Crutzen P (1982). Atmospheric Chemistry. Goldberg D, Ed., pp. 313-328. Ann Arbor Press Ann Arbor, MI, USA.

Dyksen J (2005). Aeration and air stripping (Chapter 5). In: Water treatment plant design (4th ed.), Ed. EE Baruth. McGraw- Hill. pp. 25.

Environmental Protection Agency (EPA) (2000). EPI SuiteTM, Estimation Program Interface Suite, v3.12. USEPA, Washington, DC, USA.

Environmental Protection Agency (EPA) (2008). TRI Explorer. USEPA website [ http://www.epa.gov/cgi-bin/broker?_SERVICE=oiaa&_PROGRAM= xp_tri.sasmacr.tristart.macro&VIEW =USCH&trilib=TRIQ0&TAB_RPT= 1&_LINESPP=ALL&sort=RELLBY&FLD=E41&FLD=E51A&FLD=E51B&FLD= STONDISP&FLD=E1&FLD=E2&FLD=E3&FLD=E42&FLD=E52&FLD=E53A&FLD= E53B&FLD=E54&FLD=STOTHDIS&FLD=RELLBY&FLD=TSFDSP&FLD= RE_TOLBY&ONDISPD=Y&OTHDISPD=Y&OFFDISPD=+&OTHOFFD=+&sort_fmt= 1&_TOP=&INDUSTRY=ALL&STATE=ALL+STATES&COUNTY= All+counties&CHEMICAL=000106990&YEAR=2006#REPORT_TOP#REPORT_TOP ] EPA, Washington, DC, USA.

Federal Register (2008). Part II - Env ironmental Protection Agency. EPA-HQ-OW-2007-1189 FRL-8529-7. Drinking Water Contaminant Candidate List 3-Draft. Vol. 73, No. 35. Thursday, February 21, 2008. Notices.

Mackay D (2001). Multimedia Environmental Models: The Fugacity Approach. Second Edition, pp. 1-261, Lewis Publishers, Boca Raton, FL, USA.

Mackay D, Di Guardo A, Paterson S and Cowan C (1996). Evaluating the env ironmental fate of a variety of types ofchemicals using the EQC model. Environ. Toxicol. Chem. 15:

1627-1637.

Mackay D, Shiu W , Ma K-C and Lee S (2006). Handbook of physical-chemical properties and environmental fate for organic chemicals, 2nd ed. CRC Press.

Mackay D and Yeun A (1983). Mass transfer coefficient correlations for volatilization of organic solutes from water. Environ. Sci. Technol. 17: 211-217.

McAuliffe C (1966). Solubility in water of paraffin, cycloparaffin, olefin, acetylene, cycloolefin, and aromatic hydrocarbons. J. Physical Chem. 70: 1267-1275.

Meylan Wand Howard P (1993). Computer estimation of the atmospheric gas-phase reaction rate of organic compounds with hydroxyl radicals and ozone. Chemosphere 12: 2293-2299. CS Title: 0090 Company/group/association name: Comment:

Please refer to the accompanying attachment supporting my recommendation that members of the bacterial group, Mycobacterium avium Complex (MAC) be included in the "Drinking Water Contaminant Candidate List 3".

Comments in Response to Publication of EPA-HQ-OW-2007-1189 FRL- 8529-7 RIN 2040-AD99

Drinking Water Contaminant Candidate List 3 - Draft

AuthorJoseph O. Falkinham, III Department of Biological Sciences Virginia Tech Blacksburg, VA 24061-0406Phone (540) 231-5931

FAX (540) 231-9307 E-mailjofiii@vt.edu

Note. The recommendation reflects the views of the author and does not represent the views of Virginia Tech.

Recommendation

Mycobacterium avium and Mycobacterium intracellulare (M. avium Complex, MAC) should be included in the drinking water Contaminant Candidate List 3.

Justification for Recommendation

(1) The prevalence and incidence of MAC disease in the United States and Canada is increasing.

(2) The prevalence and incidence of MAC disease is particularly increasing among the elderly. MAC pulmonary disease is dramatically increasing amongst elderly individuals (> 60 years). In as much as the proportion of elderly US citizens will continue to increase, the increase in MAC disease will continue to increase.

(3) MAC disease has long-term adverse health, economic, and social effects on individuals, their families, and communities.

(4) MAC are normal inhabitants of drinking water distribution systems that persist, grow, and form biofilms throughout drinking water systems. The majority of MAC cells reside in biofilms on pipe surfaces and are dislodged or released by water flow to enter household, hospital and building water systems.(5) Current methods for delivery of contaminant-free water

actually select for the growth and persistence of MAC in drinking water distribution systems.

(6) The presence of MAC in drinking water has been linked to infection and disease in persons exposed to that water.

(7) Opportunities exist for reduction of health risks through imposition of water treatment measures.

Details Relevant to Summary Comments

(1) The Prevalence and Incidence of MAC Disease is Increasing

Recent reports document a rising prevalence and incidence of disease and infection by M. av ium complex bacteria (MAC) and other nontuberculous mycobacteria (NTM). The reports have analyzed three sets of data. First are reports of increased incidence of patients suffering from MAC or NTM disease (Marras and Daley, 2002). Second are reports of increases in the number of samples sent to mycobacteriology laboratories for culture and the increased number and frequency of patient specimens yielding MAC or NTM (Yates et al., 1997; Martin-Casabona et al., 2004; Lipsky et al., 1984; Gordin et al., 1990; Yajko et al., 1994; Stone et al., 1997; W right et al., 1998; Marras et al., 2007). Third, is a report of the increase in skin sensitiv ity to mycobacterial antigens over three decades in the United States (Khan et al., 2007). All three measures reflect the increasing burden of exposure to MAC and NTM in the United States.

Although infections caused by nontuberculous mycobacteria, including members of the M. avium complex (MAC) are not required to be reported, estimates of disease incidence in the United States have been published. Most estimates of infection and disease in the United States and Canada are outdated (1960 - 1996) and range from 0.1 to 1.8 per 100,000 (rev iewed in Marras and Daley, 2002). For example, in 1987, a studyconducted by the CDC reported that the incidence of NTM disease

was 1.8 per 100,000 and that for MAC alone was 1.1/100,000 for MAC (O'Brien et al., 1987). A more recent estimate of the prevalence of pulmonary NTM infection in Ontario (Marras et al., 2007) showed significant increases for MAC from 5.6 (1997) to 8.4 (2003)/100,000, M. xenopi (another waterborne pathogenic mycobacterium) from 2.6 (1997) to 4.2 (2003), and rapidly growing mycobacteria from 1.2 (1997) to 2.0 (2003). Because MAC and NTM disease is not reportable, it is likely that the estimates are low and the prevalence of MAC and NTM disease are considerably higher.

Reports of increased frequency of MAC and NTM isolation from specimens submitted to reference mycobacteriology laboratories have come from England (Yates et al., 1997) and 14 European nations (Martin-Casabona et al., 2004). A recent study of the Public Health Laboratory Information System resulted in estimates of 3.5 and 3.7 MAC isolates (alone) per 100,000 in 1993 and 1996, respectively. If total pathogenic NTM are included, the rates are 4.4 (1993) and 4.5 (1996). Another example of the increasing incidence of MAC and NTM in the United States (where MAC predominates) is ev idence of the increased proportion of nontuberculous mycobacterial isolations amongst samples submitted to laboratories in the United States

over the period 1984 to 1998. During this period of time there was no substantial change in the incidence of Mycobacterium tuberculosis infection or isolations.

Reference Specimen NumberNTM (%)

Lipsky et al. (1984) 58 1 (2 %) Gordin et al. (1990) 142 5 (4 %) Yajko et al. (1994) 30633 (11 %) Stone et al. (1997) 38796 (25 %) Wright et al. (1998) 1315638 (49 %)

Finally, the incidence of positive skin sensitivity reactions to antigens prepared from Mycobacterium intracellulare, a member of the M. avium complex, over the period 1971-1972 and 1999-2000 were compared (Khan et al., 2007). Unlike many otherbacterial pathogens, skin sensitiv ity reactions to

mycobacterial antigens can be used to detect infection. The prevalence of positive M. intracellulare antigen sensitivity reactions increased from 11.2 % to 16.6 % of the individuals tested (Khan et al., 2007). Thus, individuals in the United States are being exposed to MAC and NTM either through wider distribution (not just southeastern), higher numbers, or more frequently.

Clearly, all three measures of MAC or NTM disease or exposure document the increasing prevalence of MAC and NTM in humans in the United States and elsewhere.

(2) MAC Pulmonary Disease Incidence is Increasing Dramatically amongst the Elderly

The prevalence and incidence of MAC pulmonary disease amongst elderly individuals has been increasing dramatically since it was first described (Albelda et al., 1985; Prince et al., 1989). This new presentation of MAC pulmonary disease appears in elderly men and women who lack any of the classic risk factors for mycobacterial pulmonary disease (Prince et al., 1989). The only common feature is that the infected individuals are elderly and low weight.

Increases of MAC disease amongst the elderly, geriatric population have been noted in several published community-based studies, not at referral hospitals. In particular, increases have been documented in two geographically separated regions of the United States, Portland, Oregon (Reich and Johnson, 1991) and Chapel Hill, North Carolina (Kennedy and Weber, 1994). Similarly, increases amongst the elderly have been noted in Calgary, Alberta, Canada (Field et al., 2004) and Toronto, Ontario, Canada (Marras et al., 2007). Thus, the dramatic increase in MAC pulmonary disease is not restricted geographically, but occurs across the United States and Canada. One common feature of persons living in those areas in the united States and Canada is access to high quality treated drinking water; a normal habitat of MAC and NTM.In as much as all models of future U.S. population composition

roject that the proportion of elderly will increase, it is logical to expect that the incidence and prevalence of MAC and NTM pulmonary disease will continue to increase. In fact, the increases will accelerate as the proportion of elderly amongst the US population increases.

Other groups of individuals, whose incidence in the US population is expected to increase include patients that arte immunosuppressed as a consequence of transplantation or chemotherapy. Members share the common characteristic of reduced immune competence and greater susceptibility to infection. Both transplant (Simpson et al., 1982) and immunosuppressed patients (Skogberg et al., 1995) as well as those with malignancies (Claass et al., 1995) are more susceptible to MAC and NTM infection. Again, as is the case for the elderly, it is expected that the proportion of those individuals is expected to rise in the United States.

(3) MAC Disease has Strong Adverse Health, Economic, and Social Effects on Individuals

MAC and NTM pulmonary disease has severe adverse effects on persons with the disease. The list of salient clinical symptoms of MAC and NTM disease includes:

Cough Malaise and Fatigue Fevers and Night Sweats Anorexia and Weight Loss (Prince et al., 1989; Field et al., 2004)

Thus, there can be no doubt that MAC and NTM disease dramatically reduce the quality of life for infected persons.

Recommended MAC and NTM therapy involves multi-drug regimens (Field et al., 2004; Griffith et al., 2007). Guidelines fromthe American Thoracic Society and Infectious Disease Society of

America recommend combinations of two, three, and four antibiotics (Griffith et al., 2007). It is well-established that treatment with each drug is accompanied with side-effects. Further, rather than simply adding side-effects, there are drug interactions that multiply the side-effects. In treatment of MAC and NTM disease, high failure rates of treatment are due to an inability to tolerate side-effects (Field et al., 2004).

Long treatment durations are characteristic of treatment of MAC and NTM infections (Griffith et al., 2007). Relapses are common amongst MAC and NTM pulmonary patients, requiring hospitalization and additional medical attention. Both lead to

severe economic hardships on MAC- or NTM-infected indiv iduals that are beyond those caused by the symptoms that reduce energy levels and mobility. Multi-drug regimens are quite expensive, particularly because mycobacteria are not susceptible to antibiotics used to treat other bacteria infections.

(4) MAC are Normal Inhabitants of Drinking Water Distribution Systems

Members of the M. avium complex (MAC) as well as other nontuberculous mycobacteria (NTM) are normal inhabitants of the human env ironment. In addition to natural waters (Falkinham, et al., 1980) and soils (Brooks et al., 1984), MAC and other NTM are also normal inhabitants of drinking water distribution systems (Aronson et al., 1999; Covert et al., 1999; Falkinham et al., 2001). As the water distribution systems were located throughout the United States and employed different methods of water treatment and had different organic matter contents, it is likely that most, if not all, US drinking water systems carry a resident and persistent population of MAC and NTM.

MAC and other NTM are not contaminants of drinking water distribution systems, but they grow in the distribution system. In fact, the further the distance the water sample is collected in a distribution system, the higher the numbers of MAC (Falkinham et al., 2001).In addition to water distribution systems MAC and NTM have been

shown to increase in number in hospital hot water systems (du Moulin et al., 1988; Kusnetsovet al. 2003). W hat is troubling about this discovery is that hospitals are comprised primarily of persons more susceptible to infection as a consequence of their conditions leading to hospitalization. Further, the information on hospitals suggests that MAC and NTM, whose original source is the public or private water supply, can populate the water systems of buildings and homes.

(5) Drinking Water Treatment and Practice Selects for MAC Growth and Persistence in Drinking Water Systems

MAC are at least 100-times more resistant to chlorine, chloramine, chlorine dioxide and ozone than Escherichia coli, the standard for disinfection (Taylor et al., 2000). Consequently use of any disinfectant leads to killing of other microorganisms and the surv ival of MAC and other NTM. The hydrophobic cell envelope of MAC and other NTM leads to their preferential attachment to surfaces where they grow and form a biofilm. Thus, MAC and NTM are not washed out of a drinking water distribution system. Further, biofilm-grown MAC are significantly more resistant to disinfectants than are those grown and exposed in suspension (Steed and Falkinham, 2006). MAC can grow in drinking waters at assimilable organic carbon (AOC) concentrations as low as 50 μg/L; they are oligotrophic (Norton et al., 2004).

The goal of water treatment is to reduce the number of pathogenic microorganisms and organic and inorganic chemicals in water. However, achieving those aims using chemical disinfection selects for MAC and NTM. Addition of disinfectant and reduction of AOC both select for MAC and NTM persistence and growth. In the absence of competitors, disinfectant- resistant, slowly growing MAC and NTM on the surfaces of pipes can utilize all the available nutrients for growth. As the mycobacteria grow cells are released into the water where they can colonize and grow in new habitats; for example hospitals, buildings, and households.A recent, troubling report indicates that disinfectant changes,

to reduce the formation of trihalomethanes (Stage 1 Disinfection-Byproducts Rule, January 1, 2002) may lead to increases in MAC and NTM in drinking water distribution systems. A change from chlorine to chloramine in the drinking water system of Pinellas County, Florida led to an increase in the frequency of isolation and number of MAC and NTM (Pryor et al., 2004). Thus, changes in water treatment to reduce chemical exposures, may select for increased MAC and NTM numbers.

(6) The Presence of MAC in Drinking Water has been Linked to Disease in Persons Exposed to that Water.

MAC in drinking water has been epidemiologically linked to disease in humans. Patients in a Boston AIDS outpatient clinic were infected with M. avium that shared the same DNA fingerprint pattern as M. avium isolates recovered from the water used to prepare coffee (von Reyn et al., 1994). More recently, the fingerprints of M. avium isolates recovered from the hot and cold water and biofilm in a bathroom showerhead in a condominium in New York were shown to be clonally related to the M. avium isolate recovered from a resident who used the shower regularly (Falkinham et al., 2008). The significance of the latter case lies in the fact that the resident was young, not immunodeficient, and had none of the classic risk factors for M. avium (Falkinham et al., 2008).

(7) Opportunities Exist for Reduction of Health Risks Through Imposition of Water Treatment Measures.

Although MAC and NTM are disinfection-resistant, they are as susceptible to ultrav iolet light (UV) as are other microorganisms, such as Escherichia coli. Thus, UV- disinfection is a viable and alternative means for reducing numbers of MAC and NTM in drinking water.

Numbers of MAC in drinking water systems are correlated withparticulate matter (Falkinham et al., 2001). MAC and NTM are

bound to particulates because of their very high cell surface hydrophobicity (Stormer and Falkinham, 1989; Bendinger et al., 1993). If particulate matter is effectively removed from water entering and leav ing treatment facilities, MAC and NTM numbers will be reduced.

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Stormer, R. S. and J. O. Falkinham, III. 1989. Differences in antimicrobial susceptibility of pigmented and unpigmented colonial variants of Mycobacterium avium. J. Clin. Microbiol. 27:2459-2465.

Taylor, R.H., J.O. Falkinham, III, C.D. Norton, and M.W . LeChevallier. 2000. Chlorine-, chloramine-, chlorine dioxide- and ozone-susceptibility of Mycobacterium av ium. Appl. Environ. Microbiol. 66:1702-1705.

von Reyn, C. F., J. N. Maslow, T. W . Barber, J. O. Falkinham, III, and R. D. Arbeit. 1994. Persistent colonisation of potable water as a source of Mycobacterium avium infection in AIDS. Lancet 343:1137-1141.

Wright, P. W ., R. J. Wallace, Jr., N. W . W right, B. A. Brown, and D. E. Griffith. 1998. Sensitivity of fluorochrome microscopy for detection of Mycobacterium tuberculosis versus nontuberculous mycobacteria. J. Clin. Microbiol. 36:1046-1049.

Yajko, D. M., P. S. Nassos, C. A. Sanders, J. J. Madej, and W . K. Hadley. 1994. High predicitve value of the acid-fast smear for Mycobacterium tuberculosis despite the high prevalence of Mycobacterium avium complex in respiratory specimens. Clin. Infect. Dis. 19:334-336.

Yates, M. D., A. Pozniak, A. H. C. Uttley, R. Clarke, and J. M. Grange. 1997. Isolation of environmental mycobacteria fromclinical specimens in south-east England: 1973-1993. Int. J.

Tuberc. Lung Dis. 1:75-80. CS Title: 0091 Company/group/association name: Comment:

19 May 2008

Water Docket, Environmental Protection Agency Mail code: 2822T, 1200 Pennsylvania Ave., NW . Washington, DC 20460 USA

Dear Sirs

Subject: Comments on the US EPA Drinking Water Contaminant Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) Docket ID No.: EPA-HQ-OW-2007-1189

The International Molybdenum Association submits the following comments to the above referenced notice published by the United States Environmental Agency at 73 Fed. Reg. 9628 (Feb. 21, 2008). That notice relates to the US EPA's Drinking Water Contaminant Candidate List 3, which includes molybdenum as one of the ninety three chemicals or groups of chemicals listed.

As set forth in the Federal Register notice, US EPA seeks to classify contaminants on the basis of available data to characterize the occurrence and adverse health risks that a contaminant may pose to consumers of a public water supply. The Federal Register notice identifies the US EPA Integrated Risk Information System (IRIS) as among the primary sources used in developing the draft CCL3. We wish to comment on one of the criteria the US EPA uses for retaining a chemical on the candidate list, namely, the potential to cause adverse effects in humans.For molybdenum we note that the potency score was based on a

reference dose derived in the IRIS. In turn, the IRIS entry for molybdenum and derivation of the reference dose (0,005 mg/kg/day) was derived using data for increased uric acid levels found by Koval'skiy et al. 1961. However, as noted by US EPA in IRIS, 2008, when referring to the study by Koval'skiy et al., the "increased copper excretion and elevated serum ceruloplasmin are not definitive adverse effects, and as presented here are associated with no frank adverse effects in a human population."

The IRIS entry also refers to other documents which, importantly, do not support the finding that molybdenum increases uric acid levels. Instead, two cited studies found that 0,022 mg/kg/day molybdenum did not affect urinary acid excretion (Deosthale and Gopolan, 1974) and that uric acid was lower in blood with higher molybdenum exposure (US EPA, 1979). Nonetheless, the aforementioned reference dose in IRIS was still based on the Koval'skiy et al., 1961 study, with confidence in this value noted as 'medium'.

The United States National Research Council (NRC) has noted many weaknesses in the Koval'skiy study and concluded that the involvement of molybdenum in the apparent adverse effects that were identified was "speculative" and insufficient to establish a cause-and-effect relationship (Vyskocil and Viau, 1999). A further relevant comment about the Koval'skiy et al., 1961 study is with regard to the fact that it was retained by the European Chemicals Bureau as the basis for its R48[FN1: R48 means Harmful: Danger of serious damage to health by prolonged exposure through inhalation and if swallowed.] classification of pure molybdenum trioxide in the EU in the late 1990's. This was subsequently challenged by IMOA, and the ECB Classification and Labelling Committee, at its 21-24 September 2004 meeting in Arona, Italy, agreed to withdraw the R48 classification, and documented this in its molybdenum trioxide entry in the 30th Adaptation to Technical Progress of EU Directive 67/548/EEC.

Some primary concerns about the Koval'skiy study were the potential for cross-contamination of the analysed samples, the limited number of control subjects (5) compared with exposedpersons (52), the criteria for the selection of subjects for

blood and urine sampling. This cast substantial doubt on the role of molybdenum in the aetiology of the findings. IMOA and the ECB concluded that the study did not contribute to the understanding of the potential toxicity of ingested molybdenum. Its quality for NOAEL derivation was considered severely inadequate.

Lastly, we wish to inform you that as part of industry's obligations under REACH (the new chemicals legislation in Europe) to provide proof of safe production, use and disposal of a substance, IMOA has very recently conducted a thorough

review of the available literature on molybdenum Repeated Dose Toxicity. More than 55 articles (including animal and human studies) have been identified and assessed. Specifically, each study has been thoroughly rev iewed and catergorised based on stringent criteria for reliability and relevancy, and IMOA has identified the available data that can be used for deriving a NOAEL for systemic effects after chronic oral exposure. This IMOA review concludes that the NOAEL should be an order of magnitude higher than the level derived in IRIS from in the Koval'skiy et al., 1961 study. The results of this rev iew can be made available to the Agency once the IMOA internal review process is completed.

Given the substantial concerns about the quality of the Koval'skiy et al., 1961 study, and the combined evidence from other human health studies, the basis for listing molybdenum on the draft CCL3 is weak. The scores for the occurrence of molybdenum in public water systems were also low for prevalence (9) and magnitude (8). On the other hand and as confirmed by

several other studies, molybdenum is an essential trace element in the human body. IMOA considers that, in this context, molybdenum does not merit EPA prioritisation, and proposes that it not be assigned any further priority at this time.

Wethank you for this opportunity to submit our above comments, and remain at your disposal for further dialogue.

Yours sincerely,Sandra Carey

HSE Executive Kindly direct further correspondence to: sandracarey@imoa.info and Iregoli@imoa.info Tel: + 44 (0) 7778 813721

References:

Koval'skiy, G.A. et al., 1961. Changes of purine metabolism in man and animals under conditions of molybdenum biogeochemical prov inces. Zh. Obshch.Biol. 22: 179-191

Deosthale, Y.G. and C. Gopalan. 1974. The effect of molybdenum levels in sorghum (Sorghum vulgare Pers.) on uric acid and copper excretion in man. Br. J. Nutr. 31: 351-355.

U.S. EPA. 1979. Human health effects of molybdenum in drinking water. Cincinnati, OH. EPA-600A-79-006.

30th Adaptation to Technical Progress, EU Directive 67/548/EEC CS Title: 0092 Company/group/association name: Comment:

Docket ID No. EPA-HQ-OW-2007-1189

Candidate Contaminant List- Cyanobacterial Toxins

Submitted by Ian R. Falconer, Pharmacology, University of Adelaide, South Australia, 5005 and Cooperative Research Centre for Water Quality and Treatment.

There are currently three cyanobacterial toxins listed, thepeptide toxin(s) microcystin(s), and alkaloid toxins

cylindrospermopsin and anatoxin-a.

Microcystins

The W HO issued a Prov isional Guideline Value for microcystin-LR in 1998, and since that time 14 countries have issued similar guidelines. This value was derived from rodent No Observed Adverse Effect Level data, with standard safety factors. In 2006 the International Agency for Research on Cancer (IARC) carried out a rev iew of carcinogenicity data for microcystins, and resolved that microcystin-LR is a 'Possible Carcinogen (class 2B). This was based on an overall review of human epidemiology data, experimental carcinogenicity data and mechanistic data. The most significant element was the data for tumour promotion by microcystin.

While there are substantial gaps in the data for human toxicology of microcystins, the frequency of occurrence in drinking water sources (including in the USA) and human and animal epidemiological data, make these compounds of concern to health. Their variability of removal in water treatment makes assessment of this contaminant essential under circumstances of cyanobacterial contamination of reservoirs.

Attention also needs to be given to contamination of cyanobacterial health food products, which have been shown in many cases to contain microcystins. Appropriate analytical techniques and standards are available.

I recommend that microcystins (in toxicity equivalents to microcystin-LR) be determined to be regulated contaminants, with applicable Maximum Contaminant Levels, in drinking water and 'algal' (cyanobacterial) food supplements.

CylindrospermopsinThe compound came to attention in 1980 after about 150 children

suffered hepatoenteritis following a water-bloom of Cylindrospermopsis raciborskii on the local drinking water

reservoir. The toxin was subsequently isolated and characterized. Since that time it has also been identified as the most abundant cyanotoxin in the Brazilian dialysis poisoning in 1996, in which more than 50 patients died. There are adequate data for rodent toxicity and toxicology, in vitro mechanisms of cytotoxicity and genotoxicity, and limited data on teratogenicity and carcinogenicity of cylindrospermopsin. There is inadequate current data to resolve issues of carcinogenicity. Second species toxicology is absent, though in vitro studies of cell lines derived from different species and organs prov ide a similar pattern of toxicity. This cytotoxic and genotoxic alkaloid was referred to the W HO Chemical Safety Committee in 1998, and to the IARC in 2006. Both bodies resolved that there was insufficient data for resolution at that time.

The toxin is widely distributed in natural and artificial water bodies, and there are appropriate analytical techniques and standards available.

I recommend that this compound be retained on the candidate contaminant list. The National Toxicology Program as a matter of urgency should carry out studies of chronic toxicity and carcinogenicity.

On the basis of the results of these studies, cylindrospermopsin should be evaluated for classification as a regulated contaminant.

Anatoxin-a

The toxicity, toxicology and mechanism of action of this neurotoxin are known.

As far as I am aware there have been no substantiated humanpoisoning events with this toxin. Dogs appear to be vulnerable,

with reports of rapid death following eating of cyanobacterial scum, or dogs licking their contaminated coats. The relatively high dose required for oral toxicity, together with no reported chronic low-dose effects, teratogenicity, or carcinogenicity, indicate that this alkaloid is unlikely to present a challenge to human health from drinking water.

Consumption of cyanobacterial concentrates as health food supplements however may pose a risk if anatoxin-a producing species are used.

I recommend that anatoxin-a be removed from on the Candidate Contaminant List.

References

Toxic Cyanobacteria in Water; a guide to their public health consequences, monitoring and management. Chorus, I and Bartram, J., E & FN Spon, on behalf of W HO, London 1999

Cyanobacterial Toxins of Drinking Water Supplies; cylindrospermopsins and microcystins. Falconer, Ian R., CRC Press, Boca Raton, Fl. 2005

Cyanobacterial Harmful Algal Blooms; state of the science and research needs. Hudnell, H.K., Adv . In Exp. Med. and Biol. 619, Springer 2008

20 May 2008 CS Title: 0095 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3Docket: EPA-HQ-OW-2007-1189

April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that: i) Mycobacterium avium remain on the CCL and that ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water. At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence A recent study from Toronto, Ontario, provides concrete

evidence that the prevalence of pulmonary NTM infections is much higher than prev iously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.

Health Effects As data is not currently collected by the CDC or any otheragency, it is difficult to assess the mortality rates of

pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women. This is in addition to individuals with underlying

vu lnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. I request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.

Sincerely, J. DavisCS Title: 0096

Company/group/association name: Comment:

Docket ID No. EPA-HQ-OW-2007-1189

I am a member of Citizens Concerned About Chloramine, but these are my personal comments.

I am concerned about the possible health effects of chloramine when it is used as a residual disinfectant in drinking water. (By "chloramine", I mean the three inorganic chloramines, namely, monochloramine, dichloramine, and trichloramine.)

---

Chloramine is not on CCL 3: <http://www.epa.gov/OGW DW/ccl/ccl3.html#ccl3> nor is it on PCCL 3 (see Appendix 2 of this document): <http://www.epa.gov/OGW DW/ccl/pdfs/report_ccl3_chemicals_screeni ng.pdf> Was chloramine on the list of 7,500 chemicals from which the PCCL 3 chemicals were selected? Does this list have a name? Is it available online?

According to this document: <http://www.epa.gov/EPA-WATER/2006/October/Day-16/w17099.htm> the deadline for submitting nominations for the universe from which PCCL 3 was subsequently selected was 12-15-06.

At a "stakeholders" meeting of 9-5-07 in San Francisco, which was initiated by Dennis Agatep, from Rep. Anna Eshoo's office, and facilitated by EPA's Jim Vreeland, EPA's Dr. Bruce Macler said that he was working on the CCL 3 list and that it was possible that chloramine would be on the list. Given the status of the 7,500-chemical list as of 9-5-07, was that still a possibility then?---

Hypothetically, is it possible that chloramine could ever appear on a Contaminant Candidate List in the future? Or, for example, is it the case that, by definition, chloramine cannot be a contaminant because it is a residual disinfectant? If so, is there a process -- analogous to the CCL process -- by which EPA determines when to study the possible health effects of residual disinfectants? CS Title: 0098 Company/group/association name: Comment:

Water Docket EPA-HQ-OW-2007-1189 Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Ave., NW . Washington, DC 20460

Re: Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

April 30, 2008

Dear Sir or Madam,

Pursuant to the proposed list of contaminants on the Federal Register, I respectfully request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits .M. avium and related strains of mycobacteria (nontuberculous

mycobacteria, or NTM) are known water contaminants that cause significant lung disease and are associated with significant morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health EffectsAs data is not currently collected by the CDC or any other

agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy).

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on the U.S. population. Pulmonary NTM disease is being diagnosed with increasing frequency across the United States. I request that the EPA continue to monitor M. avium in the water supply and give it a higher score.Thank you for your attention and consideration in this matter.

Sincerely,

Ed Chan, MD Associate Professor of Medicine K720, Goodman Building National Jewish Medical and Research Center 1400 Jackson St Denver, Colorado 80206 Tel: 303-398-1491 Fax: 303-398-1806 e-mail: chane@njc.org CS Title: 0099 Company/group/association name: Comment:

April 29, 2008

Water Docket EPA-HQ-OW-2007-1189 Environmental Protection Agency 1200 Pennsylvania Ave., NWMailcode: 2822T Washington, DC

Dear Gentlemen and Ladies:

As an academic physician working in the field of mycobacterial lung infections for the last 35 years, I am immensely concerned with rapidly increasing numbers of cases due to the nontuberculous mycobacteria (NTM), especially M. avium Complex (MAC).

Due to the absence of systematic surveillance, I cannot quantitate this epidemic. Suffice it to say, the number of new patients being seen by pulmonary and infectious disease specialists across the United States has by description ofthese specialists soared over the past two decades.

Although both men and women are afflicted, recent trends suggest a rising proportion of the morbidity is seen among middle-aged women.

MAC infection requires extended (18 to 24 months) therapy and frequently entails retreatment. Resectional surgery may be employed in the attempt to control the disease.

Preliminary data suggest that MAC may be acquired from our potable water system. Current hygienic practices limit coliform contamination but do nothing to diminish NTM contamination.

It is unthinkable that at this junction the EPA would drop M.

avium from the list of drinking water contaminant candidate list.

If/when the linkage between potable water contamination and this epidemic of MAC lung disease is established this will be a major blemish and embarrassment for the EPA.

Sincerely

Michael D. Iseman, MD Professor of Medicine Division of Mycobacterial and Respiratory Infections

Department of Medicine University of Colorado Health Sciences Center CS Title: 0101 Company/group/association name: Comment:

This comment is related to the manner in which chemicalmobility is ranked in the CCL classification procedure.

Currently, in the CCL classification procedure, pH- independent physicochemical parameters are used to predict chemical mobility in water. The use of pH-dependent physicochemical parameters is more appropriate scientifically. For more information, refer to the document attached.

May 20,2008

Water Docket

U.S. Environmental Protection Agency Mail Code 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

Dear Colleagues:

I am writing to comment on Docket No. EPA-HQ-OW-2007-1189, the Drinking Water Contaminant Candidate List 3 - Draft as published in the Federal Register. Vol. 73, No. 35, February 21, 2008. I suggest a change in the manner in which mobility is ranked in the CCL classification procedure.

I have studied the procedures used by the U.S. Env ironmental Protection Agency to prepare the Drinking Water Contaminant Candidate List under adv isement from the National Drinking Water Advisory Council (NDWAC). I commend you for using a well- conceived, science-based approach when considering the chemical and microbial candidates to be listed in CCL 3. However, there is one aspect of this procedure that I request that you reconsider, that being, the manner in which the mobility scoring hierarchy used to select chemicals for CCL classification was developed, realizing that mobility data comprise but one part of the complex process.

I ask that you consider these aspects of the mobility scoringhierarchy applied in the CCL procedure:

* pH-dependence of the physical properties used to determine chemical mobility is not expressly incorporated into the CCL classification process at present;

* knowledge that drinking water commonly undergoes treatment at pH 7-8 and is distributed between pH 6-9 is important to determining the potential mobility of a chemical; and,

* a "very high" category should be added to the mobility scoring hierarchy in addition to the "low," "medium," and "high" categories included in the CCL classification procedure.

Currently, in the CCL classification procedure, pH-independent physicochemical parameters are used to predict chemical mobility in water (refer to Federal Register. Vol. 73, No. 35, February 21,2008, page 9641). The application of pH-dependent physicochemical parameters is more scientifically correct, especially because many microconstituents in water are ionizable. Converting the CCL mobility score ranking to reliance on pH-dependent parameters instead of pH-independent parameters is an application of the appropriate science. The effect of this change would be that more chemicals, particularly highly hydrophilic chemicals, would be more intensely scrutinized for their potential to be very highly mobile in the environment.

In two publications, I have presented data to substantiate this position:

* M.J.M. Wells. 2006. Log Dow: Key to Understanding and Regulating Wastewater-Derived Contaminants. Environ. Chern., 3:439-449

* M.J.M. Wells. 2007. Examination of the Mobility Scoring Hierarchy Used to Select Chemicals for the U.S. EPA ContaminantCandidate List Classification Procedure [CDROM pp. 86-98].

Proceedings of the Water Environment Federation 2007 Specialty Conference Series. Compounds of Emerging Concern: W hat Is on the Horizon? Providence, RI.

It is not possible to upload these manuscripts to the Docket because they are copyrighted materials..

The character of the ionized chemical forms present in water impacts their mobility. The CCL procedure already recognizes that mobility is important to transport of chemicals in the aquatic environment based on physical properties of the contaminant. Please consider my suggestion that the pH- independent physical properties currently used in the CCL mobility scoring hierarchy are not chemically appropriate for microconstituents that are ionized at the pH of drinking water.

If I can answer questions or supply additional information, please contact me.

Sincerely,

Martha J.M. Wells, Ph.D. Professor, Environmental Chemistry Center for the Management, Utilization, and Protection of Water Resources and Department of Chemistry Tennessee Technological University Box 5033 Cookev ille, TN 38505 Phone: (931)372-6123 FAX: (931)372-6346 Email: mjmwells@tntech.edu CS Title: 0102 Company/group/association name: Comment:

Environmental Protection AgencyDocket ID No. EPA-HQ-OW-2007-1189

Comments submitted by Sierra Club, National Water Committee May 21, 2008

Re: Drinking Water Contaminant Candidate List 3--Draft; Notice Federal Register: February 21, 2008 (Volume 73, Number 35)] [Page 9627-9654]

Dear Sir or Madame:

On behalf of the Sierra Club, please accept these comments on the Drinking Water Contaminant Candidate List 3.

Thank you.

Sincerely your,

Debbie Neustadt, Chair

National Water Committee, Sierra Club

Part I. EXCLUSION OF HEALTH EFFECTS ON IMMUNOSUPPRESSED POPULATION IN PCCL (PRELIMINARY CONTAMINANT CANDIDATE LIST) SCREENING VIOLATES THE SDWA AND IS CONTRARY TO REASONABLE AND DILIGENT ACTION BY US EPA.

According to US EPA, "SDWA refers to several categories of sensitive populations including the following: children and infants, elderly, pregnant women, and persons with a history of serious illness." (US EPA, 2008) However, EPA also states that "Health effects for individuals with marked immunosuppression (e.g., primary or acquired severe immunodeficiency, transplant recipients, individuals undergoing potent cytoreductivetreatments) are not included in this health effects scoring."

(US EPA, 2008)

Individuals with marked immunosuppression qualify as "persons with a history of serious illness," a sensitive population referenced in the SDWA. So, in its screening of microbial contaminant candidates, EPA should have included health effects for individuals with marked immunosuppression. Failure to consider the health effects in this sensitive subpopulation violates the SDWA. .

EPA justifies exclusion of the immunosuppressed subpopulation from the health effects screening by claiming that individuals with marked immunosuppression "often have a higher standard of ongoing health care and protection required" than children and infants, elderly, pregnant women, and persons with a history of serious illness, all of whom are included in the health effects screening. However, the SDWA requires EPA to consider health effects for sensitive persons and makes no provision for disregarding health effects for persons who may require a higher standard of ongoing health care and protection.

Whatever immunosuppressed persons may require in terms of health care and protection, many of them receive no health care. According to Fleming et al. 2002, "Advances in HIV/AIDS treatment have substantially reduced AIDS related morbidity and mortality and extended the lives of many. New treatments, however, are not a cure and do not benefit all people with HIV. An estimated 42% to 59% of people living with HIV/AIDS are not in regular HIV care." Fleming concludes, "The proportion of [HIV] infected persons who know their status is increasing; three-quarters have been diagnosed, but a large proportion may not be in ongoing care." So US EPA's failure to consider the health effects of microbial contaminants on this sensitive population deprives the HIV/AIDs population of equitable consideration for protection from pathogens as prov ided by the SDWA. For the roughly 50% of those suffering HIV/AIDs infection and without regular HIV care, EPA's failure to consider enhancing prevention of infection leaves them without any protection at all.EPA is incorrect in its claim that "nearly all pathogens have

very high health effect scores for the markedly immunosuppressed indiv iduals; therefore there is little differentiation between pathogens based on health effects for the immunosuppressed subpopulation." Certain pathogens tend to plague certain sensitive populations and to pose elevated risks for severe illness and death to those populations. Some of the pathogens listed on the PCCL (preliminary contaminant candidates list) have plagued the HIV/AIDs population while others are not generally considered in the associated medical literature. So in failing to consider the association between certain of the pathogens and the HIV/AIDs population, EPA has failed to include an important factor which would have been useful in determining which pathogens pose a current or emerging health threat to the American public.

Selkir et al., 1997, examined national multicause death certificates to ascertain the impact of HIV on mortality from opportunistic infection. For each opportunistic infection, the percentage of deaths with HIV infection reported as the underlying cause was calculated for toxoplasmosis, cryptosporidiosis/isosporiasis, and for nontuberculous mycobacteriosis. The data prov ided by Selkir indicates that these opportunistic infections are of critical concern to the HIV/AIDs population. We conclude that in failing to consider the health effects of the candidate pathogens on the HIV/AIDs population, EPA disregarded nearly all of the risk posed to the public by these pathogens. As HIV/AIDs patients become infected, antibiotic resistant strains of these pathogens will emerge. So, EPA should have considered which pathogens are known to be presently causing high death rates in the HIV/AIDs population because antibiotic strains of these pathogens are likely to emerge. Preventing infection of the HIV/AIDs population protects the lives of this sensitive subpopulation now and reduces the opportunity for the emergence of antibiotic resistance.

The World Health Organization (W HO, 2008) has assessed the magnitude of the problem of antibiotic resistant Mycobacterium tuberculosis, estimating that about 489,139 cases emerged in 2006, and the global proportion of resistance among all casesis 4.8%. Data indicated that HIV status and drug-resistant TB

are related, "Despite the expansion of HIV testing and treatment globally, only seven countries were able to report drug resistance data disaggregated by HIV status. The two countries with the most robust data both showed a significant association between HIV and MDR-TB. Both of these countries are situated in the former Soviet Union where diagnostic networks for both TB and HIV are relatively well developed."

In conclusion, we urge EPA to revisit the health effects screening so that HIV/AIDs population, women suffering breast cancer, kidney transplant surv ivors, and other immunosupressed indivuals will receive the consideration due them under the SDWA.

Fleming PL, Wortley PM, Karon JM, DeCock KM. 2002. "HIV Prevalence in the United States, 2000", Abstract #11, Oral Abstract Session 5, 9th Conference on Retroviruses and Opportunistic Infections, 2002.

Selik R. M. ; Karon J. M. ; Ward J. W . 1997. Effect of the human immunodeficiency virus epidemic on mortality from opportunistic infections in the United States in 1993., The Journal of infectious diseasesvol. 176(3), pp. 632-636

US EPA. Office of Water. 2008. Contaminant Candidate List 3 Microbes: PCCL to CCL Process Office of Water (4607M) EPA 815- R-08-007 February 2008 page 5-6

WHO. 2008. Anti-Tuberculosis Drug. Resistance In The World. Fourth Global Report.

PART II. INCLUSION OF THE CHOLERA PATHOGEN VIOLATES SDWA STATUATORY REQUIREMENTS FOR INCLUSION ON THE CCL.

Under the SDWA, statutory requirement #2 requires that a candidate contaminant should be known or likely to occur inpublic water systems at a frequency and level of concern. The

cholera pathogen does not meet this requirement. It is not reasonable for EPA to conclude that V. chloera is "known or likely to occur in public water systems at a frequency and level of concern" with the following facts in evidence:

* A cholera epidemic has not occurred in the US in the last hundred years.

* The CDC surveillance data from cases of laboratory-confirmed toxigenic Vibrio chloera between 1995 and 2000 showed 61 cases of cholera, non of them associated with U.S. drinking water. There were 61% of the cases picked up outside the U.S., 23% from undercooked seafood, 2% from a melon contaminated by a food handler, and 8% with no source identified (Steinberg et al.,) . No cases were traced to drinking water.

* No epidemic of cholera occurred when thousands of Americans were literally awash in Gulf Coast waters in the wake of hurricanes Rita and Katrina. The CDC noted that, "No evidence suggests increased risk for cholera among Gulf Coast residents or consumers of Gulf Coast seafood after the hurricanes." (CDC 2006)

Selection of the cholera pathogen also v iolates statutory requirement 3: Does regulation of the contaminant present a meaningful opportunity for health risk reduction for persons

served by public water systems? The causative agent for cholera is killed by the same water treatment which kills E. coli and other common coliform bacteria. Public water systems are already monitored and treated for coliform bacteria. So there is no meaningful opportunity for health risk reduction for persons served by public water systems.

Steinberg EB, Greene KD, Bopp CA, Cameron DN, Wells JG, Mintz ED. Cholera in the United States, 1995-2000: trends at the end of the milennium. J Infect Dis. 2001;184:799-802.CDC. 2006. Editorial note re: Two Cases of Toxigenic Vibrio

cholerae O1 Infection After Hurricanes Katrina and Rita- Louisiana, October 2005 in JAMA. 2006;295:1118-1120. MMW R. 2006;55:31

PART III. INCLUSION OF Salmonella enterica, Shigella sonnei, and E. coli (0157) VIOLATES THE SDWA STATUTORY REQUIREMENTS FOR INCLUSION ON THE CCL.

The SDWA Statutory Requirement 3 requires that the regulation of the contaminant present a meaningful opportunity for health risk reduction for persons served by public water systems. Enteric bacteria are already well-controlled in treated drinking water. Appearance of Salmonella, Shigella, or E. coli occurs when drinking water treatment breaks down or is interrupted, but not due to inadequacy of water treatment methodology. So, further regulation presents no opportunity for health risk reduction for persons served by public water systems.

PART IV. SDWA REGULATION OF Naegleria. fowlerii WOULD BE INADEQUATE AND INEFFECTUAL.

The deaths of children exposed to the pathogenic amoeba N. fowlerii in bathing water are tragic. N. fowlerii only lives in warm water so prohibiting the use of hot source water for drinking water could potentially prevent such deaths. These deaths through exposure to drinking water while bathing are extremely rare, however. The more common route of exposure and death associated with N. fowlerii is through recreational waters such as hot springs. The SDWA does not cover such recreational waters. We urge US EPA to utilize the CWA to issue additional guidance for recreational waters which are warm enough to harbor N. fowlerii. CS Title: 0103 Company/group/association name: Comment:

May 20, 2008Water Docket

Environmental Protection Agency Mail code: 2822T, 1200 Pennsylvania Ave., NW . Washington, DC 20460 USA

Dear Sir or Madam:

Subject: Comments on the US EPA Drinking Water Contaminant Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) Docket ID No.: EPA-HQ-OW-2007-1189

Climax Molybdenum Company (Climax), a subsidiary of Freeport- McMoRan Copper and Gold Inc., presents the following comments on the draft Drinking Water Contaminant List 3 (CCL3) relative to the inclusion of molybdenum in the draft list. W hile there are multiple reasons that the inclusion of molybdenum in the CCL3 is not warranted, Climax believes that the primary reason is that the science behind the reference dose has significant issues that warrant rev isiting. Specifically, the Koval'skiy study that was relied on by EPA in establishing a reference dose of 0.005 mg/Kg is almost 50 years old, has limited value under current scientific protocols, and the conclusions made by this study are not supported by more recent studies.

Detailed Comments

Climax has over the past 25 years maintained an ongoing assessment program of the env ironmental and human health effects of molybdenum. As part of this program and via our membership in the International Molybdenum Association (IMOA) extensive literature studies have been carried out to identify relevant articles and studies that will improve our understanding of the effects of molybdenum compounds on human health and the environment.IMOA is also submitting comments on the draft CCL3 list and

Climax supports those comments and conclusions. Climax concurs with the IMOA submittal, specifically the following statements:

"...IMOA has very recently conducted a thorough review of the

available literature on molybdenum Repeated Dose Toxicity. More than 55 articles (including animal and human studies) have been identified and assessed. Specifically, each study has been thoroughly rev iewed and catergorised based on stringent criteria for reliability and relevancy, and IMOA has identified the available data that can be used for deriv ing a NOAEL for systemic effects after chronic oral exposure. This IMOA review concludes that the NOAEL should be an order of magnitude higher than the level derived in IRIS from in the Koval'skiy et al., 1961 study." Page 2 of the IMOA submittal; and

"Given the substantial concerns about the quality of the Kowal'skiy et al., 1961 study, and the combined evidence from other human health studies, the basis for listing molybdenum on the draft CCL3 is weak. The scores for the occurrence of molybdenum in public water systems were also low for prevalence (9) and magnitude (8). On the other hand and as confirmed by

several other studies, molybdenum is an essential trace element in the human body. IMOA considers that, in this context, molybdenum does not merit EPA prioritisation, and proposes that it not be assigned any further priority at this time." Page 2 of IMOA submittal.

One of IMOA's activities was to review and evaluate each molybdenum related technical study as to the quality of the study, either as a Q1, Q2, or Q3 level. Q1 studies meet currently accepted test designs, analytical protocols, are peer

reviewed, and are considered of high quality. Q1 studies are fully acceptable for proper evaluation and interpretation of

env ironmental and human health effects and would be appropriate for use in establishing regulatory limits. Q3 studies, on the other hand, are seriously flawed and are of very limited use for regulatory guidance or establishment of limits. The sole basis for EPA's establishment of a reference dose for molybdenum under the IRIS system, and that is referenced as support in listing Mo in the CCL3, is derived from theKoval'skiy (1961) study in Armenia. The IMOA expert panel

concluded that this study is a Q3 study and of very limited

value in establishing regulatory limits/guidelines. EPA and the Institute of Medicine both concluded that this study is of marginal value.

Climax is also aware that the National Mining Association (NMA) has submitted comments that address a number of EPA and government sponsored studies that characterize molybdenum content of major drinking water supplies across the United States. Climax concurs with and supports the NMA comments.

Climax Molybdenum Company appreciates your consideration of these comments and if there is any further information or clarification that might be required by EPA, please contact Mr. Kenneth Kloska, Director Env ironmental Services - Global Operations at 303-569-3221 x 1226.

Sincerely,

Kenneth Kloska Director Environmental Services - Global Operations Climax Molybdenum Company CS Title: 0104 Company/group/association name: Comment:

In the United States over 5,000,000 people are diagnosed each year with gastric illnesses, 1,000,000 are hospitalized, 40,000 undergo surgery, and 6,500 die from ulcer related complications. Costs in the United States associated with gastric ulcer disease are estimated at five billion dollars per year.

Recent ev idence of the ability of the viable but non culturable form of H. pylori to resist disinfection along with the significant economic burden of diseases related to this organism warrant its inclusion in the regulatory process.Furthermore, when considering the burden of disease caused by a

microorganism acute or chronic categorization should not be factored into the decision. The decision should be made as a function of risk to the consumer along with the feasibility of controlling such risk.

May 19, 2008

Water Docket EPA/DC EPA West, Room 3334 1301 Constitution Ave. N.W . Washington, DC

Re: Docket ID No. EPA-HQ-OW-2009-1189

[Federal Register: February 21, 2008 (Volume 73, Number 35)] [Notices] [Page 9627-9654]

Dear Sir or Madam:

The following comments are offered in support of the inclusion of Helicobacter pylori (H. pylori) on the third Contaminant Candidate List. Recent evidence of the ability of the viable but non culturable form of H. pylori to resist disinfection along with the significant economic burden of diseases related to this organism warrant its inclusion in the regulatory process. Furthermore, when considering the burden of disease caused by a microorganism acute or chronic categorization should not be factored into the decision. The decision should be made as a function of risk to the consumer along with the feasibility of controlling such risk.

INTRODUCTION

Helicobacter pylori infection is the leading cause of gastricdiseases including gastric inflammation, ulcers,[FN1: Gomes, B.

C. & De Martinis, E. C. P. The significance of Helicobacter pylori in water, food and environmental samples. Food Control 15, 397-403 (2004).] and some forms of stomach cancer [FN2: Dawsey, S. M., Mark, S. D., Taylor, P. R. & Limburg, P. J. Gastric cancer and H pylori. Gut 51, 457-458 (2002).]. Although estimates vary, it is believed that 50% of people in developed countries and 90% of people in developing nations have been infected by this pathogen [FN3: Rolle-Kampczyk, U. E. et al. Well water - one source of Helicobacter pylori colonization. International Journal of Hygiene and Env ironmental Health 207, 363-368 (2004).].

In the United States over 5,000,000 people are diagnosed each year with gastric illnesses, 1,000,000 are hospitalized, 40,000 undergo surgery, and 6,500 die from ulcer related complications [FN4: Degnan, A. J., Sonzogni, W . C. & Standridge, J. H. Development of a Plating Medium for Selection of Helicobacter pylori from Water Samples. Applied and Environmental Microbiology 69, 2914-2918 (2003).]. Costs in the United States associated with gastric ulcer disease are estimated at five billion dollars per year. Consequently, H. pylori infection is a significant public health problem worldwide including the United States.

The difference in prevalence of gastric diseases in developed

versus developing nations has led to the speculation that drinking water has an important role in exposure to H. pylori since developed nations tend to have better water supplies and sanitation. However, the relative significance of drinking water as a route of exposure compared to other routes has not been well defined. Hulten et al.[FN5: Hulten, K., Enroth, H., Nystrom, T. & Engstrand, L. Presence of Helicobacter species DNA in Swedish water. Journal of Applied Microbiology 85, 282-286 (1998).] suggest that the success of H. pylori results from its ability to use multiple transmission routes. They also propose that the success of this bacterium might result from its efficiency in establishing an infection once inside a susceptible host. W hile the issue of host susceptibility is an area that should be pursued by clinical researchers, a clearer understanding of the microbial ecology of H. pylori is paramount to the control of this pathogen.Regulatory Context

In 2000, a Federal Advisory Committee for the Microbial and Disinfectant/Disinfection By-Products Rules was convened under the United States Environmental Protection Agency (USEPA)'s required six year review process. The Committee recommended that the USEPA "evaluate available data and research on aspects of distribution systems that may create risks to public health" [FN6: USEPA. 83015-83024 (Federal Register, December 29, 2000).]. That directive led to a series of expert workshops and panels aimed at understanding risks in drinking water including the establishment of a National Academy of Science Committee that produced the report: Drinking Water Distribution Systems: Assessing and Reducing Risks. The committee concluded that "distribution system ecology is poorly understood...there is

very little information available about the types, activities, and distribution of microorganisms in distribution systems..." and to "more adequately assess risk, more information on the microbial ecology of distribution systems...is needed".

In their 2008 report on Env ironmental and Workplace Health, Health Canada concluded "Further studies are needed to confirm that H. pylori are present in drinking water in a v iable state and that they can be transmitted by this medium."[FN7: anonymous. (Health Canada, 2008).] Helicobacter pylori appropriately appears on USEPA's Contaminant Candidate List (CCL) [FN8: USEPA. 9071-9077 (February 24, 2005).]. Microorganisms are listed on the CCL if they have significant adverse health effects and have been found in drinking water. Both are true of this organism and recent publications regarding the microbial ecology and susceptibility to disinfectants warrants its consideration for regulation.

Identification of H. pylori Infection

The identification of Helicobacter pylori infection can be broadly div ided into four categories [FN9: Mitchell, H. & Megraud, F. Epidemiology and diagnosis of Helicobacter pyloriinfection. Helicobacter 7, 8-16 (2002).]: 1) Microscopic

identification of a biopsy sample that may include a step to culture the organisms and thereby increase the numbers of

recovered organisms. 2) Stool antigen tests or serologic antibody tests. Antibodies are formed in response to an H. pylori infection. 3) The urea breath test for assessing urease (enzyme) activity of H. pylori. This is a non-invasive test in which the subject expels air after ingestion of a test solution containing radio-labeled urea. Helicobacter pylori's prolific production of urease is key to the liberation of ammonia needed to neutralize stomach acid and allow penetration of the mucus and epithelium layers of the gut. 4) Genetic methods for identifying the DNA of H. pylori. The DNA from a sample is amplified in the polymerase chain reaction (PCR) and compared to known DNA of H. pylori. Evolution of PCR methods in clinical settings is proceeding at a rapid pace.

Reports in the literature conflict when defining the "gold standard". Published reports identify either biopsy from endoscopy [FN10: Agreus, L. & Talley, N. J. Dyspepsia: Current understanding and management. Annual Rev iew of Medicine 49, 475-493 (1998).] or the urea breath test [FN11: Pathak, C. M., Bhasin, D. K., Pramod, K. A. & Khanduja, K. L. C-14-urea breath test as a 'Gold Standard' for detection of Helicobacetr pylori infection. Medical Science Monitor 10, LE14-LE15 (2004).] as the "gold standard". However recent reports describe advantages of the stool antigen test as a non-invasive test appropriate for diagnosis in children [FN12: Gisbert, J. P. & Pajares, J. M. Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review. Helicobacter 9, 347-368 (2004).]. In addition to being non-invasive the stool antigen test does not require expensive equipment required for the breath test. Some clinicians prefer the stool antigen test for these reasons and are comfortable selecting one that has a high level of accuracy [FN13: Jacobshon, S. (October 12, 2008).]. For example, the Premier Platinum HpSA (Meridian, Cincinnati, OH) has 91% sensitivity and 93% specificity [FN14: Perry, S. et al. Gastroenteritis and transmission of Helicobacter pylori infection in households. Emerging Infectious Diseases 12, 1701-1708 (2006).].

Occurrence of H. pylori in Source Waters and Drinking WaterPerhaps the reason most epidemiologic studies have not included

env ironmental samples is the difficulty in isolating H. pylori. Helicobacter pylori is microaerophilic, meaning it requires

very low dissolved oxygen levels. W hen transferred from the gut to an oxygen-rich environment the organism converts from its bacillary (rod shaped) form to a coccoid (spherical) form [FN15: Benaissa, M. et al. Changes in Helicobacter pylori ultrastructure and antigens during conversion from the bacillary to the coccoid form. Infection and Immunity 64, 2331-2335 (1996).; FN16: Shahamat, A. et al. Development of two PCR-based techniques for detecting helical and coccoid forms of Helicobacter pylori. Journal of Clinical Microbiology 42, 3613-3619 (2004).]. The coccoid form of H. pylori represents a viable but non-culturable (VBNC) state. Adams et al.[FN17: Adams, B. L., Bates, T. C. & Oliver, J. D. Survival of Helicobacter pylori in a natural freshwater environment. Applied and Env ironmental Microbiology 69, 7462-7466 (2003).] have examined the relationship between culturability of H. pylori and its morphological state in laboratory strains. They were able to show for the first time that environmental isolates exist in all morphological forms (rod, U and cocci) as viable but non-culturable, and suggest that all forms could be infectious. Azevedo et al.[FN18: Azevedo, N. F., Pacheco, A. P., Keevil, C. W . & Vieira, M. J. Nutrient shock and incubation atmosphere influence recovery of culturable Helicobacter pylori from water. Appl Environ Microbiol 70, 490-3 (2004).] posited two reasons for the failure of culture techniques to reveal the presence of H. pylori in drinking water: either the organisms are in fact not there because they have not survived the disinfection procedure or the culture techniques are inadequate to recover the organism. Degnan et al.[FN4: Degnan, A. J., Sonzogni, W . C. & Standridge, J. H. Development of a Plating Medium for Selection of Helicobacter pylori from Water Samples. Applied and Env ironmental Microbiology 69, 2914-2918 (2003).] developed a selective media (HP agar) for culturing H. pylori that is based on inhibiting competing organisms found in natural waters. Unfortunately, the group has recently reported the failure to identify H. pylori in private wells in W isconsin using this agar [FN19: Degnan, A. in Proceedings, AWWA WQTC (AWWA, Quebec City, Quebec, November 9, 2005).].Since such extremely small concentrations of bacteria exist in

drinking water samples a method is required that amplifies their existence. Polymerase chain reaction (PCR) is such a method and has greatly enhanced the identification of microbes in these environments. Recent advances in PCR [FN20: Bunn, J. E. G., MacKay, W . G., Thomas, J. E., Reid, D. C. & Weaver, L. T. Detection of Helicobacter pylori DNA in drinking water biofilms: implications for transmission in early life. Letters in Applied Microbiology 34, 450-454 (2002).; FN21: arbone, M. et al. Occurrence of Helicobacter pylori DNA in the coastal

env ironment of southern Italy (Straits of Messina). Journal of Applied Microbiology 98, 768-774 (2005).] methods including quantitative-(Q)-PCR [FN22: Sen, K. (2007).; FN23: Nayak, A. K. & Bose, J. B. Detection of Helicobacter pylori in sewage and water using a new quantitative PCR method with SYBR (R) green. Journal of Applied Microbiology 103, 1931-1941 (2007).] have allowed for detection of H. pylori in water. Polymerase Chain Reaction has been used for the identification of H. pylori DNA in water sources in developed nations including the United States [FN24: Hegarty, J. P., Dowd, M. T. & Baker, K. H. Occurrence of Helicobacter pylori in surface water in the United States. Journal of Applied Microbiology 87, 697-701 (1999).] England [FN25: Watson, C. L. et al. Detection of Helicobacter pylori by PCR but not culture in water and biofilm samples from drinking water distribution systems in England. Journal of Applied Microbiology 97, 690-698 (2004).], Germany [FN3: Rolle-Kampczyk, U. E. et al. Well water - one source of Helicobacter pylori colonization. International Journal of Hygiene and Env ironmental Health 207, 363-368 (2004).] and Sweden [FN5: Hulten, K., Enroth, H., Nystrom, T. & Engstrand, L. Presence of Helicobacter species DNA in Swedish water. Journal of Applied Microbiology 85, 282-286 (1998).]. In the British study H. pylori DNA was detected by PCR from drinking water and pipe biofilm samples. This confirmation of H. pylori in a municipal drinking water supply in a developed nation highlights the need to investigate the relationship between water system operations (i.e., disinfection practices) and H. pylori viability.

Non-env ironmental routes of exposure have been reported by

various researchers. Malaty et al. [FN26: Malaty, H. M. et al. Evidence from a nine-year birth cohort study in Japan of transmission pathways of Helicobacter pylori infection. Journalof Clinical Microbiology 38, 1971-1973 (2000).] showed that

breastfeeding was protective against H. pylori infection in a study of infants, but Kitagawa et al. [FN27: Kitagawa, M. et al. Maternal transmission of Helicobacter pylori in the perinatal period. Journal of Obstetrics and Gynaecology Research 27, 225-230 (2001).] concluded that if a mother does not wash her nipples and hands prior to breastfeeding the infant might become infected. Sinha et al.[FN28: Sinha, S. K. et al. The incidence of Helicobacter pylori acquisition in children of a Canadian First Nations community and the potential for parent-to-child transmission. Helicobacter 9, 59-68 (2004).] reported that passage from mother to child is associated with the practice of putting a pacifier in the mothers mouth before offering it to the child. Higher rates of infection with H. pylori have been associated with low socioeconomic status (SES) in several studies [FN29: Brown, L. M. et al. Helicobacter pylori infection in rural China: demographic, lifestyle and environmental factors. International Journal of Epidemiology 31, 638-646 (2002).; FN30: Glynn, M. K. et al. Seroincidence of Helicobacter pylori infection in a cohort of rural Bolivian children: Acquisition and analysis of possible risk factors. Clinical Infectious Diseases 35, 1059-1065 (2002).; FN31: Mazari-Hiriart, M. et al. Longitudinal study of microbial diversity and seasonality in the Mexico City metropolitan area water supply system. Applied and Environmental Microbiology 71, 5129-5137 (2005).]. Low socio- economic status is frequently related to density of living conditions and access to safe water. Differences in rates among those in high-density living conditions have been explored in both high and low SES cohorts. Wallace et al. [FN32: Wallace, R. A., Schluter, P. J., Forgan-Smith, R., Wood, R. & Webb, P. A. Diagnosis of Helicobacter pylori infection in adults with intellectual disability. Journal of Clinical Microbiology 41, 4700-4704 (2003).] compared the prevalence of H. pylori infection in institutionalized intellectually disabled adults to intellectually disabled adults who had never been institutionalized and reported twice the infection rate in the institutionalized subjects. The increased prevalence was attributed to high-density living conditions. A large prospective cohort study in Northern California implicated

vomitus as the most significant route of exposure [FN14: Perry, S. et al. Gastroenteritis and transmission of Helicobacter pylori infection in households. Emerging Infectious Diseases 12, 1701-1708 (2006).]. The risk of converting to H. pyloripositive status (by stool or serology) was 4.8 times higher

(adjusted odds ratio 95% CI: 1.4-17.1) if the infected household member had gastroenteritis. The adjusted odds ratio was 6.3 times higher (95% CI: 1.6-24.5) if exposure was to a household member who had gastroenteritis with vomiting compared to being in a household where inhabitants did not have gastroenteritis. The study included low income Hispanic members living in the south San Francisco Bay area. Many of these individuals reside in areas served by an predominantly unfiltered but disinfected water supply. None of these studies investigated drinking water as a route of exposure, or as a confounding variable.

Only a few studies have attempted to attribute the prevalence of H. pylori infection to environmental exposures. A cross- sectional study in 13 villages from Linqu County, Shandong Prov ince, China [FN29: Brown, L. M. et al. Helicobacter pylori infection in rural China: demographic, lifestyle and

env ironmental factors. International Journal of Epidemiology 31, 638-646 (2002).] included 3,288 adults ages 35-69. In this population 1,994 people (61.7%) were infected, 1,019 (31.6%) were uninfected, and the status of 275 (8.5%) could not be determined. Serostatus was used as the measure of H. pylori infection. Prevalence odds ratios were used to compare the odds of being exposed to a factor given the subject was seropositive to the odds of being exposed to a factor given that the subject was seronegative. Exposure was determined by a 15 minute interview in which neither the interviewer nor interviewee knew the serostatus of the subject. W hile this data collection process is subject to recall and reporting biases there is no reason to assume that the biases would be more pronounced in one group over the other. The investigators reported an association between seropositiv ity and low "village education level", being single, sharing a bed with more than 2 people, lack of hand-washing before eating, washing or bathing in a pond or ditch, and source of drinking water. The 13 villages were grouped into three categories referred to as "v illage education level" which was based on the average number of years of schooling village residents as a group had completed. High "village education" level was defined as 3.99-3.83 years (4 villages), medium as 3.74 to 3.37 years (5 villages), and low 3.27-2.32 years (4 v illages). Even with these small differences a strong association was reported for "village education level"and seropositivity, but not on individual's education level and

H. pylori infection. To their credit they point out that a limitation in the study is the homogeneity of the population. The investigators suggest that "village education level" may be a surrogate for cultural practices that may lead to exposure. An association between "v illage education level" and source of drinking water was alluded to but not fully described. No association was reported between H. pylori seropositiv ity and alcohol or tobacco use, raw fruit and vegetable intake, or individual social class measures. The investigators conclusion based on these data is that person-to-person contact is the most likely route for H. pylori infection in this population, but that waterborne exposure should be further investigated. Since the population excluded individuals less than 35 years old, transmission from parent to child could not be assessed. As pointed out in the study, serostatus provides no information regarding duration of the infection. The seropositive subjects in this study may have been infected since childhood. Like most of the epidemiologic studies to date, analyses in the Shandong study were performed at the individual subject level. Associations to factors were based on reported exposure to those factors by the individual for the individual. Environmental samples (including drinking water samples) were not collected.

Only one group has reported analysis of both H. pylori infection and H. pylori in drinking water samples from a public water systems. The widely cited reports of Klein et al.[FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for Helicobacter- Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 (1991).] and Hulten et al.[FN34: Hulten, K. et al. Helicobacter pylori in the drinking water in Peru. Gastroenterology 110, 1031-1035 (1996).] provide the most convincing evidence of drinking water as a route of exposure. They performed urea breath tests on 266 Peruvian children in families of low socioeconomic status and 141 Peruv ian children of high economic status. All children were 2 months to 12 years old. The children lived in households that received either "municipal water" or water from "community wells". "Municipal water" was either delivered by water trucks to 55 gallon drums or 150 gallon cisterns in front of homes in the first town (average annual income US$1,500), v ia pipes that fed taps spaced at 50meter intervals along the streets in the second town (average

annual income US$1,500), piped from a river to internal plumbing in the third town (average annual income US$6,000), or "municipal water" delivered to three towns with an annual

average income greater than US$15,000 [FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for Helicobacter-Pylori Infection in Peruv ian Children. Lancet 337, 1503-1506 (1991).]. Prevalence of H. pylori infection was strongly correlated with the SES of the towns. Prevalence of infection was three times higher for children living in homes without internal plumbing. No information was prov ided regarding the treatment of the systems sources nor distribution system water quality. The more enlightening result was that of the high SES group split into those that received "municipal water" and those that received water from "community wells". "The unadjusted disease incidents [sic] was 37% for municipal water and 4% for community well water; the corresponding odds ratio was 11.4 (p=0.02)" [FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for Helicobacter- Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 (1991).]. The adjusted odds ratio (holding age and sex constant) was 12.8 times higher for "municipal water" then "well water"[FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for Helicobacter-Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 (1991).]. Five years after the epidemiologic study the group was able to test water samples that had been collected and frozen until development of PCR assays [FN34: Hulten, K. et al. Helicobacter pylori in the drinking water in Peru. Gastroenterology 110, 1031-1035 (1996).]. Twenty-four of the 34 water samples tested positive for H. pylori by PCR, all were from systems fed with "municipal water". Klein et al.[F[FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for Helicobacter- Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 (1991).] likened their findings to that of John Snows comparison of cholera incidence in those receiving water from the Southwark and Vauxhall Company versus the Lambeth Company. Two years later Hulten et al.[FN5: Hulten, K., Enroth, H., Nystrom, T. & Engstrand, L. Presence of Helicobacter species DNA in Swedish water. Journal of Applied Microbiology 5, 282-286 (1998).] reported positive identification in 24 private wells and 3 of 24 tap water samples from municipalsupplies in Sweden using PCR methods.

Glynn et al. [FN30: Glynn, M. K. et al. Seroincidence of Helicobacter pylori infection in a cohort of rural Bolivian children: Acquisition and analysis of possible risk factors. Clinical Infectious Diseases 35, 1059-1065 (2002).] considered drinking water quality in a prospective cohort study of Bolivian children. Although not randomized, some children were part of an ongoing project that supplied families with capped plastic water containers and the addition of a chlorine solution to be used in lieu of an open bucket traditionally used to store water. Of 188 children who were seronegative in the first survey, 44 (23%) were seropositive one year later. The investigators speculate that the plastic containers could become infected when cups were dipped into them. Lindkvist et al. [FN35: Lindkvist, P. et al. Helicobacter pylori infection in Ethiopian children: A cohort study. Scandinavian Journal of Infectious Diseases 31, 475-480 (1999).] reported higher seropositiv ity among children in Ethiopia whose families used a well (26/39 [67%]), compared to whose who used the public water system (18/39 [47%]). (Relative risk=1.41; 95% CI 0.94-2.10). This study would have been strengthened by clearer delineation between exposures. Perhaps some children utilized both sources.

Conflicting results leave the significance of person-to-person contact, fecal-oral, gastro-oral, and waterborne routes unresolved. Thus 25 years after identification of H. pylori as the etiologic agent of gastric disease [FN36: Marshall, B. Unidentified Curved Bacilli on Gastric Epithelium in Active Chronic Gastritis. Lancet 1, 1273-1275 (1983).; FN37: Marshall, B. J. & Warren, J. R. Unidentified Curved Bacilli in the Stomach of Patients with Gastritis and Peptic-Ulceration. Lancet 1, 1311-1315 (1984).] there still exists a lack of consensus regarding transmission of this organism. Public health protection measures such as water quality regulations rely on occurrence data [FN38: USEPA. 27486 (Federal Register, June 29, 1989).]. To determine whether drinking water poses a risk of exposure to H. pylori the occurrence of the organism in source waters and drinking water must be known. An understanding of the microbial ecology (optimum growth conditions, including temperature, nutrient requirements, interactions with other organisms, and life cycle), areimportant. Next, the susceptibility of the organism to

treatment and factors that reduce susceptibility to disinfection must be known. Once the microbial ecology and the effectiveness of treatment are understood, strategies for limiting exposure in drinking water (including treatment and operational strategies or regulations) can be applied.

Susceptibility to Drinking Water Treatment

The bacillary (spiral/rod) form of H. pylori is easily killed with chlorine and other disinfectants when dispersed in water, [FN39: Baker, K. H., Hegarty, J. P., Redmond, B., Reed, N. A. & Herson, D. S. Effect of oxidizing disinfectants (chlorine, monochloramine, and ozone) on Helicobacter pylori. Applied and Environmental Microbiology 68, 981-984 (2002).] but some morphological states are not as vulnerable. Moreno et al. [FN40: Moreno, Y. et al. Survival and viability of Helicobacter pylori after inoculation into chlorinated drinking water. Water Research 41, 3490-3496 (2007).] used culture methods and fluorescent in situ hybridization to identify viable but non culturable H. pylori, and Reverse Transciptase-PCR to evaluate the response of cells exposed to chlorine under laboratory conditions. Their results suggest that VBNC H. pylori can

survive disinfection.

CT is the measure of disinfectant effectiveness and is the acronym for disinfectant concentration (C) in milligrams per liter multiplied by contact time (T) in minutes. Johnson et al. [FN41: Johnson, C. H., Rice, E. W . & Reasoner, D. J. Inactivation of Helicobacter pylori by chlorination. Applied and Environmental Microbiology 63, 4969-4970 (1997).] determined CT values for H. pylori in chlorinated drinking water and compared them to CT values for E. coli. For freely dispersed bacteria the value of 0.12 mg*min/liter was calculated for 99% (2 log10) inactivation of H. pylori compared to a CT value of 0.045 mg*min/liter for 2 log10 inactivation of E. coli. Believing that the inactivation rates are actually closer the investigators attributed the discrepancy between the two rates to particulate matter in the H. pylori samples that protected the organisms from disinfection. The authors concluded that the H. pylori CT values would be higher if theorganisms were not protected by particles or biofilms.

Baker et al. also compared the disinfection of H. pylori to E. coli and found it to be more resistant to chlorine even though their samples were washed to remove particulate matter [FN39: Baker, K. H., Hegarty, J. P., Redmond, B., Reed, N. A. & Herson, D. S. Effect of oxidizing disinfectants (chlorine, monochloramine, and ozone) on Helicobacter pylori. Applied and Environmental Microbiology 68, 981-984 (2002).]. They found H. pylori to be more resistant to ozone than E. coli, but equally resistant to chloramine. As with most bacteria, the CT values for 2 log inactivation were highest for chloramine and lowest for ozone. CT values for chloramine were reported to be 9.5 mg*min/liter. Similarly, these investigators include the caveat that disinfection CT values were based on dispersed cells.

Although additional work needs to be done to more completely characterize the susceptibility of the coccoid form of H. pylori as well as biofilm and amoeba-associated bacteria to disinfectants. However, the literature is adequate to indicate that H. pylori should remain on CCL3, and be considered for future regulation to protect the health of drinking water consumers in the United States, it's territories and in Tribal lands.

This letter is being submitted solely as my opinion and may not reflect the opinion of others, with whom I have current or past formal or informal affiliations including the National Academy of Sciences, the USEPA, the American Water Works Association, the Association of Metropolitan Water Agencies, public or private water systems, or the University of California, Berkeley. Please contact me if there are any questions on the information contained in this letter. I appreciate the opportunity to offer these comments.

Sincerely,

Charlotte D. Smith CS Title: 0105Company/group/association name:

Comment:

March 10, 2008 US EPA Drinking Water Quality Ariel Rios Bldg 1200 Pennsylv ia Ave, N.W . Washington, D.C. 20460

Dear Sirs:

It has come to our attention that the drinking water provided by the muninucipalities of Philadelphia, PA and South Jersey are prov iding drinking water contaminated with trace amounts of prescription drugs.

It may be time to require local water companies to remove these drugs and other organic compounds since they have the economies of scale and the incremental costs to consumers may be minimal.

I have written to other appropriate authorities regarding this matter.

Thank you for your consideration in this matter.

Sincerely,

Thomas C Jordan + family 1110 Elena Court Sicklerville, NJ 08081 RNC # (35-662502-6033 CS Title: 0114 Company/group/association name: Comment:THIS SHOULD BE CONSIDERED AS THIS W RITER INDICATES. THE REPORT

IS SOUND. HEALTH IS IMPORTANT AND SHOULD BE THE PRIMARY REASON FOR ACTION. NOT LISTENING TO PROFITEERS. CS Title: 0115 Company/group/association name: Comment:

The USWis submitting its comments on drinking water standards under the Safe Drinking Water Act. USWis concerned with a particular chemical listed on the Contaminant Candidate List, PFOA (perfluorooctanoic acid), as well as another perfluorinated chemical, PFOS (perfluorooctane sulfonic acid).

USWbelieves it is vital to regulate these chemicals through the Safe Drinking Water Act.

Docket: EPA-HQ-OW-2007-1189

Drinking Water Contaminant Candidate List 3

May 21,2008

Please see the enclosed comments regarding the Drinking Water Contaminant Candidate list submitted by the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied-Industrial and Serv ice Workers International Union AFL-CIO/CLC (USW ).

For further information regarding USW's comments please contact either Diane Heminway or Shawn Gilchrist at 412-562-2400.

Diane Heminway Environmental Projects Coordinator USWHealth, Safety and Environment DepartmentShawn Gilchrist

Resource Technician USWSC Global Bargaining Department

Docket: EPA-HQ-OW-2007-1189 Drinking Water Contaminant Candidate List 3

May 21,2008

The United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, AlliedIndustrial and Serv ice Workers International Union AFl-CIO/ClC (USW ) thanks EPA for giving us the opportunity to comment on drinking water standards under the Safe Drinking Water Act. The USWis North America's largest manufacturing union. We represent over 850,000 workers in the U.S. and Canada.

The union is concerned with a particular chemical listed on the Contaminant Candidate List, PFOA (perfluorooctanoic acid), as well as another perfluorinated chemical, PFOS (perfluorooctane sulfonic acid). We are aware of EPA's decision to exclude PFOS from the draft CCl 3, and the agency's willingness to accept comments on that decision.

EPA has long known of human health concerns of PFOS, and its unique ability to bind to proteins, unlike most persistent organic compounds, which accumulate in fatty tissue. Eight years ago, EPA acknowledged that:

"PFOS accumulates to a high degree in humans and animals. It has an estimated half-life of 4 years in humans. It thus appears to combine Persistence, Bioaccumulation, and Toxicity properties to an extraordinary degree."

In addition, citing a 3M rat study, EPA noted:"PFOS caused postnatal deaths (and other developmental effects)

in offspring in a 2-generation reproductive effects rat study (NOAEL of O. 1 mg/kg/day and LOAEL of 0.4 mg/kg/day). At higher doses in this study, all progeny in the first generation died while at the LOAEL many of the progeny from the second generation died. It is very unusual to see such second generation effects." (Source: http://www.chernicalindustryarchives.org/search/pdfs/scotchgard /20000516_226-0629.pdf

Further, PFOS has been of great interest to the Organisation for Economic Cooperation and Development (OECD) who, in 2006, made strong recommendations for industry and government to monitor the impact of PFOS. (Source: http://www.olis.oecd.org/olis/2007doc.nsf/LinkTo/NT00002AB6/$FI LE/JT03229256.PDF)

While it is presently ubiquitous in the environment, the threat of exposure is likely to increase as consumers dispose of household products containing PFOS. In turn, it is reasonable to anticipate that PFOS will continue to accumulate in the

env ironment, including in ground and surface water, aquatic biota and humans. Although PFOS is no longer being manufactured, its persistence, and bio-accumulative and toxic properties warrant careful monitoring and regulation.

The EPA is well aware of the numerous studies documenting the exposures and dangers of PFOA. Although DuPont, currently the only major U.S. producer of PFOA, continues to claim that there is no proof that PFOA causes harm to human health, evidence to the contrary continues to mount, such as:

* EPA's Science Adv isory Board identifies PFOA as a "likely" human carcinogen. (Source: Washington Post; Compound in Teflon a "likely carcinogen;" Juliet Eilperin; June 29, 2005)

* Researchers found PFOA and PFOS in the umbilical cord blood of children indicating that these chemicals cross the placenta between mother and child. (Source: Environmental WorkingGroup/Commonweal, Body Burden Study- The Pollution in Newborns,

Executive Summary; July 14, 2005)

* The Centers for Disease Control and John Hopkins University have reported health impacts in newborn babies such as low birth weight and reduced head circumference. (Source: Possible Etiologies of PFAA-Induced Developmental Effects: Reflections from a Pediatric Perspective; Johns Hopkins University, Baltimore, MD; U.S. Centers for Disease Control and Prevention)

* PFOA has been found in the breast milk of nursing mothers, and has been found in children between the ages of 2 and 12 at blood levels similar to those found in adults. (Source: Study conducted by Kathleen Arcaro of the University of Massachusetts Amherst-results are scheduled for publication in Env ironmental Science and Technology ( http://www.umass.edu/loop/talkingpoints/articles/74700.php); other breast milk studies reported in February and May 2007 Issue of Environmental Health Perspectives)

* A study by the National Institute for Occupational Safety and Health has shown that PFOA may prime the immune system to

overreact to allergens in mice. (Source: Toxicological Sciences, DOI: 10.1093/toxsci/kfm053; From Issue 2609 of New Scientist magazine, page 14; June 25, 2007)

* Researchers at the University of Pennsylvania School of Medicine found PFOA to be present in about 96 percent of the U.S. population, tending to accumulate within the body. (Source: Today's Sunbeam; DuPont reports PFOA testing; Randall Clark; May 07, 2008)

* Exposure to PFOA may be associated with changes in liver and immune function, as well as higher cholesterol levels in children. In May 2008, the preliminary results of a study of PFOA's possible impacts on the health of nearly 70,000 residents in the mid-Ohio Valley were released. The study examined the potential health impacts of PFOA released from DuPont's Washington Works plant south of Parkersburg, WestVirginia. Previous studies of workers exposed to PFOA revealed

elevated levels of kidney cancer, heart disease and diabetes. (Source: AScribe Newswire; Big Study of Teflon Chemical in People Suggests Harm to Immune System, Liver, Thyroid; May 13, 2008; www.hsc.wvu.edu/som/cmed/ophp/grandRoundsWebcast.asp)

USWrepresents 1,600 members at six DuPont facilities. We first became active in PFOA issues over three years ago. USWhas tested the blood of some of our DuPont members and retirees at the Chambers Works facility in Pennsville, New Jersey and discovered exposure levels in some individuals to be hundreds of times higher than those found in the general public.

Studies have shown that some workers exposed to perfluorinated chemicals (PFCs) are more prone to prostate and bladder cancer and experience higher than normal levels of cholesterol - a risk factor for heart attack and stroke. (Source: Minneapolis Star Tribune; Death rate up for 3M workers exposed to PFOA; Tom Meersman; March 5, 2008

Numerous samples of surface water and drinking water supplies taken by the USWand others have revealed the presence of PFOA, PFOS and other PFCs. The PFCs being found in drinking water supplies are also found in the blood of the general population as reported by the Centers for Disease Control and Prevention. The agency found 11 polyfluoroalkyl compounds, including perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and perfluorohexane sulfonic acid (PFHxS) in 1562 serum samples collected from a representative U.S. population 12 years of age and older in the 1999-2000 National Health and Nutrition Examination Survey. (Source: Division of Laboratory Sciences, National Center for Env ironmental Health, Centers for Disease Control and Prevention, Abstract Received for review November 9, 2006, Revised manuscript received January 31, 2007, Accepted February 2,2007)

USWbelieves that the EPA must determine nation-wide regulations to protect the public from further exposure to PFOA and PFOS. States, such as Minnesota, North Carolina and New Jersey have instituted their own standards or guidelines forone or both PFCs. For example, after finding widespread

contamination of drinking water supplies in the state, the NJDEP set a safe drinking water guidance value of .04 parts per billion for PFOA. (Source: http://www.state.nj.us/dep/watersupply/pfoa.htm)

PFOA makes its way into products and downstream industries further exacerbating the contamination of people and the

env ironment. DuPont and other companies promised EPA they would reduce and eventually eliminate PFOA use and manufacture via the 2010/2015 PFOA Stewardship Program. Unfortunately, DuPont refuses to make public verifiable annual PFOA production amounts. Recent test results of wells conducted by DuPont near its Chambers Works, NJ facility show levels of PFOA that exceed the NJDEP guidance level. (Source: Today's Sunbeam; DuPont reports PFOA testing, Randall Clark; May 07,2008)

The 2010/2015 PFOA Stewardship Program is voluntary. We have little faith this program will achieve its goals, nor will it assure the protection of public water supplies. USWbelieves

voluntary promises are not a substitute for much needed regulation and accountability. Therefore, it is vital to regulate PFOA through the Safe Drinking Water Act. CS Title: 0116 Company/group/association name: Comment:

May 21, 2008

Water Docket Docket ID No. EPA-HQ-OW-2007-1189 U. S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

To W hom It May Concern:Thank you for the opportunity to provide comment on the draft

third Contaminant Candidate List (CCL3) as published in the February 21, 2008 Federal Register. We have reviewed the proposed list and offer the comments found in the attachment.

Wehope EPA will carefully consider our comments and provide a final CCL3 that will lead to sound decisions in the regulatory development process.

Sincerely,

Mark S. Mayer, P.E. Natural Resources Administrator SD Drinking Water Program

Attachment

Attachment

Comments on the third Contaminant Candidate List (CCL3) by South Dakota Department of Environment and Natural Resources (DENR)

Overall, we support the proposed CCL3 process and EPA's efforts to increase public health protection. We do, however, offer the following comments noted below.

Specific Comments:

* Pharmaceuticals and Personal Care Products: Although this issue is not new, in light of the recent media attention, we feel it is important to develop the science necessary to make sound decisions when regulating these compounds. We also feel that scientific study focused in this area will assist us in answering questions in this area from consumers. We do notsupport efforts to regulate through legislation in lieu of a

scientific based approach as outlined in the 1996 Safe Drinking Water Act amendments. Furthermore, we support efforts made to reduce these compounds from the source rather than add costly and complex treatment systems to address an issue that may more easily be impacted through proper handling and disposal.

* Synergistic Effects: The current health effects information on Maximum Recommended Daily Doses is derived based on the effects of single compounds. We support efforts to look at the cumulative and synergistic effects of these compounds in addition to the current process.

* CCL Process: South Dakota has limited staff resources to study issues related to development of standards for various drinking water contaminants. We therefore rely on the scientific studies conducted by EPA and other partners in developing standards and regulatory determinations. Recognizing that we all operate in a resource constrained env ironment, we feel the CCL process is an important step in regulatory determinations and should be used to prioritize those contaminants that pose the greatest risk to public health. CS Title: 0119 Company/group/association name: Comment:

METOLACHLOR TASK FORCE (Agan Chemical Manufacturers, Ltd., Drexel Chemical Co. and Sipcam Agro USA, Inc.)

May 20, 2008

Water Docket U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, N.W . Washington, D.C. 20460Dear Sir or Madam:

SUBJECT: Docket ID No. EPA-HQ-OW-2007-1189

The Metolachlor Task Force (EPA Company Number 75008) wishes to make the following comments on two metolachlor metabolites listed on your Draft Contaminant List 3, Federal Register, Volume 73, No. 35, page 9633, February 21, 2008. Specifically, these two are:

Metolachlor ethanesulfonic acid (ESA) CASRN: 171118-09-5

Metolachlor oxanilic acid (OA) CASRN: 152019-73-3

The Health Effects Division has reviewed the following toxicology studies (each performed by Oak Ridge National Laboratories), and found them acceptable. These studies are Developmental Toxicity and Subchronic Oral Toxicity studies on the two metabolites. Results for each were:

Developmental Rat for ESA, MRID No. 44931711: No signs of maternal or fetal toxicity No ev idence of teratogenicity Maternal toxicity NOAEL is >= 1000 mg/kg/day

Developmental Rat for OA, MRID No. 44929510: Maternal Toxicity NOEL = 100 mg/day No ev idence of teratogenicity Maternal toxicity NOAEL is >= 1000 mg/kg/day

Subchronic Oral Toxicity Rat (ESA), MRID No. 44931710: NOAEL is >= 20,000 ppm NOEL is >= 6,000 ppm

Subchronic Oral Toxicity Rat (OA), MRID No. 44929509:NOAEL is >= 15,000 ppm

Subchronic Oral Toxicity Dog (ESA), MRID No. 44931709: NOAEL is >= 1,000 mg/kd/day

These toxicological results indicate that these two metolachlor metabolites are not teratogenic and are relatively non-toxic to rats and to the dog (ESA).

Further, an additional study, MRID No. 44931716, a bile cannulation study with ESA, demonstrated that ESA was not absorbed. Therefore, there is no risk associated with ESA in this regard.

The presence of these two metabolites in water is clearly an indication of the prior presence of metolachlor. We believe that it is misleading to list these without also indicating that these two metabolites are relatively non-toxic. The presence of these two metabolites in water does not constitute a toxicological concern and this should be clearly stated. Since there is no toxicological concern, it is not clear why, simply because they are present, they should be on the List.

Our point is simply that the mere presence of these metabolites in water, which pose no toxicological concern, does not warrant inclusion on a list which implies "contaminants" of concern nor inclusion in regulations under the Safe Drinking Water Act.

Sincerely,

E. M. Bellet Technical Manager Metolachlor Task Force 16160 Nall Stilwell, Kansas 66085 CS Title: 0120 Company/group/association name: Comment:Since the Contaminant Candidate List process began about 10

years ago, none of the contaminants included on the two prior Contaminant Candidate Lists have been adopted by the United States Environmental Protection Agency (USEPA) as National Primary Drinking Water Regulations. The NJDEP is very concerned about this practice since many of the contaminants on the past Contaminant Candidate Lists, as well as many of the contaminants on the present CCL3, both occur widely in drinking water and have health effects of potential concern. The health effects data for many of these chemicals are extensive and complicated. For such chemicals, the risk assessment involves a large amount of time and effort. Most states have limited resources as far as risk assessment and cannot address all chemicals of concern in drinking water without assistance from USEPA. We urge USEPA to use its vast resources to address such chemicals by regulating when appropriate, rather than simply determining that every chemical evaluated does not need regulation. Our comments focus on four chemicals of concern to New Jersey: PFOA, 1,2,3-trichloropropane, MTBE, and perchlorate.

May 21, 2008

Water Docket Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave, NW Washington, DC 20460

RE: Docket ID No. EPA-HQ-OW-2007-1189 Drinking Water Contaminant Candidate List 3--Draft (Federal Register:February 21, 2008, Volume 73, Number 35, p. 9627-9654, DOCID:fr21fe08-134)

To W hom It May Concern:

In response to Federal Register notice of the February 21, 2008, the New Jersey Department of Environmental Protection(NJDEP) is pleased to comment on the Draft Contaminant

Candidate List 3 (CCL3). Our comments focus on four chemicals of concern to New Jersey: PFOA, 1,2,3-trichloropropane, MTBE, and perchlorate.

General Comments

Section 1412(b) (1) of the federal Safe Drinking Water Act (SDWA), as amended in 1996, requires USEPA to publish the Contaminant Candidate List every five years. The SDWA specifies that the list must include contaminants that are not subject to any proposed or promulgated National Primary Drinking Water Regulations, are known or anticipated to occur in public water systems (PWSs), and may require regulation under SDWA. The 1996 SDWA Amendments also specify three criteria to determine whether a contaminant may require regulation: 1) the contaminant may have an adverse effect on the health of persons; 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) 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.

Since the Contaminant Candidate List process began about 10 years ago, none of the contaminants included on the two prior Contaminant Candidate Lists have been adopted by the United States Environmental Protection Agency (USEPA) as National Primary Drinking Water Regulations. The NJDEP is very concerned about this practice since many of the contaminants on the past Contaminant Candidate Lists, as well as many of the contaminants on the present CCL3, both occur widely in drinking water and have health effects of potential concern. The health effects data for many of these chemicals are extensive and complicated. For such chemicals, the risk assessment involves a large amount of time and effort. Most states have limited resources as far as risk assessment and cannot address all chemicals of concern in drinking water without assistance from USEPA. We urge USEPA to use its vast resources to address such chemicals by regulating when appropriate, rather than simplydetermining that every chemical evaluated does not need

regulation.

Specific Contaminants of Concern to New Jersey

Perfluorooctanoic acid (PFOA)

PFOA is a chemical of concern in drinking water, which NJDEP strongly urges USEPA to address, as discussed below. It is well known that drinking water has been contaminated by PFOA from point sources, such as the Ohio and West Virginia area contaminated by the DuPont Washington Works facility in Parkersburg, West Virginia and the several sites contaminated by 3M in Minnesota. However, it is also important to recognize that the lower levels of PFOA found in drinking water not impacted by a known point source may also result in health effects of concern.

As discussed below, it appears that health-based drinking water concentrations developed using a very conservative approach involving application of standard uncertainty factors for Reference Dose development, as well as animal-to-human extrapolation based on blood levels instead of administered dose, do not protect against health effects in the human population.

New Jersey Occurrence Information

In 2006, NJDEP conducted a small statewide PFOA and perfluorooctane sulfonic acid (PFOS) occurrence study (NJDEP, 2007a). Twenty-nine samples from twenty-three ground and surface water systems were collected in various areas throughout the state. STL Denver, the only laboratory certified by NJDEP for PFOA, conducted the analysis. The detection limit was 0.001 ug/L and the quantitation limit was 0.004 ug/L. Samples consisted of raw groundwater and surface waters, as well as samples of finished water. PFOA was found in raw and treated surface water, and raw and treated ground water fromunconfined wells.

The data from the occurrence study show levels of PFOA from 0.003 ug/L, a level that is detected but not quantified to 0.039 ug/L. PFOA was detected and quantified at 65% of the 23 systems sampled. If the samples where PFOA was detected but was not quantifiable are included, PFOA was found in 78% of the systems sampled.

NJDEP is continuing to sample at water systems where PFOA was detected. In this follow-up sampling, PFOA was detected at four water systems at or above 0.04 ug/L (the NJDEP health-based drinking water guidance level, discussed below). The highest concentration was measured at systems with no known point source of PFOA was 0.069 ug/L.

Significance of Drinking Water Exposure to Human Body Burden

Although these drinking water concentrations of PFOA are relatively low, they may contribute significantly to the body burden of PFOA in the general population (Post et al., 2007). The average blood concentration of PFOA in the general population is approximately 5 ug/L and the 90th percentile is 9.4 ug/L (USEPA, 2005a).

A study of a community whose drinking water was contaminated with PFOA showed that, on average, ingestion of water with a given PFOA concentration results in a blood concentration 100- fold higher (Emmett et al., 2006). Similar results are predicted by modeling done by Gray (2005) and Hinderliter and Jepson (2001). For example, ingestion of drinking water with 0.03 ug/L PFOA would be expected to contribute about 3 ug/L to the blood concentration of PFOA. Therefore, the contribution to total human exposure of PFOA in drinking water at levels below 0.1 ug/L may be significant.

Toxicology and Risk AssessmentNew Jersey Health-based Drinking Water Guidance

In 2007, NJDEP developed a health-based drinking water guidance for PFOA of 0.04 ug/L in response to a request from a New Jersey water supply with detections of up to 0.19 ug/L in its wells, located near a point source of PFOA (NJDEP, 2007b).

The NJDEP health-based drinking water guidance is based on the endpoints identified by USEPA (2005a) in its draft PFOA risk assessment. Since the half life of PFOA is much longer in humans than in the experimental animals used in the studies, the risk assessment was based on blood levels of PFOA rather than administered doses of PFOA. This approach was recommended by the USEPA Science Advisory Board (USEPA, 2006a). Appropriate uncertainty factors and a Relative Source Contribution factor were applied to the blood levels in the animal studies at the NOAELs and LOAELs identified by USEPA to determine target human blood levels. A similar approach was used for the cancer endpoint to determine the blood level at the 10-6 risk level. The 100:1 blood/drinking water concentration factor observed by Emmett et al. (2006) was used to determine drinking water concentrations anticipated to result in the target blood levels.

The most sensitive endpoints, resulting in a health-based drinking water concentration of 0.04 ug/L, were body weight and hematological changes in a chronic study of adult female rats. The drinking water concentrations based on endpoints from

several other studies were very close to 0.04 ug/L (adult male rat - 0.08 ug/L, cynomolgus monkey - 0.05 ug/L, pregnant female rat - 0.07 ug/L, carcinogenicity in male rats at 10-6 risk level - 0.06 ug/L).

The USEPA (2005a) draft risk assessment did not consider more recent studies, which reveal additional effects of PFOA of serious concern, as discussed below.

Recent mouse developmental dataThe developmental data considered by USEPA (2005a) were from

rat studies. The rat is not a good model for developmental effects of PFOA because the half-life of PFOA in female rats is

very short (2-4 hours), so that steady state is never reached with daily dosing, and the fetus receives minimal exposure. In contrast, PFOA has a longer half-life in female mice, resulting in a higher steady state blood level and greater exposure to the fetus. Recent mouse developmental studies, reviewed by Lau et al. (2007), have revealed effects resulting from prenatal exposure including post-natal mortality, decreased birth weight, delayed post-natal growth and development, obesity at 18 months of age, and inhibition of mammary gland development.

Recent data on mechanism of liver carcinogenicity

Very recent new data shed light on the relevance of the positive carcinogenicity studies in rats to PFOA's human carcinogenic potential, which has been a subject of ongoing controversy.

PFOA was found to induce liver adenomas, Leydig cell adenomas, and pancreatic acinar cell tumors in male Sprague-Dawley rats and mammary cell fibroadenomas in female rats, although USEPA (2005a) questioned the significance of the mammary tumors compared to historical background incidences. USEPA (2005a) interpreted the liver, Leydig cell, and pancreatic acinar cell tumors as constituting a "tumor triad" known to be caused by a class of chemicals which are peroxisome proliferator-activated receptor-alpha (PPAR-a) agonists. USEPA (2005a) states that the relevance to humans of tumors caused by this group of chemicals is uncertain. Additionally, they state that there are no adequate human studies of PFOAs carcinogenic potential since the occupationally exposed cohorts are still quite young. Based upon this, USEPA (2005a) concluded that PFOA was best described as having "suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential".

The USEPA Science Advisory Board (2006a) disagreed with USEPA(2005a) as to the most appropriate descriptor for the

carcinogenicity of PFOA. They concluded that the PFOA cancer data are consistent with the USEPA cancer guidelines descriptor "likely to be carcinogenic to humans" which applies to chemicals which have been shown to cause tumors in more than one species, sex, strain, site, or exposure route, regardless of the existence of evidence in humans. Most Science Advisory Board panel members felt that the animal data are much stronger than the type of data which would warrant a "suggestive" descriptor. This conclusion was based on the following: 1) existence of two positive cancer studies in animals for PFOA, 2) data suggesting that PPAR-a activation may not be the sole mechanism of liver carcinogenesis (discussed above in regard to liver toxicity of PFOA), 3) disagreement about the appropriateness of comparison to historical controls rather than concurrent controls in evaluating the mammary tumor date, and 4) disagreement about the USEPA (2005a) assumptions about the mode of action for the Leydig cell and pancreatic acinar cell being related to PPAR-alpha agonist activ ity, and the USEPA comparison of mammary tumors to historical, rather than concurrent, controls.

A new study (Tilton et al., 2008) suggests that PFOA promotes liver tumors in rainbow trout by a mechanism independent of PPAR-alpha and peroxisome proliferation. The rainbow trout has been used as a model for chemically induced liver cancer in humans for over 40 years, and, like humans, is insensitive to liver toxicity through peroxisome proliferation. PFOA was shown to enhance liver carcinogenesis post-initiation through an estrogenic mechanism independent of peroxisome proliferation, which may be relevant to human carcinogenic potential.

Recent human birth weight and clinical effects at very low exposures

Recent human data suggest effects in humans at blood levels of PFOA typical of the general population, orders of magnitude below effect levels seen in animal studies.

Several studies associating PFOA blood levels in the generalpopulation with effects on birth weight and other fetal growth

indicators (ponderal index, head circumference, and birth length) have been published (Apelberg et al., 2007; Fei et al. 2007; Fei et al., 2008). The effects observed within the general population are of a very large magnitude. For example, in a study of 1400 Danish mothers and their infants (Fei et al., 2007), the largest decrease in mean birth weight, 126 g, was seen between the lowest quartile for PFOA in maternal blood (3.91 ug/L or below) and the second quartile (3.91-5.20 ug/L). The decrease in mean birth weight between the lowest quartile (less than 3.91 ug/L and the highest quartile (6.97 ug/L and above) was 175 g. No association between birth weight and PFOS blood levels was observed.

Additionally, recent preliminary data from a study of approximately 70,000 Ohio and West Virginia residents exposed to PFOA in their drinking water at levels from 0.05 ug/L to 3 ug/L or higher suggest an association between several clinical parameters and exposure to PFOA. Apparent effects are seen at blood levels orders of magnitude below the blood levels at which effects have been seen in animals (Frisbee, 2008). The effects involved include decreased C-reactive protein (an indicator of inflammation), decreased immunoglobulin G, increases in two liver enzymes (SGPT and SGOT), increased cholesterol in children, and effects on thyroxine levels. These effects are consistent with the known toxicity of PFOA from animal and/or human occupational studies, as rev iewed by Lau et al. (2007), as PFOA is known to produce liver toxicity, suppress the immune system, and suppress inflammatory response in animal studies, and has been observed to increase thyroid hormone and cholesterol levels in occupational studies.

In this study, the study population was divided into deciles based on PFOA blood levels, with about 6700 people in each group. The mean blood levels for each decile is shown below (S. Frisbee, personal communication):

Decile Mean PFOA Blood Level (ug/L) 1 5.65 2 9.80 3 13.474 18.06

5 24.28 6 33.26 7 47.44 8 71.33 9 124.11 10 482.33

The PFOA levels in the first decile and the second decile are almost identical to the mean and the 90th percentiles in the United States population. No threshold was apparent for a number of the observed effects in human populations, both for the birth weight study (Fei et al., 2007) and for clinical parameters (C-8 reactive protein, liver enzymes, and increased cholesterol in children), and effects appear to occur down to the lowest exposure groups, which are in the range of the mean concentration general population.

Effects are seen well below the blood levels derived by applying conservative uncertainty factors to animal data by NJDEP (2007b); the blood level for the most sensitive effect thus derived was 18 ug/L.

Recommendation

As discussed above, it appears that health-based drinking water concentration for PFOA developed using a very conservative approach involving application of standard uncertainty factors for Reference Dose development, as well as animal-to-human extrapolation based on blood levels instead of administered dose, is not protective against health effects in the human population. Because humans appear to be so sensitive to PFOA's effects and PFOA appears to occur ubiquitously in drinking water, based on New Jersey and other data, it is important that exposure to PFOA through drinking water be appropriately limited through MCL development.

1,2,3-Trichloropropane1,2,3-Trichloropropane (1,2,3-TCP) is a chemical of concern in

drinking water, which NJDEP strongly urges USEPA to address. 1,2,3-TCP is a potent genotoxic carcinogen which occurs in drinking water at levels resulting in significant cancer risk based on test results from New Jersey public and non-public water supplies. Currently, USEPA does not prov ide any information as to 1,2,3-TCP's carcinogenicity on its 2006 USEPA Office of Water Drinking Water Regulations and Health Advisory Table (USEPA, 2006b). Instead, it provides a Lifetime Health Advisory which results in a lifetime cancer risk of 4 x 10-3 to 3 x 10-2, based on available slope factors. This information, which is not protective of public health, has been used by

several states to develop drinking water and groundwater guidance for 1,2,3-TCP, as the basis for evaluating situations of drinking water and groundwater contamination, etc. Therefore, NJDEP strongly urges USEPA to provide appropriate public health protective information in its Drinking Water Regulations and Health Adv isory Table and to develop an MCL for 1,23-trichloropropane.

Uses

1,2,3-TCP is a known contaminant of nematocides and soil fumigants including D-D (NTP, 2005) (1,2-dichloropropane and 1,3-dichloropropene [mixed isomers] ) and Telone (1,3- dichloropropene). Telone has been reported to contain up to 0.17% 1,2,3-TCP by weight (W HO, 2003). This is thought to be the source of 1,2,3-TCP contamination of rural wells in New Jersey and other locations. W hen 1,2,3-TCP was detected in Galloway Township, Atlantic County, New Jersey, in 1999, three other chemicals were also found at the sampling sites: dibromochloropropane, 1,2-dichloropropane, and ethylene dibromide. The occurrence of 1,2,3-TCP is discussed in more detail.

1,2,3-TCP was extensively used in the past as a solvent, cleaning and degreasing agent, and paint and varnish remover. It is used as intermediate in the synthesis of several organic compounds including polysulfone liquid polymers, dichloropropene, hexafluorpropylene, and polysulfides (NTP,2005).

1,2,3-TCP is a byproduct produced in significant quantities in the manufacture of other chlorinated compounds, including epichlorohydrin. It is listed as a component which is present at greater than 0.01% (a reporting threshold) on the Right to Know lists of New Jersey, Pennsylvania, and Massachusettes, as well as the California Proposition 65 list. According to the SPI Epichlorohydrin Task Force, the majority of 1,2,3-TCP produced as a byproduct of epichlorohydrin production today is incinerated on-site (W HO, 2003). 1,2,3-TCP is also a byproduct of dichloropropene, propylene dichlorohydrin, dichlorohydrin, and glycerol (NTP, 2005).

A polymer used as a coagulant in the treatment of potable water and wastewater is produced by reacting epichlorohydrin with dimethylamine. Epichlorohydrin is a known contaminant of these polymers, and is likely to be present in finished drinking water due to its use in the coatings of drinking water pipes (USEPA, 1985). Since 1,2,3-trichloropropane is a contaminant in epichlorohydrin, it might also be present in drinking water, especially since 1,2,3-trichloropropane is more stable in water than epichlorohydrin.

An NSF International (2000) report prepared for Health Canada on impurities in drinking water treatment, 1,2,3-TCP was identified as a contaminant in an unidentified well drilling aid. However, the Action Level (target drinking water level based on health effects) used by Health Canada was 5 ug/L, which is much higher than the health based drinking water level or practical quantitation limit (see below).

A health-based drinking water guidance of 0.005 ug/L was developed by NJDEP in 1999 based upon the 10-6 risk level and the slope factor of 7 (mg/kg/day)-1 in the USEPA HEAST (1995) tables. This slope factor was based on the combined incidence of benign and malignant tumors at various sites in rats. Standard exposure factors for body weight (70 kg) and drinking water ingestion (2 L/day) were used. The New Jersey Drinking Water Quality Institute is currently in the process ofrecommending a Maximum Contaminant Level (MCL) to NJDEP for

1,2,3-TCP for possible standard setting. A more complete explanation of the risk assessment is presented below.

Occurrence

1,2,3-Trichloropropane has been found in both public water supplies (including in USEPA Unregulated Contaminant Monitoring) and private wells. As discussed above, it is known to be present in soil fumigants including D-D (mixed isomers of 1,2-dichloropropane and 1,3-dichloropropene) and Telone (1,3- dichloropropene), and there are also other potential sources of contamination. Because the health-based drinking water concentration (at the10-6 risk level) for 1,2,3- trichloropropane is so low (see below), less sensitive analytical methods will miss occurrences at levels of concern, and reporting limits given by each state for the UCMR Round 1 monitoring ranged from 0.5 ug/L to 5 ug/L.

In 2005, NJDEP conducted a rev iew of occurrence of 1,2,3- trichloropropane in New Jersey drinking waters. 1,2,3- Trichloropropane was detected at levels above the health-based drinking water guidance developed by NJDEP of 0.005 ug/L (see below) in 30 of the 2,640 private wells (1.1%) sampled during contaminated site investigations overseen by NJDEP s Site Remediation Program between 1999 and 2004. In addition, as part of NJDEP s Synthetic Organic Compound (SOC) Waiver Program sampling, 1,2,3-trichloropropane was detected at levels above the health-based drinking water guidance of 0.005 ug/L developed by NJDEP in 11 of approximately 260 community water systems (4%) sampled between 1999 and 2004.

In unregulated contaminant monitoring in California from 1989 through the 1990s, fewer than 20 sources reported detections, reflecting the less sensitive analytical methods available at that time, with a reporting limit of 0.5 μg/L. However, more recent monitoring in California with a more sensitive analytical method reported 1,2,3-trichloropropane detections in 303 sources, at levels up to 57 μg/L. Of the 303 detections, 2 were below 0.005 ug/L, 171 between 0.005 and 0.05 ug/L, 104between 0.05 and 0.5 ug/L, 20 between 0.5 and 5 ug/L, 4 between

5 and 50 ug/L, and 1 above 50 ug/L. This dataset is not yet complete (CDPH, 2007).

California Department of Public Health (CDPH, 2007) states on its fact sheet that the primary possible contaminating activity for 1,2,3-TCP in drinking water appears to be hazardous waste sites. No further justification is given for this statement.

1,2,3-Trichloropropane is the main contaminant at a Superfund site, MacKenzie Chemical Works in Suffolk County, New York (ATSDR, 2004). ATSDR conducted an evaluation of this site in 2004, and used New York's MCL of 5 ug/L to evaluate the significance of the contamination. (5 ug/L is New York's MCL for Principal Organic Contaminants, a generic number for organic contaminants when there is no information indicating that a lower value is warranted.) The cancer risk level at 5 ug/L is about 10-3. Analytical methods used in this investigation were chosen with the belief that a detection limit below 5 ug/L was not needed.

According to the ATSDR report on this site, concentrations of 1,2,3-trichloropropane of up to 34,000 ug/L were detected in off-site groundwater, at 10,000 ug/L one block from the site, and above 100 ug/L more than 0.25 miles from the site. A well field is located about 0.5 miles downgradient from the site. No VOCs were detected in routine monitoring of a deep well in that well field that serves the local community. ATSDR concluded that "the site poses no public health hazard at the present because there are no known exposures to site-related contaminants." It is troubling that a drinking water benchmark of 5 ug/L, which is 1000 times above the public health protective concentration of 0.005 ug/L, was used by ATSDR and the state of New York to evaluate this highly contaminated site. This information was used to provide reassuring, but perhaps incorrect, conclusions to the local community that there is no exposure of concern to 1,2,3-trichloropropane.

Additional test results posted on web sites reveal many other cases of drinking water and ground water contamination by1,2,3-trichloropropane at high levels, including a site in

Dover Township, New Jersey where concentrations up to 210 ug/L in ground water were found (NJDHSS, 2001).

Toxicology and Risk Assessment

1,2,3-Trichloropropane is metabolically activated to a reactive intermediate and is a potent carcinogen. It is genotoxic in almost every system in which it was tested, and it caused a high incidence of tumors at multiple sites in male and female rats and mice in an NTP (1993) carcinogenicity bioassay. From the 1993 study, NTP concluded that there was clear ev idence of carcinogenic activity in both sexes of both species. Additionally, it was reasonably anticipated to be a human carcinogen in the NTP Eleventh Report on Carcinogens (2005). Thus, the weight of evidence for carcinogenicity for 1,2,3- trichloropropane is much stronger than for many other chemicals which are treated as non-threshold carcinogens as a

conservative default assumption. From this information, there is no doubt that the risk assessment for 1,2,3-trichloropropane should be based on a non-threshold low dose model, and that a risk assessment based on a Reference Dose is inappropriate for this chemical.

Three slope factors have been developed for 1,2,3- trichloropropane using the data from the 1993 NTP study: an older USEPA HEAST (1995) slope factor which was based on classification as a probable human carcinogen (B2) and the linearized multistage model, and slope factors in the draft risk assessments developed by USEPA IRIS (2007) and the California EPA Public Health Goal program (2007) which both use time-to-tumor low dose modeling, but differ in choice of species and modeling details. The range of drinking water concentrations at the 10-6 risk level, based on the three slope factors available, is 0.0015 ug/L to 0.009 ug/L, assuming water consumption of 2 liters per day.

A health-based drinking water guidance of 0.005 ug/L was developed by NJDEP in 1999 based upon the 10-6 risk level and the slope factor of 7 (mg/kg/day)-1 in the USEPA HEAST (1995)tables. This slope factor was based on the combined incidence

of benign and malignant tumors at various sites in rats. Standard exposure factors for body weight (70 kg) and drinking water ingestion (2 L/day) were used. The New Jersey Drinking Water Quality Institute is currently in the process of developing a Maximum Contaminant Level recommendation to NJDEP for 1,2,3-TCP.

Health Adv isory information provided by USEPA Office of Water

The 2006 USEPA Office of Water Drinking Water Regulations and Health Adv isory Table (HA Table) does not indicate that 1,2,3- trichloropropane is a carcinogen and provides a Lifetime Health Advisory for this contaminant. As you know, the users of this table do not necessarily have any toxicology or risk assessment expertise, since it is a practical reference table intended to be used by persons directly addressing local public health issues, such as detection of drinking water contaminants without MCLs in public water supplies or private wells. Examples of users of the HA Table are county and local health officials or water purveyors.

As discussed above, there is no doubt that the cancer risk assessment for 1,2,3-trichloropropane should be based on a non- threshold linear low dose model, and that a risk assessment based on a Reference Dose is inappropriate for this chemical. In spite of this, the IRIS entry for 1,2,3-TCP, fifteen years after the 1993 NTP study was published in final form, provides a Reference Dose for non-cancer effects of 0.006 mg/kg/day which was developed in 1989, prior to completion of the 1993 NTP study. For carcinogenicity, the only entry is "no data, dated 11/1/1993."

USEPA Office of Water does not prov ide Lifetime Health Advisories for known or probable human carcinogens (Groups A or B, using the older weight of evidence terminology). However, the HA Table does not even indicate that 1,2,3-trichloropropane is a carcinogen, and gives a Lifetime Health Advisory of 40 ug/L, based on the IRIS Reference Dose of 0.006 mg/kg/day. The range of lifetime cancer risks at the Lifetime Health Advisoryof 40 ug/L, using the slope factors currently being considered

by USEPA and California EPA is 4 x 10-3 to 3 x 10-2 or 4 in 1000 to 3 in 100. Thus, an unacceptably high level of cancer risk will result if the guidance provided in the table is used by local health officials to provide advice about 1,2,3- trichloropropane contamination of drinking water. Additionally, this guidance may be used as the basis to choose analytical methods which are not sensitive enough to detect levels of

concern.

Current USEPA Office of Water procedures do not allow information from final NTP studies, HEAST, NCEA, IRIS drafts, or other such reliable sources, to be posted on the HA Table,

even if this information clearly demonstrates that the information provided on the HA Table is not protective of public health. USEPA Office of Water procedures do not allow for inclusion of any carcinogenicity information until the IRIS cancer assessment for this chemical is finalized, which will likely take years due to the number of time consuming reviews required by the IRIS process.

Ironically, older versions of the Drinking Water Regulations and Health Adv isory Table (e.g. 1996) listed 1,2,3- trichloropropane as a Group B2 (probable human) carcinogen and prov ided a drinking water concentrations based on cancer risk, based on the slope factor prov ided in the 1995 HEAST table. As discussed above, the HEAST slope factor was the basis for the drinking water guidance value of 0.005 ug/L developed by NJDEP in 1999.

The Lifetime Health Advisory of 40 ug/L provided in the HA Table is widely used by states and other parts of USEPA as a health-based drinking water concentrations for 1,2,3- trichloropropane. Some examples follow:

1) Situations where Lifetime Health Advisory from the HA Table has been routinely used by state and local env ironmental or public health officials in states with no listed guidance to assess the significance of detections in drinking water. It is obv iously not possible to determine how many times that thishas occurred, since this information is not normally posted on

the Internet.

2) Several states, including Arizona (42 ug/L), Florida (42 ug/L), Minnesota (40 ug/L), New York (5 ug/L) Washington (21 ug/L), and W isconsin (50 ug/L) have drinking water standards or guidance concentrations at high risk levels, based on the USEPAs incorrect and outdated toxicity information (USEPA, 2000; HSDB, 2008).

3) Because the health-based drinking water concentration (at the 10-6 risk level) for 1,2,3-trichloropropane is so low, less sensitive analytical methods will miss occurrences at levels of concern, and reporting limits given by each state for the Unregulated Contaminant Monitoring Round 1 monitoring ranged from 0.5 ug/L to 5 ug/L. Additionally, the 2001 USEPA Office of Water reports "Occurrence of Unregulated Contaminants in Public Water Systems-A National Summary" (Table V.A.1) (USEPA, 2001a) and "Occurrence of Unregulated Contaminants in Public Water Systems-An Initial Assessment" (Tables A58 a, c) (USEPA, 2001b) incorrectly give 40 ug/L as the "MCL" for 1,2,3- trichloropropane, although it is currently not a regulated contaminant.

Recommendations

NJDEP strongly urges USEPA Office of Water to update its HA Table to provide appropriate public health protective drinking water guidance based on the carcinogenic effects of 1,2,3-TCP. NJDEP strongly urges USEPA Office of Water to develop an MCL for 1,2,3-TCP based on its occurence in drinking water and its carcinogenic effects.

Methyl tertiary butyl ether (MTBE)

MTBE is a chemical of concern in drinking water, which NJDEP strongly urges USEPA to address, as discussed below. MTBE was listed on CCL1 and CCL2, and both times a decision was made not to regulate this chemical. In addition, MTBE is included in thecurrent CCL3. There is as much or more relevant toxicology data

on MTBE than for many other regulated chemicals, and it is a contaminant which is commonly found in drinking water throughout the United States. At least 41 of 50 states have developed a drinking water or ground water standard or guidance for MTBE as shown on a map linked from the USEPA website ( http://www.epa.gov/swerust1/mtbe/mtbemap.pdf). MTBE is the most frequently detected volatile organic contaminant in data collected through New Jersey's Private Well Testing Act. Of the 51,028 wells tested under the Private Well Testing Act, 38 (0.01%) exceeded the New Jersey MCL of 70 ug/L and the highest concentration detected was 1550 ug/L.

New Jersey was among the first states to develop an MCL for MTBE. The basis for New Jersey s MCL was published in 1994 (NJDWQI, 1994), and it was adopted in 1996.

There is controversy over the reporting and interpretation of the results of the only available chronic oral study for MTBE (Belpoggi et al.,1995; Belpoggi et al., 1998). In this study, rats were dosed with MTBE by gavage in olive oil. The New Jersey Drinking Water Quality Institute (1994) recognized the uncertainties regarding the carcinogenicity of MTBE, specifically by oral exposure, and classified MTBE as a possible human carcinogen (equivalent to USEPA Group C under the 1986 USEPA guidelines). This classification forms the basis for New Jersey s Drinking Water Health-based Maximum Contaminant Level (MCL) for MTBE. The Health-based MCL is based on a subchronic oral gavage study in rats (Robinson, 1990), and the endpoint of concern was increased relative kidney weight. An additional uncertainty factor of 10 was incorporated to account for possible carcinogenic effects, following USEPA's and New Jersey s approach for drinking water risk assessment of possible human carcinogens. Some states have followed New Jersey s approach, while other states have based their MTBE risk assessments on a cancer slope factor.

A subchronic drinking water study for MTBE in rats was recently conducted (Bermudez et al., 2008) in order to set the doses for a two year drinking water study. This two year study is currently in progress, with the in-life phase expected to endin April 2009. The target date for the final report for this

study is January 2010 (E. Bermudez, personal communication). The results of this study may answer some of the unresolved issues regarding the oral carcinogenicity of MTBE.

Recommendation

MTBE is a contaminant for which the states have a strong need for guidance from USEPA. It is recommended that USEPA evaluate the results of the current chronic oral drinking water study when it is complete, along with other toxicology information, and develop an MCL for MTBE.

Perchlorate

Perchlorate is a chemical of concern in drinking water, which NJDEP strongly urges USEPA to address, as discussed below. Perchlorate is a chemical with diverse uses in flares, fireworks, rocket fuel, and explosives. It is also found in fertilizers from certain geographic regions. Its widespread occurrence in drinking water has been well documented by others.

After perchlorate was found in New Jersey drinking water as part of monitoring required by USEPA's Unregulated Contaminant Monitoring Rule, the New Jersey Drinking Water Quality Institute was asked by NJDEP to recommend a drinking water standard for perchlorate. NJDEP anticipates proposing a perchlorate MCL of 5 ug/L in the near future, as discussed below.

The National Research Council (2004) recommended a Reference Dose for perchlorate based on a small, but detailed study by Greer et al. (2002), which measured the inhibition of iodine uptake by the thyroid and the levels of thyroid hormone in adults receiving doses of perchlorate. The No Observed Effect Level for inhibition of iodine uptake in this study was 0.007 mg/kg/day. Iodine uptake is a full biological step away from areduction in thyroxine or an increase in TSH, neither of which

was observed even at the highest dose of perchlorate in this study.

The Reference Dose of 0.0007 mg/kg/day incorporates an uncertainty factor of 10 to protect sensitive subpopulations including fetuses and infants. Additional uncertainty factors were not considered necessary since the observed effect was not in and of itself considered adverse. This conclusion was supported by other data indicating the absence of effects on thyroid hormone in newborns and pregnant women in areas with perchlorate in the drinking water. Additional data since then has confirmed this for both groups. This Reference Dose was adopted by USEPA IRIS in 2005.

After reviewing the scientific literature the New Jersey Drinking Water Quality Institute concurred with National Research Council s Reference Dose (NJDWQI, 2005). From this Reference Dose, the Institute established a drinking water equivalent level of 24.5 micrograms of perchlorate per liter of water based on a 70 kilogram adult.

The last step in developing a health-based drinking water concentration is to adjust the drinking water equivalent level to account for other sources of exposure, such as food. W hen little data is available on other exposures that may add to the exposure from water, the default assumption is that the drinking water contribution should be limited to 20% of the total. Application of a 20% Relative Source Contribution factor results in a health-based drinking water concentration of 5 ug/L, which was recommended as the basis for New Jersey s MCL (NJDWQI, 2005). Based on their relative intakes of water and formula or breast milk, infants were considered to be protected. This is supported by the recent publication of Food and Drug Administration data on exposure to perchlorate in foods.

RecommendationNJDEP strongly urges USEPA to develop an MCL for perchlorate

based on its widespread occurrence, well characterized effects on thyroid function, and adequate information on the relative contributions of food and drinking water to perchlorate exposure.

Other CCL3 Contaminants Addressed by NJDEP

New Jersey has developed Health-based MCLs (equivalent to USEPA MCLGs) for formaldehyde, n-hexane, and ethylene glycol, and is currently in the process of developing analytical methods for these so that an MCL may be adopted. The basis for the formaldehyde and n-hexane Health-based MCLs is found on the New Jersey Drinking Water Quality Institute's website http://www.nj.gov/dep/watersupply/njdwqinstitute.htm.

A recommendation has been made to revise the Health-based MCL for ethylene glycol from 290 ug/L to 10,000 ug/L, based on

evaluation of more recent data on both renal toxicity and developmental effects.

New Jersey promulgated an MCL for 1,1-dichloroethane in 1996. The New Jersey carcinogenicity classification, Reference Dose, and Health-based MCL for 1,1-dichloroethane, which were developed in 1994 and are found on the website given above, were recently reevaluated by the New Jersey Drinking Water Quality Institute. Based on reevaluation of the data relevant to carcinogenic effects and the current cancer risk assessment guidelines, it is recommended to classify 1,1-dichloroethane in New Jersey Carcinogenicity Category II, equivalent to Group C, under the previous (1986) USEPA guidance, and analogous to Suggestive Evidence of Carcinogenic Potential under the current (2005) guidance. USEPA IRIS does not provide a slope factor for 1,1-dichloroethane. It was recommended that an additional uncertainty factor of 10 for potential carcinogenicity be incorporated into the Reference Dose.

The current basis of the Reference Dose, kidney effects in cats exposed by inhalation, is a more sensitive endpoint than anewer rat oral subchronic study, and it was recommended to

continue to use the current endpoint. It is recommended that the uncertainty factor of 5 currently used for small number of animals in the cat study be removed. The basis for the Reference Dose is already very conservative and health protective and the total uncertainty factor would exceed the maximum uncertainty factor of 10,000 used in Reference Dose development.

Based on the above, the recommended Reference Dose is 0.0032 mg/kg/day, which is a two-fold decrease from current Reference Dose of 0.0065 mg/kg/day. The recommended Health-based MCL is 23 ug/L, also a two-fold decrease from the current value of 46 ug/L.

Conclusion

Weappreciate the opportunity to comment on the Draft Contaminant Candidate List 3. If you have any questions or require additional information, please contact Dr.Gloria Post of the NJDEP Division of Science, Research and Technology at (609) 292-8497 or gloria.post@dep.state.nj.us.

Attachment [See PDF for Attachment]

Sincerely,

Judith Louis, Ph.D., Chief Bureau of Environmental Assessment Division of Science Research and Technology

Barker Hamill, Assistant Director Water Supply Operations Division of Water Supply

C: Eileen Murphy, NJDEPMichele Putnam, NJDEP

Sandra Krietzman, NJDEP CS Title: 0122 Company/group/association name: Comment:

COMMENTS OF 3M COMPANY ON EPA'S INCLUSION OF PFOA ON THE THIRD CONTAMINANT CANDIDATE LIST (CCL 3)

INTRODUCTION

3M Company (3M) appreciates the opportunity to comment on the U.S. Environmental Protection Agency's (EPA) inclusion of perfluorooctanoic acid (PFOA) on the Draft Third Drinking Water Candidate Contaminant List (CCL 3). 73 Fed. Reg. 9628 (Feb. 21, 2008). 3M supports the mission of the CCL process to protect our Nation's drinking water. As discussed below, however, 3M believes that in assessing PFOA for inclusion on the CCL 3, EPA should use more relevant information to characterize PFOA's potential human health effects and exposure levels. To ensure a clear and accurate record, it is important that EPA properly characterize PFOA health effects and exposure during the CCL 3 process. 3M offers the following comments for EPA's consideration.

DISCUSSION

1. A More Relevant Study Should Be Used to Characterize the Potency and Severity of PFOA Health Effects

According to the PFOA Contaminant Information Sheet[FN1: See EPA, Contaminant Information Sheets for the Draft CCL 3 Chemicals (February 2008), Docket ID No. EPA-HQ- OW-2007-1189-0043, p. 151-52.], EPA used a 1 mg/kg/day LOAEL included in EPA's 2005 Draft Risk Assessment of PFOA[FN2: EPA, Draft Risk Assessment of the Potential Human Health Effects of Associated with Exposure to Perfluorooctanoic Acid and its Salts, Office of Pollution Prevention and Toxics, RiskAssessment Division (January 4, 2005). (Hereinafter "Draft Risk

Assessment").] to characterize the potential for PFOA to cause adverse health effects. For the reasons explained below, 3M believes this LOAEL should not be used to characterize the potency and severity of PFOA health effects in laboratory animals.

EPA's use of the 1 mg/kg/day LOAEL value reported in the Draft Risk Assessment fails to properly capture the nature and intent of that document. The Draft Risk Assessment reported multiple endpoints and did not purport to determine a particular "critical effect" and effect level for regulatory or formal listing purposes. In its review of the Draft Risk Assessment, the EPA Science Adv isory Board (SAB) agreed with EPA's inclusion of multiple endpoints in the "current draft", and did not render an opinion as to appropriateness of any single value for use in characterizing PFOA health effects.[FN3: See EPA, SAB Review of EPA's Draft Risk Assessment of Potential Human Health Effects Associated with PFOA and its Salts (May 30, 2006), EPA-SAB-06-006.] In fact, the Draft Risk Assessment calculated two margins of exposure (MOEs) for PFOA in adult animals -- one based on a LOAEL from a two-generation study of rats and another based on a LOAEL from a study of cynomolgus monkeys -- and did not render an opinion as to whether one was more appropriate than the other. (EPA also separately calculated MOEs for developmental effects).

Studies based on primates are a better model than rats for human risk assessment in the case of PFOA. Notably, the only agency to establish a drinking water criterion for PFOA through rulemaking -- the Minnesota Department of Health -- based its interim Health Risk Level for PFOA on an effect level from the monkey study.[FN4: See 32 Minn. Reg. 374 (Aug. 27, 2007).] Primates are preferable to rats because PFOA is known to act, at least in part, through a mechanism of action in rodents that is much less operative in humans.

EPA calculated margins of exposure from the monkey study in its Draft Risk Assessment, but has not derived a Reference Dose from the monkey study. EPA's risk assessment guidance calls for the use of a benchmark dose for determining the point ofdeparture and Reference Dose when such a benchmark dose is

available. In a published risk assessment for PFOA, 3M and co- authors (Butenhoff et al. 2004a) have calculated benchmark doses for endpoints in the monkey study (Butenhoff et al. 2002). The benchmark dose for liver-weight-to-brain-weight ratio is 3.9 mg/kg/day. 3M believes this is a more relevant point of departure.

Indeed, not only are rats less relevant for human risk assessment than non-human primates, but the particular point of departure used in the draft EPA risk assessment for the rat study is not appropriate. The 1 mg/kg/day point of departure chosen by EPA during the CCL 3 process is based on a reduction in male post-weaning body weight in the first-generation pups in a two-generation reproductive study in rats reported in York (2002) and Butenhoff et al. (2004b). Although the Draft Risk Assessment did base one of the MOE calculations on this effect, the Draft Risk Assessment itself acknowledges that the "significance of reduced body weight for human health is not clear." [FN5: Draft Risk Assessment at 96.] 3M agrees that the effects on male body weights in this study are not of clear significance for human health and therefore urges that EPA not use this effect to characterize PFOA health effects in the CCL 3 process.

2. A Default Relative Source Contribution Value of 20% Should Not Have Been Used in the Calculation of a PFOA Health Reference Level

3M believes that the relative source contribution (RSC) value that EPA used to calculate the health reference level (HRL) for PFOA as part of the CCL 3 process does not follow EPA guidance. Although 3M recognizes that EPA used this HRL for CCL screening purposes only, we are concerned that EPA's calculation approach could influence future regulatory activity. Accordingly, EPA should follow the procedures for calculating HRL values prov ided in its own guidance.

In Step Three of the CCL 3 process (Classification to the CCL), EPA used a default 20% (0.2) RSC value for PFOA.[FN6: See EPA,Draft: Contaminant Candidate List 3 Chemicals: Classification

of the PCCL to CCL, EPA 815-R-08-004, February 2008 (hereinafter "Classification to CCL") at p. 61.] The RSC is a factor used to describe the proportion of the total permissible dose that is derived from the ingestion of water, versus other exposure routes. EPA guidance on the derivation of water quality criteria, referenced in the CCL,[FN7: EPA, Methodology for deriving ambient water quality criteria for the protection of human health. Office of Water, EPA-822-B-00-004, October, 2000, p. 1-7.] allows RSC values in the range of 0.2 to 0.8, with a default value of 0.2 applied in the absence of data supporting a different RSC. (20% relative source contribution used "unless there are data to suggest that the 20% is inappropriate)."[FN8: Classification to CCL at 61.] In fact, there are data which show that a 20% RSC for PFOA is inappropriate. As described below, a comparison of exposures in persons with and without known drinking water PFOA exposure shows that where there is drinking water exposure, it is the major source of exposure -- well above 20% of the total exposure.

Background exposures in the general population, which generally does not have drinking water exposure, have been well documented in a number of studies published by both the Centers for Disease Control and Prevention (CDC) and 3M.

* 3M's studies have used American Red Cross samples from adult blood donors. 3M has published data on Red Cross samples from a

variety of geographic locations in the U.S., including Minneapolis-St. Paul donors (Olsen et al., 2003). The levels in this study are also consistent with levels in studies of children from twenty states, and with levels found in a separate study of the elderly (Olsen et al., 2004a and 2004b).

* The 3M national study has been confirmed by published Centers for Disease Control data based on a statistically representative sample of the U.S. population. (Calafat et al., 2007a).

* 3M has also published a more recent study of levels of PFOAin Minneapolis-St. Paul blood donors, showing a decline in

general population exposures (Olsen et al., 2007). CDC s data also show a decline in PFOA concentrations in the general population (Calafat, et al., 2007b).

Data on persons known to be exposed to PFOA in drinking water

are available from three sources: 1) a peer-rev iewed University of Pennsylvania study of a community exposed to PFOA in drinking water in West Virginia (Emmett et al., 2006a, 2006b); 2) recently published study of a German population exposed to PFOA in drinking water (Holzer, et al., 2008); and 3) exposure data on persons liv ing in Washington County, Minnesota, presumably exposed to PFOA in municipal or private well water prior to the installation of treatment.[FN9: Blood sampled by attorneys (Taft, Stettinius & Hollister LLP) who are suing 3M in private litigation. Data available in EPA FYI Docket No. AR 226.] Exposure data for both the general population and persons exposed through drinking water are summarized in Table 1, below.

Table 1. Geometric Mean Serum/Plasma Concentrations of PFOA (ppb) [see PDF]

Although we must assume that people who live in Oakdale were exposed via the consumption of Oakdale municipal drinking water, the number of samples is sufficient to demonstrate a marked difference between the serum concentrations in the Oakdale population with exposure through city water and the general population in the Minneapolis/St. Paul metropolitan area or the U.S. general population. These data show that background serum concentrations based on non-drinking water exposures (serum ranging from 2.2 to 5.2 ppb) account for between 6 and 14 % of the serum concentrations in persons exposed via drinking water (whose mean serum concentration is 36.5 ppb). Thus, in persons exposed through drinking water, drinking water accounts for between 86 and 94% of exposures.[FN10: The proportion for the German population studied in Holzer et al. (2008) is similar - 75 to 88%.]

The Oakdale blood data, while unpublished, are consistent withthe published data on the West Virginia/Ohio population exposed

to PFOA. In studying the association of drinking water concentrations with serum concentrations of PFOA in a population in West Virginia/Ohio, University of Pennsylvania researchers similarly found that drinking water was the major source of exposure. Emmett et al. (2006a, 2006b). This study concluded that serum PFOA concentrations "depended on the source of residential drinking water, and not potential air exposure," and that "[r]esidential water source was the primary determinant of serum (PFOA)."

In that study, serum concentrations among 291 residents using Little Hocking, Ohio city water were, on average, 105 times the residential drinking water concentration. PFOA concentrations in Oakdale city well samples averaged 0.3 to 0.8 ppb between October 2005 and March 2006, before 3M prov ided treatment. Therefore, the reported 2005 geometric mean Oakdale serum PFOA concentration of 36.5 ppb is consistent with the relationship between drinking water and serum PFOA concentrations observed in the University of Pennsylvania study.

Finally, in the German study (Holzer, et al., 2008), persons consuming municipal water currently containing 0.5 ppb PFOA in drinking water had serum levels elevated 4.5-8.3 times the reference population. The authors concluded that drinking water consumption is a significant predictor of serum levels.

These facts provide strong, objective evidence that exposures from sources other than water are low and declining, and that the higher concentrations observed in the Oakdale population and the University of Pennsylvania study in West Virginia/Ohio, are most certainly due to the drinking water source.

Based on these data, EPA guidance would lead to a RSC of 50-80% rather than the 20% based on a default assumption. 3M believes that because data are available showing that the default 20% RSC value is inappropriate for PFOA, EPA should not use the default value in the CCL 3 process or in other regulatory proceedings.3. An Inappropriate Measure Was Used to Classify PFOA Occurrence

3M believes the information used to classify PFOA occurrence in Step Three of the CCL 3 process also is inappropriate. To define the magnitude aspect of PFOA's occurrence in drinking water, EPA used the highest public drinking water level reported for Little Hocking, OH (7.2 μg/l) cited in Emmett et al. (2006a). Because Emmett et al. does not contain prevalence data for PFOA, EPA described the prevalence of PFOA using data for "Select Minnesota Municipal Wells" as described in a February 27, 2006 presentation by the Minnesota Department of Health (MDH) to the Minnesota Senate Environment and Natural Resources Committee.[FN11: MDH (H. Goeden and J. Kelly), "Perfluorochemicals in Minnesota" (February 27, 2006), EPA Docket ID No. EPA-HQ-OW-2007-1189-0027.] In using Minnesota prevalence data and West Virginia magnitude data, EPA has derived a measure of occurrence for PFOA that does not actually exist in the environment, which creates an artificial and inaccurate impression of the extent of PFOA s occurrence in drinking water. 3M believes that it is more scientifically appropriate to use occurrence and magnitude data that actually occur simultaneously in the environment.

In addition, 3M believes EPA's characterization of the MDH prevalence data used in deriving a measure of PFOA occurrence is somewhat misleading. As noted by EPA in the PFOA Contaminant Information Sheet, the MDH presentation indicates that 6 of 37, or 16.2%, of municipal wells sampled contained detectable levels of PFOA.[FN12: See Id. at slide 17.] However, MDH sampled 37 municipal wells in seven Minnesota communities (Cottage Grove, Hastings, Lake Elmo, St. Paul, North St. Paul, Woodbury and Oakdale) and all six wells with PFOA detections were located in a single community, Oakdale, which has known contamination. No PFOA was detected in the other six communities municipal wells. Thus, the positive occurrence data relied upon by EPA are linked to a single location, and therefore do not support the prevalence of PFOA in Minnesota suggested by the 16.2% figure. Indeed, the aggregate of Minnesota well samples, which includes data from non-community wells and private wells is only 8.2%, even with the bias introduced by the Oakdale data. Moreover, the 6 out of 37 wellswith PFOA is an artificially high proportion, and not

representative of more widespread prevalence because all wells sampled were in Washington County, which was chosen specifically because PFOA from waste sites was expected to be found in the drinking water.

CONCLUSION

As explained above, 3M believes that, in the process of assessing PFOA for inclusion on the CCL 3, EPA did not use the most relevant information to characterize PFOA s potential human health effects and exposure levels. A clear and accurate record of the CCL 3 process with respect to PFOA is important, in our view, particularly given that determinations made in the process may influence other regulatory or formal listing determinations. 3M hopes that EPA finds the foregoing comments useful in helping to ensure a clear and accurate CCL 3 record.

References

Amacher, D. E., Schomaker, S. J., Boldt, S. E., Mirsky, M. (2006) The relationship among microsomal enzyme induction, liver weight, and histological change in cynomolgus monkey toxicology studies. Food. Chem. Toxicol. 44, 528-537.

Butenhoff, J., Costa, G., Elcombe, C., Farrar, D., Hansen, K., Iwai, H., Jung, R., Kennedy, G., Jr., Lieder, P., Olsen, G., Thomford, P. (2002) Toxicity of ammonium perfluorooctanoate in male cynomolgus monkeys after oral dosing for 6 months. Toxicol. Sci. 69:244-257.

Butenhoff, J.L., Gaylor, D.W ., Moore, J.A., Olsen, G.W ., Rodricks, J., Mandel, J.H., Zobel, L.R. (2004 ) Characterization of risk for general population exposure to perfluorooctanoate. Reg. Toxicol. Pharmacol., 39:363-380.

Calafat, AM., Kuklenyik, Z., Reidy, J. A, Caudill, S. P.,Tully, J. S., Needham, L. L. (2007a) Serum concentrations of 11

polyfluoroalkyl compounds in the U.S. population: data from the national health and nutrition examination survey (NHANES). Environ. Sci. Technol. 41, 22372242.

Calafat, A.M., Wong, L-Y., Kuklenyik, Z., Reidy, J.A., Needham, L.L. (2007b) Polyfluoroalkyl Chemicals in the U.S. Population: Data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004 and Comparisons with NHANES 1999-2000, Env . Health Persp. 115:1596-1602.

Emmett, E. A., Shofer, F. S., Zhang, H., Freeman, D., Desai, C., Shaw, L. M. (2006a) Community exposure to perfluorooctanoate: relationships between serum concentrations and exposure sources. J .Occup. Environ. Med. 48:759-770.

Emmett, E. A., Zhang, H., Shofer, F. S., Freeman, D., Rodway, N. V., Desai, C., Shaw, L. M. (2006b) Community exposure to perfluorooctanoate: relationships between serum levels and certain health parameters. J Occup Environ Med 48:771-779.

EPA (2002), "Hepatocellular Hypertrophy." Health Effects Division Guidance Document # G2002.01, October 21, 2002.

Holzer, J., Midasch, O., Rauchfuss, K., Kraft, M., Reupert, R., Angerer, J., Kleeschulte, P., Marschall, N., W ilhelm, M. (2008) Biomonitoring of Perfluorinated Compounds in Children and Adults Exposed to Perfluorooctanoate-Contaminated Drinking Water, Env. Health Persp. 116:651-657.

Olsen, G. W ., Church, T. R, Miller, J. P., Burris, l M., Hansen, K. J., Lundberg, J. K., Armitage, J. B., Herron, R. M., Medhdizadehkashi, Z., Nobiletti, J. B., O'Neill, E. M., Mandel, J. H., Zobel, L. R (2003) Perfluorooctanesulfonate and other fluorochemicals in the serum of American Red Cross adult blood donors. Env iron. Health Perspect. 111, 1892-1901.Olsen, G.W ., Church, T.R, Hansen, K.J., Burris, lM., Butenhoff,

J.L., Mandel, J.H., and Zobel, L.R (2004a) Quantitative

evaluation ofperfluorooctanesulfonate (PFOS) and other fluorochemicals in the serum of children," Journal of Children s Health 2:53-76.

Olsen, G.W ., Church, T.R., Larson, E.B., van Belle, G., Lundberg, lK., Hansen, K.J., Burris, lM., Mandel, J.H., and Zobel, L.R. (2004b) Serum concentrations ofperfluorooctanesulfonate and other fluorochemicals in an elderly population from Seattle, Washington, Chemosphere 54:1599-1611.

Olsen, G. W ., Mair, D. C., Reagen, W . K., Ellefson, M. E., Ehresman, D. l, Butenhoff, J. L., Zobel, L. R (2007) Preliminary evidence of a decline in perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) concentrations in American Red Cross blood donors. Chemosphere 68, 105-111.

York, R.G. (2002). Oral (gavage) two-generation (one litter per generation) reproduction study of ammonium perfluorooctanoate (APFO) in rats. Argus Research Laboratories, Inc. CS Title: 0123 Company/group/association name: Comment:

May 21,2008

Via E-Mail

Water Docket U.S. Environmental Protection Agency Mail Code 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Docket No. EPA-HQ-OW-2007-1189 -- Drinking WaterContaminant Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21,

2008)

Dear Sir/Madam:

The Ethylene Oxide/Ethylene Glycols Panel (Panel) of the American Chemistry Council submits these comments on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA). The Panel is comprised of companies that manufacture most of the ethylene oxide (EO) produced in the United States or use large amounts of EO, as well as the major domestic producers of ethylene glycol (EG). Because EO and EG are two of the chemical contaminants included on the draft CCL 3, the Panel has a strong interest in the list and the approach that EPA used to develop it.

As discussed in the appended comments, the Panel urges EPA not to include EO and EG on the final CCL 3 for the following

reasons:

* EO should be removed from the final CCL 3 because:

~ EPA must rely on the most relevant data for EO;

~ EPA did not use the most relevant data in scoring EO's health effects;

~ EPA erred in defining EO's potential to occur in drinking water based on total environmental releases rather than on surface water releases; and

~ Inasmuch as EPA has not made its three models publicly

available, the Panel has been deprived not only of an opportunity to verify the model results but also of an_adequateopportunity to comment on the models.

* EG should not have moved from the Universe to the Preliminary CCL (PCCL) because:

~ EPA should have categorized EG in Toxicity Category 5;

~ EG is not known to occur in drinking water; and

~ EPA erroneously used total environmental releases as the data element for characterizing EG's potential to occur in drinking water.

* Even assuming EG's movement from the Universe to the PCCL was not erroneous, which it was, EG does not belong on the final CCL 3, or at the very least EPA must reconfigure and rerun its algorithms and models so that they are based on the level of EG's surface water releases, not the total env ironmental releases.

~ EPA erred in defining EG's potential to occur in drinking water based on total environmental releases rather than on surface water releases, which are the most relevant data for characterizing potential drinking water occurrence; and

~ Because EPA has not made its three models publicly available, the Panel has been deprived not only of an opportunity to

verify the model results but also of an adequate opportunity to comment on the models.

The Panel appreciates the opportunity to submit these comments. For the reasons noted above, the Panel urges EPA not to include EO and EG on the final CCL 3.

If you have any questions, please contact me, at (703) 741-5607or via e-mail at Sarah_McLallen@americanchemistry.com.

Sincerely,

Sarah McLallen Manager, EO and EG Panels

Attachment [See PDF for Attachment]

BEFORE THE U.S. ENVIRONMENTAL PROTECTION AGENCY COMMENTS OF THE ETHYLENE OXIDE/ETHYLENE GLYCOLS PANEL OF THE AMERICAN CHEMISTRY COUNCIL ON DRINKING WATER CONTAMINANT CANDIDATE LIST 3-DRAFT

Drinking Water Contaminant Candidate List 3-Draft 73 Fed. Reg. 9628 (Feb. 21, 2008)

Docket No. EPA-HQ-OW-2007-1189

Sarah C.L. McLallen Manager, Ethylene Oxide/Ethylene Glycols Panel

Theodore R. Waugh, Esquire Assistant General Counsel

Of Counsel:

Lynn L. Bergeson, Esquire Ira Dassa, Esquire Bergeson & Campbell, P.C. 1203 Nineteenth Street, N.W . Suite 300 Washington, D.C. 20036-2401AMERICAN CHEMISTRY COUNCIL

1300 W ilson Boulevard Arlington, VA 22209

May 21, 2008

EXECUTIVE SUMMARY

The Ethylene Oxide/Ethylene Glycols Panel (Panel) of the American Chemistry Council submits these comments on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA). The Panel is comprised of companies that manufacture most of the ethylene oxide (EO) produced in the United States or use large amounts of EO, as well as the major domestic producers of ethylene glycol (EG). Because EO and EG are two of the chemical contaminants included on the draft CCL 3, the Panel has a strong interest in the list and the approach that EPA used to develop it.

The Panel urges EPA not to include EO and EG on the final CCL 3 for the following reasons:

* EO should be removed from the final CCL 3 because:

~ EPA must rely on the most relevant data for EO;

~ EPA did not use the most relevant data in scoring EO's health effects;

~ EPA erred in defining EO's potential to occur in drinking water based on total environmental releases rather than on surface water releases; and~ Inasmuch as EPA has not made its three models publicly

available, the Panel has been deprived not only of an opportunity to verify the model results but also of an adequate opportunity to comment on the models.

* EG should not have moved from the Universe to the Preliminary CCL (PCCL) because:

~ EPA should have categorized EG in Toxicity Category 5;

~ EG is not known to occur in drinking water; and

~ EPA erroneously used total environmental releases as the data element for characterizing EG's potential to occur in drinking water.

* Even assuming EG's movement from the Universe to the PCCL was not erroneous, which it was, EG does not belong on the final CCL 3, or at the very least EPA must reconfigure and rerun its algorithms and models so that they are based on the level of EG's surface water releases, not the total env ironmental releases.

~ EPA erred in defining EG's potential to occur in drinking water based on total environmental releases rather than on surface water releases, which are the most relevant data for characterizing potential drinking water occurrence; and

~ Because EPA has not made its three models publicly available, the Panel has been deprived not only of an opportunity to

verify the model results but also of an adequate opportunity to comment on the models.

TABLE OF CONTENTSEXECUTIVE SUMMARY.....i

TABLE OF CONTENTS.....iii

INTRODUCTION.....1

I. EO SHOULD NOT BE INCLUDED ON THE FINAL CCL 3.....2

A. EO Should Be Removed from the Final CCL 3.....3

1. EPA Must Rely on the Most Relevant Data for EO.....3

2. EPA Did Not Use the Most Relevant Data in Scoring EO's Health Effects.....3

3. EPA Erred in Defining EO's Potential to Occur in Drinking Water Based on Total Environmental Releases Rather Than on Surface Water Releases.....7

a. EO Is Not Known to Occur in Drinking Water.....7

b. EO Is a Gas That Easily Evaporates.....7

c. EPA Should Define EO's Potential to Occur in Drinking Water Based on Surface Water Release Data, W hich Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence.....10

4. Inasmuch As EPA Has Not Made Its Three Models Publicly Available, the Panel Has Been Deprived Not Only of an Opportunity to Verify the Model Results But Also of an Adequate Opportunity to Comment on the Models.....11II. EG SHOULD NOT BE INCLUDED ON THE FINAL CCL 3.....12

A. EG Should Not Have Moved from the Universe to the PCCL.....12

1. EPA Should Have Categorized EG in Toxicity Category 5.....12

2. EG Is Not Known to Occur in Drinking Water.....14

3. EPA Erroneously Used Total Environmental Releases As the Data Element for Characterizing EG's Potential to Occur in Drinking Water.....14

B. Even Assuming EG's Movement from the Universe to the PCCL Was Not Erroneous, W hich It Was, EG Does Not Belong on the Final CCL 3, or at the Very Least EPA Must Reconfigure and Rerun Its Algorithms and Models So That They Are Based on the Level of EG's Surface Water Releases, Not the Total Environmental Releases.....16

1. EPA Erred in Defining EG's Potential to Occur in Drinking Water Based on Total Environmental Releases Rather Than on Surface Water Releases, W hich Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence.....16

2. Because EPA Has Not Made Its Three Models Publicly Available, the Panel Has Been Deprived Not Only of an Opportunity to Verify the Model Results But Also of an Adequate Opportunity to Comment on the Models.....17

CONCLUSION.....18

INTRODUCTIONThe Ethylene Oxide/Ethylene Glycols Panel (Panel) of the

American Chemistry Council submits these comments on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA).[FN1: 73 Fed. Reg. 9628 (Feb. 21, 2008).] The Panel is comprised of companies that manufacture most of the ethylene oxide (EO) produced in the United States or use large amounts of EO, as well as the major domestic producers of ethylene glycol (EG).[FN2: Panel member companies include: ARC; BASF Corporation; Bayer Corporation; Celanese Chemicals, on behalf of itself and Old World Industries; The Dow Chemical Company; Eastman Chemical Company; Equistar Chemicals LP; Honeywell; Huntsman Corporation; Sasol North America Inc.; Shell Chemical LP; and Sunoco, Inc.] Because EO and EG are two of the chemical contaminants included on the draft CCL 3, the Panel has a strong interest in the list and the approach that EPA used to develop it.

Under Section 1412(b)(1)(B) of the SDWA, as amended, EPA is required to publish every five years "a list of contaminants which, at the time of publication, are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation under [the SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I). For a contaminant to be regulated under the SDWA, EPA must make three findings: (1) the contaminant may have an adverse effect on the health of persons; (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 presents a meaningful opportunity for health risk reduction for persons served by public water systems. Id. § 300g1( b)(1)(A)(i)-(iii).] Congress made it clear that in selecting unregulated contaminants for this list, known as the CCL, EPA must "consider the [National Contaminant Occurrence Database (NCOD)] established under section [1445(g) of the SDWA]"[FN4: Id. § 300g-1(b)(1)(B)(i) (I).] and "select contaminants that present the greatest public health concern."[FN5: Id. § 300g-1(b)(1)(C).] Inclusion of a contaminant on the CCL means that the contaminant, at a laterdate, may become subject to an EPA determination to

regulate.[FN6: Id. §§ 300g-1(b)(1)(B)(ii), (E).] Once listed, there is no procedure set forth in the SDWA, short of a determination not to regulate, for a contaminant's removal from the particular CCL on which it appears.[FN7: See 70 Fed. Reg. 9071, 9073 (Feb. 24, 2005) (a determination not to regulate a particular contaminant serves to "remove that contaminant from the CCL"); but see 63 Fed. Reg. 10273, 10275 (Mar. 2, 1998) (stating that EPA is "not precluded from modifying the CCL prior to the due date of the next CCL").]

I. EO SHOULD NOT BE INCLUDED ON THE FINAL CCL 3

For the reasons discussed more fully below, EO should not be included on the final CCL 3, and the Panel urges EPA to remove it from the list.

A. EO Should Be Removed from the Final CCL 3

1. EPA Must Rely on the Most Relevant Data for EO

In the classification step through which the 532 Preliminary CCL (PCCL) chemical contaminants were further evaluated, modeled, and narrowed to the draft CCL 3 on which EPA seeks comment, EPA stated that it sought to ensure, inter alia, a "meaningful basis for classification" as well as the "incorporati[on] [of] relevant data."[FN8: EPA, Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCL, at 2 (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0046.] EPA stated that "[t]he classification process ... must consider the potential for occurrence in water," and "[t]he most relevant data used for the classification process include health effects data that are appropriate for drinking water exposures, and occurrence data that indicate the nature and spatial extent of potential occurrence in drinking water."[FN9: Id. In implementing Section 1412 of the SDWA, EPA is required to use "the best available, peer-rev iewed science and supporting studies conducted in accordance with sound and objective scientific practices." 42 U.S.C. § 300g-1(b)(3)(A).]2. EPA Did Not Use the Most Relevant Data in Scoring EO's

Health Effects

EPA used the attributes of "potency" and "severity" to evaluate health effects of the chemicals it reviewed.[FN10: Classification of the PCCL to CCL at 5.] EPA gave EO a score of 6 for potency and 8 for severity; EPA stated that the key health effects data element upon which it relied for this scoring was the California Office of Environmental Health Hazard Assessment's (OEHHA) oral slope factor of 0.31 mg/kg- day-1.[FN11: See EPA, Contaminant Information Sheets for the Draft CCL 3 Chemicals, at 85 (Feb. 2008 Draft) (Information Sheets), available at EPA-HQ-OW-2007-1189-0042.]

The most recent OEHHA Toxicity Criteria Database indicates that the oral slope factor for EO is identical to the inhalation slope factor for EO.[FN12: See OEHHA, "OEHHA Toxicity Criteria Database," at 2 (Jan. 25, 2008), available at http://www.oehha.ca.gov/risk/pdf/TCDB012508cas.pdf.] This single unit risk number is based on an analysis conducted by EPA in 1985, which was reevaluated by OEHHA in 1987 as part of California's Toxic Air Contaminant (TAC) Program.[FN13: See OEHHA, Toxic Air Contaminant Report for Ethylene Oxide, Part B - Health Effects of Ethylene Oxide, at 60-64 (revised Aug. 31, 1987), available at http://www.arb.ca.gov/toxics/id/summary/ethylenoxideb.pdf; OEHHA, Air Toxics Hot Spots Program Risk Assessment Guidelines, Technical Support Document for Describing Available Cancer Potency Factors, at 293, 303-304 (Dec. 2002) (OEHHA Cancer Potency Factors), available at http://www.oehha.ca.gov/air/hot_spots/pdf/TSDNov2002.pdf.] This slope factor is based on excess mononuclear cell leukemias (MCL) observed by Snellings, et al. in female F344 rats exposed to EO by inhalation.[FN14: Snellings, W ., Weil, C., and Maronpot, R. (1984). A two-year inhalation study of the carcinogenic potential of ethylene oxide in Fischer 344 rats. Toxicol. Appl. Pharm. 75:105-117.]

More recent evaluations by EPA's Office of Research andDevelopment (ORD)[FN15: EPA, Evaluation of the Carcinogenicity

of Ethylene Oxide (Aug. 2006 External Review Draft), available at http://cfpub.epa.gov/ncea/cfm/iris/recordisplay.cfm?deid=157664 .] and by Health Canada[FN16: Health Canada, Canadian Environmental Protection Act, 1999, Priority Substances List Assessment Report, Ethylene Oxide (2001), available at http://www.ec.gc.ca/substances/ese/eng/psap/final/ethyleneoxide .cfm.] of the unit risk for the various tumors induced in animal bioassays with EO have confirmed that the highest unit risk is associated with excess MCL tumors reported by Snellings, et al. in female rats. As part of the development of the Reregistration Eligibility Decision for EO, EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) prepared a summary of the unit risk numbers for all of the tumors from animal bioassays that have been derived by ORD and Health Canada.[FN17: EPA, "Ethylene Oxide (ETO): Selection of Interim Unit Risk Estimates in Rodents; PC Code 042301, DP Barcode: D316656" (May 15, 2007) (EO Unit Risk Memorandum), available at EPA-HQ-OPP-2005-0203-0098.]

Although the MCL tumors in female rats yield the largest unit risk estimates, OPPTS concluded that it would not be appropriate to utilize numbers for these tumors because "this tumor type is unique to F344 rats and does not have a human counterpart. Additionally, the cell of origin is not known, nor is it known if the tumor is hematopoietic in origin. MCL in F344 rats arise spontaneously, primarily in older animals."[FN18: Id. at 3.] This conclusion by OPPTS is consistent with a broad range of scientific opinion that such tumors have dubious relevance to humans.[FN19: Swaen, G.J.W . and P. Van Heerde (1987). Tumors of the hematopoeitic system. In Pathology of tumors in laboratory animals. Vol 1. Tumors of the Rats (Ed., TurusovVS). Lyon, France: International Agency for Research on Cancer; Stefanski, S.A., M.R. Elwell, P.C. Stronmberg (1990). Spleen, lymph nodes, and thymus. In: Pathology of the Fischer rat. (Ed: Boorman G.A., et al.). San Diego, CA: Academic Press; Ward, J.M., S. Rehm, C.W . Reynolds (1990). Pathology of tumors in laboratory animals. Tumors of the rat. Tumors of the haematopoietic system. IARC Sci Pub. 125-57; Caldwell, D.J. (1999). Rev iew of mononuclear cell leukemia in F-344 rat bioassays and its significance to human cancer risk: A case study using alkyl phthalates. Reg. Toxicol.Pharmacol. 30:45-53; Walker, V.E., K.Y. W u, P.B. Upton, A.

Ranasinghe, N. Scheller, M.H. Cho, J.S. Vergnes, T.R. Skopek, J.A. Swenberg (2000). Biomarkers of exposure and effect as indicators of potential carcinogenic risk arising from in vivo metabolism of ethylene to ethylene oxide. Carcinogenesis 21(9):1661-1669.]

Instead of using the MCL tumors, OPPTS concluded that the most appropriate tumor types to use to estimate human risk based on the available animal bioassays are the lung adenomas/carcinomas observed in male B6C3F1 mice and brain tumors in male F344 rats.[FN20: EO Unit Risk Memorandum at 3.] In the older analysis from 1987, the California Department of Health Serv ices discussed these other tumor types,[FN21: OEHHA Cancer Potency Factors at 299, 301.] but elected instead to use "data from the most sensitive sex, site and species, the female rat mononuclear cell leukemia."[FN22: Id. at 303.] Nevertheless, it is not scientifically defensible for EPA to disregard the broad scientific consensus that has emerged in subsequent years that MCL tumors in the F344 rat are not relevant to humans.

The Panel recognizes that EPA may have selected the OEHHA oral slope factor for EPA's CCL 3 analysis because it purports to be an oral unit risk factor and because it is also expressed in units that are appropriate for potential oral consumption. Nevertheless, this number is based on the same inhalation bioassays as the subsequent assessments by ORD, Health Canada, and OPPTS. EPA cannot justify use of an earlier assessment based on the same data that no longer reflects the best

available science. For the current CCL 3 analysis, EPA should use the unit risk numbers that have been derived by ORD for the lung adenomas/carcinomas observed in male B6C3F1 mice and brain tumors in male F344 rats, after correcting these numbers to a slope factor that is appropriate for an oral route of administration.

3. EPA Erred in Defining EO's Potential to Occur in Drinking Water Based on Total Environmental Releases Rather Than on Surface Water Releasesa. EO Is Not Known to Occur in Drinking Water

EPA utilized the occurrence attributes of "prevalence" and "magnitude" to define EO's actual or potential occurrence in drinking water.[FN23: Classification of the PCCL to CCL at 18.] Importantly, however, EO is not known to occur in drinking water, and indeed, neither the NCOD that EPA is required to consider in its development of the CCL, nor any other source of finished water or ambient water occurrence data, reflects any detections of EO.[FN24: See Information Sheets at 86 (showing no entries under Finished Water Occurrence Data or Ambient Water Occurrence Data).]

b. EO Is a Gas That Easily Evaporates

EPA relied on the "prevalence" and "magnitude" attributes as the basis for evaluating EO's potential to occur in public water systems, with magnitude corresponding to the total on- and off-site disposal or other releases of EO (i.e., 374,110 pounds) reported under the Toxics Release Inventory (TRI) for 2004, and prevalence corresponding to the number of states (38) with releases.[FN25: Id; see also 73 Fed. Reg. at 9637, 9640.] Reliance on TRI release data without considering EO's physical properties and env ironmental fate has led, however, to the erroneous conclusion that EO might occur in drinking water.

EPA stated in drafting the previous CCL (i.e., CCL 2) that "[a] contaminant was considered to have the potential to occur [in drinking water] if, using the TRI, the release to surface water was in excess of 400,000 pounds per year and the physical- chemical properties indicated persistence and mobility of the contaminant."[FN26: 69 Fed. Reg. 17406, 17409 (Apr. 2, 2004) (emphasis added).] For some contaminants, then, physical- chemical properties played a distinct role in the CCL 2 process. In the CCL 3 process, EPA considered physical and chemical properties, but only in those cases where production data under the Toxic Substances Control Act Chemical Update System/Inventory Update Rule constituted the sole measure of occurrence.[FN27: See 73 Fed. Reg. at 9640-41. In those instances, EPA used "persistence-mobility" as a surrogatemeasure for magnitude.] EPA should also consider the physical

and chemical properties of those substances for which TRI release data served as the basis for occurrence attribute scoring, particularly given that the expert panel convened by EPA to provide input on EPA's approach to the draft CCL 3 stated that "[TRI] release data, as well as the physical properties of each chemical, especially gases, should be analyzed to determine if model results would change if surface water release information was used instead of total release data."[FN28: EPA, Chemical Expert Input and Review for the Third Contaminant Candidate List, at 8 (emphasis added) (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0038.]

In contravention of its intent to incorporate "[t]he most relevant data" and in spite of the expert panel's recommendation, EPA inexplicably did not account for EO's well- known physical properties. Not only is EO a gas, it is one that "evaporates very easily."[FN29: Agency for Toxic Substances and Disease Registry, Toxicological Profile for Ethylene Oxide (EO Toxicological Profile), at 2 (Dec. 1990), available at http://www.atsdr.cdc.gov/toxprofiles/tp137.html; see also Ethylene Oxide Product Stewardship Guidance Manual, at 34 (May 2007) ("Because of its volatility, EO has a tendency to

evaporate from water or soil to the air.").] As the Agency for Toxic Substances and Disease Registry (ATSDR) has pointed out, "[a]lthough [EO] dissolves in water in any proportion, it ... has the tendency to escape (volatilize) due in part to its high

vapor pressure. Conway et al. (1983) reported that about 95% of [EO] mixed with water volatilizes within 4 hours ...."[FN30: EO Toxicology Profile at 60; see also World Health Organization (W HO), Concise International Chemical Assessment Document 54 - Ethylene Oxide, at 8 (2003) (CICAD 54), available at http://www.who.int/ipcs/publications/cicad/en/cicad54.pdf.] ATSDR therefore states in the Public Health Statement portion of the EO Toxicological Profile that any EO released to water "will either break down or be destroyed ... within a few days."[FN31: EO Toxicology Profile at 2; see also Product Stewardship Guidance Manual at 35 ("EO will biodegrade in aerobic systems such as rivers [and] lakes").]

Moreover, it is significant that of the total quantity of EO released to the env ironment in both 2005 and 2006, almost 88percent was in the form of fugitive and point source air

emissions.[FN32: See TRI Explorer Chemical Reports for 2005 and 2006, available at http://www.epa.gov/triexplorer/. In 2004, air releases of EO amounted to more than 89 percent of the total quantity released to the environment. See TRI Explorer Chemical Report for 2004.] As W HO states, "release of [EO] to the atmosphere is unlikely to result in transfer to other

env ironmental compartments in significant quantities," and "[a] lthough water solubility suggests that washout from the atmosphere by precipitation could be important, volatilization from the water is too rapid to suggest this to be a significant fate process."[FN33: CICAD 54, at 7.]

In sum, quantities of EO that are released to water volatilize, and quantities that are released to air, which are the vast majority of the total environmental releases, do not end up in drinking water.

c. EPA Should Define EO's Potential to Occur in Drinking Water Based on Surface Water Release Data, W hich Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence

In view of EO's highly relevant physical properties, EPA should base its characterization of EO's potential to occur in drinking water not on the total quantity released to the

env ironment, but rather on the total quantity released to surface water. The latter figure constitutes the "most relevant data [for indicating] the nature and spatial extent of potential occurrence in drinking water."[FN34: Classification of the PCCL to CCL at 2.]

In 2004, the level of EO surface water releases was 4,761 pounds encompassing only four states,[FN35: Information Sheets at 86.] and in 2006, the latest year for which TRI data are

available, the figure was considerably lower, 1,010 pounds.[FN36: See TRI Explorer Chemical Report for 2006,

available at http://www.epa.gov/triexplorer/.] Moreover, as indicated above, quantities of EO that are released to water will either break down or be destroyed such that no EO shouldbe present in drinking water.

Thus, EO does not meet the statutory standard for CCL listing, as it is not known or anticipated to occur in public water systems, nor is there a substantial likelihood of it occurring in public water systems.

4. Inasmuch As EPA Has Not Made Its Three Models Publicly Available, the Panel Has Been Deprived Not Only of an Opportunity to Verify the Model Results But Also of an Adequate Opportunity to Comment on the Models

For the reasons explained above, EO should not be included on the CCL 3. In addition, EPA has not made publicly available, either in the regulatory docket or elsewhere, the three classification models that it used to select contaminants from the PCCL for the CCL. As a result, neither the Panel nor any other interested stakeholder is able either to verify the model results or to comment adequately on the models themselves. For this reason, EPA at the very least must reconfigure and rerun the models so that they are based on the most relevant data for EO - an appropriately determined oral slope factor, EO's physical-chemical properties, and the amount of surface water releases -- before making a determination on whether EO should be included on the final CCL 3.

II. EG SHOULD NOT BE INCLUDED ON THE FINAL CCL 3

For the reasons discussed more fully below, EG also should not be included on the final CCL 3, and the Panel urges EPA to remove it from the list as well.

A. EG Should Not Have Moved from the Universe to the PCCL

1. EPA Should Have Categorized EG in Toxicity Category 5During the screening step, EPA categorized EG in Toxicity

Category (TC) 4, the second lowest of the five toxicity categories.[FN37: See EPA, Contaminant Candidate List 3 Chemicals: Screening to a PCCL, at 29 (Feb. 2008 Draft),

available at EPA-HQ-OW-2007-1189-0044.] EPA relied on the World Health Organization's (W HO) Tolerable Daily Intake (TDI) value of 0.05 mg/kg-day and partitioned this value into TC 4.[FN38: Id. at 7-8 (Exhibit 4), 29.] EPA, however, failed to acknowledge that the W HO's TDI value, which is derived from a study by Gaunt, et al. (1974) and is "based on a benchmark dose of 49 mg/kg body weight per day calculated for non-neoplastic renal effects in animals and an uncertainty factor of 1000," is, according to W HO, "uncertain, owing primarily to lack of information on progression of renal lesions in the most sensitive animal model."[FN39: W HO, Concise International Chemical Assessment Document 45 - Ethylene Glycol: Human Health Aspects, at 5 (2002), available at http://www.who.int/ipcs/publications/cicad/en/cicad45.pdf.] The Panel has presented and published over 20 studies in the last 10 years on EG's mode of action. Table 1 (appended as Attachment 1) provides a listing of these research projects on metabolism and clearance with pharmacokinetic and pharmacodynamic data that support a reduction in uncertainty factors for purposes of EG risk assessment, and the appended technical comments (appended as Attachment 2) discuss in detail why the Gaunt study is unreliable. [See PDF for Attachments] Based on the Panel's studies, the appended technical comments, and W HO's self- acknowledged "uncertainty" concerning the TDI

value, EG is properly categorized in TC 5.

Moreover, EPA relied on the 0.05 mg/kg-day TDI value as a reference dose (RfD)-equivalent in the Universe-to-PCCL screening step, yet in the PCCL-to-CCL classification step, EPA relied on the Integrated Risk Information System (IRIS) oral RfD of 2 mg/kg-day.[FN40: See Information Sheets at 83. The IRIS oral RfD is based on the DePass, et al. (1986) study.] The basis for this divergence is not explained, and the Panel believes it is not supportable, particularly when, in the case of EG, it yields a perverse result. Inasmuch as the classification step involves "a more detailed evaluation of ... health effects" data,[FN41: 73 Fed. Reg. at 9631.] EPA should have relied on the IRIS oral RfD in the screening step as well. Exhibit 4 in the PCCL Screening Document reveals that an oralRfD of 2 mg/kg-day, which is greater than 0.1 mg/kg-day, puts

EG in TC 5, not TC 4.[FN42: See PCCL Screening Document at 8.]

2. EG Is Not Known to Occur in Drinking Water

EG is not known to occur in drinking water, and indeed, neither the NCOD that EPA is required to consider in its development of the CCL, nor any other source of finished water or ambient water occurrence data, reflects any detections of EG in water.[FN43: See Information Sheets at 84 (showing no entries under Finished Water Occurrence Data or Ambient Water Occurrence Data).]

3. EPA Erroneously Used Total Environmental Releases As the Data Element for Characterizing EG's Potential to Occur in Drinking Water

In the penultimate stage of the Universe-to-PCCL screening process, EPA erroneously used the total env ironmental releases from the TRI for 2004 -- 10,076,483 pounds -- to define EG's potential to occur in drinking water.[FN44: Id. According to the TRI Explorer, total environmental releases of EG in 2004 equaled 8,648,773 pounds, not 10,076,483 pounds. See TRI Explorer Chemical Report for 2004.] Particularly given the absence of any water detections of EG, EPA should have focused instead on the level of surface water releases of EG (i.e., 576,990 pounds in 2004).

EPA indicated that it "chose to use the pounds released per year into the env ironment for screening because the mass applied to the env ironment was more directly related to a potential concentration in water than the number of States where a chemical is released or applied."[FN45: 73 Fed. Reg. at 9637; see also PCCL Screening Document at 14 ("EPA chose to use the data on the pounds per year released to the environment for screening rather than the number of states with releases.").] Nowhere, though, did EPA explain why the level of total

env ironmental releases, or even the number of states with releases, is more directly related to a potential concentrationin water than the level of surface water releases. Surface

water release data, precisely because they are specific to waterbodies, are far more relevant to potential drinking water occurrence than total env ironmental release data, whether the latter is expressed in pounds per year or the number of states with releases.

Proper reliance on surface water releases -- 576,990 pounds -- together with EG's proper toxicity categorization -- TC 5 -- means that EG, according to Exhibit 11 in the PCCL Screening Document, should stay in the Universe and should not move to the PCCL.[FN46: See PCCL Screening Document at 18. Even if EG falls into TC 4, which it does not, it remains in the Universe and does not move to the PCCL with a surface water release level of less than 1,000,000 pounds per year.] Furthermore, in the 2006 TRI, the level of EG surface water releases decreased by almost 15%, to 494,440 pounds. According to Exhibit 11, this level, too, should not result in EG moving from the Universe to the PCCL.

Finally, should EPA nevertheless use total env ironmental releases rather than surface water releases for purposes of the screening step, EPA should consider the fact that according to the TRI Explorer, total environmental releases of EG in 2004 equaled 8,648,773 pounds, not 10,076,483 pounds.[FN47: See TRI Explorer Chemical Report for 2004. Total environmental release levels for 2006 and 2005 were lower, equaling 7,543,760 and 7,320,942 pounds, respectively. See TRI Explorer Chemical Reports for 2006 and 2005.] This level of releases places EG in the 1M - <10M occurrence column on Exhibit 11. As a TC 5 chemical, EG falls into the shaded area on the exhibit, meaning that EG should stay in the Universe and should not move to the PCCL.

B. Even Assuming EG's Movement from the Universe to the PCCL Was Not Erroneous, W hich It Was, EG Does Not Belong on the Final CCL 3, or at the Very Least EPA Must Reconfigure and Rerun Its Algorithms and Models So That They Are Based on the Level of EG's Surface Water Releases, Not the Total Environmental Releases1. EPA Erred in Defining EG's Potential to Occur in Drinking

Water Based on Total Environmental Releases Rather Than on Surface Water Releases, W hich Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence

EPA utilized the occurrence attributes of prevalence and magnitude to define EG's actual or potential occurrence in drinking water. As discussed above, there are no data showing that EG is known to occur in drinking water. The prevalence and magnitude attributes thus served as the basis for evaluating EG's potential to occur in public water systems, with magnitude corresponding to the total on- and off-site disposal or other releases of EG (i.e., 10,076,483 pounds) reported under the 2004 TRI, and prevalence corresponding to the number of states (49) with releases.[FN48: Information Sheets at 84. As noted above, supra n.44, total environmental releases of EG in 2004 actually equaled 8,648,773 pounds.]

In contravention of its intent to incorporate "[t]he most relevant data" and in spite of the expert panel's recommendation, discussed in Section I.A.3.b above, that the physical properties of chemicals should be analyzed, EPA did not take into account that EG "degrades rapidly in all

env ironmental media," including water and soil, and "does not bioaccumulate."[FN49: ATSDR, Draft Toxicological Profile for Ethylene Glycol, at 183 (Sept. 2007), available at http://www.atsdr.cdc.gov/toxprofiles/tp96.pdf.] Considering this and the fact that EG is not known to occur in drinking water, EPA should have based its characterization of EG's potential to occur not on the total quantity released to the

env ironment, but rather on the total quantity released to surface water. This figure constitutes the "most relevant data [for indicating] the nature and spatial extent of potential occurrence in drinking water."[FN50: Classification of the PCCL to CCL at 2.]

2. Because EPA Has Not Made Its Three Models Publicly Available, the Panel Has Been Deprived Not Only of an Opportunity to Verify the Model Results But Also of an Adequate Opportunity to Comment on the ModelsFor the reasons explained above, EG should not be included on

the CCL 3. In addition, EPA has not made publicly available, either in the regulatory docket or elsewhere, the three classification models that it used to select contaminants from the PCCL for the CCL. As a result, neither the Panel nor any other interested stakeholder is in a position either to verify the model results for EG or to comment adequately on the models themselves. For this reason, EPA at the very least must reconfigure and rerun the models so that they are based on the most relevant data for EG -- its physical-chemical properties and the amount of surface water releases -- before making a determination on whether EG should be included on the final CCL 3.

CONCLUSION

The Panel appreciates the opportunity to submit these comments. For the reasons stated above, the Panel urges EPA not to include EO and EG on the final CCL 3. CS Title: 0126 Company/group/association name: Comment:

If a profiteer tells you there is nothing wrong with the water, you still have to investigate further since that is their money talking. The money and profits is what concerns them. They dont want to clean up anything they dont have to. And what they are getting away with is horrible. I believe dirty water filled with drugs is out there. I have seen many studies showing that so I think taxpayers who fund epa should have this agency do the job for them, not for money grubber profiteers. The whole couintry, our children, our parents, needs the safe practice o fnot polluting our water with drugs. We cannot focus on profiteers needing money. The level of protection needs to be higher, not lower. CS Title: 0127 Company/group/association name: Comment:May 21, 2008

Via E-Mail

Water Docket U.S. Environmental Protection Agency Mail Code 2822T 1200 Pennsylvania Avenue, N.W . Washington, D.C. 20460

Re: Docket No. EPA-HQ-OW-2007-1189 -- Drinking Water Contaminant Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21, 2008)

Dear Sir/Madam:

The N-Methyl-2-Pyrrolidone Producers Group, Inc. (NMP Producers Group or Group) submits these comments on the U.S. Environmental Protection Agency's (EPA) February 21, 2008, Federal Register notice on the draft third Contaminant Candidate List (CCL 3) under the Safe Drinking Water Act (SDWA). The NMP Producers Group members include the domestic producers of NMP.[FN1: Members of the NMP Producers Group are: BASF Corporation, International Specialty Products, Inc., and LyondellBasell Industries.] Because NMP is one of the chemical contaminants included on the draft CCL 3, the Group has a strong interest in the list and the approach that EPA used to develop it.

The Group urges EPA not to include NMP on the final CCL 3.

Based on EPA's own criteria, NMP should not have moved from the universe of potential CCL candidates (Universe) to the Preliminary CCL (PCCL). Moreover, EPA did not use the best

available data in scoring NMP's health effects.EPA Should Have Categorized NMP in Toxicity Category 5 and Not

Moved NMP from the Universe to the PCCL

EPA states that it used a "multi-step process, based on

available data, to characterize occurrence and adverse health risks a contaminant may pose to consumers of public water systems for inclusion on the [CCL]."[FN2: EPA, Contaminant Candidate List 3 Chemicals: Screening to a PCCL, at 1 (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0044 (Screening to a PCCL).] These steps included building a universe of potential drinking water contaminants for consideration (Universe), using "straightforward screening criteria" to narrow the Universe to the PCCL, and "using a structured classification approach (e.g., a classification model) as a tool, along with expert judgment, to develop a proposed CCL from the PCCL."[FN3: Id.]

During the Universe-to-PCCL screening step, EPA partitioned chemicals into one of five toxicity categories (TC). EPA states that it "selected ranges of toxicity values for each toxicity category that differed based upon the type of data element."[FN4: 73 Fed. Reg. at 9636.] The data element types included reference doses (RfD) and their equivalents (e.g., tolerable daily intakes (TDI) from the World Health Organization (W HO)), no observed adverse effect levels, lowest observed adverse effect levels (LOAEL), maximum recommended daily doses, and lethal dose 50 (LD50) levels.[FN5: See Screening to a PCCL at 2-8 (showing how Exhibit 4 indicates "how the Universe dose-response data elements partition into their toxicity categories for screening").]

During the Universe-to-PCCL screening step, EPA categorized NMP in TC 4, the second lowest of the five toxicity categories.[FN6: Id. at 3, 31.] EPA relied on a 120 milligrams per kilograms per day (mg/kg/day) LOAEL and partitioned this

value into TC 4.[FN7: Id. at 7-8 (Exhibit 4), 31.] Based on this toxicity categorization and NMP's environmental release data, EPA moved NMP from the Universe to the PCCL.[FN8: Id. at 18 (Exhibit 11).]Once on the PCCL, EPA undertook the PCCL-to-CCL classification

step, in which it used the attributes of "potency" and "severity" to evaluate NMP's health effects.[FN9: EPA, Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCL, at 5 (Feb. 2008 Draft) (Classification of the PCCL to CCL), available at EPA-HQ-OW-2007-1189-0046.] In assessing NMP's health effects during this more detailed step, EPA relied not on the 120 mg/kg/day LOAEL, but on the W HO's TDI value of 0.6 mg/kg-day.[FN10: EPA, Contaminant Information Sheets for the Draft CCL 3 Chemicals, at 135 (Feb. 2008 Draft) (Information Sheets), available at EPA-HQ-OW-2007-1189-0042.] NMP received a score of 3 for potency and 5 for severity based on the TDI value. In view of these scores and NMP's

env ironmental release data, EPA selected NMP for inclusion on the draft CCL 3.

EPA stated that the PCCL-to-CCL classification step involves "a more detailed evaluation of ... health effects" data. EPA further stated that during the classification step, EPA sought to ensure, inter alia, a "meaningful basis for classification" as well as the "incorporati[on] [of] relevant data."[FN11: Classification of the PCCL to CCL at 2.] There is no rational basis for EPA to rely upon the TDI during its more detailed

evaluation, but not to rely upon that same value during the Universe-to-PCCL screening step. Given EPA's criteria for determining which chemicals move from the Universe to the PCCL, NMP should not have moved to the PCCL based on a 0.6 TDI -- which, as an RfD-equivalent value, falls within TC 5 -- in combination with its environmental release data.[FN12: See Screening to a PCCL at 8 (Exhibit 4), 18 (Exhibit 11).]

EPA Must Be Transparent and Rely on the Best Available Data for NMP

EPA's guidelines under the Information Quality Act (IQA)[FN13: Congress enacted the IQA to ensure the consistency and quality of information disseminated by federal agencies. The statute required the Office of Management and Budget (OMB) to develop federal government-wide guidelines that "provide policy and procedural guidance to Federal agencies for ensuring andmaximizing the quality, objectivity, utility, and integrity of

information (including statistical information) disseminated by Federal agencies," and called upon individual agencies to issue their own guidelines "ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by the agency." 44 U.S.C. § 3516, note. OMB issued the final version of the government- wide IQA guidelines in early 2002, see 67 Fed. Reg. 8452 (Feb. 22, 2002), and EPA issued its IQA guidelines later that year. See EPA, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity, of Information Disseminated by the Env ironmental Protection Agency (Oct. 2002) (IQA Guidelines), available at http://www.epa.gov/quality/informationguidelines/documents/EPA_ InfoQualityGuidelines.pdf.] affirm that "EPA is dedicated to the collection, generation, and dissemination of high quality information."[FN14: IQA Guidelines at 10, 21.]

Consistency with its IQA Guidelines requires EPA to ensure transparency and disclose fully all the data that it relies upon in making regulatory decisions, such as NMP's inclusion on the PCCL or draft CCL 3. Even though, for the reasons discussed above, EPA should not rely upon the 120 mg/kg/day LOAEL in determining whether NMP moves from the Universe to the PCCL, it is difficult for the Group to determine what study EPA relied upon in using a 120 mg/kg/day LOAEL for purposes of the Universe-to- PCCL screening step. A review of information made

available publicly regarding the values upon which EPA relied during the CCL 3 process indicates that the 120 mg/kg/day LOAEL was derived from a National Technical Information Service (NTIS) document and that the critical effect was "endocrine -- changes in spleen weight."[FN15: Information Sheets at 135.] EPA does not reference the particular study, however, and it is unclear which study EPA is relying upon. The Group urges EPA to ensure transparency and clearly identify the study upon which EPA determined that NMP should move from the Universe to the PCCL.

Moreover, EPA did not use the best available data in scoring NMP's health effects for purposes of the classification step. In implementing SDWA Section 1412, EPA is required to use "the best available, peer-rev iewed science and supporting studiesconducted in accordance with sound and objective scientific

practices."[FN16: 42 U.S.C. § 300g-1(b)(3)(A).] EPA, acting as the Organization for Economic Cooperation and Development (OECD) sponsor country for NMP, presented NMP at the Screening Information Data Set (SIDS) Initial Assessment Meeting (SIAM) 24 held in Paris, France in 2007. A copy of the most recent draft version SIDS Initial Assessment Report (SIAR) is appended. The studies identified as critical studies in the SIAR represent the best available data available for NMP and should be used by EPA in scoring NMP's health effects.

The Group appreciates the opportunity to submit these comments. For the reasons discussed above, NMP should not be included on the final CCL 3. [ See PDF for attachment.]

Sincerely,

Patrick L. Gibson, Chair NMP Producers Group, Inc.

Attachment

cc: NMP Producers Group, Inc. (w/attachment) (via e-mail) CS Title: 0129 Company/group/association name: Comment:

May 21, 2008

Via Electronic Submission

Water Docket U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460Re: Comments on Drinking Water Contaminant Candidate List 3-

Draft Docket ID No. EPA-HQ-OW-2007-1189; Chemical Abstract Serv ices Registry Number (CASRN) 7440-62-2

The Vanadium Producers and Reclaimers Association (VPRA) welcomes the opportunity to prov ide these comments concerning the U.S. Environmental Protection Agency's (EPA) draft Contaminant Candidate List (CCL 3),[FN1: 73 FED. REG. 9628 (Feb. 21, 2008).] specifically with respect to the EPA's recommendations with respect to elemental vanadium (CASRN 7440-62-2).[FN2: Id. at 9633, Exh. 2.] The VPRA is a not-for- profit corporation whose members are engaged in the production and reclamation of vanadium in the United States, primarily in the metals and materials manufacturing and chemical industries. The VPRA recommends that vanadium be removed from further consideration for CCL 3 listing under the Safe Drinking Water Act (SDWA) for the following reasons: EPA's health effects data show only minor effects that do not support listing elemental

vanadium as a contaminant; EPA's occurrence data show elemental

vanadium as present well below the levels identified by the MRL, RfD, and chronic LOAEL values that the EPA selected for analysis; and the data set on which EPA relies is weak and is not focused specifically on elemental vanadium-the substance EPA has listed in the draft CCL 3-thus undercutting the basis for listing. EPA's apparent assumption that the toxicity of

vanadium compounds is due merely to their vanadium content is not supportable. As explained in VPRA's comments, available chemical, physical and toxicological data demonstrate that

vanadium compounds differ significantly from one another.

I. Summary of EPA's Findings for Vanadium

To develop the draft CCL 3 that is the subject of this comment period, EPA initially evaluated a broad universe of approximately 7,500 potential chemical and microbial contaminants, and applied screening criteria to pare that universe down to 560 substances for further study (the "preliminary CCL", or PCCL).[FN3: See generally U.S. EPA Office of Water, Contaminant Candidate List 3 Chemicals: Screening toa PCCL (Draft), EPA 815-R-08-003 (Feb. 2008) (hereinafter "PCCL

Screening Document").] EPA then selected 104 substances (93 chemicals, including vanadium, and 13 microbials) from the PCCL to comprise this draft CCL 3 using a highly complex series of classification algorithms, explained in some detail.[FN4: Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCL, Office of Water 4607M, EPA 815-R-08-004, Feb. 2008-Draft, www.eap.gpv/safewater (hereinafter "PCCL to CCL Screening Document").]

EPA is proposing to designate vanadium as a Toxicity Category 3 chemical, with Toxicity Category 1 being the category of most concern and Toxicity Category 5 being reserved for substances of low concern.[FN5: PCCL Screening Document, Appx. 22, at 35.] Toxicity Category 3 is also referenced in EPA background documents as the most common toxicity categorization, or the "central tendency grouping";[FN6: Contaminant Candidate List 3 Chemicals: Screening to a PCCL, Office of Water (4607M), EPA 815-R-08-003, Feb. 2008-Draft, at p. 3.] it is also the first EPA Category grouping in which any toxicological effects (no matter how small) are observed, and does not in itself serve as a basis alone to go forward with a CCL 3 listing. This designation appears to be based on the "attribute scores" that the EPA has assigned vanadium to evaluate its health effects and occurrence in drinking water.[FN7: See PCCL Screening Document, Vanadium Contaminant Information Sheet, p. 188 ("Attribute Scores" summary table at the top of the page).] EPA's proposed conclusions with respect to vanadium may be summarized as follows:

[EPAs proposed conclusions with respect to vanadium may be summarized as follows:] * Low doses of vanadium are not of significant concern for adverse health effects.

* The critical effects selected for vanadium for consideration are slight effects that are reversible or of minimal toxicological significance.[FN8: See PCCL to CCL Screening Document, Exh. A-3.] In this study, other parameters that were unaffected at all exposure levels include weight gain, organ weights, and liver function.[FN9: See, e.g., Agency for Toxic Substances and Disease Registry, Toxicological Profile for Vanadium and Compounds (July 1992) (hereinafter "ATSDR 1992Profile"). The toxicology profile is available at

http://www.atsdr.cdc.gov/mrls/index.html.]

* The occurrence ranking for vanadium implies that it has a relatively high prevalence, although the summary of the database findings that EPA provides in the public record does not appear to support such a determination.[FN10: PCCL Screening Document, Vanadium Contaminant Information Sheet, at 188.]

* EPA's prevalence ranking of "10" for vanadium (the highest prevalence factor possible) makes little sense given that elemental vanadium is virtually insoluble in water.[FN11: See, e.g., ATSDR 1992 Profile, at Table 3-2.] EPA's background information notes a water solubility for vanadium of 8,000 mg/L.[FN12: PCCL Screening Document, Vanadium Contaminant Information Sheet, at 188.] This is not accurate. As explained further in Section III below, it is very unlikely for vanadium to be present in drinking water systems at a level that warrants listing on the CCL 3.

* A distinct but corollary concept is EPA's proposed identification of vanadium as "assume persistent", based on uncited data that is not provided in the public record for a specific vanadium compound.[FN13: PCCL Screening Document, Vanadium Contaminant Information Sheet, at 188.] It is not appropriate for EPA to use relative persistence[FN14: See, e.g., 63 FED. REG. 53,417, 53,421 (Oct. 5, 1998) (one must also

evaluate a substance's tendency to bioaccumulate). In this regard, a review of the relevant scientific literature tends to indicate that vanadium's bioavailability is very low, usually found to be less than 1% of an administered dose, and most ingested vanadium is excreted unabsorbed. See, e.g., Harris, W. R., Friedman, S.B., and Silberman, D. (1984) J. INORG. BIOCHEM. 20, 157-69; Patterson, B.W . et al. (1986) AM. J. PHYSIOL. 251, R325-32.] alone as a criterion for evaluating the

env ironmental effects of a naturally occurring element such as

vanadium. Also, in this regard, EPA's note "biodegrades sometimes" is confusing and inconsistent with EPA's proposed, unqualified finding of persistence. For these reasons, the VPRA requests that the reference be deleted.* EPA's complex classification algorithm process has resulted

in a determination of "L?", indicating that the agency believes that vanadium is on the boundary of a decision to include or not include on the final CCL. In addition, the expert disagreement with the proposed "L?" decision favors not listing

vanadium on the CCL 3.[FN15: PCCL to CCL Screening Document, Appx. F (Chemicals Reviewed by the EPA Evaluation Team: Summary of Results), at F-4.]

II. The Health Effects Data Used Do Not Support the Proposed Listing for Elemental Vanadium.

EPA chose to rely on the Agency for Toxic Substances and Disease Registry's (ATSDR's) Minimum Risk Level (MRL) of 0.003 mg/kg/day rather than the RfD value of 0.007 mg/kg/day listed under the Health Effects Data for the Risk Assessment Information System (RAIS) database maintained by the Department of Energy. W hile EPA maintains that, in general, an MRL is "roughly equivalent to the RfD,"[FN16: Id.] this is not true for vanadium and EPA's modeling results. EPA's use of the MRL has a direct and overly conservative effect on the outcome of EPA's modeling, and has resulted in an inflated potency rating for vanadium.[FN17: Id. at Appx. A, Exh. A.1, and Potency Scoring Table, Exh. A-2] ATSDR states that "[i]t is important to note that MRLs are not intended to define clean up or action levels for ATSDR or other Agencies" (emphasis in original).[FN18: See Footnote 9, supra, available at http://www.atsdr.cdc.gov/mrls/.] EPA has not sufficiently articulated for the record why it used the MRL value instead of the RfD in this case. Because both of these values exist, the use of the MRL in this case fundamentally undermines the degree of confidence associated with the already borderline "L?" decision.

A more serious flaw in EPA's use of the MRL is the inconsistency of the database noted for the health effects information. EPA lists the Registry of Toxic Effects of Chemical Substances (RTECS) Lowest Oral Chronic Effect Level (LOAEL) of 960 mg/kg/day, but this dataset is not considered inEPA's assessment.[FN19: See PCCL to CCL Screening Document,

Vanadium Contaminant Information Sheet, at 187. The corresponding ATSDR toxicology profile is available at http://www.atsdr.cdc.gov/mrls/index.html. The corresponding RAISHE database can be viewed at http://rais.ornl.gov/.] The RTECS value for a LOAEL for chronic exposure indicates a very low toxicity and is not consistent with either the MRL or RfD

values noted. Use of this alternative dataset would yield an RfD that would be markedly higher than the one EPA employs. Both the RfD and RTECS LOAEL are found in EPA's summary tables for vanadium.[FN20: PCCL Screening Document, Vanadium Contaminant Information Sheet, at 187.] Furthermore, the RTECS LOAEL is for chronic toxicity and is consistent with the EPA's assessments for drinking water. Use of the RTECS value also would result in a potency score for vanadium significantly ower than the value of "6" employed in the EPA's modeling approach.[FN21: See Footnote 17, supra.]

Another basis to forego further consideration of elemental

vanadium in this process is that none of the data relied upon by the EPA are studies on the health effects of elemental

vanadium, which is the substance identified for proposed listing by CASRN 7440-62-2. EPA's apparent assumption that the toxicity of vanadium compounds is due merely to their vanadium content is not supportable. "The toxicity of vanadium depends on its physico-chemical state; particularly on its valence state and solubility."[FN22: Dennis M. Opresko, Ph.D., Toxicity Summary for Vanadium and Vanadium Compounds (Dec. 1991), at 1,

available at http://risk.lsd.ornl.gov/rap_hp.shtml.] It is not scientifically sound to assess the risks of elemental vanadium by grouping all vanadium compounds together.

The wide disparity of the data reflects the limitations in the dataset EPA used in its assessment. Examples of the data EPA has inappropriately used in this listing proposal include:

* The study used to establish the critical health effect to be regulated is a study of sodium metavanadate that showed mild histological changes in a few tissues while other parameters measured (including weight gain, organ weights, and liver function) were unaffected at all doses tested.* Data on vanadium pentoxide were listed in the tables of EPA's

draft background documents.[FN23: See PCCL Screening Document, Vanadium Pentoxide Contaminant Information Sheet, at 1057-58.] These data should not be used as the basis for the proposed listing for elemental vanadium; the Contaminant Information Sheets and other listings in the background tables related to

vanadium pentoxide should be deleted, as this specific vanadium compound is not being proposed for listing.

In addition, the reference to vanadium pentoxide as a teratogen is directly contradicted by the ATSDR toxicology profile. The ATSDR concluded under developmental effects that minor skeletal abnormalities (including supernumary ribs and delayed skeletal ossification) have been noted in the offspring of animals that have been injected with vanadium.[FN24: See ATSDR 1992 Profile, at 28.] Compounds causing only such minor effects are not classified as teratogens, and the ATSDR did not do so. Moreover, the ATSDR 1992 Profile clearly states the relevance of these findings is not known.[FN25: Id.] Furthermore, EPA's reliance on injection as the route of exposure is not appropriate for assessing potential effects from ingestion, and this exposure pathway is not appropriate for developmental studies. In particular, the reference to the University of Maryland's (UMD's) "Partial List of Acute Toxins" should be deleted because it is not for elemental vanadium, it does not specify a teratogenic effect, and it is not supported by the ATSDR assessment.[FN26: PCCL Screening Document, Vanadium Pentoxide Contaminant Information Sheet, at 1057.]

The use of studies examining other compounds and inapplicable exposure pathways necessarily undercuts any reasonable basis for establishing the effects of elemental vanadium through oral ingestion of drinking water. Indeed, EPA has so indicated in its technical support documents to this rule.[FN27: See, e.g., PCCL to CCL Screening Document, at 2, n. 12 ("The most relevant data used for the classification process include health effects data that are appropriate for drinking water exposures, and occurrence data that indicate the nature and spatial extent of potential occurrence in drinking water.").]In summary, the health effects data used to propose this

listing form an inadequate public record for listing elemental

vanadium on the CCL 3.

III. The Occurrence Data Used Do Not Support the Proposed Listing for Elemental Vanadium.

EPA's assignment for vanadium of the highest prevalence factor ("10") makes little sense given that, as the ATSDR 1992 Profile (on which EPA relies) indicates, elemental vanadium is virtually insoluble in water.[FN28: See ATSDR 1992 Profile at Table 3-2.] ATSDR's conclusion on this point is consistent with other scientific data sources,[FN29: See, e.g., CRC HANDBOOK OF CHEMISTRY AND PHYSICS, 37th Ed., at 618-19.] contradicts plainly EPA's uncited water solubility value of 8,000 mg/L,[FN30: See PCCL Screening Document, Vanadium Contaminant Information Sheet, at 188.] and makes it exceedingly unlikely that vanadium could persist in drinking water systems at the levels suggested by the EPA Evaluation Team's documents. For these reasons the VPRA requests that EPA revise its prevalence factor findings to be consistent with the ATSDR 1992 Profile's data on solubility.

Moreover, EPA fails to articulate its reasoning associated with the information presented in its summary of the NIRS data on

vanadium.[FN31: Id.] The NIRS data represents relatively old (1985) monitoring results in which vanadium was detected; at that time, only 146 of the 989 public water systems (PWSs) were sampled. The median detection value of 7.3 μg/L indicates a low level of concern, well below the MRL and RfD values[FN32: The use of the median is consistent with EPA's statement that "[t] he median was selected [for use] over mean because it typically is a more stable estimate of central tendency in environmental occurrence data." PCCL to CCL Screening Document, at 20.] based on the VPRA's use of EPA's default assumptions for determining Drinking Water Level of Comparison (DW LOC) values.[FN33: See U.S. EPA Office of Pesticide Programs, Standard Operating Procedure (SOP) for Incorporating Screening-Level Estimates of Drinking Water Exposure into Aggregate Risk Assessments, Public Comment Draft (Sept. 1, 2000), at 10.] Using the median of 7.3μg/L from the NIRS reported data, the following exposure values

were derived:

Adult males: 7.3 μg/L (10-3 μg/mg(2 L/day) / 70 kg bw = 2.09 x 10 -4 mg/kg bw/day

Adult females: 7.3 μg/L (10-3 μg/mg(2 L/day) / 60 kg bw = 2.43 x 10 -4 mg/kg bw/day

Infants/children: 7.3 μg/L (10-3 μg/mg(2 L/day) / 10 kg bw = 7.3 x 10 -4 mg/kg bw/day

These results show potential exposures to be well below the no significant risk levels established by the MRL and RfD values based on the NIRS data. VPRA respectfully submits that additional considerations such as these are reasonable and appropriate in the case of substances such as elemental

vanadium, that are naturally occurring and that are recognized as nutritionally important in the human diet.[FN34: Vanadium is a beneficial trace element that is unavoidably present at low levels (micrograms or less) in most plant and animal tissues. In rats, chicks and goats, a variety of inconsistent deficiency symptoms have been seen under conditions of synthetic diets with all vanadium excluded. Such signs include reduced growth, poor bone development, impaired reproductive capacity and, in chicks, poor feather development. See generally Nielsen, F.H. (1995) MET. IONS BIOL. SYST. 31, 543-73; Nechay, B.R. et al. (1986) FASEB J. 45, 123-132; W hitney, E.N., Cataldo, C.B., and Rolfes, S.R. (2002) Understanding normal and clinical nutrition, 6th ed., Wadsworth/Thomas Learning, Stamford, CT USA.] These data do not justify going forward with a listing for vanadium on the CCL 3, because they do not adequately establish that there is a substantial likelihood that vanadium occurs in public water systems with a frequency and at levels of public health concern.

IV. Conclusion and Request for ReliefIn conclusion, VPRA is asking EPA to decide not to list

elemental vanadium on the CCL 3 list. A CCL listing depends in no small measure, on having a high degree of confidence that the data relied upon for the listing (1) are clear and easily understood by the regulated community; (2) are generated from data on the chemical substance that is the subject of the listing; and (3) represent the same or similar exposure pathways as the pathway EPA seeks to eventually regulate. The weak data set underpinning EPA's proposed findings for elemental vanadium does not allow EPA to meet these elements. Vanadium at the levels of detection reported in the NIRS survey possesses a low risk for human health impacts. EPA's modeling conclusion squarely reflects the questionable nature of going forward with a listing. For these reasons, the record in this rulemaking has not sufficiently established the factual basis by which to determine that vanadium "may require regulation under [the SDWA]."[FN35: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I).]

* * *

The VPRA appreciates this opportunity to prov ide its comments, and would be pleased to address any questions the EPA may have concerning these comments. Questions may be directed to John Hilbert, President of the VPRA, at (202) 842-0219.

Respectfully submitted,

John W . Hilbert III, President The Vanadium Producers and Reclaimers Association 900 Second Street, N.E. Suite 201 Washington, D.C. 20002 Tel: (202) 842-3204 Fax: (202) 842-0439

Of Counsel: Martha E. Marrapese, Esq. Jason E. Yearout, Esq. Keller and Heckman LLP1001 G Street, N.W .

Suite 500 West Washington, DC 20001 CS Title: 0133 Company/group/association name: Comment:

21 May 2008

Water Docket, Environmental Protection Agency Mail code: 2822T, 1200 Pennsylvania Ave., NW . Washington, DC 20460 USA

Subject: Comments on the US EPA Drinking Water Contaminant Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) Docket ID No.: EPA-HQ-OW-2007-1189

Dear Sir or Madam:

I am writing on behalf of the North American Metals Council ("NAMC") to express the Council's views on the listing of molybdenum on EPA's Drinking Water Contaminant Candidate List 3 (CCL3). NAMC is an unincorporated not-for-profit group of North American-based metals-producing and metals-using associations and companies.[FN1: A more complete description of NAMC can be found on its website at http://www.namc.org.] One of NAMC's prime objectives is to ensure that sound science is used in regulatory decision-making for metals. Toward that end, we wish to comment on the application to molybdenum of one of the criteria EPA uses for evaluating whether a chemical should be added to (or remain on) the Contaminant Candidate List, namely, the potential to cause adverse effects in humans.

NAMC does not believe EPA has made use of all of the available scientific information in proposing to include molybdenum on CCL3. In particular, we note that the potency score for molybdenum was based on a reference dose (0.005 mg/kg/day) thatwas derived using data for increased uric acid levels from a

study published by Koval'skiy et al. (1961) almost half a century ago and that EPA itself characterizes as having only a "medium" level of confidence. Other more recent (and better conducted) studies do not support the finding that molybdenum increases uric acid levels (Deosthale and Gopolan, 1974 and US EPA, 1979), even when ingested at higher dosage levels. That being the case, it is not appropriate to use 0.005 mg/kg/day as the reference dose to derive a human health effects potency score for molybdenum.

The International Molybdenum Association (IMOA) has very recently conducted a thorough rev iew of the available literature on molybdenum Repeated Dose Toxicity. The results of this review and an assessment of the need for additional data should be undertaken before a final decision regarding the inclusion of molybdenum on CCL3 is made.

Wethank you for this opportunity to submit comments on CCL3, and we would be prepared to discuss the issue further if that would be helpful.

Yours sincerely,

William J. Adams, Ph.D. Chairman, NAMC

Kindly direct further correspondence to: William.adams@riotinto.com Tel: + 1 801 558 0222

References:

Koval'skiy, G.A. et al., 1961. Changes of purine metabolism in man and animals under conditions of molybdenum biogeochemical prov inces. Zh. Obshch.Biol. 22: 179-191Deosthale, Y.G. and C. Gopalan. 1974. The effect of molybdenum

levels in sorghum (Sorghum vulgare Pers.) on uric acid and copper excretion in man. Br. J. Nutr. 31: 351-355.

U.S. EPA. 1979. Human health effects of molybdenum in drinking water. Cincinnati, OH. EPA-600A-79-006. CS Title: 0063 Company/group/association name: Comment:

The EPA online draft of the Contaminant Candidate List 3 gives a short description of each of the candidate contaminants. The description on perchlorates while not inaccurate gives the impression that the majority of the perchlorate contaminant in the United States is from manufacture for aerospace use.

Research found the following interesting facts. Chilean nitrate has been imported into the United States since early 20th century. In 2001 the U.S. imported 88,150 metric tons of Chilean nitrate according to the Foreign Trade division, U.S. Census Bureau. Perchlorates make up 3.64% +/- 0.34 of Chilean Nitrates. That makes approximately 3,209 metric tons of perchlorates distributed on U.S. fields in one year by one product alone. This averages out to approximately 0.3 ounces per acre of every crop land acre of the U.S. or 1.36 pounds of pure perchlorate per acre since Chilean nitrates have been imported. This does not account for the other fertilizer components that contain perchlorates, the fact that the U.S. imports less Chilean nitrates in recent years than in the past, nor the fact that some fields would have much more and some less. The percentages of other fertilizer components that are also high in perchlorates include langbenite: 1.86%, dihydrogen ammonium phosphate: 0.46%, and potash (murate): 0.36%. It is recommended that EPA revise their description of perchlorates and not emphasize the manufacture of solid rocket propellant as heav ily, and continue to search for true sources of this contaminant. Otherwise, perchlorates will continue to be a real threat to Americans by way of contaminated water and foodstuffs. CS Title: 0086Company/group/association name:

Comment:

USEPA Drinking Water Contaminant Candidate List and Regulatory Determinations

Submitted by: Joseph Cotruvo, Joseph Cotruvo & Associates, LLC Richard Bull, MoBull Consulting James Crook, Reuse Consultant Margaret W hittaker, ToxServices, LLC

Weare providing the attached information and dossiers to the record of the CCL3 process for your consideration. These documents were prepared as part of the WateReuse Foundation's funded Project 06-004: Identifying Health Effects Concerns of the Water Reuse Industry and Prioritizing Research Needs for Nomination of Chemicals for Research to Appropriate Health Agencies . They were prepared by the research team that consisted of Joseph Cotruvo PI, Richard Bull, Margaret Whittaker and staff of ToxServices and James Crook. The comments and views detailed herein may not necessarily reflect the views of the WateReuse Foundation, its officers, directors, employees, affiliates, or agents. These draft documents and their concepts were reviewed by an invited interdisciplinary expert committee that met on April 22-23, 2008, and they will form the basis for expanded documents that will ultimately become the deliverables for the project.

Although the title of the project refers to concerns of the water reuse industry, the information contained therein is relevant to public water supplies in general, and in particular, those whose source waters are recipients of treated upstream discharges, therefore these comments are highly pertinent to the CCL3 decision process. Some of them amply demonstrate the intimate linkage between wastewater treatment and upstream discharges, and the quality of treated drinking water as determined by the technologies that are employed.

The information provided includes a compilation of waterquality data associated with standard and advanced waste

treatment processes and it identifies monitored chemicals that are either removed or not well removed by these unit processes. For example, the data demonstrate that membrane processes and particularly reverse osmosis remove virtually all organic (and inorganic) chemicals of potential concern to very low usually not detectable levels, (except e.g., low molecular weight nitrosamines derived from interactions between chloramines disinfectants and wastewater components, for which, if present, other technologies are required). They demonstrate that well designed advanced waste treatment aimed at planned indirect potable reuse produces product water that is higher quality than surface sources that are receiv ing waters and sources of unplanned potable reuse.

The proposed CCL3 contains numerous chemicals that are either chemically reactive (e.g., oxirane, methyl-, not toxic (e.g., N-methyl-2-pyrrolidone), unlikely to be found widely in national drinking waters (e.g.,RDX ), more likely to be found in foods (e.g., methanol), unstable in the water process system (e.g., cumene hydroperoxide, and toluene diisocyanate) indicating that the selection and screening process requires significant reconsideration.

However it is notable by the absence of disinfection by- products, except for 5 N-nitrosamines. We find this to be remarkable and baffling considering that disinfection by- products are virtually unique to drinking water supplies and they may result in almost universal exposures to consumers based upon the type of disinfection and treatment system being utilized in their water supply. The dossiers include substantial information on disinfection by-products that have not received sufficient investigation with regard to risk. One (DBP-1) is a general review of the chemistry of major drinking water disinfectants and identifies several categories of by- products that have a high probability of being relatively toxic compounds. These include compounds that have been identified and others that have a high potential to be present. They include: N-chlorinated amines and other N-chloroorganic nitrogen compounds, haloquinones, other nitrosamines and halonitriles, haloaldehydes, halopropanones. The additional DBP dossiers prov ide more specific information on the categories ofsubstances and identify specific research that is needed to

allow risk assessments to be conducted on the chemicals. The latter is important to help EPA develop research strategies to prepare for decisions to be made in future CCL determinations.

The several Pharmaceuticals documents provide assessments of the pharmaceuticals that have been reported in drinking waters and source water and conclude that most of them are of little or no concern for public health because their MOEs relative to their lowest therapeutic doses (assumed to be LOAELs for most pharmaceuticals) are very large. However, they also point out that certain types of pharmaceuticals cannot be assessed in that way because of their modes of action. Some are genotoxic carcinogens (e.g. chemotherapeutic agents). Others, like the statins ,are potential hazards to sensitive populations that are not considered in their therapeutic uses in older populations. Because there are many statins prescribed and they are developmental toxicants, their cumulative risk during gestation and early postnatal development should be assessed. In addition there are several different mechanisms represented among antilipidemic drugs that could well lead to synergistic effects on the developing fetus. Similarly, antihypertensives are generally considered to be developmental toxicants and act by a large number of different mechanisms of action.

Importantly, we also conclude that many pharmaceuticals of high current use are not among the reported measured chemicals in drinking water and that analytical methods development is needed and a nationally organized survey should be carried out that is representative not only of the volume of these drugs that are used, but also takes into account the very large differences in the effective doses of pharmaceuticals. The lowest therapeutic dose is a rational and easily identified reference to levels of these compounds that are biologically active and which could be minimally harmful (i.e., LOAELs). For many drugs, the frequency of adverse effects associated with these doses in humans is known, prov iding a much better benchmark for estimating safe doses than the pre-clinical animal studies. The national survey should also consider the metabolism of these drugs, focusing primarily on metabolites that are pharmacologically and toxicologically active.Nanoparticles as a group are subjects of interest, although

there is a meager amount of research on ingestion toxicology. On the other hand it is likely that many of them are removed by

env ironmental transport, aggregation and coagulation and sedimentation, and certainly by membrane processes.

Wewould like to have the opportunity to meet with appropriate persons and offices in EPA to provide elaborations and to discuss the occurrence and exposure and toxicology research that is need to address the issues that we have identified.

Attachments

DBP-1 Disinfection as a Source of Diverse By-Products of Potential Health Concern

DBP-2 Nitrosamines

DBP-3 Developmental Neurotoxic Effects of Bromate

DBP-4 Halonitriles

DBP-5 Haloaldehydes

DBP-6 Halopropanones

DBP-7 Organic N-Chloramines

DBP-8 Halofuranones, haloquinones, and related compounds [See PDF for Attachments]

Pharm 2- Cumulative Risk from Pharmaceuticals with Common Modes of Action: StatinsPharm 3- Synergisms Among Pharmaceuticals and Other Water

Contaminants that Have Different Modes of Action, but Affect the Same Physiological Systems: Antilipidemic Drugs, Phthalates, PFOAs & Disinfectant By-products

Pharm 4- Synergisms among Pharmaceuticals with Different Modes of Action that Affect the Same Physiological Functions: Anti- Hypertensive Drugs

Pharm 5- Bioavailability of Organic Iodine in Contrast Media

Pharm 6- Genotoxic Carcinogens

Pharm 8- Survey of Pharmaceuticals in Wastewaters and Drinking Waters that is Representative of Important Classes [See PDF for Attachments]

Summary from 38 Data Sets from Wastewater Treatment Facilities

Nanotechnology [See PDF for Attachments] CS Title: 0093 Company/group/association name: Comment:

May 19, 2008

Water Docket U.S. Environmental Protection Agency Ariel Rios Building, Mail Code 2822T 1200 Pennsylvania Avenue, N.W . Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2007-1189 Drinking Water Contaminant Candidate List 3-Draft (73 Fed. Reg. 9628, February 21, 2008)

Ladies and Gentlemen:

The Pharmaceutical Research and Manufacturers of America(PhRMA) is pleased to submit these comments on the U.S.

Environmental Protection Agency's (EPA) Drinking Water Contaminant Candidate List 3 (CCL3). EPA has published the methodology that it used to identify the candidate chemicals for CCL3 (73 Fed. Reg. 9628, February 21, 2008) (Notice). The Notice makes available for public review and comment the results and recommendations of EPA's evaluation of potential drinking water contaminants that should be investigated further for addition to the primary drinking water regulations. PhRMA has carefully reviewed the Notice and is pleased to offer these comments on the CCL3 and EPA's methodology for identifying candidate chemicals.

PhRMA represents the country's leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to lead longer, happier, healthier and more productive lives. Investing over $30 billion annually in discovering and developing new medicines, PhRMA companies are leading the way in the search for cures. PhRMA member companies are continuously developing new products and optimizing their production processes. Because active pharmaceutical ingredients (API) are a class of chemicals that has been evaluated for inclusion in the CCL3, EPAs evaluation process for determination of which APIs are included on the proposed CCL3 is of considerable importance to PhRMA.

EPA has requested comments on the methodology that it used to develop the draft CCL3 and on its decisions to identify chemicals in specific contaminant classes, including pharmaceuticals, in the draft CCL3 (73 Fed. Reg. 9651-53). The Agency also requests any additional data and studies that support its proposed listings and that may support adding chemicals to the draft list.

PhRMA is specifically responding to EPA's request for comments in the following sections of the Notice:

EPA's methodology for identifying candidate contaminants has a strong scientific foundation and has been rigorously applied.EPA has responded to recommendations from the National Research

Council (NRC) and National Drinking Water Advisory Council (NDWAC) by developing and implementing a multi-step process to identify candidate contaminants for addition to the National drinking water standards. This methodology incorporates both public input and expert review at several points in the process to identify a broad universe of candidate contaminants and then

evaluate the potential frequency of occurrence in drinking water supplies and the potential health effects of each such contaminant to develop candidates for further evaluation for potential drinking water criteria.

The EPA methodology evaluates contaminant health effects, occurrence (prevalence), and environmental fate to identify specific contaminants of concern. All of these factors are essential elements of a science-based assessment procedure and PhRMA supports EPA's implementation of these in the CCL3 methodology.

The inclusion of the public in the methodology considerably strengthens the identification of contaminants of concern. The opportunity for the public to offer suggestions and recommendations for the list allows both the general public and regulated entities (e.g., states, cities, water suppliers) to prov ide EPA with specific drinking water concerns that should be considered in the selection of contaminants for detailed study.

External expert panels, which EPA has used in preparing the draft list, are an invaluable and indeed necessary component of developing such a list. External experts, including academic and corporate researchers, bring to the evaluation process considerable knowledge of specific contaminants that complement EPA's data collection effort. In the case of APIs, the pharmaceutical industry researchers have knowledge of the human health effects, potency, occurrence, and environmental fate of specific chemicals that may not be available in EPA's data sources and its is essential that this information be included in the evaluation process. PhRMA strongly supports the use ofexternal experts in the contaminant listing process.

The CCL3 methodology, as described in the Notice and supporting documents, has a strong scientific foundation and has been rigorously applied by EPA to develop the candidate list of drinking water contaminants. PhRMA strongly supports EPA's methodology and how it has applied it to develop the draft CCL3.

EPA's conclusion that only one active pharmaceutical ingredient deserves listing on the draft CCL3 is supported by recent scientific publications.

EPA's CCL3 methodology evaluated 287 active pharmaceutical ingredients (API) as candidate CCL3 contaminants (the universe). Approximately 10% of these APIs were included on the preliminary CCL. The Agency concluded that only one API, nitroglycerin, should be proposed for inclusion on the CCL3 (73 Fed. Reg. 9652).

A 2008 research paper that is not included in EPA's contaminants database supports the conclusion of the draft CCL3 that few APIs are likely to be present in drinking water at potentially significant concentrations.[FN1: Focazio MJ, et al, "A national reconnaissance for pharmaceuticals and other organic wastewater contaminants in the United States-II) Untreated drinking water sources," Sci Total Env iron (2008), doi:10.1016/j.scitotenv .2008.02.021] This paper presents a summary of U.S. Geological Survey (USGS) reconnaissance sampling of 74 untreated surface and ground drinking water sources and analysis of the samples for sub-microgram/litre (μg/L) concentrations of emerging contaminants, including 36 APIs. USGS analyzed source samples for thirty-six (36) APIs (including prescription pharmaceuticals and antibiotics) and sixty percent (22) of the APIs were never detected at the sub- μg/L target detection limits. Only one API, carbamazepine, was detected in more than 8.1 percent (21.6 percent) of the source samples analyzed by the USGS.A 2005 paper published results of a study that evaluated human

health risk from pharmaceuticals in surface waters. The study

evaluated 26 APIs and used PhRMA's PhATE model to predict surface water concentrations, which were then used to evaluate human health risk due to drinking water exposure and fish consumption. The model predictions of surface water concentrations were compared to USGS surface water data for the same APIs and were shown to be conservative - i.e., the model predictions were higher than the measured concentrations. Based on the acceptable daily intakes of each API, the study concluded that the drinking water risk from the 26 APIs that

were evaluated was very low.[FN2: Schwab, B.W ., et al, "Human pharmaceuticals in US surface waters: A human health risk assessment," Regulatory Toxicology and Pharmacology, 42 (2005), 296-312/] EPA's CCL3 methodology has come to the same conclusion.

While there is considerable public concern regarding the presence of pharmaceutical compounds in public water supplies, there is a significant amount of data that supports the conclusions of EPA's draft CCL3 list - that APIs in drinking water are typically not present at concentrations that merit detailed evaluation for the potential development of drinking water standards.

Summary

PhRMA supports the methodology that EPA has developed and implemented to create the draft CCL3. Data collected and

evaluated by EPA regarding APIs in public water supply source water are supported by the technical literature and demonstrate that there is no current scientific basis for adding more APIs to the CCL3. PhRMA continues to actively develop new methodologies to evaluate the presence, fate and potential human health effects of APIs in surface and ground waters and will continue to share this information with EPA.

Weappreciate the opportunity to offer these comments. If you have any questions about PhRMA's comments, please contact me.Sincerely,

Michael Garvin, Pharm.D. Assistant Vice President, Science and Regulatory Affairs CS Title: 0094 Company/group/association name: Comment:

May 20, 2008

TO: Docket ID No. EPA-HQ-OW-2007-1189

FROM: Paul S. Berger, Ph.D.

SUBJECT: Comments on the Drinking Water Contaminant Candidate List 3-Draft (73 FR 9628, 21 February 2008)

I have the following three comments in response to the draft CCL3.

Comment 1: Please include adenov iruses, enterov iruses, and the Mycobacterium avium complex on CCL3.

I urge EPA to include the adenoviruses, enterov iruses, and the Mycobacterium avium complex (MAC) on CCL3. These PCCL pathogens were on the CCL1 and CCL2, and research to control these pathogens in drinking water is ongoing. It would be a shame if, after EPA and other groups had funded and conducted much of the needed research, EPA were to reverse its position and not make a regulatory decision regarding these pathogens. The exclusion of pathogens from a previous CCL without a regulatory decision on them seemingly represents both a waste of research money and a disruption of an orderly regulation development process.In addition, my sense is that little or no additional research

is needed for EPA to make a regulatory decision on Salmonella enterica, Shigella sonnei, Vibrio cholerae, and the hepatitis A virus, all of which are listed in the draft CCL3. I believe sufficient data are already available in the published literature to make a reasoned decision on these four pathogens.

Thus, I believe EPA resources for pathogens could be made

available to continue needed research on the adenov iruses, enteroviruses, MAC, and perhaps several other pathogens on the PCCL that EPA did not include on the draft CCL3.

Comment 2: The number of chemicals on the draft CCL3 relative to the number of pathogens is disproportionate.

The CCL2 included 42 chemicals and chemical groups. In the draft CCL3, this number has dramatically increased to 93, more than double. In marked contrast, the number of microbes has only increased from 9 on CCL2 to 11 (or 12 if the cyanotoxins are included). This stance suggests that a wildly disproportionate increase in EPA resources will be going to chemicals, compared to, and at the expense of, pathogens. W hat is the scientific justification for this resource allocation disparity? W hat is EPA's basis for claiming that every one of the 93 chemical and chemical groups listed in the draft CCL3 is more likely to pose a public health risk than the adenoviruses, enteroviruses, Mycobacterium av ium complex, and other PCCL pathogens that were not selected?

Comment 3: I support inclusion of cyanotoxins on the CCL3.

I strongly support EPA's decision to include the cyanotoxins on CCL3. CS Title: 0106 Company/group/association name: Comment:May 20,2008

Mr. Benjamin H. Grumbles Assistant Administrator U.S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N.W . Washington, D.C. 20460

Dear Administrator Grumbles:

I received your April 11, 2008, letter outlining the Environmental Protection Agency's interest and current actions regarding pharmaceuticals in our ambient and treated waters. We, too, are attentive to ensuring that our public water systems continue to provide safe drinking water for all consumers. Although our agency has received few inquiries from Arkansas consumers, this issue has generated many media inquires.

As you are aware, the results of monitoring programs examining the prevalence of pharmaceuticals and personal care products in water have been available for a number of years. It appears

evident from these results that waters located downstream from a sewer discharge or from a livestock operation will likely contain some traces of these contaminants at the parts per billion, parts per trillion, or even lower levels.

The Arkansas Department of Health is currently reviewing the feasibility and resources needed to initiate a public water systems pharmaceuticals or personal care product monitoring program. Currently, the Department does analysis for most of the regulated and unregulated contaminants outlined in the National Primary Drinking Water Regulations or attains the results from certified private laboratories for those contaminants for which we do not analyze. All of those data are contained within the federal Safe Drinking Water Information System (SDW IS) and are reported by our Department to the EPA on a quarterly basis.In order to best determine the feasibility of implementing a

program, the question of paramount importance is whether a chemical or a group of chemicals constitutes a health concern. If so, at what level does that concern begin and how can the level of exposure be reduced. A greater perspective of the types of chemicals present in wastewater and in ambient waters, the concentrations of the chemicals, the degree of removal of the chemicals by both wastewater and drinking water treatment processes, and the degree of natural degradation over time and distance in ambient waters are questions that deserve greater research. Additional data is also needed on the total body dose of these contaminants from other media, food, and air, as well as from our environmental exposure, including what we wear, where we work, and how we live our lives. Because these contaminants have multiple origins and involve multiple methods of exposure, the answers to these questions should not fall on any individual agency, but requires a coordinated national effort to harness the resources of federal, state, and local partners.

Such an effort should include:

* Improved data gathering to determine the prevalence and concentration of chemicals in the environment.

* Expanded research on the health effects from trace levels of chemicals.

* Improved communication with the public on the conclusions from the health effects research.

* Expanded programs to reduce the amount of waste going into the environment including better programs for proper disposal and take back of pharmaceuticals, and better treatment of wastewater before its discharge.* Enhanced awareness and education efforts among physicians,

pharmacists, and veterinarians.

* Greater emphasis on the importance of source water protection.

* Partnerships with generators of chemicals, including pharmaceutical companies, on responsible stewardship programs.

Your letter illuminated that the EPA considered 287 pharmaceuticals and personal care products for possible inclusion in the Contaminant Candidate List 3 (CCL3) for public water systems; however, only one chemical was included in the Draft CCL3. The reason given for this decision was your conclusion that "most of these chemicals occurred at very low levels compared to the best available human health effects date." Such a conclusion seems to imply that the EPA does not believe the presence of pharmaceuticals and personal care products in drinking water at the levels detected constitutes a public health concern based on currently available information. If that implication is correct, then it would be helpful to Arkansas for EPA to assist our state in communicating that conclusion to the public and to the media. If that implication is not correct, then it is reasonable to reevaluate the Draft CCL3 and to explore modifying that draft to include more of these chemicals as contaminants.

I stand ready to assist you in any way that I can. I am pleased that you have requested our input in this all-important matter and look forward to more dialogue on this topic as appropriate.

Sincerely,

Paul Halverson, DrPH, FACHE Director and State Health Officer CS Title: 0107 Company/group/association name: Comment:May 21, 2008

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

Re: Comments of the Pesticide Policy Coalition on EPA's "Drinking Water Contaminant Candidate List 3 - Draft; Notice." 72 FR 9627. February 21, 2008. Docket No. EPA-HQ-OW-2007-1189.

Dear Docket Manager:

The Pesticide Policy Coalition ("PPC" or the "Coalition") is pleased to submit comments to the U.S. Environmental Protection Agency ("EPA" or the "Agency") in response to the publication of the Agency's Draft Drinking Water Contaminant Candidate List 3 ("Draft CCL3") [EPA-HQ-OW-2007-1189 FRL-8529-7].

PPC represents a membership of food, agriculture, pest management and related organizations that support transparent, fair and science-based regulation of pest management. PPC members include: nationwide and regional farm, commodity, specialty crop, and silviculture organizations; cooperatives, food processors and marketers; pesticide manufacturers, formulators and distributors; pest- and vector-control operators; research organizations; and other interested parties. PPC serves as a forum for the review, discussion, development and advocacy of pest management policies and issues important to its members.

PPC recognizes that § 1412(b)(1) of the 1996 Safe Drinking Water Act Amendments ("SDWA") requires that EPA publish an updated list every five years of contaminants that are* not subject to any proposed or promulgated national primary

drinking water regulations,

* are known or anticipated to occur in public water systems, and

* may require regulation under the SDWA if

(a) the contaminant may have an adverse effect on the health of persons;

(b) 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

(c) if, 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.

EPA must evaluate candidate substances from several sources, including those registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"). EPA has finalized previous CCLs in 2002 and 2007, in which seven pesticides and two degradates were identified but not chosen for regulation.

The Coalition understands the CCL3 was compiled through a complex, multi-step process recommended by the National Academy of Sciences' National Research Council and developed by the Agency. EPA used an "adaptive management approach" to create a broadly defined universe of 7,500 chemical and biological drinking water contaminants from 284 data sources that, upon assessment with screening criteria for potential to occur in public water systems and potential for public health concern,was reduced to a preliminary CCL ("PCCL") of most significant

candidates. A final draft CCL3 of 93 chemicals or chemical groups and 11 microbiological contaminants was produced by EPA from the PCCL with structured classification models and expert judgment for chemicals that may occur in public water systems and cause adverse health effects. EPA also included on the CCL3 contaminants nominated by the public during the public comment period. Among these are 42 pesticides and pesticide degradates.

PPC supports the use of a transparent, objective, and scientifically robust selection mechanism for this and future CCLs. The Coalition recognizes the iterative process EPA used to develop the draft CCL3 goes a long way towards achieving these goals. However, PPC wishes to make the following observations and suggestions:

(1) The SDWA §1412(b)(1)(C) directs the Agency to select "contaminants for consideration ... that present the greatest public health concern." In the process of narrowing the universe of 7,500 unregulated chemicals down to the 93 most notable on this draft list, EPA selected nearly half to be pesticides or pesticide degradates. Such a selection bias is inconsistent with the toxicological knowledge and use controls posed by FIFRA, and with the extremely low levels of pesticides detected in either polished or ambient drinking water ("The likelihood of pesticide concentrations exceeding a human-health benchmark in a public-supply well or domestic well is low..." "pesticide concentrations exceeded one or more human-health benchmark in about 10% of [ambient] agricultural streams, 7 percent of urban streams, and in 1% of mixed-land-use streams." USGS, Pesticides in the Nation's Streams and Ground Water, 1992-2001). EPA has not clearly demonstrated in the process used to derive the draft CCL3 that these 42 pesticides and degradates represent a proportional share (42/93) of "those contaminants that pose the greatest public health concern..." The proportional share of pesticides and pesticide degradates on the list should also reflect the Agency's experience with prev ious CCLs, where none of the selected pesticides and degradates were ultimately deemed appropriate for regulation.

(2) Of the pesticides listed in the draft CCL3, three are nolonger in registered pesticide products. Ethion (CAS 563-12-2)

products were all cancelled in 2003, and all use of existing stocks was prohibited after 12/31/2004 (67 FR 13327; 3/22/2002). All ethion tolerances have been revoked, effective 10/1/2008 (69 FR 43918; 7/23/2004). For fenamiphos (CAS 22224-922), voluntary cancellation of the final remaining uses was published 4/23/2008; (73 FR 21942). Nitrofen (CAS 1836-75-5) has not been marketed since 1980. All product registrations were cancelled in 1984, and all tolerances were

revoked in 1985 (50 FR 37850; 9/18/1985).

(3) The PPC understands that data collected under the Unregulated Contaminant Monitoring Rule ("UCMR", [40 CFR §141.40]) are an important source of occurrence information for the CCL process. The UCMR requires all large public water systems and a subset of small systems to monitor for an identified list of unregulated contaminants, including several pesticides and pesticide degradates, and report occurrence data to EPA. The first UCMR of 30 chemicals was finalized in 1999, and in January 2007 EPA published a second list, "UCMR 2" (72 FR 367; 1/4/2007), of 25 additional chemicals to be monitored using five different analytical methods. From the UCMR, EPA collects data to evaluate and prioritize what action the agency will take on contaminants included in the CCL. However, as part of EPA's narrowing of the PCCL to this draft CCL3, EPA simply swept all of the UCMR 2 chemicals into the draft CCL3, even though the UCMR 2 monitoring won t be completed for several years. The PPC believes it would be more prudent for EPA to let public water systems actually collect the required UCMR 2 occurrence data instead of assuming the results, as the Agency has done. Undoubtedly, the UCMR 2 data can be appropriately used in the CCL4 list that will be required in the future.

(4) The PPC acknowledges that the EPA applied structured classification models to evaluate and identify drinking water priority contaminants. Decisions to include chemicals on the final draft CCL3 generally were made using model results and best available data to identify contaminants that may occur in public water systems where they may cause adverse health effects. More than a third of the chemicals were selected in this way - high certainty data from finished or ambient water monitoring and a potency/90th percentile concentration ratio of= 10. However, the balance of the CCL3 compounds were selected

on the basis of less rigorous selection data, including the use of surrogates for many important parameters (e.g., pounds sold per year in place of prevalence, or persistence and mobility in place of potential magnitude). Of this less rigorous group, pesticides and degradation products were selected from EPA's Office of Pesticide Programs' (OPP) registration and re- registration database of modeled surface and/or ground water data. W hen possible, EPA obtained ambient water values from the USGS National Water Quality Assessment Program (NAWQA), UCMR monitoring, USDA Pesticide Data Program, and numerous other sources. However, EPA selected the highest reported concentration as the occurrence value used in screening. Pesticides on the CCL3 were selected from a "medium certainty bin," characterized by the Agency as needing further occurrence and/or health effects research. The PPC agrees with this "medium certainty" determination, but urges EPA to limit its CCL3 selection to those with high certainty, high quality data.

(5) From the CCL3, EPA is to make a regulatory determination on five of the 93 chemicals and 11 microbiological contaminants that, if regulated, would present the most meaningful opportunity for improvement of water quality and public health. From our perspective, there are more essential choices among the CCL3 candidates than the pesticides identified in the draft list. The listed pesticides are part of an arsenal of crop production tools that are subject to more than 200 toxicology and ecological tests before they are licensed by EPA to control pests in orchards, grain fields, forests, highway road sides, homes, home lawns, gardens, and city parks. All aspects of their sale and use are strictly regulated by FIFRA, and water quality standards already exist or are being developed for many. New products are continually entering the marketplace, bringing lower use rates and improved env ironmental characteristics to this arsenal of products. Furthermore, the strong emphasis on mixtures for synergistic effectiveness, new containers that promote proper use, and education promoting protection of streams, wells and aquifer recharge areas, all are paying div idends.

PPC appreciates the opportunity to comment on this proposal. If you have any questions or comments regarding this submission,please feel free to contact us.

Sincerely,

Beau Greenwood, Acting Chair Pesticide Policy Coalition Telephone: 202-296-1585 CS Title: 0108 Company/group/association name: Comment:

May 21, 2008

Water Docket U.S. Environmental Protection Agency Mail Code 4607 M 1200 Pennsylvania Ave. NW Washington, DC 20360-0001

Re: Comments on Drinking Water Contaminant Candidate List 3 - Draft Notice; Docket ID EPA-HQ-OW-2007-1189

Dear Water Docket:

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the draft Contaminant Candidate List 3 (CCL 3) (73 FR 9628). As directors and CEOs of the largest publicly owned drinking water systems in the United States serving more than 127 million Americans, AMWA strongly supports the scientific and data-driven CCL process. As required by the 1996 Amendments to the Safe Drinking Water Act, the CCL process identifies potential contaminants, gathers needed information to determine if a national regulation is needed, and presents a formal evaluation and determination on whether to regulate a given contaminant.AMWA believes that EPA should focus the CCL in a way that will

best utilize its scarce resources and optimize its resource budget. In fact, we suggest that EPA reduce the number of substances included in each CCL to help this effort.

The Office of Ground Water and Drinking Water (OGW DW ) relies on the Office of Research and Development (ORD) to perform the research needed to support its mission. ORD needs to clearly identify how it intends to support the CCL process by working with OGW DWto prioritize research on listed contaminants. ORD should detail its projects related to CCL research in its multi-year plan. In addition, EPA should use the CCL as an opportunity to communicate the progress and results of research on CCL contaminants and AMWA encourages EPA to note in the final CCL how this will be accomplished.

The attached comments prov ide AMWA's views on various aspects of the development of CCL 3 and recommendations for the CCL process in general. AMWA appreciates the opportunity to comment on the draft CCL 3. Please contact Erica Brown, Director of Regulatory Affairs, at 202-331-2820 if you have any questions.

Sincerely,

Diane VanDe Hei Executive Director

Association of Metropolitan Water Agencies Comments On the Drinking Water Contaminant Candidate List 3; Draft Notice 73 Federal Register 9628, February 21, 2008

1. EPA requested comment on various aspects of the development of CCL 3. In response to this request, AMWA provides the following comments and recommendations:

a. AMWA supports EPA's efforts to provide a transparent, data- driven CCL process. In prev ious letters to the agency, AMWA hassupported the recommendations of the National Drinking Water

Advisory Council (NDWAC, 2004) as well as the National Academy of Science/National Research Council report, Classifying Drinking Water Contaminants for Regulatory Consideration (NAS/NRC, 2001) and encouraged the agency to employ a process that is transparent and reproducible.

AMWA commends EPA for including experts throughout the CCL process by hosting various workshops to identify screening criteria, evaluate data sources, assess the data training set of the chemical contaminants and review the CCL prior to its publication. AMWA encourages the agency to continue to improve the transparency in the final CCL 3 notice and in future endeavors by clearly documenting when and how EPA experts or authorities outside of the agency were consulted and by making their assessments public. If this information is currently

available in the docket documents, it is not easily identified.

b. AMWA encourages EPA to continue to promote a transparent process using expert judgment to ensure that the classification process or algorithm is repeatable. In the Federal Register notice, there is one place where AMWA suggests EPA could be more transparent in explaining how expert judgment was used to develop the draft CCL. For example, on 73 FR 9651, one of the microbial expert panels recommended that EPA remove microbial contaminants from the list if they are inactivated by

conventional treatment. It's not apparent in the FR notice how EPA addressed this recommendation.

AMWA thanks EPA for the opportunity to participate in the CCL process by identifying experts who could provide valuable information to improve the process in these key areas. EPA should continue to leverage the expertise of subject matter experts and stakeholders to help identify emerging contaminants and the latest peer rev iewed literature. AMWA would like to continue to support the Agency in this process by prov iding assistance or by identifying experts who could inform the process in these key areas.

c. EPA should focus the CCL list in a way that will bestutilize its scarce resources and optimize its resource budget.

In past comment letters, AMWA has asked EPA to more clearly inform the public how the agency intends to use the CCL to prioritize drinking water research in order to make regulatory decisions about contaminants on the list.

AMWA has several ideas for how this could be accomplished:

EPA should provide a synopsis of the data required for each contaminant listed that identifies the information that is still needed to make a regulatory determination. The contaminant information sheets available in the docket currently show whether data that would likely be used to make a regulatory determination (e.g., RfD, concentrations in ambient water or finished water) were available for the screening, but this information is not easily accessed across all contaminants listed, nor is it prioritized in any way.

This synopsis env isioned could be used to prioritize research needs and information for the Office of Research and Development (ORD) multiyear plan. A clear presentation of these data gaps could also help other research organizations such as AwwaRF and universities to more easily identify key areas to focus needed research.

Given limited resources, the development of a synopsis would benefit the process by improv ing its transparency and also by helping the agency to prioritize the CCL based on information required to make a regulatory decision, or based on achievable goals for obtaining missing data, or both.

d. EPA should remove Legionella and Viruses from CCL 3 since these microbials already have MCLGs and treatment techniques under the Surface Water Treatment Rule. Since these contaminants already have MCLGs, it seems that EPA should be

reviewing these regulations as part of the 6-Year Rev iew process and not considering them as "new" contaminants for potential regulation under the CCL.e. EPA should reduce the number of substances on the CCL to

better focus its resources. The SDWA states that the Administrator shall regulate contaminants that will provide a "meaningful opportunity for health risk reduction for persons

served by public water systems" (Sec. 1412 (b)(1)(A)(iii)). It is unclear how the agency intends to focus its efforts on prioritizing research and data gathering on a list of over 100 contaminants in order to ultimately make regulatory decisions.

AMWA therefore recommends that EPA keep the list at a more manageable level and list only those chemical contaminants that the agency currently believes are the largest potential threat to public health. AMWA suggests listing only those chemicals (36 in all) that came out of screening process in the high certainty bin, with consideration of those chemicals nominated by the public that had additional data prov ided to the agency that could be used in the data screening process. W ith regard to the medium certainty bin, EPA can retain those chemicals on the PCCL and prioritize them over other PCCL contaminants given their attribute scores.

With respect to the microbes on the CCL, AMWA agrees with the use of waterborne disease outbreak data, health effects and occurrence in the scoring protocols for ranking pathogens on the PCCL.

f. ORD's Multi-year Plan Should Correlate To CCL Needs. OGW DW relies on the Office of Research and Development (ORD) to perform the research needed to support its mission. Listing contaminants on the CCL should enable all offices in EPA responsible for supporting regulatory determinations with the ability to focus precious research dollars on those chemical and microbial contaminants that are a potential health risk to drinking water consumers.

ORD needs to clearly identify how it intends to support the CCL process by working with OGW DWto prioritize research on CCL contaminants. ORD should detail its projects related to CCL research in its multi-year plan.The CCL process is a mechanism that has been created to help

the Agency effectively determine which contaminants to regulate. AMWA supports the process and believes Congress intended for it to help determine future drinking water regulations. AMWA therefore encourages EPA to work to integrate this process into its regulatory and research programs as it believes Congress intended.

g. EPA should use the CCL as an opportunity to clearly communicate the progress and results of research on CCL contaminants. AMWA suggests EPA include the status of research on CCL contaminants that have been on the list since 1997 in the final CCL3 and future list proposals. This information could be included in the synopsis of research gaps. Including this information in future CCL documentation would speak to the issue of transparency by informing the public about research that has been completed up to this point. Such information would also help EPA make future decisions about whether to list contaminants on the CCL and could help guide other experts in deciding where to focus their research efforts.

h. EPA's should use the OPPT HPV chemicals in the CCL analysis based on drinking water related data. AMWA agrees that including chemicals from EPA's Office of Pollution Prevention & Toxics (OPPT) High Production Volume (HPV) list in the universe is important. However, inclusion of these chemicals on the PCCL or CCL should be based on a drinking water occurrence or exposure component. OGW DWshould work with OPPT to ensure that its screening protocol for HPV chemicals includes a drinking water exposure component and use this information to inform future CCLs.

i. EPA should continue to leverage the connection between the CCL and UCMR. AMWA thanks EPA for specifying the connection between the CCL and Unregulated Contaminant Monitoring rule (UCMR) in the CCL proposal. AMWA is pleased to see the explanation of how information from certain UCMR 2 monitoring will be used in the finalization of CCL 3 and the development of future CCLs. AMWA encourages EPA to improve correlation ofCCL and UCMR wherever possible by using the UCMR to gather

occurrence data for contaminants on the CCL with the highest potential public health threat and largest data gaps for

occurrence.

For example, many of the testing methods for microbial contaminants require highly specific media (serological and/or molecular) and technical expertise. Outsourced testing would be required for many utilities if these contaminants were listed on a future UCMR. Similarly, testing for the more explosive, radioactive or toxic chemicals on the draft list would require specialized facilities, instrumentation and expertise to run (e.g., strontium, perchlorate, nitroglycerin).

EPA must keep these issues in mind as it considers CCL contaminants in the development of the next UCMR.

2. EPA also requested comments on how pharmaceuticals were considered in the CCL3 process. AMWA urges EPA and the Food and Drug Administration to address whether the presence of trace amounts of pharmaceuticals results in short-term or long-term effects on human health and how such chemicals affect the

env ironment.

In addition, EPA should continue to work to improve source water quality through education as well as using existing regulatory authority to establish water quality standards and protect source waters from animal feeding and production operations and other nonpoint sources of pollution.

AMWA believes the federal government should take the lead in developing a national program to prov ide consumers with an easy way to dispose of unused prescriptions. Likewise, EPA should work with other federal agencies, such as the Drug Enforcement Agency to rev ise guidelines that currently encourage consumers to flush certain unused prescriptions down the sewer system. Federal regulations should remove barriers that prevent hospitals and other medical facilities from disposing unused medicines and medical substances in an env ironmentallyresponsible manner.

CS Title: 0110 Company/group/association name: Comment:

Docket: EPA-HQ-OW-2007-1189 Drinking Water Contaminant Candidate List 3

May 21, 2008

The NJ Environmental Federation (NJEF) thanks EPA for giving us the opportunity to comment on drinking water standards under the Safe Drinking Water Act. The NJ Environmental Federation has 100,000 members and 100 member groups, and is the NJ chapter of Clean Water Action.

NJEF is concerned with a particular chemical listed on the Contaminant Candidate List, PFOA (perfluorooctanoic acid), as well as another perfluorinated chemical, PFOS (perfluorooctane sulfonic acid). We are aware of EPA's decision to exclude PFOS from the draft CCL 3, and the agency's willingness to accept comments on that decision.

EPA has long known of human health concerns of PFOS, and its unique ability to bind to proteins, unlike most persistent organic compounds, which accumulate in fatty tissue. Eight years ago, EPA acknowledged that:

"PFOS accumulates to a high degree in humans and animals. It has an estimated half-life of 4 years in humans. It thus appears to combine Persistence, Bioaccumulation, and Toxicity properties to an extraordinary degree."

In addition, citing a 3M rat study, EPA noted:

"PFOS caused postnatal deaths (and other developmental effects)in offspring in a 2-generation reproductive effects rat study

(NOAEL of 0.1 mg/kg/day and LOAEL of 0.4 mg/kg/day). At higher doses in this study, all progeny in the first generation died while at the LOAEL many of the progeny from the second generation died. It is very unusual to see such second generation effects." (Source: http://www.chemicalindustryarchives.org/search/pdfs/ scotchgard/20000516_226-0629.pdf

Further, PFOS has been of great interest to the Organisation for Economic Co-operation and Development (OECD) who, in 2006, made strong recommendations for industry and government to monitor the impact of PFOS. (Source: http://www.olis.oecd.org/olis/2007doc.nsf/LinkTo/NT00002AB6/$FI LE/JT03229256.PDF)

While it is presently ubiquitous in the environment, the threat of exposure is likely to increase as consumers dispose of household products containing PFOS. In turn, it is reasonable to anticipate that PFOS will continue to accumulate in the

env ironment, including in ground and surface water, aquatic biota and humans. Although PFOS is no longer being manufactured, its persistence, and bio-accumulative and toxic properties warrant careful monitoring and regulation.

The EPA is well aware of the numerous studies documenting the exposures and dangers of PFOA. Although DuPont, currently the only major U.S. producer of PFOA, continues to claim that there is no proof that PFOA causes harm to human health, evidence to the contrary continues to mount, such as:

* EPA's Science Adv isory Board identifies PFOA as a "likely" human carcinogen. (Source: Washington Post; Compound in Teflon a "likely carcinogen;" Juliet Eilperin; June 29, 2005)

* Researchers found PFOA and PFOS in the umbilical cord blood of children indicating that these chemicals cross the placenta between mother and child. (Source: Environmental Working Group/Commonweal, Body Burden Study- The Pollution in Newborns,Executive Summary; July 14, 2005)

* The Centers for Disease Control and John Hopkins University have reported health impacts in newborn babies such as low birth weight and reduced head circumference. (Source: Possible Etiologies of PFAA-Induced Developmental Effects: Reflections from a Pediatric Perspective; Johns Hopkins University, Baltimore, MD; U.S. Centers for Disease Control and Prevention)

* PFOA has been found in the breast milk of nursing mothers, and has been found in children between the ages of 2 and 12 at blood levels similar to those found in adults. (Source: Study conducted by Kathleen Arcaro of the University of Massachusetts Amherst-results are scheduled for publication in Env ironmental Science and Technology ( http://www.umass.edu/loop/talkingpoints/articles/74700.php); other breast milk studies reported in February and May 2007 Issue of Environmental Health Perspectives)

* A study by the National Institute for Occupational Safety and Health has shown that PFOA may prime the immune system to

overreact to allergens in mice. (Source: Toxicological Sciences, DOI: 10.1093/toxsci/kfm053; From Issue 2609 of New Scientist magazine, page 14; June 25, 2007)

* Researchers at the University of Pennsylvania School of Medicine found PFOA to be present in about 96 percent of the U.S. population, tending to accumulate within the body. (Source: Today's Sunbeam; DuPont reports PFOA testing; Randall Clark; May 07, 2008)

* Exposure to PFOA may be associated with changes in liver and immune function, as well as higher cholesterol levels in children. In May 2008, the preliminary results of a study of PFOA's possible impacts on the health of nearly 70,000 residents in the mid-Ohio Valley were released. The study examined the potential health impacts of PFOA released from DuPont's Washington Works plant south of Parkersburg, West Virginia. Previous studies of workers exposed to PFOA revealedelevated levels of kidney cancer, heart disease and diabetes.

(Source: AScribe Newswire; Big Study of Teflon Chemical in People Suggests Harm to Immune System, Liver, Thyroid; May 13, 2008; www.hsc.wvu.edu/som/cmed/ophp/grandRoundsWebcast.asp)

The NJ Environmental Federation first became active in PFOA issues over three years ago, when PFOA was detected in the public water supply wells in Penns Grove and Carneys Point in NJ, some of which exceeded the interim NJ DEP guidance for PFOA of .04 ppb. United Steel Workers has tested the blood of some of their DuPont members and retirees at the Chambers Works facility in Pennsville, New Jersey and discovered exposure levels in some individuals to be hundreds of times higher than those found in the general public.

Studies have shown that some workers exposed to perfluorinated chemicals (PFCs) are more prone to prostate and bladder cancer and experience higher than normal levels of cholesterol - a risk factor for heart attack and stroke. (Source: Minneapolis Star Tribune; Death rate up for 3M workers exposed to PFOA; Tom Meersman; March 5, 2008

Numerous samples of surface water and drinking water supplies taken by the USWand others have revealed the presence of PFOA, PFOS and other PFCs. The PFCs being found in drinking water supplies are also found in the blood of the general population as reported by the Centers for Disease Control and Prevention. The agency found 11 polyfluoroalkyl compounds, including perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and perfluorohexane sulfonic acid (PFHxS) in 1562 serum samples collected from a representative U.S. population 12 years of age and older in the 1999-2000 National Health and Nutrition Examination Survey. (Source: Division of Laboratory Sciences, National Center for Env ironmental Health, Centers for Disease Control and Prevention, Abstract Received for review November 9, 2006, Revised manuscript received January 31, 2007, Accepted February 2, 2007)

NJEF believes that the EPA must determine nation-wide regulations to protect the public from further exposure to PFOAand PFOS. States, such as Minnesota, North Carolina and New

Jersey have instituted their own standards or guidelines for one or both PFCs. For example, after finding widespread contamination of drinking water supplies in the state, the NJDEP set a safe drinking water guidance value of .04 parts per billion for PFOA. (Source: http://www.state.nj.us/dep/watersupply/pfoa.htm)

PFOA makes its way into products and downstream industries further exacerbating the contamination of people and the

env ironment. DuPont and other companies promised EPA they would reduce and eventually eliminate PFOA use and manufacture via the 2010/2015 PFOA Stewardship Program. Unfortunately, DuPont refuses to make public verifiable annual PFOA production amounts. Recent test results of wells conducted by DuPont near its Chambers Works, NJ facility show levels of PFOA that exceed the NJDEP guidance level. (Source: Today's Sunbeam; DuPont reports PFOA testing; Randall Clark; May 07, 2008)

The 2010/2015 PFOA Stewardship Program is voluntary. We have little faith this program will achieve its goals, nor will it assure the protection of public water supplies. NJEF believes

voluntary promises are not a substitute for much needed regulation and accountability. Therefore, it is vital to regulate PFOA through the Clean Water Act.

Submitted by Jane Nogaki, Vice Chair NJ Environmental Federation 223 Park Avenue Marlton, NJ 08053 CS Title: 0112 Company/group/association name: Comment:

May 21, 2008

Via Electronic MailWater Docket

U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460 RE: Docket ID No. EPA-HQ-OW-2007-1189

Dear Sir or Madam:

The National Mining Association (NMA) submits these comments in response to the U.S. Environmental Protection Agency's request for comments on Drinking Water Contaminant Candidate List 3 (CCL3)-Draft. 73 Fed. Reg. 9628 (Feb. 21, 2008).

NMA is a trade association representing producers of most of America's coal, metals, and industrial and agricultural minerals. Its membership also includes manufacturers of mining and mineral processing machinery and supplies, transporters, financial and engineering firms, and other businesses related to mining. NMA has a strong interest in any regulatory decision that would lead to establishing a primary drinking water standard for any contaminant occurring in drinking water to the extent NMA member companies provide water supply services to mining and mineral processing facilities and their associated communities. In addition, NMA members may also be affected by the impact of establishing a drinking water standard for constituents that are regulated in other federal and state regulatory programs, particularly in the areas of groundwater standards, waste management and site remediation, costs that should be considered when making such determinations.

General Comments:

Wereviewed EPA's draft listing methodology, including the health effects data and occurrence data contained in the February 2008 Contaminant Information Sheets for the PCCL Chemicals Considered for CCL 3. We focused on certain metal parameters, which are molybdenum, cobalt, vanadium, strontiumand germanium, and assessed the toxicological and occurrence

data available at this time for these parameters. Based on this

review, we do not believe that sufficient support is available for these parameters to remain on a final list of contaminants that would be subject to any proposed or promulgated national primary drinking water regulations under the Safe Drinking Water Act. There is insufficient information available to conclude that these parameters are either a concern for drinking water or a national concern for which federal regulation is appropriate or supportable. Each parameter is discussed below.

Specific Comments:

Molybdenum

Molybdenum (Mo) is an essential trace mineral, and a cofactor for enzymes xanthine oxidase, aldehyde oxidase and sulfide oxidase that are needed for a variety of metabolic processes. Levels of Mo in national Public Water System ("PWS") finished water samples reported in the National Inorganics and Radionuclides Survey ("NIRS") ranged from 0 to 180 μg/L, although as discussed below the highest reported value of 180 μg/L may be an anomaly.

Average US daily intakes of Mo range from 76 to 350 μg (Schroeder et al. 1970, Tsongas et al. 1980, Pennington and Jones 1987). The Tolerable Upper Limit (UL) for Mo is 2.0 mg/day (IOM 2000). EPA established a reference dose (RfD) of 0.005 mg/kg-day for Mo based on a cross-sectional epidemiological study conducted almost 50 years ago in Armenia (Koval'skiy et al. 1961).

Molybdenum compounds appear to have low toxicity in humans and are generally considered not to be a serious env ironmental contaminant in terms of human health (IOM 2000, Jarrell et al. 1980). There are limited human toxicity data for Mo; most data pertain to animals, especially ruminants. The biological basis for toxicity in ruminants (production of thiomolybdates) is notrelevant for humans. Several important beneficial roles of Mo,

such as the absorption and retention of fluorine, may indirectly reduce dental caries and osteoporosis.

A screening level review conducted by an EPA contractor in August 2003 did not identify any critical new studies on which to base a new risk assessment. However, there are several studies by Mertz (1976) and Turnlund et al. (1995-2007) that could be useful in re-evaluating the potential risks of dietary Mo. For example, Turnland reports on the interrelated roles of copper and Mo metabolism and on the physiological adaptations to Mo intake, such as lower tissue storage and greater urinary excretion during high Mo intake, which help prevent Mo deficiency and toxicity. Summarized below are key points regarding the listing of Mo on CCL 3.

Occurrence data in finished water samples - It is unknown how representative the NIRS occurrence data are of actual national PWS Mo concentrations. NIRS concentrations ranged from 6 to 180 μg/L, with a median value of 10 μg/L. However, USGS (1964) reported that Mo concentrations in finished drinking water samples from the 100 largest U.S. cities ranged from 0 to 68 μg/L, with a median value of 1.4 μg/L. Greathouse and Craun (1979) reported Mo concentrations in tap water ranged from 1.1 to 52.7 μg/L, with a mean concentration of 8 μg/L. The Environmental Working Group, a non-profit health advocacy organization, tested Mo concentrations in tap water supplied by PWS between 1998 and 2003. The highest detected level was 76 μg/L, which is less than half the highest value of 180 μg/L reported in NIRS. Based on concentrations measured in finished drinking water in these other reports, and the 90% and 99% detect values of 30 and 110 μg/L, respectively, in the occurrence data, the high value of 180 μg/L may be an anomaly and the NIRS overestimated Mo concentrations in national PWS.

Risk assessment or available data to conduct a risk assessment - The EPA established a reference dose (RfD) of 0.005 mg/kg-day for molybdenum (Mo) based on a cross-sectional epidemiological study in Armenia (Koval'skiy et al. 1961). Mo content in soil and plants in the v illage of Ankava was 38 and 190 times, respectively, that of the smaller adjoining settlement thatserved as the control. The average intakes of Mo in Ankava

residents were in the range of 10-15 mg/day (corresponding to an intake of 0.14-0.21 mg/kg-day for a 70 kg adult). W hereas, Mo levels were relatively high in Ankava, copper levels were quite low. Compared with the adjoining settlement, results from medical exams demonstrated an increased prevalence of gout-like symptoms along with hyperuricemia (elevated serum uric acid) that increased with increasing residency time in the region. Based on these results, a Mo intake of 0.14 mg/kg/day was designated as a lowest observed adverse effect level ("LOAEL"). EPA applied an uncertainty factor ("UF") of 3 for sensitive individuals instead of 10 because of the moderately large study size (300 v illagers from Ankava and 100 villagers from the adjoining settlement) and a factor of 10 because of the absence of a no-effect level in the study. The oral RfD of 0.005 mg/kg- day was derived by div iding the LOAEL of 0.14 mg/kg/day by a UF of 30. EPA could have applied a higher UF to account for the lack of reproductive and developmental toxicity, but did not because the RfD is already only slightly above the Effective Safe and Daily Intake (ESSADI) established for Mo, an essential trace mineral, by the U.S. Food & Drug Administration. A lower RfD value could result in insufficient intake to meet minimal nutritional requirements.

The Koval'skiy study, selected as the principal study for the derivation of the RfD, is subject to several limitations. As a cross-sectional study, only prevalence, rather than incidence, of gout-like symptoms can be determined. The absence of information on the temporal relationship between exposure and health outcomes in a cross-sectional study substantially weakens the strength of ev idence for a causal relationship. It is also possible that an unmeasured covariate may contribute to the increased prevalence of gout-like symptoms among residents of the Ankava community. Gout can develop as co-morbidity of other diseases, including obesity, alcohol, diabetes, hypertension, renal disorders, lead toxicity and hereditary factors. In the absence of detailed information on the presence of other essential trace elements in the diets of the study subjects, the possible contribution of metal imbalance is difficult to assess.

One of the weaknesses in the Koval'skiy study identified by theNational Research Council (1977) was the significantly

decreased mean serum copper levels in residents presenting with elevated uric acid levels and gout-like symptoms and the elevated mean copper levels of the controls (compared with normal baseline levels). The Nuclear Regulatory Commission (NRC) interpreted this finding to suggest external contamination of the control samples during the assay procedure (NRC 1977). Urinary copper levels were also elevated in the controls, suggesting similar procedural contamination (NRC 1977). Standard analytical methods for collecting samples for metal analyses (for example, use of acid-washed polypropylene and other laboratory materials) were likely not followed in the early Armenian study and could explain the higher than expected copper levels in the controls. However, it would not explain the low copper levels in the residents.

Koval'skiy reported a positive correlation between serum uric acid levels and serum Mo and xanthine oxidase (a Mo-containing enzyme) levels. The strength of this correlation is questionable because of limitations in the analytical methods used to determine Mo tissue concentrations. (Serum Mo is difficult to measure, especially in 1961, and does not accurately reflect serum Mo status due to temporal dietary fluctuations.) More recent studies in humans, such as those onducted by Deosthale and Goplan (1974) and Chappell et al. (1979) that were rev iewed by EPA in IRIS do not support the finding of increased serum uric acid levels in response to dietary Mo intake at levels lower than those in the Koval skiy study. Deosthale and Goplan (1974) reported no change in uric acid excretion at intakes up to 1.5 mg/day and Chappell et al. (1979) reported a decrease in serum uric acid concentrations at intakes of greater than 0.49 mg/day (based on 70 kg adult). These studies, along with that conducted by Turnlund and Keyes (2000), which was not included in IRIS, identified levels of dietary Mo intake that were not associated with adverse health effects.

In summary, the current RfD for Mo of .005 mg/kg-day or 350 μg/day (based on a 70 kg adult) is notably lower than the value of 1500 μg/day that produced no adverse health effects (Deosthale and Goplan 1974, Turnlund and Keyes 2000) and the UL of 2,000 μg/day (IOM 2000). Therefore, the RfD warrants furtherevaluation. The need for additional research is supported by

the National Academies' National Research Council (1977) and Institute of Medicine (2000). The National Research Council concluded that the involvements of Mo in the induction of adverse health effects are speculative, especially considering the small size of the control group (n=5) compared with the Ankava group (n=52), and a cause-andeffect relationship between Mo and these putative adverse effects needs to be established. The Institute of Medicine (2000) also concluded that because of the deficiencies in the Koval skiy study, inadequate data exist to identify a causal association between excess Mo intake in normal, apparently healthy individuals and any adverse health outcomes. The current RfD relies heavily on an epidemiological study conducted over 50 years ago by Koval'skiy et al. (1961), which, because of its cross-sectional design, is insufficient to establish causality. As such, Mo should be removed from the CCL 3 until more reliable information is available that supports the toxicity of molybdenum to humans and that explains the influence of low dietary copper concentrations and other potential metals imbalances.

Cobalt

There are several important toxicological concerns with the

available data that would need to be addressed before cobalt could be listed on the CCL 3. The current RAIS does not include a toxicity profile for cobalt, so the principal and supporting studies to support the RAIS RfD value of 0.02 mg/kg/day is unknown. Most toxicological studies are inhalation and not oral exposure studies. There is very little oral human exposure data

available.

ATSDR established a minimal risk level (MRL) based primarily on one 40-year old study involving 6 subjects administered a single dose. RIVM derived a TDI, which is one order of magnitude lower than the ATSDR MRL, based on patients with alcoholism who chronically consumed excessive amounts of beer containing cobalt sulfate. Although these studies were cited in the 1992 ATSDR Toxicological Profile for Cobalt, ATSDR did not consider them when deriving its MRL in 2004. Although IARC and NTP have classified cobalt for its carcinogenic potential basedon non-oral routes of exposure, EPA has not. It is debatable

whether reversible changes in hematological parameters constitute a critical health effect. Cobalt was detected in only 3 out of 989 sites (0.3%) and even the maximum concentration detected (10.6 μg/L) is 1 order of magnitude lower than the calculated DWS/MCLG of 140 μg/L using the RAIS RfD. Based on these low concentrations and the limited number of detections, we believe that cobalt does not qualify for inclusion on the CCL 3.

Vanadium

Wehave concerns that the vanadium level for purposes of a CCL 3 listing is too low, and a protective level of vanadium in drinking water may be one order of magnitude higher than that estimated by EPA. The occurrence data indicate that concentrations of vanadium detected in 15% of PWS samples ranged from 3.1 to 70.4 μg/L (median 7.3, 90% 23, 99% 45). These values are within the range of a hypothetically- calculated DWS/MCGL using either the RAIS RfD or ATSDR MRL, and hence could support consideration of the CCL 3 listing of

vanadium. However, in the contaminant information sheet, EPA did not include the IOM 2000 findings in which a UL of 0.026 mg/kg/day was determined to be the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects. In support of a more conservative NOAEL of 5 ppm, ATSDR cites other studies that reported adverse developmental, cardiovascular, and gastrointestinal effects at doses greater than 5 ppm; however, IOM (2000) evaluated these reports to be inconsistent and did not consider them when deriv ing the UL. Hence, based on the IOM report findings, the level of vanadium in drinking water that is protective of human health may be one order of magnitude higher than that estimated by RAIS/EPA and ATSDR. Additional support for a higher vanadium standard includes the RTECS LOAEL value of 960 mg/kg/day, which EPA did include in the contaminant information sheet for

vanadium, and that is 125 times the LOAEL value of the IOM (2000) report.

For the purpose of assessing the available health guidelines, the table below is provided comparing the RAIS RfD, ATSDR MRL,and IOM UL and their respective DWS/MCGLs.

Table 1 [see PDF]

Based upon the RTECS value, vanadium should be excluded from the CCL 3 until such time that additional information is

available on the health effects of this parameter.

Strontium

Wehave questions about the risk factor used by EPA to calculate the RfD. EPA calculated the RfD by using the NOAEL

value of 190 mg Sr/kg/day reported in the Storey (1961) study and a UF of 300 (factor of 10 for extrapolating from lab animals to humans; factor of 10 for an incomplete database and to account for uncertainties in using data for SrCO3 to estimate risk for other Sr salts; and a factor of 3, instead of 10, because the study was performed in young animals which are a sensitive subpopulation). However, ATSDR calculated a MRL of 2 mg/kg/day using the same NOAEL value of 190 mg/kg/day and a UF of 30 and modifying factor of 3. It is questionable whether the UF of 300 used by EPA was warranted considering other compounds for which there is an incomplete database or numerous chemical states and an additional factor of 10 is not applied. The NOAEL value of 525 mg/kg/day reported in the more recent, better designed study by Marie et al. (1985) would result in a RfD of 1.75 mg/kg/day, which is consistent with the ATSDR MRL of 2 mg/kg/day.

Germanium

The occurrence data indicate that germanium was detected in only 0.4% (4 out of 989) of PWS samples and measured concentrations ranged from 26 to 230 μg/L (median 220, 90% 220, 99% 230). Based on an oral-chronic LOAEL value of 0.318 mg/kg/day, the hypothetically-calculated DWS/MCGL would be 2,226 μg/L, which is 10-fold higher than the median or highest concentration detected in the PWS samples. Based on the verylow prevalence of germanium detected in PWS samples and the

relatively low toxicity of germanium based on human data, the CCL 3 listing is unsubstantiated and the additional burdens and costs associated with monitoring and reporting are not warranted.

(Source - Obara et al., 1991. Germanium Poisoning: Clinical Symptoms and Renal Damage Caused by Long-Term Intake of Germanium. Japanese Journal of Medicine, 30:1, 67-72)

If you have any additional questions regarding the National Mining Association s comments, please feel free to contact me at kbennett@nma.org.

Sincerely,

Karen Bennett Vice President, Env ironmental Affairs National Mining Association CS Title: 0113 Company/group/association name: Comment:

May 21, 2008

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

Re: Docket ID No. EPA-HQ-OW-2007-1189 Drinking Water Contaminant Candidate List 3- Draft

To W hom It May Concern:The State-FIFRA Issues Research and Evaluation Group (SFIREG)

Water Quality-Pesticide Disposal Working Committee (WQPD-WC) would like to thank the EPA Office of Groundwater and Drinking Water (OGW DW ) for the opportunity to comment on the release of Contaminant Candidate List 3 (CCL3). The WQPD-WC has rev iewed the CCL3 and asks that that the Agency consider the following comments as the CCL3 process is finalized.

The WQPD-WC within the SFIREG is comprised of 10-12 individuals that seek to represent state agencies on pesticides and water quality technical information needs and regulatory matters. The WQPD-WC works primarily with the EPA-Office of Pesticide Programs, but the EPA's Office of Groundwater and Drinking Water (OGW DW ) has shown continued interest in working with SFIREG on issues related to pesticides and water quality. On May 5, 2008, OGW DWrepresentatives attended a WQPD-WC meeting to further explore water quality themes of interest to both parties. The WQPD-WC would like to thank the OGW DWfor this interest and for soliciting input from the state lead agencies (SLAs) in the completion of the current and future CCL efforts. Many SLAs have a wealth of data on ambient and targeted water monitoring for pesticides that could serve positively in the development of CCLs and subsequent regulatory determinations. In addition, data held by SLAs will aid the OGW DWin identifying priority analytes for the unregulated contaminant monitoring rule and subsequent data collection efforts, therein.

Although many registered pesticides may pose a potential threat to public and private water supplies and to ambient water quality, there are very few pesticide active ingredients or degradates, for which OGW DWhas adopted either primary drinking water regulations or developed health adv isory values that represent currently used compounds. For the many states that lack an infrastructure to readily develop standards for pesticides in drinking water or risk-based guidance values, communicating potential risks or making a risk management decision is all that more difficult. Therefore, the WQPD-WC is

very encouraged to see that of the 93 chemical contaminants included in the draft CCL3, 35 are pesticide active ingredientsor pesticide degradates, many of which have already received

much scrutiny from the WQPD-WC and SLAs with regard to potential impacts on ambient or potable water supplies.

Understanding that the OGW DWhas a history in CCL1 and CCL2 of including pesticide active ingredients in the final CCL, the WQPD-WC encourages the OGW DWto include as many pesticide active ingredients as possible in the final CCL3 list. As mentioned, regulatory levels for pesticides in drinking water are sparse. Including pesticide active ingredients or degradates in the final list will greatly benefit state lead agencies charged with pesticide regulation due to the fact that by including such compounds, OGW DWproceeds with a regulatory determination that either no regulation is needed or that primary drinking water regulation is needed. This process ultimately provides SLAs with valuable information on risk management since regulatory determinations typically lead OGW DW to develop either a primary standard (Maximum Contaminant Level), Health Advisory values (e.g., Lifetime-HAs) or preliminary reference levels such as Health Reference Levels (HRLs), any of which can be used to aid in the interpretation of monitoring data with respect to potential human health risk.

Lastly, to further aid SLAs, the SFIREG WQPD-WC requests that OGW DWwork with SFIREG to facilitate access to HRLs developed for CCL3 compounds that are considered for the regulatory determination process, and also encourages the OGW DWto consider developing pesticide HRL values or other drinking water risk assessment advice outside of the CCL process.

Thank you for your consideration of these comments. The WQPD-WC looks forward to working further with the OGW DW .

Sincerely, Jeff Comstock SFIREG- WQPD-WC Agrichemical Management Section Vermont Agency of AgricultureDavis H. Daiker

SFIREG- WQPD-WC Administrator- Scientific Evaluation Section Florida Department of Agriculture and Consumer Service

Cc: Mr. Dave Frederickson, SIFREG Mr. Jack Peterson, WQ&PD-WC Mr. Joe Zachmann, SFIREG Ms. Maureen Serafini, AAPCO Mr. Dan Helfgott, OPP Dr. Debbie Edwards, OPP CS Title: 0118 Company/group/association name: Comment:

May 20, 2008

Re: Drinking Water Contaminant Candidate List.3 - Draft (EPA-HQ-OW-2007-1189)

To W hom It May Concern:

I am writing in support of the regulation of perfluorooctanoic acid (PFOA) under the Safe Drinking Water Act.

Minnesota is one of seven states with widespread contamination of Perfluorochemicals (PFC), including PFOA. In 2005, PFOA was first detected in the community of Oakdale, Minnesota. It has since been detected in seven additional metropolitan communities located near or on the Mississippi River and former industrial waste disposal sites used by the manufacturing company 3M.

PFOA is a very stable, man-made chemical that the human body is unable to break down, and if exposure is constant, the chemicals are likely to persist in humans' bodies. The long term potential health risks of PFOA have been documented by agrowing body of scientific research that shows PFOA causes

liver cancer, testicular cancer and may cause other types of cancer such as breast cancer, as well as, birth defects, weakened immune system and Altered Hormone System Function. In 2006, the EPA Science Adv isory Board classified PFO as a likely human carcinogen, A recent industry funded study, showed that 3M employees exposed to PFOA died of stroke and prostate cancer at higher rates than other workers at the company's Chemolite plant in Cottage Grove, Minnesota.

As the state senator who represents many people who have been exposed to PFOA and other perflourochemicals, I urge federal regulation of PFOA. W ithout such regulation, it is incumbent on states to try to set guidelines for exposure. W hile Minnesota has such a guideline for exposure to PFOA, it is a higher rate than other states. This, in effect, leaves Minnesotans to question whether the Minnesota Department of Health has set appropriate levels of exposure.

For the safety of the thousands of people around the country whose drinking water has been contaminated with PFOA, I strongly urge the EPA to increase regulation of PFOA through the Safe Drinking Water Act.

Sincerely,

Katie Sieben Minnesota State Senator CS Title: 0124 Company/group/association name: Comment:

NRDC Comments on the Draft Drinking Water Contaminant Candidate List 3 Docket Number: EPA-HQ-OW-2007-1189 May 21, 2008

Pursuant to the Safe Drinking Water Act Amendments of 1996(SDWA), the U.S. Environmental Protection Agency (EPA) is

required to publish, every five years, a list of unregulated contaminants that are known or anticipated to occur in public water systems and may require regulation under the SDWA. The Agency then must make a decision about whether or not to regulate at least five of the contaminants on the list.

EPA is on the third round of this process and has published a list of candidate contaminants, called the CCL3. The draft list contains 104 contaminants: 11 microbiological contaminants and 93 chemical contaminants. EPA culled this list down from a universe of over 7000 contaminants. NRDC submits the following comments on EPAs Draft CCL3.

I. SUMMARY

NRDC requests that EPA take the following actions concerning the Draft CCL3:

* Delete the pesticide nitrofen (CAS # 1836-75-5) from the Draft CCL3. The available information on use, release and potential env ironmental occurrence of this chemical does not support its inclusion in the CCL3.

* Regulate perchlorate (CAS # 7790-98-9) in drinking water pursuant to the Safe Drinking Water Act (SDWA). NRDC agrees with the inclusion of perchlorate in the CCL3 and supports the promulgation of a fully heath-protective Maximum Contaminant Level (MCL) for perchlorate.

* Regulate perfluorooctanoic acid (PFOA, CAS # 335-67-1) in drinking water pursuant to the Safe Drinking Water Act (SDWA). This chemical is a known endocrine disruptor and drinking water contaminant, and is appropriately included in the Draft CCL3.

* Add the following chemicals to the CCL3:o Alkylphenol polyethoxylates (APEs):

* Alkylphenol mono- to tri-oxylates (CAS # 68555-24-8) * Nonylphenol (NP) (CAS # 25154-52-3) * Nonylphenol ethoxylate (NPE) (CAS # 9016-45-9) * Octylphenol ethoxylate (OPE) (CAS # 9036-19-5)

[This commenter recommends that EPA add the following chemicals to the CCL3:]o Antibiotics: * Amoxicillin (CAS # 26787-78-0) * Bacitracin zinc (CAS # 1405-89-6) * Linezolid (CAS # 165800-03-3) * Methicillin (CAS # 61-32-5) * Oxacillin (CAS # 66-79-5) * Penicillin (multiple CAS #s) * Spiramycin (CAS # 8025-81-8) * Tylosin (CAS # 1401-69-0) * Vancomycin (CAS # 1404-90-6) * Virginiamycin (CAS # 11006-76-1)

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Bisphenol A (BPA) (CAS # 80-05-7)

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Microbials: * Mycobacterium Avium Complex (MAC)

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Pesticides: * Aldicarb (CAS # 116-06-3) * Azinphos-methyl (CAS # 86-50-0) * Carbaryl (CAS # 63-25-2) * Chlorpyrifos (CAS # 2921-88-2) * Dichlorvos (DDVP) (CAS # 62-73-7) * Dicofol (CAS # 115-32-2) * Endosulfan (CAS # 115-29-7)

[This commenter recommends that EPA add the following chemicals to the CCL3:] * Linuron (CAS # 330-55-2)

[This commenter recommends that EPA add the following chemicals to the CCL3:] * Phosmet (CAS # 732-11-6) * Trichlorfon (CAS # 52-68-6) * Triclocarban (CAS # 101-20-2) * Triclosan (CAS # 3380-34-5)[This commenter recommends that EPA add the following chemicals to the CCL3:] o Phthalates:

* Benzyl butyl phthalate (BzBP) (CAS # 85-68-7) * Di-isononyl phthalate (DiNP) (CAS # 28553-12-0) * Di-n-octyl phthalate (DnOP) (CAS # 117-84-0) * Dibutyl phthalate (DBP) (CAS # 84-74-2) * Dicyclohexyl phthalate (DCHP) (CAS # 84-61-7) * Diethyl phthalate (DEP) (CAS # 84-66-2) * Dimethyl phthalate (DMP) (CAS # 131-11-3)

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Reproductive hormones: * Equilenin (CAS # 517-09-9) * Equilin (CAS # 474-86-2) * 17a-Ethynyl estradiol (CAS # 57-63-6) * 17 a -Estradiol (CAS # 57-91-0 70) * 17ß-Estradiol (CAS # 50-28-2) * Estriol (CAS # 50-27-1) * Estrone (CAS # 53-16-7) * Mestranol (CAS # 72-33-3) * 19-Norethisterone (CAS # 68-22-4) * Progesterone (CAS # 57-83-0) * Testosterone (CAS # 58-22-0)

II. DETAILED COMMENTS

The CCL3 contains contaminants that need not be listed at this time.

EPA listed nitrofen (CAS # 1836-75-5) as one of the chemical contaminants on the draft CCL3. However, NRDC does not believe that nitrofen needs to be included on the list. Nitrofen does not appear to pose a threat of contamination to drinking water supplies due to the lack of significant sources of nitrofen releases to the environment and to its rapid biodegradation in the aquatic env ironment. Nitrofen is no longer sold or manufactured in the United States[FN1: National Library of Medicine. Hazardous Substances Data Base. http://toxnet.nlm.nih.gov/cgibin/sis/htmlgen?HSDB.] and all EPA registrations for nitrofen products were cancelled in 1983.[FN2: U.S. Environmental Protection Agency (U.S. EPA).1998. Status of Pesticides in Registration, Reregistration, and

Special Rev iew (aka Rainbow Report.http:// www.epa.gov/oppfead1/international/piclist.htm.] Nitrofen in water biodegrades relatively quickly, with about 99% biodegradation occurring within 50 days.[FN3: Spectrum Laboratories. Chemical Fact Sheet: CAS # 1836755. http://www.speclab.com/compound/c1836755.htm] A search of the EPA Superfund Information Systems database found no hazardous waste sites proposed, listed, or deleted from the National Priorities List where nitrofen was a contaminant of concern.[FN4: U.S. EPA. Superfund Information Systems. http://cfpub.epa.gov/supercpad/cursites/srchsites.cfm.] The HazDat database of the Agency for Toxic Substances and Disease Registry (ATSDR), which contains information on the release of hazardous substances from Superfund sites or from emergency

events, did not contain listings of any sites where nitrofen was detected.[FN5: Agency for Toxic Substances and Disease Registry (ATSDR). Hazardous Substance Release and Health Effects Database (HazDat). http://www.atsdr.cdc.gov/Hazdat.html] A search of the EPA STORET database back to 1980 found data for only 75

env ironmental samples of any kind analyzed for nitrofen. All of these were water samples from Dade County in the state of Florida taken between 1997 and 1999. No nitrofen was detected in any of the samples.[FN6: U.S. EPA. STORET. http://www.epa.gov/storet/dbtop.html]

The EPA Toxics Release Inventory contains reports of nitrofen disposal and other releases for only three years since reporting began in 1988: 505 pounds were released into the air from the Custom Alloy Corporation facility in High Bridge, NJ in both 2000 and 2001, and 25,300 pounds were disposed of in RCRA Subtitle C (hazardous waste) landfills from a Chemical Waste Management facility in Kettleman City, CA.[FN7: U.S. EPA. Toxics Release Inventory. http://www.epa.gov/triexplorer.] As such, nitrofen releases appear to be very limited in both time and geographic location.

Currently, the lack of sources of nitrofen releases to the

env ironment suggests that exposure among the U.S. population is through consumption of imported vegetables treated with nitrofen,[FN8: National Library of Medicine. HazardousSubstances Data Base. http://toxnet.nlm.nih.gov/cgi-bin/

sis/htmlgen?HSDB.] and not through drinking water. Therefore, EPA should prioritize other, more troubling, chemicals to be listed on the CCL3 and considered for regulation.

EPA must regulate some of the chemicals listed on the CCL3

Perchlorate. NRDC agrees with the inclusion of perchlorate (CAS # 7790-98-9 ) in the CCL3 and supports the promulgation of a fully health-protective Maximum Contaminant Level (MCL) for perchlorate in drinking water that is protective of sensitive subpopulations such as pregnant women, fetuses, infants and children. Perchlorate is known to interfere with the normal function of the thyroid gland. The thyroid gland produces a hormone that is necessary for regulation of many body functions including heart rate, metabolism, energy, mood, cognitive function, and growth and development. Iodide is a necessary ingredient of the thyroid hormone thyroxine (T4). Normally, iodide is transported into the thyroid gland by the sodiumiodide symporter (NIS). Once in the gland, iodide is bound to thyroglobulin. Perchlorate blocks the NIS and prevents uptake of iodide into the gland.

Thyroid hormone deficiency is associated with neurodevelopmental deficits W hile there may be other toxic actions and target organs for perchlorate toxicity, it is a scientific certainty that the thyroid is a critical target organ, and inhibition of iodine uptake is a critical mechanism of toxicity. Furthermore, it is well established that thyroid hormones are critically important for normal growth and development of the central nervous system, and therefore that gestation and infancy are periods of vulnerability to perturbations in normal thyroid hormone activity. Adequate levels of thyroid hormone are necessary for correct migration of cortical neurons during brain formation (1st trimester), neuronal proliferation during cerebellar formation (2nd trimester), microtubule formation, and myelin deposition (postnatal).[FN9: Glinoer D. Potential consequences of maternal hypothyroidism on the offspring: Evidence and implications. Horm Res 55:109-114, 2001.] Since the need for adequate thyroid hormone begins early in development, often before a mother mayknow that she is pregnant, treatment with iodide supplements

may be too late to rescue early thryroid-dependent developmental processes.

In infants with early-life or prenatal onset of hypothyroidism, a condition where the thyroid does not produce adequate levels of thyroid hormone, researchers have recorded lasting effects in selective memory and attention deficits, language, hearing, and vestibular function [FN10: Rovet JF. Congenital hypothyroidism: an analysis of persisting deficits and associated factors. Neuropsychol DevCogn C Child Neuropsychol. 2002 Sep;8(3):150-62. Review.]. Congenital hypothyroidism in infants is not uncommon, occurring in one out of every 3,500-5,000 children in North America. Surveys in pregnant women in the U.S. have reported that 2.5 percent of pregnant women have borderline or subclinical hypothyroidism (thyroid stimulating hormone (TSH) concentrations above 6 mU/l), and about 1 percent are estimated to have frank hypothyroidism. Since there are over 4 million babies born annually, this represents 40,000 infants born to mothers with frank hypothyroidism. A 1999 study by Dr. James Haddow, medical director, Foundation for Blood Research, showed that children born to mothers with untreated hypothyroidism during pregnancy score lower on IQ tests than children of healthy mothers.[FN11: Haddow JE, Palomaki GE, Allan WC, W illiams JR, Knight GJ, Gagnon J, O'Heir CE, Mitchell ML, Hermos RJ, Waisbren SE, Faix JD, Klein RZ. N Engl J Med. 1999 Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. Aug 19;341(8):549-55. Comment in: N Engl J Med. 1999 Aug 19;341(8):601-2. N Engl J Med. 1999 Dec 23;341(26):2015-6; discussion 2017. N Engl J Med. 1999 Dec 23;341(26):2015; discussion 2017. N Engl J Med. 1999 Dec 23;341(26):2016-7. N Engl J Med. 1999 Dec 23;341(26):2016; discussion 2017.] Of the 62 women in Dr. Haddow's study, only 14 were diagnosed and receiving treatment for hypothyroidism before their pregnancies. Of those with untreated hypothyroidism, their children's IQ scores averaged 7 points below the children of mother's with normal thyroid hormone levels, and 19 percent had IQ scores below 85. Children who have an I.Q. less than 85 are more likely to have difficulties in school, and may be less successful in their careers and interpersonal relationships. In a later study researchers reported that pregnant women with borderline or more severehypothyroidism (TSH levels 6mU/L or greater) have an almost

four-times greater risk for miscarriage during the second trimester.[FN12: Allan WC, Haddow JE, Palomaki GE, W illiams JR, Mitchell ML, Hermos RJ, Faix JD, Klein RZ. Maternal thyroid deficiency and pregnancy complications: implications for population screening. J Med Screen. 2000;7(3):127-30.] This study suggests that 6 out of every 100 late term miscarriages may be attributable to thyroid deficiency during pregnancy.

The World Health Organization recognizes iodine deficiency as the most common preventable cause of mental retardation in the world. W ithout adequate maternal iodine intake, both the fetus and mother are hypothyroid. W ithout appropriate diagnosis and treatment with iodide supplements the child may suffer abnormal neurodevelopment, in extreme cases leading to cretinism with mental retardation, deaf-mutism and spasticity. The World Health Organization estimated in 1990 that 20 million people worldwide had some degree of brain damage due to iodine deficiency experienced in fetal life. Although iodine deficiency is less common in the United States, the CDC biomonitoring data found that among women of childbearing age, 15% have low urine iodine concentrations (below 5 ug/dl) indicative of iodine deficiency. These women would be expected to be most vulnerable to the toxic effects of perchlorate during pregnancy. CDC reported that iodide deficiency was most common in women living below the poverty level, and people in the Southern U.S.

Because perchlorate crosses the placenta, it has the potential to directly affect the fetus, and may induce hypothyroidism in the fetus and newborn, in addition to its indirect fetal effects through interference with maternal thyroid activity.[FN13: Clewell RA, Merrill EA, Yu KO, Mahle DA, Sterner TR, Mattie DR, Robinson PJ, Fisher JW , Gearhart JM. Predicting fetal perchlorate dose and inhibition of iodide kinetics during gestation: a physiologicallybased pharmacokinetic analysis of perchlorate and iodide kinetics in the rat. Toxicol Sci. 2003 Jun;73(2):235-55.] A 2005 study reported that perchlorate was detected in all 38 samples of breast milk from women living in 18 states across the U.S. Perchlorate was also detected in all but one of the 47 store milk samples from 11 states. Although the study had a limitednumber of samples, it did report that the breast milk with the

highest perchlorate levels (above 10 ug/L) also had the lowest iodide content.[FN14: Kirk AB, Martinelango PK, Tian K, Dutta A, Smith EE, Dasgupta PK. Perchlorate and iodide in dairy and breast milk. Environ Sci Technol. 2005 Apr 1;39(7):2011-7] These data suggest that perchlorate contamination in breast milk may lower the iodide content, thereby creating a double jeopardy for the breastfeeding infant, robbing its food source of necessary iodide while also dosing it with perchlorate. Most concerning, these researchers reported that in the breast milk samples the average concentration of perchlorate was five times higher than in store milk, raising concern that the healthiest source of food for newborns is in need of regulatory protection.

Several studies have demonstrated exposure and measurable effects of perchlorate exposure in children and adults:

* Blount et al. (2006a). This study found detectable perchlorate levels in all urine samples from 2,820 individuals studied as part of the National Health and Nutrition Examination Survey (NHANES) in 2001 and 2002. Researchers found a median perchlorate level of 3.6 ug/l (3.38 ug/g creatinine) and a 95th percentile level of 14 ug/l (12.7 ug/g creatinine). The estimated doses corresponding to the urinary levels of perchlorate were below the EPA Reference Dose (RfD).[FN15: Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle JL. Perchlorate Exposure of the U.S. Population, 2001-2002. J Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7.]

* Blount et al. (2006b). This study involved a portion of the study cohort described in Blount 2006a, cited above. The researchers studied the relationship between low-level perchlorate exposure as indicated by perchlorate concentrations in urine and serum levels of total thyroxine (T4) and thyroid stimulating hormone (TSH) in 2,299 men and women aged 12 and older. The study found that higher perchlorate levels were significantly correlated with lower levels of T4 and higher levels of TSH in women with low urinary iodine (<100 ug/l).[FN16: Blount BC, Pirkle JL, Osterloh JD, Valentin- Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormonelevels in adolescent and adult men and women living in the

United States. Environ Health Perspect. 2006 Dec;114(12):1865-71.]

* Brechner et al, 2000. Authors report an association between perchloratecontaminated drinking water in Yuma, Arizona and abnormal thyroid function in newborns. Their data suggest that

even low-level perchlorate may increase risk of thyroid disruption in newborns.[FN17: Brechner RJ, Parkhurst GD, Humble WO , Brown MB, Herman W H. Ammonium perchlorate contamination of Colorado River drinking water is associated with abnormal thyroid function in newborns in Arizona. J Occup Env iron Med. 2000 Aug;42(8):777-82.]

* Schwartz 2001. An unpublished study reported that perchlorate contaminated drinking water in a Southern California community is associated with thyroid disruption in newborns in a dose- dependent manner, with measurable effects at contamination levels of 3 to over 13 ug/L.

The Blount et al. 2006a and 2006b studies cited above were published after EPA issued its 24.5 ppb Drinking Water Equivalent Level (DW EL) for perchlorate. Taken together, these studies provide key evidence about perchlorate interference with thyroid hormones at levels below the EPA Reference Dose (RfD) and demonstrate the inadequacy of the 24.5 ppb DW EL that was calculated based on the RfD.

EPA drinking water monitoring data show that widespread contamination may be exposing millions of people to perchlorate throughout the country. EPA's Unregulated Contaminant Monitoring Rule (UCMR) required all large public water systems (serv ing a population of over 10,000 people) and a sample of

smaller systems to monitor for perchlorate for a period of three years beginning in 2001. Public water systems (PWS) in 26 states and two U.S. territories had reported perchlorate detections as of the January 2005 UCMR data release.[FN18: U.S. EPA. Unregulated Contaminant Monitoring Rule, [January 2005 data release]. http://www.epa.gov/safewater/ucmr/index.html] Concentrations in the samples that tested positive forperchlorate ranged from 4.0 ppb (the minimum reporting level or

MRL) to 420.0 ppb, with an average of 10.0 ppb. Of the 32,877 samples analyzed nationally, 614, or 1.9 percent, contained perchlorate at or above the MRL. A total of 153 of the 3,722 PWS tested, or 4.1 percent, detected perchlorate in their water. These systems served a population of 12.6 million, or 7.0 percent of the population served by all the PWS monitored. California and Arizona had the largest populations served by systems that detected perchlorate, with 5.3 million and 2.7 million, respectively.

Some perchlorate detections in PWS seem to correspond closely with the locations of known perchlorate releases, particularly in some sites in California and Arizona, while in other states there is no apparent connection. Unidentified releases may play a role, but since perchlorate contamination can travel long distances in groundwater and surface water, geographic proximity to a release site is not always necessary for a water source to become contaminated. EPA had listed 109 sites of known perchlorate releases in 29 states as of December 10, 2004.[FN19: U.S. EPA. Known Perchlorate Releases in the U. S. - December 10, 2004. http://www.epa.gov/fedfac/pdf/detection_with_dates_12_10_04.pdf ]

Other agencies have collected perchlorate occurrence data that demonstrate that perchlorate is even more widespread than the UCMR database indicates. NRDC has reviewed the following data

sources:

* Arizona: The Arizona Departments of Environmental Quality (ADEQ) and Water Resources (ADW R) conducted a study of perchlorate contamination in water between May and August, 2004, after two earlier studies by ADEQ and the City of Phoenix documented numerous occurrences of perchlorate in ground and surface waters in 1999 and 2000. Researchers analyzed a total of 41 surface water samples, 35 groundwater samples, and 12 samples from underground recharge facilities supplied by Colorado River water. The sampling points included both drinking and non-drinking water sources.[FN20: Arizona Department of Environmental Quality (ADEQ)., Perchlorate inArizona: Occurrence Study of 2004 (revised).

http://www.azdeq.gov/function/about/perch.html.]

* California: The California Department of Health Services (DHS) began tracking perchlorate occurrence in drinking water wells in 1997, and has required PWS to test for it since 1999. The data produced by the early well tests have been entered together with more recent drinking water monitoring data in a database maintained by the DHS Drinking Water Program. Although the database reporting limit is 4 ppb, it contains results for some samples with perchlorate levels as low as 1 ppb. As of April 2005, the database contained perchlorate sampling results for 1,231 PWS with active water sources. It also contained perchlorate results for 34 agricultural and monitoring sites belonging to 17 systems.[FN21: California Department of Health Serv ices (DHS). California Drinking Water Data [database on CD], April 2005.]

* Massachusetts: The Massachusetts Department of Environmental Protection (DEP) promulgated an emergency regulation in February 2004 that required all community and non-transient, non-community (NTNC) water systems to test for perchlorate at each entry point. Groundwater systems were required to monitor in April and September, 2004. Surface water systems had to test in March 2004 and quarterly during the remainder of 2004. The DEP database contains results as low as 0.19 ppb, but concentrations below 1 ppb were below the limit of quantitation. The concentrations reported for these positive samples are usually laboratory estimates.[FN22: Personal communication from D. Guterman, Massachusetts DEP, April 5, 2005.] The DEP database contained monitoring results for 706 PWS as of March 2005.[FN23: Massachusetts Department of Environmental Protection. Perchlorate monitoring results [data prov ided by Drinking Water Program], March 2005.]

* Texas: In 2002 Texas Tech University (TTU) Water Resources Center initiated a two-phase study of perchlorate contamination in the High Plains area of western Texas for the Texas Commission on Env ironmental Quality. In 2003 the second phase of the investigation extended the initial nine-county study area to encompass 54 counties. A total of 560 PWS wells, 29U.S. Geological Survey (USGS) wells, 99 High Plains Water

District (HPW D) wells and 76 private wells were sampled.[FN24: W.A. Jackson et al., Distribution and Potential Sources of Perchlorate in the High Plains Region of Texas: Final Report, Texas Tech University Water Resources Center, prepared for Texas Commission on Environmental Quality, 2004., http://www.waterresources.ttu.edu/research.htm.]

* U.S. Government Accountability Office (GAO): In May 2005 GAO published a report on perchlorate contamination and actions taken to address this problem in the U.S. This report listed perchlorate release sites and perchlorate detections in public water systems and private wells.[FN25: U.S. Government Accountability Office (GAO), Perchlorate: A System to Track Sampling and Cleanup Results Is Needed, 2005, GAO-05-462. http://www.gao.gov]

A review of these data sources conducted by NRDC in 2005 found reports of of 5,369 public water systems sampled, of which 402 (7.5 percent) detected perchlorate in their water. The highest concentrations were reported by systems in Massachusetts and Puerto Rico, where the highest levels found were 1,300 and 420 ppb, respectively. Water systems in California, the state with the most affected systems, had concentrations ranging from 1.0 to 130 ppb, with an average of 9.2 ppb in positive samples

The occurrence, exposure and health effects data discussed above support the establishment of a Maximum Contaminant Level (MCL) for perchlorate. Unlike the existing DW EL, which fails to take into account the demonstrated effects of perchlorate exposure at low doses, the MCL should be protective of sensitive subpopulations such as pregnant women, fetuses, infants and children. In developing the MCL, EPA must consider factors such as body weight and routes and patterns of exposure, and include an appropriate margin of safety.

Perfluorooctanoic acid. We are pleased that the Agency included perfluorooctanoic acid or PFOA (CAS # 335-67-1) on the draft CCL3. Because of the toxicity and widespread exposure to PFOA, we believe that the time is ripe for EPA to regulate PFOAwithin this cycle, as required by the SDWA.

The adverse health effects associated with exposure to PFOA are well documented. PFOA binds to serum proteins in blood and acts as an endocrine disruptor (lowering testosterone concentrations while increasing estradiol levels) and developmental toxicant, as found in some animal studies on rats.[FN26: Jensen AA, Leffers H. Emerging endocrine disrupters: perfluoroalkylated substances. Int J Androl. 2008 Apr;31(2):161-9.] A study of fish hepatocytes has confirmed the estrogenic properties of PFOA found in rat studies.[FN27: Liu C, Du Y, Zhou B. Evaluation of estrogenic activities and mechanism of action of perfluorinated chemicals determined by vitellogenin induction in primary cultured tilapia hepatocytes. Aquat Toxicol. 2007 Dec 30;85(4):267-77.]

A study in female mice found that PFOA decreased IgM antibody synthesis.[FN28: Dewitt JC, Copeland CB, Strynar MJ, Luebke RW . Perfluorooctanoic Acid-Induced Immunomodulation in Adult C57BL/6J or C57BL/6N Female Mice. Environ Health Perspect. 2008 May;116(5):644-50] PFOA has also been found to cause liver damage in mice, which is characterized by multifocal coagulation, liquefaction necrosis, hepatocytomegaly, acidophilic cytoplasm and other cellular changes.[FN29: Son HY, Kim SH, Shin HI, Bae HI, Yang JH. Perfluorooctanoic acid- induced hepatic toxicity following 21-day oral exposure in mice. Arch Toxicol. 2008 Apr;82(4):239-46.; FN30: Wolf DC, Moore T, Abbott BD, Rosen MB, Das KP, Zehr RD, Lindstrom AB, Strynar MJ, Lau C. Comparative Hepatic Effects of Perfluorooctanoic Acid and WY 14,643 in PPAR-{alpha} Knockout and W ild-type Mice. Toxicol Pathol. 2008 May 8.] This compound also causes liver, testis and pancreatic tumors in rats.[FN31: Kennedy GL Jr, Butenhoff JL, Olsen GW , O'Connor JC, Seacat AM, Perkins RG, Biegel LB, Murphy SR, Farrar DG. The toxicology of perfluorooctanoate. Crit RevToxicol. 2004 Jul- Aug;34(4):351-84.] PFOA causes changes in gene expression affecting inflammation, cell cycle regulation, and metabolic processes.[FN32: Rosen MB, Abbott BD, Wolf DC, Corton JC, Wood CR, Schmid JE, Das KP, Zehr RD, Blair ET, Lau C. Gene Profiling in the Livers of W ild-Type and PPAR{alpha}-Null Mice Exposed to Perfluorooctanoic Acid (PFOA). Toxicol Pathol. 2008 May 8.; FN33: Wei Y, Chan LL, Wang D, Zhang H, Wang J, Dai J. Proteomicanalysis of hepatic protein profiles in rare minnow

(Gobiocypris rarus) exposed to perfluorooctanoic acid. J Proteome Res. 2008 Apr;7(4):1729-39.] Neurotoxic effects have also been found in mice exposed neonatally to PFOA.[FN34: Johansson N, Fredriksson A, Eriksson P. Neonatal exposure to perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) causes neurobehav ioural defects in adult mice. Neurotoxicology. 2008 Jan;29(1):160-9.]

Studies have indicated effects on humans as well. A study of newborn children in Maryland found an association between PFOA concentrations in cord serum and infants' birth weight and size.[FN35: Apelberg BJ, W itter FR, Herbstman JB, Calafat AM, Halden RU, Needham LL, Goldman LR. Cord serum concentrations of perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) in relation to weight and size at birth. Environ Health Perspect. 2007 Nov ;115(11):1670-6.] In a study of 454 workers occupationally exposed to PFOA, higher levels of serum PFOA were associated with increased total cholesterol, decreased total bilirubin and increased serum aspartate aminotransferase, prov iding evidence of PFOA effects on the human liver.[FN36: Sakr CJ, Leonard RC, Kreckmann KH, Slade MD, Cullen MR. Longitudinal study of serum lipids and liver enzymes in workers with occupational exposure to ammonium perfluorooctanoate. J Occup Environ Med. 2007 Aug;49(8):872-9.]

In addition to these health effects, concerns about the occurrence and bioaccumulation of PFOA in the general population have existed since the 1990s.[FN37: U.S. Environmental Protection Agency. Basic Information on PFOA. http://www.epa.gov/oppt/pfoa/pubs/pfoainfo.htm] Wastewater treatment plants (WWTP) are an important source of PFOA contamination in surface water,[FN38: Sinclair E, Kannan K. Mass loading and fate of perfluoroalkyl surfactants in wastewater treatment plants. Environ Sci Technol. 2006 Mar 1;40(5):1408-14.] which degrades drinking water sources. As a result, drinking water is an important pathway of PFOA exposure.

Elevated concentrations of PFOA have been found near facilities that use perfluorinated compounds or process wastewatercontaining these chemicals. For example, PFOA concentrations of

253 to 1150 ng/L were detected in the Conasauga River in Georgia. The study location was downstream of a wastewater land application site in Dalton, GA home to a large carpet manufacturing facility that is a source of fluorinated chemicals. Meanwhile, PFOA levels in streams and ponds in the Dalton area ranged from 49.9 to 299 ng/L.[FN39: Konwick BJ, Tomy GT, Ismail N, Peterson JT, Fauver RJ, Higginbotham D, Fisk AT. Concentrations and Patterns of Perfluoroalkyl Acids in Georgia, USA Surface Waters Near and Distant to a Major Use Source. Env iron Toxicol Chem. 2008 Apr 17:1.]

It has been estimated that the daily exposure of Americans to PFOA ranges from 1 to 130 ng/kg(bw)/day, the greater portion of which is due to oral exposure through food and drinking water.[FN40: Trudel D, Horowitz L, Wormuth M, Scheringer M, Cousins IT, Hungerbühler K. Estimating consumer exposure to PFOS and PFOA. Risk Anal. 2008 Apr;28(2):251-69.] A study near a fluoropolymer production facility determined that exposure through drinking water, rather than inhalation exposure, was the determinant factor in serum PFOA levels.[FN41: Emmett EA, Shofer FS, Zhang H, Freeman D, Desai C, Shaw LM. Community exposure to perfluorooctanoate: relationships between serum concentrations and exposure sources. J Occup Env iron Med. 2006 Aug;48(8):759-70.] A similar German study also concluded that drinking water is a key exposure pathway near PFOA-contaminated sites. In this study, researchers analyzed blood PFOA levels in a study population of 691 indiv iduals aged 6 to 69 years who lived near an agricultural area contaminated by the application of soil conditioner mixed with industrial waste. This population was exposed to PFOA through contaminated drinking water at concentrations of 500-640 ng/L The study found average PFOA levels in blood of 24.6 ug/L (children 5-6 years), 26.7 ug/L (mothers 23-49 years), and 28.5 ug/L (men 18-69 years). These values are 4.5 to 8.3 times higher than concentrations detected in a control population. PFOA concentrations were significantly related to tap water consumption at home.[FN42: Hölzer J, Midasch O, Rauchfuss K, Kraft M, Reupert R, Angerer J, Kleeschulte P, Marschall N, W ilhelm M. Biomonitoring of perfluorinated compounds in children and adults exposed to perfluorooctanoatecontaminated drinking water. Env iron Health Perspect. 2008 May;116(5):651-7.]The 2003-2004 National Health and Nutrition Examination Survey

(NHANES) found PFOA levels in 99.7% of the samples of human blood serum collected from the 2,094 study participants. The geometric mean PFOA concentration was 3.9 ug/L (95% confidence interval: 3.6 - 4.3 ug/L). This study population was representative of the general U.S. population above 12 years of age.[FN43: Calafat AM, Wong LY, Kuklenyik Z, Reidy JA, Needham LL. Polyfluoroalkyl chemicals in the U.S. population: data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004 and comparisons with NHANES 1999-2000. Environ Health Perspect. 2007 Nov ;115(11):1596-602.] In addition, a study of 299 newborn children born in Baltimore, MD, determined that PFOA was present in 100% of the cord serum samples. The geometric mean concentration was 1.6 ng/mL.[FN44: Apelberg BJ, Goldman LR, Calafat AM, Herbstman JB, Kuklenyik Z, Heidler J, Needham LL, Halden RU, W itter FR. Determinants of fetal exposure to polyfluoroalkyl compounds in Baltimore, Maryland. Environ Sci Technol. 2007 Jun 1;41(11):3891-7]

PFOA is persistent both in the environment and in the human body. In a study of retired perfluorochemical workers, the arithmetic and geometric mean elimination half-life of PFOA in blood serum was found to be 3.8 years, respectively, indicating a long persistence in the organism.[FN45: Olsen GW , Burris JM, Ehresman DJ, Froehlich JW , Seacat AM, Butenhoff JL, Zobel LR. Half-life of serum elimination of perfluorooctanesulfonate,perfluorohexanesulfonate, and perfluorooctanoate in retired fluorochemical production workers. Environ Health Perspect. 2007 Sep;115(9):1298-305.]

Given the adverse health effects associated with exposure to PFOA, as well as the widespread PFOA contamination in the

env ironment, EPA must determine to regulate levels of this chemical in drinking water, which will meaningfully reduce health risks for those served by public water systems.

EPA has not included some contaminants on the CCL3 that should be listedDespite the appearances of having a comprehensive process for

creating the CCL3 - by first looking at the universe of contaminants and then culling that list down - EPA failed to include some important categories of contaminants that are posing significant risk of adverse health effects in drinking water.

Alkylphenol polyethoxylates (APEs). These compounds include:

* Alkylphenol mono- to tri-oxylates (CAS # 68555-24-8) * Nonylphenol (NP) (CAS # 25154-52-3) * Nonylphenol ethoxylate (NPE) (CAS # 9016-45-9) * Octylphenol (OP) (CAS # 27193-28-8) * Octylphenol ethoxylate (OPE) (CAS # 9036-19-5)

An estimated 450,000,000 pounds of alkylphenol polyethoxylates (APEs) are produced annually in the United States, and about half that amount is estimated to be released to wastewater. Alkylphenols were first reported to be estrogenic in the 1930s. In 1991, publication of the effects of nonylphenol on cultured human breast cancer cells led to health concerns. Estrogenic effects have also been shown in the mouse. Estrogenic effects are present at tissue concentrations of 0.1 μM for octylphenol and 1 μM for nonylphenol. A recombinant yeast screen using the human estrogen receptor has shown similar results.[FN46: Ying GG, W illiams B, Kookana R. Environmental fate of alkylphenols and alkylphenol ethoxylates--a rev iew. Env iron Int. 2002 Jul;28(3):215-26.]

Alkylphenol polyethoxylates do not break down effectively in sewage treatment plants or in the environment. Instead they degrade to alkylphenols and alkylphenol ethoxylates, which persist for longer. Nonylphenol and its ethoxylates, and other alkylphenols, have been detected in wastewater and in waterways.[FN47: Gatidou G, Thomaidis NS, Stasinakis AS, Lekkas TD. Simultaneous determination of the endocrine disrupting compounds nonylphenol, nonylphenol ethoxylates, triclosan and bisphenol A in wastewater and sewage sludge by gas chromatography-mass spectrometry. J Chromatogr A. 2006 Oct 27.]Antibiotics. In March 2008, the Associated Press released a

report on finding pharmaceuticals in drinking water that garnered considerable press across the country, despite EPA being cognizant of this problem for at least a decade. Currently, there are no pharmaceuticals listed on any of the CCLs. In light of the widespread presence of these chemicals in our drinking water, EPA must act now and include a subset of the chemicals on the CCL3.

Widespread exposure to antibiotics is contributing to the growth of bacterial resistance, and this problem is of grave concern. In the past several decades almost every bacteria that can cause infections in humans has developed resistance to at least one antibiotic, and some are resistant to multiple antibiotics. The Centers for Disease Control and Prevention (CDC) have identified antibiotic resistance as one of the most pressing public health problems to face our nation.[FN48: Centers for Disease Control and Prevention (CDC). Campaign to Prevent Antimicrobial Resistance in Healthcare Settings. http://www.cdc.gov/drugresistance/healthcare/problem.htm] Infections caused by bacteria with resistance to at least one antibiotic have been estimated to kill over 60,000 hospitalized patients each year.[FN49: Health Care W ithout Harm. Antibiotic Resistance and Agricultural Overuse of Antibiotics, 2005. http://www.noharm.org/details.cfm?ID=938&type=document]

Antibiotic resistance is caused by a number of factors including repeated and improper use of antibiotics in both humans and animals. Scientists also agree that exposure to low levels of antibiotics actually promotes bacterial resistance by exerting selective pressure for genes that promote resistance. Antibiotics are found in wastewater because the body does not completely metabolize all drugs, so both the metabolized and unmetabolized drug are excreted by humans into wastewater. For example, when amoxicillin is ingested, 60-75% of the antibiotic is excreted unchanged into the urine. This antibiotic, now in the environment, may encounter other bacteria and promote resistance. It is unknown how much of an impact current low levels of antibiotics in drinking water are having on the problem of bacterial resistance. However, the potential has been recognized for many years.[FN50: USA Today, in an 11/8/00news article stated, "Experts fear that even low levels of

antibiotics fouling the nations water supply may help create super-bugs: micro organisms that have evolved to survive an antibiotic s lethal assault."]

Massive quantities of antibiotics are used in agriculture both to treat infections and as food additives to promote growth and to compensate for conditions that contribute to infection. Animals raised in Concentrated Animal Feeding Operations (CAFOs) are at increased risk for infection due to close confinement and stress. In fact, it has been estimated that 70% of the antibiotics used in the U.S. are for animal husbandry.[FN51: Mellon et al. Hogging It: Estimates of Antimicrobial Abuse in Livestock. Union of Concerned Scientists: Cambridge MA. 2000.] Improper use and overuse of antibiotics in livestock and poultry can cause resistance in strains of bacteria that can infect humans. Furthermore, half of the antibiotics used in livestock are in the same classes of drugs that are used in humans. As a result the U.S. Institute of Medicine (IOM) and the World Health Organization (W HO) both stated that the widespread use of antibiotics in agriculture is contributing to antibiotic resistance in humans.[FN52: Quotes from the Healthcare W ithout Harm factsheet. Antibiotic Resistance and Agricultural Overuse of Antibiotics. 2005. http://www.noharm.org/us/food/issue U.S. Institute of Medicine/National Academy of Science: "Clearly, a decrease in antimicrobial use in human medicine alone will have little effect on the current [antibiotic-resistant] situation. Substantial efforts must be made to decrease inappropriate

overuse in animals and agriculture as well." World Health Organization: "There is clear evidence of the human health consequences due to resistant organisms resulting from non- human usage of antimicrobials. These consequences include infections that would not have otherwise occurred, increased frequency of treatment failures (in some cases death) and increased severity of infections."]

Large animal feeding operations generate a large amount of waste that can potentially contaminate groundwater and waterways contributing to antibiotic resistance and contamination of waterways with steroid hormones.[FN53: Gilchrist MJ, Greko C, Wallinga DB, Beran GW , Riley DG, ThornePS. The potential role of concentrated animal feeding

operations in infectious disease epidemics and antibiotic resistance. Environ Health Perspect. 2007 Feb;115(2):313-6. Wallinga D, Mellon M, Roach S. Antibiotic use in swine farms in Alberta. Can Vet J. 2006 Dec;47(12):1153; author reply 1153-4. Wallinga D. Public health advocate. Prev Vet Med. 2006 Feb 24;73(2-3):221-8. Epub 2005 Oct 28.] As occurs in humans, some portion of the antibiotics administered to livestock will pass unchanged through their bodies and will be excreted in their waste. It has been estimated that between 25-75% of antibiotics are excreted unchanged in feces and can persist in the soil after land application.[FN54: Chee-Sanford, J.C., et al. Occurrence and Diversity of Tetracycline Resistance Genes in Lagoons and Groundwater Underlying Two Swine Production Facilities. Applied and Environmental Microbiology, April 2001. Vol. 6 no. 4, pp. 1494-1502.] Manure is applied in large quantities as fertilizer in farm fields. In addition to potentially contaminating the food supply with antibiotic resistant bacteria, antibiotics in manure can persist in soil and promote the development of more antibiotic resistant bacteria. Animal waste and its associated contaminants can enter waterways through groundwater contamination, overflow of waste lagoons into surface water or by over-application of manure as fertilizer in farm fields. A recently published study found evidence of fecal contamination and increased levels of antibiotic resistant bacteria downstream of a swine concentrated feeding operation.[FN55: Sapkota AR, et al. Antibiotic-resistant enterococci and fecal indicators in surface water and groundwater impacted by a concentrated Swine feeding operation. Env iron Health Perspect. 2007 Jul;115(7):1040-5.] Other studies have found antibiotic resistance in groundwater underlying a swine waste lagoon.[FN56: Chee-Sanford, J.C., et al. Occurrence and Diversity of Tetracycline Resistance Genes in Lagoons and Groundwater Underlying Two Swine Production Facilities. Applied and Environmental Microbiology, April 2001. Vol. 6 no. 4, pp. 1494-1502.]

As such, antibiotics that are used both for human medical needs and in large-scale agriculture operations at low levels in animal feed to promote animal growth must be included on the CCL3 and must be regulated. These antibiotics include bacitracin zinc, spiramycin, tylosin, and virginiamycin.Notably, these antibiotics were all banned for agricultural use

in the European Union in 1998.

Infections among hospital patients (nosocomial infections) from enterococci bacteria are very common. Such infections that result in human disease can be fatal, particularly those caused by strains of vancomycin-resistant enterococci (VRE). During 2004, VRE caused about one of every three infections in hospital intensivecare units, according to the Centers CDC. As of 2007, the U.S. had reported seven cases of vancomycin- resistant Staphylococcus aureus (VRSA) infection. Therefore,

vancomycin must be included on the CCL3.

Beta-lactam antibiotics are a broad class of antibiotics which include penicillin derivatives, cephalosporins, monobactams, carbapenems and Beta-lactamase inhibitors. Methicillin, a form of penicillin, had been relied upon as an common effective treatment for Staphylococcus aureus infections but now many strains of S. aureus bacteria are resistant to methicillin. These are now called MRSA, or 'methicillin-resistant Staphylococcus aureus'. Unfortunately, MRSA is actually resistant to much of the entire class of penicillin-like antibiotics called beta-lactams. Therefore, EPA must include penicillin, amoxicillin, oxacillin and methicillin on the CCL3.

Linezolid resistance in Staphylococcus aureus was reported in 2003. Community-acquired MRSA (CA-MRSA) has now emerged as an epidemic that is responsible for rapidly progressive, fatal diseases including necrotizing pneumonia, severe sepsis and necrotizing fasciitis. Outbreaks of CA-MRSA infections have been reported in correctional facilities, among athletic teams, among military recruits, in newborn nurseries, and among active homosexual men. Therefore, linezolid must be included on the CCL3.

Bisphenol A (BPA). Bisphenol A (4,4'-(1-Methylethylidene) bisphenol or 4,4'-Isopropylidenediphenol), (CASRN 80-05-7), is a monomer used as the building block of polycarbonate plastics and other plastics including epoxy resins. BPA is found in a wide variety of everyday consumer products, such as the coatingof food and drink packaging, dental sealants, baby bottles,

water bottles, microwave ovenware and eating utensils. As these products age, the polycarbonate polymer breaks down, releasing the BPA monomer. BPA is produced at over one million pounds per year and is frequently found in the environment. BPA releases to the environment in the U.S. totaled 1.4 million pounds in 2006, including 3,410 pounds released directly to water and 108,805 pounds released to the air.[FN57: U.S. EPA, Toxics Release Inventory, http://www.epa.gov/triexplorer.]

A number of recent studies have revealed that early life exposures to low-doses of BPA result in adverse effects later in life. The developing fetus is especially vulnerable. Although many of these studies were done in laboratory animals, the exposures occurred at concentrations currently found in the human population.[FN58: Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Env iron Health Perspect. 2008 Jan;116(1):39-44.]

* In rats, in utero exposure to BPA causes long-term effects on development of mammary tissue, causing preneoplastic lesions, increased susceptibility to cancer and increased sensitivity to a chemical known to cause breast cancer.[FN59: Durando M, Kass L, Piva J, Sonnenschein C, Soto AM, Luque EH, Muñoz-de-Toro M. Prenatal Bisphenol A Exposure Induces Preneoplastic Lesions in the Mammary Gland in W istar Rats. Environ Health Perspect, 2007 Jan;115(1):80-6.; FN60: Murray TJ, Maffini, MV, Ucci AA, Sonnenschein C and Soto AM. Induction of mammary gland ductal hyperplasias and carcinoma in situ following fetal bisphenol A exposure. Reprod Toxicol, 2007 Apr-May;23(3):383-90.]

* Perinatal exposure to low levels of BPA causes precancerous prostate lesions (prostatic intraepithelial neoplasia) in rats. The effect appears to result from the failure in exposed animals of a gene to become hypermethylated as the rats age.[FN61: Ho SM, Tang WY, Belmonte de Frausto J, and Prins GS. Developmental exposure to estradiol and bisphenol A increases susceptibility to prostate carcinogenesis and epigenetically regulates phosphodiesterase type 4 variant 4. Cancer Res. 66(11):5624-32 (2006).]* Experiments with mice reveal that chronic adult exposure to

BPA causes insulin resistance, a common problem in humans that can lead to Type II diabetes and heart disease.[FN62: Alonso- Magdalena P, Morimoto S, Ripoll C, Fuentes E and Nadal A. The estrogenic effect of bisphenol A disrupts pancreatic beta-cell function in vivo and induces insulin resistance. Environ Health Perspect.114(1):106-12 (2006).]

* BPA has been shown to cause aneuploidy in mouse oocytes. Meiotic aneuploidy is the most common cause of miscarriage in women.[FN63: Hunt PA, Koehler KE, Susiarjo M, Hodges CA, Ilagan A, Voigt RC, Thomas S, Thomas BF, and Hassold TJ. Bisphenol A exposure causes meiotic aneuploidy in the female mouse. Curr Biol. 13(7):546-53 (2003).]

* In a small prospective study, researchers in Japan found women with a history of repeated spontaneous miscarriages had higher levels of BPA. The researchers found ev idence of aneuploidy in several of the miscarried fetuses in concordance with previous studies showing BPA causes meiotic aneuploidy.[FN64: Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino T and Suzumori K. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod. 20(8):2325-9 (2005).]

* BPA lowers sperm count in adult rats even at extremely low levels.[FN65: Sakaue, M, S Ohsako, R Ishimura, S Kurosawa, M Kurohmaru, Y Hayashi, Y Aoki, J Yonemoto and C Tohyama. Bisphenol-A Affects Spermatogenesis in the Adult Rat Even at a Low Dose. J Occup Health 43:185-190 (2001).]

Recently, a group of 38 scientists issued a consensus statement expressing their concern that current levels of BPA exposure were contributing to the human health conditions of neurobehav ioral problems, obesity, infertility and reproductive cancers.[FN66: vom Saal FS, Akingbemi BT, Belcher SM, Birnbaum LS, Crain DA, Eriksen M, Farabollini F, Guillette LJ Jr, Hauser R, Heindel JJ, Ho SM, Hunt PA, Iguchi T, Jobling S, Kanno J, Keri RA, Knudsen KE, Laufer H, LeBlanc GA, Marcus M, McLachlanJA, Myers JP, Nadal A, Newbold RR, Olea N, Prins GS, Richter

CA, Rubin BS, Sonnenschein C, Soto AM, Talsness CE, Vandenbergh JG, Vandenberg LN, Walser-Kuntz DR, Watson CS, Welshons WV, Wetherill Y, Zoeller RT. Chapel Hill bisphenol A expert panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure. Reprod Toxicol. 2007 Aug-Sep;24(2):131-8] In addition, the U.S. National Toxicology Program has issued a draft report expressing "some concern" that BPA could cause neurobehav ioral abnormalities, early onset puberty, and reproductive cancers, especially in fetuses, infants and children who are exposed.[FN67: Draft NTP brief on Bisphenol A. Released April 14, 2008. http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF_ 04_14_08.pdf]

BPA is a water contaminant. A study in Germany found BPA in surface water (0.0005 to 0.41 ug/L), in sewage effluents (0.018 to 0.702 ug/L), in sediments (0.01 to 0.19 mg/kg) and in sewage sludge (0.004 to 1.363mg/kg dw).[FN68: Fromme H, Kuchler T, Otto T, Pilz K, Muller J, and Wenzel A. Occurrence of phthalates and bisphenol A and F in the environment. Water Res. 36(6):1429-38 (2002).] Cousins et al. (2002) rev iewed prev iously published monitoring data for the United States and found a median reported water concentration of 0.5 ug/l (below the detection limit of the studies) and a 90th percentile of 4.4 ug/l. The same study also suggested a half-life for BPA of 4.5 days in surface water, indicating that BPA can be transported hundreds of kilometers in rivers before levels fall below detection limits.[FN69: Cousins IT, Staples CA, Klecka GM, Mackay1 D. Multimedia assessment of the environmental fate of bisphenol A. Human and Ecological Risk Assessment 2002 8(5):1107-1135.]

Microbials. Mycobacterium Avium Complex (MAC) causes lung infections in immunocompromised individuals.[FN70: Centers for Disease Control, Mycobacterium av ium Complex. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/mycobacteriumavium_t .htm] Mycobacteria are able to survive and grow in aquatic

env ironments due to their protective outer coating, which also makes them resistant to chlorine treatment of water. Environmental sources are thought to be the main route oftransmission of these pathogens. These bacteria are widely

present in water sources and can also be found in biofilms that form on the inside of water pipes.[FN71: U.S. EPA, Mycobacteria: Drinking Water Fact Sheet, EPA-822-F-02-002. http://www.epa.gov .]

About 20 to 30 percent of people with AIDS become infected with MAC. Although adults usually do not get MAC disease until their T-cell count drops below 50, children can get it earlier. People with disseminated MAC disease develop fever, night sweats, weight loss, abdominal pain, tiredness, and diarrhea. EPA researchers estimate that approximately 1500 indiv iduals with advanced AIDS ingest tap water with detectable concentrations of MAC organisms each day.[FN72: Rice G, W right JM, Boutin B, Swartout J, Rodgers P, Niemuth N, Broder M. Estimating the frequency of tap-water exposures to Mycobacterium avium complex in the U.S. population with advanced AIDS. J Toxicol Environ Health A. 2005 Jun 11-25;68(11-12):1033-47.] A related species typically considered MAC, Mycobacterium av ium intracellulare, has been listed in Contaminant Candidate Lists (CCLs) 1 and 2. MAC should be included again in CCL3. The health effects and demonstrated occurrence in drinking water of MAC support the establishment of an MCL for this microbial contaminant.

Pesticides. Aldicarb (CAS # 116-06-3) is an N-methyl carbamate insecticide that causes reversible red blood cell and plasma cholinesterase inhibition. This pesticide is classified as Toxicity Category 1 because of its high toxicity through all routes of exposure (oral, dermal and inhalation). Symptoms of acute aldicarb exposure observed in animal studies include decreased motor activ ity, lacrimation, tremors, salivation, pinpoint pupils, and decreased grip strength. A rat study by EPA/ORD demonstrated that young animals are more susceptible to aldicarb-induced brain cholinesterase inhibition than adults.[FN73: U.S. EPA, Aldicarb, HED Revised Preliminary Human Health Risk Assessment for the Reregistration Eligibility Decision Document (RED). May 12, 2006.] Although it is generally believed that acute high level exposure to aldicarb will not cause chronic health effects, one case study by Grendon et al. (1994) in Washington State documented long-term health problems in men and sheep resulting from a singlepoisoning incident.[FN74: Grendon J, Frost F, Baum L. Chronic

health effects among sheep and humans surviving an aldicarb poisoning incident. Vet Hum Toxicol. 1994 Jun;36(3):218-23.]

EPA has not assessed the risks of chronic exposure to aldicarb in its 2006 Rev ised Human Health Risk Assessment (HRA). The Agency reasoned that since cholinesterase inhibition due to aldicarb exposure is reversed in less than 24 hours, such an assessment is unnecessary and chronic exposure can be treated as a series of acute exposures.[FN75: U.S. EPA 2006, supra.] However, EPA mentioned in the Revised HRA that effects such as pale kidneys and hydroceles in the ov iducts occurred in dams in a developmental study, symptoms that suggest chronic damage not seen in acute single-exposure cases. In addition, some studies suggest that chronic exposure to aldicarb may have longer-term effects on the immune and nervous systems. Fiore et al (2006) analyzed immune function in two groups of women, one exposed to aldicarb at environmental concentrations in groundwater at levels below 61 ppb (23 subjects), and an unexposed group (27 subjects). No women in either group had known reasons for immune problems. The researchers found a significant association between aldicarb exposure and abnormalities in T- cell subset ratios.[FN76: Fiore MC, Anderson HA, Hong R, Golubjatnikov R, Seiser JE, Nordstrom D, Hanrahan L, Belluck D. Chronic exposure to aldicarb-contaminated groundwater and human immune function. Environ Res. 1986 Dec;41(2):633-45.] Hajoui et al. (1992) also found changes in the percentages of certain T- cell subsets after subchronic, but not chronic exposure.[FN77: Hajoui O, Flipo D, Mansour S, Fournier M, Krzystyniak K. Immunotoxicity of subchronic versus chronic exposure to aldicarb in mice. Int J Immunopharmacol. 1992 Oct;14(7):1203-11.] The results of a rat study by Smulders et al. (2003) suggest that exposure to carbamates such as aldicarb may also lead to chronic changes in the nervous system resulting from the inhibition of neuronal nicotinic acetylcholine receptors.[FN78: Smulders CJ, Bueters TJ, Van Kleef RG, Vijverberg HP. Selective effects of carbamate pesticides on rat neuronal nicotinic acetylcholine receptors and rat brain acetylcholinesterase. Toxicol Appl Pharmacol. 2003 Dec 1;193(2):139-46.] A similar study of the carbamates fenoxycarb, carbaryl, and S-ethyl N,N-dipropylthiocarbamate (EPTC), which have the same mechanism of action, showed that increasing the pesticide dose or the length of exposure reducedthe rate of reversal of acetylcholine receptor

inhibition.[FN79: Smulders CJ, Van Kleef RG, de Groot A, Gotti C, Vijverberg HP. A noncompetitive, sequential mechanism for inhibition of rat alpha4beta2 neuronal nicotinic acetylcholine receptors by carbamate pesticides. Toxicol Sci. 2004 Nov ;82(1):219-27.] Therefore, two mechanisms, cholinesterase inhibition and acetylcholine receptor inhibition may lead to chronic neurotoxicity from exposure to carbamate pesticides such as aldicarb. This raises concerns about chronic low-level exposure such as may result from aldicarb contamination of drinking water.

EPA placed aldicarb under Special Rev iew in 1984 due to concerns about groundwater contamination.[FN80: U.S. EPA, 49 FR 28320, 1984, and 53 FR 24630, 1988.] Aldicarb degradation in groundwater is slow. This chemical is persistent and mobile in soil, and degrades in the env ironment to aldicarb sulfoxide and aldicarb sulfone, both of which are cholinesterase inhibitors. In 1991 EPA established MCLs of 0.003 ppb for aldicarb, 0.004 ppb for aldicarb sulfoxide and 0.002 ppb for aldicarb sulfone, but these MCLs never went into effect. Instead, EPA issued a 7 ppb health advisory for each of the aldicarb species and for combined aldicarb residues.

EPA based its drinking water risk assessment in the HRA on the highest aldicarb concentrations in groundwater found in eight regions where aldicarb was used. The concentrations ranged from 0 to 24 ppb. The region with no aldicarb detections was removed from the analysis. Surface water concentrations, on the other hand, were derived from models for lack of sufficient monitoring data.

Acute dietary exposure estimates from food alone exceeded the level of concern for children 1 to 2 years old (159% of the acute Population Adjusted Dose, or aPAD), and children 3 to 5 years old (129% aPAD), so that any additional exposures from drinking water would increase these risks of concern. The highest exposure from groundwater calculated for the regions where this pesticide was detected was 945% aPAD for the 95th percentile of the most exposed population sub-group. For the general U.S. population and other sub-groups, exposure rangedfrom 20% aPAD to 393% aPAD.[FN81: U.S. EPA, 2006, supra.]

It is clear from EPA's own analysis that aldicarb is a water contaminant that poses health risks of concern at levels found in food and drinking water. Given that food exposure alone exceeds levels of concern for children, drinking water exposure creates an additional unacceptable risk. EPA must move to establish a protective MCL for aldicarb.

Azinphos-methyl (CAS # 86-50-0) is an organophosphate pesticide classified as toxicity category 1 for oral exposure. Exposure to azinphos-methyl causes plasma, red blood cell and brain cholinesterase inhibition, with symptoms including headache,

nausea, vomiting, dizziness, anxiety, muscle tremors and weakness. Studies by Souza et al. (2004, 2005) found that azinphos-methyl affected human placental enzymatic activity, which may have adverse consequences for fetal development.[FN82: Souza MS, Magnarelli de Potas G, Pechen de D'Angelo AM. Organophosphorous and organochlorine pesticides affect human placental phosphoinositides metabolism and PI-4 kinase activity. J Biochem Mol Toxicol. 2004;18(1):30-6.; FN83: Souza MS, Magnarelli GG, Rovedatti MG, Cruz SS, De D'Angelo AM. Prenatal exposure to pesticides: analysis of human placental acetylcholinesterase, glutathione S-transferase and catalase as biomarkers of effect. Biomarkers. 2005 Sep-Oct;10(5):376-89.] Exposure to organophosphate pesticides (OPs) such as azinphos- methyl has been associated with lower performance on neurobehav ioral tests in exposed adults.[FN84: Rothlein J, Rohlman D, LasarevM, Phillips J, Muniz J, McCauley L. Organophosphate pesticide exposure and neurobehav ioral performance in agricultural and non-agricultural Hispanic workers. Environ Health Perspect. 2006 May;114(5):691-6.] Children are more vulnerable than adults to the neurotoxic effects of OPs and may suffer developmental effects from low- level chronic exposures.[FN85: Rohlman DS, Arcury TA, Quandt SA, LasarevM, Rothlein J, Travers R, Tamulinas A, Scherer J, Early J, Marin A, Phillips J, McCauley L. Neurobehavioral performance in preschool children from agricultural and non- agricultural communities in Oregon and North Carolina. Neurotoxicology. 2005 Aug;26(4):589-98.]Azinphos-methyl has a high potential to pollute surface waters

due to runoff and spray drift.[FN86: U.S. EPA, Interim Reregistration Eligibility Decision for Azinphos-Methyl, Case No. 0235. October 30, 2001.; FN87: Dabrowski JM, Bennett ER, Bollen A, Schulz R. Mitigation of azinphos-methyl in a

vegetated stream: comparison of runoff- and spray-drift. Chemosphere. 2006 Jan;62(2):204-12.] Data on environmental concentrations of azinphos-methyl in the United States are limited, but studies in South Africa suggest that under certain conditions azinphos-methyl may also reach high concentrations (>40 ppb) in groundwater.[FN88: Loewy RM, Carvajal LG, Novelli M, de D'Angelo AM. Effect of pesticide use in fruit production orchards on shallow ground water. J Environ Sci Health B. 2003 May;38(3):317-25.; FN89: Loewy RM, Carvajal LG, Novelli M, Pechen de D'Angelo AM. Azinphos methyl residues in shallow groundwater from the fruit production region of northern Patagonia, Argentina. J Env iron Sci Health B. 2006;41(6):869-81.]

EPA indicated in its drinking water assessment in the Interim Reregistration Eligibility Decision (IRED) document for azinphos-methyl that the estimated environmental concentration (EEC) of this pesticide in surface water is 16 ppb at typical application rates in peaches. This concentration is over three times the acute drinking water level of comparison (DW LOC) [FN90: The drinking water level of concern (DW LOC) is the amount of allowable risk left for exposure through drinking water, after considering the contribution from food to the total allowable dietary risk. The DW LOC is compared with the drinking water estimated env ironmental concentration (EEC) to determine whether drinking water exposure risks are of concern.] the agency calculated for infants less than a year old (5 ppb), and over twice the DW LOC for children 1-6 years (6 ppb). The highest annual mean concentrations in surface water according to monitoring data and EPA models ranged from 0.27 ppb to 7.2 ppb. The latter concentration exceeds the chronic DW LOC the agency calculated for infants less than a year old (7 ppb).

While EPA argued in the IRED that the phase-out of azinphos - methyl use on peaches will eliminate drinking water risks of concern, EPA is still allowing the use of azinphos-methyl onapples (the most frequently treated crop) at application rates

equal to or higher than those for peaches (1.0-1.5 lb ai/A per application, 4.5 lb ai/A per year maximum on apples vs. 1.125 lbs ai/A per application, 4.5 lbs ai/A per year maximum on peaches). Furthermore, the total amount of azinphos-methyl used on apples (890,000 lb active ingredient) is over seven times the amount used on peaches (120,000 lb). Therefore, the EPA assessment indicates that azinphos-methyl poses a risk to drinking water supplies. W hile EPA has issued a four-year limited registration for azinphos-methyl use on apples and

seven other crops, the Agency has stated that these registrations may be extended, thus creating the need to regulate azinphosmethyl as a drinking water contaminant.

Carbaryl (CAS # 63-25-2) is an N-methyl carbamate pesticide that acts as a neurotoxic acetylcholinesterase inhibitor and a "likely" carcinogen according to the Office of Pesticide Programs Cancer Assessment Review Committee. The systemic effects of carbaryl include headache, dizziness, weakness, shaking, nausea, stomach cramps, diarrhea, and sweating. Effects may also include loss of appetite, weakness, weight loss, and general malaise. Carbaryl is particularly toxic to the developing nervous system of fetuses, infants, and young children. Exposure to elevated levels of carbaryl may cause developmental neurotoxicity and "significant changes in some of the morphometric measurements of the brain".[FN91: Brenda Tarplee, U.S. EPA Health Effects Division, Carbaryl Reassessment Report of the FQPA Safety Factor Committee, Memorandum, December 13, 1999, Tox Review No. 013891.; FN92: Brenda Tarplee, U.S. EPA Health Effects Division, Carbaryl - 2nd Reassessment Report of the FQPA Safety Factor Committee, Memorandum, April 30, 2001, Tox Review No. 014553.]

Approximately 3.9 million pounds of carbaryl active ingredient are used annually in the U.S. W hen EPA issued its Rev ised Risk Assessment for carbaryl in 2003, its water assessment did not consider non-agricultural sources of carbaryl, which constitute a total of 40% of carbaryl use by weight, and which are the dominant sources of carbaryl pollution in surface water. Despite ignoring non-agricultural uses, the carbaryl health risk assessment in the Interim Reregistration Eligibility Decision (IRED) found that acute surface water risks presumingmaximum label application rates exceeded the drinking water

level of concern (DW LOC) for children and the general population when combined with estimated food exposures.[FN93: U.S. EPA, Interim Reregistration Eligibility Decision for Carbaryl, Case No. 0080. Rev ised October 22, 2004.]

U.S. Geological Survey National Water-Quality Assessment (USGS NAWQA) monitoring data presented in the carbaryl assessment demonstrated that streams draining urban areas had both higher concentrations of carbaryl and more frequent detections, when compared with streams draining agricultural or mixed land use areas. It is clear that contamination of water is predominantly from non-agriculture uses of carbaryl, and that by not considering these uses, the Agency dramatically underestimated the amount of carbaryl in drinking water (Estimated Environmental Concentration, or EEC), which is likely to be two-times higher than EPA estimates. Twenty-one (21) percent of surface water samples in the NAWQA database contained detectable levels of carbaryl.

EPA discussed in its IRED the limitations of existing monitoring data:

"Carbaryl is fairly mobile, but is not likely to persist or accumulate in the environment. As such, it is difficult for monitoring studies to detect peak concentrations that can occur. EPA determined that currently available monitoring studies for carbaryl are limited in this regard, and did not use them to define peak values for carbaryl."

As a result of these data limitations, EPA used models to estimate drinking water EECs for currently registered uses in the carbaryl IRED. The Agency reported that the acute drinking water EECs ranged from 23 to 410 ppb for acute exposure, and from 1.3 to 23 ppb for chronic exposure, which exceeded the acute DW LOC for children 1-2 years old (7.4 ppb) and for the general population (200 ppb). This is especially concerning, given that these calculations are likely to underestimate risk by excluding non-agricultural uses of carbaryl, which comprise 40% of total carbaryl used. Therefore, it is likely that actualEEC s are even higher, possibly 40% higher, than what the

Agency calculates. The high toxicity of carbaryl, coupled with the high exceedances of acceptable levels in drinking water, make this level of risk to infants and children unacceptably high.

Given the limitations in the monitoring data that the Agency has acknowledged, and the fact that the highest EEC estimated by EPA models was 55 times the acute DW LOC for children 1 to 2 years old, it is clear that carbaryl presents risks of concern from drinking water exposure and should be regulated as a drinking water contaminant by establishing an MCL.

Chlorpyrifos (CAS # 2921-88-2) is an organophosphate pesticide used at approximately 21-24 million pounds active ingredient (a.i.) annually in the United States. Most chlorpyrifos is used in agriculture on crops such as corn and cotton, but other uses include golf courses, road medians, food processing plants, manufacturing plants, ship holds, railroad boxcars, and non- structural wood treatments. Chlorpyrifos is applied aerially, by chemigation, groundboom, hand wand, airblast sprayer, and other methods.[FN94: U.S. EPA, Interim Reregistration Eligibility Decision for Chlorpyrifos. 2002.]

With chlorpyrifos and other developmental neurotoxic chemicals, risk to the fetus, infant, and child comes primarily from the timing of exposure. Even a very small dose, for even a short duration, during a developmental period of vulnerability will result in permanent neural dysfunction. There is no demonstrated reliable threshold of safety for this highly toxic chemical, as indicated in the IRED, where a no-effect level could not be determined for developmental neurotoxicity. However, there is demonstrated ev idence of neuropathology and increased vulnerability of fetuses when exposed to chlorpyrifos [FN95: Makris S, Raffaele K, Sette W , Seed J. A retrospective analysis of twelve developmental neurotoxicity studies submitted to the USEPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Draft November 12, 1998.]. EPA has acknowledged this susceptibility in the chlorpyrifos Human Health Risk Assessment:"In conclusion, the weight of the evidence raises concern for

an increase in both the sensitivity and susceptibility of the fetus or young animal to adverse biochemical, morphological, or behav ioral alterations from chlorpyrifos treatment during brain development. W ith respect to cholinesterase inhibition, an increase in sensitiv ity of the young compared to adults was seen all along the dose response curve, even at relatively low doses." [FN96: U.S. EPA. Human Health Risk Assessment: Chlorpyrifos. 2000.]

Although EPA said in the IRED that the drinking water risk is below the level of concern, the Agency noted that there have been cases of high levels of drinking water well contamination associated with localized applications of chlorpyrifos as a subterranean termiticide. This was addressed, EPA said, by eliminating all termiticidal uses. However, despite EPA s assertions that only termiticidal use leads to water contamination problems, USGS and others have found contamination of ground and surface water with chlorpyrifos and its metabolites, and EPAs own modeling shows that it is likely that in certain areas of heavy use, chlorpyrifos (and its metabolites) present significant water risks. There is no

evidence that the water risks of chlorpyrifos and its metabolites are limited to termiticidal use.

There is extensive evidence of the potential of chlorpyrifos to contaminate surface and groundwater. Combined USGS data for state, local, national, and multi-state studies that measured chlorpyrifos concentrations in surface water detected the pesticide at 7 of 108 (6%) sites sampled.[FN97: Larson, Steven J., Capel, Paul D., and Majewski, M.S., 1997, Pesticides in Surface Waters: Distribution, Trends, and Governing Factors. Chelsea, MI: Ann Arbor Press, 373 p. 19.] Chlorpyrifos has medium runoff potential due to its relatively low water solubility, 2 mg/L [FN98: Becker, R.L., Herzfeld, D., Ostlie, K.R., and Stamm-Katovich, E.J., 1989, Pesticides: Surface runoff. leaching, and exposure concerns, University of Minnesota, Minnesota Extension Service Publication AG-BU-3911, 32 p.; FN99: Goss, DW . Screening procedure for soil and pesticides relative to potential water quality impacts: Weed Technol. 1992 6:701-8.]. A chlorpyrifos flux as a percentage ofuse of 0.15 has been measured in the Minnesota River.[FN100:

Larson et al, 1997, supra.] Chlorpyrifos is also used in non- agricultural settings and can drift or runoff directly into surface water bodies in areas of high population density.

Data from the Mid-Continent Pesticide Study [FN101: Burkart MR, Kolpin DW . Hydrologic and land-use factors associated with herbicides and nitrate in near-surface aquifers. J. Environ. Qual. 1993 22(4):646-56.] show that chlorpyrifos was present in the ground water in 4.2% of the wells sampled.[FN102: Barbas, JE, Resek, EA. 1996, Pesticides in Ground Water: Distribution, Trends, and Governing Factors. Chelsea, MI: Ann Arbor Press, 588 p., at p. 98-9] Chlorpyrifos has been detected in 0.6% of wells sampled, according to the U.S. EPA's Pesticides in Ground Water Database.[FN103: Barbas & Resek, supra, at p. 167] Long (1989) detected chlorpyrifos in the ground water of 30% of 56 sites examined beneath pesticide mixing and loading facilities in Illinois.[FN104: Long, T., 1989, Groundwater contamination in the vicinity of agrichemical mixing and loading facilities, in Illinois Agricultural Pesticides Conference: Proceedings: University of Illinois, College of Agricultural Consumer and Environmental Services, Urbana-Champaign, Ill., pp. 139-149; Barbas & Resek at 327.] The maximum concentration detected was 0.5 ppb.

Water monitoring sample sites are not necessarily correlated with chlorpyrifos use sites, and in particular, may miss sites where multiple fields are treated with chlorpyrifos resulting in pooled runoff into a common water source. In fact, the IRED states, "it is not clear that they [monitoring data] represent the most vulnerable groundwater where chlorpyrifos is used most intensively" (IRED p.18). Monitoring of surface water is likely to be subject to the same problem. Levels of chlorpyrifos in pooled runoff sites are likely to be many times higher than single field sites. Similarly, data collection is not timed to correspond with worst-case scenarios, such as closely following chlorpyrifos applications, or following large storm runoff

events, and thus most often misses these highly toxic

env ironmental exposures.

Using the PRZM/EXAMS screening model, EPA estimated that 90-dayaverage and peak chlorpyrifos concentrations were 6.7 and 40

ppb respectively. Meanwhile, acute DW LOCs for infants less than a year old, children 1-6 years and females 13 to 50 years ranged from 0.9 to 9 ppb. Chronic DW LOCs for these population groups ranged from 0.2 to 0.72 ppb. EPA's modeling estimates therefore show that chlorpyrifos exposure in drinking water has the potential to expose vulnerable groups of the population to unacceptable levels of this chemical.

Dichlorvos (CAS # 62-73-7), or DDVP, is an organophosphate insecticide widely used in agriculture. Like other organophosphates, dichlorvos is an acetylcholinesterase inhibitor. DDVP exposure may cause symptoms such as nausea,

vomiting, dizziness, muscle spasms, and seizures. According to a 2000 EPA Cancer Assessment review, there is suggestive

evidence that dichlorvos may cause cancer.[FN105: U.S. EPA, Dichlorvos (DDVP) - Report of the Cancer Assessment Rev iew Committee. 2000.] The National Toxicology Program has stated that there is "clear ev idence" of carcinogenic activity of dichlorvos in a mice study.[FN106: National Toxicology Program. NTP Toxicology and Carcinogenesis Studies of Dichlorvos (CAS No. 62-73-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). National Toxicology Program Technical Report Series 1989;342:1-208] One study has linked dichlorvos exposure to leukemia in children under 15.[FN107: Leiss JK, Sav itz DA. Home pesticide use and childhood cancer: a case-control study. Am J Public Health. 1995; 85:249-52] Another study has also found an association between dichlorvos exposure and leukemia in adult men.[FN108: Brown LM, Blair A, Gibson R, et al. Pesticide exposures and other agricultural risk factors for leukemia among men in Iowa and Minnesota. Cancer Res. 1990;50(20):6585-91] Furthermore, EPA has determined that "dichlorvos has been shown to be a direct acting mutagen by common in vitro bacterial genetic toxicity assays and in vitro mammalian test systems."[FN109: U.S. EPA. HED Preliminary Risk Assessment for Dichlorvos. October 11, 2000.]

Dichlorvos is soluble in water and may enter surface waters in runoff. However, no data on its occurrence in surface waters has been collected; there is also little data on dichlorvos in groundwater. Two other pesticides, naled and trichlorfon, degrade to dichlorvos in the env ironment and representadditional inputs of dichlorvos to water. However, monitoring

data on these two pesticides is also very limited.

Given the lack of monitoring data, EPA used IR-PCA PRZM/EXAMS models to calculate estimated drinking water concentrations (EDWCs) of dichlorvos in surface water. The models produced estimates that were below the EPA level of concern.[FN110: U.S. EPA. Interim Reregistration Eligibility Decision for Dichlorvos (DDVP), 2006.] However, the complete lack of monitoring data raises questions about whether an exclusive reliance on modeling results is appropriate for a neurotoxic and potentially carcinogenic pesticide such as dichlorvos. EPA should collect data monitoring data for dichlorvos by requiring such data from the registrants or commissioning its own studies to better assess drinking water risks and set an MCL if necessary.

Dicofol (CAS # 115-32-2) is an organochlorine pesticide used in agriculture, primarily on cotton and citrus crops. Approximately 860,000 pounds of active ingredient are used

every year. Animal studies have found that dicofol causes toxicity in the liver, adrenal glands, kidneys, thyroid, reproductive organs, heart and stomach. Liver and thyroid effects occurred at relatively low doses (100 ppm and 10 ppm, respectively). Dicofol is a possible human carcinogen.[FN111: U.S. EPA. Reregistration Eligibility Decision, Dicofol, 1998.] Dicofol has shown endocrine disruptor activ ity in vivo and in vitro.[FN112: Hoekstra PF, Burnison BK, Garrison AW , Neheli T, Muir DC. Estrogenic activity of dicofol with the human estrogen receptor: Isomer- and enantiomer-specific implications. Chemosphere. 2006 Jun;64(1):174-7. Epub 2005 Dec 7.; FN113: Thibaut R, Porte C. Effects of endocrine disrupters on sex steroid synthesis and metabolism pathways in fish. J Steroid Biochem Mol Biol. 2004 Dec;92(5):485-94. Epub 2004 Dec 21.; FN114: Ishihara A, Sawatsubashi S, Yamauchi K. Endocrine disrupting chemicals: interference of thyroid hormone binding to transthyretins and to thyroid hormone receptors. Mol Cell Endocrinol. 2003 Jan 31;199(1-2):105-17.] This chemical has been shown to interfere with blastocyst implantation in rats.[FN115: Jadaramkunti UC, Kaliwal BB. Possible mechanisms for the anti-implantation action of dicofol in albino rats. J Basic Clin Physiol Pharmacol. 2001;12(3):217-26.]EPA used its SCI-GROWmodel to estimate dicofol concentrations

in groundwater and calculated a 90-day average peak concentration of 0.069 ppb. An overall mean surface water concentration of 0.5 ppb was estimated with the PRZM-EXAMS model. Both concentrations were below the Drinking Water Levels of Comparison (DW LOCs) for children and the general U.S. population for both acute and chronic exposure. However, there are some important shortcomings in EPA's assessment of dicofol exposure and risk.

The first problem with the assessment is related to the way EPA calculated the Reference Dose (RfD). EPA is supposed to apply an additional safety factor of 10x to the RfD calculation to protect infants and children, who may have increased susceptibility to health effects from chemical exposures compared to adults. The Agency reduced the FQPA safety factor of 10x to 3x based on the lack of increased pre-natal or post- natal susceptibility to dicofol in developmental toxicity studies. However, EPA stated that a developmental neurotoxicity study was necessary because dicofol produced neurotoxicity in rats and such a study might identify an endpoint for dietary risk. Despite lacking such a study, EPA improperly reduced the safety factor to 3x. If the 10x factor had been applied as mandated by the Food Quality Protection Act, a more protective acute RfD of 0.015 mg/kg day-1 would have been chosen instead of the 0.05 mg/kg day-1 dose EPA used in its assessment. Had EPA applied the 10x safety factor, dicofol exposure from food alone would have exceeded the acute RfD and the EPA level of concern for all population groups (see Table 1). This would have resulted in a DW LOC of zero (0), so that any drinking water exposure would have been of concern.

Table 1. Comparison of acute dietary exposure values from food at the 99.9th percentile [see PDF]

The unwarranted reduction of the FQPA safety factor also affected the outcome of the chronic dietary exposure assessment. As shown in Table 2, if the 10x factor had been applied, chronic exposures from food alone for infants andchildren 1 to 6 years old would have exceeded the level of

concern. Therefore, any drinking water exposure would have been of concern as well.

Table 2. Chronic dietary food exposure and risk estimate from Dicofol (in food alone) [see PDF]

Another shortcoming in the EPA assessment is that the Agency relied on models to estimate environmental concentrations in surface and groundwater, but did not have a robust set of monitoring data. EPA should require the collection of surface and groundwater monitoring data in areas where dicofol is applied. The Agency should use these data to corroborate its exposure estimates and make a regulatory determination for dicofol under the SDWA.

Endosulfan (CAS # 115-29-7) is an organochlorine insecticide and acaricide. Technical grade endosulfan is made of both alpha and beta stereoisomers whose toxicity is manifested through blockage of inhibitory GABA (gamma amino butyric acid) gated chloride channels, resulting in over-stimulation of the central

nervous system. Endosulfan is a recognized neurotoxin [FN116: Lakshmana MK, Raju TR. 1994. Endosulfan induces small but significant changes in the levels of noradrenaline, dopamine, and serotonin in the developing rat brain and deficits. Toxicology, 91(2): 139- 150.] and endocrine disruptor [FN117: Willey JB, Krone PH. 2001. Effects of endosulfan and nonylphenol on the primordial germ cell population in pre- larval zebrafish embryos. Aquat Toxicol, 54(1-2): 113-123], making even extremely low-dose exposures of very great concern, especially to vulnerable populations such as children and fetuses.

Endosulfan is similar in its acute oral toxicity to the related insecticides aldrin and dieldrin, except that it is slightly more toxic than these substances in female laboratory animals.[FN118: OSHA comments from the January 19, 1989 Final Rule on Air Contaminants Project extracted from 54 FR 2332 et. seq.] Inhalation of endosulfan dust by humans has been associated with slight nausea, confusion, excitement, flushing,and dry mouth [FN119: State of California: Department of

Industrial Relations/Ex. 1-8]. Nine employees who had been working with 50-percent water-wettable endosulfan powder for only a few days had convulsions [FN120: Association of American Pesticide Control Officials, Inc. 1969, as cited in ACGIH 1986/Ex. 1-3, p. 230].

Endosulfan is a significant endocrine disruptor and reproductive toxicant. This pesticide increases the rate of testosterone breakdown and excretion.[FN121: W ilson V, LeBlanc GA. Endosulfan elevates testosterone biotransformation and clearance in CD-1 mice. Toxicol Appl Pharmacol 148:158-168, 1998.] In immature rats, endosulfan causes significant dose- related decreases in sperm counts, and causes sperm deformities at low exposure levels.[FN122: Sinha N, Narayan R, Saxena DK. Effect of endosulfan on the testis of growing rats. Bulletin Environ Contamination Toxicol 58:79-86, 1997. Sinha N, Narayan R, Shanker R, Saxena DK. Endosulfan-induced biochemical changes in the testis of rats. Veterinary and Human Toxicol 37:547-549, 1995.] In fish, endosulfan elevates levels of thyroxine and suppresses levels of triiodothyronine, probably by inhibiting the conversion of thyroxine to T3.[FN123: Sinha N, Lal B, Singh TP. Pesticides induced changes in circulating thyroid hormones in the freshwater catfish clarias batrachus. Comparative Biochem Physiol 100C: 107-110, 1991.] The developing brain is potentially most severely affected by this pesticide via altered levels of critical neurotransmitters such as dopamine, noradrenaline and serotonin; the altered neurotransmitter levels are associated with deficits in learning and memory.[FN124: Lakshmana MK, Raju TR. Endosulfan induces small but significant changes in the levels of noradrenaline, dopamine and serotonin in the developing rat brain and deficits in the operant learning performance. Toxicology 91:139-150, 1994.]

The EPA estimates that 1.4 million pounds of endosulfan are applied annually to U.S. crops. According to the EFED risk assessment for the RED on endosulfan, monitoring data show widespread contamination of surface water. EPA modeled surface water contamination and calculated acute estimated

env ironmental concentrations ranging from 4.49 ppb to 23.86 ppb. Chronic EECs ranged from 0.53 ppb to 1.5 ppb. The acuteand chronic EEC for endosulfan in groundwater was 0.012 ppb.

EPA concluded in the RED that "residues of endosulfan in drinking water are of concern" for acute exposure for infants less than one year old and for children 1-6 years old. EPA determined that exposure from food alone created risks of concern for children 1 to 6 years old and set a DW LOC of zero (0) ppb for this population.[FN125: U.S. EPA, Reregistration Eligibility Decision for Endosulfan. 2002.]

EPA proposed mitigation measures to address risks from endosulfan contamination of drinking water (110-foot setbacks for ground applications, 3-foot vegetative buffers, and reductions in application rates). However, the implementation of required mitigation measures to reduce pesticide risks is rarely monitored or enforced. Given the risk indicated in the drinking water exposure assessment, EPA should require more widespread monitoring for endosulfan and take regulatory action to establish an MCL for endosulfan.

Linuron (CAS # 330-55-2) is an urea-based herbicide used primarily on soybeans (79 percent of usage). It has been shown to cause non-malignant testicular and liver tumors in animals.[FN126: Extension Toxicology Network (EXTOXNET), Pesticide Information Profiles. June 1996. http://extoxnet.orst.edu/pips/linuron.htm.] Investigation of the testicular tumors revealed that this herbicide acts by blocking the function of male androgens. In animals, at relatively low doses, linuron is a recognized anti-androgen. This chemical has been shown in laboratory studies to decrease male sex organ weights, cause testicular atrophy, delay puberty, and increase estrogen levels in males.[FN127: Cook JC, Mullin LS, Frame SR, Biegel LB. Investigation of a mechanism for Leydig cell tumorigenesis by linuron in rats. Toxicol Appl Pharmacol 119:195-204, 1993.; FN128: Gray LE Jr, Wolf C, Lambright C, Mann P, Price M, Cooper RL, Ostby J. Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodione, chlozolinate, p,p'-DDE, and ketoconazole) and toxic substances (dibutyl- and diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiation produces diverse profiles of reproductive malformations in the male rat. Toxicol Ind Health. 1999 Jan-Mar;15(1-2):94-118.]About 400,000 pounds of linuron are used in U.S. agriculture

each year. This herbicide persists for 1-5 months in soil, and has been shown to run off of fields into surface and groundwater supplies. EPA concluded in its Reregistration Eligibility Decision (RED) that linuron exceeded the Levels of Concern (LOC) for groundwater quality. EPA also expressed "moderate concerns" for drinking water supply systems relying on surface water sources.[FN129: U.S. EPA. Reregistration Eligibility Decision for Linuron, 1995.]

Several factors in EPA's drinking water exposure assessment raise concerns about groundwater contamination. In the groundwater portion of the assessment, data were present for only four states: Georgia, Missouri, Virginia, and W isconsin. In Georgia linuron was found in groundwater in concentrations up to 5 ppb. EPA later cast doubt on the reliability of the data and removed it from consideration in the final RED, basing its decision on new information received from the State of Georgia.

Valid groundwater detections in Missouri (up to 1.9 ppb), Virginia (up to 1.31 ppb in 4 of 8 wells) and W isconsin (up to 2.7 ppb) may seriously underestimate linuron levels throughout the country because these three states are not among the 16-20 states where linuron is most heav ily used. The sixteen states listed on page 3 of EPA's Overview of Linuron Risk Assessment appear to account for well over 80% of linuron use in the United States, [FN130: U.S. EPA., Overview of Linuron Risk Assessment. 2002. http://www.epa.gov/oppsrrd1/reregistration/linuron/linuron_over view _5-31-02.PDF.] so the complete absence of any data on groundwater in any of these states is a critical data gap. The USGS has also reported on areas where linuron is most heav ily used on a per-acre basis. The USGS maps indicate that Indiana, Ohio, Michigan, Delaware, and Maryland are heavy use states.[FN131: U.S. Geological Survey (USGS). 1992 Pesticide Use Maps. http://ca.water.usgs.gov/pnsp/pesticide_use_maps/show_map.php?y ear=92&map=m1993] These states are not among the ones from which groundwater data are available. Strangely, only one ofthese (Michigan) is listed by EPA as among heavy use states.

Casting further doubt on EPA's estimates of the risks of linuron in drinking water sources is the fact that the model used for surface water assessment was not tested against any data whatsoever. The exposure estimates (18 ppb) for infants and children exceed EPA's chronic DW LOC (6 ppb) by three-fold. This result is of particular concern in light of the serious flaws in the drinking water risk assessment that conspire to underestimate the actual risk. EPA admits that "residues of linuron and its metabolites in drinking water may represent a chronic human health risk..."

Since linuron is not regulated under the Safe Drinking Water Act (SDWA), water supply systems are not required to sample or analyze for it. This is a particular problem because EPA admits that drinking water treatment is unlikely to remove linuron and its degradates. The Agency must move rapidly to collect more data on linuron in water and must make a high priority of regulating linuron under the SDWA.

Phosmet (CAS # 732-11-6) is an organophosphate pesticide used primarily on apples, peaches, walnuts, almonds and pears. Approximately 1.25 million pounds of active ingredient are applied every year. Phosmet is a neurotoxicant that causes red blood cell, plasma, serum and brain cholinesterase inhibition. It also shows mutagenic activity.[FN132: Vlckova V, Miadokova E, Podstavkova S, Vlcek D. Mutagenic activity of phosmet, the active component of the organophosphorus insecticide Decemtione EK 20 in Salmonella and Saccharomyces assays. Mutat Res. 1993 Jul;302(3):153-6.; FN133: Hasegawa R, Cabral R, Hoshiya T, Hakoi K, Ogiso T, Boonyaphiphat P, Shirai T, Ito N. Carcinogenic potential of some pesticides in a medium-term multi-organ bioassay in rats. Int J Cancer. 1993 May 28;54(3):489-93. Erratum in: Int J Cancer 1993 Sep 30;55(3):528.] Phosmet interferes with human placental enzymatic activity, which may affect fetal development.[FN134: Souza MS, Magnarelli GG, Rovedatti MG, Cruz SS, De D'Angelo AM. Prenatal exposure to pesticides: analysis of human placental acetylcholinesterase, glutathione S-transferase and catalase as biomarkers of effect. Biomarkers. 2005 Sep-Oct;10(5):376-89]EPA has stated in its Interim Reregistration Eligibility

Decision (IRED) for phosmet that there is "suggestive evidence of carcinogenicity" based on increased incidence of liver adenomas and carcinomas in male mice, and of mammary gland tumors in females.[FN135: U.S. EPA, Interim Reregistration Eligibility Decision for Phosmet, Case No. 0242. October 30, 2001.]

Phosmet is mobile in runoff and has the potential to contaminate drinking water sources. EPA has done a drinking water risk assessment for phosmet as part of the pesticide reregistration process. The EPA IRED used modeling estimates to assess phosmet exposure through drinking water due to the limited amount of monitoring data available. Estimated

env ironmental concentrations ranged from 0.4 to 140 ppb. W hile EPA concluded that drinking water exposure through surface and groundwater was not of concern, there are several flaws in the EPA analysis that undermine that conclusion, as explained below. The IRED drinking water assessment should not be relied upon to decide whether to regulate phosmet under the SDWA

EPA determines whether the drinking water risks of a pesticide are of concern as part of its dietary risk assessment for that chemical. For drinking water risk to remain below the Agency's level of concern, the sum of food and drinking water exposures must be less than the Population Adjusted Dose (PAD).[FN136: The PAD is a term that expresses the dietary risk of a chemical, and reflects the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e., RfD/FQPA safety factor). A risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency s risk concern.] The IRED risk summary for phosmet indicates that dietary risk, acute and chronic, is below the Agency s level of concern. However, the Agency had initially determined that acute dietary exposures were of great concern for infants and children, with up to 2000% of the acute Reference Dose (aRfD) consumed [FN137: Swartz, C., U.S. EPA. Phosmet. HED review of the Gowan Co. probabilistic (Monte Carlo) acute dietary exposure risk assessment. July 30, 1999 ]. Such an exceedance in exposure from food alone means that any additional exposure from drinking water would create additional unacceptable risks.The assessment of food exposure was subsequently revised using

a newly submitted acute neurotoxicity study by the registrant [FN138: Phosmet: Acute neurotoxicity study. (GD Cappon, lead investigator; Gowan Co., Yuma, AZ, sponsor). MRID No. 44673301. WI L Research Labs, Ashland OH. Oct 8, 1998.], reviewed by the Agency in February 1999,[FN139: Raffaele K. 1999. Phosmet: Acute neurotoxicity study. U.S. EPA. DER of study MRID 44673301. Obtained by FOIA #RIN 0593-02, to Jennifer Sass, Jan. 16, 2002] and by the hazard identification assessment rev iew committee (HIARC) in July, 1999.[FN140: Taylor LL. 1999. Phosmet: Revised report of the hazard identification assessment

review committee on phosmet. HED Doc No. 013604. August 4, 1999.] This new acute neurotoxicity study in rats was used to raise the No Observable Adverse Effects Level (NOAEL) to 4.5 mg/kg/day, from the 1.1 value that had been used, based on a chronic toxicity study in rats. The result was a four-fold change, which also resulted in an increase in the PAD. The HIARC executive summary of the study states that "no effects of treatment were seen in the 3.0 or 4.5 mg/kg group", which is in agreement with the registrants conclusions. However, the study DER [FN141: Raffaele K. 1999. Phosmet: Acute neurotoxicity study. U.S. EPA. DER of study MRID 44673301. Obtained by FOIA #RIN 0593-02, to Jennifer Sass, Jan. 16, 2002. Discussion and conclusions, p. 13-14] finds some critical problems with this study:

* "Extremely high variability was noted in the data from the motor activity testing, raising questions about the sensitivity of the procedures used in this study. For example, an increase in subsession activity approaching 300% above control levels was not found to be statistically significantly different from controls."

* "There was also some large variability in some of the blood cholinesterase measurements (especially for the red blood cells), such that decreases of 25% were not statistically significant. Again, it is possible that true differences caused by exposure to phosmet might be obscured by the high

variability of the measure." In fact, the DER states that "the

smallest statistically significant change detected in bloodmeasures was 40% (DER p. 10)

* "no information is available regarding the dose response

curves for cholinesterase inhibition or behavioral effects. This is especially relevant since similar levels of inhibition (60-75%) were seen in brain and red blood cell cholinesterase at the high dose, with brain inhibition persisting throughout the study."

NRDC suggests that this study is not sufficient to establish a NOAEL, since the variability in cholinesterase inhibition was so great that the study design did not provide any statistical power to detect treatment effects. Therefore, the increase in the PAD that made it possible for food and drinking water exposures to remain below the level of concern was not scientifically supported.

Notwithstanding EPA's previous determination that phosmet in drinking water does not pose risks of concern (which, as noted above, was based on a flawed study), phosmet should be regulated as a water contaminant under the SDWA and an MCL should be established.

Trichlorfon (CAS # 52-68-6) is an organophosphate insecticide with agricultural non-food and feed crop uses (e.g. agricultural non-cultivated areas, ornamental trees, etc.), as well as indoor and outdoor residential use. Usage volume data for these registered uses is not available.[FN142: U.S. EPA. Reregistration Eligibility Decision for Trichlorfon, List A, Case 0104. 1997.]

Like the other organphosphates, trichlorfon is a neurotoxicant and cholinesterase inhibitor. Trichlorfon exposure is associated with kidney, lung and gastrointestinal abnormalities in animal studies. Anemia has also been reported, as well as benign pheochromocytomas. A statistically significant increase in mononuclear cell leukemia was also observed. Incidences of alveolar/bronchiolar adenomas, renal tubular adenomas and alveolar/bronchiolar carcinomas, while not statisticallysignificant, occurred with frequencies "well outside of the

historical control range for all three tumor types."[FN143: U.S. EPA, 1997, supra.] W hile EPA decided to classify trichlorfon in Group E for carcinogenicity arguing that the statistically significant increases in tumors in the studies were seen in the lower but not the higher doses, we argue that the evidence remains suggestive given that separate studies found significant increases in the same types of tumors.

In the studies analyzed by EPA during the reregistration process, trichlorfon also showed developmental toxicity in animals (decreased fetal body weight, delayed or reduced ossification) and mutagenic activity in an in vitro cytogenetic study in mammalian cells.

Trichlorfon is highly mobile in soil, but EPA did not assess its groundwater contamination potential during the reregistration process for lack of appropriate data. Trichlorfon can enter surface waters in ground spray and runoff. Well samples from Georgia in the EPA Pesticides in Ground Water Database showed trichlorfon detections in 12 of 179 wells with concentration up to 10 ppb. EPA did not consider these samples useful, citing analytical uncertainties.

Trichlorfon has a half-life in soil of 1 to 27 days, depending on soil type, which increases its potential to contaminate surface waters. However, the trichlorfon RED does not address drinking water risks. Despite the cancellation of feed and food crop uses, trichlorfon still has registered agricultural and residential outdoor uses that pose a risk of surface and possibly groundwater contamination. The scarcity of monitoring data on environmental concentrations should not lead to an assumption of negligible risk. The known toxicity of trichlorfon, its mobility and extended half-life in soil all make it a likely water contaminant in high use areas. EPA should require the collection of monitoring data for these areas to enable the Agency to assess water contamination risks and make a regulatory decision concerning trichlorfon.

Triclocarban (Urea, N-(4-chlorophenyl)-N'-(3,4-dichlorophenyl)3,4,4'-Trichlorocarbanilide), CAS # 101-20-2, an antimicrobial

pesticide also known as TCC, is a possible endocrine disruptor that has been widely detected in effluent from wastewater treatment plants (WWTPs) in the United States. TCC has also been frequently detected in environmental water samples. An animal study indicates that triclocarban exposure enhanced the effects of testosterone both in vitro and in vivo in male rats.[FN144: Chen J, Ahn KC, Gee NA, Ahmed MI, Duleba AJ, Zhao L, Gee SJ, Hammock BD, Lasley BL. Triclocarban enhances testosterone action: a new type of endocrine disruptor? Endocrinology. 2008 Mar;149(3):1173-9.]

The half-life of TCC in sediment is 540 days. One study predicted the magnitude and frequency of TCC contamination nationwide based on experimental and modeling data to be 1150 ng/L and 60%, respectively; much higher than previously recognized by EPA (240 ng/L, 30%).[FN145: Halden RU, Paull DH. Co-occurrence of triclocarban and triclosan in U.S. water resources. Environ Sci Technol. 2005 Mar 15;39(6):1420-6.] Another study in the Greater Baltimore area found an average TCC level of 6.75 ug/L in wastewater samples, while river water samples had concentrations of up to 5.6 ug/L.[FN146: Halden RU, Paull DH. Analysis of triclocarban in aquatic samples by liquid chromatography electrospray ionization mass spectrometry. Environ Sci Technol. 2004 Sep 15;38(18):4849-55.] These concentrations are higher than the Predicted Env ironmental Concentrations (PEC) calculated by the TCC Consortium in a report submitted to EPA in 2003 as part of the High Production Volume Chemical program, which estimated PECs from 0.0013 to 0.050 μg/L.[FN147: TCC Consortium. High Production Volume (HPV) Chemical Challenge Program Data Availability and Screening Level Assessment for Triclocarban. 2002. http://www.epa.gov/chemrtk/pubs/summaries/tricloca/c14186.pdf] The actual measurements from the Greater Baltimore area study also exceed the TCC Consortium s Predicted No Effect Concentration of 0.146 μg/L.[FN148: TCC Consortium. High Production Volume (HPV) Chemical Challenge Program Data Availability and Screening Level Assessment for Triclocarban. 2002. http://www.epa.gov/chemrtk/pubs/summaries/tricloca/c14186.pdf]

A study of a 684 million liter per day typical activated sludgeWWTP found a concentration of 6.1 ± 2.0 ug/L in the influent

and 0.17 ± 0.03 ug/L in the effluent. Approximately 127 ± 6 g/d exited the plant in the effluent, a clear indication that

conventional wastewater treatment may leave considerable levels of TCC in the water.[FN149: Heidler J, Sapkota A, Halden RU. Partitioning, persistence, and accumulation in digested sludge of the topical antiseptic triclocarban during wastewater treatment. Environ Sci Technol. 2006 Jun 1;40(11):3634-9.] Because of this, TCC concentrations tend to be higher downstream of WWTPs.[FN150: Sapkota A, Heidler J, Halden RU. Detection of triclocarban and two co-contaminating chlorocarbanilides in US aquatic env ironments using isotope dilution liquid chromatography tandem mass spectrometry. Environ Res. 2007 Jan;103(1):21-9.] The most important sources of triclocarban to the aquatic environment were estimated to be activated sludge treatment plants (contributing 39-67%), followed by trickling filters (31-54%), combined sewer

overflows (2-7%) and sanitary sewer overflows (<0.2%).[FN151: Halden RU, Paull DH. Co-occurrence of triclocarban and triclosan in U.S. water resources. Env iron Sci Technol. 2005 Mar 15;39(6):1420-6.]

Given these data, triclocarban should be added to the CCL3.

Triclosan (5-chloro-2-(2,4-dichlorophenoxy)-phenol) (CAS # 3380-34-5), is a broad spectrum antimicrobial pesticide that is widely used in personal care products such as soaps, toothpastes, cosmetics, skin creams and deodorants; kitchen accessories such as cutting boards and utensils; and in textiles such as sportswear, shoes and carpets.

Triclosan is produced at over one million pounds per year. The chemical structure of triclosan is similar to other endocrine disrupting compounds and potential breakdown products of triclosan include dioxins.[FN152: Latch DE, Packer JL, Stender BL, VanOverbeke J, Arnold WA, and McNeill K. Aqueous photochemistry of triclosan: formation of 2,4-dichlorophenol, 2,8-dichlorodibenzo-p-dioxin, and oligomerization products. Environ Toxicol Chem. 24(3):517-25 (2005).]Recently, low levels of triclosan were found to interfere with

the metamorphosis of frogs. Exposure to as little as 0.15 micrograms/l triclosan caused an earlier metamorphosis than normal, with effects on the tadpole brain and tail.[FN153: Veldhoen N, Skirrow RC, Osachoff H, W igmore H, Clapson DJ, Gunderson MP, Van Aggelen G, and Helbing CC. The bactericidal agent triclosan modulates thyroid hormone-associated gene expression and disrupts postembryonic anuran development. Aquat Toxicol. 80(3):217-27 (2006).] Triclosan activates the human pregnane X receptor (hPXR), which is involved in the enzymatic metabolism of steroids and xenobiotics.[FN154: Jacobs MN, Nolan GT, Hood SR. Lignans, bacteriocides and organochlorine compounds activate the human pregnane X receptor (PXR). Toxicol Appl Pharmacol. 2005 Dec 1;209(2):123-33.]

Triclosan has been found in wastewater treatment effluent and drinking water sources.[FN155: Greyshock AE, Vikesland PJ. Triclosan reactivity in chloraminated waters. Environ Sci Technol. 2006 Apr 15;40(8):2615-22.] Triclosan was detected in Louisiana sewage treatment plant effluent at 10-21 ng/l.[FN156: Boyd GR, Reemtsma H, Grimm DA, Mitra S. Pharmaceuticals and personal care products (PPCPs) in surface and treated waters of Louisiana, USA and Ontario, Canada. Sci Total Environ. 2003 Jul 20;311(1-3):135-49.] Boyd (2004) reported triclosan concentrations of ND - 29 ng/l in two stormwater canals in New Orleans.[FN157: Boyd GR, Palmeri JM, Zhang S, Grimm DA. Pharmaceuticals and personal care products (PPCPs) and endocrine disrupting chemicals (EDCs) in stormwater canals and Bayou St. John in New Orleans, Louisiana, USA. Sci Total Environ. 2004 Oct 15;333(1-3):137-48.] Triclosan has also been detected in raw and finished drinking water samples from Southern California.[FN158: Loraine GA and Pettigrove ME. Seasonal variations in concentrations of pharmaceuticals and personal care products in drinking water and reclaimed wastewater in southern California. Env iron Sci Technol. 40(3):687-95 (2006).]

Phthalates. Phthalates are endocrine disruptors that have been found to cause developmental and reproductive abnormalities in animal studies.[FN159: Centers for Disease Control and Prevention. Third National Report on Human Exposure to Environmental Chemicals. Atlanta (GA): CDC, 2005.] Furthermore,studies have found an association between phthalate metabolite

concentrations and obesity, insulin resistance and thyroid hormone levels in humans.[FN160: Meeker JD, Calafat AM, Hauser R. Di(2-ethylhexyl) phthalate metabolites may alter thyroid hormone levels in men. Environ Health Perspect. 2007 Jul;115(7):1029-34.] Stahlhut et al. (2007) analyzed urinary concentrations of seven phthalate metabolites in 1,443 adult men and found a statistically significant positive association between concentrations of the metabolites MBzP, MEHHP, MEOHP and MEP and abdominal obesity. Concentrations of MBP, MBzP and MEP were positively and significantly associated with insulin resistance.[FN161: Stahlhut RW , van Wijngaarden E, Dye TD, Cook S, Swan SH. Concentrations of urinary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males. Env iron Health Perspect. 2007 Jun;115(6):876-82.] In a different study, baby boys exposed to the phthalates, DMP, DEP or BBP, in their mothers breast milk were found to have hormonal disturbances at 3 months of age.[FN162: Main KM, Mortensen GK, Kaleva MM, Boisen KA, Damgaard IN, Chellakooty M, Schmidt IM, Suomi AM, Virtanen HE, Petersen DV, Andersson AM, Toppari J, Skakkebaek NE. Human breast milk contamination with phthalates and alterations of endogenous reproductive hormones in infants three months of age. Env iron Health Perspect. 2006 Feb;114(2):270-6.] Studies have found that di-isononyl phthalate (DiNP) is an anti- androgenic endocrine disruptor with developmental and reproductive toxicity. Exposures in pregnant rats have been shown to adversely affect development of the male reproductive tract. Adverse effects include a cluster of outcomes that has been called "phthalate syndrome" and includes underdeveloped or absent reproductive organs, retained nipples, cryptorchidism, decreased anogenital distance (AGD), hypospadias, and decreased or abnormal sperm. DINP does not bind to the androgen receptor and these effects are likely mediated through interference with testosterone synthesis.[FN163: Gray LE Jr, W ilson VS, Stoker T, Lambright C, Furr J, Noriega N, Howdeshell K, Ankley GT, and Guillette L. Adverse effects of environmental antiandrogens and androgens on reproductive development in mammals. Int J Androl. 29(1):96-108 (2006).; FN164: Gray LE Jr, Ostby J, Furr J, Price M, Veeramachaneni DN, and Parks L. Perinatal exposure to the phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, alters sexual differentiation of the male rat. Toxicol Sci.58(2):350-65 (2000).]Phthalates enter the env ironment as a result of releases from

industrial facilities that manufacture or use these compounds, from waste disposal sites, through the use of phthalate- containing products by consumers and through discharge of municipal wastewaters containing phthalates. Phthalates have been found in numerous hazardous waste sites: diethyl phthalate (DEP) has been identified at 348 sites, dibutyl phthalate (DBP) at 602 sites, dimethyl phthalate (DMP) at 167 sites, benzyl butyl phthalate (BzBP) at 413 sites, dicyclohexyl phthalate (DCHP) at one site, and di-n-octyl phthalate (DnOP) at 433 sites, among other phthalates.[FN165: Agency for Toxic Substances and Disease Registry (ATSDR). Hazardous Substance Release and Health Effects Database (HazDat). http://www.atsdr.cdc.gov/Hazdat.html]

Phthalates have been detected in environmental water samples across the United States, which raises concerns about drinking water as a route of exposure. The following data were found in a search for stream water samples analyzed for phthalates in the EPA STORET database. Results are for the period January 2000 through May 2008:[FN166: U.S. EPA. STORET. http://www.epa.gov/storet/]

* Benzyl butyl phthalate (BzBP) was present in 167 of 677 stream water samples analyzed for this chemical, with a maximum concentration of 3.6 ug/L.

* Di-isononyl phthalate (DiNP) - No data available.[FN167: The Institute for Health and Consumer Protection (IHCP) of the Europen Chemicals Bureau estimated a half life in surface water for DINP of 50 days. According to the IHCP, 7 percent of the DINP in the influent in sewage treatment plants will be released in the effluent. See European Commission Joint Research Centre, Institute for Health and Consumer Protection, 1,2-Benzenedicarboxylic acid,Di-C8-10-Branched Alkyl Esters, C9-Rich and Di-"Isononyl" Phthalate (DINP), CAS Nos: 68515-48-0 and 28553-12-0, EINECS Nos: 271-090-9 and 249-079-5, Summary Risk Assessment Report, 2003. http://ecb.jrc.it/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/SUMMARY/dinpsum046.pdf. Given thewidespread use and high production volumes of DINP, these

releases could pose risks for water quality.]

* Di-n-octyl phthalate (DnOP) was found in 42 (8%) of 497 stream water samples, with a maximum concentration of 0.85 ug/L.

* Dibutyl phthalate (DBP) was found in 221 (34%) of 659 stream water samples for that period, with a maximum concentration of 7.4 ug/L.

* Diethyl phthalate (DEP) was detected in 264 (35%) of the 748 stream water samples analyzed. The maximum concentration found was 10.14 ug/L. DEP levels were >= 1 ug/L in 79 (11%) of the samples tested.

* Dimethyl phthalate (DMP) was present in 49 (7%) of 678 stream water samples, with a maximum of 3.2 ug/L.

Phthalates are ubiquitous in the U.S. population. Although significant exposure can occur due to consumer products, the contribution of drinking water to overall exposure deserves to be examined. The NHANES measured the concentrations of 12 phthalate metabolites in the urine of over 2,500 children and adults. The highest average concentration was 163 ug/g creatinine for MEP, a metabolite of the plasticizer diethyl phthalate (see Table 3). The Centers for Disease Control and Prevention (CDC) did not report what percentage of samples had detectable concentrations of each of the metabolites, but nine of the metabolites were found in the urine of at least half of the individuals.[FN168: Centers for Disease Control and Prevention. Third National Report on Human Exposure to Environmental Chemicals. Atlanta (GA): CDC, 2005.]

Table 3. CDC report of phthalate concentrations in urine; NHANES 1999 - 2000 and 2001 - 2002 [see PDF]Table 4. Frequency of detection of phthalate metabolites in

human urine samples, United States [see PDF. Note that footnotes 169-174 are associated with this table]

Therefore, the following phthalate compounds should be added to the CCL 3:

* Benzyl butyl phthalate (BzBP) (CAS # 85-68-7) * Di-isononyl phthalate (DiNP) (CAS # 28553-12-0) * Di-n-octyl phthalate (DnOP) (CAS # 117-84-0) * Dibutyl phthalate (DBP) (CAS # 84-74-2) * Dicyclohexyl phthalate (DCHP) (CAS # 84-61-7) * Diethyl phthalate (DEP) (CAS # 84-66-2) * Dimethyl phthalate (DMP) (CAS # 131-11-3)

Reproductive hormones. The U.S. Geological Survey (USGS) conducted a study of 139 streams in 30 states that found widespread presence of estrogenic compounds, ovulation inhibitors and other reproductive hormones in surface water near urbanized and agricultural areas (see Table 5).[FN175: Kolpin DW , Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber LB, Buxton HT. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: a national reconnaissance. Env iron Sci Technol. 2002 Mar 15;36(6):1202-11.]

While each of these compounds is generally found at low concentrations, the potential effects on human health of mixtures of these compounds are unknown. Based on the individual effects of these chemicals, possible risks include defects of the reproductive system in individuals exposed during critical stages of development (e.g. testosterone) [FN176: Hotchkiss AK, Lambright CS, Ostby JS, Parks-Saldutti L, Vandenbergh JG, Gray LE Jr. Prenatal testosterone exposure permanently masculinizes anogenital distance, nipple development, and reproductive tract morphology in female Sprague-Dawley rats. Toxicol Sci. 2007 Apr;96(2):335-45.], decreased fertility (ovulation inhibitors such as mestranol, 19-norethisterone), and increased risk of breast cancer (e.g. equilenin, equilin)[FN177: Ding S, Shapiro R, Geacintov NE,Broyde S. Equilenin-derived DNA adducts to cytosine in DNA

duplexes: structures and thermodynamics. Biochemistry. 2005 Nov 8;44(44):14565-76.], among others.

Table 5. Concentrations of reproductive hormones in U.S. streams (USGS, 2002)[see PDF]

Wastewater treatment plants (WWTPs), the likely sources of most of these chemicals, do not treat sewage for these pollutants. Furthermore, drinking water treatment plants do not generally test or treat water for these contaminants, so the frequency of occurrence of these chemicals in treated drinking water and the degree of human exposure are not known. Additional monitoring of water sources and drinking water are necessary to determine the full extent of the contamination, to assess risks to human health, and to determine acceptable levls of exposure and appropriate regulatory action. Therefore, equilenin, equilin, 17a-ethynyl estradiol, 17 a - estradiol, 17ß-estradiol, estriol, estrone, mestranol, 19-norethisterone, progesterone and testosterone should be added to the CCL3.

III. RECOMMENDATIONS

Weurge EPA to add the contaminants recommended above by NRDC to the CCL3. These contaminants meet EPA's criteria to be listed in CCL3. Their health effects, use patterns and known or likely environmental occurrence in drinking water sources should make them candidates for regulation under the SDWA.

Furthermore, NRDC also recommends that EPA delete the pesticide nitrofen (CAS # 1836-75-5) from the Draft CCL3. The available information on this chemical does not support its inclusion in the CCL3.

NRDC agrees with the inclusion of perchlorate and perfluorooctanoic acid (PFOA) in the Draft CCL3 and requests that EPA act promptly to regulate these endocrine disruptors in drinking water pursuant to the Safe Drinking Water Act (SDWA).Finally, we recommend that the Agency act to promptly assess

the risks associated with other contaminants nominated to the CCL3 and take appropriate regulatory action under the SDWA to establish Maximum Contaminant Levels (MCLs) as necessary.

Respectfully submitted,

/s/

Mae W u Staff Attorney Health and Env ironment Program CS Title: 0128 Company/group/association name: Comment:

Regarding: Drinking Water Contaminant Candidate List 3-Draft; Docket EPA-HQ-OW-2007-1189 FRL-08529--7

The Environmental Working Group (EWG) is a non-profit public health and environmental research and advocacy organization based in Washington, DC. EWG research addresses toxic industrial chemicals that pollute the environment and may be present in everyday consumer products. W ith the attached letter, we provide detailed comments and recommendations to the EPA regarding its draft Drinking Water Contaminant Candidate List 3 (CCL3), especially highlighting the urgent need for the inclusion of pharmaceuticals and perfluorochemicals (PFCs) on the final CCL3, and the promulgation of drinking water standards for these wide-spread pollutants that pose health risks to millions of Americans.

May 21, 2008

Water Docket (2822T) Environmental Protection Agency1200 Pennsylvania Ave., NW .

Washington, DC 20460

Regarding: Drinking Water Contaminant Candidate List 3-Draft; Docket EPA-HQ-OW-2007-1189 FRL-08529--7

To W hom It May Concern:

The Environmental Working Group (EWG) is a non-profit public health and environmental research and advocacy organization based in Washington, DC. EWG research addresses toxic industrial chemicals that pollute the environment and may be present in everyday consumer products. W ith this letter, we prov ide detailed comments and recommendations to the EPA regarding its draft Drinking Water Contaminant Candidate List 3 (CCL3), especially highlighting the urgent need for the inclusion of pharmaceuticals and perfluorochemicals (PFCs) on the final CCL3, and the promulgation of drinking water standards for these wide-spread pollutants that pose health risks to millions of Americans.

EWG analysis of water utilities' tap water test results shows that nationwide, water contaminated with 260 chemicals, including 166 industrial pollutants, such as plasticizers, solvents, pharmaceutical production ingredients, and propellants, are served to 210,528,000 people in 42 states (EWG 2005b). Fifty six percent of those people drink water with one or more industrial contaminants present at levels above non- enforceable EPA guidelines. In fact, more than 140 of the chemical contaminants detected in tap water are unregulated, without an enforceable, health-based limit in tap water. Due to the lack of federal oversight and the absence of monitoring and health standards, vulnerable populations, especially pregnant women and children, are not protected from this multitude of toxic chemicals in drinking water.

As highlighted by the recent national investigation by the Associated Press (Mendoza 2008), in addition to industrial chemicals, a wide range of pharmaceuticals that includeantibiotics, sex hormones, and drugs used to treat epilepsy and

depression, contaminate drinking water supplies of at least 41 million Americans. W ith every refreshing glass of water, millions of Americans are also drinking low-level mixtures of highly potent pharmaceuticals. The health effect of this cocktail of chemicals and drugs has not been studied, but there are many reasons to be concerned about risks for infants and others who are vulnerable. Pharmaceuticals, hormones, pesticides, and anti-microbial ingredients from personal care products contaminate many streams around the entire United States (Kolpin 2002). Chemical pollution of ambient waters contributes to the load of chemicals in tap water. EPA needs to show leadership and act with utmost dedication to protecting public health by mandating monitoring and setting enforceable health standards for these hazardous contaminants.

Weespecially urge the EPA to include perfluorinated compounds on the final CCL3 list. PFCs are persistent, long-lasting industrial chemicals that have been utilized in a variety of manufacturing applications such as production of non-stick Teflon cookware, stain-proof Scotchgard products, grease- resistant food packaging and other types of paper materials, as well as carpets, water-proof textiles, and fire-fighting foam. In addition to the major fluorochemical producers (DuPont and 3M in the United States), many secondary manufacturers have used PFCs for decades in their products. Industrial wastewater discharges and air emissions of PFCs from businesses that produce stain-and grease-resistant paper, carpets, textiles, and furniture likely contributed to the PFC pollution of drinking water supplies across the country. Due to their extraordinary stability, PFCs last in the environment for thousands of years. PFCs accumulate in bodies of both wildlife and humans, recirculating through groundwater, lakes, rivers, and oceans, and coming back to people with water, food, air and dust. As a result of decades of environmental discharges of PFCs, these toxic chemicals are now found in many areas of the country, in many bodies of water, and in bodies of more than 98% of all Americans (Calafat, Kuklenyik 2007; Calafat, Wong 2007). At least 11 different states have documented drinking or ambient water contamination with PFCs and a national survey is critically needed to reveal the full extent of PFC water contamination.PFCs such as perfluorooctanoic acid (PFOA), perfluorooctane

sulfonic acid (PFOS) and related chemicals, bioaccumulate and remain in blood, liver, and other tissues for years. This persistence in the human body distinguishes PFCs from other contaminants and significantly elevates the level of health concern, making monitoring and the establishment of tap water standards critical for PFC compounds. Contamination of drinking water with PFCs creates a constant source of exposure and has been associated with some of the highest blood levels of these toxic compounds ever measured. Some residents of communities in Ohio and West Virginia drinking PFOA contaminated tap water had blood levels of PFOA 250 times the national average. These individuals experienced PFOA exposures equivalent to occupational levels and in amounts associated with serious adverse health effects, as demonstrated by initial data obtained in a major ongoing epidemiological study in the region (West Virginia University School of Medicine 2008). It is thus reasonable to feel concerned that other communities in other states drinking PFOA contaminated water would face similarly elevated exposures and health problems.

PFCs have a broad spectrum of adverse health effects. PFOA exposure has been associated with impaired fetal and neonatal development, changes in reproductive and thyroid hormones, compromised immune and liver function, increased blood cholesterol levels, and potential predisposition to chronic diseases later in life. Gestational period, newborn babies and young children are the most sensitive developmental stages that should be especially protected from PFC contaminants in drinking water. During pregnancy, PFCs move to the body of the fetus through the placenta (Apelberg, Goldman 2007; Inoue 2004; Midasch 2007; Tittlemier 2004); a newborn child also gets a large dose of PFCs with breast milk (Arcaro 2008; Karrman 2007; Kuklenyik 2004; So 2006; Tao 2008; Volkel 2007). Tap water standards for PFOA and other PFC will go a long way in protecting the health of this vulnerable population from adverse effects both in early development and in later life.

The Safe Drinking Water Act (SDWA) requires EPA to publish an updated list every five years which details currently unregulated drinking water contaminants that may pose humanhealth risks. From this list, EPA must make determinations on

whether to establish tap water standards for at least five contaminants with a national primary drinking water regulation. EPA originally considered three candidate perfluorochemicals for inclusion into the Contaminant Candidate List 3: PFOA, a processing aid for manufacturing of Teflon non-stick and water- resistant chemicals, PFOS, the primary ingredient in the furniture stain-proofing coating Scotchgard that was phased out in 2000, and perfluorobutanoic acid (PFBA), a replacement chemical that manufacturers are increasingly using instead of longer-chain PFCs.

Of the three PFCs nominated for CCL3, only PFOA was included in the current draft of CCL3. W hile we support the EPA decision to place PFOA on the list, we urge the agency to add other perfluorochemicals including, but not limited to PFOS and PFBA, as potential water contaminants that ought to be regulated under the Safe Drinking Water Act. Given the widespread use of PFCs in industrial applications and consumer goods ranging from food packaging to carpets and textiles, as well as detection of multiple PFCs in bodies of 98% of Americans, PFC contamination of drinking water requires thorough scrutiny in order to meet current scientific and regulatory standards for safety.

Specifically, we urge EPA to:

* List a full range of perfluorochemicals on the CCL3, including, but not limited to, PFOA, PFOS, PFBA, and other PFCs that have been found in the env ironment and in people and that are likely to contaminate both finished and ambient water sources;

* Establish regulatory standards for PFOA in drinking water;

* Include in the final CCL3 a broader list of contaminants found by water utilities in tap water, especially focusing on antibiotics and other pharmaceuticals.Details and our rationale for these recommendations are

prov ided below.

1. List a full range of perfluorochemicals on the CCL3, including PFOA, PFOS, PFBA, and other PFCs found in the

env ironment and in people.

Wesupport the EPA decision to place PFOA on the Draft Drinking Water Contaminant Candidate List 3. However, we disagree with the Agency's decision to exclude PFOS and PFBA from consideration as hazardous water contaminants. The stability of PFCs in the environment makes these chemicals distinct from many other classes of chemical water pollutants that have been prev iously regulated by the EPA (Conder 2008). Biomonitoring studies carried out by the Center for Disease Control found PFOS, PFOA, perfluorohexane sulfonic acid (PFHxS) and perfluorononanoic acid (PFNA) in more than 98% of 2,094 people tested. For some of these chemicals, children younger than 12 years of age have higher levels than adults (Olsen, Church 2004). PFCs enter human bodies from different sources, such as food, chemical-laden dust and water (Emmett 2006; Frisbee 2008). Various PFCs have been detected in finished and/or ambient water sampled in various locations in 11 states (Table below). PFOA has been found in tested water samples from all of these 11 states, PFOS has been found in 7 states, and PFBA appears poised to become an emergent water contaminant (MDH 2008).

Weurge the Agency to add PFOS and PFBA to the CCL3. Even though production of PFOS has been banned by the EPA (US EPA 2002), this persistent and bioaccumulative compound is still present in many water sources in the US (MDH 2008). PFOS negatively affects early development in animals and humans (Apelberg, W itter 2007; Lau 2004); it interferes with the function of the nervous system and causes neurobehavioural defects (Johansson 2008), kills immune cells and weakens body's capacity to resist infection (Keil 2008; Peden-Adams 2008), and affects thyroid hormones that are critical for normal growth and maturation in children (Lau 2003; Luebker 2005). Considering how common is PFOS contamination of water sources, we believe EPA needs to set a regulatory standard to protectthe health of people, especially young children, from PFOS.

In the absence of EPA guidance, states need to carry out their wn risk assessments and set water contamination levels for PFCs. For example, the Minnesota Department of Health issued adv isory guidelines of 1.0 μg/L for PFBA and set the limits for other PFCs chemicals in drinking water as well (MDH 2008). The presence of PFBA and other PFCs in groundwater at the fluorochemical manufacturing sites points to the potential of these replacement PFC chemicals to become new, emergent water contaminants whose health consequences will be directly tested on people exposed through drinking water. Now that the human health effects of PFC contamination in drinking water are becoming widely known from the C8 (PFOA) Health Project (West Virginia University School of Medicine 2008), it is imperative to protect vulnerable populations from future exposures to PFCs.

EPA needs to assess cumulative risks associated with multiple PFCs in finished and ambient water sources for children and other vulnerable populations. New data are constantly coming to light that demonstrate the extent of water contamination with PFCs (Fuchs 2008; Fuquay 2008; Hawthorne 2008; Konwick 2008; United Steelworkers Union 2006). Already, drinking and ambient water in 11 states is contaminated with PFCs and the full scope of this problem might be even larger since businesses using fluorochemical products are found all around the country. This gap in our knowledge should be filled with a national survey of PFCs in water and a full range of PFCs should be included in the Unregulated Contaminant Monitoring Program.

In summary, we urge the EPA to list perfluorochemicals on the final CCL3, including, but not limited to, PFOA, PFOS and PFBA, and other PFCs that are commonly detected in people and the

env ironment, so that the agency can mitigate the human health risks posed by these chemicals.

2. Establish regulatory standards for PFOA in drinking water.Wesupport the EPA in including PFOA on the Contaminant

Candidate List 3 and we urge the agency to take the next, urgently needed step for public health protection by issuing national regulatory standards for PFOA levels in drinking water. In order to help the indiv idual states that look to EPA for guidance and protect the health of all Americans, the agency should proceed with this step immediately, even while the data on other PFC water contaminants are collected.

Unquestionably, PFOA meets all the criteria for a contaminant that requires regulation by the EPA. Together with other PFCs, PFOA is now found in bodies of 98% of Americans (Calafat, Wong 2007); often, children younger than 6 years of age have higher PFOA levels compared to adults (Emmett 2006; Olsen, Church 2004). PFOA can cross the placenta and transfer from the mothers body to the fetus (Apelberg, Goldman 2007; Inoue 2004; Midasch 2007; Tittlemier 2004). PFOA contaminates the milk of breast-feeding mothers (Karrman 2007; Kuklenyik 2004; So 2006; Tao 2008; Volkel 2007). Once ingested with food or water, PFOA accumulates in the human body to 100-fold greater levels and persists for many years (Emmett 2006; Olsen, Burris 2007). This means that trace levels of PFOA in tap water can produce much higher long term exposures in people. For example, drinking water from the Little Hocking water system in Ohio was contaminated with PFOA at about 3.5 parts per billion (ppb), but some individuals drinking this water, who had no other unique exposures to PFOA, had blood levels of PFOA as high as 1,000 ppb (Emmett 2006).

As demonstrated by numerous studies in people and in animals, PFOA has an adverse effect on many health parameters, such as fetal and neonatal development (Lau 2004), immune function (DeW itt 2008; Yang 2002), reproductive and thyroid hormones (Lau 2007), liver function (Frisbee 2008; Son 2007), and blood levels of cholesterol and other lipids (Frisbee 2008; Olsen and Zobel 2007; Sakr, Kreckmann 2007; Sakr, Leonard 2007). In two studies of newborn babies, higher PFOA levels correlated with

smaller weight and size at birth (Apelberg, W itter 2007; Fei 2007, 2008). PFOA exposure increases predisposition to obesity, heart disease, diabetes, and stroke (European Congress on Obesity 2008; Leonard 2007; Lundin 2007). PFOA causes liver, pancreatic, testicular, and mammary cancer in animals (Sibinski1987). In epidemiological studies, PFOA has been shown to

increase the risk of various cancers, especially prostate cancer, as well as liver, kidney, and bladder cancers (Leonard 2007; Lundin 2007; Olsen, Burlew 2004).

Despite extensive denial of PFOA health effects by the chemical industry, toxic effects of this chemical have been revealed by the chilling initial results from the C8 Health Project (West Virginia University School of Medicine 2008), a major epidemiological survey of residents in Ohio and West Virginia whose drinking water supply has been contaminated by PFOA. Sixty nine thousand people have been enrolled in the project, making it by far the largest study ever of PFC health effects in people (Frisbee 2008). The health effects observed in the study population are strong indicators of health problems that might be caused by PFOA in average Americans. Toxic effects from PFOA were observed in study participants with blood levels of the chemical equal to those found in the more highly exposed individuals in the US population. It is reasonable to expect that people in other states with contaminated drinking water may reach the same levels of exposure associated with significant adverse health effects in this study. As reported by the scientific team from the West Virginia University:

* Higher levels of PFOA in people correlate with lower levels of liver-produced Creactive protein that helps the body fight bacteria, viruses, and other pathogens.

* PFOA exposure is associated with higher serum levels of two enzymes that can indicate liver damage; the same findings as have been found in occupational studies (Olsen and Zobel 2007; Sakr, Kreckmann 2007). These two findings indicate powerful liver toxicity of PFOA.

* Elevated PFOA levels in children are associated with high cholesterol levels, predisposing children to future weight problems and accompanying risk of heart disease.

* PFOA-exposed people have abnormal levels of thyroid hormones.The multitude of PFOA health effects is especially worrisome

because both PFOA and other PFCs are known to occur in public water systems with a frequency and at levels of public health concern. PFOA has been detected in public water supplies in many localities in West Virginia and Ohio (Emmett 2006; WVDEP 2005), 78% of drinking water systems tested by the New Jersey Department of Environmental Protection (NJDEP 2007), and in multiple townships in Washington County, Minnesota (MDH 2008). Additionally, drinking water supplies in some localities in Georgia may potentially be contaminated with PFOA (United Steelworkers Union 2006), where surface waters have been shown to be polluted with high levels of various PFCs (Konwick 2008). Other affected states include North Carolina (NCDENP 2008a), where groundwater contamination with PFOA in the vicinity of DuPont's Fayetteville Works plant doubled between 2006 and 2007 (Fuquay 2008), Alabama, where the Tennessee River is contaminated with PFOA and PFOS emitted by the 3M fluorochemical plant (Decatur) (Hansen 2002), Illinois, where both PFOA and PFOS have been detected in Chicago drinking water supply (Hawthorne 2008) as well as New York and Virginia (Clean Water Action Alliance of Minnesota 2008). All of these data are presented in the Table below:

[Table 1 - see PDF]

All together, various PFCs have been detected in finished and/or ambient water sampled in various locations in 11 states. PFOA has been found in tested water samples from all of these 11 states; PFOS has been found in 7 states. Most worrisome, groundwater levels of PFBA, a replacement chemical for some of the older PFC applications, appear to be on the rise (MDH 2008).

Without federal health standards for PFOA, individual states are forced to set their own standards so as to protect their citizens. For example, PFOA standards or risk-based levels have been established by North Carolina (2 μg/L) (NCDENP 2008b), Minnesota (0.5 μg/L) (MDH 2007) and New Jersey (0.04 μg/L) (NJDEP 2007). The 2006 consent order between EPA and DuPontrequired the company to offer alternative drinking water source

or treatment for both public and private water users living near the Washington Works plant in Parkersburg, West Virginia whenever PFOA levels in their drinking water exceed 0.5 μg/L (US EPA 2006).

When confronted with such regulatory patchwork and the lack of guidance from the EPA, many states do not know how best to proceed, leav ing the health of Americans at jeopardy (Hawthorne 2008; Sohn 2008). Many other states do not have the resources or expertise to establish and enforce drinking water standards for PFCs. Most states and the people who live in them depend on the EPA to protect them from drinking water contaminants. A failure to act will leave the residents in those states drinking tap water contaminated with highly toxic and persistent PFC pollutants for many years to come.

EPA regulation of PFOA and other PFCs that are commonly detected in people and the env ironment presents a meaningful opportunity for reduction of health risk due to these industrial chemical pollutants in drinking water. We urge the EPA to take much-needed action on PFOA and set a health- protective standard for PFOA in drinking water that will rely on the best available science and safeguard the health of millions of people.

3. Include in the final CCL3 a broader list of contaminants found by water utilities in tap water, especially focusing on antibiotics and other pharmaceuticals.

Pharmaceutical residues contaminate drinking water supplies when people take various prescribed and over the counter medications. W hile their bodies absorb and metabolize some of the chemicals, the rest is flushed out of the body and down the drain. Drinking water treatment plants are not designed to remove these residues, and the Associated Press (AP) National Investigative Team uncovered data showing these same chemicals in treated tap water and water supplies in 24 major metropolitan areas around the US (Mendoza 2008). Together with earlier publications by the US Geological Survey thatidentified pharmaceuticals and personal care product chemicals

in waters bodies and streams around the United States (Kolpin 2002), the results of the AP investigation point to the potential health dangers presented by pharmaceuticals in drinking water.

All of the pharmaceuticals reported in drinking water supplies are unregulated in treated tap water-any level is legal. So far, the federal agencies have failed to set standards for pharmaceuticals which are generally exempted by the FDA from any env ironmental assessment (FDA 2008). Moreover, the EPA has not even required water utilities to test for these chemicals. Drug residues in tap water join hundreds of other synthetic chemicals Americans are exposed to daily, as contaminants in food, water, and air, or in common consumer products. EWG found

an average of 200 industrial chemicals, pesticides and other pollutants in umbilical cord blood from 10 babies born in the U.S., indicating that our exposures to toxic chemicals begin in the womb, when risks are greatest (EWG 2005a). EWG analysis shows that of the top 200 drugs commonly prescribed in the U.S., 13 percent are known to have serious side effects at levels less than 100 parts-per-billion (ppb) in human blood, with some causing potential health risks in the parts-per- trillion range. These levels are dangerously close to the ones found in drinking and ambient water sources (Kolpin 2002; Mendoza 2008).

Wenow call on the EPA to take swift action by setting standards for antibiotics and pharmaceuticals in tap water that will protect the health of all Americans, especially children. By the very nature of their design, pharmaceuticals can have effects on human body even at low doses. We urge the EPA to include in the final CCL3 a broad range of pharmaceutical resides and other contaminants found in tap water. This action will serve as the first, much needed step for ensuring the long-term health of our tap water - and the people who drink it.

In conclusion, presence of pharmaceuticals and perfluorochemicals in all states where water samples have been tested for these compounds, and their effects on theenv ironment and on human health makes these chemicals very

important candidates for federal regulation under the Safe Drinking Water Act. Federal drinking water policies and regulations should be set to ensure that vulnerable populations, including pregnant women and children, are protected from chemical contaminants in drinking water. Ingestion of drugs and PFCs with drinking water presents a significant hazard for human health, especially during sensitive times in life, such as in utero. Most states do not have the resources to establish or enforce drinking water standards, and people in these states depend on strong protections from the EPA. Regulation of these pollutants will assure equitable and uniform protection for the health of all Americans. Thus, we urge the EPA to follow up on the draft CCL3 by setting regulatory standards for both pharmaceuticals and PFCs in drinking water.

Sincerely,

Olga V. Naidenko, Ph.D. Senior Scientist Environmental Working Group 1436 U street NWSuite 100 Washington, DC 20009 202-939-9157 olga@ewg.org

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May 21, 2008

U.S. Environmental Protection Agency EPA Docket Center, Water Docket Mailcode: 2822T 1200 Pennsylvania Ave., NW Washington, D.C. 20460

Re: Comments On the Drinking Water Contaminant Candidate List 3 -- Draft; Docket Number EPA-HQ-OW-2007-1189

These comments are submitted by Waterkeeper Alliance ("Waterkeeper") in response to the third Drinking Water Contaminant Candidate List ("CCL 3").

Waterkeeper Alliance, Inc. is a non-profit organization representing the interests of 177 member watershed groups. Each of these groups, and their members, has an express mission to preserve and protect local waterbodies for aesthetic, recreational, and other purposes.[FN1: The following Waterkeeper Alliance member programs have expressed their concurrence with these comments: Altamaha Riverkeeper, GA; Altamaha Coastkeeper, GA; Apalachicola Riverkeeper, FL;Assateague Coastkeeper, MD; California Coastkeeper Alliance,

CA; Casco Baykeeper, ME; Columbia Riverkeeper, OR; Cook Inletkeeper, AK; French Broad Riverkeeper, NC; Kansas Riverkeeper, KS; Galveston Baykeeper, TX; Long Island Soundkeeper, CT; Lower Neuse Riverkeeper and Neuse River Foundation, NC; Milwaukee Riverkeeper, W I; Mobile Baykeeper, AL; Nantucket Soundkeeper, MA; NY/NJ Baykeeper, NY and NJ; Pamlico-Tar Riverkeeper, NC; Patuxent Riverkeeper, MD; Potomac Riverkeeper, DC; Raritan Riverkeeper, NJ; Russian Riverkeeper, CA; San Diego Coastkeeper, CA; Saranac Riverkeeper, NY; Sehanandoah Riverkeeper, VA; South Riverkeeper, MD; St. Johns Riverkeeper, FL; Tualatin Riverkeeper, WA; West/Rhode Riverkeeper, MD; West Virginia Headwaters Waterkeeper, WV; Western Lake Erie Waterkeeper, OH; Youghiogheny Riverkeeper, PA.]

Waterkeeper is exceedingly concerned with the state of our nation's drinking waters. It believes that the Safe Drinking Water Act ("SDWA") can provide needed protections to the public by regulating the variety and amount of contaminants found in public water supplies. However, to provide these protections, United States Environmental Protection Agency ("EPA") must comprehensively address the pollution of America's drinking water sources. To do so, and to meet the objectives of the SDWA, EPA must consider all potential adverse effects of aqueous contaminants to the public; it should account for these hazards by controlling their occurrence, creating accountability; and it should promote the security of our public water systems.

The CCL 3 list prov ides some essential contaminants for regulation. Yet, EPA must go further to protect public health and welfare. One way for EPA to do so is to follow the enclosed suggestions for improv ing the list. Specifically, EPA should categorically include, or, at a minimum, individually list, pharmaceuticals and personal care products, including endocrine disrupting compounds, in the final National Primary Drinking Water Regulations ("NPDW R").

I. BACKGROUND: THE SAFE DRINKING WATER ACTThe Safe Drinking Water Act requires EPA to promulgate national

drinking water regulations for public water systems.[FN2: 42 USC § 300g-1.] EPA must issue regulations for each contaminant that may have any adverse effect on health and that is known or anticipated to occur in such systems.[FN3: 42 USC § 300g-1(b).] In creating the regulations, EPA goes through a number of steps.

EPA first lists a number of unregulated contaminants for analysis and possible addition to the NPDWA. This list, the CCL, must be published for public comment by EPA at least once

every five years.[FN4: 42 USC § 300g-1(b)(1)(B)(ii).] The

overarching listing criteria are:

1. That 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;

2. That the contaminant may have an adverse effect on the health of persons; and

3. ...regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.[FN5: 42 USC § 300g-1(b)(1)(A).]

After EPA identifies drinking water contaminants, it must determine whether the contaminant is likely to be present at hazardous levels in public water, and, if so, it establishes the contaminant's maximum contaminant level goals ("MCLG"), the ideal maximum level at which the contaminant can be in the water without causing a risk to health.[FN6: 42 USC § 300g-1(b) (3). See US EPA, Safe Drinking Water Act, at www.epa.gov/safewater/sdwa (May 6, 2008).] Finally, EPA performs a cost-benefit analysis to set contaminant standards, the maximum contaminant level ("MCL") that can feasibly be implemented under the SDWA.[FN7: Id.]MCLG are to be set "at the level at which no known or

anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety."[FN8: 42 USC § 300g-1(b)(4)(A).] The resultant MCL should be set as close to the MCLGs "as is feasible."[FN9: 42 USC § 300g-1(b)(4)(B).] In determining "feasibility," the Administrator may weigh both the "quantifiable and nonquantifiable costs and benefits" of setting particular levels.[FN10: 42 USC §§ 300g-1(b)(3)(C), (4).] If EPA determines that the benefits would not outweigh the costs, the MCL is to be set to "maximize health risk reduction benefits at a cost that justifies the benefits."[FN11: 42 USC § 300g-1(b)(7).]

The resulting SDWA regulations should be both comprehensive and protective. This point was reinforced in 1996 when President Clinton revised the act to provide new regulatory flexibility to the EPA by repealing the maximum number of contaminants to be regulated per year.[FN12: See Pub. L. 104-182, 110 Stat. 1615.] The 1996 amendments further modified EPA's requirements under the SDWA to include the treatment of source water.[FN13: Id.] The resultant regulatory scheme places a proactive requirement on EPA to ensure protection to public water and human health.

II. DETAILED COMMENTS

A. EPA SHOULD ENSURE THAT THE CONTAMINANTS LISTED IN CCL 3 SUFFICIENTLY PROTECT THE PUBLIC AGAINST ADVERSE HEALTH IMPACTS FROM INADEQUATE DRINKING WATER REGULATIONS.

1. EPA Should Again Rev ise The Candidate Selection Process To Include Greater Public Participation.

Congress requires public participation opportunities be included in the SDWA listing process.[FN14: 42 USC § 300g-1.] In 1996, Congress recognized that "safe drinking water is essential to the protection of public health,"[FN15: Pub. L. 104-182, Sec. 3 (1).] and, therefore, that "procedures forassessing the health effects of contaminants establishing

drinking water standards should be rev ised to provide greater opportunity for public education and participation."[FN16: Pub. L. 104-182, Sec. 3 (6).] The opportunities available with CCL 3 show EPA's recognition of this mandate. However, to ensure protection of the public health and public interest, EPA must go further.

In creating CCL 3, EPA amended its previous classification approach.[FN17: See Drinking Water Contaminant Candidate List 3 - Draft, 73 Fed. Reg. 9627, 9631 (2008).] EPA's purported intent in making this change is to "increase transparency and reproducibility of the CCL decision process," and to increase public participation opportunities.[FN18: Id.] The result was a tiered process in which EPA first identified a broad universe of potential drinking water contaminants, then narrowed the list through a variety of screening processes, and, finally, solicited public review on considered contaminants. W hile it is somewhat understandable that EPA does not wish to rev iew comments at every stage of CCL creation, it is not understandable, nor is it acceptable, to restrict public comment to an extremely limited number of these potentially dangerous contaminants.

Under this new tiered approach, EPA reduced the potential contaminant list from over 7,500 contaminants to less than 200 without any intermediate public comment periods.[FN19: Id.] As a result, the new approach actually decreases transparency in the regulatory process. We would suggest EPA involve the public much earlier in the selection process so that the public may: (1) assess the contaminants EPA is focusing on and (2) suggest further alternate contaminants for EPA to consider as it goes forward in the process[FN20: We recognize that EPA requested the public submit chemical and microbial contaminant nominations for CCL 3. 71 FR 60704 (2006). Riverkeeper participated in this process. However, EPA should open at least one more comment period with the purpose of identifying further contaminants for regulation.].

A more inclusive selection process might have remedied a glaring deficiency in CCL 3: the noticeable absence ofpharmaceuticals and personal care products ("PPCPs"), including

endocrine disrupting compounds. The 1996 amendments to the SDWA gave EPA immense power to regulate large numbers of contaminants[FN21: See Pub. L. 104-182, 110 Stat. 1615.], but EPA is not effectively using that power. As section B shows, a wide range of PPCPs must be regulated under the NPDW R; otherwise, the Agency simply cannot claim to be adequately protecting human health.

2. Pathogens

Each listed pathogen causes extremely adverse health effects in humans in relatively small concentrations. Therefore, every pathogen listed should be regulated as a contaminant under the SDWA.

3. Chemical Contaminants

Every chemical contaminant listed causes extremely adverse health effects in humans and should be regulated under the SDWA.

a. Pesticides

Waterkeeper applauds EPA's choice to include a number of pesticides in the CCL 3 listing. As EPA has noted, some pesticides, "such as the organophosphates and carbamates, affect the nervous system. Others may irritate the skin or eyes. Some pesticides may be carcinogens."[FN22: EPA, Pesticides: Health and Safety, at: www.epa.gov/pesticides/health/human.htm (May 15, 2008).] In fact, since pesticides "[b]y their nature [are] substances that in many cases are designed to kill pests, [they] can pose risks to humans and to the environment."[FN23: EPA, Reducing Pesticide Risk. Pesticides: Health and Safety, at: http://www.epa.gov/pesticides/health/reducing.htm (May 15, 2008).]For example, listed pesticide Tebufenozide is known to cause

human health effects including (but not limited to) reproductive effects, developmental toxicity, toxicity to the

nervous system, and carcinogenicity.[FN24: See 61 Fed. Reg. 60628, 60629 (1996).]

Webelieve that all of the listed pesticides should be regulated as contaminants under the SDWA. However, the list is still missing a number of especially hazardous pesticides. Therefore, as a necessary protective measure, EPA should continue adding pesticides to this list.

b. Pharmaceuticals and Personal Care Products

Waterkeeper agrees with EPA that there are concerns regarding the presence of pharmaceuticals in the water supply.[FN25: See 73 Fed. Reg. at 9652.] W hat Waterkeeper does not agree with is EPA's use of the word "potential" in describing this problem.[FN26: Id] Detailed below are numerous studies addressing the ongoing problems and hazards associated with pharmaceuticals in public drinking water supplies. Of particular importance is a recent study by the Associated Press addressing the fact that marked amounts of pharmaceuticals were found in at least 50 percent of the municipal water sources of the 50 cities tested.[FN27: See, Prescription drugs found in drinking water across U.S, Associated Press, April 4, 2008 at www.cnn.com/2008/HEALTH/03/10/pharma.water1 (May 15, 2008).]

Further, Waterkeeper is unsure how EPA was able to go from originally considering 287 pharmaceutical contaminants to listing only one pharmaceutical, nitroglycerin, in the CCL 3.[FN28: See 73 Fed. Reg. at 9652.] W ith so much information

available regarding the hazardous results of elevated pharmaceutical levels in public drinking water, including source water, more pharmaceuticals should be listed for regulation. Waterkeeper hopes that the following section proves helpful to the EPA in identifying and listing a greater number of PPCPs for regulation.EPA's CCL 3 process produced enough ev idence to show that the

listed contaminants:

1. Are prevalent in public water systems;

2. Have an adverse effect on the health of persons; and

3. That regulation of such contaminants would provide noticeable health risk reductions.

Therefore, these contaminants must be regulated under the SDWA

B. THE CONTAMINANT CANDIDATE LIST IS MISSING A NUMBER OF EXCEPTIONALLY HAZARDOUS DRINKING WATER POLLUTANTS.

Weappreciate that EPA must take a number of issues into account in determining which contaminants to list under CCL 3 and, ultimately, the NPDW Rs. However, there are a number of notable hazardous contaminants that were not publicly addressed in the past three listing processes, and which must be regulated in order to protect US drinking water supplies. An important category of contaminants that must be regulated is PPCPs.

1. EPA Must Regulate Pharmaceuticals and Personal Care Product Levels in Public Water.

PPCPs are scientifically shown to degrade drinking water quality and adversely affect human health.[FN29: See, e.g., Dr. Jennifer Sass, Senior Scientist NRDC, Statement before the Committee on Environment and Public Works Subcommittee on Transportation Safety, Infrastructure Security and Water Quality (April 15, 2008) ("Pharmaceuticals and personal care products (PPCPs) include human and veterinary drugs, both prescription and over-the-counter, medical agents such aschemotherapeutic drugs and x-ray contrast media, antibiotics,

anti-inflammatories, blood pressure and cholesterol lowering medications, psychotropic drugs, oral contraceptives, anti- seizure medications, fragrances, sunscreens, 'antibacterial' soaps, lotions, shampoos, and creams.").] An investigation by the Associated Press revealed that pharmaceutical residues were detected in the drinking water supplies serving 41 million Americans.[FN30: See Jeff Donn, et al., AP Probe Finds Drugs in Drinking Water, Associated Press, March 9, 2008, at www.msnbc.msn.com/id/23503485/]

Endocrine disrupting compounds ("EDCs") are included in PPCPs. EDCs are substances that directly or indirectly affect the body's ability to regulate homeostasis, growth, and reproduction. Endocrine disrupting compounds may influence the synthesis, transport, or metabolism of hormones in the body. Endocrine disrupting compounds may be medical substances like ethinyl estradiol, the active ingredient used in hormonal birth control, or they can include metals, pesticides, plasticizers, toxins such as polychlorinated biphenyls (PCBs), and naturally occurring phytoestrogens.

PPCPs enter the environment in a number of ways including: waste from human or animal excretion, improper disposal such as flushing down a toilet, runoff from animal feeding operations, or leaching from municipal landfills.[FN31: Id.] As PPCPs are only partially metabolized by humans and other animals, they remain largely unchanged in urine and feces.[FN32: See Daughton, PPCPs as Env ironmental Pollutants, U.S. Environmental Protection Agency: Office of Research and Development (2004).]

Human PPCPs, including hospital wastes, are often disposed of through sewage treatment systems or in landfills, ultimately being released into the environment.[FN33: Id.] Currently, wastewater treatment plants are not designed to remove PPCPs from the wastestream. This inadequacy results in PPCP- contaminated liquid effluent either being discharged to a eceiv ing waterbody or injected to groundwater, putting both surface water and aquifers at risk. Overflow, bypass, upsets, and system failures at wastewater treatment facilities also allow PPCP-contaminated waste to enter receiving waterbodies.Further, contamination can occur when treatment sludge

(biosolids), containing pharmaceuticals attached to solid particles, are land applied.

The research, manufacturing, and sale of PPCPs may also lead to

env ironmental contamination. Pharmaceuticals in any stage of clinical testing are subject to release into the

env ironment.[FN34: See Daughton. and Ternes, Special report: pharmaceuticals and personal care products in the env ironment: agents of subtle change?, Environmental Health Perspectives at 107 (1999).] Drug surpluses, treated and untreated pharmaceutical waste, and pharmaceutical byproducts from manufacturing and research facilities, pharmacies, physicians, and humanitarian efforts are often expelled into sewer systems, ultimately ending up at wastewater treatment plants which allow the contaminants to travel, untreated, into receiving waterbodies.

Pharmaceuticals are also used heav ily in agriculture. Confined animal feeding operations ("CAFOs") often utilize antibiotics for both infection control and enhanced growth, while hormones are used to control reproductive cycles and to speed growth.[FN35: See, e.g., Song, et al., Determination of Amprolium, Carbadox, Monensin, and Tylosin in Surface Water by Liquid Chromatography / Tandem Mass Spectrometry, Rapid Communications in Mass Spectrometry 21: 1944-1950 (2007).] Like humans, animals do not completely metabolize pharmaceuticals, and their waste contains measurable levels of pharmaceutical compounds. Animal agricultural waste, and its associated contaminants, can enter the drinking water supply in a variety of ways. For example, much of the more than 110 million tons of swine waste produced in the United States each year[FN36: See Environmental Defense, Animal Waste Summary (1997) at www.hogwatch.org/maps/index (June 15, 2004).] is disposed of through direct land application, contaminating soil and groundwater resources.[FN37: See Daughton, PPCPs as Environmental Pollutants, U.S. Environmental Protection Agency: Office of Research and Development (2004); Chapin, et al. Airborn Mutlidrug-Resistant Bacteria Isolated from a Concentrated Swine Feeding Operation. Env ironmental Health Perspectives 113: 137-142 (2005)] Further, land application frequently results in manure-laden runoff, which introducespharmaceuticals to receiv ing waterbodies. Contamination can

also occur as a result of leaking manure storage facilities and improper disposal of euthanized or medicated carcasses. W ith no primary waste treatment required for animal wastes and without PPCP regulation, virtually all excreted PPCP compounds are flowing unfettered into drinking water sources.

Aquaculture also uses many antibiotics and other anti- infectives and anesthetics. The close proximity of aquaculture facilities, medicated feed, and waste to natural aquatic ecosystems increases the probability that pharmaceuticals will enter the environment.[FN38: See Daughton. and Ternes, Special report: pharmaceuticals and personal care products in the

env ironment: agents of subtle change?, Environmental Health Perspectives at 107 (1999).]

From the outset, PPCPs represent a large regulatory category, but, in advancing a workable regulatory schedule, this category can be reduced through a few simple steps. First, PPCPs can easily be broken into two categories: pharmaceuticals and endocrine disrupters. Pharmaceuticals can then be further divided into therapeutic pharmaceuticals and non-therapeutic pharmaceuticals. Non-therapeutic pharmaceuticals refer to drugs administered at sub-therapeutic levels or for purposes other than their original design, as often seen in industrial agriculture. From this categorization, EPA can further narrow the regulatory category by analyzing which pharmaceuticals cause the greatest threat to water quality and the feasibility of limiting the use of these contaminants and treatment options.

As discussed above, EPA engages in a three step process to determine whether and at what contaminant level to regulate a pollutant. As the following PPCPs have been proven to:

1. Be prevalent in public water systems;

2. Have an adverse effect on the health of persons; and3. Regulation of such contaminants would provide noticeable

health risk reductions.

They must be regulated, thereby reducing the health risks they pose to public health, drinking water, and the env ironment.

a. Proposed Therapeutic Pharmaceuticals Meet Listing Standards

i. Identifying and Prioritizing Drinking Water Problems: Best Available Science Dictates the Listing of Therapeutic Pharmaceuticals

1. Therapeutic Pharmaceuticals are prevalent in public water systems.

The domestic use of PPCPs is on par, in terms of quantity, with agrichemicals.[FN39: See, Daughton, C.G. and T.A. Ternes. Special report: pharmaceuticals and personal care products in the environment: agents of subtle change? Env ironmental Health Perspectives. 107. 1999.] The prevalent use of PPCPs makes them ubiquitous in the env ironment - they can be found in the rivers, lakes, and coastal waters of any place humans live or

even visit.[FN40: Id.] PPCPs have been detected in wastewater effluents, surface waters, groundwater, and drinking water supplies around the world.[FN41: See, e.g., Westerhoff,et al., Fate of endocrine-disrupter, pharmaceutical, and personal care product chemicals during simulated drinking water treatment processes, Environmental Science and Technology at 39(17) (2005).]

About 100 PPCPs have been detected in European and U.S. surface waters in the parts per trillion (ppt) to parts per billion (ppb) range.[FN42: See Hemminger, Damning the flow of drugs into drinking water, Environmental Health Perspectives at 113(10) (2005).] An Environmental Working Group analysis shows that of the top 200 drugs in the U.S., thirteen percent list serious side effects at levels less than 100 parts-per-billion(ppb) in human blood, with some causing potential health risks

in the parts-per-trillion range.[FN43: Environmental Working Group. Pharmaceuticals Pollute U.S. Tap Water (2008) at http://www.ewg.org/node/26128 (May 15, 2008).] However, despite the fact that "[t]he drug residues in tap water join hundreds of other synthetic chemicals Americans are exposed to daily," such as contaminants in food, water, air, and common consumer products, there continue to be no standards for these, or any, pharmaceuticals and there are no requirements that utilities test for these contaminants.[FN44: Id.]

The United States Geological Survey ("USGS") conducted a study of pharmaceuticals, hormones, and other organic wastewater contaminants in 139 U.S. streams in1999 and 2000.[FN45: See Buxton and Kolpin, Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, United States Geological Survey: Toxic Substances Hydrology Program, Fact Sheet FS-027-02 (2002).] They analyzed stream water for 95 different organic compounds routinely found in residential, industrial, and agrichemical wastewaters. They found human and

veterinary drugs, including antibiotics and natural and synthetic hormones, detergent metabolites, plasticizers, insecticides, and fire retardants in waters downstream of animal production facilities and heavily urbanized areas. Eighty-two contaminants were detected at least once and one or more organic wastewater contaminants were detected in 80 percent of the streams sampled.[FN46: See Kolpin, et al., Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: A national reconnaissance, Env ironmental Science and Technology at 36(6) (2002).] Mixtures of contaminants were common in 75 percent of the sampled streams had more than one, 50 percent had seven or more, and 34 percent had ten or more contaminants present.[FN47: Id.]

In March 2008, the Associated Press ("AP") released the results of an investigation into pharmaceutical contamination of U.S. drinking water supplies, finding that at least 41 million Americans are exposed to drugs such as pain relievers, antibiotics, anticonvulsants, mood stabilizers, and sex hormones through their drinking water.[FN48: 48 See Associated Press, Prescription drugs found in drinking water across U.S.,April 4, 2008, at www.cnn.com/2008/HEALTH/03/10/pharma.water1

(May 15, 2008).] The AP National Investigative Team reviewed hundreds of scientific reports; analyzed federal drinking water databases; visited environmental study sites and treatment plants; surveyed the nation's largest 50 cities, a dozen major water providers, and small water prov iders in all 50 states; and interv iewed more than 230 officials, academics, and scientists. Besides identifying pharmaceuticals in drinking water supplies, the team also determined that 34 of the major water providers do not conduct any testing for these substances, and that those communities that do test do not share the results with the public. As detection methods are developed and improved these numbers will most likely only rise, especially since thousands of distinct PPCPs are

available commercially and thousands of tons per year are used.[FN49: See, e.g., Daughton, PPCPs as Environmental Pollutants, U.S. Environmental Protection Agency: Office of Research and Development (2004).]

Even EPA's own science details the ominous quantity of pharmaceuticals being released into drinking water: "[i]n addition to antibiotics and steroids, over 100 indiv idual [Pharmaceuticals and Personal Care Products] have been identified (as of 2007) in environmental samples and drinking water."[FN50: US EPA, Pharmaceuticals and Personal Care Products at www.epa.gov/ppcp/faq.html (May 6, 2008).] It goes on to detail the major sources of PPCPs released into the

env ironment. Of the six primary sources listed, two, veterinary drug use and agribusiness, fall within the CAFO category.[FN51: Id.] This representation shows the cogent link between the necessity for regulation of the PPCPs used in CAFOs and the reduction of pharmaceutical amounts in public waters.

2. Therapeutic Pharmaceuticals in public water have an adverse effect on health and regulation of such contaminants would prov ide health risk reductions.

The health risks associated with allowing pharmaceuticals to remain in public drinking water are clear. Pharmaceuticals make up a category of contaminants that, by their nature, affect the human body. Since pharmaceuticals began being prescribed inmass quantities for therapeutic use, physicians and the Food

and Drug Administration ("FDA") have repeatedly stated that such pharmaceuticals are only to be taken by the person to which they were prescribed. W hile such pharmaceuticals are frequently life-saving for that person, they can be life- threatening for someone who does not possess a similar affliction. Such adverse effects become heightened if those pharmaceuticals are taken with liquor or paired with other pharmaceuticals. However, by not regulating pharmaceutical concentrations in the public drinking water, EPA is allowing the American public to unwittingly dosing itself with pharmaceuticals not prescribed to them.

Even at very low levels of exposure, PPCPs have the potential, at the cellular level, to effect humans, and wildlife.[FN52: See Goodman, Sedatives and sex hormones in our water supply Democracy Now! , April 4, 2008 at www.alternet.org/water/80505/?page=1 (For many PPCPs, the specific modes of action and interaction with other substances are not fully understood.); Daughton, PPCPs as Env ironmental Pollutants, U.S. Environmental Protection Agency: Office of Research and Development (2004) (Eco-toxicity data is available for less than one percent of human pharmaceuticals.).] This is largely because PPCPs are bioreactive by design, leading to an intended physical or psychological response in the body. PPCPs bioreactive designs may cause a number of unintended reactions, and their hazards to public health are particularly strong, especially where the pathway of interactions is unknown.[FN53: See Daughton, PPCPs as Environmental Pollutants, U.S. Environmental Protection Agency: Office of Research and Development (2004).] Therefore, the effects on non-target species are unpredictable and potentially volatile.[FN54: Id.]

Further, some PPCPs are proven to bioaccumulate, build up, in the body over time.[FN55: Bioaccumulation is "[t]he accumulation of a substance, such as a toxic chemical, in

various tissues of a living organism. Bioaccumulation takes place within an organism when the rate of intake of a substance is greater than the rate of excretion or metabolic transformation of that substance." Bioaccumulation, The American Heritage Science Dictionary, Houghton Mifflin Company (2008) athttp://dictionary.reference.com/browse/Bioaccumulation (May 13,

2008).] This can cause both acute and chronic problems such as toxicity and carcinogenesis, as well as antibiotic resistance, neurobehav ioral changes, and genetic and reproductive mutation.

Recently, the Center for Disease Control identified antibiotic resistance as one of the most pressing public health problems to face our nation. It has implemented a campaign to halt antimicrobial resistance in healthcare settings, but such program will be ineffective without concerted removal of pharmaceuticals from drinking water.[FN56: See Center for Disease Control at www.cdc.gov/drugresistance/healthcare/problem.htm (May 15, 2008).]

Mutation of aquatic organisms is of extreme concern as these mutations signify "canaries in a coal mine" regarding impacts of excess pharmaceutical intake on human beings. For example, a study in a 1994 issue of Chemistry and Ecology linked production of vitellogenin, an egg protein usually only found in females, by male carp and trout to exposure of sewage effluent containing the active ingredient in birth control pills.[FN57: See Hemminger, Damning the flow of drugs into drinking water, Environmental Health Perspectives at 113 (2005).]

The improper and uncontrollable intake of pharmaceuticals through drinking water is hazardous to the public by, among other things, causing antibiotic resistance, overdose, sickness and possibly death.[FN58: See Jay Cohen, Overdose: The Case Against Drug Companies at http://www.lauralee.com/news/overdose2.htm (May 19, 2008) ("Aggressive marketing, slanting research, unethical publishing of results, pressuring medical centers, intimidating researchers, influencing physicians, limiting information, manipulating the FDA, marketing drugs with inaccurate safety information and inappropriate doses -- all of these have created an env ironment in which medication development has become, in Dr. Angell's fitting term, a 'race to the bottom (72).'").] Therefore, reasonability and science dictate that regulation of these contaminants would reduce health risks.ii. Cost-Benefit Analysis

EPA is not in the appropriate stage to determine whether pharmaceutical contaminants are too costly to regulate under National Drinking Water Regulations.[FN59: 42 USC § 300g-1(b) (1).] That determination should be made after the contaminant has been adopted for regulation and at the time that MCL limits are being finalized.[FN60: Id.] At the current stage, EPA should only be considering the likelihood that pharmaceuticals will occur in the public water system, the adverse health effects caused by these contaminants, and the health risk reductions that will come from regulating.[FN61: Id.] As detailed above, each of these benchmarks have been evidenced, and PPCPs should be considered for regulation.

However, even if it is appropriate for EPA to perform cost- benefit analyses at this stage, the benefits of regulation greatly outweigh the associated costs. Under the SDWA, in determining a regulated contaminant's MCL, the Administrator should analyze seven issues:

1. Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur as the result of treatment...

2. Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur from reductions in co-occuring contaminants...

3. Quantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record to conclude that such costs are likely to occur solely as a result of compliance with the maximum contaminant level...4. The incremental costs and benefits associated with each

alternative maximum contaminant level considered...

5. The effects of the contaminant on the general populations and on groups within the general population such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that are identified as likely to be at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population...

6. Any increased health risks that may occur as a result of compliance...

7. Other relevant factors, including the quality and extent of the information, the uncertainties in the analysis supporting subclauses (I) through (IV), and factors with respect to the degree and nature of the risk.[FN62: 42 USC § 300g-1(b)(3)(C).]

These factors can be broken down into two categories: benefits of regulation and costs.

As detailed above, the human health and welfare benefits of regulating PPCPs are innumerable. The threat to human health caused by the ingestion of unprescribed pharmaceuticals through drinking water will be most apparent in infants, children, and pregnant women. Children and pregnant women are the most sensitive populations to drugs and the exposure to these contaminants may cause miscarriages, developmental abnormalities, and other life altering adverse effects.[FN63: See, e.g., Montenegro, et. al., Assessment of How Pregnancy Modifies Plasma Lead and Plasma/W hole Blood Lead Ratio in ALAD 1-1 Genotype Women, Basic & Clinical Pharmacology & Toxicology 102: 347-351 (2008).] For example, the Environmental Working Group "found an average of 200 industrial chemicals, pesticides and other pollutants in umbilical cord blood from 10 babies born in the U.S., indicating that our exposures to toxic chemicals begin in the womb, when risks are greatest."[FN64: Environmental Working Group, Pharmaceuticals Pollute U.S. TapWater at: www.ewg.org/node/26128 (May 15, 2008).]

As the 1996 SDWA amendments highlight, American have the right to know what pharmaceuticals are contained in their drinking water.[FN65: See Pub. L. 104-182, 110 Stat. 1615.] If regulated, such crucial information on PPCP content would be

available in the annual consumer confidence reports. However, since the consumer confidence reports only contain information on regulated contaminants, such regulation is necessary for the public to protect itself against adverse health affects as a result of drinking medicated water.

The costs of controlling pharmaceutical pollution are found in source control (dischargers) and treatment (drinking water suppliers). Industrial dischargers include pharmaceutical research and manufacturing companies, medical serv ice prov iders such as hospitals and mortuaries, and privately owned wastewater treatment plans. Municipal dischargers include publicly owned treatment works.

EPA does not appear to quantify the costs of removing PPCPs from public waters, and there are few other sources that directly address this issue.[FN66: See Daughton and Ternes, Special report: pharmaceuticals and personal care products in the environment: agents of subtle change?, Environmental Health Perspectives. at 107 (1999).] However, if EPA is using the cost burden as a crutch for claiming that PPCPs cannot be regulated, it must provide adequate data to illustrate this conclusion. Without such essential information, EPA cannot reject PPCP regulation under the premise of cost constraints.

Based on this analysis, PPCP regulations must be implemented.

b. Proposed Non-therapeutic Pharmaceuticals Meet Listing Standards

i. Identifying and Prioritizing Drinking Water Problems: Best Available Science Dictates the Listing of Non-therapeuticPharmaceuticals

1. Non-Therapeutic Pharmaceuticals are prevalent in public water systems.

Therapeutic and non-therapeutic pharmaceuticals are often the same drugs, with the same active and inert ingredients. However, the rampant use of pharmaceuticals for nontherapeutic means in confined animal feeding operations ("CAFOs") is threatening surface and groundwater supplies across the United States. Non-therapeutic pharmaceutical use is the administration of drugs to animals to treat or prevent the spread of illnesses or to prevent death.[FN67: Non-therapeutic pharmaceutical use is the standard application of hormones, steroids, and antibiotics to livestock and poultry feed for no discernable, non-preventative medical reason.] For example, CAFOs often utilize antibiotics to prevent infections due to crowded and stressful conditions and to enhance growth. Hormones are used to control reproductive cycles for

convenience and to speed growth and production.

An estimated 70 percent of all the antibiotics used in the US are used for animal husbandry.[FN68: See Mellon et al., Hogging It: Estimates of Antimicrobial Abuse in Livestock, Union of Concerned Scientists (2000); Antibiotic Resistance and Agricultural Overuse of Antibiotics, fact sheet, Health Care Without Harm, at www.noharm.org/details.cfm?ID=938&type=document (May 15, 2008).] In fact, "[i]n the United States, hormone supplements are used in the production of approximately 90 percent of the beef cattle."[FN69: Balter, Scientific Cross-Claims Fly in Continuing Beef War, Science 284:1453-1455 (1999).] Also, "[a]n estimated 10.3 million pounds of antibiotics are used annually in U.S. swine production for nontherapeutic purposes."[FN70: Sapkota, et al. Antibiotic-Resistant Enterococci and Fecal Indicators in Surface Water and Groundwater Impacted by a Concentrated Swine Feeding Operation, Env ironmental Health Perspectives 115:1040-1045 (2007).]

It is essential for EPA to generate a control mechanism againstthis excess use of pharmaceuticals; however, in the meantime,

regulating under the SDWA ensures some protections are afforded to human health and drinking water against these powerful pollutants. Non-therapeutic pharmaceuticals are clearly a category that can be regulated, and that, in being regulated, will greatly improve water quality and potability.

Types of non-therapeutic pharmaceuticals that could be regulated include, but are not limited to:

1. Tetracycline,

2. Erythromycin,

3. Lincomycin,

4. Virginiamycin,

5. Ampicillin, and

6. Bacitracin.

Land application of PPCP-contaminated manure can pollute soil resources and ultimately groundwater.[FN71: See Daughton at PPCPs as Environmental Pollutants.] Manure-laden runoff and leaking manure storage facilities also introduce waste to receiving waterbodies. Further, improper disposal of carcasses also allows PPCPs to enter the env ironment. Since livestock at CAFO facilities are perpetually narcotized with non-therapeutic pharmaceuticals and since animals, like humans, do not completely metabolize pharmaceuticals, there is no question that pharmaceutical byproducts are released in factory farm animal waste, and that such byproducts reach public waters.

2. Non- Therapeutic Pharmaceuticals in public water have anadverse effect on health and regulation of such contaminants

would prov ide health risk reductions.

The health risks associated with non-therapeutic pharmaceuticals are comparable to the health risks of therapeutic pharmaceuticals. This is because many of the pharmaceuticals are the same. However, because of their superfluous use, the impacts of non-therapeutic pharmaceuticals on water quality and public health are more poignant.

A plentitude of studies address the impacts of the steroids, antibiotics, and hormones commonly used in CAFO operations on health and water quality. For example, USGS conducted an entire series of reports on the contaminants found in animal wastes.[FN72: Dr. Robert Hirsch, Associate Director for Water USGS, Statement before the Committee on Environment and Public Works Subcommittee on Transportation Safety, Infrastructure Security and Water Quality, April 15 (2008) ( Studies found at http://toxics.usgs.gov/bib/bib-Emerging.html).] These reports range in topic, but several address the movement of antibiotics from animal, to waste, to land application.[FN73: See, e.g., Barnes et. al., Water-quality data for pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000, U.S. Geological Survey Open-File Report 02-94 (2002) at http://toxics.usgs.gov/pubs/OFR-02-94/; Buxton and Kolpin, Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, U.S. Geological Survey Fact Sheet FS-027-02, 2 (2002) at http://toxics.usgs.gov/pubs/FS-027-02/; Kinney et. al, Presence and distribution of wastewater-derived pharmaceuticals in soil irrigated with reclaimed water, Environmental Toxicology and Chemistry, 25, 317-326 (2006) at http://pubs.acs.org/cgibin/abstract.cgi/esthag/2008/42/i06/abs/ es702304c.html; Kinney et. al., Survey of organic wastewater contaminants in biosolids destined for land application, Environmental Science & Technology, 40, 7207-7215 (2006) at http://www.setacjournals.org/perlserv/?request=get-abstract& doi=10.1897%2F05-187R.1; Kinney et al., Bioaccumulation of pharmaceuticals and other anthropogenic waste indicators in earthworms from agricultural soil amended with biosolid or swine manure, Environmental Science and Technology, 42 (6), 1863-1870 (2008) at http://pubs.acs.org/cgi-bin/abstract.cgi/esthag/2006/40/i23/abs/es0603406.html.]

The Pew Commission on Industrial Farm Animal Production, a non- partisan organization, conducted a comprehensive impact study regarding the impacts of CAFOs on the environment and water quality. Pew researchers determined "unlike human use of antibiotics, non-therapeutic uses in animals typically do not require a prescription."[FN74: Putting Meat on the Table: Industrial Farm Animal Production in America, PEWCommission on Industrial Farm Animal Production at 66 (2008) at www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Industr ial_Agriculture/PCIFAP_FINAL.pdf (May 12, 2008).] Further, it was determined that pharmaceutical use by farmers was regularly "not in accordance with approved labeling."[FN75: Id.] For example, farmers were found to be administering drugs "for a species not listed on the label; for an indication, disease, or other condition not on the label; or by a route of administration not on the label."[FN76: Id.]

As a result of their findings, the Commission concluded its report by recommending a number of necessary procedural changes industrialized factory farms should make in order to improve neighboring health and env ironmental quality. Two recommendations of particular interest are:

1. Restrict the use of antimicrobials in food animal production to reduce the risk of antimicrobial resistance to medically important antibiotics[FN77: An analysis of the antibiotic resistance hazards of antimicrobials use in food animal production are discussed in the "cost-benefit analysis" section below.], and

2. Increase veterinary oversight of all antimicrobial use in food animal production to prevent overuse and misuse of antimicrobials.[FN78: Putting Meat on the Table: Industrial Farm Animal Production in America, at 61,66.]

These recommendations illustrate that the unregulated and inappropriate uses of the pharmaceuticals are one of the waysin which excess quantities of pharmaceuticals are poisoning our

drinking waters, and they demonstrate that best available science dictates the listing of non-therapeutic pharmaceuticals.

Available reports clearly prove that the pharmaceutical- contaminated waste produced by animal feeding operations are polluting waterways and, as detailed below, contributing to antibiotic resistant pathogens. Such concerns plainly impact water quality and risk human health. Therefore, EPA must regulate a number of non-therapeutic steroids, hormones, and antibiotics under the SDWA. To do otherwise will be a violation of the Congressional mandate to establish enforceable criteria and procedures which will assure healthy and safe drinking water.[FN79: See 42 USC §§ 300f to 300j-26.]

ii. Cost-Benefit Analysis

The regulation of non-therapeutic pharmaceuticals has many of the same costs and benefits as the regulation of therapeutic pharmaceuticals; however, the benefit of regulating non- therapeutic pharmaceuticals is even more pronounced.

Many of the pharmaceuticals that CAFOs use non-therapeutically are the same as those being used therapeutically in humans. This results in two main problems. The first problem is the shear volume of pharmaceuticals being released into the water. Since some pharmaceuticals are being used for both therapeutic and non-therapeutic purposes, higher quantities of these pharmaceuticals are put into circulation, and, therefore, higher quantities are being excreted into the water.

The second problem is antibiotic resistance. "Antibiotics are the leading treatment method for bacterial infectious diseases, which remain the most common cause of worldwide death."[FN80: Isolation of Antibiotic-Resistant Bacteria from the Air Plume Downwind of a Swine Confined or Concentrated Animal Feeding Operation, Env ironmental Health Perspectives 114: 1032-1037 at 032 (2006), citing McGeer, Agricultural Antibiotics andResistance in Human Pathogens: Villian or Scapegoat?, Can Med.

Assoc J 159: 1119-1120 (1998).] "It is widely accepted that antibiotic-resistant pathogens make clinical treatment more difficult."[FN81: Id] Because "some classes of antibiotics that are used to treat life-threatening infections in humans, such as penicillins and tetracyclines, are allowed in animal feeds to promote growth,"[FN82: Putting Meat on the Table: Industrial Farm Animal Production in America, at 15.] an increased number of antibiotic resistant pathogens are forming, leaving human populations unprotected. Studies show that:

Antimicrobial-resistant bacteria have been found both in and downwind of IFAP [Industrial Farm Animal Production] facilities (e.g., swine) but not upwind.[FN83: Id., citing Gibbs et al. (2004).] Several groups have reviewed the association between the use of lowlevel antimicrobials in food animal production and the development of antimicrobial resistance in humans[FN84: Id., citing Teuber (2001); Harris et al. (2002)]; FN85: Id. at 16.]

Those groups have found a correlative relationship.

For example, in 2001 Chee-Sanford et al. found that "the movement of resistant bacteria and resistance determinants from swine CAFOs into the environment can be extensive." On thing that the group found was, "a high occurance of tetracycline resistance determinants in groundwater wells located close to swine lagoons."[FN86: Id., citing Sapkota et al at 1044.] And, in 2007,

Sapkota et al. found "antibiotic resistant Enterococcus ssp. ...in a drinking water well located 400 m down gradient from the facility."[FN87: Id.]

As stated by the U.S. Institute of Medicine/National Academy of Science, "[c]learly, a decrease in antimicrobial use in human medicine alone will have little effect on the current [antibiotic-resistant] situation. Substantial efforts must be made to decrease inappropriate overuse in animals andagriculture as well."[FN88: Antibiotic Resistance and

Agricultural Overuse of Antibiotics, Healthcare W ithout Harm factsheet, Novermber 8, 2005 at www.noharm.org/us/food/issue.] The World Health Organization ("W HO") also expressed its concern when it stated "[t]here is clear ev idence of the human health consequences due to resistant organisms resulting from non-human usage of antimicrobials."[FN89: Id.] The Center for Disease Control estimated that 2 million people contract resistant infections annually, and, of those, 90,000 die.[FN90: Putting Meat on the Table: Industrial Farm Animal Production in America, at 15.] Further, "A decade ago the Institute of Medicine estimated that antimicrobial resistance costs the United States between $4 and $5 billion annually, and these costs are certainly higher now."[FN91: Id.]

In Denmark, which in 1998 banned the use of antibiotics in food animal production for non-therapeutic purposes, it was found that

the termination of antimicrobial growth promoters in Denmark has dramatically reduced the food animal reservoir of enterocicci resistant to these growth promoters, and therefore reduces a reservoir of genetic determinants (resistance genes) that encode antimicrobial resistance to several clinically important antimicrobial agents in humans.' The report also determined that the overall health of the animals (mainly swine) was not affected and the cost to producers was not significant.[FN92: Id. at 61, quoting W HO 2002 report]

While the Safe Drinking Water Act may not be the appropriate location to ban the use of non-therapeutic pharmaceuticals, EPA can use it to ensure against further antimicrobial resistance by removing the contaminants from the water. The benefits of these regulations are clear.

Much like the pesticide use, the use of non-therapeutic antibiotics is unnecessary and can be easily regulated. Based on this analysis, regulations must be implemented.c. Proposed Endocrine Disrupting Compounds Meet Listing

Standards

i. Identifying and Prioritizing Drinking Water Problems: Best Available Science Dictates the Listing of Endocrine Disrupting Compounds

1. Endocrine Disrupting Compounds are prevalent in public water systems.

In 1996, Congress mandated that EPA address endocrine disrupting compounds ("EDCs") in drinking water.[FN93: In 1996, the Food Quality Protection Act (FQPA) required EPA to develop a screening program to ascertain which substances may have estrogenic (or other endocrine) effects on humans. P.L. 104-170. The Safe Drinking Water Act extended this mandate to include substances that may be found in sources of drinking water. 42 USC § 300g-1.] Twelve years later the Endocrine Disruptor Screening Program has failed to even start testing chemical contaminants and EPA has yet to implement necessary regulations. These compounds have long been identified as posing a threat to health and water quality, and EPA is

severely delinquent in its response.

Types of EDCs that could be regulated include, but are not limited to, estrogens, androgens and progesterones. Each of these have been reported to appear in significant concentrations around fields fertilized with poultry litter[FN94: See Finley-Moore, et al., 17ß-Estradiol and Testosterone in Soil and Runoff from Grasslands Amended with Broiler Litter, J Environ Qual 29: 1604-1611 (2000); Nichols, et al. Runoff of Estrogen Hormone 17ß-estradiol from Poultry Litter Applied to Pasture. J Environ Qual 26: 1002-1006 (1997).] and in ponds below cattle holding facilities.[FN95: See Irwin, et al. Vitellogenin Induction in Painted Turtle, Chrysemys picta, as a Biomarker of Exposure to Environmental Levels of Estradiol, Aquat Toxicol 55: 49-60 (2001); Orlando, et al. Endocrine- Disrupting Effects of Cattle Feedlot Effluent on an Aquatic Sentinel Species, the Fathead Minnow,Environmental Health Perspectives 112:353-358 (2004).]

2. Endocrine Disrupting Compounds in public water have an adverse effect on health and regulation of such contaminants would prov ide health risk reductions.

EDCs are substances that directly and indirectly affect the body's ability to regulate homeostasis, growth, and reproduction. EDCs may influence the synthesis, transport, or metabolism of hormones in the body. EDCs are medical substances like ethinyl estradiol, the active ingredient used in hormonal birth control, but also include metals, pesticides, plasticizers, toxins such as polychlorinated biphenyls (PCBs), and naturally occurring phytoestrogens from plants like soy.

"Endocrine disruption is one adverse health effect of concern because it may occur as a result of exposure to very low levels of hormonally active chemicals,"[FN96: Dr. Robert Hirsch, Associate Director for Water USGS, Statement before the Committee on Environment and Public Works Subcommittee on Transportation Safety, Infrastructure Security and Water Quality, April 15, 2008.] and it can be caused by any one of the number of unnecessarily endocrine disrupting hormones being injected daily into factory raised animals. For example, beef cattle CAFOs frequently use the anabolic steroid androgen mimic, trebolone acetate, to promote the growth of muscle.

During degradation this steroid creates a product that is both stable in water and highly capable of binding to androgen receptors in fish.[FN97: See Durhan EJ, et al., Identification of metabolites of trebolone acetate in androgenic runoff from a beef feedlot, Environental Health Perspectives, 114 Suppl 1:65-8 (2006); See also, Hotchkiss, et al., Fifteen years after "W ingspread" - Env ironmental Endocrine Disruptors and human and wildlife health: W here are we today and where we need to go, Toxicological Science Advance Access published Feb 16, 2008.] Exposure to this compound causes the masculinization of female fish and results in reduced fertility at even low concentrations.[FN98: Id.] The result in fish is an indication of the results that can be felt in humans.ii. Cost-Benefit Analysis

The regulation of EDCs has many of the same costs and benefits as the regulation of therapeutic and non-therapeutic pharmaceuticals; however, Congress pointedly mandated the regulation of EDCs.

Additionally, children and pregnant women are particularly sensitive to EDC exposure. This is known because of the predictive signs of toxicity and abnormality displayed in effected wildlife. All vertebrates, including fish, amphibians, reptiles, birds, and mammals including humans, are fundamentally similar during early embryonic development.[FN99: Natural Resources Defense Council, Endocrine Disruptors (2008) at http://www.nrdc.org/health/effects/qendoc.asp#children\ (May 15, 2008).] Since EDCs affect the development of the body's vital organs and hormone system, developing fetuses, infants, and children are more vulnerable to exposure. Additionally, parents' exposure to certain EDCs may produce unexpected and tragic effects in their children, even decades after the exposure occurs.

Based on this analysis, EDC regulations must be implemented.

2. EPA Can Include These Contaminants In the Currently Proposed Regulations

Under the SDWA, "[t]he Administrator may make a determinations to regulate a contaminant that does not appear on a list under clause (i) if the determination to regulate is made pursuant to subclause (II)."[FN100: 42 USC § 300g-1(b)(1)(B)(ii)(III).] Under this language, EPA may chose to list a contaminant for regulation even if that contaminant was not proposed for public comment if the contaminant is determined to:

1. Have an adverse effect on the health of persons;2. Occur or there is a substantial likelihood that the

contaminant will occur in public water systems with frequency and at levels of public health concern; and

3. Regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.[FN101: 42 USC § 300g-1(b)(1)(A); See 42 USC §§ 300g-1(b)(1)(B)(ii)(II),(III).]

As we have shown above, PPCPs, including EDCs, meet these three points and, thus, should be regulated in the current listing process.

If EPA does not include PPCPs in this provision, it should promulgate an interim national primary drinking water regulation to address this "urgent threat" to public health.[FN102: 42 USC § 300g-1(b)(1)(D).] As the AP investigation, USGS studies, and other studies show, PPCPs in water present an urgent and growing threat to public water, and, as such, they should not continue being unregulated when such a feasible alternative exists.

III. CONCLUSION

The public has a right, in both knowledge and action, to clean drinking water. A valuable step for EPA to take in ensuring drinking water purity is to include pharmaceutical and personal care products discharged by municipal wastewater treatment plants and by industry, including confined animal feeding operations, in the NPDW R. At a bare minimum, PPCPs should be included in the unregulated contaminant monitoring rule to require public water systems to monitor for their presence in our drinking water and to identify in the consumer confidence reports the levels found in drinking water. W ith every glass of water we draw from our taps and bottle of water we open, we are unwittingly dosing ourselves with chronic levels of everything from Percocet to hormonal birth control to pesticides. EPA must act before another five years goes by.Thank you for your time and consideration.

Hannah Connor Staff Attorney

Janelle Robbins Staff Scientist

Waterkeeper Alliance 50 South Buckhout Street Suite 302 Irvington, New York 10533 t. 914.674.0622 f. 914.674.4560

hconnor@waterkeeper.org jrobbins@waterkeeper.org CS Title: 0131 Company/group/association name: Comment:

Julie E. Macedo Phone: 415.983.1590 Julie.macedo@pillsburylaw.com

May 21,2008

U.S. Environmental Protection Agency Via www.regulations.gov Docket ID No. EPA-HQ-OW-2007-1189

Re: City of Rialto's Comments on EPA's Draft Drinking Water Contaminant Candidate List 3Dear Gentlepersons:

Rialto appreciates the opportunity to provide comments on the draft "Drinking Water Contaminant Candidate List 3" ("CCL") released by the EPA on or about February 21, 2008. Rialto supports the listing of perchlorate on the CCL, and the ultimate regulation of perchlorate as a contaminant under the Safe Drinking Water Act.

No National Standard for Perchlorate Currently Exists

In July 2006, Massachusetts became the first state in the country to promulgate a drinking water standard for perchlorate of 2 parts per billion (see Massachusetts Department of Environmental Protection website at http://www.mass.gov/dep/water/drinkinglpercfs77.htm, a copy of which is enclosed for your convenience). Effective October 18, 2007, California adopted a maximum contaminant level (MCL) of 6 micrograms per liter (see California Department of Public Health website at http://www.cdph.ca.gov/certlic/drinkingwater/Pages/Perchlorate. aspx, a copy of which is enclosed for your convenience.) [See PDF for Attachments.]These regulations were promulgated after careful consideration of the potential adverse health effects perchlorate can have when ingested.[FNl: The California Governor's Office, the California Environmental Protection Agency and the Office of Environmental Health Hazard Assessment ("OEHHA") prepared the "Public Health Goal for Perchlorate in Drinking Water" in March 2004, which is publicly available through the OEHHA website and is incorporated herein by reference.] No national standard for perchlorate currently exists.

A National Standard for Perchlorate Is Necessary

The listing of perchlorate on the CCL is necessary as a step closer to a national standard for perchlorate. Perchlorate is found in fireworks, military munitions and other manufacturingprocesses, and the City of Rialto has spent more than four

years trying to force the parties responsible for the perchlorate contamination in Rialto to remove the perchlorate and provide an alternative source of uncontaminated drinking water. The contamination in Rialto is a result of more than 60 years of manufacturing of munitions, including those contracted for by the United States Department of Defense for World War II, fireworks and other explosive devices. There are likely hundreds of other sites around the country that are affected by perchlorate, and inclusion on the CCL would result in further study, investigation, and ultimately, clean up.

While California's adoption of an MCL for perchlorate is a step in the right direction, a remediation plan for the Rialto- Colton Basin (Rialto's source of its groundwater) has not yet been developed. The parties responsible for the contamination have significant financial assets which have been used to delay and oppose any ultimate adjudication of their liability. Public interest groups, such as Env ironment California and Center for Community Action and Environmental Justice were involved in prov iding public comment in an administrative proceeding against three suspected dischargers of perchlorate, but were forced to terminate their involvement due to the heavy financial burden. Listing of perchlorate on the CCL would result in further public comment, study of the health effects of perchlorate, and investigation into additional sites, probably many of which have not been used for decades. Under federal and state env ironmental laws, responsible parties must pay to remove and remediate the contamination their manufacturing operations caused. The lapse in time and current lack of regulation makes it easy for. the contamination to go unnoticed and the responsible parties to evade prosecution. Many of the sites across the country in which perchlorate is likely to be found are former industrial and/or military sites, which are often in disadvantaged neighborhoods. Placing the financial burden of providing clean, safe drinking water on the ratepayers rather than the parties responsible for the contamination is a fundamental injustice. In order to address this injustice, a national regulatory standard for perchlorate is needed.

Very truly yours,Julie E. Macedo,

Attorneys for City of Rialto, Rialto Utility Authority

Attachments CS Title: 0132 Company/group/association name: Comment:

RE: Comments for EPA Drinking Water contaminant Candidate List 3 - Draft

Thank you for accepting comments for the Drinking Water contaminant Candidate List 3 draft list. The City of Peoria, Arizona is a growing suburban city in the Phoenix metropolitan area. Peoria is active in a variety of water quality committees and organizations, including Arizona Water and Pollution Control (AW PCA), the Western Coalition of Arid States (W ESTCAS), the Water Systems Coordinating Council (WSCC), Environmental Laboratory Adv isory Committee (ELAC) and Multi- agency Laboratory Association (MALA). The City participates in these groups to be actively involved in promoting and developing scientifically sound laws, regulations and policies that protect public health and the env ironment on a Federal, State and Regional level.

The City of Peoria supports the use of sound scientific testing, yielding results which are accurate, reproducible and have appropriate quality control requirements consistent with current EPA methods. Therefore, any contaminant where methodology has not been rigorously tested to meet these requirements can yield inaccurate and invalid results. The City is concerned about pharmaceuticals, personal care products and Naegleria fowleri.

Personal care products and pharmaceuticals have received a great deal of press recently and have elevated the public's concern. However, these contaminants do not have EPApromulgated methods for testing. Therefore, it is prudent to

prov ide additional funding to ensure appropriate methods are developed which yield reliable, reproducible results. Upon promulgation of acceptable scientifically valid methods, utilities would be able to test various water supplies to

evaluate the prevalence of these analytes using data that would be comparable and be assured that appropriate Quality Control standards were applied. The City suggests that additional funding be prov ided to continue developing testing methodologies appropriate for these analytes.

Naegleria fowleri should be removed from the CCL 3 list. There is currently no promulgated method for identification of the organism in a water matrix. The organism's presence is typically only discovered post mortem. Due to two deaths in Arizona, staff members from the Arizona Department of Environmental Quality, Maricopa County Environmental Services, the University of Arizona and various Arizona water providers (including the City of Peoria) developed a coalition to study Naegleria fowleri.

After several years of testing, County and State regulators requested that a Naegleria fowleri Proposed Operational Practices be developed. The draft document includes maintaining chlorine residual within the distribution system and cleaning wells and reservoirs on a routine basis. It also includes screening for v iable organisms by plating the sample and observ ing the plate for the formation of amoebic plaques. Any plaque formation would trigger analysis of the plaque utilizing real time polymerase chain reaction methodology to evaluate the type of organism present.

At this time, the City suggests removing Naegleria fowleri from the contaminant list and funding additional research to

evaluate the proposed Operational Practices outlined above and to determine appropriate quality control to allow data to be confidently compared. CS Title: 0134 Company/group/association name: Comment:May 16, 2008

Water Docket U.S . Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Ave., NW . Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2007-1189, Draft CCL3

To W hom It May Concern:

Riverkeeper is a nonprofit, member-supported environmental organization dedicated to protecting the ecological integrity of the Hudson River, its tributaries, and the 2,000-square-mile New York City watershed, which provides unfiltered drinking water to more than 9 million consumers. As a signatory to the 1997 Watershed Memorandum of Agreement, Riverkeeper has a demonstrated interest in protecting the New York City watershed and its stakeholders from contaminants entering surface water supplies. Accordingly, we submit the following comments on EPA's Draft Contaminant Candidate List 3 (CCL3).

Research History Documents. Presence of Organic Wastewater Contaminants and Sodium Chloride in Drinking Water Supplies

In 2000, a USGS-sponsored survey of organic wastewater contaminants (OWCs) in U.S. streams included eleven sampling sites in the Croton watershed, which is part of the unfiltered New York City drinking water supply watershed. All except one of the sampled stream sites contained detectable levels of

seven steroid and hormone compounds; eight streams contained detectable levels of six selected antibiotic compounds and all eleven streams contained detectable levels of ten other selected human pharmaceutical compounds.[FN1: See D. KOLPIN, ET AL., WATER-QUALITY DATA FOR PHARMACEUTICALS, HORMONES, AND OTHER ORGANIC WASTEWATER CONTAMINANTS IN U.S. STREAMS,1999-2000 (2002), USGS Open-File Report 02-94, available at

http://toxics.usgs.gov/pubs/OFR-02-94/.]

In June 2006, the New York State Department of Health (NYSDOH) released its Pharmaceutical Project Report (Attachment I), which consistently detected pharmaceuticals in the effluent of four surface water-discharging wastewater treatment plants in the New York City watershed. [See PDF for Attachment] NYSDOH also detected pharmaceuticals in several New York City drinking water reservoir samples.

In December 2006, Riverkeeper submitted comments regarding the nomination process for EPA's CCL3. Because concentrations of any OWCs in water resources may be toxic to humans and aquatic life, and because the drinking water resources for nine million New Yorkers are contaminated with detectible concentrations of OWCs, our comments included the nomination of all 50 OWCs USGS found in U.S. streams (Attachment II). [See PDF for Attachment] In addition, because the long-term deposition of millions of tons of salt (sodium chloride) on impervious road surfaces has resulted in roadside habitat degradation, wildlife kills, drinking water quality impacts, and corrosion of automobiles and infrastructure, we also nominated sodium and chloride to the CCL3.

In February 2008, EPA released the Draft CCL3, which included 93 chemical compounds and 11 microbiological contaminants. The list included only one pharmaceutical compound (nitroglycerin) despite the aforementioned studies that detected pharmaceuticals in public drinking water supplies.

In March 2008, the Associated Press (AP) released the results of an independent study that detected a "vast array of pharmaceuticals...in the drinking water supplies of at least 41 million Americans."[FN2: See Jeff Donn, NYC: Traces of Sedatives in NYC Water, ASSOC. PRESS, March 9, 2008.] The study included samples of New York City's drinking water.

In April 2008, the U.S. Senate convened a hearing to addressEPA's failure to require monitoring for pharmaceuticals in

public drinking water supplies.[FN3: See Martha Mendoza, Senators Rip EPA Over Lack of Knowledge on Drugs in Drinking Water, MERCURY NEWS, April 15, 2008, available at http://www.mercurynews.com/healthandscience/ci_8935134.] Although EPA claimed to be "very concerned...[and] taking this

very seriously,"[FN4: See id.] these claims are belied by the agency's abject failure to include any pharmaceuticals other than nitroglycerin on the Draft CCL3. Instead, EPA is merely "seeking additional data and information on the concentrations of pharmaceuticals in finished or ambient water..."[FN5: See Drinking Water Contaminant Candidate List 3 -- Draft, 73 Fed. Reg. 9,652 (Feb. 21, 2008).]

The Draft CCL3 Should Promote the Precautionary Principle and Include Organic Wastewater Contaminants and Sodium Chloride

EPA's application of its complex methodology for evaluating and listing contaminants appears to be shortsighted. Although these contaminants are currently found in low concentrations, the cumulative effects of ingesting them daily pose a potentially significant threat to human health and the environment. Requiring a preexisting, significant cause-and-effect relationship between existing pharmaceutical concentrations in water supplies and existing env ironmental or human health impacts ignores known risks and dangerously delays additional study and, if needed, corrective action. This is the same type of bureaucratic inertia and circular logic that drove the bald eagle (Haliaeetus leucocephalus) to the brink of extinction when DDT was approved for widespread use despite its known toxicity in the environment.

Many studies have documented impacts to aquatic organisms when exposed to human pharmaceuticals, such as sex reversal in male American alligators[FN6: See B. LANCE AND M. BOGART, TAMOXIFEN SEX REVERSES ALLIGATOR EMBRYOS (1991), Cellular and Molecular Life Sciences, Vol. 47, No. 3, 263-266, available at http://www.springerlink.com/content/w644821311911312.] and wild fish populations,[FN7: See Karen A. KIDD, ET AL., Collapse of a Fish Population After Exposure to a Synthetic Estrogen, 104 PROC. NAT'L ACAD. SCI. 8897-8901 (May 22, 2007), available athttp://www.pnas.org/cgi/content/abstract/104/21/8897.]

resulting in a collapse of the latter. Researchers also have documented the occurrence of a synthetic human hormone, ethinyl estradiol, in surface waters at concentrations more than ten times higher than the LD50 for at least one fish species.[FN8: B. HALLING-SORENSEN, B., ET AL., OCCURRENCE, FATE AND EFFECTS OF PHARMACEUTICAL SUBSTANCES IN THE ENVIRONMENT - A REVIEW (1998), Chemosphere 36(2):357-393, Cited In: National Oceanic and Atmospheric Administration, National Centers for Coastal Ocean Science, Pharmaceuticals in the Environment,Information for Assessing Risk, available at http://www.chbr.noaa.gov/peiar/detail.aspx?substanceid=146.] However, such studies typically focus on the effect of a single pharmaceutical in isolation; few have examined the synergistic effects of pharmaceuticals in combination or their metabolites. Despite these and other studies over the past two decades, EPA has steadfastly refused to regulate or even require monitoring of pharmaceuticals that are known to have deleterious effects on aquatic organisms.

Rather than reactively list pharmaceuticals after their existing concentrations in water supplies are known to risk or have already impacted aquatic life and human health, EPA should act in accordance with the precautionary principle and proactively list all detected surface water pharmaceuticals before they cause health impacts. Contaminants should be removed from the list only after sound science has demonstrated that their concentrations occur at levels clearly demonstrated to be below health risk thresholds.

For the foregoing reasons, Riverkeeper incorporates by reference our December 11, 2006 comments on contaminant nominations to the CCL3 process (Attachment II) and we re- nominate all previously nominated OWCs, sodium and chloride for inclusion on the final CCL3. [See PDF for Attachment] We also urge EPA to re-examine its approach to identify and evaluate contaminants for inclusion on the CCL3 so that consumers of public water supplies are safeguarded against unnecessary ingestion of many potentially harmful pharmaceuticals.

Sincerely,William Wegner

Staff Scientist

Attachment CS Title: 0135 Company/group/association name: Comment:

May 26, 2008

CCL3 Comments Environmental Protection Agency Mail Code: 4607M 1200 Pennsylvania Ave., NW Washington, D.C. 20460

Re: Drinking Water Contaminant Candidate List 3 EPA-HQ-OW-2007-1189

The American Society for Microbiology (ASM) is submitting comments on the proposed microbial contaminants listed in the draft CCL 3 document. The following comments were developed by the ASM Public and Scientific Affairs Board Committee on Environmental Microbiology.

The ASM is the largest single life science society with more than 42,000 members, including scientists in academic, industrial, clinical, and government institutions, working in areas related to basic and applied research, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, the environment, and water and food safety.

In providing nominations for CCL 3 in 2006, the ASM strongly encouraged the EPA to develop and implement a systematic strategy and set of criteria to identify and review allpotential CCL organisms. Further, the ASM recommended that in

evaluating CCL organisms, the EPA should use a formal decision- making process that reflects both the objectives of the CCL and the Safe Drinking Water Act.

The ASM noted that a comprehensive strategy and set of

evaluation criteria could lead to inclusion of additional organisms of concern, for example, E. coli O157:H7 and various campylobacteria that did not meet CCL criteria. The ASM applauds the EPA for including these organisms as candidate contaminants, and for including its nominated candidate, Naegleria fowleri.

However, the ASM notes a number of concerns about the draft list. In particular, the use of the details regarding waterborne outbreaks and endemic diseases appear minimal and not to have been adequately incorporated or considered. Further, there appears not to have been adequate scrutiny of scientific papers addressing the occurrence of some of the candidate contaminants.

Vibrio cholerae occurs on the list as does Entamoeba histolytica, presumably due to recorded outbreaks. These outbreaks were limited to the Marshall Islands and a prison, respectively, and appear inappropriate for justifying inclusion of either organism on CCL 3. Cholera is not endemic in the mainland U.S., and the reported E. histolytica cases appear related to sexual transmission and not waterborne. The listing of these two organisms, along with Salmonella enterica and Shigella sonnei, raises questions about the extent to which CCL 3 is oriented to future and current needs and serving public health by addressing and placing appropriate weight on disease outbreaks.

The ASM is also concerned that the CCL 3 pathogen list does not have a strong science-based justification. The data on occurrence in water is very poor for all pathogens, and thus surrogates or other published work are needed. The EPA should examine endemic levels of disease for all enteric pathogens reported to HHS and CDC. A high endemic disease rate suggeststhat pathogens are being excreted in sewage, and thus

occurrence is probably higher than for Vibrio cholerae, which when detected is in marine or saline env ironment and most often lacks virulence factors.

The ASM is pleased to have this opportunity to prov ide comments on the draft CCL 3 list, and hopes that its comments and recommendations are of assistance.

Sincerely,

Ruth Berkelman, M.D. Chair, Public and Scientific Affairs Board

Gary King, Ph.D. Chair, Committee on Environmental Microbiology CS Title: 0136 Company/group/association name: Comment:

May 21, 2008

Via Mail : Docket ID No. EPA-HQ-OW-2007-1189

Water Docket U.S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: E.I. duPont de Nemours and Company Comments on EPA's Draft Drinking Water Contaminant List 3

To whom it may concern:E.I. duPont de Nemours and Company ("DuPont") appreciates the

opportunity to provide comments on the draft "Drinking Water Contaminant List 3" released by EPA on February 21, 2008 (EPA- HQ-OW-2007-118, FRL-8529-7). As the primary manufacturer of the chemical diuron (CAS 330-54-1), DuPont recommends that EPA remove diuron from the draft list for regulation as a contaminant under the Safe Drinking Water Act. DuPont will prov ide rationale for this recommendation based on current labeled use practices that reduced the risk of occurrence compared to the env ironmental release data reported for 2004 from the Toxic Release Inventory and the National Pesticide Use Database, developed by the National Center for Food and Agricultural Policy used for this draft determination. Due to the risk mitigation reqirements now required on all registrants labeling diuron end-use products from the September 30, 2003, EPA Reregistration Eligibility Decision for diuron, the current risk of occurrence is dramatically reduced from what the above 2004 data would conclude. These risk mitigation requirements include:

* Reduction of application rates and increased retreatment intervals between applications in numerous crops

* Elimination of aerial applications with some specific exceptions

* Implementation via labeling of best management practices to reduce spray drift

DuPont will submit a more detailed rationale to support this recommendation in the proceeding weeks that will include more discussion of the above current reduced risk of occurrence and other pertinent information.

Sincerely,Richard J. Ambrose

US Product Registration Manager DuPont Crop Protection CS Title: 0137 Company/group/association name: Comment:

May 21, 2008

Water Docket U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

RE: Docket ID # EPA-HQ-OW-2007-1189

Gentlemen:

The Pennsylvania Coal Association is the principle trade organization of Pennsylvania's bituminous coal producers. PCA represents both large and small companies, partnerships and individuals that produce over 75% of the bituminous coal annually mined in Pennsylvania. Our members produce bituminous coal by surface (open pit and auger) methods and by underground mining methods. Also, they operate coal preparation plants and engage in other coal mining activities for which they are required to meet water quality standards.

Our members would like to express their opposition to the addition of molybdenum (MO) as a parameter on a final list of contaminants that would be subject to proposed or promulgated national primary drinking water regulations under the Safe Drinking Water Act. MO is not a carcinogen (per your agency; nor is it listed in your "National Recommended Water Quality Criteria, 2006," as a toxic or non-priority pollutant.It is our understanding that, at least in Pennsylvania, the MO

standard is being proposed because of a discharge permitting

event for one (1) discharge in western Pennsylvania by a non- coal mining company, for which Pennsylvania DEP believed it was possible to amend the MO limit under current regulations. It is illogical and unnecessary to add nontoxic criteria for which there is no known technology for treatment to reduce its incidence to levels that may be required by both the Federal and state proposals.

Wealso would add our support for comments submitted by the National Mining Association (NMA), in which it concluded that there is insufficient data to conclude that cobalt, vanadium, strontium and germanium should, together with MO, be included on a final list of contaminants subject to primary drinking water regulations.

Thank you for considering PCA's comments.

Sincerely,

George Ellis, President Pennsylvania Coal Association

GE:sg CS Title: 0138 Company/group/association name: Comment:

NRDC Addendum to Comments on the Draft Drinking Water Contaminant Candidate List 3

Docket Number: EPA-HQ-OW-2007-1189 May 21, 2008

Pursuant to the Safe Drinking Water Act Amendments of 1996(SDWA), the U.S. Environmental Protection Agency (EPA) is

required to publish, every five years, a list of unregulated contaminants that are known or anticipated to occur in public water systems and may require regulation under the SDWA. The Agency then must make a decision about whether or not to regulate at least five of the contaminants on the list. EPA is on the third round of this process and has published a list of candidate contaminants, called the CCL3. The Natural Resources Defense Council (NRDC) submits the following additional comments to those submitted previously by NRDC on EPA's Draft CCL3.

These additional comments pertain specifically to cyanotoxins, chemical contaminants whose occurrence in drinking water is likely to increase as a result of projected climate change impacts on natural systems.

I. SUMMARY

NRDC additionally requests that EPA take the following actions concerning the Draft CCL3:

* Include cyanotoxins (no CAS # listed) in the CCL3. These chemicals are known to cause serious and occasionally fatal human liver, digestive, neurological, and skin diseases. Monitoring for these chemicals in water sources and drinking water is needed to fully assess their risks to human health and determine whether regulation is necessary.

* Address Vibrio cholerae, a microbial pathogen, in drinking water pursuant to the Safe Drinking Water Act (SDWA). This bacterium is known to cause outbreaks of cholera, an acute diarrheal illness caused by intestinal infection with the bacterium Vibrio cholerae, with serious and occasionally fatal human consequences. Monitoring for this pathogen in water sources and drinking water is needed to fully assess their risks to human health and determine whether regulation is necessary.II. DETAILED COMMENTS

EPA must regulate cyanotoxins, which are among the chemicals listed on the CCL3.

Cyanotoxins (3). NRDC urges EPA to include cyanotoxins (no CAS # listed) in the CCL3, in particular because these chemicals are produced by cyanobacterial species whose blooms are likely to expand further as a result of climate change. Climate change is a "potent catalyst" for the expansion of harmful cyanobacterial algal blooms in aquatic ecosystems [FN1: Paerl HW , Huisman J. 2008. Blooms like it hot. Science 320:57-58 (4 April 2008).]. Rising water temperatures and increasingly frequent extreme rainfall events can contribute to the growth of these blooms, which are caused primarily by inflows of nutrient-rich runoff, among cyanobacterial algae species. Alternating periods of drought and deluge, which are also associated with climate change, promote cyanobacterial blooms in a number of freshwater lakes. Warming water temperatures, increasingly frequent extreme rainfall events, and alternating periods of drought and deluge -each of which can favor the growth of cyanobacteria - are consistent with the climate changes projected across much of the U.S. in the coming decades.[FN2: Intergovernmental Panel on Climate Change (IPCC). 2007. Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change [Solomon S, Qin D, Manning M, Chen Z, Marquis M, Averyt KB, Tignor M, Miller HL (eds.)]. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA.; FN3: Confalonieri U, Menne B, Akhtar R, Ebi KL, Hauengue M, Kovats RS, Revich B, Woodward A. 2007. Human health (Chapter 8). Climate Change 2007: Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change, Parry ML, Canziani OF, Palutikof JP, van der Linden PJ, Hanson CE, Eds. Cambridge University Press, Cambridge, UK.] Ingestion of cyanotoxin- contaminated water can cause serious human illnesses, including neurological, liver, digestive, and skin diseases, as well as tumor promotion.[FN4: U.S. Centers for Disease Control and Prevention (US CDC). 2008. Env ironmental hazards and healthEffects - Facts about cyanobacteria and cyanobacterial harmful

algal blooms. Accessed May 21, 2008, available at: http://www.cdc.gov/hab/cyanobacteria/facts.htm#cyanotoxins.; FN5: Paerl and Huisman (2008).] An increase in occurrences of the cyanobacteria Microcystis in the Great Lakes in recent years, and associated exposures to the cyanotoxin microcystin in drinking water, has caused considerable concern[FN6: National Centers for Coastal Ocean Science, National Oceanic and Atmospheric Administration (NOAA), Silver Spring, MD. 2004. "Examine Environmental Regulation of Toxin Production by Cyanobacteria Capable of Disrupting Ecosystems and Endangering Drinking Water Supplies," available at: http://www8.nos.noaa.gov/nccos/npe/projectdetail.aspx?id= 385&fy=2004.]. Preliminary studies have documented the presence of microcystins in the Great Lakes, at times exceeding the recommended limit of 1 μg/L established by the World Health Organization for drinking water supplies.[FN7: Ibid.] This argues for the inclusion of cyanotoxins on the CCL3 list and for monitoring the distribution and concentration of these substances such as microcystin which have "demonstrated the potential to jeopardize human health and drinking water quality."[FN8: National Oceanic and Atmospheric Administration (NOAA). 2008. "Harmful Algal Blooms and Hypoxia in the Great Lakes Region," available at: http://www.cop.noaa.gov/stressors/extremeevents/hab/habhrca/GL_ fact_09-06.pdf.]

Vibrio cholerae. NRDC urges EPA to include Vibrio cholerae in the CCL3, in particular because the occurrence of this microbial pathogen is likely to expand further as a result of climate change.[FN9: Confalonieri et al. (2007).] Rising water temperatures and increased climate variability, which can result in higher stream flow rates, are projected to occur as climate change continues and "could favor conditions that increase the occurrence of V. cholerae in Chesapeake Bay."[FN10: Louis VR, Russek-Cohen E, Choopun N, Rivera ING, Gangle B, Jiang SC, Rubin A, Patz JA, Huq A, Colwell RR. 2003. Predictability of Vibrio cholerae in Chesapeake Bay. Appl Environ Microbiol 69(5):2773-2785.] The adverse health effects of cholera outbreaks can be devastating, with an estimated one in 20 infected persons developing "severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps"[FN11: U.S. Centers for Disease Control and Prevention (US CDC). 2008.Cholera. Accessed May 21, 2008, available at:

http://www.cdc.gov/nczved/dfbmd/disease_listing/cholera_gi.html .] which, without treatment, can prove rapidly fatal. Vibrio cholerae is a natural inhabitant of aquatic env ironments, and there is concern that as environmental changes associated with climate change continue, natural populations of V. cholerae may

serve as a "precursor for new pathogenic or epidemic strains"[FN12: Louis et al. (2003).] when ingested via inadequately treated drinking water or contaminated shellfish. Cholera cases from domestic source exposures continue to be reported in the U.S.,[FN13: U.S. Centers for Disease Control and Prevention (US CDC). 2008. "Cholera and Other Vibrio Illness Surveillance System (COVIS)," available at: http://www.cdc.gov/nationalsurveillance/cholera_v ibrio_surveill ance.html.] mostly from contaminated seafood, yet concerns about potential drinking water exposures under a changing climate argue for enhanced monitoring for these pathogens in water sources, to fully assess the risks they pose to human health.

III. RECOMMENDATIONS

Weurge EPA to add cyanotoxins to the CCL3. These contaminants meet EPA's criteria to be listed in CCL3. Their health effects are known and they are likely to occur in drinking water sources. Their occurrence is also likely to expand as climate change continues, which makes it appropriate to include them in the CCL3.

Wealso urge EPA to add Vibrio cholerae to the CCL3. This microbial pathogen meets EPA's criteria to be listed in CCL3. The adverse health effects of exposures to Vibrio cholerae are known and they are likely to occur in drinking water sources. Their occurrence is also likely to expand as climate change continues, which makes it appropriate to include this pathogen in the CCL3.

Finally, we recommend that the Agency act to promptly assess the risks associated with these and the other contaminants nominated to the CCL3 and take appropriate regulatory actionunder the SDWA to establish Maximum Contaminant Levels

(MCLs) as necessary.

Respectfully submitted,

/s/

Kim Knowlton, Dr.P.H. Scientist, Global Warming and Health Science Fellow Health and Env ironment Program Natural Resources Defense Council CS Title: 0140 Company/group/association name: Comment:

May 21, 2008

Water Docket, U. S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue NW Washington, DC 20460

Re: Docket ID No. EPA-HQ-OW-2007-1l89 [Federal Register: February 21, 2008 (Volume 73, Number 35)] [Notices] [Page 9627-9654]

Dear USEPA:

I am writing on behalf of Gelman Sciences, Inc., d/b/a Pall Life Sciences (PLS), in response to USEPA's request for public comments regarding the inclusion of the chemical 1,4-dioxane on the draft third Contaminant Candidate List (CCL3). PLS does not believe it would be appropriate or necessary to include 1,4- dioxane on the final CCL3 or to develop a "Maximum Contaminant Level" (MCL) for this compound given the potential for it topose a public health concern and its potential to occur in

public water systems.

USEPA is currently updating the 1,4-dioxane Integrated Risk Information System (IRIS) risk assessment. The updated assessment is expected to provide more scientifically defensible toxicity values since they will have been developed using a larger body of toxicological studies and using updated approaches. Based on USEPA's IRIS Track system, the assessment is expected to be final by March 13, 2009. We urge you not to include 1,4-dioxane on the CCL3 list until this assessment can be updated to be consistent with the most recent federal guidance and the results of the ongoing IRIS assessment are

available for consideration. Should USEPA identify 1,4-dioxane for MCL development, the updated toxicity values should be used rather than the older values referenced in the current documentation regarding why 1,4-dioxane was included on the draft CCL3 list.

Weare also prov iding additional information regarding the prevalence of 1,4-dioxane in public water supplies that USEPA may not be aware of. Michigan's Department of Environmental Quality (MDEQ) conducted a vulnerability assessment of its public drinking water supplies in 2004 regarding 1,4-dioxane. The MDEQ sampled approximately 50 public water supplies in Michigan, 25 of which were selected randomly. The remaining 25 were targeted based on prev ious detections of chemicals commonly associated with 1,4-dioxane (primarily other chlorinated solvents). The results of this targeted survey are attached [See PDF for attachments]. Only one operating public water supply had detectable levels of 1,4-dioxane present in its water, between 3 and 5 parts per billion (ppb). The Ann Arbor Montgomery Well referenced in the attached summary as hav ing 3 ppb of 1,4- dioxane, was taken out of service in April 2001 and, therefore, was not in operation when sampled. Based in part on the results of this assessment, the MDEQ decided that not to promulgate an MCL for 1,4-dioxane under the State's

version of the Safe Drinking Water Act. USEPA may contact Brock Howard from the MDEQ if additional information regarding Michigan's vulnerability assessment is desired. ((517) 335-4101); HOWARDB1@michigan.gov).Given the pending IRIS reassessment and the available evidence

that 1,4-dioxane is not a prevalent contaminant in public drinking water supplies, we suggest that it would be inappropriate and unnecessary to develop a MCL for 1,4-dioxane at this time. Thank you for your consideration of these comments.

Very truly yours,

ZAUSMER, KAUFMAN, AUGUST, CALDW ELL & TAYLER, P.C.

Michael L. Caldwell

MLC:hlr Enclosures cc: Farsad Fotouhi, PLS CS Title: 0141 Company/group/association name: Comment:

May 21, 2008

Docket ID No. EPA-HQ-OW-2007-1189 Environmental Protection Agency Mail Code : 2822T 1200 Pennsylvania Ave., NW . Washington, DC 20460

Re : Contaminant Candidate List 3 (CCL3)

To W hom it May Concern:

In response to the notice in the Federal Register of February21, 2008 (Volume 73, Number 35) I am offering comments on the

draft third Contaminant Candidate List (CCL3). In December 2006, we provided the US Environmental Protection Agency (EPA) our nominations to the CCL3 "universe" as solicited in the publication in the Federal Register Vol. 71, Number 199, October 16, 2006. Our approach for nominating compounds to the universe was to identify groups of chemicals that pose a concern for water supplies from an exposure and/or health perspective.

Subsequent to prov iding our comment letter we were nominated by the Association State Drinking Water Administrators (ASDWA) to serve on an expert panel convened by US EPA. The panel reviewed the methodology applied to select the CCL3 from the universe of potential contaminants. EPA has greatly improved its methodology compared to other CCLs and we commend EPA for this effort.

The groups of compounds that we identified in our December 2006 letter (attached) to be in the universe were disinfection by- products (DBPs), oxygenates, pharmaceuticals and personal care products (PPCPs), herbicides and solvent stabilizers. [See PDF for Attachment] We are pleased to see that representatives from these groups were present in the CCL3 and that several of the specific contaminants we described including but not limited to 1,4- dioxane, alachor ethanesulfonic acid, and methyl tertiary- butyl ether (MTBE) are listed.

Although the CCL3 list only has one PPCP listed, we are aware that the EPA is sensitive to the public demand for more work to understand the fate and transport of these chemicals. We think including more PPCPs on the CCL3 is not justified based on the information at this time, although more information is needed to evaluate their importance as a drinking water issue. We think EPA should continue to move forward with the CCL3 as proposed. If new information becomes available that changes the results from use of your evaluation methodology, then this information should be used in creating CCL4.

If you would like any more information please feel free to contact either Lloyd W ilson Ph.D., of my staff or me at518-402-7650.

Sincerely,

Victor E. Pisani Director Bureau of Water Supply Protection

cc: N. Kim, Ph.D. R. Svenson, P.E. J. Dunn, P.E. L. W ilson, Ph.D D. Luttinger, Ph.D. J. Storm, Ph .D. S. Stoner, DEC CS Title: 0142 Company/group/association name: Comment:

May 20, 2008

Water Docket, US Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW ., Washington, DC 20460.

RE: Docket In No. EPA-HQ-OW-2007-1189-Drinking Water Contaminant Candidate List 3--Draft

To The Docket:

The Massachusetts Department of Environmental Protection (MassDEP) is responding to the opportunity for comment on the Drinking Water Contaminant Candidate List (CCL) 3 published February 21, 2008 in the Federal Register (FR Volume 73, Number 35, Page 9627-9654). The chemicals listed in the final list are not presently regulated in drinking water and have beenidentified as potential candidates for regulation in public

water supplies under the Safe Drinking Water Act.

Given the objectives of the CCL and the large number of presently unregulated chemicals, EPA is to be commended for developing a comprehensive and ordered approach for identifying these chemicals.

Several chemicals on the CCL 3 list have been of interest to our Drinking Water Program for some time: MTBE, perchlorate, RDX, 1,4-dioxane and NDMA. More recently, we, like many others, have been paying attention to newly developing information on PFOA. We would welcome federal guidance on them and look forward to having access to additional data that will be generated as part of a national reconnaissance study which could be used to support and update the current regulatory standards.

Closely linked to the MTBE issue, but notably missing from the CCL 3 list are two other compounds: tertiary butyl alcohol (TBA, CAS No. 75650) and tertiary-amyl methyl ether (TAME, CAS No. 994058). TBA is a breakdown product of MTBE in groundwater. Both TBA and TAME have also been used as gasoline octane enhancers. We have found both associated with MTBE at many gasoline release sites in Massachusetts. In the absence of federal guidance on these two compounds, Massachusetts has identified drinking water guidelines for use in the state.

MassDEP has devoted significant resources to address issues associated with contaminants of emerging concern, with special emphasis on pharmaceuticals/personal care prodncts (PPCP) and endocrine disrupting chemicals (EDC). W ith the recent scientific and popular interest in understanding the potential effects of these classes of compounds to the environment, including the potential for contaminating source water and drinking water, MassDEP recommends that PPCPs and EDCs be included in this round.

Nitrogen-containing disinfection by-products are another classof emerging, unregulated contaminants that should be part of

the CCL; for example, haloacetonitriles and halogenated nitro- methanes[FN1: Zwiener, C. et al. 2007, Water, Env . Sci. Technol., 41(2) 363-372; and Muellner, M.G. et al., 2007, Env. Sci. Technol., 41(2) 645-651.].

Wefeel that it is important also to comment on the CCL process in the wider context of the US EPA's efforts to address chemicals in drinking water. MassDEP finds fault with EPA for devoting resources to the generation of the CCL 3 list which could otherwise have been used more profitably to address those chemicals already known to be problematic. The CCL exercise leads to a need to derive guidance and possibly standards for more chemicals. This process has taken place during a time when the agency and administration have shown to the public that it cannot complete the work in producing guidance it already has in hand.

The identification of several high-profile chemicals through the the CCL process merely validates what many of the states have collectively been telling EPA for years: these chemicals have contaminated water in the states, and the states need both toxicological guidance and standards for these chemicals in order to limit exposures, provide goals for remediation and to protect public health. EPA's failures to provide timely guidance have been putting public health at unnecessary risk.

For example, states have been adv ising EPA at many annual meetings of the Federal State Toxicology and Risk Assessment Committee (FSTRAC) of their needs for federal guidance on MTBE and perchlorate; beginning significantly well prior to the completion of the CCL 2 list (2005) which listed both of these chemicals. Both are also on the CCL 3 list.

Once it was recognized that MTBE presence was widespread in groundwater at least 8-10 years ago, states urged EPA to issue toxicological guidance to help them deal with this issue. EPA chose to issue a hybrid piece of guidance termed the MTBE "Drinking Water Health Advisory" which many state government toxicologists and public health specialists v iew as not trulyaddressing the need for health-based guidance. W hile EPA has

continued to work on the toxicology of this chemical internally in the intervening years, they have failed to share their interpretations of the underlying toxicology of this compound with states even after direct requests to do so. To do so would have prov ided state toxicologists with insight into the thinking of EPA's many excellent scientists who have been working on this compound, enabling state staffs at a minimum to issue their own guidance based on some of the best science and interpretations available.

Perchlorate is another example of EPA's inability to put forth timely guidance in response to state's needs for such information. California was the first to recognize and inform EPA of the scope of perchlorate problems in its state in the l990s. Once Massachusetts recognized that it had perchlorate contamination problems, it too pressed EPA for timely guidance. EPA undertook early comprehensive reviews of the toxicology of this compound (2002) well in advance of the appearance of perchlorate on the CCL list. EPA's assessment then went through a lengthy review process culminating in the publication of an oral reference dose 20-fold less stringent than the Agency originally proposed in 2002. This value has not been critically accepted by the states, including ours.[FN2: Ginsberg G, Rice D. 2005. Environ Health Perspect 113(9):1117-9.] EPA has also notably not yet developed a drinking water standard for perchlorate.

In the absence of federal action to expeditiously identify and promulgate national drinking water standards for perchlorate and MTBE over the last at least 6-8 years, MassDEP has established a Massachusetts Maximum Contaminant Level (MMCL) for perchlorate and a MassDEP Office of Research and Standards Guideline (ORSG) for MTBE.

To many of those charged with protecting public health through drinking water regulation, EPA and the administration have demonstrated an institutional problem generating timely drinking water guidance and standards. This problem is not limited to the drinking water area, as EPA has also been embarassingly slow to process guidance for inhalationexposures; most notably and recently with tetrachloroethylene.

This serious shortcoming of the process needs to be addressed before a program such as the CCL 3 can be effective.

Thank you for the opportunity to comment.

Sincerely yours,

Michael S. Hutcheson, PhD, MPH Head, Air and Water Toxics Section Office of Research and Standards CS Title: 0145 Company/group/association name: Comment:

May 21, 2008

Water Docket Docket ID No. EPA-HQ-OW-2007-1189 Environmental Protection Agency Mail Code: 2822 T 1200 Pennsylvania Ave., NW . Washington, DC 20460

To W hom It May Concern:

In response to the draft notice in the Federal Register of February 21, 2008 (Volume 73, Number 35), the California Department of Public Health would like to officer comments on the Drinking Water Contaminant Candidate List 3 (CCL3).

* Need to Consider Synergistic Effects: California believes the current process has serious limitations because contaminants are typically, considered individually and not in mixtures. The health effects information from the Food and Drug Administration database on Maximum Recommended Daily Doses (MRDD) is derived based on the effects of single compounds. When in actuality, the compounds exist as mixtures in the

env ironment. EPA should endeavor to address the cumulative-and synergistic effects of these compounds as well. As there may besynergistic effects, and resources are limited to properly

evaluate the infinite numbers of contaminant combinations that are possible, there is a need to minimize the number of contaminants and their concentrations in water supplies through a source water assessment approach.

* Comments on Pharmaceuticals and Personal Care Products: It is appropriate to add pharmaceuticals and personal care products (PPCPs) to the current and future CCL lists only as enough information becomes available to warrant consideration of these chemicals for possible regulation. We collectively need to

avoid the "knee-jerk" reaction of calling for regulation of specific chemicals in response to media attention and instead, should continue to resolve that regulations be based on sound science. We urge EPA to continue to carefully evaluate

available health effect information on contaminants of concern. Pharmaceuticals, in particular, have a voluminous amount of data on health effects available as a result of FDA requirements associated with the use of these compounds. As a goal, it would be ideal to have none of these contaminants in the drinking water but practicaliy, this is impossible. Thus, we should be guided by the premise that, if there is no observable health effect at levels found in drinking water (with an adequate margin of safety), then EPA should not set a standard. Resources could be better spent trying to prevent or minimize the amount of PPCPs that get into water sources in the first place.

Nonetheless, public and legislative concern over pharmaceuticals and personal care products is not going away. EPA and the drinking water community need to get out ahead of the issue to avoid mandates from Congress prescribing a specific regulatory schedule. EPA should carefully review the data already evaluated in the CCL3 process and any new data reported in response to the February 21, 2008 Federal Register Notice to identify any contaminants in this group that could prov ide a meaningful opportunity for health risk reduction. If there is insufficient data on any of the PPCPs to warrant their inclusion on the CCL3, EPA needs to identify these as candidates for additional study and include them in a future Unregulated Contaminant Monitoring Regulation.

California would also like to emphasize the importance of EPA carrying out studies on the possible health effects, if any, oflow concentration of the pharmaceuticals that are being

detected in water sources. We know a lot about therapeutic levels from FDA, but the levels are generally significantly higher than the levels that are seen in water sources.

The presence of pharmaceuticals in drinking water supplies is an indication that protection of water supplies needs more attention, as does public education about the proper disposal of drugs.

- Comments on Specific Contaminantsfor CCL4 (and beyond):

* Contaminants Warranting Further Analysis - Highly Prescribed Drugs : Water reuse is becoming an increasingly important tool as water systems stretch their water resources to meet growing demand. California wants to make sure EPA considers the most highly prescribed drugs and over the counter sales leaders for future health effects and occurrence study. We do not have sufficient information about these contaminants to categorically recommend that they appear on CCL3, but ask that EPA consider developing occurrence data for these contaminants through a future Unregulated Contaminant Monitoring Regulation.

~ ACE inhibitors such as Lisinopril, Enalipril

~ Anti-anxiety such as Aprazolam, Lorazepam, Diazepam

~ Antiarrythmics such as Digoxin

~ Antibiotics such as Amoxicillin, erythromycin

~ Anticoagulants such as Clopidogrel, warfarin

~ Anticonvulsants such as Gabapentin, carbamazepine, primidone

~ Antidepressants such as sertraline, Escitalopram, fluoxetine, meta

~ Antihistamines such as pheniramine, bromopheniramine, chloropheniramine, clemastine, doxylamine, diphenylhydramine, triprolidine

~ Antihypertensives such as clonidine~ Antiosteoporietics such as alandronate, risedronate

~ Antiulcer drugs such as esomeprazole, lansoprazole, pantoprazole

~ Bronchodilators such as albuterol, salmeterol

~ Corticosteroids such Prednisone, fluticasone proprionate, mometasone furoate,triamcinolone

~ Decongestants such as oxmetazoline, pseudoephredrine, xylometazoline, phenyipropylamine

~ Antiulcer (H-2 receptor antagonists) such as Ranatidine, cimetidine, famotidine, nizatidine

~ Expectorants such as guaifenesi n

~ Glucocorticiods such as hydrocortisone

~ Antifungals such as haloprogin, miconazole, clotrimazole, butaconazole, tioconazole, terbinafine

~ Antismoking aids such as nicotine, continine

* Contaminants Warranting Further Analysis--Genotoxic Compounds: Genotoxic carcinogens, pharmaceuticals that are used for patients who, without the treatment would die, but are considered carcinogenic. W hile providing a benefit, they obv iously may pose a health risk. These compounds should be considered for further examination.

~ Flutamide

~ Methotrexate

~ Carboplatin

~ Ifosfamide

~ Megestrol

~ Cyclophosphamide

~ Bleomycin Al~ Topotecan

~ Cisplatin

~ Mitomycin

~ Fluorouracil

~ Docetaxel

~ Mephalan

~ Cyclosporine

~ Procarbazine HCI

~ Mercaptopurine

~ Busulfan

~ Epirubicin

Thank you for your consideration of these comments . Please contact me at (916) 449-5577 if we may provide additional information or if any clarification of these comments are needed .

Sincerely, Gary Yamam to, Assistant Chief Division of Drinking Water and Environmental Management

cc: Rufus B. Howell, Chief California Department of Public Health Division of Drinking Water and Environmental Management

Leah Walker California Department of Public Health Division of Drinking Water and Environmental Management

Carl Lischeske California Department of Public HealthDivision of Drinking Water and Environmental Management

Cindy Forbes California Department of Public Healt h Division of Drinking Water and Environmental Management

CS Title: 0100 Company/group/association name: Comment:

May 21, 2008

U.S. Environmental Protection Agency Docket ID No. EPA-HQ-OW-2007-1189 Office of Groundwater and Drinking Water (OGW DW ) Mail code: 2822T 1200 Pennsylvania Ave. NW Washington, DC 20460

RE: Drinking Water Contaminant Candidate List 3--Draft

Dear Docket:

Enclosed are the comments of the American Water Works Association (AWWA) on the draft Contaminant Candidate List 3 (CCL3) as published in the February 21st Federal Register. The Contaminant Candidate List is the starting point and the foundation for the Environmental Protection Agency's (EPA's) drinking water standard-setting process. AWWA appreciates the opportunity to comment on this critical starting point of the standard-setting process, and we have several significant comments that we feel should be addressed in the final CCL3.

If you have any questions about these comments, please feel free to contact me or Alan Roberson in our Washington Office.

Yours Sincerely,Thomas W . Curtis

Deputy Executive Director

cc: Ben Grumbles-USEPA OW George Gray-USEPA ORD Audrey Lev ine-USEPA ORD Brian Mannix-USEPA OPEI Cynthia Dougherty-USEPA OGW DW Alan Roberson

COMMENTS BY THE AMERICAN WATER WORKS ASSOCIATION ON THE DRAFT DRINKING WATER CONTAMINANT CANDIDATE LIST 3 (CCL3)

Executive Summary

The American Water Works Association (AWWA) is providing detailed comments on the draft CCL3 as published in the February 21st 2008 Federal Register (73 FR 9628). The following

overview summarizes the central issues we address in our comments:

* AWWA and the Environmental Protection Agency (EPA) should continue to rely on a science-driven CCL process to identify potential candidates for new drinking water regulations;

* AWWA commends EPA for the substantial effort and increased scientific rigor applied to developing the draft CCL3;

* AWWA also commends EPA for its implementation of the contaminant nominations process and for its involvement with stakeholders, but both processes need significant improvements.AWWA

recommends increased stakeholder engagement for future CCLs.

AWWA recommends the following:

* In the final CCL3, EPA should clearly state the purpose of the CCL, and develop criteria for evaluating the effectiveness of future CCLs in meeting the drinking water program's goals;

* EPA must critically assess the suitability of the current CCL process for identifying potential regulatory needs for Disinfection By-Products (DBPs);

* The Agency should develop an integrated research agenda for CCL3 and other drinking water issues in a timely manner, beginning with an examination of the health effects data and identification of significant gaps in health effects data;

* The number of contaminants on the final CCL3 should be commensurate with what can be supported with EPA's drinking water research program; and

* EPA should work with states, water and wastewater utilities, the agricultural community, and the chemical and manufacturing industries to minimize source water contamination.

AWWA independently developed processes for screening and prioritizing chemical contaminants and for listing priority microbial contaminants. For chemical contaminants, this process used space diagrams to visually summarize a large quantity of diverse data. For microbial contaminants, based on our process, AWWA recommends the addition of human enteroviruses, Mycobacterium avium, and rotavirus to the final CCL3. AWWA also recommends the removal of Entamoeba histolytica, Heliobacter pylori, Naegleria fowleri, Salmonella spp., Shigella spp., andVibrio cholerae from the final CCL3.

AWWA would like to work with EPA to integrate our approaches into the approach used by EPA, and believes that our approach increase transparency and ensures that data quality is appropriately considered in the development of the final CCL3.

Introduction

The American Water Works Association (AWWA) 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,

env ironmental 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.

AWWA appreciates the opportunity to comment on the draft CCL3 as published in the February 21st 2008 Federal Register (73 FR 9628). The CCL is the foundation for the standard-setting process mandated in the 1996 Safe Drinking Water Act (SDWA) Amendments. A robust, science-drive regulatory development process is the best means for protecting public health while at the same time, ensuring responsible and appropriate allocation of public resources.

I. General Comments

Science-Driven Process

AWWA and the Environmental Protection Agency (EPA) should continue to rely on a science-driven CCL process to identifypotential candidates for new drinking water regulations.

Section 1412(b)(1)(A) of the 1996 Safe Drinking Water Act (SDWA) lists three criteria for listing of contaminants for consideration for potential national drinking water regulations:

1. The contaminant may have an adverse health effect;

2. The contaminant occurs, or is likely to occur, at a level and frequency of public health concern;

3. A national regulation provides a meaningful opportunity for health risk reduction.

This past two CCL processes can be summarized as follows:

* In 1998, EPA listed 60 contaminants on the first CCL (CCL1), and in 2003, determined, based on the above criteria, that 9 of these contaminants did not need to be regulated (EPA, 1998, 2003);

* In 2005, EPA listed the 51 remaining CCL1 contaminants on the second CCL (CCL2), and in 2007, proposed not regulating 11 of these contaminants based on the same criteria (EPA, 2005, 2007). For example, five CCL1 contaminants were undetected in the first Unregulated Contaminant Monitoring Rule (UCMR1), which included monitoring by over 3,300 public water systems (Roberson, 2005).

The best available, peer-rev iewed science must remain the foundation for the development of national drinking water regulations. As clearly articulated in the above SDWA criteria, occurrence of a particular contaminant in water does not, in and of itself, justify national regulation. This becomes increasingly important to recognize as continuously improving analytical technology leads to ever lower detection limits and consequently, greater numbers of contaminants being found.National drinking water regulations should not be driven by the

"contaminant du jour."

Endocrine disruptors and pharmaceuticals have both gotten increased levels of publicity over the past few years. Based on the mandates in the Food Quality Protection Act (FQPA) and the SDWA, EPA is in the process implementing the Endocrine Disruptor Screening Program (EDSP) to screen and test potential endocrine disruptors. Admittedly, it has taken several years to systematically organize the screening and testing processes, and to develop appropriate analytical methods. But the analytical methods issues have been resolved, and AWWA believes that EPA should be allowed to complete the implementation of the EDSP, and then take the appropriate regulatory actions.

AWWA does not have any additional occurrence data on pharmaceuticals as requested in the February 21st Federal Register. Again, AWWA believes that EPA should be allowed to look at pharmaceuticals with the same scientific rigor as any other potential CCL contaminant. In fact, EPA included 287 pharmaceuticals in the CCL Universe (p. 9652). Again, improved analytical methods should not be the driver for national drinking water regulations. In April 15th testimony to the Senate Subcommittee on Transportation Safety, Infrastructure Security, and Water Quality, Dr. Shane Snyder of the Southern Nevada Water Authority, a national leader in research on trace contaminants in water, stated "If our study had been constrained to find these compounds at parts-per-billion levels instead of delving into the parts-per-trillion range, none of them -not a single one- would have been found."

The public health significance of contaminant occurrence data, and thus any potential needs for regulatory controls, cannot be ascertained without the scientific context of health effects information. The SDWA's contaminant listing criteria recognizes this need for integration of occurrence and health effects information. Dr. Snyder's testimony addressed this in a rhetorical question, "Are we going to make decisions based upon our ability to find contaminants, or based on protection of public health?" To date, health effects research has not been able to keep pace with rapid advances in detectioncapabilities. Clearly, more research is needed before

sciencebased decisions on many trace contaminants can be made. More detailed comments on drinking water research needs and implementation of that research follow.

Increased Scientific Rigor

AWWA commends EPA for the substantial effort and increased scientific rigor applied to developing the draft CCL3. CCL1 was developed through an expert process, using the best available data to meet a statutory deadline. CCL2 simply carried over the remaining CCL1 contaminants after the first 9 regulatory determinations were made in 2003. The draft CCL3 represents an

overhaul of the approach, an unprecedented effort from EPA to access and evaluate a vast amount of data on potential drinking water contaminants, and a reproducible and largely transparent process amenable to continuous improvement through adaptive management. This initiative followed upon recommendations from the National Research Council (NRC) and the National Drinking Water Advisory Council (NDWAC), from whom EPA solicited guidance. AWWA

applauds EPA for soliciting such outside expert opinion, and for stepping up to the arduous task of implementing these recommendations. The result has been a more rigorous scientific approach for CCL3 with capacity for further refinement as needed. AWWA believes that inclusion of additional expert review panels in the draft CCL3 development process was a critical element of the approach and commends EPA for incorporating a portion of their input.

AWWA recognizes and appreciates the magnitude of EPA's effort in developing the draft CCL3, including the considerable work involved in providing transparency to the overall process. AWWA has identified a few areas in these comments where additional transparency is needed. The first case would seem to involve minimal effort on the Agency's part by adding of a second row to the attribute score summary table found at the top right of chemical dossier pages. This new row would characterize the data tier level associated with the particular data element on which each attribute score was based. Additional comments concerning issues of transparency are included in the sections below on nominations (access to dossiers), on backgrounddocumentation in the docket, and on DBPs.

Nominations

AWWA commends EPA for its past nominations process, but significant improvements are necessary for future nominations. AWWA nominated 21 chemicals and 13 pathogens in December 2006. Given the short comment period (60-days) and the limited

available data at that time, it is not surprising that most of AWWA's nominations did not end up on the draft CCL3. As stated in the draft CCL Federal Register notice, most of the nominated contaminants (152 out of 172) were already under Agency consideration. The support document, Summary of Nominations for the Third Contaminant Candidate List provides considerable information about nominations but it's not always clear why particular contaminants did or did not advance to the PCCL or the draft CCL3. AWWA recommends that this document be enhanced to clarify the specific data-basis for the decisions to list or not list all of the nominations.

Nominations are a central component of stakeholder participation in CCL development. In our 2006 nominations, AWWA recommended "...the nomination process should occur in tandem with, or preferably after, the publications of future draft CCLs so that the nomination process would allow AWWA and other drinking water stakeholders to make nominations for contaminants that may have been missed for one reason or another by the EPA process". Based on our analysis of the draft CCL3 and the associated documentation, AWWA now recommends that the nominations occur between the future Preliminary Contaminant Candidate Lists (PCCLs) and the future draft CCLs, as long as the PCCL dossiers are made publicly available as discussed below. This timing allows the nominated contaminants to go through the same screening/scoring processes as every other PCCL contaminant that is considered to be listed on future draft CCLs. EPA would have difficulties in comparing nominated candidates to the future draft CCLs after the screening/scoring is completed.

AWWA's second major issue with the 2006 nominations could besolved with the release of the Preliminary Contaminant

Candidate List (PCCL) dossiers to the public as part of the request for nominations for future CCLs. This release would

serve three purposes:

1. The dossiers could assist in increasing the scientific rigor of the nominations.

2. Due to a longer timeframe between the nominations and the draft CCL, the PCCL itself and the dossiers could then be assessed with some rigor to better understand the health effects and occurrence data used in the PCCL/CCL process.

3. The PCCL can then be used as one of the tools to develop research priorities, both at a national level with EPA, CDC, USGS, AwwARF, and others, and at the local level though utility research.

Stakeholder Involvement

AWWA commends EPA for its past stakeholder efforts and recommends increased stakeholder engagement for future CCLs. AWWA members participated in both the NRC and NDWAC efforts. EPA and other drinking water stakeholders participated in the AWWA CCL workshop in Scituate in the summer of 2005. Some AWWA members also participated in EPA's expert review panels; however, these expert panels were not typically open to the public so some elements of the CCL3 development process remain obscure to stakeholders. Experts participating in these rev iew panels were under strict instructions to not talk about the proceedings.

AWWA recommends that EPA consider additional options for both increased transparency to stakeholders and stakeholder engagement in future CCLs. The CCL docket is an example where the Agency's current approach to publishing dockets on www.regulations.gov . does not contribute to transparency. The CCL3 docket is limited to a number of static documents that aresupposed to be read in their entirety (several hundred pages)

within the 90-day comment period. Reading these static documents does not explain what key decisions and post-hoc analyses actually shaped the decision-making process on whether to list or not list. The documents present the underlying data in formats that are not searchable, not easily understood, and are unusable for future analyses by the public, certainly within the brief comment period.

The proposed Integrated Risk Information System (IRIS) Dialogue Group provides a good model for how an expanded stakeholder effort could work. W hether this would be a "formal" EPA body, either as a subcommittee of the NDWAC or Board of Scientific Counselors (BOSC) or otherwise, or more of an informal body, is less important than there being an open pathway for ongoing dialogue between EPA and the "customers" of the CCL (utilities, consulting engineers, state regulatory agencies, academics,

env ironmental advocates, etc.).

This approach would remedy the "stop-and-start" characteristic of past CCL stakeholder involvement, affording better opportunities to identify and share available data and expertise on specific contaminants. As recommended by the NDWAC, CCL development, and stakeholder involvement should be an ongoing process, not a once-every-five-year event. AWWA recommends that EPA dedicate a portion of its website towards access to the CCL, the underlying data and database, and progress reports in resolving data gaps.

AWWA has begun planning an informal stakeholder effort for late 2008 to begin discussions on incentives/disincentives for emerging contaminant monitoring. The potential impacts to future utility monitoring from the recent story on pharmaceuticals in drinking water by the Associated Press and other media outlets is not clear at this time. Some utilities are focusing their efforts on better public affairs and risk communications, while others are concerned about conducting any monitoring at all due to the potential to be asked for that data in the future and any other associated reporting/notification issues. This is a conundrum that is not easily solved, and AWWA is planning a short series ofconference calls with a limited number of stakeholders from

utilities, environmental advocates, pharmaceutical manufacturers, and state regulators to identify the major issues with monitoring for emerging contaminants. W hat should be done about those major issues may required broader and more significant stakeholder effort over a few years.

Purpose of the CCL

AWWA recommends that EPA clearly state the purpose of the CCL in the final CCL3. AWWA's understands that the CCL serves multiple roles, being the starting point or foundation for the process for developing drinking water regulations as well as a mechanism to help prioritize research needs. It is important for the drinking water community that EPA clearly articulate its central objectives in the final CCL3. Because of the inextricable dependency of the CCL process on research data, which has become more transparent through the data mining activities underpinning the current effort, identification of research needs is clearly a natural outgrowth of the CCL process.

The current ambiguity about research prioritization leads AWWA to wonder if the focus of the CCL process has changed since CCL1. W hile the mandate of the CCL remains the same, implementation of the process appears to have shifted toward regulatory determinations. Such a shift is acceptable as long as it is clearly articulated in the final CCL3, and it appears that developing the overall research agenda is now a lower priority for the draft CCL3.

Criteria for Success for Future CCLs

AWWA recommends that EPA develop criteria for evaluating the effectiveness of future CCLs in meeting the drinking water program's goals. EPA's ongoing work on developing performance indicators for two drinking water regulations (Arsenic and the Long-Term 2 Enhanced Surface Water Treatment Rule [LT2ESWTR]) is a small step in the right direction. More work is needed todevelop performance indicators for the entire SDWA regulatory

program and future CCLs should be included in this effort.

AWWA suggests the following categories and considerations for CCL success measures:

1. Systematic process

2. Process allows EPA to make timely regulatory determinations

3. Public health protection achieved with meaningful risk reduction

4. Consumer confidence in public drinking water systems

5. Has any retrospective study been conducted to assess the relative risk reduction (lives saved, cancer endpoints avoided, etc.) achieved by existing drinking water regulations?

6. Has there been a retrospective study comparing projected and realized cost/benefits for existing drinking water regulations?

7. Could such studies be extended to the CCL?

8. Do supplementary data need to support such assessment need to be considered early on in the regulatory development process, and be embedded in the regulation itself?

Disinfection By-Products (DBPs)

AWWA recommends that EPA critically assess the suitability of the current CCL process for identifying potential regulatory needs for Disinfection By-Products (DBPs). DBPs clearly havethe potential for significant exposure, as disinfection is

required by all surface water systems (serving 191 million people) and by a significant portion of groundwater systems (serv ing over 89 million people). W ith respect to the wide range of known unregulated DBPs, the draft CCL3 includes only 4 nitrosamines (one of the listed nitrosamines has not been identified as a DBP), and even excludes 2 of the nitrosamines that are required to be monitored under the 2007 second Unregulated Contaminant Monitoring Rule (UCMR2). Further comments on the relationship between the CCL and UCMR processes follow in the research section below.

Some DBPs have been recognized for a long time already. Several new DBPs have been identified more recently by researchers such as Stuart Krasner of Metropolitan Water District of Southern California (MW DSC), Susan Richardson of EPA, and others. The list is expected to grow further with increased research focus and improved analytical methods.

Many classes of unregulated halogenated DBPs that commonly occur are not represented in the CCL3. These include haloacetaldehydes (di-and tri-), halopicrins (mono-, di-, and tri-), halofuranones (MX and analogues), brominated trihaloacetic acids, and haloacetonitriles (di-and tri-). It is difficult to follow the logic for inclusion/exclusion of these contaminants in the universe or PCCL. The Federal Register notice states that DBPs and treatment additives were automatically added to the universe based on a default occurrence assumption and moved to the PCCL even if limited health or occurrence data were available. However, while the CCL3 "universe" included a number of the above-listed compounds, it skipped many others, and only one of these DBPs (chloropicrin) moved to the PCCL. It's very difficult to

evaluate the CCL process with respect to the appropriateness of listing outcomes for DBPs because data gaps for contaminants that do not pass from the universe to the PCCL are not documented. This also presents a lost opportunity for identifying research needs.

Does this indicate a gap in the process? The CCL process, as derived from the recommendations of the NRC and the NDWAC, doesnot appear, in AWWA's opinion, to be able to accommodate the

evaluation of unregulated DBPs. Would significant modifications to the existing process make sense, or is a different process (an alternate regulatory pathway) needed for this contaminant class?

Under the current framework, when research "happens", DBPs will come into the universe and pass to the PCCL, and CCL, if the data so indicate. The problem with this scenario is the apparent disconnect between research and the listing process. There seems to be a considerable amount of research planned, or in place, according to the multi-year research plan. But no reference is made to these efforts, or how they dovetail with the CCL process.

The relationship of the six year review cycle to this question needs clarification. Bromoform was excluded from the universe because of its implicit coverage by review of the Stage 2 DBP rule. Is EPA assuming that the existing DBP regulations (i.e., TTHM and HAA5 MCLs and Total Organic Carbon (TOC) removal requirements) control all halogenated DBPs? The validity of such an assumption has not been addressed.

AWWA recommends that a research plan be developed as soon as possible to evaluate whether or not EPA's current regulatory approach is adequate for DBPs. More research is needed to assess the adequacy of the current regulations with respect to halogenated DBPs. The Agency needs to more clearly trace the ecision making process employed for DBPs in the current CCL. AWWA is concerned that EPA appears to be "done" with re-

evaluating or refining its regulatory approach towards DBPs and recommends that a research plan be developed as soon as possible to answer the question "Is the current regulatory approach for DBPs adequate?" At this time, AWWA is NOT recommending revisions to the DBP regulations, and we want to make that point perfectly clear. However, AWWA believes that more research is needed in a timely manner to answer the question on the adequacy of the current DBP regulatory approach The appropriate research should be identified, prioritized, and then implemented, given the increasing body of knowledge on DBPs and their unique status among drinking water contaminants.Drinking Water Research and the CCL

AWWA recommends that EPA develop an integrated research agenda for CCL3 and other drinking water issues, beginning with an examination of the health effects data and identification of significant gaps in health effects data. AWWA makes the following recommendations for drinking water research, with further details below:

* The number of contaminants on the final CCL3 should be commensurate with what can be appropriately supported by EPA's drinking water research budget;

* The drinking water research budget should be increased to a level equivalent to the air pollution health effects research budget (in the range of $60 million/year);

* The research of EPA's National Laboratories should be re- prioritized to reflect the research needs of the CCL;

* A table of the research needs (analytical methods, occurrence, health effects, treatment) should be included in the final CCL3 and that table should be the starting point for developing an overall drinking water research program;

* The linkages between the CCL and UCMR need to be clearly articulated in the final CCL3.

Number of Contaminants

AWWA recommends that the number of contaminants on the final CCL3 be commensurate with what can be supported with EPA's drinking water research program. If EPA's research program can only conduct the necessary research on 30 contaminants, thenthe final CCL3 should include only 30 contaminants. AWWA

recommends that EPA link the number of contaminants on the final CCL3 with the appropriate resources being devoted to CCL research.

Inclusion of more contaminants on the final CCL3 than be effectively researched and evaluated dilutes the research and monitoring efforts of the entire drinking water community. For example, progressive utilities that want to monitor for emerging contaminants or contaminants that might be regulated in the future are stuck with a large list that cannot be monitored. Consulting engineers that are master-planning future treatment facilities want to allow flexibility for future treatment processes for future contaminants, but again, the list is too large and too complex to allow for such flexibility.

For example, if the final CCL3 contains a table (as detailed later in these comments) categorizing each contaminant's research needs among analytical methods, occurrence, health effects, or treatment, this information could then be extended to a cost estimate for the necessary research.

For example, assume that each contaminant could be placed in the following categories based on the amount of research needs:

* Limited-assume $2 million of research is needed

* Moderate-assume $5 million of research is needed

* Significant-assume $10 million of research is needed.

Assuming an equal split of research needs (1/3 limited, 1/3 moderate, 1/3 significant) across the 104 draft CCL3 contaminants yields a total CCL3 research cost approaching $600 million. This would take over 20 years to complete assuming EPA's current drinking water research budget at $50 million peryear, with half (which may or may not be close to the actually

percentage) of that drinking water research budget directed towards the CCL. This does not match up with the five year cycles for the CCLs and subsequent regulatory determinations.

Analyzing a research budget can be challenging, and in particular, attempting to distinguish what is in support of a specific area of research (CCLs, DBPs, perchlorate, arsenic, etc.). AWWA

is currently conducting a retrospective analysis of EPA's arsenic and DBP research plans to determine how much of the identified research was completed and used in the final regulations. This project may prov ide some limited insight into future planning, but clearly, better information about the impacts of research on the regulatory development process is needed.

Drinking Water Research Budget

AWWA recommends that the drinking water research budget be increased to a level equivalent to the air pollution health effects research budget (in the range of $60 million per year). AWWA supports a dedicated research authorization to support EPA's regulatory development process through the CCL and regulatory determinations.

Outside reviewers have also recognized the need for increased research funding to meet the needs of the CCL. In late 2005, EPA's Board of Scientific Counselors (BOSC) completed a review of the Office of Research and Development's (ORD's) drinking water research program. This report made several important recommendations, and recommendation #5 addressed the CCL research needs:

"The CCL process is challenging, given the potential for large numbers of contaminants. Additional research ultimately will be needed by ORD to respond adequately to this mandate. ORD is strongly encouraged to aggressively pursue partnering with other agencies and nongovernmental organizations (NGOs) to ensure that the CCL needs are addressed adequately".Drinking Water Research Priorities

AWWA recommends that the research of EPA's National Laboratories be re-prioritized to reflect the research needs of the draft CCL3. Minimizing the uncertainties in the health effects data of the CCL3 contaminants should be a top priority of these National Laboratories. Additionally, these National Laboratories should develop a carefully managed plan to

evaluate the occurrence of contaminants in source waters. This program should include the improvement of sampling methods, the development of new analytical methods, and statistical methods to appropriately analyze the occurrence data. The development of occurrence data should be not be solely at the expense of water utilities through the Unregulated Contaminant Monitoring Rule (UCMR).

Table of Research Needs and Drinking Water Research Program

AWWA recommends that research needs be identified and documented in the CCL process. The potential areas of research needs include health effects, analytical methods, occurrence and treatment studies. Research is needed in all of these areas at every stage of the CCL process as shown below:

Universe ---> PCCL -> CCL--> MCL

As the process stands, inputs for research are typically addressed between the CCL and MCL development process. This is one of the last steps in developing a regulation and includes research and data needs for appropriate cost/benefit analyses as mandated by SDWA. However, the process of moving compounds from the universe to the PCCL and from the PCCL to the CCL also prov ides unique opportunities to identify data and research gaps and needs.

AWWA recommends that EPA take advantage of these opportunitiesin a more deliberate and formal approach. For example, in the

present scheme, compounds that are not ranked high because of data gaps can be filtered back to the universe or otherwise

never make it to the CCL. These compounds should be further considered as potential future research needs and these needs should be captured in a formal document made available to stakeholders and the public. This information is vital to advancing research before each subsequent CCL is published.

By better identifying research needs earlier in the process, EPA is likely to generate more interest and receive more input from the research community. Currently, EPA does not have a formal process to make these data gaps well known. Therefore, the research community is not as aware as they could be of research needs at the various points of the regulatory development process. A focused effort with effective leadership can improve implementation of research for future CCL development.

One example would be the use of surrogate data (such as production or env ironmental release information) to list a compound on the CCL. The use of surrogates is an opportunity for EPA to publicize the research needs for compounds that have no actual env ironmental measurements. Another example would be the case in which a compound drops from the process because of a lack of data. This should be identified and documented as a research need to give the research community the opportunity to investigate these topics.

AWWA recommends that a table or other summary of research needs be developed for the final CCL3, similar to the research needs table in the final CCL1. A table or other summary of research needs would be helpful to the overall CCL development process. Listing of specific compounds or classes of compounds would allow the research community to investigate areas which EPA sees as research needs.

For example, in CCL1, compounds that were listed included associated research needs such as analytical methods research, occurrence research, health effects research, and treatmentresearch. AWWA suggests that the same categories of research needs formerly categorized on CCL1 be readopted for subsequent CCLs. Furthermore, AWWA suggests these research need categories not be limited to the compounds on the final CCL but should include compounds and associated research needs as identified in the process of moving compounds through Universe/PCCL/CCL (as stated above). AWWA recommends that EPA more clearly identify and document research needs for compounds in the CCL process. This includes both compounds on CCL3 as well as compounds in the universe, and especially in the PCCL, which failed to move further through the process due to missing required data.

Such a table or summary of research needs should be included in the formal release of CCLrelated documents. This type of research summary would not only provide information for the wider research community but it would also allow public water systems to better prioritize their capital and operating budgets to address potential issues on the regulatory/research agenda.

Linkages Between CCL and the Unregulated Contaminant Monitoring Rule (UCMR)

The UCMR is a key mechanism to: 1) advance research/data gaps for contaminant occurrence identified through Universe/PCCL/CCL and 2) develop and refine research plans (i.e., results can be used to revise hypotheses about occurrence of contaminants and contaminant groups, which can then be used as feedback to

overall research planning).

AWWA recommends EPA clarify where the UCMR fits into the regulatory process and how it can benefit the research needs of the scientific community as well as future CCLs. It is not clear how EPA connects the UCMR with the CCL process. Are data from UCMR used to support the CCL or is the CCL process used to determine which unregulated contaminants should be added to future rounds of the UCMR, or both?For example, UCMR2 requires monitoring for 6 nitrosamines, but

the draft CCL3 only lists 4 of the 6. W hat happened to the other 2? Logically, if utilities are required to monitor for a class of compounds (with an approximate cost of $15 million), then all 6 of the UCMR2 nitrosamines should be on the final CCL3

Source Water Protection

AWWA recommends that EPA work with states, water and wastewater utilities, the agricultural community, and the chemical and manufacturing industries to minimize source water contamination. Source water protection is an important issue for drinking water utilities. Public water suppliers must treat surface waters in order to deliver potable water that meets drinking water standards and protects public health. Protecting public health includes treating for high levels of nitrite and nitrate, removing algal biomass, reducing algal toxins, and addressing operational challenges that stem from many industrial and agricultural operations.

AWWA supports a dedicated authorization in the Research Title of the Agriculture Reauthorization bill for collaborative research between the drinking water sector and the agriculture industry on ways to limit contaminants from entering water supplies.

II. Specific Comments on CCL3 Chemical Contaminants

Reviewing the significant amount of documentation for Universe/PCCL/CCL processes and the dossiers for each of the 93 chemical contaminants was challenging, given the short comment period. Given the five-year CCL cycle, AWWA and its technical experts knew of the need for data for informed internal deliberations prior to the scheduled publication of the draft CCL3 in early 2008. So in 2007, in order to be better prepared for this publication, AWWA contracted with Missouri University of Science and Technology, with Dr. Craig Adams as the principal investigator. This project was to build upon theoccurrence-toxicity space diagram concept by using a variety of

public data sources (Rosen and Roberson, 2007).

The purpose of the risk analysis conducted by Missouri University of Science and Technology, Rosen, and Roberson was to provide a tool with which to screen against the CCL3 list to identify oversights, omissions, or unwarranted inclusions with respect to chemical contaminants. The process did not have the advantage of having early access to the EPA's chemical dossiers nor some of the data included in the dossiers. A relatively large number of contaminants were initially analyzed, and this approach produced a completely transparent result for each chemical in the database, specifically showing the data sources, normalization, and data quality estimates.

Visually-useful occurrence-toxicity space diagrams, as well as

averaged normalized risk indices, using both high quality only, and all data, were initially generated. Initially, two diagonal dashed lines were generated to aid in this v isual analysis. The first diagonal line connected the highest toxicity score (10) with the highest occurrence score (10), while the second line connected 5/5. The logic was to develop three areas for each contaminant:

1. List-to the right and/or above the 10/10 line

2. Possibly list-between the 10/10 line and the 5/5 line

3. Do not list-to the left and/or below the 5/5 line.

After the initial graphing, the project team decided to "kink" the 10/10 line so that contaminants with high occurrence but relatively low toxicity would fall into the "possibly list"

area.

Again, give the short comment period, AWWA technical experts decided that the occurrence and toxicity data contained withinthe dossiers for the draft CCL3 also be entered into the AWWA

database, using EPA's normalization factors. This approach combined the EPA data in the space diagrams with the data that was found prior to the publication of the draft CCL3. This allows a simple visual comparison of the different data and different combinations of occurrence-toxicity. The charts for the 93 chemical contaminants are enclosed separately from these comments.

The analysis prov ided a useful tool for examining proposed CCL3 compounds by AWWA's CCL Technical Advisory Workgroup (TAW ), but did not result in any significant recommended changes to EPA's CCL3 list. In all cases, the project occurrence-toxicity data was either at a higher level than, or bracketed by, the EPA occurrence-toxicity data. In other words, the project data did not contradict any of the EPA data,

Another observation from this project was that there was much more variability in the occurrence data as opposed to the health effects data. This observation points to the need for improved analytical methods research that could then be used by a wide variety of laboratories to develop sounds estimates of national occurrence, where occurrence data is needed.

Currently, it is proposed that, due to the incompleteness in data sets used and the potential implications or misinterpretation of ranked chemical lists for a larger number of chemicals, the technical results of the project on the larger database will only be written up in a master's thesis. A related drinking water policy paper will be published in 2009 that will summarize the process used in the projects and the resultant drinking water policy implications.

A question remains as to whether all PCCL compounds (approximately 500) should be entered into the database. This would require additional resources and additional time that is not available during the short comment period. The key question is what would be the purpose of this additional work, and specifically, what would be the application of the resulting data and/or database either or both internally (to AWWA) orexternally.

Treatability

Inclusion of treatability considerations in the CCL3 criteria is problematic for a specific chemical agent due to the plant- to-plant and temporal within plant variability in treatment processes, temporal and spatial variability in physical, chemical and biological parameters in source waters and sediments (onto which agents may partition), and other factors. For example, two plants using the same powdered activated carbon may achieve nearly no removal versus complete removal of a specific chemical agent depending on water characteristics (e.g., natural organic matter concentration, temperature, pH, etc) and carbon dosage. Similarly, oxidative removal or transformation of a chemical may be significantly affected by these same water characteristics. Additionally, removal by filtration of a chemical agent may vary from negligible to complete depending on many varying factors such as use of filtration aids, pH, total turbidity and biological activity on filters.

Therefore, AWWA

suggests the most appropriate assumption for chemical contaminants is to assume no net removal through a water treatment plant with respect to the CCL process. This is a different assumption that for microbial contaminants as detailed later in these comments as disinfection is a regulatory requirement, but we believe this is appropriate for chemical contaminants.

Use of Release/Production Data

The use of release data as a surrogate measure for occurrence data in the magnitude and prevalence scores is a key decision in the CCL3 process. AWWA was surprised that release/production data or modeled concentrations were used for the majority of the chemical contaminants, as opposed to actual concentrations in drinking water sources or in treated drinking water. The lack of concentration data points to the need for increasedresearch for new analytical methods that could be used on a

widespread basis, as opposed to methods that can only be used by research laboratories. These new methods would then be used to develop sound estimates of national occurrence. Development of national occurrence distributions appears to be a critical research need for many contaminants.

A key component for assessing risk to the public for a chemical or biological contaminant is their exposure to the agent including both magnitude (i.e., concentration) and prevalence. Concentrations are relevant especially in relation to references doses for the agent. Prevalence, however, can be impacted by either or both temporal or spatial variations, and thus, the total mass loading consumed by a given individual. Ideally, both magnitude and prevalence should be assessed in a statistically-sound manner using measured samples in raw and treated waters. However, in most cases as mentioned previously, measured values are not available and surrogates are used including either application rate data or production data.

Key and significant problems are involved in the use of mass application or production data that make its use potentially highly misleading. For example, a contaminant concentration is dependent on the volume of water into which the agent is discharged and, therefore, dependent on factors such as the area of application, size of watersheds, and amount of rainfall or snowmelt in a watershed. Furthermore, the mass of a discharged or applied agent that is transported into a water supply is highly dependent on the chemical's properties and the local soil or water characteristics (including linear and non- linear partition coefficients, hydrolysis rates, biodegradation rates, etc.). Use of known parameters such as octanol-water partition coefficients can often lead to highly misleading results and may significantly under-or over-estimate the amount of an agent ending up in a watershed.

While the AWWA

recognizes the dilemma regarding a lack of sufficient magnitude and prevalence data, we strongly recommend that application or production data only be used with great caution. At a minimum, state-by-state application data should be the largest spatial areas considered, with a watershed-to-watershed approach being more optimal. Furthermore, because of

the near impossibility of predicting the amount of an agent that will be transported to and remain in the aqueous phase in a drinking water source, we advocate that ideally a magnitude score for an agent in a watershed be based on its application rate relative to the volume of source water within the watershed. AWWA

also recommends that the prevalence score be estimated based on the number of watersheds, and the relative populations served by the watershed, into which the agent is applied.

The EPA should consider collaboration with other state and federal agencies (e.g., USGS, FDA, and USDA) in conducting this analysis. Use of a Graphical Information System (GIS) approach containing application data and hydrological data is appropriate.

III. Specific Comments on CCL3 Microbial Contaminants Summary

AWWA commends EPA for embracing many of the NRC and NDWAC recommendations in the development of a more rigorous scientific approach for identifying and evaluating microbial contaminants included on the draft CCL3 than was used for the CCL1 or CCL2. AWWA presents an alternative ("streamlined" decision tree) approach for evaluating PCCL contaminants that more explicitly, consistently, and transparently uses expert judgment and appropriate data to identify those pathogens whose potential regulation are more likely to lead to improvements in public health than the EPA process. The integrated and transparent use of focused expert input in the CCL process is clear from the language of SDWA and was supported by NRC and NDWAC reports. Based on the results of our alternative approach, which we recommend EPA use in developing the final CCL3, AWWA

specifically recommends the addition of human enteroviruses, Mycobacterium av ium, and rotavirus to the final CCL3. AWWA

also recommends the removal of Entamoeba histolytica, Helicobacter pylori, Naegleria fowleri, Salmonella spp., Shigella spp., and Vibrio cholerae from the draft CCL3. Lastly, AWWA

supports the inclusion of draft CCL3 microbial contaminants Campylobacter-like organisms, human caliciviruses, Hepatitis A, Legionella pneumophila, and toxigenic E. coli onthe final CCL3. The details, results, and comparison of AWWA's

approach with EPA's are prov ided in the comments below and in the Appendices.

Documenting Expert Judgment for CCL3 Microbial Contaminants

AWWA commends EPA for adopting and implementing the NRC paradigm (i.e., universe to preliminary CCL (PCCL) to CCL), which was subsequently supported by the NDWAC CCL Work Group, to develop the draft CCL3 for microbial contaminants. However, the agency needs to better define the process to describe all the interim steps that will be required to actually implement the CCL process-especially the integration of experts, particularly external experts. The majority of AWWA comments and critique of EPA's approach to develop the draft CCL3 focus on the third step of the CCL process (the "Classification Process") whereby PCCL contaminants are evaluated using a combination of health effect and occurrence attributes to obtain a composite score. As recommended by NDWAC (2004), this key step should also include "Evaluation" and "Expert Rev iew" defined, respectively, as follows: "...After implementing the classification process, the prioritized list of contaminants would be evaluated by experts, including a review of the quality of information...The CCL classification process and draft CCL list would undergo a critical Expert Review by EPA and by outside experts before the CCL is proposed." However, it is not clear whether the purpose and results of any of the three expert workshops support or fulfill the Evaluation and Expert review components of the third step of the CCL process.

AWWA recommends that EPA provide a document in the docket that identifies all of the internal and external experts used to develop the draft CCL3 and their expertise, how they were selected, their affiliation and expertise, and results of the deliberations-especially concerning the scoring and re-scoring of PCCL pathogens-to facilitate transparency of expert input into the CCL3 process for microbial contaminants. Although it is not clear from either the NRC (2001) report or NDWAC (2004) report what the actual role of experts will be or how the experts' input will be specifically captured, tested, or employed, clearly expert judgment and input continues to form acritical and integral part of the CCL3 process- particularly

for microbial contaminants. Regarding the scoring process in general, AWWA

notes that the March 2007 experts stated the following: "Perhaps there is an issue regarding the measure of reproducibility for scoring (i.e., could similar scores be reproduced with other experts or is there too much flexibility in scoring and professional judgment?). The group recommends that another group scoring should occur to determine scoring

variability." Consistent with previous related comments, it is not clear whether the final scores prov ide in the Federal Register notice for the draft CCL3 were scored more than once and by more than one group of internal or external experts. AWWA agrees that the role of experts in the CCL process should continue in all phases of identifying, screening, and

evaluating pathogens from the microbial universe to the PCCL and then to CCL. It remains unclear, however, exactly who were the selected experts (necessary information to determine the appropriate expertise of each of these experts), how the experts were chosen, by whom, what input was provided by these experts, and how such input was used (or modified or not used) as part of the CCL3 process.

The draft CCL3 states that EPA convened a total of three workshops to review, discuss, and comment on the microorganism considered and selected for the draft CCL3 and notes that "The Agency's considerations of these and other recommendations are discussed in the Microbial Expert Review support document [EPA, 2008b]." However, that document only identifies the six experts (including infectious disease microbiologists) and their selection process for the third expert workgroup that met on March 20-21, 2007, in addition to prov iding a summary of that group's deliberations, findings, and recommendations (EPA 2008b). W hile the draft CCL3 discusses the importance and summarizes the key contributions of these other two expert panels to the CCL3 microbial process, whether the experts were internal, external, or a combination (or even their numbers) and how they were identified is not discussed. There is also no documentation of the deliberations of either group in the supporting docket. As stated in the Federal Register notice for the draft CCL3 (EPA, 2008):

In December 2005, a group of expert microbiologists reviewedand commented on the universe of human pathogens and the

screening criteria used to develop the PCCL. This panel agreed that focusing on human pathogens is a reasonable and pragmatic way to identify potential drinking water contaminants. W hile the panel suggested that animal pathogens may develop the ability to infect humans, they noted that these emerging contaminants should not be listed on the CCL based on the theoretical potential to become zoonotic pathogens. They also identified additional criteria and methods to apply those criteria to the Microbial Universe, which EPA incorporated into the CCL process. In June 2006, a panel of experts met for three days to review EPA's implementation of recommendations by NRC and NDWAC to select microbes for the CCL. EPA implemented the NDWAC recommendation to develop a process that paralleled the chemical process yet still accounted for the different types of data and information that are uniquely available for microbial contaminants. Panel members agreed that health effects and occurrence of microbes importance. The panel recommended that EPA use a decision tree approach for microbes rather than the classification approach suggested by NRC and NDWAC. The panel further recommended that the Agency consider a different selection process than the one used for chemical contaminants, related to the different information available for microbes. Based on this recommendation, the Agency evaluated options to consolidate the potency and severity attributes for microbes into a single health effect attribute, developed a waterborne disease outbreak protocol, and considered occurrence as a single attribute...The panel also recommended that the Agency consider drinking water treatment and removing microbes from further consideration if conventional drinking water treatment protects public health [emphasis added].

The two previous expert workshops clearly played a key role in the CCL3 microbial identification and selection process. Therefore, EPA should have prov ided a document in the docket that identifies the experts and how they were selected, and that summarizes the workshops in order to facilitate transparency in the CCL3 process for microbial contaminants.

March 2007 Expert Workshop for CCL3 Microbial ContaminantsThe goal of the March 2007 workshop was to obtain expert input

on the approach EPA is using to establish the microbial CCL3, focusing on prov iding comments on the draft list of microorganisms, the screening process, and scoring protocols used to establish the list (EPA, 2008a,b). Notably, two of the EPA experts-Kellogg Schwab and Rebecca Hoffman-were members of the AWWA

microbial workgroup (see more below) that helped develop the proposed PCCL scoring approach and these comments. To facilitate this review, EPA provided the panel with background materials and staff presentations. Panel members also scored all PCCL pathogens independently using the EPA process, commented on specific pathogens considered for the draft CCL 3, and commented on the data and processes EPA used to identify the microbial contaminants. Many of the findings and recommendations of that expert workshop summary-including those that were apparently ignored and were not mentioned in the Federal Register notice for the draft CCL3-are discussed throughout these comments.

AWWA Expert Microbial Workgroup

In early 2008, AWWA

formed an independent group of expert microbiologists (AWWA microbial workgroup) to independently assess EPA's process for evaluating (scoring) and selecting PCCL microbial contaminants included on the draft CCL3, as well as develop and use an alternative ("streamlined" decision tree) approach for evaluating PCCL contaminants. AWWA believes that the alternative process (i.e., the AWWA approach) more explicitly, consistently, and transparently uses expert judgment and appropriate data to identify those pathogens whose potential regulation are more likely to lead to improvements in public health than the EPA process. The AWWA microbial group met twice and includes the following experts: Ms. Rebecca Hoffman (W isconsin State Laboratory of Hygiene, University of Wisconsin, Madison); Ms. Marilyn Marshall (Quality Assurance Officer, University of Arizona); Dr. Paul Rochelle (Interim Microbiology Unit Manager, Metropolitan Water District of Southern California Water Quality Laboratory); Dr. Kellogg Schwab (Director-Johns Hopkins Center for Water and Health, Johns Hopkins Bloomberg School of Public Health); and Dr. Donna Wolk (Clinical Director, Microbiology and Molecular Diagnostics, University of Arizona). The microbial workgroupalso helped prepare these comments. Note, these comments focus

on critiques of EPA's process for developing and finalizing the draft CCL3 and specific microorganisms included or excluded on the CCL3; therefore, no attempt was made by the microbial workgroup to systematically prov ide statements of support for the draft CCL3 or the CCL process in general.

Critique of EPA Approach

AWWA's evaluation of EPA's approach identified several broad methodological critiques as well as specific critiques for scoring waterborne disease outbreaks, occurrence, and health effects for individual PCCL contaminants.

General Methodological Weaknesses

AWWA recommends that EPA provide and document the results of an explicit and transparent expert post-scoring reality/confirmation check of draft CCL3 pathogens, preferably conducted by outside experts. AWWA's chief concern of EPA's list of pathogens on the draft CCL3 is the apparent lack of any sort of "post-scoring reality/confirmation check" by outside experts. This check is needed to confirm the appropriateness of the scoring of individual PCCL contaminants and whether the inclusion of a pathogen on the CCL3 would fulfill the core SDWA criteria regarding the regulation of individual CCL contaminants, such as the new regulation would constitute a meaningful opportunity for health risk reduction. The 2007 workshop experts cautioned that EPA was not being proactive regarding new and potential pathogens and adv ised that only including pathogens that have been fully researched may take resources needed to research pathogens for which waterborne infection routes are suggested but unable to be proven since reliable and sensitive analytical methods do not exist. Therefore, the EPA experts recommended and were themselves a part of a post-scoring consensus vote of the highest ranked PCCL pathogens to assess whether or not the pathogens are those most appropriate to focus EPA's limited resources (EPA, 2008b). However, many of these expert opinions (e.g., Helicobacter pylori) were not only dismissed but were never mentioned in theFederal Register notice for the draft CCL3 (EPA, 2008a).

AWWA recommends that EPA provide transparent support and justification for all of the March 2007 scores that were changed in an apparently "back door" and closed process that circumvented the expert scoring process. AWWA is concerned that EPA appears to have modified their own expert-based PCCL scoring process in a non-transparent manner by changing 13 scores after the March 2007 expert scoring workshop (summarized in Table A-1; Appendix). [See PDF for Appendix] Several of these scoring rev isions resulted in the inclusion of a pathogen (e.g., Helicobacter pylori) on the draft CCL3 while other changes and kept a pathogen off the draft CCL3 (e.g., human enteroviruses).

AWWA recommends that treatability should be included in

evaluating PCCL contaminants for potential inclusion on the CCL since treatability will be part of the regulatory determination-at least as part of any sort of post-scoring reality/confirmation checks by expert assessment of individual pathogens. AWWA's technical experts were surprised to find Vibrio cholera included on the CCL3. Typhoid and cholera were essentially eliminated in the U.S. in the early 1900s through the nationwide adoption of conventional treatment (filtration and disinfection). The absence of consideration of treatability in the CCL process could result in listing on many organisms for which existing treatment already removes or inactivates the pathogens (e.g., as evidenced by a lack of W BDOs in the U.S.) and thereby does not focus CCL3 pathogens to those whose regulation may result in meaningful reductions in public health risk for those served by public water systems. EPA's rationale for not considering treatment was the high number of untreated ground water systems, despite the recent Ground Water Rule [EPA, 2006b], and existing Surface Water Treatment Rule (SWTR) for surface water systems.

AWWA recommends that all materials used in the identification,

evaluation, and selection process for the CCL3, with the exception of those that are clearly proprietary, should be publicly available in the docket. Further, EPA should rely whenever possible on peer rev iewed literature for CCL purposes.It is not sufficiently clear (i.e., transparent) from the

February 2008 Federal Register notice for the draft CCL3 or supporting documents in the docket how data on pathogens were identified and organized, and the role of expert judgment as part of this process. Indeed, the March 2007 experts (EPA, 2008b) commented that "...it appears that the draft fact sheets may not adequately represent the available and updated information for each contaminant; a number of data omissions were pointed out." Further, the 2007 workshop experts recommended that quality assurance activities be incorporated into the process including an overall plan to assess the quality of the data collection, data, entry, and interpretation of available literature (data quality).

With a few notable exceptions (e.g., Legionella pneumophila), AWWA recommends that the CCL3 list the target pathogenic microorganism belonging to a specific genus (e.g., Shigella spp.) and prov ide a typical species of concern (e.g., Shigella sonnei). AWWA

believes that listing CCL contaminants to detail both the genus and species is often inappropriate for CCL purposes; for example, documented outbreaks and occurrence often do not differentiate between species. EPA (2008a) alludes to the fact that there are taxonomic issues that relate to the width of the pathogen groups that they are assessing for CCL purposes. However, after discussing this in a general way, the draft CCL3 notice indicates that EPA selected a single species within the genus and then listed it accordingly.

AWWA recommends that the CCL3 listing for E. coli expand beyond O157:H7 and include other waterborne, toxigenic E. coli of public health significance (e.g., other enterohemorrhagic serotypes of E. coli, enterotoxigenic E. coli; Hunter, 2003) in the U.S. and other developed nations.

Furthermore, the taxonomy of Campylobacter should be expanded to include Campylobacter- like organisms such as Arcobacter, which was not distinguished from Campylobacter in the literature (e.g., Snelling et al., 2006; Vandamme et al., 1991) until relatively recently but was evaluated separately by both EPA (2008a) and then the outside experts in March 2007 (EPA, 2008b).Waterborne Disease Outbreak Assessment Issues

EPA's reliance on the current Centers for Disease Control and Prevention (CDC's)/Morbidity and Mortality Weekly Rev iew (MMW R) definition as constituting a documented waterborne disease outbreak (W BDO) is inappropriate; EPA should have developed their own working definition of an outbreak that is appropriate for CCL purposes. The March 2007 workshop experts recommended that EPA develop a means of scoring the magnitude of W BDOs and noted that an outbreak affecting 1-2 individuals (per CDC's definition of a W BDO below) received the same score as outbreaks affecting thousands of persons. There is no incorporation of this recommendation listed in the description of scoring protocols for the draft CCL3 and EPA's scoring approach for W BDOs does not account for the magnitude of the outbreak. AWWA's approach incorporates both the frequency of outbreaks and the number of indiv iduals affected.

"CDC definition: A waterborne disease outbreak is an incident in which 1) two or more persons experience a similar illness after consumption or use of water intended for drinking and 2) epidemiologic evidence implicates the water as the source of illness. The stipulation that at least two persons be ill is waived for single cases of laboratoryconfirmed primary amebic meningoencephalitis. Second, epidemiologic evidence must implicate water as the probable source of the illness."

AWWA recommends that EPA rely whenever possible on peer

reviewed literature when evaluating outbreak data (e.g., drinking water supply suspected as source of Naegleria, Cabral et al., 2003). Moreover, the NDWAC report (2004) recommended that "EPA should generate and include, along with the actual

values or the attribute scores that are generated, descriptive "tags" that provide additional data quality information that may be used by experts reviewing the data, attribute scores..." The Federal Register (EPA, 2008a) notice for the draft CCL3 notes the following on p. 9629: "In developing the draft CCL 3, the Agency consider the best available data and information for unregulated contaminants."AWWA

recommends the use of outbreak data tied to the implementation of the SDWA and its amendments. It is inappropriate to consider outbreaks occurring anywhere before 1974 (i.e., prior to implementation of SDWA). AWWA advocates the use of outbreaks taking place on or after 1980 in the U.S. because of limited data availability and time constraints associated with providing comments on the draft CCL3.

AWWA recommends that outbreaks should be defined for CCL purposes as those occurring in developed nations exclusively. EPA's inclusion and consideration of outbreak information from undeveloped countries, despite often vastly different laws, regulations, and practices concerning drinking water treatment, distorts the scoring and is inappropriate for regulations intended to be applied in the U.S. Further, data from U.S. territories should be carefully screened for usefulness (e.g., Vibrio in Marshall Islands, 2000).

AWWA recommends that serological data associated with a W BDO must be linked with occurrence data in water (e.g., what is the linkage between actual waterborne microorganism and a concrete marker of exposure?). The sole use of serological data to determine waterborne outbreaks is hampered by the difficulty in determining the relationship between seropositivity and clinical disease (NRC, 2004). For example, the use of serology to detect immunoglobulin G (IgG) antibody to norovirus has been established (Anderson et al., 2001). However, diagnosis by IgG antibody to norov irus requires collection of an acute and

convalescent serum sample with the first serum sample drawn within 5 days of symptom onset. Often, there is a lag time of

several days after an outbreak is recognized before clinical specimens are collected to test for a viral etiology. In addition, it is possible for asymptomatic infection to occur with norov irus infection, making it more difficult to know if an individual is shedding the virus. Therefore, immunoglobulin A (IgA) testing may be the only method for the late detection of a norovirus infection as IgA antibody peaks earlier than IgG but for a shorter duration of time. However, the kinetics of IgA response to norov irus infection are still largely unknown. Consequently, it is not possible to determine precisely when viral shedding would most likely occur solely on the basis ofthe IgA titer. Thus, serologic data alone cannot be used to

determine the cause of a norovirus outbreak. These issues would be similar for serological determination of W BDOs caused by other microorganisms.

AWWA recommends that outbreaks should be defined for drinking water and their sources, not recreational waters such as swimming pools, hot tubs, etc., unless the source specifically

serves as a designated source of drinking water. The SDWA Amendments of 1996 state that the focus of the CCL should be on public water systems. A sampling of the swimming pool outbreaks listed in CDC's MMW R (CDC, 2000, 2002, 2004) is illustrative:

California, 1999, Apartment complex pool, 23 persons ill-The health department conducted a physical inspection of the pool and examined pool maintenance records. No water testing was performed by the health department, nor were pool maintenance records available for the dates immediately after the day of exposure.... However, swimmers reported that on the day in question, the pool was overcrowded and that toddlers were swimming in the pool.

Florida, 2000, apartment complex pool, 3 persons ill-Inadequate water quality and low chlorine levels were documented in an outbreak at an apartment complex. Fecal material had been visible in the pool at the apartment complex.

Nebraska 2000, 225 persons ill-Fecal accidents had occurred before the outbreak. Review of the pool maintenance logs

revealed a 2-day period when the baby pool had not been chlorinated.

Georgia 2002, 3 children ill-Records on water treatment for the pool were not available.

Minnesota, 2002, 52 persons ill-An investigation revealed that in the 2 weeks before the outbreak, the chlorine feeder had been out of service, and the chlorine had been administered byhand. The flow meters had not been working, and the rate-of-

flow meter readings were not monitored or documented. The filter sand bed was later discovered to be missing 8 of the required 18 vertical inches of sand.

Each of these MMW R-documented outbreaks was triggered by fecal accidents, failure to maintain proper disinfection practices, or a combination of these two factors. AWWA feels it is inappropriate to consider W BDOs of this nature for CCL purposes.

Occurrence Scoring Issues

Using the rationale described above for outbreaks, for CCL purposes, AWWA

strongly objects EPA's (1) use of pathogen occurrence data obtained in U.S. territories and undeveloped countries; (2) linking pathogen occurrence to the local residents' serological positiv ity; (3) assigning pathogen occurrence scores based on reports in non peer-rev iewed literature (reports of Naegleria occurrence in ground water by Gerba et al., 2007 that is not peer reviewed); and (4) using occurrence data that was derived from water sources strictly used for recreational purposes.

AWWA recommends that molecular methods should be assigned a lower weight (score) until there are standard practices in place to ensure that all molecular laboratories perform their testing in properly engineered laboratory space and apply strict contamination measures to their processes. Until that time, molecular testing for pathogen occurrence may be more prone to false positives results than culture methods, and therefore, should not receive equal weight. AWWA disagrees with EPA's protocol of assigning equal occurrence scores to pathogens regardless of the method used to measure their occurrence (i.e., molecular-vs. culture-based detection methods).

In comments regarding occurrence, the draft CCL 3 (EPA, 2008a; p. 9646) states "This attribute does not characterize theextent to which a pathogen's occurrence poses a public health

threat from drinking water exposure. Because v iability and infectivity cannot be determined by noncultural methods, the public health significance of non cultural detections is unknown." Given this statement, which AWWA agrees with, AWWA asks the agency to prov ide the justification and address the appropriateness for scoring molecular-and culture-based occurrence information the same. This recommendation is supported by NDWAC (2004): "The Work Group noted a related key consideration in the CCL process should be that, in general, false negatives should be avoided when going from the Universe to the PCCL and false positives should be avoided when going from the PCCL to the CCL [emphasis added]."

AWWA recommends that EPA carefully scrutinize occurrence information and assign higher scores to organisms for which multiple, independent laboratories have produced multiple peer-

reviewed publications documenting the pathogen's occurrence. By equally weighting scores for microorganisms that have been repeatedly detected but only by a single laboratory, the potential bias introduced by laboratory contamination incidents is minimized and the waterborne disease-causing potential reflected by the pathogen's frequent presence may be more accurately assessed.

Health Effects Scoring Issues

AWWA agrees with the agency's decision to not consider severely immunocompromised populations (e.g., primary or acquired severe immunodeficiency, transplant recipients) in their health effects scoring. Each year, increasing numbers of U.S. residents become immunocompromised due to organ transplants, cancer therapy and HIV, etc. Combined with the opposing ends of the age spectrum, very young and very old, the numbers of immunocompromised persons increases each year. Although such populations are definitely sensitive subpopulations, such immunosuppressed indiv iduals usually have a higher standard of ongoing health care and protection than the other sensitive populations (e.g., elderly, pregnant women). Moreover, nearly all pathogens would result in high health effect scores for

severely immunocompromised, which would devalue the scoringprocess for this key attribute. There are advantages as well as

limitations to EPA's approach of separately scoring health effects in the general population as well in several sensitive subpopulations, then combining scores for the general population and the highest scored subpopulation. The same can be said for approaches that use sub-strata or normalization to try to balance the effects of healthy and immunocompromised hosts. Advantages of separate scoring include the realistic assessment of the raw numbers of human hosts at risk for disease caused by each of the organisms. This perspective allows for a focus on the overall cost-benefit of research and regulations that may result from the final CCL3 list. In contrast, the ethical impact of minimizing the small numbers of immunocompromised hosts in comparison to immune competent hosts may warrant discussion and further expert review from a human ethics perspective. An alternate approach may be to assess health effects based on the most vulnerable populations and quality of life issues. W hile there is no universal approach, it is important to note that the AWWA approach (described below) attempted to determine the "most common" health outcome for each of five sub-criteria in the general population or non-

severely immunocompromised populations.

AWWA recommends that health effects scores should be determined primarily through the consensus of practicing infectious disease specialists, rather than environmental microbiologists. This is consistent with the recommendation by the 2007 workshop experts that practicing infectious disease specialists determine scores for health effects rather than (they presumed)

env ironmental microbiologists. Given previous comments regarding the agency's lack of providing consistent information on which experts comprised the various expert groups that helped identify, evaluate, and list the microorganisms on the draft CCL3 (or summaries of their deliberations, conclusions, and recommendations), it is not clear whether the health effects scores for PCCL contaminants were evaluated by a sufficient number of infectious disease microbiologists outside of the March 2007 expert workshop.

AWWA reiterates its recommendation that EPA provide and document the results of an explicit and transparent expert post-scoring reality/confirmation check of draft CCL3pathogens, preferably conducted by outside experts. It is

disconcerting that EPA appears to have modified their scoring process for Helicobacter pylori and rev ised several other PCCL pathogens health effect scores following the March 2007 expert workshop (EPA, 2008b) in a non-transparent manner. This resulted in a dramatically higher ranking of an organism than was originally obtained by the expert scoring process. H. pylori was initially scored relatively low by the outside experts brought in by EPA in March 2007 (EPA, 2008b). The normalized health effects sum based on the EPA experts scoring was 2.1, resulting in an overall total score of 5.1 (normalized health effect score = 2.1 + occurrence = 3) and ranking H. pylori 21 out of 29 PCCL pathogens. In March 2007, the EPA experts scored each of the individual health effects categories (general population, children, elderly, pregnant women, and chronic disease) as 3, indicating that the illness requires physician intervention. However, the EPA subsequently gave H. pylori a normalized health effects score of 5.0, resulting in

an overall score of 8.0 and ranking the organism 6 out of 29-thus it was included on the draft CCL3. The EPA's scoring of health effects categories differed from the experts' scoring in two areas: the general population and the elderly. EPA scored both of these groups as 7, indicating that the organism causes significant mortality whereas the EPA experts scored both groups as 3 (as stated above). Because the normalized health effects sum is obtained by adding the general population score to the highest sensitive group score, increasing both of these scores to the maximum (7) will obviously have a large impact on the overall score. How does EPA support and rationalize a combined score of 8.0 for H. pylori when the expert panel assigned it a score of 5.1? This elevation in score made the difference between exclusion and inclusion on the draft CCL3 for H. pylori.

As noted prev iously, a total of 13 scores were changed by EPA after the expert scoring workshop (summarized in Table A-1; Appendix). [See PDF for Appendix] As described in the Federal Register notice (p. 9649), EPA chose to list the 11 highest ranked pathogens (Exhibit 18) and cites a number of "natural breakpoints," ultimately using a breakpoint of 7.1. Examination of the scores assigned by the March 2007 microbial experts and assembled highest to lowest in Table A-1 shows that the "natural breakpoints" occur at 5.9 or at 4.5. Furthermore, anumber of the revisions of the expert review scores-namely

those for rotavirus, Arcobacter butzleri, human enterov iruses, human adenov iruses, and Plesiomonas shigelloides-moved them out of the lower range of listed pathogens and into the group of unlisted microorganisms. These scoring changes altered the top 11 pathogens that were included on draft CCL3. EPA appears to have subjectively manipulated the scoring process to ensure that H. pylori would be listed on CCL3, despite the fact that a strict application of EPA's process, and review by an independent panel of experts (as recommended by NRC and NDWAC), did not support its placement on the draft CCL3. Similarly, this manipulation relegated rotaviruses and enterov iruses to below the threshold score despite the EPA expert panel's recommendation (EPA, 2008b) that they be included on the CCL3.

Further, at least one member of the March 2007 expert panel has raised this issue in comments submitted to the docket (Docket ID: EPA-HQ-OW-2007-1189). This indiv idual stated the following:

"This was not a trivial exercise and we had some difficulties with some agents that were included in the final list...It is my opinion that although we may have included some organisms where there was not uniform agreement, we did not exclude any organisms that we felt were appropriate for this. For that reason, I take exception at the inclusion of Helicobacter pylori and Entamoeba histolytica and the exclusion of Enterov irus and Rotav irus. The classification scores listed in Exhibit 17 do not reflect the opinion of the Expert Panel. If the currently published list of candidate agents is to be retained, then justification for the variance from the panel's recommendations, particularly for inclusion of H. pylori and exclusion of Enterovirus, needs to be justified using the stated selection criteria"

AWWA Approach

AWWA evaluated EPA's PCCL to CCL scoring process and revised it somewhat to address several of the perceived shortcomings of EPA's approach. Note, the AWWA microbial workgroup evaluated a total of 22 of 29 PCCL contaminants. The remaining sevenpathogens were not indiv idually evaluated due to their low EPA

and EPA expert scores, which AWWA more-or-less agrees with, while Arcobacter was not evaluated due to taxonomy concerns that were discussed in the preceding section. (See Table A-1 in the Appendix for a full listing of EPA and EPA expert scores for all 29 PCCL pathogens.) [See PDF for Appendix] The AWWA scoring approach is essentially a streamlined, decision tree

version of the EPA approach in that the organisms are ranked according to published accounts of causing waterborne disease outbreaks, occurrence in water, and health effects. However, a number of important distinctions from the EPA process have been made and are described below.

Waterborne Disease Outbreaks (W BDOs)

The AWWA

process for W BDO scoring follows a decision tree format (see Figure A-1; Appendix) and poses a series of questions designed to most accurately categorize the information available on W BDOs in the U.S. that are attributed to PCCL pathogens. [See PDF for Appendix] In AWWA's process, waterborne disease outbreaks were considered only when cited in peer-rev iewed literature or CDC's Morbidity and Mortality Weekly Reports (MMW R). AWWA feels it is inappropriate to cite non-peer rev iewed literature such as conference proceedings papers (e.g., Gerba et al., 2007) as supporting documentation. Additionally, outbreak data with only serological association of waterborne disease were not considered because the sole use of serological data to determine waterborne outbreaks is hampered by the difficulty in determining the relationship between seropositiv ity and clinical disease as outlined above. If the PCCL pathogen could not be linked to a W BDO using this approach, the organism received a score of 0 and W BDO scoring was complete. (Again, EPA scoring for W BDOs always results in a score of at least 1, even if the pathogen has never resulted in a documented W BDO in any country.) If one or more W BDOs were attributed to the pathogen, the outbreak was evaluated further to determine a score from 1-5.

In EPA's approach, pathogens responsible for W BDOs in developing countries were assigned a W BDO score, albeit lower than when the outbreaks occurred in the U.S. or the developedworld. AWWA feels it is inappropriate to assign any score to outbreaks that have occurred in countries where sound water treatment and sanitation practices have not been widely implemented. Therefore, the AWWA approach only considered outbreak data from the U.S. and other developed countries. Outbreaks in U.S. territories (i.e. Vibrio outbreaks in Northern Mariana Islands 1994; Marshall Islands 2000; reported in CDC MMW R 2002) and those in the developing world were not considered because access to fresh, high quality finished drinking water in the majority of these locations is limited at best. If the W BDO did not occur in the U.S. or another developed country, then the pathogen received a score of 0 and WB DO scoring was complete for that pathogen.

The intended use of the water responsible for an outbreak occurring in the U.S. and other developed countries was also considered. AWWA's approach scores only outbreaks in water intended for use as drinking water or serving as a drinking water source. Waterborne disease outbreaks in water explicitly used for recreational purposes were excluded from consideration. For example, consider the report of a 2001 Cryptosporidium outbreak infecting 358 patrons of a waterpark in Illinios. This outbreak was attributed to feces from an infected patron; furthermore, ...this waterpark's records indicate that one fecal or vomit accident every 1-2 days was usual in 2001. (CDC MMW R 2004). Further, a CDC report attributing a Naegleria outbreak to infection via mudhole exposure (CDC MMW R, 2002) was excluded from consideration. Again, if the W BDO occurred in water that was not intended for human consumption, the pathogen received a score of 0 and W BDO scoring was complete.

Subsequent questions incorporate the frequency and magnitude of the outbreaks. In agreement with the EPA approach, the AWWA process assigned a higher score to organisms responsible for more frequent outbreaks, although AWWA's approach scores <5 or >=5 outbreaks. Additionally the AWWA approach considered the magnitude of outbreak giving higher scores to outbreaks affecting greater numbers of persons (<100, 101-500, >500 cases). A maximum outbreak score of 5 was assigned based on the decision tree endpoint.Occurrence in Water

Similar to data used to determine waterborne disease outbreak scores, the data used to score occurrence in water (see Figure A-2; Appendix) were derived from peer-reviewed literature and included only reports from inside the U.S. or other developed counties. [See PDF for Appendix] Furthermore, occurrence reports were only considered if the organism(s) was present in water targeted for human consumption. The AWWA approach further differentiates pathogen occurrence in treated drinking water from occurrence in untreated drinking water. This was accomplished by taking into account that many pathogenic microorganisms are easily controlled with basic disinfection.

For example, in order to control for viruses and pathogenic bacteria, the Ground Water Rule (GW R; EPA, 2006b) set treatment technique requirements because it was not feasible to monitor for viruses (or pathogenic bacteria) in all sources of drinking water obtained from ground water. Under the GW R, if systems detect total coliforms in the distribution system, they are required to monitor for a more specific fecal indicator (E. coli or enterococcus). Therefore, ground water systems and states are already monitoring for possible contamination that may suggest microbial contamination. These systems are then required to disinfect. Thus, between existing drinking water regulations and the GW R, there is good reason to believe that untreated surface and ground water systems that are at risk are, or soon will be, disinfecting. For these reasons, AWWA believes pathogens-especially bacteria-that are known to be easily inactivated using conventional disinfection should not be prioritized as highly as those which are not as sensitive to disinfection processes for CCL purposes. Subsequent steps in the scoring process discriminate frequency of detection (i.e. was there a single report by a single research group or multiple reports by multiple research groups); however, the scores of organisms in which there were multiple reports from only a single research laboratory were decremented by one point. The AWWA

approach also assigns higher scores to pathogens when organisms have been cultured directly from the water source as opposed to molecular detection because molecular methods may be more prone to false positives. Scoreswere assigned accordingly with a range of 0-5 (e.g., Legionella

pneumophila received an occurrence score of 5 while Hepatitis A received a score of 2; see Appendix). [See PDF for Appendix]

Health Effects Scoring

Health effects were scored on a scale of 1-5 as outlined in the decision tree template (see Figure A-3; Appendix). [See PDF for Appendix] For each microorganism the most common health outcome for the general population and non-severely immunocompromised sensitive subpopulations (e.g., children, pregnant women, elderly and chronically ill individuals) was determined. A single health effects score was developed for the microbe under

evaluation. If death was the most common health outcome the health effect score was 5. If death was not a common health outcome, AWWA

experts subsequently scored 5 subcriteria to obtain a consensus-based overall health effect score. These subcriteria included the following:

1. Require medical attention to get better a. Self limiting (i.e., low score) b. Medical treatment (i.e., high score) 2. Severity (any one of the four severity outcomes listed below receiving a high [i.e., bad] score results in an overall high score for this sub criteria) a. Hospitalization b. Doctor visit c. Duration d.Intensity 3. Infectious dose (ID) a. High ID (i.e., low score) b. Low ID (i.e., high score) 4. Secondary spread a. Low (i.e., low score) b. High (i.e., high score) 5. Sequellae a. low (i.e., low score) b. High (i.e., high score)

It is important to note that selection criteria focused on attempting to determine the "most common" health outcome foreach of the sub criteria. For most microorganisms, a small

percentage of the exposed population, even within a subpopulation, can have more significant health outcomes than the majority of the exposed population. W hile this effect was acknowledged, scoring was still assigned on consensus following determination of the most common outcome without overly weighting exceptional cases. It was also determined that because the population and subpopulations under consideration are within the U.S., all individuals are well nourished and do not have chronic microbial infections (commonly observed in developing nations) that could exacerbate a microbial infection.

Score Summary

The scores from the W BDO (0-5), occurrence (0-5), and health effects (1-5) decision trees were compiled and the organisms were ranked from highest to lowest scores. Unlike the EPA process, the AWWA

approach included both W BDO and occurrence scores provided the occurrence report was distinct from that of the outbreak report. W hile they are related, they are not the same and do not provide the same information. Outbreaks are directly related to public health concerns while occurrence data provides an indication of the continued presence of the organism in water and therefore the potential of the organism to cause future waterborne disease. The intent of the AWWA expert group was to ensure that outbreaks and occurrence were not "double-counted"; that is, the group intended to avoid using a single report to score both outbreak and document pathogen occurrence. AWWA also believes it is appropriate to score both outbreak and occurrence given that these pieces of information are likely to be underestimated for a variety of reasons, including the fact that many outbreaks are either not reported or the causative agent is not identified (NRC, 2004). Additionally, outbreak and occurrence data may be limited due to the lack of reliable and sensitive detection methods.

The final step in the AWWA approach relied on expert opinion. AWWA's microbiology workgroup independently evaluated the list of scored microbes, as was done by the external experts at the March 2007 workshop (EPA, 2008b), and voted to include or notinclude the pathogens on the draft CCL3 (see Table A-2;

Appendix). [See PDF for Appendix] These expert opinions were based largely on whether a pathogen is known or likely to occur in public water systems with a frequency that poses a public health threat, the likelihood of the microorganism to withstand

conventional treatment (filtration and disinfection), and whether or not there would be a meaningful opportunity to improve public health if this microorganism was regulated. The

evaluation also included an uncertainty assessment to account for organisms that have documented adverse health effects but have limited occurrence information, perhaps due to lack of detection methodologies, although they are anticipated to occur in water. In addition, the AWWA microbiologists-including a practicing expert in clinical infectious disease microbiology- considered whether or not additional regulations would be appropriate given the knowledge of each organism's susceptibility to conventional water treatment. AWWA believes that listing some microbes that are widely (and in some cases,

even historically) known to be sensitive to chlorination will misdirect EPA resources and limit the evaluation of more robust pathogens that are known or anticipated to occur in drinking water and have adverse health effects but for which data may be limited due to the lack of health effects information and the

availability of sensitive and reliable analytical methods from which occurrence and outbreak information may be determined.

As discussed above, in March of 2007, EPA invited experts in the field of microbiology to review and critique their process for identifying organisms to be listed on CCL3. The expert

reviewers were asked to answer the following question: "Does the CCL3 represent pathogens that have the most potential to occur in PWSs and cause health effects?" Based on the summaries prov ided in the Federal Register notice (EPA, 2008a), the summary of the microbial expert meeting (EPA, 2008b), and as noted above, AWWA

believes that many of the comments and recommendations prov ided by that expert review panel were not sufficiently implemented or addressed nor integrated into EPA's CCL approach, especially for the PCCL to CCL step.

Comparison of Results of EPA's and AWWA's Approach for Evaluating PCCL PathogensThe EPA used a list of 1,415 human pathogens (bacteria,

viruses, protozoa, helminths, and fungi) compiled by Taylor et al. (2001) as the starting point for populating the microbial universe, as recommended by NDWAC (2004). Based on a review of the literature, EPA added six fungi and reovirus to the microbial universe. In response to EPA's request for nominations, additional organisms were added (Methylobacterium spp. and Mimivirus) bringing the microbial universe to 1,425 organisms.

A variety of screening criteria were then used to exclude pathogens whose biological properties are incompatible with water transmission by ingestion, inhalation or dermal contact, and those pathogens that are typically transmitted by sources other than drinking water (e.g., exclusively vector- borne microbes and pathogens transmitted solely by respiratory secretions). This screening process resulted in exclusion of 97.8% of the microbial universe and 29 pathogens moving to the PCCL. AWWA

recognizes EPA's efforts in building a comprehensive microbial universe and supports the use of pragmatic screening criteria to define the PCCL.

EPA then used a scoring system based on W BDOs, occurrence in water, and adverse health effects to score and rank the PCCL microbes and determine the draft CCL3. As noted above, the higher of the W BDO score or the occurrence score was added to the normalized health effects score to produce a composite pathogen score (maximum = 10 on EPA scale). EPA (2008a) notes that there were a few "natural" breakpoints in the 29 pathogen scores with the top 11 forming the highest ranked group of pathogens (score >7.1; see Table 1). AWWA does not prescribe an a priori fixed number of contaminants on the CCL but is concerned that too many contaminants render the list impractical and ineffective for its stated purposes. Consequently, natural or arbitrarily assigned breakpoints are necessary to pragmatically prioritize the contaminants that pass through to the final CCL. The maximum score of a pathogen using AWWA's approach was 15.0, so the breakpoint was somewhat arbitrarily assigned at half of the highest score of 14.5 (7.25).As summarized in Table 1 below, using a breakpoint of 7.1,

EPA's draft CCL3 includes 11 pathogens while the EPA experts scoring of PCCL pathogens using EPA's approach includes 12 pathogens. The AWWA scoring approach resulted in 11 pathogens as the top ranked list, prior to the post-scoring reality/confirmation check that is an integral part of the AWWA process.

Table 1 Comparison Between EPA, EPA Experts, and AWWA's Process for Ranking PCCL Pathogens (rank is in parentheses after each organism) [see PDF]

Discussion of Controversial Microorganisms

The sections that follow provide detailed discussions of nine "controversial microorganisms" from the PCCL for which the AWWA process-to include the results of the post-scoring reality/confirmation voting by the five AWWA microbial workgroup experts-results in a different list of pathogens for inclusion on the final CCL3 than that of EPA's draft CCL3. These pathogens include the following: (human) enterov iruses, Entamoeba histolytica, Helicobacter pylori, Mycobacterium

avium, Naegleria fowleri, rotavirus, Salmonella sp., Shigella sp., and Vibrio sp. The Appendix (see Table A-2) provides a color-coded, side-by-side comparison of PCCL pathogen scores by EPA (i.e., the draft CCL3), the March 2007 EPA experts, and using the AWWA

approach. [See PDF for Appendix] The completed decision trees for all pathogens in alphabetical order are enclosed separately from these comments.

Furthermore, these comments do not include discussion of PCCL pathogens for which there is agreement between the draft CCL3 and the AWWA

approach for their inclusion (e.g., Legionella pneumophila) or exclusion (e.g., Hepatitis E) on the CCL3-despite variances in their respective scores and overall rankings. Note, although the EPA experts scores using the EPA approach resulted in recommending adenov irus for inclusion on the CCL3 (see Tables 1, A-1, and A-2), it is not discussed because AWWA

agrees with EPA that it should not be included on the CCL3.On AWWA Prioritized List but not on EPA draft CCL3

Enterov irus

Enterov iruses are common human viruses associated with various clinical syndromes, ranging from minor febrile illness to

severe, potentially fatal conditions (e.g., aseptic meningitis, paralysis, myocarditis, and neonatal enteroviral sepsis). Although most cases are asymptomatic, enterov iruses are the most common cause of meningitis in the U.S. (principally echov iruses and coxsackiev iruses) with an estimated 30,000-50,000 hospitalizations each year (Khetsuriani et al, 2002; Kim et al 2001; Khetsuriani 2003). There are an estimated 10-15 million symptomatic enterovirus infections each year in the U.S. Viruses belonging to the enterovirus group have been responsible for at least one waterborne disease outbreak in the developed world (Hafliger et al., 2000) and have been detected in U.S. source waters and treated drinking water (Borchardt et al., 2003; Keswick et al., 1984; Lieberman, et al., 2002; Vivier et al., 2004). A variety of group B and group A coxsackieviruses and echov iruses were identified by molecular methods in municipal well water (Borchardt et al., 2004). AWWA's approach scored enterov iruses as 7.5, making it 11th out of the 29 PCCL organisms, and above the cut-off score of 7.25 for inclusion on the CCL. The EPA expert panel scored enteroviruses at 7.9, placing it 6th on the list, above the "natural" breakpoint of 7.0, and the EPA experts post-scoring

vote was unanimous for inclusion of enteroviruses on the CCL3. However, EPA's final score was reduced to 6.6, ranking this group of viruses at position 13 and excluding them from draft CCL3. If EPA did use any sort of post-scoring reality/confirmation check to downgrade the enterov irus score such that it was excluded from the final CCL, the rationale for the reality/confirmation check needs to be fully explained.

Mycobacterium avium

Mycobacterium avium complex organisms are opportunisticpathogens that cause pulmonary disease and are capable of

disseminating through the body and leading to debilitating and lifethreatening infection. The incidence rates of pulmonary mycobacteriosis appear to be increasing in the U.S. and in the developed world (Salama et al., 2003). EPA researchers Hilborn and Ghio (2008) conducted a review of peer-rev iewed literature related to mycobacteria and drinking water and presented their findings at the 2008 Emerging Infectious Disease Conference. They concluded that there is clear ev idence that drinking water is a source of pulmonary env ironmental mycobacteriosis; however the etiologic fraction of the disease attributable to drinking water is unknown.

In the U.S., current disinfection practices appear to be efficient for inactivation of most of the microorganisms on the draft CCL3 with the possible exception of Mycobacterium avium.

Because M. av ium is more resistant to most disinfectants than other waterborne bacteria (Gerba et al., 2003; Taylor et al., 2000), it is reasonable to assume that these biofilm-associated organisms (Torv inen et al., 2007; Vaerewijck et al., 2005) may continue to pose risks to treated water supplies as the nidus of bacteria would continue to exist in the water distribution system (Hilborn et al., 2006). In addition, the degree of M.

avium resistance to disinfection remains uncertain. M. avium cells grown in low nutrient conditions have been show to be 10- fold more resistant than bacteriologic culture medium-grown M.

avium cells (Torvinen et al., 2007). Furthermore, resistance to disinfection has been shown to be directly related to growth rate, with slower growing strains showing greatest resistance. Notably, in addition to its high overall score and ranking (7th of 11 top scoring pathogens, the AWWA experts voted unanimously for its inclusion in the post-scoring voting. Moreover, EPA's own microbial expert panel voted 4 to 2 in favor of its inclusion on the draft CCL3 despite not quite making the 7.1 cut-off value for inclusion (EPA, 2008b). AWWA believes M.

avium to be a pathogen whose inclusion on the CCL3, as it was on the CCL1 and CCL2, could bring about increased research to resolve important questions related to water treatment resistance, risks, and whether its regulation in drinking water would result in public health benefits.Rotav iruses

A variety of rotaviruses are widespread throughout the animal kingdom, but the majority of human strains belong to G serotypes 1-4. Rotavirus infection is the most common cause of diarrhea in children worldwide, occurring primarily in winter epidemics with a high level of person-to-person transmission. Rotav iruses are excreted in very large quantities in the feces of infected subjects, so they are present in relatively high concentrations in wastewater and env ironmental water (Abad et al., 1998; Ansari et al., 1991; Dubois et al., 1997). Rotav iruses have been detected by molecular methods in treated drinking water (Gratacap-Cavallier et al., 2000) and non- disinfected well water (Borchardt et al., 2004), and 13.8% of groundwater samples were positive in a large survey (Abbaszadegan et al., 1999). They are relatively resistant to

env ironmental stresses and conventional drinking water treatment may not completely remove or inactivate them. Consequently, drinking water may play a role in the transmission of these viruses but further study is warranted. Therefore, it is appropriate that rotaviruses are included on the CCL. AWWA's process scored rotavirus as 8.5, placing it 9th out of the 29 PCCL organisms. The EPA expert panel scored rotavirus at 7.2, placing it 10th on their list, above the "natural breakpoint" of 7.0. However, EPA's final score was reduced to 6.5, which means rotavirus is excluded from the draft CCL3. In post-scoring voting, EPA's expert panel was split (50/50) on whether rotaviruses should be on the CCL3. This uncertainty over its placement is reflected in the relatively low ranking by both the AWWA process and the EPA expert panel although both groups of experts placed it on the list. If EPA did use any sort of post-scoring reality/confirmation check to downgrade the rotavirus score such that it was excluded from the draft CCL3, the rationale for the reality/confirmation check needs to be fully explained.

On EPA draft CCL3 but not on AWWA List

Entamoeba histolyticaEntamoeba histolyica is very common in developing countries,

but rare in the U.S. Waterborne disease outbreaks are not anticipated in the U.S. and although still reportable in most states, amoebiasis was dropped from the list of nationally notifiable diseases in 1994 (Keene, 2006). W hile one report, the Morbidity and Mortality Weekly Surveillance Report (MMW R, 2006) reference of the Palau outbreak in 2002 has been reported, this occurrence did not occur in the

U.S. and the outbreak was reported from a stream that was not a drinking water source. Thus, this report is not a valid reference for CCL purposes. In another MMW R (2006)-reported outbreak cited by EPA, the source of the outbreak was a well in a community water source in which stool samples were found to contain not only E. histolytica, but some also contained Campylobacter jejuni and Giardia sp. These results suggest that it would be impossible to determine which of the diarrheal agents actually caused the outbreak because all reports of pathogens were derived from stool specimens. Moreover, E. histolytica was not found in the well water, and because of the mixed infections, there was no clear proof of E. histolytica being the primary cause of the human symptoms (MMW R, 2006). The AWWA approach scores E. histolytica low in outbreak and occurrence and results it being ranked near the bottom of the

evaluated PCCL pathogens; thus, AWWA believes that it is inappropriate to include E. histolytica on the CCL3.

Helicobacter pylori

Although Helicobacter pylori remains one of the most common worldwide human infections and is associated with a number of important upper gastrointestinal conditions, including chronic gastritis, peptic ulcer disease, and gastric malignancy, its prevalence is closely tied to socioeconomic conditions and is more common in developing countries than in the U.S. and other developed countries (Chey and Wong, 2007). In some indiv iduals, H. pylori causes acute gastric ulcers and can lead to gastric cancer, although the route of transmission into susceptible hosts remains largely unknown (Bellack et al., 2006; Brown, 2000). It is an emerging pathogen whose impact on human healthhas only recently begun to be elucidated. Fecal-oral and

personto- person contact have been proposed as possible routes of exposure to this pathogen; however, contaminated drinking water may also be a source (e.g., McDaniels et al., 2005; Reav is, 2005). In this regard, surv ival of H. pylori in different types of waters and biofilms (Park et al., 2001) in drinking water systems have been reported as possible

reservoirs of this organism. However, attempts to culture H. pylori cells from environmental water samples continue to be largely unsuccessful and discussions on whether this fastidious microorganism can exist in an infectious state are controversial.

As discussed prev iously, EPA appears to have modified the PCCL scoring process in a nontransparent manner that resulted in H. pylori receiving a dramatically higher ranking than was originally obtained by the expert scoring process as documented in EPA (2008a) and resulted in its inclusion on the draft CCL3. Also, at least one member of the March 2007 expert panel questioned the changes in expert scores by EPA and noted that the discussions of H. pylori in the draft CCL3 do not reflect the consensus opinion of the EPA expert panel. The Federal Register notice for the draft CCL3 (EPA, 2008a) states:

"Given the slow development of adverse health effects due to infection by H. pylori, it is more difficult to link contamination of drinking water and show a waterborne disease outbreak. Therefore, given the long timeframe of cancer and ulcer development (as opposed to the commonly acute gastrointestinal illness of nearly all the other pathogens on the PCCL) as well as the ongoing nature of the research, EPA used peer-reviewed scientific papers to score the health effects of H. pylori."

This implies that EPA rationalizes inclusion of H. pylori on the draft CCL3 based solely on the potential for causing gastric cancer. AWWA does not minimize the significance and impact of such a potentially devastating disease but questions the validity of its inclusion based on this single dramatic health effect, and contrary to the EPA's scoring process and in opposition to the EPA's expert panel and the lack of ev idencefor drinking water as a route of transmission. For these

reasons, and because H. pylori was not ranked sufficiently high by consistent application of the AWWA scoring process and the post-scoring reality/confirmation check process, AWWA does not believes that it is inappropriate to include it on the CCL3.

Naegleria fowleri

Primary amebic meningoencephalitis (PAM) associated with exposure to Naegleria fowleri is an uncommon condition with a high mortality rate and is indeed a serious infection; however, since the organism is sensitive to chlorine at 1 ppm (DeJonckheere and van de Voorde, 1976), AWWA believes that this organism is not a viable candidate for inclusion on the final CCL3 list due to its ease of treatability and rareness of PAM associated with exposure in contaminated water. .

The Arizona cases involving two children have been suggested by molecular analysis to be "associated" with a domestic water source but it is important to note that the water source had been stagnant and open to outside contamination. Molecular analysis revealed that 17/19 samples, collected from bathroom, kitchen pipes and sink traps were found to contain Naegleria DNA by nested PCR analysis; however, there was no assessment of viability. The domestic water was supplied from a private water company and disinfection did not occur at the time of the incidents. Therefore, the exposure scenario associated with this "outbreak" is not one of a chlorinated water system (Marciano-Cabral et al., 2003). Because N. fowleri is an organism that can be found in U.S. soils and thus in standing water, this outbreak report should not be considered conclusive for evidence of contamination in the treated drinking water supply. Although a small number of PAM-related deaths have been reported from contaminated recreational waters in the U.S., none have been reported from treated water supplies. Each of these cases involved bathing or swimming in warm freshwater and therefore should not receive focus from the drinking water regulations (Schuster and Visvesvara, 2003). A recent report (Gerba et al. 2007) describes the widespread occurrence of N. fowleri in well water, and reports some resistance to chlorine; however, this report was not peer reviewed and has not sincebeen substantiated by other investigators.

A catastrophic outcome for a very small number of individuals should not be the sole driver behind placing an organism on the CCL. W hile it is acknowledged that N. fowleri occurs in untreated and recreational waters and can cause death, there is no strong (and corroborated) ev idence that treated drinking water is a significant mode of transmission. Thus, the AWWA approach resulted in N. fowleri scoring below the cut-off of 7.25. Although the EPA experts ranked N. fowleri high at their workshop in March 2007, they subsequently identified some concerns with this ranking, stating that (EPA, 2008b) "although Naegleria fowleri received a high score, it may not be appropriate to include it on the CCL due to its rarity in the

env ironment."

On EPA Draft CCL3 and AWWA List but Excluded from AWWA List because of Post-Score Reality/Confirmation Check

Salmonella spp., Shigella spp.

Despite the fact that these bacteria pathogens continue to cause W BDOs (e.g., 124 cases of salmonellosis in June 1999 in Missouri due to a community well that had inadequate chlorine levels, MMW R, 2006; and the March 2008 salmonellosis outbreak in the City of Alamosa, Colorado), these outbreaks are uniformly attributed to breaches in water treatment or untoward weather events. Both microorganisms are sensitive to chlorine and do not pose a risk when conventional drinking water treatment is applied. Because regulations governing chlorination of surface and ground water public water systems are already in place, AWWA believes it is not prudent to use existing regulatory resources to enforce the SWTR and GW R than to potentially create new regulations through the CCL process, which would be specific to these organisms.

Vibrio sp.No outbreaks have been reported in U.S. drinking water

supplies. Foodborne (mostly seafood) and foreign travel is responsible for the burden of V. cholera cases in U.S. (Steinberg et al., 2001). One outbreak reported by CDC (MMW R) in 2004 originated in Alaska and was the result of raw oysters consumption from harvests in Alaskan waters. The MMW R (2006) reports disease resulting from exposure to Vibrio as a result of wading in flood water of Hurricane Katrina. In another report, non-01 V. cholerae was isolated from surface waters in Western Colorado; however, none of these environmental isolates have ever been associated with human disease (Rhodes et al. 1986). Because this vegetative bacterium is widely (even "historically"; NRC, 2004) known to be sensitive to chlorination and does not pose a risk when drinking water is properly disinfected, similar to Salmonella and Shigella spp. above, AWWA

does not feel it is appropriate to include V. cholerae on the CCL3.

Recommendations for CCL3 Contaminants

Based on the results of our alternative approach, which we recommend EPA use in developing the final CCL3, AWWA specifically recommends the addition of human enteroviruses, Mycobacterium avium, and rotaviruses to the final CCL3. AWWA also recommends the removal of Entamoeba histolytica, Helicobacter pylori, Naegleria fowleri, Salmonella spp., Shigella spp., and Vibrio cholerae from the draft CCL3. Lastly, AWWA supports the inclusion of draft CCL3 microbial contaminants Campylobacter-like organisms, human caliciviruses, Hepatitis A, Legionella pneumophila, and toxigenic E. coli on the final CCL3.

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See APPENDIX [See PDF for Appendix] CS Title: 0146 Company/group/association name: Comment:

Maryland Department of the Environment 1800 Washington Boulevard Baltimore MD 21230 410-537-3000 1-800-633-6101

Martin O'Malley Governor

Anthony G. Brown Lieutenant Governor

Shari T. W ilson Secretary

Robert M. Summers, Ph.D. Deputy Secretary

Mr. Benjamin H. Grumbles Assistant Administrator U.S. Environmental Protection Agency Office of Water (4101M) 1200 Pennsylvania Avenue, N.W . Washington, D.C. 20460

Dear Mr. Grumbles:

Thank you for your letters to John Colmers, Secretary of the Maryland Department of Health and Mental Hygiene, and me regarding pharmaceuticals in water and drinking water systems. The Maryland Department of the Environment (MDE) appreciates your interest in this matter.Weagree with the Environmental Protection Agency's (EPA's)

concern regarding the need to clarify the uncertainty of the effects of trace levels of pharmaceuticals in our water supplies. The States have limited resources to develop the potential effects for both public health and aquatic life and we look forward to EPA taking a strong leadership role in this

area.

Currently the department has undertaken a limited number of activities related to the areas of pharmaceutical research and prevention. In 2007, we prepared a summary of documented endocrine disruptor occurrences in Maryland which identified data for a small number of pharmaceuticals and personal care products (PPCPs), including Roxarsone, used in poultry feed, and Triclosan and Triclocarban used as antimicrobials in soaps. Wealso participated in several stakeholder groups. The Potomac Drinking Water Source Water Protection Partnership is investigating emerging contaminants broadly and supporting national-level studies such as those by EPA and the U.S. Geological Survey. The Maryland Chapter of the Hospitals for a Healthy Environment (H2E) provides assistance and networking initiatives to promote environmental sustainability in healthcare and is addressing pharmaceutical waste disposal. We maintain a presence in the EPA Region 3 PHARMS group, which is exploring best management practices for the handling of pharmaceuticals. The EPA's website about PPCPs has been useful to this committee, and MDE will share with EPA any outreach materials that we develop.

You requested comments on EPA's selection of contaminants for the draft Contaminant Candidate List (CCL). We understand the difficulty of this task of narrowing down the many potential contaminants that exist in the environment and offer these comments in hopes that they may be appropriate for the screening process. The Maximum Recommended Daily Dose (MRDD), used to indicate a potential for adverse effect, is determined from clinical trials involving daily treatments over 3-12 months. The MRDDs may not reflect the risks associated with long-term, very low-dose exposures to sensitive human populations and aquatic organisms. Applying a 10-fold uncertainty factor to MRDDs, as is done to derive long-term reference doses from acute or subchronic toxicity data, may be justifiable. Factors such as persistence and bioaccumulationsmay be used to adjust toxicity and occurrence rankings to the

extent this type of information is available.

The potential for endocrine disruption is also important, since we already understand the importance of low-dose exposures for these compounds. Because the number of pharmaceutical candidates is so large and the available research is limited, it may be reasonable and consistent with the CCL goals to limit the focus to a smaller number of compounds that represent major classes of pharmaceuticals and show ev idence of occurrence in the aquatic env ironment in studies by the U.S. Geological Survey and others. Because many of the same pharmaceuticals are used in regions of the U.S., it might be possible to divide the work of testing, assigning different compounds to different locations, e.g., assigning agents A thru E to 10 states, agents F thru L to 10 other states, etc.

Welook forward to continuing our partnership with EPA and the transfer of knowledge on pharmaceuticals in the environment. Thank you again for your letter. If you would like further information, please contact me or Mr. Jay Sakai, Director of Water Management Administration at (410) 537-3512 or by e-mail at jsakai@mde.state.md.us.

Sincerely,

Shari T. W ilson Secretary

cc: John M. Colmers, Secretary, Maryland Department of Health and Mental Hygiene

Dr. Phil Heard, Science Service Administration

Jay Sakai, Director, Water Management Administration

STW/cj CS Title: 0147 Company/group/association name: Comment:

Lindon Park Neighborhood AssociationMay 20, 2008

Mr. David Ryan USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N.W . Mail Code: 1703A Washington, DC 20460

Re:Public Comment on Possible Drinking Water Contaminants

Dear Mr. Ryan;

The Lindon Park Neighborhood Association (LPNA) is the US EPA Technical Assistance Grant (TAG) recipient for the Motorola 52nd Street (M52) Superfund Site in Phoenix, AZ. Our Superfund site is one of the larger and more complicated sites in the country and involves both Superfund CVOC contaminants and jet fuel commingled with Superfund CVOCs. The site is divided into three operable units (OU1, OU2, and OU3). EPA has the lead at OU3, where there is no interim or final remedy yet. The Arizona Department of Environmental Quality has the project management and community involvement lead at OU1 and OU2, which both have interim remedies in place.

Webecame aware of the proposed 104 additions to the drinking water contaminants list through the sharing of information by community members involved with sites in other parts of the country. The TAG immediately recognized the potential importance of these additions and shared this information with our EPA contacts. LPNA has also included this topic for discussion at our last two TAG meetings on March 6 and April 29, 2008 as well as distributing printouts of the CCL3 information.

A query of a database containing some of the M52 Superfund site sampling data found contaminants presented in the EPA CCL3. In particular the following contaminants are present in the Motorola 52nd Superfund site groundwater at varying levels: Bromomethane; 1,4-Dioxane; Chloromethane; Methyl Tert-butyl Ether; 1,1,1,2-Tetrachloroethane; 1,1-Dichloroethane; and Perchlorate.

The Linden Park Neighborhood Association supports the additionof these contaminants as well as the others on the CCL3 to the

draft list and supports establishment of MCLs for these contaminants.

If these contaminants are added to the Drinking Water list and MCLs are established, there are two ways our Superfund site may be impacted: (1) when the final remedy is selected those contaminants would have to be added to the remedy ARARs (Applicable or Relevant and Appropriate Requirements), and (2) there may be an impact to the requirement to discharge the treated groundwater to the Salt River Project canal at Operable Unit 2 (OU2). There may be additional impacts when an interim and final remedy are selected for OU3 at our site.

EPA has indicated that there are proposed, but not yet established, MCLs for those contaminants, and the ADEQ Drinking Water Program Unit Manager, Tony Bode, is not aware of any MCLs being established yet. Since Arizona protects its aquifers to Drinking Water Standards, the groundwater might be in v iolation for these contaminants once MCLs are established.

Weencourage the addition of the contaminants on the CCL3 to the regulated drinking water standards and hope that MCLs will be established soon. Setting MCLs as quickly as possible is crucial to reducing risk and protecting public health.

Obviously the impact of these contaminant candidate additions with the establishment of MCLs goes well beyond the treatment at drinking water facilities and may be relevant at many, if not most, Federal and State Superfund sites in Arizona and perhaps throughout the country.

Thank you for this opportunity to comment on the proposed additions to the draft Contaminant Candidate List.

Sincerely,

Mary I. Moore Vice President, Lindon Park Neighborhood Association TAG Project Manager, Motorola 52nd Street Superfund Site 4839 East Brill Street Phoenix, AZ 85008 CS Title: 0148 Company/group/association name:Comment:

SubjectRe: Docket W-98-02, Perchlorate andthe UCM list

Government should include in water test for the contaminant... perchlorate be subject to "unregulated contaminant monitoring in public water systems" CS Title: 0149 Company/group/association name: Comment:

SubjectRe: Docket W-98-02, Perchlorate and the UCM list

Hello. Let's do whatever we can to keep our water safe. Herma

CS Title: 0150 Company/group/association name: Comment:

May 8, 2008

Benjamin H. Grumbles, Assistant Administrator Office of Water United States Environmental Protection Agency Washington, DC 20460

Dear Mr. Grumbles:

Thank you for your letter of March 28, 2008, regarding the issue of pharmaceuticals in water and drinking water. I appreciate the attention you are focusing on this topic and look forward to working with the Environmental Protection Agency (EPA) as we all move forward to address the potential public health issues associated with this topic.

As you know, the issue of pharmaceuticals and personal care products (PPCPs) in the environment is not new. As our analytical abilities have improved, PPCPs have been detected in many water bodies across the country. W hile we can find theseproducts almost every place we look, our understanding of the

potential effects these contaminants can have on public health and aquatic life remains uncertain. I hope EPA can help improve our understanding of the health and environmental effects of these contaminants by conducting further research and health risk studies in these areas.

Public health practice is focused on the prevention of human health problems, and inasmuch as humans need a healthy

env ironment in which to flourish, I appreciate your attention to the stewardship and pollution prevention aspects of this issue. I urge your strong support of efforts to keep PPCPs out of the environment in the first place. Two important aspects of such prevention efforts would include enhanced research into wastewater treatment technologies and more effective and widely

available pharmaceutical take-back programs.

In the enclosure to this letter, I have provided additional specific information regarding the efforts in Washington State to address PPCPs in the environment. I have also included suggestions on some efforts EPA could take to provide the needed national leadership on this complex and challenging issue. [See PDF for Attachments]

Again, I appreciate your attention on this important matter and look forward to working with EPA to address the many significant issues involved. If you have any follow-up questions on our activities and issues in Washington State, please contact Gregg Grunenfelder, Assistant Secretary of our Division of Environmental Health, at 360-236-3050.

Sincerely,

Mary C. Selecky Secretary

Enclosures

cc: Sarah Neiderer, Association of State & Territorial Health Officials

Jay Manning, Department of EcologyGregg Grunenfelder, Department of Health

Pharmaceuticals and Personal Care Products

Washington State Perspectives

May 6, 2008

Monitoring Efforts for PPCPs in the Environment

In Washington State, monitoring for PPCPs has been very limited. The only state monitoring effort undertaken to-date was conducted by the Washington State Department of Ecology in 2003-04. The enclosed report presents the full findings from that monitoring effort: Results of a Screening Analysis for Pharmaceuticals in Wastewater Treatment Plant Effluents, Wells, and Creeks in the Sequim-Dungeness Area, November 2004. The study involved analysis for 24 PPCPs in tertiary wastewater treatment plant effluents and nearby wells and creeks in northwestern Washington. The treated effluents were ultimately used in re-use programs and conventional land application. A total of 16 compounds were detected in one or both effluents. Only caffeine, nicotine, and the diabetes drug Metformin (tentatively identified) were consistently detected in well and creek samples.

Recommended Focus for Future Monitoring Efforts

Future monitoring efforts for PPCPs should focus on the presence and fate of PPCPs in leachate, biosolids, and other byproducts of our solid waste and liquid water treatment systems. Given the state of our analytical monitoring techniques, more general monitoring will simply reconfirm what we already know - PPCPs are widely present in our env ironment. Wesuggest that a more responsible use of the limited federal resources that may be available for expanded monitoring efforts should be more focused in areas that will help inform future actions to address the pollution prevention aspects of this issue.Need for More Research

Greater support for continued research is needed in the areas of wastewater treatment and water reclamation technologies to address the removal of PPCPs in effluent. Identifying efficient and effective ways to treat for these contaminants in wastewater, while at the same time not interfering with the treatment effectiveness to control known health threats such as microbial pathogens, is an essential action needing support from EPA.

In addition, more research is needed to better understanding the health and environmental risks associated with the very low levels of PPCPs found in our environment. W hile our analytical techniques to detect these compounds in minute quantities have improved greatly, our understanding of the human and

env ironmental impacts of these low levels of contamination is lagging - especially for endocrine disrupting compounds. To address this issue responsibly, greater understanding of the effects low level concentrations of these compounds have on aquatic life and human health is needed.

Consideration of PPCPs in EPA's Drinking Water Regulatory Efforts

PPCPs should receive priority consideration for both occurrence and health effects review as the next Contaminant Candidate List (CCL) is developed for potential future drinking water contaminant regulations. In future CCL efforts EPA needs to go beyond evaluation of determining acute and chronic toxicity and address the potential impacts associated with endocrine disruption. Future regulatory consideration should be based upon a process of comprehensive and sound scientific rev iew.

National Policy Direction on the Disposal of Unwanted Pharmaceuticals Needs to be Refocused

Current national guidelines call for direct disposal of unuseddrugs into the solid waste stream. This seems to be an ill-

adv ised long-term strategy because leachate from many landfills is often sent to the same wastewater treatment systems that receive residential wastewater. This disposal route may merely delay the continued pollution of surface water and ground water.

A more effective and convenient way to safely and dispose of collect unwanted drugs is needed. In addition to protecting our nation's waters, another reason to establish more effective drug collection programs is to help prevent unintentional poisonings. In 2005, Washington State had 923 poisoning deaths. More than 90 percent of those deaths were associated with drug

overdoses. Nationally and in Washington, prescription opiate

overdose deaths have fueled a significant increase in poisoning deaths. The increase in deaths mirrors the increase in the

volume of opiates prescribed. It is essential that at the national and state level we do everything we can to efficiently and effectively collect and dispose of unwanted medicines.

Here in Washington, we do have a pilot pharmaceutical take-back program. Information on our program can be viewed at: www.medicinereturn.com. Enclosed for your information is a report on our state's pilot project for the collection of pharmaceuticals from households - Disposal of Medications from Residential Consumers - October 2005, rev ised November 2007. [See PDF]

Weneed support from EPA and other federal agencies to help remove the barriers to safe and responsible pharmaceutical take-back programs. We hope EPA will join in watching closely the efforts of the Drug Enforcement Administration as they move to amend their regulations to better accommodate the proper disposal of unwanted medicines (see enclosed April 23, 2008 from Mark Caverly, DEA). [See PDF] In addition, EPA's assistance is needed to bring the producers of pharmaceuticals into the discussions of responsible stewardship. Those manufacturing and profiting from the sale of these products should provide the resources necessary to ensure proper collection and disposal of their products when they are no longer needed.Federal Leadership is Needed

Federal leadership in the development of a national chemical policy is badly needed. More thoughtful and meaningful

oversight is needed in the review and approval of PPCPs and endocrine disrupting chemicals (EDCs) for use in our country. In order to protect our overall environment, including the quality of our waters, the U.S. Food and Drug Administration should more thoroughly screen pharmaceuticals for environmental persistence and accumulation prior to approval for use. In addition, harmful EDCs need to be identified and action taken to phase out the production and use of the most harmful of these chemicals. As a nation, we need to be positioned better in the future to prevent contamination of environment, rather than responding to the many complex issues which arise once we have discovered contamination has occurred from products approved for use by inadequate rev iew processes.

Greater Outreach and Education is Needed

Resources and support are also needed to help develop and implement programs to reach out to inform the public, health care prov iders, and veterinarians about this very complicated and important issue. Understanding the effects of PPCPs on our health and environment is challenging for everyone. Awareness and education efforts must be enhanced and be targeted towards the public as well as the physicians and veterinarians that prescribe pharmaceuticals to the people they serve. It is important to engage in a meaningful public dialogue on these issues so that the public can help in developing, supporting, and using the protections that are necessary.

CS Title: 0151 Company/group/association name: Comment:

May 13, 2008

United States Environmental Protection Agency Mr. Benjamin H.Grumbles, Assistant Administrator Ariel Rios Building1200 Pennsylvania Avenue, N.W .

Washington, D.C. 20460

Dear Mr. Grumbles:

Thank you for your letter dated March 28, 2008, seeking input regarding the Contaminant Candidate List (CCL3) and requesting information regarding pharmaceuticals and personal care products (PPCPs) in ambient water and treated drinking water in Texas.

The Texas Commission on Env ironmental Quality (TCEQ) supports the goals you stated in the letter to partner with governmental agencies, stakeholders, and the private sector. A rulemaking process that includes strong technical and stakeholder partnerships results in more equitable rules. We appreciate

every opportunity to partner with the Environmental Protection Agency (EPA).

The contaminant candidate list development process is peer-

reviewed process that includes many stakeholders, including TCEQ. The process that was used in developing CCL3 had prev iously been used in developing CCL1 and CCL2. It has been modified and strengthened over time through the input of many experts. The screening process that EPA currently uses to choose which contaminants should be on the list is based on good science. The TCEQ is not aware of any new scientific

evidence that would require mid-course changes to CCL3.

In the period of time before CCL4, EPA should continue to gather data about PPCPs. Specifically, EPA should attempt to gather health effects information related to very low levels of PPCPs in drinking water and ambient water.

EPA should not consider reprioritizing contaminants for CCL3 without obtaining new scientific information that would change how specific PPCPs should be ranked for CCL3. The current list should be abandoned, and the process should be reinitiated taking into account that new information. Recent elevation of the topic of PPCPs in the news media should not be taken as a mandate to change the normal process of evaluating contaminantsfor any contaminant candidate list. PPCPs in drinking water and

ambient water is a major concern to the public and therefore additional research on health effects by EPA is warranted.

The TCEQ does not have any additional information regarding the presence of PPCPs in ambient water or treated drinking water. Although we are aware that some universities and other agencies in Texas are doing work in this area, TCEQ has not funded any work in this area.

The TCEQ understands that EPA will be doing additional monitoring of PPCPs in ambient water as part of its Large River Project. The TCEQ's Water Quality Monitoring and Assessment Section is ready to assist in this effort.

The TCEQ wishes you great success in bringing together nationwide information related to PPCPs that will help the process of developing future contaminant candidate lists. We appreciate the opportunity to comment on this topic.

If we can be of any further service, please do not hesitate to contact Todd Chenoweth, Director of the Water Supply Division at (512) 239-4691.

Sincerely,

Buddy Garcia, Chairman

Texas Commission on Environmental Quality

BG/AD/hh CS Title: 0152 Company/group/association name: Comment:

April 11, 2008

Benjamin H. Grumbles Assistant AdministratorUnited States Environmental Protection Agency

Washington, D.C. 20460

Dear Mr. Grumbles:

Werecently received your letter regarding trace amounts of pharmaceuticals in water and drinking water systems. This issue does not come under the purview of the Health Department, however, we have been in contact with the Oklahoma State Department of Environmental Quality and they do plan to respond to you as requested.

Sincerely,

James M Crutcher, MD, MPH

Secretary of Health and Commissioner of Health CS Title: 0153 Company/group/association name: Comment:

May 19, 2008

Benjamin H. Grumbles Assistant Administrator United States Environmental Protection Agency East Building 1201 Constitution Avenue NW Room 3219 Washington, D.C. 20460

Dear Mr. Grumbles:

I am writing in response to your March 28 letter requesting information about pharmaceuticals in surface water and drinking water systems in New Jersey.

New Jersey Department of Environmental Protection (DEP) has been active in this area, and I am pleased to provide you with

an overview of our activities (see enclosure). This is inaddition to the discussion between DEP Div ision of Water Supply

Director Michele Putnam and Assistant Director Barker Hamill at the March 26, 2008, regional meeting in New York City with yourself, Mike Shapiro and staff. In addition, Assistant Director Hamill emailed two presentations authored by NJDEP Division of Science, Research and Technology Director Dr. Eileen Murphy to EPA Office of Science and Technology Deputy Director Suzanne Rudzinski, as she had requested following the regional meeting.

Weare aware of the release of the CCL 3 and are preparing comments from New Jersey. As you know, the issue of pharmaceuticals in drinking water is still being investigated by many states. Our concern in New Jersey is not so much the presence of any indiv idual compound (which occur at sub parts per billion levels), but of the fact that we find mixtures of these and other chemicals in our samples. It was not uncommon to find ten different synthetic organic compounds (some of which were pharmaceuticals or their breakdown products) in a drinking water compound. Assuming each were detected at one part per billion, the additive concentration is ten. The science is not available to assess the human health impacts of this scenario. Further, while we cannot say definitely that pharmaceuticals or other contaminants are causing ecological effects, we are indeed observing feminization of fish and other detrimental aquatic life effects downstream of wastewater discharges.

Also of note in New Jersey is the fact that we are conducting demonstration projects at two ground water systems to investigate the idea of a treatment-based regulatory approach for unregulated synthetic organic contaminants, including pharmaceuticals and their by-products. The State has awarded $1 million contracts with the Fairlawn Water System and Merchantv ille - Pennsauken Water System to install full-scale carbon units within their systems. Advanced analytical techniques will be used to track the fate, transport and removal of organic contaminants from the raw ground water through the carbon. The information acquired from these two projects will help inform us as we consider this treatment- based approach to deal with multiple organic contaminants.I am glad to provide you with this summary information of what

New Jersey has and continues to do in this area. If you would like additional information about any of these projects, please contact Eileen Murphy at 609-984-6070, Director of Science, Research and Technology or Michele Putnam, Director of Water Supply at 609-292-5550.

Sincerely,

Lisa P. Jackson Commissioner

Enclosed: Summary of Projects -Unregulated Contaminants in Drinking Water

Summary of Projects

Unregulated Contaminants in Drinking Water

Completed Projects

Studies conducted cooperatively with the New Jersey Department of Environmental Protection (NJDEP) with the Environmental and Occupational Health Sciences Institute (EOHSI) of New Jersey and the United States Geological Survey (USGS) with the federal Centers for Disease Control and Prevention (CDC) have shown that water samples analyzed by advanced analytical methods contain low levels of household (including pharmaceutical), commercial, and industrial compounds. The studies show that while the number of unregulated organic contaminants is highest for raw waters (i.e., rivers, ground water), many of these chemicals are not removed by current conventional water treatment technologies.

* NJDEP-DSRT/EOHSI "TIC" study:

NJDEP worked with analytical chemists at the EOHSI to analyze raw and finished drinking water for the presence of synthetic organic contaminants, indicated as Tentatively IdentifiedCompounds (TICs). The study, which focused on ground water

systems near hazardous waste sites, showed that both raw and finished drinking water at vulnerable areas contain a number of TICs at low levels (at or below one part per billion). Over the course of the 4-year study, approximately 600 tentatively identified organic compounds were detected in 199 water samples collected (including five bottled waters that are sold in New Jersey). Follow-up research with EOHSI and the School of Public Health at the University of Medicine and Dentistry of New Jersey show that there is little to no information on toxic effects for most of the chemicals detected in the prev ious study.

* UMDNJ/NJDEP-DSRT/USGS/CDC cooperative project:

NJDEP/USGS cooperative: The Passaic Valley Water Commission's Little Falls Water - Treatment (LFWT) plant is located in the heav ily populated, highly urbanized Passaic River drainage basin which includes more than 50 wastewater facilities that discharge effluent to the two streams from which the LFWT plant withdraws its raw-water supplies. Forty-five wastewater related organic chemicals were detected in samples of source water and 34 were detected in samples of settled sludge and (or) filter- backwash sediments. The number of wastewater compounds increased during conditions of low flow in the river. The

average percent removal of these was 53% of the chemicals removed by granular activated carbon filtration; 32% removed by disinfection; and 15% by clarification.

Projects Underway:

* Settlement of Environmental Penalty (SEP) with New Jersey American Water Company (NJAWC)

The primary objectives of this study are to document the occurrence and concentration of synthetic organic contaminants in raw and finished water supplies from New Jersey American Water Company's water treatment facilities that are supplied by surface waters and to identify the primary physical and chemical processes that govern the fate of synthetic organic contaminants through select water treatment facilities. Specific objectives are to:1. determine the occurrence and concentration of synthetic

organic contaminants in coupled raw-and finished-water samples from four NJAWC water treatment facilities that are supplied by surface waters; and

2. at a select water treatment facility, identify the physical and (or) chemical unit processes by which synthetic organic contaminants are most effectively removed from raw-water supplies, assess sludge from sedimentation tanks and activated carbon from filter systems as potential sinks for the removal of synthetic organic contaminants from source waters, identify the synthetic organic contaminants that persist through water treatment and determine their occurrence and concentrations at select locations throughout the distribution system.

* Demonstration Projects:

Based on a literature rev iew prepared for NJDEP by Black & Veatch, it was determined that the best available technology for removing a broad number of synthetic organic chemicals from New Jersey ground water was activated carbon.

The two ground water candidate systems that have been evaluated for contamination are the Fairlawn (Bergen County) and Merchantv ille/Pennsauken (Camden County) systems. They were selected because they both contained high numbers of unregulated synthetic contaminants in raw-water when they were sampled in prev ious studies.

Granular activated carbon (GAC) units are being constructed at both of these utilities. A report funded by NJDEP and conducted by Black & Veatch indicates that GAC is the most practical and effective treatment technology for removal of classes of synthetic organic chemicals from ground water. A fundamental issue that these demonstration projects will address is how to measure effectiveness of removal for the unregulated contaminants. If a treatment approach regulatory strategy is adopted, it is important to know how to monitor removalefficiency of the treatment.

* Tailored Collaboration :

NJDEP is collaborating with Black & Veatch Consultants and with

several water utilities throughout the state (including Passaic Valley) to conduct comprehensive studies on the occurrence and removal of unregulated contaminants, including nanomaterials, in drinking water. A proposal has been submitted to the American Water Works Association Research Foundation for funding consideration. It is anticipated that at least six surface water utilities will participate and possibly several groundwater systems.

* DEP Response:

* Development of a "treatment-based" MCL for synthetic organic contaminants.

* Begin a literature review for treatment of wastewater treatment plants similar to the one done for drinking water plants. This would represent the first step in determining how/if wastewater plants can address the persistence of these chemicals throughout the existing treatment. CS Title: 0154 Company/group/association name: Comment:

May 21, 2008

Mr. Benjamin H. Grumbles, Assistant Administrator Office of Water U.S. Environmental Protection Agency Washington, DC 20460

Dear Mr. Grumbles:

This is in response to your letter of March 28, 2008, requesting information on the State of Delaware's activity in investigating "emerging" contaminants of concern.One of the main contaminant initiatives of the Delaware

Department of Natural Resources and Environmental Control (DNREC) was the collection of data on polybrominated diphenyl ethers (PBDE) as a part of a toxics in biota monitoring program. This is due to its long-known widespread occurrence in the Delaware basin. DNREC analyzed PBDEs in 80 fish and shellfish samples collected over the period between fall 2003 through fall 2005 and in 33 additional samples during the 2006 monitoring cycle. However, only a fraction of the samples were collected from the main-stem tidal Delaware River. Several samples were collected from the Delaware Bay or tributaries that flow into the Delaware Bay. The results of the project were presented on July 23, 2007, at the National Forum on Contaminants in Fish, in Portland, ME (Greene, R. 2007. Polybrominated Diphenyl Ethers (PBDEs) in Fish from the Delaware River Drainage Basin). In summary the study showed that while fish species in the Delaware Estuary have comparatively high concentrations of PBDE compared to other waters, nationally and globally, the human health risks from consumption of this specific compound appear to be very low.

The Delaware River Basin Commission conducted studies (noted below) at regional levels and included substantial samplings in the main-stem tidal Delaware River, along with various sampling localities in the Delaware portion. Sampled were a wide variety of pharmaceuticals (prescription and non-prescription drugs, steroids, and antibiotics) and assorted industrial and household wastewater constituents.

MacGillivray, AR. 2008. Monitoring Emerging Contaminants in the Tidal Delaware River. Presented February 20, 2008, Delaware River Basin Commission's Ambient Toxicity Workgroup, West Trenton, NJ.

MacGillivray, AR. 2007. Emerging Contaminants of Concern in the Delaware River Basin, Vulnerability Assessment Preliminary Report. Delaware River Basin Commission, West Trenton, NJ.

The sampling done for the above studies will be repeated laterthis year.

Currently the United States Geological Survey (USGS) is conducting an ongoing statewide survey in cooperation with the Pennsylvania Department of Environmental Protection to investigate primarily pharmaceuticals, antibiotics, and hormones in their surface waters and ground water. Delaware requested, and the project sponsors agreed, to augment their sampling network to include the upper Brandywine Creek because it is the headwater for the City of W ilmington's water supply. The USGS began sampling in 2007 and plans to conduct quarterly sampling at all locations for a total of five years.

The completed and ongoing studies, similar to many others conducted across the nation, revealed a widespread occurrence of numerous species in ground water, surface water, and aquatic organisms. Again, similar to findings elsewhere, the concentrations of the contaminants are exceedingly low-below all thresholds of known human health effects - with concentration typically in the parts per trillion range.

Delaware also is preparing to do statewide sampling of the shallow ground water and all surface water intakes used for public water supply in the state. This is an extension of a similar study targeted at public water supply sources at potential risk due to proximity to known contaminant sources conducted several years ago. The work is being conducted by the Division of Public Health and funded by the Delaware Cancer Consortium. This study was primarily focused on volatile organics and will include two radionuclides. It did not originally include "emerging" contaminants; however, due to the latter being the recent object of national and local media attention, a select set of compounds is included for sampling. This list was provided to the Region III Office of Drinking Water and is attached for your reference. Approximately two hundred samples will be collected statewide and will be conducted in late May and June 2008. The findings will be made public online.

Delaware has taken steps that will help reduce "emerging"contaminants into our surface waters and aquifers. Our main

approach is to encourage land-based reuse and recycling alternatives for wastewater management, as opposed to direct surface water discharges. Delaware encourages municipalities and wastewater utilities to reuse and recycle highly treated wastewater for irrigation purposes.

It bears mentioning that Delaware has not issued any new National Pollutant Discharge Elimination System (NPDES) permits in over 15 years; and in order to comply with Total Maximum Daily Load (TMDL) regulations issued for almost every watershed in the state, DNREC has capped the loading limit of many NPDES facilities. We require them to seek land-based wastewater management alternatives if they plan to increase their nutrient load.

Furthermore, Delaware eliminated five NPDES dischargers in the Inland Bays basin and two more currently are rev iewing alternatives in order to eliminate their discharges.

Delaware finds that land application of highly treated wastewater prov ides additional barriers and hostile pathways that reduce overall pollutant loads to the environment and will do likewise for "emerging" comtaminants. Delaware will continue to stress the environmental benefits ofreusing and recycling treated wastewater.

Other action to reduce this contaminant stream is handled by the Solid and Hazardous Waste Management Branch (SHW MB). SHW MB prov ides case-by-case adv ice for the proper disposal of pharmaceuticals and personal care products. Our pollution prevention program is co-sponsoring a collection drive for unused drugs with the Delaware Nursing Association. One recent drive resulted in the collection and eventual destruction of 46,000 prescription pills. Three more statewide drives are planned for this year. The Delaware Solid Waste Authority offers regular household hazardous waste collection events throughout the State where unwanted pharmaceuticals and personal care products are accepted.In addition, you requested comment on the EPA's draft

contaminant candidate list (CCL 3) dated February 21, 2009 (73 FR9628-54). I understand that only one of the candidates labeled as emerging is included on the list. This seems to indicate that EPA is moving with proper prudence. Since the Division of Public Health, Office of Drinking Water, is the primacy agency for the Safe Drinking Water Act in Delaware, I wish to defer specific comment on the CCL 3 to that agency.

Much research remains to be conducted in this area to determine potential human health and ecological effects. W hile we may have limited understanding and an absence of regulations, that is not an excuse to avoid reducing the release of these compounds into the env ironment whenever possible. This only can reduce the possibility of risks in the future. Therefore, Delaware remains committed to continuing our efforts in this area of concern.

I appreciate the opportunity to share information on Delaware's activities. Please contact me if you have any questions or wish to discuss this further.

John A. Hughes

Secretary

Enclosure -contaminant list

cc: Jamie Rivera, M.D.

Katherine Bunting-Howarth

Study of Source Water for Potential Carcinogens in Delaware

Delaware Cancer Consortium Project

Water Supply Survey

May -June 2008List of "Emerging" Contaminants Detection Limit [See PDF]

CS Title: 0155 Company/group/association name: Comment:

MAY 27 2008

Mr. Benjamin H. Grumbles Assistant Administrator United States Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N.W . Washington, DC 20460

Dear Mr. Grumbles:

Thank you for your letter regarding pharmaceuticals in water and drinking water. I share your commitment to addressing this important issue through a collaborative approach that makes the most of the collective state and federal resources that can be brought together to assure that the citizens of New York State share a toxic-free future. In support of that commitment and in response to your request, I offer the following information on DEC's activities related to pharmaceuticals, as well as feedback on EPA's activities regarding these substances.

DEC Activities

DEC recognizes that pharmaceuticals and personal care products (PPCPs) in the water is a multifaceted issue with no single solution. Sources include unused drugs flushed by individuals and institutions, the discharge of pharmaceutical waste from drug manufacturers, and the passage of used pharmaceuticals through human bodies. Wastewater treatment plants (WWTPs) are not designed to remove these drugs, so treatment of municipal and industrial discharge is not the entire answer. DEC has established an internal Pharmaceuticals Work Group that includes staff from our Divisions of Water, Solid and Hazardous Materials, Pollution Prevention, Public Affairs and Policy Office. The group has initially focused on reducing the disposal of unused pharmaceuticals into the waters of New YorkState. This work group assures that the multiple programs that

have a role in addressing this issue are coordinated and in constant communication.

The work group's initial aim is to achieve a major reduction in the flushing of unused pharmaceuticals by individuals and institutions. To that end, DEC hosted a roundtable discussion in Albany on May 15, 2008. The purpose of the roundtable was to convene stakeholders to discuss management options for unused pharmaceuticals so that consumers can avoid flushing and ensure unused products are safely managed. I am pleased that EPA accepted our invitation to participate in these discussions and I look forward to the Agency's input.

DEC is also participating in a newly formed pharmaceuticals- related work group sponsored by the New England Interstate Water Pollution Control Commission (NEIW PCC) that will be fostering interstate communication and collaboration in addressing a variety of issues associated with pharmaceuticals in the environment. Last year, DEC staff worked with NEIW PCC to plan the "2007 Northeast Water Science Forum Pharmaceuticals and Personal Care Products: State of the Science" in Portland, Maine.

DEC is working closely with the U.S . Geological Survey (USGS) and New York State Department of Health on the monitoring of the New York City water supply watershed (NYC Watershed) for pharmaceuticals. Since 2003 USGS, in cooperation with DEC, has been conducting a study of the occurrence of trace organic compounds, including pharmaceuticals in the NYC Watershed. Much of the USGS effort in monitoring for trace organic compounds, including pharmaceuticals, has focused on assessing the effectiveness of wastewater treatment plant processes on the removal of these compounds. Sampling of these compounds has expanded in the last few years to include critical locations in the water supply system and source waters within the New York City reservoir system and tributary streams. As expected, the levels identified were a function of effluent concentration and proportion of discharge to stream flow. DEC is committed to continuing to work with USGS in this endeavor. Future work with USGS will assess the fate of these compounds in the aquaticenv ironment as well as the effectiveness of various treatment

technologies.

In addition to our internal activities, DEC will work closely with our Legislature on any bills associated with PPCPs in the

env ironment and drinking water. To date, a product stewardship bill has been introduced.

DEC is also participating in the Product Stewardship Institute's (PSI) pharmaceuticals initiative. PSI works with federal, state, local government agencies, manufacturers, retailers, env ironmental groups, and other stakeholders to reduce the health and env ironmental impacts of consumer products. The PSI pharmaceuticals initiative seeks to evaluate the need and opportunities for a nationally coordinated system for the management of unwanted pharmaceuticals. Through this process, we hope to work with other states and stakeholders to develop a viable return system for unused pharmaceuticals.

EPA Activities

The Toxic Substances Control Act appears to have been wholly ineffective at preventing occurrences of these chemicals in our nation's waters. Consequently, the nation is once again on track to repeat history - chasing after chemicals that have been already discharged for several decades. It appears that the Contaminant Candidate List process, required by Section 1412(b) (1) of SDWA, as amended in 1996, requires both information on the adverse effects of a chemical as well as indications that it is found at levels of concern in drinking water before EPA will take action to regulate it. DEC believes that EPA should take a more proactive and precautionary approach toward limiting the levels of contaminants that enter into sources of drinking water by determining effects and setting standards before the waters of the nation become contaminated.

Most states, including New York, do not have the resources to derive ambient water quality criteria for more than a small handful of contaminants of concern and EPA has moved at a lessthan satisfactory pace on publishing new and revised criteria.

Most of EPA's Ambient Water Quality Criteria date from around 1980. The Department urges EPA to significantly increase and expedite efforts to derive new and revised criteria, including criteria for pharmaceuticals and personal care products.

One of the biggest impediments to reducing the loading of unused drugs is the regulations of the federal Drug Enforcement Administration (DEA). The DEA does not permit consumers to return unused controlled substances to the point of sale (pharmacy) or to other third parties. This has made it extremely difficult and, in some cases impossible, for many states and local governments to implement a viable drug return program. The ideal return program needs to be simple,

convenient for the consumer, and economical. EPA should work expeditiously with DEA and the W hite House Office of National Drug Control Policy to facilitate DEA revision of its regulations to allow properly superv ised collection programs to move forward.

New York and other states across the country are looking to EPA to provide guidance on treatment methods that are effective at removing such chemicals from both wastewater and drinking water. This guidance can then be used by the states as they implement their wastewater and drinking water programs.

I would appreciate a detailed summary of each state's reply to your letter. I thank you for your time and attention regarding this important matter and look forward to working together to address it.

Sincerely,

Alexander B. Grannis CS Title: 0156 Company/group/association name: Comment:

May 6, 2008Mr. Benjamin H. Grumbles

U.S. EPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, DC 20460

Dear Mr. Grumbles:

Thank you for your letter requesting to share information on state activities and initiatives concerning pharmaceuticals in water. Pennsylvania has been involved in emerging contaminant research since 2006. Our primary concerns and comments include the following three areas:

First, in February 2007, the U.S. Environmental Protection Agency (EPA), the W hite House Office of National Drug Control Policy, and the Department of Health and Human Services jointly released guidelines covering the safe disposal practices of unused pharmaceuticals. However, the guidelines still encourage the flushing of controlled substances into our nation's waters. Weunderstand the concern associated with the diversion of controlled substances, but we encourage the creation of a national pharmaceutical take-back program that permits the collection of all substances, therefore eliminating the practice of flushing completely.

The Pennsylvania Department of Environmental Protection (DEP), Bureau of Waste Management, is planning to initiate one-day pharmaceutical collections through county recycling coordinators. DEP bureau staffs have encountered roadblocks during the initial collection event scheduled this summer. In order to hold such an event, the Bureau of Waste Management requires the presence of a pharmacist to sort controlled and non-controlled returned pharmaceuticals. The federal Drug Enforcement Agency's regulations prohibit anyone, except law nforcement, from handling the collection or transportation of these substances. Consequently, law enforcement officials will need to accept all controlled substances. Additionally, a licensed hazardous waste hauler is required to transport the non-controlled material to a licensed hazardous waste incinerator. This will require identification andtransportation to incinerators outside the state. Presently,

there are no licensed hazardous waste incinerators in Pennsylvania.

Second, DEP requests the addition of the following compounds to EPA's Contaminant Candidate List 3 for the following reasons:

* Estrone - hormone effects on aquatic organisms

* 17 alpha estradiol - hormone effects on aquatic organisms [Second, DEP requests the addition of the following compounds to EPA's Contaminant Candidate List 3 for the following reasons:] * Carbamazepine - most frequently detected pharmaceutical in numerous studies as well as Pennsylvania's; appears resistant to treatment removal technologies and tends not to break down in the environment

* Sulfamethoxazole - most frequently detected antibiotic; possible concerns with antibiotic resistance

* Azithromycin -leading antibiotic prescribed to humans; possible concerns with antibiotic resistance

The health effects information from the Food and Drug Administration database on Maximum Recommended Daily Doses (MRDD) is derived based on the effects of single compounds. In reality, these compounds exist as mixtures in the environment. EPA should address the cumulative and synergistic effects of these compounds as well.

Finally, concerning Pennsylvania's research, in 2006, DEP entered into a cooperative agreement with the U.S. Geological Survey (USGS) to conduct a reconnaissance study to screen for pharmaceuticals and antibiotic compounds in surface and well waters in southcentral Pennsylvania. The study does not represent typical surface waters across the state because it targeted effluent-dominated streams.

* Sampling for pharmaceutical and antibiotics has occurred at the following number of locations: 6 - Groundwater6 - Intensive agricultural areas

5 - Wastewater treatment plants

* Samples were collected upstream and downstream of the agricultural and wastewater sites.

* Samples were collected each quarter to determine if seasonal

variation was evident. A total of 120 water samples were analyzed in Phase I.

* Samples were analyzed for 15 pharmaceutical and 31 antibiotic compounds. In the stream samples, 13 pharmaceuticals and 11 antibiotics were detected at least one time. For additional details, please refer to the published data series, dated September 2007, at http://pubs.water.usgs.gov/ds300/.

To build on the first study, DEP entered into a three year cooperative agreement with the USGS titled Characterization of Emerging Contaminants and Fish Health in Pennsylvania Surface Waters. Samples will be collected and analyzed for antibiotics, pharmaceuticals, hormones, pathogens (Cryptosporidium), and bacteria (E.coli & Enterococcus).

The sites identified in our previous study, which are located downstream from wastewater treatment plants, will undergo ongoing sampling for three additional years. We have expanded the study to include both water and bed sediment samples. Also, the study will include hormones and organic wastewater compounds in addition to analyzing for pharmaceutical and antibiotic compounds. A final report is anticipated in 2010. We are only beginning to receive prov isional data from last year's analyses and will be happy to share future data as it becomes

available.

Should you require additional information, please contact me or Deputy Secretary Cathy Myers by telephone at 717-787-4686.

Sincerely,

Kathleen A. McGintySecretary

CS Title: 0157 Company/group/association name: Comment:

April 30, 2008

Mr. Benjamin H. Grumbles Assistant Administrator United States Environmental Protection Agency Washington, D.C. 20460

Dear Mr. Grumbles:

Thank you for the opportunity to discuss Minnesota's efforts in monitoring the occurrence of pharmaceuticals and personal care products in the env ironment.

As you know, the U.S . Geological Survey (USGS) published its national reconnaissance of organic wastewater compounds, which included select pharmaceuticals, in 2002. This was followed by a similar study in Minnesota, published by USGS in 2004 (Lee et al), that focused not only on the presence of these compounds in surface water, but also in ground water in the proximity of landfills. In response to the concerns raised by these studies, Minnesota initiated several efforts to help us better understand the extent to which these chemicals are present in Minnesota's environment.

Specifically, the Minnesota Pollution Control Agency (MPCA) is planning the following monitoring programs to analyze pharmaceuticals and personal care products in surface water and sediments in lakes and streams throughout the state:

* Endocrine Disruptor Statewide Monitoring Study - MPCA, in cooperation with the USGS and Dr. Heiko Schoenfuss of St. Cloud State University, will collect and analyze surface water and sediments from lakes and streams throughout Minnesota for a suite of pharmaceuticals and personal care products. Samplingwill take place in summer 2008.

* EPA National River Survey - MPCA will sample and analyze ambient surface water from 50 streams throughout the state for the antidepressant selective seratonin reuptake inhibitors and a suite of personal care products as part of EPA's National River Survey. Sampling will take place in summer 2009.

These studies will prov ide valuable data regarding the occurrence and distribution of pharmaceuticals in ambient surface waters and sediments in Minnesota.

The EPA has many opportunities to help improve National, Tribal, and State responses to pharmaceuticals and personal care products in the environment, with improving communication and partnerships being key. Our partnership with the USGS's Toxics Substances Hydrology Program is benefiting national as well as local efforts to determine occurrence and presence of organic wastewater compounds and pharmaceuticals and personal care products by building on their datasets.

There are several ways EPA could improve its efforts in the area of pharmaceutical monitoring. First, the national lake and flowing rivers surveys that began in 2007 should include pharmaceutical monitoring as a component of these studies. Second, EPA should actively foster collaborative studies with state programs through its Office of Research and Development (ORD) Laboratories.

There are several lines of inquiry that states cannot assume due to financial constraints or lack of technical expertise. EPA ORD is uniquely positioned to undertake studies that would assist states in answering questions about the presence, effect, and fate of pharmaceuticals in the surface water, ground water, and soil env ironments. Third, more work is needed on the transformation of pharmaceuticals in wastewater treatment, data critical to examining various treatment options. Fourth, EPA should begin to explore, in coordination with state programs, effective methods for interceptingpharmaceuticals before they enter the waste stream.

In addition, through programs such as the Contaminant Candidate List (CCL), data on pharmaceutical and personal care product use, occurrence, and fate can be combined, either through monitoring results or models to determine which compounds are the most persistent and toxic. This would allow EPA to focus monitoring and stewardship efforts. These data would also support the FDA's reviews of environmental impacts of pharmaceuticals and enhance green pharmacy initiatives.

Many high production volume compounds are used in personal care products and other commercial products. More information is needed on product sources to help determine loadings from point

versus non-point sources. Addressing pharmaceuticals and personal care products at wastewater treatment plants may focus on what may actually be a minor conduit to the environment.

The CCL3 process should continue to evaluate any chemicals that may have been omitted from the process based on gaps in the data sources used and clearly define those groups of chemicals. A few personal care products that were not in the preliminary CCL that may have been expected were: polycyclic musk fragrances, mainly 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8- hexamethylcyclopenta(g)-2- benzopyran (HHCB) and 7- acetyl-1,1,3,4,4,6-hexamethyltetrahydronaphthalene (AHTN), triclosan, bisphenol A, and nonylphenol. These compounds are persistent, high production, and detected in surface waters based on USGS studies (http://toxics.usgs.gov/regional/emc/index.html). The CCL3 process, in cooperation with USGS, should re-consider any pharmaceuticals and personal care products eliminated during the initial evaluation for possible inclusion in the next Unregulated Contaminants Monitoring round.

Please note that MPCA is not the lead state agency for the Safe Drinking Water Act; the Minnesota Department of Health serves this role. However, MPCA's Water Quality Standards include Maximum Contaminant Levels in Minnesota's water quality rules, giving the MPCA a lead role in tracking this program.Thank you again for the opportunity to comment on these

important issues. Please feel free to contact us if you have any questions or would like further information.

Sincerely,

Brad Moore Commissioner

BM:cmbg

CS Title: 0158 Company/group/association name: Comment:

May 21, 2008

Mr. Benjamin Grumbles Assistant Administrator Office of Water United States Environmental Protection Agency Washington, D.C. 20460

Dear Mr. Grumbles: Re: Pharmaceuticals

Thank you for your March 28, 2008, letter to Commissioner of Health Richard F. Daines, M.D. requesting information about New York State Department of Health actions concerning pharmaceuticals in ground, surface, and drinking water. We have been aware of the potential for contamination of source water and possibly drinking water supplies by pharmaceuticals and personal care products (PPCPs) and are continuing to evaluate the information as it becomes available for potential adverse health outcomes.

In cooperation with the New York City Department ofEnvironmental Protection, the New York State Department of

Environmental Conservation (DEC) and funds from the Safe Drinking Water Act, we analyzed the effluent of four wastewater treatment plants (WWTPs) that discharge into NYC's Watershed for PPCPs. We also analyzed water samples collected downstream of these discharges at the entrance and exit of selected

reservoirs. This sampling was conducted in 2003 and 2004, with a final report (shared with your Region 2, EPA) published in June 2006 and in Science of the Total Env ironment, Vol. 394, pages 90-102.

This survey detected some pharmaceuticals in the WWTP effluent discharging into the NYC Watershed, but at concentrations much lower than therapeutic doses. Only a very small percentage of the samples collected downstream of the discharges contained detectable levels of pharmaceuticals. These detections and most f the detections in the WWTP effluent were observed in part per trillion concentrations. Further study is needed to better characterize potential site-specific drinking water issues and aquatic effects.

In 2006, the Department provided significant comments on the "universe" of chemicals under consideration for the EPA's Contaminant Candidate List (CCL). PPCPs should be included in the CCL universe, and we are pleased to see that was accomplished. The attachment to your letter describes that only one pharmaceutical, nitroglycerin, was selected from the CCL3 universe to the draft list. We believe the screening criteria for selecting chemicals to a CCL is appropriate and we have prov ided more comments on the draft CCL3.

With respect to further monitoring, it is not our intent to initiate universal monitoring at pubiic water systems in NYS. Weare considering, however, the possibility of sampling targeted systems to further explore the extent and level of PPCPs in drinking water sources. We will keep your agency informed of our progress.

In conjunction with DEC, we co-sponsored a "roundtable" discussion held on May 15, 2008 among various experts andstakeholders to generate ideas on disposal of unused medicines.

These ideas may help to reduce the potential amount of pharmaceuticals entering our water resources.

In summary, we appreciate the EPA's interest pertaining to pharmaceuticals and our drinking water, surface water, and ground water. EPA, in collaboration with other scientific and drinking water organizations, should continually evaluate the need for additional information to understand and, if needed, to take action to mitigate any potential impacts. We also recognize the importance to understand and address any potential ecologic effects of these PPCPs. We will continue to investigate funding opportunities for research and monitoring, and work collaboratively with federal and state agencies on specific issues such as the disposal of unused medicines.

f you have any questions, please feel free to contact me at 518 402-7650.

Sincerely,

Victor E. Pisani Director Bureau of Water Supply Protection Center for Environmental Health

cc: N. Kim, Ph.D. R. Svenson, P.E. J. Dunn, P.E . L . W ilson, Ph.D . P. Palmer ECU #2008098.39527

CS Title: 0159 Company/group/association name: Comment:

May 12, 2008 Mr. Ben GrumblesAssistant Administrator

United States Environmental Protection Agency Washington, DC 20460

Dear Mr. Grumbles:

Thank you for your inquiry regarding Tennessee's thoughts about waste pharmaceuticals and personal care products (PPCPs) in water. Tennessee is aware of reports indicating that these contaminants are found in many of this nation's streams and that some researchers have reported adverse effects on aquatic biota. We share EPA's concern about this issue.

While we understand that some PPCP research has taken place in Tennessee, we currently lack the resources and laboratory capabilities to undertake any systematic study of this issue. Staff at our state laboratory tell us that significant purchases of equipment would be needed to quantify these materials in environmental samples and that the reliability of analytical methods have not been fully established. We would be interested in undertaking some limited sampling of ambient waters and could possibly contract with university laboratories to begin gathering data on PPCP occurrence and concentration However, with Tennessee's current budgetary restraints, this is not a certainty.

Wecertainly agree that proper disposal of discarded contaminants is a necessary component of an overall strategy to minimize their entry to streams, and we're working with other state agencies and our cities to help educational efforts on the subject.

Regarding the candidate contaminant list, perhaps like other commenters, we were surprised that the only pharmaceutical EPA listed was nitroglycerine. However, we understand that EPA will continue to refine its screening process based on comments received from those doing primary research into PPCPs. We will continue to be interested in the results of this process.

Again, thank you for EPA's leadership in the area of detection,removal, and prevention of PPCPs and your willingness to share

information. As always, we look forward to continuing our partnership to develop clean water goals and to protect human health and the aquatic ecosystem.

Should you have any questions or wish to discuss this matter further, please feel free to call me at 615-532-0102 or Mr. Robert Foster at 615-532-0155.

Sincerely,

Paul L. Sloan Deputy Commissioner

PLS:cm

CS Title: 0160 Company/group/association name: Comment:

May 5, 2008

Mr. Benjamin H. Grumbles Assistant Administrator United States EPA Washington, D.C. 20460

Subject: Pharmaceutical and Personal Care Products in groundwater and surface water

Dear Mr Grumbles (Ben):

Thank you for your letter outlining EPA's plans for addressing pharmaceutical and personal care products (PPCPs). The State of Montana Department of Env ironmental Quality (DEQ) also has concerns about the growing national issue of PPCPs being found in the nation's waters. That is why the DEQ is participating in a multi-disciplinary task force of state agencies that is looking at the various issues and how we can respond. We are also cooperating with other entities, such as the US Geological Survey and the Bureau of Mines and Geology that are either planning or looking at performing additional studies inMontana.

The task force has drafted a fact sheet/guidance document that is to be released to the public when it is completed. The purpose is to prov ide factual information about the emerging issue of PPCPs in water. It is our goal to keep concerned citizens informed so that they can make reasonable decisions about protecting their health. In addition, the task force will work to coordinate efforts to identify any viable PCPP disposal solutions in Montana.

The DEQ will be participating and cooperating with PPCP studies as much as resources allow. One such study was performed in the Helena valley and published by the Montana Bureau of Mines and Geology at the University of Montana, Montana Tech in Butte, Montana. For more information on this study please contact:

Montana Bureaus of Mines and Geology MT Tech 1300 West Park Street Butte, Montana 59701-8997 Telephone: 406/496-4167 E-mail: pubsales@mtech.edu

Webelieve that much more research and analysis of this issue is needed and we support the incorporation of PPCPs into the EPA's Contaminate Candidate List. Regulation of contaminates such as PPCPs needs to come from sound scientific research and not knee-jerk reactions to public perceptions.

I thank you for contacting us and providing the opportunity to relay what activ ities the EPA is pursuing in relation to this troubling issue. If you have any questions, please feel free to contact me.

Sincerely,

Richard H: OpperDirector

c: John Warrdell, US EPA Region 8 Montana Office, Federal Office Building, 10 West 15 St., Suite 3200, Helena, MT 59626

CS Title: 0161 Company/group/association name: Comment:

May 21, 2008

Mr. Benjamin H. Grumbles, Assistant Administrator Office of Water United States Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Dear Mr. Grumbles:

Thank you for your March 28, 2008 letter regarding pharmaceuticals and personal care products (PPCP) in water and drinking water and requesting comments on how to address control matters. Illinois is receiving many of the same questions as USEPA regarding human health effects. To address these questions and other associated issues, USEPA should initiate data collection, research and information exchange on the presence, impacts and treatability of PPCP. At the same time, USEPA needs to join with states, water utilities and associations and agricultural interests to initiate steps that will reduce levels of pharmaceuticals in waters.

This joint pollution prevention effort will need to be fueled by up-to-date information that can be widely distributed and understood by the general public. Informational brochures and possibly other outreach tools are needed that describe the health effects that are now known about trace levels of the drugs and what plans are being made to resolve problems. Outreach efforts should be led by programs to remove unused drugs from wherever they are kept (focusing especially on health care facilities), to disposal sites that will destroy or keep the PPCPs from reentering the env ironment. This needs tobe coupled with a program discouraging the flushing of drugs.

USEPA will need to interact with other federal agencies in making sure that laws and regulations are not being v iolated or modifications will be made to assist with the removal program. This initial step will need to be followed by longer term programs that will take some time to develop and evolve into operational programs.

The Illinois EPA is embarking on a sampling program for community water systems that utilize a surface water source of supply. One of the major obstacles encountered in trying to obtain laboratory service was the lack of laboratories offering to perform analyses of PPCPs. Perhaps some of the USEPA laboratory capability can be utilized to initially assist with some analyses. Further, it was noted that the analytical methods were more of the experimental type than anything approaching a uniform procedure. USEPA needs to gather the appropriate laboratory leaders and come to some sort of interim agreement until such time as a consensus on and standardization of methods can be reached.

Some information exists for water and wastewater treatment to remove PPCPs; however, more work is needed in the refinement of the processes to achieve optimal plant operations. Other treatment options need to be explored such as in-stream treatment; non-point control with perhaps in situ treatment; bio-solids and treatment residuals handling and disposal; and perhaps other methods that are under development.

There appears to be an appreciable amount of information indicating a fairly wide-spread dispersal of PPCPs in surface waters; however, at some future date, groundwaters will need to receive the same level of attention. The existing information does need to be refined to determine if there is a prevalence of PPCPs in one region/area over another. This will allow for a focus on monitoring parameters in specific geographic areas and

eventually identify predominant PPCP types.

With the present knowledge of the levels of PPCPs in waters, efforts need to get underway to establish health effects levelsbased on peer rev iewed research. It is understood that there is

presently no reliable ev idence that levels of PPCPs being found are causing adverse health effects. This will require perhaps the longest period of time because of the extremely dilute concentrations of drugs being encountered and a lack of understanding of how these dilute solutions might function. Until health effects information has been reasonably derived, for both individual chemicals, and for selected mixtures of similar-acting chemicals for additive effects, it will be difficult to make convincing arguments that the PPCPs need to be removed from drinking water. Perhaps certain cutting-edge procedures, such as computational toxicology and toxico- genomic methods, could be employed in these efforts.

USEPA should continue to use the Contaminant Candidate List process because this uses a reliable, time tested method of research based on science that will yield risk based results that can be addressed with a suitable degree of certainty that public health protection is being prov ided. We recommend that PPCPs, as a class, be placed on the list for further

evaluation. Similarly, the Unregulated Contaminant Monitoring Rule should be used to collect the data. However, because of the extremely high costs of the analyses, financial or other assistance will be needed to pay for the laboratory serv ices. The cost of the analyses may drop once a large enough demand is established, but until the price drop occurs, financial assistance is needed.

Illinois EPA appreciates the difficulties USEPA is facing at this time and is prepared to participate with USEPA in the resolution of needed program development for pharmaceuticals. As noted above, one of the activities the Illinois EPA is embarking on is a sampling program for community water systems that utilize a surface water source of supply. Raw and finished water samples will be collected and analyzed in a contract laboratory that has capability to detect PPCPs at the extremely low levels being encountered. We will be happy to share this information with USEPA as it becomes available. Illinois EPA is also including a drug collection effort as part of periodic hazardous waste collections made in various communities around the state and at four permanent hazardous waste collection sites. We are also developing a program to coordinate withcounty health departments in drug collection efforts.

Illinois EPA encourages your leadership in the areas discussed. If you have any follow-up questions, please contact Marcia Willhite at (217) 782-1654.

Very truly yours,

Douglas P. Scott Director

cc: Damon T. Arnold, M.D., M.P.H., Director Illinois Department of Public Health

CS Title: 0162 Company/group/association name: Comment:

May 22, 2008

Benjamin H. Grumbles Assistant Administrator U.S . EPA Headquarters Ariel Rios Building 1200 Pennsylvania Ave. NW Washington, D.C. 20460

Dear Mr. Grumbles:

Thank you for your letter dated March 28, 2008 concerning pharmaceuticals in source water and treated drinking water. Your letter was addressed to Dr. Dwelle, State Health Officer, North Dakota Department of Health, and copied to me. You asked for our input on the following three issues: 1) programs ND is currently implementing, or planning to implement, to monitor for pharmaceuticals and personal care products (PPCPs) in surface water, ground water, or tap water; 2) how EPA considered pharmaceuticals within the recently-released (February 1, 2008) draft Contaminant Candidate List (CCL3); and, 3) stewardship programs ND is actively pursuing to ensure proper disposal of unused medications.The Department does not presently have a monitoring program or

occurrence data for PPCPs. There are several non- Department sampling initiatives which will soon provide some occurrence data. In September and October of 2007, the U.S. Geological Survey sampled three locations on the Missouri River, above and below Bismarck and just above the Fort Yates drinking water intake. Samples (both water and sediment samples) are being tested for hormones, wastewater indicators, pharmaceuticals, and antibiotics. To date, only results for wastewater indicators and antibiotics are available (the results are all below detection limits). The results for hormones and pharmaceuticals are not expected until fall. In addition, two ND cities that utilize the Red River (and major tributaries) as their source of drinking water have recently elected to sample for PPCPs. It is our understanding that the sampling will include raw and treated drinking water as well as raw and treated wastewater. The results of this sampling are also not yet available. The Department may consider an expanded screening study based on the above results. However, in the absence of federal requirements, the Department does not

env ision mandating PPCP monitoring or treatment (water and/or wastewater) to lower PPCPs.

EPA evaluated 284 data sources to identify potential CCL3 candidates. EPA then applied screening criteria to identify candidates that should be further evaluated. The screening criteria, based on a contaminant's potential to occur in public water systems and the potential for public health concern, were used to narrow the candidates to a preliminary CCL3 for comment. This process was based on experience gained,from prev ious efforts; and recommendations from the National Academy of Sciences' National Research Council and the National Drinking Water Advisory Council.

It appears that EPA used a transparent and science-based process to identify and evaluate CCL3 candidates. To the maximum extent possible, we encourage EPA to continue to consider all peer-rev iewed data as well as agency-generated data in constructing CCLs. We also encourage EPA to fully consider such data in developing unregulated contaminantmonitoring regulations.

The 1996 SDWA Amendments specify three criteria to determine whether a contaminant may require regulation: 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 health concern; and, in the sole judgement of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems. These criteria in combination with the present CCL process appear to establish a sound and science- based approach for decisions on regulating new contaminants in drinking water.

The Department currently recommends that households dispose of unused medications in the solid waste stream versus wastewater system. This is done as one means to reduce the potential contribution of PPCPs into surface waters via wastewater discharges.

Under a new state law effective July 1, 2007, individuals may return unused prescription drugs to pharmacies or clinics for reuse (NDCC Ch. 43-15.2, Legend Drug Donation and Repository Program). The law sets forth specific requirements for the program including conditions for acceptance, storage, distribution, and re-dispensing of returned drugs. According to the North Dakota State Board of Pharmacy, pharmacies in 25 North Dakota cities participated by accepting and distributing donated drugs in 2007. It is too early to predict the long-term effectiveness and success of the program. However, it would seem that such stewardship programs have the potential to significantly reduce the quantity of PPCPs that ultimately end up in source and treated drinking waters.

Thank you for the opportunity to provide input on this important public health issue. Please feel free to contact me if you have questions or wish to discuss this matter. My telephone number and email address are 701.328.5152 anddglatt@nd.gov , respectively.

Sincerely,

L. David Glatt, P.E., Chief Environmental Health Section North Dakota Department of Health

cc: Dr. Dwelle, NDDH Loreetta Canton, NDDH Dennis Fewless, NDDH Wayne Kern, NDDH

CS Title: 0163 Company/group/association name: Comment:

April 21, 2008 Benjamin H. Grumbles, Assistant Administrator United States Environmental Protection Agency USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N.W . Mail Code 4101 M Washington, DC 20460

Dear Assistant Administrator Grumbles:

Given our joint responsibilities for the management and protection of water resources, both drinking water and surface waters in the state, we are responding to your letter of March 28, 2008 on behalf of Commissioner J. Robert Galvin, M.D., M.P.H., M.B.A and Commissioner Gina McCarthy pertaining to trace amounts of pharmaceuticals in surface waters and drinking water systems. Both of our Departments of Public Health (DPH) and Environmental Protection (DEP) appreciate EPA's timely communication on this topic and are pleased to hear more about the Agency's activities on this issue.

Unlike other parts of the United States where pharmaceuticalshave been detected in drinking water, Connecticut has a

longstanding prohibition on the discharge of sewage into all Class A and AA waters, as adopted in our Water Quality Classifications and Standards. Class A and AA waters include any stream, river or lake that is tributary to a drinking water

reservoir or water supply impoundment. Because of this unique prohibition, wastewater treatment discharges that could potentially contain trace levels of pharmaceuticals do not blend with Connecticut's highly protected public drinking water sources. Therefore, until more is known about the occurrence and human health effects of pharmaceuticals and personal care products (PPCP) in drinking water, Connecticut has no immediate plans to implement a testing program.

DPH and DEP are concerned that EPA's decision to include nitroglycerin on the CCL3 list as the sole pharmaceutical compound to be monitored will not provide the meaningful data needed to make a reasonable assessment of PCPP occurrence in drinking water. To this point, we are providing more detailed comments about the CCL3 and the selection of nitroglycerin in the attached addendum. [See PDF]

The DEP has growing concerns over the presence of PPCPs and related contaminants that are believed to affect aquatic life forms through disruption of endocrine related processes. There is a growing literature on indications of these potential effects, and research conducted in our area by the U.S. Geological Survey and the University of Connecticut has documented the presence of PPCPs in major rivers that receive treated sewage.

Ongoing research at Stony Brook University on Long Island has begun to identify some of the physiological effects on aquatic life that is related to PPCPs. W hile DEP is not in a position to conduct monitoring for these effects on a continuing basis because of cost, analytical uncertainties, and lack of definitive direction on key indicator contaminants, we are staying updated with the latest science as opportunities permit through conferences and participation in work groups established by the New England Interstate Water Pollution Control Commission and ASIW PCA. DEP has also looked atpollution prevention options as the first line of defense as

indicated below. We encourage you to direct more attention towards the aquatic life effects, as they are likely to be the most sensitive receptors of PPCP stressors; your letter and the excerpt from the Federal Register notice appeared to be primarily focused on human health effects.

That said, the Departments look to the USEPA for guidance before requiring any pharmaceutical testing in Connecticut's public drinking water supplies or contributing surface waters. In anticipation that testing requirements may evolve as more data become available, the Departments are interested in learning more about:

* W hich specific compounds or key compound classes should be tested as anthropogenic markers;

* The availability of sampling and analytical methods that could be reasonably expected to yield reliable data; and

* W hich laboratories across the country currently have the experience and capacity to test for trace amounts of PPCP's in drinking water, and at what cost.

To further our knowledge and understanding of this issue, particularly as it relates to environmental effects in all waters of the state, the Departments are also interested in learning more about:

* PPCP occurrence in groundwater; including their fate and transport;

* The relative importance of PPCP disposal with domestic wastewater compared to amounts excreted, washed from people, or contributed via other pathways;

* Human health and ecological effects attributable to trace levels of PPCP's in water and drinking water;

* The performance of contemporary drinking water treatment processes relative to PPCP removal;* The available technologies effective in removing PPCPs from

sewage treatment plants and subsurface disposal systems; and

* Possible additive and/or synergistic effects of PPCPs as they affect both human health and aquatic life.

Notwithstanding these information gaps, the DPH developed a fact sheet using available information shortly after the AP story broke to assist it in responding to a small number of inquires from concerned citizens and the media. Interestingly, there have been no recent citizen or media inquires about PPCP's in drinking water after the week of March 17th. The Department's fact sheet is available on the Drinking Water Section webpage at: http://www.ct.gov/dph/lib/dph/drinking_water/pdf/Pharmaceutical _Fact_Sheet.pdf

Regarding Connecticut's stewardship and pollution prevention efforts, the DEP has been recommending for some time that unused prescription and over-the-counter medications be properly disposed of as described in the a fact sheet available on-line at: http://www.ct.gov/dep/cwp/view.asp?a=2708&q=335480&depNav_GID= 1763

In closing, the Departments pledge to continue working closely with the numerous state, interstate and federal agencies that are studying pharmaceuticals and personal care products in water and drinking water and will adopt any prudent measures necessary to safeguard public health and the env ironment as new information becomes available.

Sincerely,

Darrell B. Smith, Acting Section Chief Department of Public Health Drinking Water Section

Betsey W ingfield, ChiefDepartment of Enivronmental Protection

Bureau of Water Protection and Land Reuse

cc: J. Robert Galvin, M.D., M.P.H., M.B.A, DPH Commissioner DPH Ellen Blaschinski, Branch Chief Gina McCarthy, Commissioner DEP

STATE OF CONNECTICUT DEPARTMENT OF PUBLIC HEALTH ADDENDUM

Connecticut's Comments Regarding the Inclusion of Nitroglycerin within CCL3

Your letter and associated enclosure indicates that the CCL-3 process has selected nitroglycerin as the sole representative of pharmaceutical contamination of drinking water resources in the draft CCL-3 list. Although DPH is not totally familiar with the CCL-3 decision-making process, the selection of only one analyte to further explore the pharmaceuticals in drinking water issue does not seem adequate. Moreover, nitroglycerin is a curious choice for a number of reasons. The USGS database, which is considered one of the largest for pharmaceuticals and personal care products in water resources in the US, has never sampled for nitroglycerin (D. Kolpin, USGS, personal communication). USGS prioritized chemicals on the basis of use, persistence, reliable analytical methodology, and where possible, health implications. Their database indicates the detection of 95 organic wastewater contaminants in streams receiving wastewater discharges (Kolpin, et al. ES&T 36: 1202-1211, 2002). Regarding nitroglycerin, according to the enclosure in your letter, this drug has release data but apparently has not actually been detected in surface waters . Nitroglycerin is rapidly metabolized by the human body to a

variety of nitrate metabolites that are both part of its mechanism of pharmacologic action and eventual elimination. Very little unchanged nitroglycerin is expected to appear in human urine or feces (Dollery, C. Therapeutic Drugs, Churchill Livingston Pubs, Edinburgh, 1999). Therefore, while some information may point to the listing of nitroglycerin in the CCL-3, it is important that additional analytes, particularly those that are frequently detected in surface and groundwaters, be included for consideration in the CCL-3. Broadening the listto include different types of chemistry and life cycle may be a

wise approach. For example, the USGS database shows the frequent appearance of lifestyle chemicals (particularly caffeine) , antibiotics (particularly erythromycin and trimethoprim) personal care ingredients (particularly DEET), consumer product chemicals (particularly bis- phenol A) and a

variety of estrogenic contaminants as among the most common constituents detected (Kolpin, et al., 2002).

Apart from the CCL3 list, a sampling program which targets leading indicator compounds across a variety of pharmaceutical, personal care and consumer product classes may prov ide the benchmarks needed to follow trends, extrapolate to other chemicals not specifically targeted, understand the effectiveness of wastewater treatment options, and ultimately project to human health and ecological risk. W hile it is comforting to know that initial screens show detected analytesare generally at concentrations that are well below healthbased comparison values, the uncertainties in these analyses warrant additional testing and prioritization, and the application of best management practices to minimize human exposure. Addition of a representative array of indicator compounds to the CCL-3 such as those found in USGA studies would further these public health goals.

Gary Ginsberg, Ph.D., Toxicologist Environmental Health Section Connecticut Department of Public Health April 18, 2008 CS Title: 0164 Company/group/association name: Comment:

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189 April 25, 2008

Pursuant to the proposed list of contaminants on the Federal Register, I request that:i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.

M. avium and related strains of mycobacteria (nontuberculous mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study [FNi: http://www.ntminfo.org/default-aspx/p/article/id/16.aspx] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii: http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 20 additional patient homes are currently being studied and compared to sputum.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv:http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on theU.S. population. Pulmonary NTM disease is being diagnosed with

increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

I'm an active 72 yr old and in remission from Mycobacterium Avium. In Kenywood Texas there are 3 women and 2 men in Houston Support Group of around 45 members. Dr. Wallace of U of Texas Health Center at Tyler is getting patients from all over U.S. Weneed lung doctors to be educated about this serious disease. I was on antibiotics for 2 years and have to be tested every month at Tyler for new infections. I have Bronchiectasis.

Thank you for your attention and consideration in this matter.

Sincerely,

Marjorie Mazurek CS Title: 0081 Company/group/association name: Comment:

700 John Ringling Blvd. #1814 Sarasota, FL 34236 April 25, 2008

Comment on Proposed EPA Drinking Water Contaminant Candidate List 3 Docket: EPA-HQ-OW-2007-1189

Pursuant to the proposed list of contaminants on the Federal Register, I request that:

i) Mycobacterium avium remain on the CCL and that

ii) Mycobacterium avium be given the significantly higher score it merits.M. avium and related strains of mycobacteria (nontuberculous

mycobacteria, or NTM) are known water contaminants that are currently being assessed relative to human morbidity and mortality.

Environmental Source and Infection

In April 2008, the Centers for Disease Control convened a meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info & Research (NTMir), the national not-for-profit organization for pulmonary NTM infection, is currently funding a pilot study[FNi] to determine the connection between household water, which includes drinking water, and pulmonary NTM infection. Of five initial patients suffering from pulmonary NTM disease and their households surveyed thus far, four (or 80%) were determined to have lung infection identical to the strain in the water.[FNii] At least 20 additional patient homes are currently being studied and compared to sputum. As the leader of the NTMir support group serving NTM patients in coastal Southwest Florida, I currently represent 40 patients in various stages of illness.

One of my patients recently died from an NTM infection identical to the strain in the sample taken from his hot tub.

Epidemiology - Increasing Prevalence

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 62:661-6.] prov ides concrete ev idence that the prevalence of pulmonary NTM infections is much higher than previously understood. A pilot study is currently in process by NAIAD and Kaiser Permanente of Southern California to provide a snapshot of the epidemiology of pulmonary NTM in the United States.[FNiv:http://www.ntminfo.org/default_aspx/p/article/id/16.aspx ]

Health Effects

As data is not currently collected by the CDC or any other agency, it is difficult to assess the mortality rates of pulmonary NTM in the United States until completion of the NAIAD/Kaiser Permanente study mentioned above.

M. avium and other NTM cause pneumonia and other severe manifestations of illness frequently requiring hospitalization in excess of one week. Many, if not most NTM-related hospitalizations last more than 7 days.

M. avium and other NTM infections can cause long term dysfunction or disability due to progressive and permanent loss of lung function.

M. avium and other NTM's cause illness requires long-term physician intervention as initial treatment typically requires 18-24 months of multi-antibiotic therapy, frequent CT scans, and frequent sputum testing.

Aging Population at Greater Risk

There appears to be an increase in pulmonary NTM infection in the immune competent population over age 60 with a majority being women.[FNv : Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in addition to individuals with underlying vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune compromised patients (HIV/AIDS, chemotherapy),

I believe that removing M. avium from the CCL is not in the public's best interest and will have a negative impact on theU.S. population. Pulmonary NTM disease is being diagnosed with

increasing frequency across the United States. We request that the EPA continue to monitor M. Avium in the water supply and give it a higher score.

Thank you for your attention and consideration in this matter.

Sincerely,

Mary K. Allyn NTM Support Group Leader, Sarasota, FL Board Member, NTMir Inc. Document ID: EPA-HQ-OW-2007-1189-0166 Last Name: Ambrose First Name: Richard J Title: US Product Registration Manager Organization: DuPont Crop Protection City: Newark State: DE Zip Code: 19714 Phone Number: Fax Number: Country Code: Email Address: Current Category Code: Comment:

October 6, 2008 Via Mail: Docket ID No. EPA-HQ-OW-2007-1189

Water Docket U.S. Environmental Protection Agency Mail Code: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

RE: E.I. duPont de Nemours and Company Comments on EPA's Draft Drinking Water Contaminant List 3To whom it may concern:

E.I. duPont de Nemours and Company ("DuPont") appreciates the opportunity to prov ide comments on the draft "Drinking Water Contaminant List 3" released by EPA on February 21, 2008 (EPA-HQ-OW-2007-118, FRL-8529-7). As the primary manufacturer of the chemical diuron (CAS 330-54-1), DuPont recommends that EPA remove diuron from the draft list for regulation as a contaminant under the Safe Drinking Water Act.

In our May 21, 2008 comments we stated that we would submit a more detailed rationale to support this recommendation in the proceeding weeks. This more detailed rationale includes more discussion of the current reduced risk of occurrence and other pertinent health effects information.

To reiterate DuPont's May 21, 2008 comments, DuPont provided rationale for this recommendation based on current labeled use practices that reduced the risk of occurrence compared to the env ironmental release data reported for 2004 from the Toxic Release Inventory and the National Pesticide Use Database, developed by the National Center for Food and Agricultural Policy used for this draft determination. Due to the risk mitigation requirements now required on all registrants labeling diuron end-use products from the September 30, 2003, EPA Reregistration Eligibility Decision for diuron, the current risk of occurrence is dramatically reduced from what the above 2004 data would conclude. These risk mitigation requirements include:

- Reduction of application rates and increased retreatment intervals between applications in numerous crops - Elimination of aerial applications with some specific exceptions - Implementation via labeling of best management practices to reduce spray drift

In addition, In the EPA's Contaminant Information Sheets for the PCCL Chemicals Considered for CCL 3, February 2008, on page77 in the Health Effects data on diuron, under the EPA OPP RfD, a value of 0.003 mg/kg-d is given. The critical effects cited are "Hemolytic anemia & compensatory hematopoiesis (decreased erythrocyte count, hemoglobin level, etc.). Known, likely, Q1*0.0191 (mg/kg- day)-1". Although a 1964 DuPont document is cited, in EPA OPP's, March 6, 2002 Diuron - Phase 2: Rev ised Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision, a similar assessment is given based on more recent chronic toxicity/oncogenicity study in W istar rats (MRID 40886501; supplementary data prov ided in MRIDs 43871901, 43804501, and 44302003). Based on the attribute scores in the Contaminant Information Sheets for the PCCL Chemicals Considered for CCL and the mention of a Reference Dose on page F-10 in the ContaminantCandidate List 3 Chemicals: Classification of the PCCL to CCL, both dated Feb.

2008, it appears that the agency used the non-cancer endpoint of hemolytic effects to assign severity.

Regarding this endpoint, OPP's, March 6, 2002 Diuron - Phase 2: Revised Toxicology Disciplinary Chapter came up with a LOAEL of 1.0 mg/kg bw, to which an extra assessment factor of 3 was added to the 100 fold uncertainty factor. However, we believe the assignment of 1.0 mg/mg as a LOAEL is inconsistent with the way EPA has interpreted other findings with compounds that lead to increased red cell turnover. Further, we have conducted a pathology peer review of the hemolytic changes and splenic changes in rats after diuron treatment. In addition, the red cell mass parameter data has been recently rev iewed by a clinical pathologist. These expert reviews concluded that 25 ppm (1.0 and 1.7 mg/kg bw/day in males and females, respectively) in this 2-year rat study should be considered a NOAEL. Most critically, our recent evaluation of this study

revealed three animals at this dose level had very low decreased red cell mass parameters which impacted the erythrocyte counts at 12 and 24 months. W hen these three animals are excluded, the red cell mass changes at 12 and 24 months are no longer to a degree considered adverse. Evidence for a lack of diuron being causative for the decrease in red cell mass parameters in these three animals includes:

- Effects of such a magnitude were not observed in animals fed 100-fold higher concentrations of diuron - Such effects were not consistent over time - The animal with the decreased red cell mass at 12 months died shortly after the blood collection (autolysis precluded identification of the cause of death) - Both rats with low red blood cell mass at 24 months had other non-compound related conditions that likely contributed to the red blood cell effects.

The following DuPont rev iews will be made available to the EPA upon request: - Pathology Working Group rev iew, DuPont-18976 - Biological Significance of Haematologic Effecs of Diuron in the Rat, DuPont-18974

While the non-threshold q1*cancer risk assessment for diuron was mentioned, but may not have been used for the classification of the PCCL to CCL, it is worth noting that a study has recently been published which strongly suggests that a threshold approach to diuron's cancer risk assessment should be considered [see M.G. Nascimento et al., (2006), Effects of Diuron [3-(3,4- dichlorophenyl)-1,1- dimethylurea on the urinary bladder of male W istar rats, Toxicology 224, 66- 73)]. This publication demonstrated that necrosis occurs in the urothelium of rats after dietary administration of diuron and that this along with subsequenthyperplasia is the probable mechanism for urothelial carcinogeneis in rats.

The EPA evaluation of Prevalence Data relied on criteria for frequency and concentration that are intended to meet the goal of selecting drinking water contaminants that may be present at levels of public health concern and would allow meaningful reduction in health risk. The databases examined in the

evaluation show clearly that diuron detections occur in a small percentage of samples, except in specific geographical areas that have been targeted for monitoring programs. Using the NAWQA database as an example, a query of the database shows that 13586 surface and groundwater samples were analyzed for diuron, which was detected in approximately 15% of the samples with a 90th percentile concentration of <0.079 ug/l (all samples) and 0.6963 ug/l for samples with detectable residues. In the post model refinements to the CCL3 process, EPA calculated an HRL/Concentration ratio as a criterion for listing. In all the databases examined, the 90th or 95th percentile diuron concentrations detected are well below the DW EL (0.1 mg/l) established by EPA Office of Water (EPA 822-R-06-013, 2006 Edition of Drinking Water Standards and Health Advisories). The HRL/Concentration ratio is greater than 10 for all databases examined, leading to a NL decision. The results of the Pesticide Pilot Monitoring Program prov ide further support for the NL decision by showing that water treatment processes reduce the concentration of diuron in finished water compared to ambient water. The result is consistent with the scientific literature on the effects of water treatment processes on diuron.

Diuron is readily degraded by typical processes used in drinking water treatment. Chlorination, ozonation and filtration are common process used in water treatment. The two chemical treatments depend on the addition of highly reactive chemicals, chlorine and ozone, that are introduced to react with organic substances, such as natural humic substances, microorganisms, viruses, inorganic chemicals and man-made chemicals. Water treatment generally includes filtration steps to remove solids, flocculated organic matter and microorganisms. The filtration steps also will remove chemicals that are sorbed to organic matter.

Diuron, a phenylurea, undergoes reactions with the active species in chlorination processes that are well known and a standard feature of the chemical literature dating from the 19th century (Hoffman degradation reaction). Publications in the scientific literature report the ready degradation of phenylurea herbicides, such as isoproturon, chlortoluron, diuron and linuron, by ozone (Camel and Bermond, 1998 and references therein). Initial reactions occur along well established degradation pathways and lead to products that may be removed by filtration.

The low frequency of detection and the low concentrations relative to the DW ELsupport a NL decision. Regulation of diuron under the national primary drinking

water regulation will not give a meaningful reduction in risk to public health as the ambient water concentrations are already well below established water quality criteria and water treatment processes further reduce the concentrations in finished water.

Sincerely, Richard J. Ambrose US Product Registration Manager DuPont Crop Protection Document ID: EPA-HQ-OW-2007-1189-0167 Last Name: Hilbert III First Name: John W . Title: President Organization: The Vanadium Producers & Reclaimers Association City: Washington State: DC Zip Code: 20002 Phone Number: 202 842 3204 Fax Number: 202 842 0439 Country Code: Email Address: Current Category Code: Comment:

November 18, 2008 Via U.S. Mail Water Docket U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460

Re: Supplement to Comments on Drinking Water Contaminant Candidate List 3- Draft, Docket ID No. EPA-HQ-OW-2007-1189; Chemical Abstract Serv ices Registry Number (CASRN) 7440-62-2

Wewrite to supplement comments provided on May 21, 2008 by the Vanadium Producers and Reclaimers Association (VPRA) concerning the U.S. Env ironmental Protection Agency's (EPA) draft Contaminant Candidate List (CCL 3),[FN1: 73 FED. REG. 9628 (Feb. 21, 2008).] specifically with respect to the EPA'srecommendations with respect to elemental vanadium (CASRN 7440-62-2).[FN2: Id.

at 9633, Exh. 2.] We are enclosing a recent study entitled "Evaluation of genotoxicity of oral exposure to tetravalent vanadium in vivo," by P. Villani et al. This study, the first in vivo genetox comparative study of which the VPRA is aware, is important to EPA's consideration of elemental vanadium because it reports essentially negative results from the tetravalent form of vanadium compared to prev iously-reported positive findings with vanadium's pentavalent form. Critically, as this study concluded, "repeated oral exposure to tetravalent vanadium, up to few tens of micrograms perk kg body weight, may be devoid of significant genotoxic effects both at somatic and germ cell levels."

For these reasons and the reasons stated in the VPRA's original comments, the VPRA is asking EPA to decide not to list elemental vanadium on the CCL 3 list because the record in this rulemaking has not sufficiently established the factual basis by which to determine that vanadium "may require regulation under [the SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(1).]

The VPRA appreciates this opportunity to prov ide this supplemental information, and would be pleased to address any questions the EPA may have about it. Questions may be directed to John Hilbert, President of the VPRA, at (202) 842-0219.

Respectfully submitted, John W . Hilbert III, President The Vanadium Producers and Reclaimers Association 900 Second Street, N.E. Suite 201 Washington, D.C. 20002 Tel: (202) 842-3204 Fax: (202) 842-0439

Of Counsel: Martha E. Marrapese, Esq. Jason E. Yearout, Esq. Keller and Heckman LLP 1001 G Street, N.W . Suite 500 West Washington, DC 20001

### LETTER_ID COMMENTER_ID LAST_NAME FIRST_NAME

6081 55646 Murray P.R. 6082 55647 Leitman Philip 6083 55648 Anonymous 6084 55649 Taft James 6502 56803 Anonymous 6503 56804 Pedersen B. 6504 56805 Jurasits Donna 6505 56806 Weinberg Laura 6506 56807 Bowman Lori G. 6507 56808 Finger K. 6508 56809 Anonymous 6509 56810 Anonymous 6510 56811 Watkins J. 6511 56812 Anonymous 6512 56813 Coniglio T.J. 6513 56814 Hoos Phil 6514 56815 Boisvert J. 6515 56816 Breslawsky D. 6516 56817 McMurrough A. 6517 56818 DeLong R. 6518 56819 Greenfield E. 6519 56820 Greenfield E. 6520 56821 Mass Comment Campaign sponsoring org unknown (59) 6521 56822 Anonymous 6522 56823 Clarkson-Shorter J.

6523 56824 Ordway Diane 6524 56825 Cherrnay A. 6525 56826 Ratchye J. 6526 56827 LaMontagne C. 6527 56828 York Deanna

6530 56831 Funari Enzo 6531 56832 Racke Kenneth D. 6532 56833 Brenner Barbara A. 6533 56834 Goodman Miriam 6534 56835 Lynn John 6535 56836 Kneiss Sharon H. 6536 56837 Falkinham, III Joseph O. 6537 56838 Carey Sandra 6538 56839 Falconer I.R. 6539 56840 Davis J. 6540 56841 Hoel J. 6541 56842 Chan Ed 6542 56843 Iseman Michael D.

### 6543 56844 Wells Martha J.M.

6544 56845 Neustadt Debbie

6545 56846 Kloska Kenneth 6546 56847 Smith Charlotte D. 6547 56848 T.&J. and Family 6548 56849 Anonymous

6549 56850 Heminway Diane 6550 56851 Mayer Mark S. 6551 56852 Bellet E.M.

6552 56853 Louis Judith 6553 56854 Santoro Michael A. 6554 56855 McLallen Sarah 6555 56856 Anonymous 6556 56857 Gibson Patrick L. 6557 56858 Hilbert, III John W. 6558 56859 Adams William J. 6561 56860 Anonymous 6562 56861 Cotruvo Joseph 6563 56862 Garvin Michael 6564 56863 Berger P.S. 6565 56864 Halverson Paul 6566 56865 Greenwood Beau 6567 56866 Van De Hei Diane 6568 56867 Nogaki Jane 6569 56868 Bennett Karen

6570 56869 Comstock Jeff 6571 56870 Sieben Katie 6572 56871 Wu Mae 6573 56872 Naidenko Olga V. 6574 56873 Connor Hannah 6575 56874 Macedo Julie E. 6576 56875 Bain Cynthia 6577 56876 Wegner William 6578 56877 Berkelman Ruth 6579 56878 Ambrose Richard 6580 56879 Ellis George 6581 56880 Knowlton Kim

6582 56881 Caldwell Michael 6583 56882 Pisani Victor 6584 56883 Hutcheson Michael S.

### 6585 56884 Yamamoto Gary

6586 56900 Curtis Thomas W. 6587 56902 Wilson Shari T. 6588 56903 Moore Mary 6601 56904 Becky 6602 56905 Herma 6603 56906 Selecky Mary C. 6604 56907 Garcia Buddy 6605 56908 Crutcher James M. 6606 56909 Jackson Lisa P. 6607 56910 Hughes John A. 6608 56911 Grannis Alexander B. 6609 56912 McGinty Kathleen A. 6610 56913 Moore Brad 6611 56914 Pisani Victor E. 6612 56915 Sloan Paul L. 6613 56916 Opper Richard H. 6614 56917 Scott Douglas P. 6615 56918 Glatt L. David 6616 56919 Smith Darrell B. 6621 56924 Mazurek Marjorie 8582 59134 Ambrose Richard J 8583 59135 Hilbert III John W. 6641 59136 Allyn Mary K.

### TITLE

Ph.D. President

Executive Director

Bureau Director

PhD., Assistant Professor

East Texas Support Group Leader

Regulatory Manager - Insecticides

President & Chief Executive Officer (CEO) Vice President, Products Division

HSE Executive

Leader

MD, Associate Professor of Medicine

### Ph.D. Professor

Chair

Director Environmental Services - Global Operations

Environmental Projects Coordinator, USW Health Safety and Environment Department P.E., Natural Resources Administrator PhD., Technical Manager Ph.D., Chief Bureau of Environmental Assessment, Division of Science Research and Technology Director, Specialty Materials Manager

Chair President Ph.D., Chairman

Joseph Cotruvo and Associates LLC Pharm.D., Assistant Vice President

DrPH, FACHE, Director and State Health Officer Acting Chair Executive Director Vice Chair Vice President, Environmental Affairs Agrichemical Management Section, Vermont Agency of Agriculture Senator Staff Attorney Ph.D., Senior Scientist Staff Attorney Attorney

Staff Scientist M.D., Chair Public and Scientific Affairs Board US Product Registration Manager President Dr.Ph.; Science Fellow, Global Warming and Health Zausmer, Kaufman, August, Caldwell & Tayler, P.C .; Attorneys & Counselors Director, Bureau of Water Supply Protection Head

### Assistant Chief

Deputy Executive Director Secretary Vice President

Secretary Chairman Secretary of Health and Commissioner of Health Commissioner Secretary Commissioner Secretary Commissioner Director, Bureau of Water Supply Protection Deputy Commissioner Director Director Chief Acting Section Chief

US Product Registration Manager President NTM Support Group Leader and Board Member

### ORGANIZATION

NTM (Nontuberculous Mycobacteria) Information & Research Inc. (NTMir)

Association of State Drinking Water Administrators (ASDWA)

The Babylon Breast Cancer Coalition Great Neck Breast Cancer Coalition Agrichemical Management, Wisconsin Department of Agriculture, Trade and Consumer Protection

Earthjustice

College of Veterinary Medicine and Biomedical Sciences, Department of Microbiology, Immunology and Pathology, Colorado State University

NTM (Nontuberculous Mycobacteria) Support Group Mechanisms of Toxicity Unit, Environment & Primary Prevention Department, Istituto Superiore di Sanità (Italian National Institute for Health) Dow AgroSciences LLC (DAS) Breast Cancer Action Mid-Island Radiation Alert Methanol Institute (MI) Olefins Panel, American Chemistry Council (ACC) Department of Biological Sciences, Virginia Tech (Virginia Polytechnic Institute and State University) International Molybdenum Association (IMOA) Pharmacology, University of Adelaide-5005 and Cooperative Research Centre for Water Quality and Treatment West Central Florida NTM Support Group

National Jewish Medical and Research Center

### Environmental Chemistry Center for the Management Utilization and Protection of Water Resources and

Department of Chemistry, Tennessee Technological University (TTU) National Water Committee, Sierra Club

Climax Molybdenum Company (Climax) Charlotte Smith & Associates Inc. (CS&A)

United Steel Workers (USW) SD Drinking Water Programs, South Dakota Department of Environment and Natural Resources (SDDENR) Metolachlor Task Force

New Jersey Department of Environmental Protection (NJDEP) Environmental Health, Safety and Regulatory Affairs, 3M Company Ethylene Oxide (EO) and Ethylene Glycols (EG) Panel, American Chemistry Council (ACC)

N-Methylpyrrolidone Producers (NMP) Group, Inc. Vanadium Producers and Reclaimers Association (VPRA) North American Metals Council (NAMC)

WateReuse Foundation Science and Regualtory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA)

Arkansas Department of Health Pesticide Policy Coalition Association of Metropolitan Water Agencies (AMWA) NJ Environmental Federation (NJEF) National Mining Association (NMA)State-FIFRA Issues Research and Evaluation Group-Water Quality-Pesticide Disposal Working Committee (SFIREGWQPD-WC) District 57, Minnesota State Senate Natural Resources Defense Council (NRDC) Environmental Working Group (EWG) Waterkeeper Alliance Pillsbury Winthrop Shaw Pittman LLP, on behalf of City of Rialto, Rialto Utility Authority City of Peoria, Arizona (AZ) Riverkeeper American Society for Microbiology (ASM) Dupont Crop Protection, Stine-Haskell Research Center Pennsylvania Coal Association Natural Resources Defense Council (NRDC)

Gelman Sciences, Inc., d/b/a Pall Life Sciences (PLS) New York State Department of Health Air & Water Toxics, Massachusetts Department of Environmental Protection (MADEP)

### Division of Drinking Water and Environmental Management, State of California-Health and Human Services

Agency, California Department of Public Health (CDPH) American Water Works Association (AWWA) Maryland Department of the Environment Lindon Park Neighborhood Association

State of Washington Department of Health Texas Commission on Environmental Quality Oklahoma State Department of Health State of New Jersey Department of Environmental Protection (DEP) Delaware Department of Natural Resources and Environmental Control (DNREC) State of New York Department of Environmental Conservation Pennsylvania Department of Environmental Protection (DEP) Minnesota Pollution Control Agency New York State Department of Health State of Tennessee Department of Environment and Conservation Montana Department of Environmental Quality (DEQ) Illinois Environmental Protection Agency North Dakota Department of Health, Environmental Health Section State of Connecticut

DuPont Crop Protection The Vanadium Producers & Reclaimers Association NTMir Inc.

### CITY STATE ZIP_CODE PHONE_NUMBER FAX_NUMBER COUNTRY_CODE

Arlington VA 22209 7038129508 7038129506

Madison WI 537088911 6082244550

Calistoga CA

Camp Hill PA

Wilmington DE 19807

Highland Village TX 75077 9723188970

Roma IT

Blacksburg VA 24061 5402315931 5402319307 BE Adelaide AU

Denver CO 80206 3033981491 3033981806

### Cookeville TN 38505 9313726123 9313726346

Phoenix AZ Orinda CA 9253771891

Pittsburgh PA

Stillwell KS

St. Paul MN 55144

Washington DC Washington DC 20002 2028423204 2028420439 Alexandria VA 8015580222

Washington DC

2022961585 Washington DC 20006 Marlton NJ 8053 Washington DC 20001 2024632600

St. Paul MN 55155 6512978060

Washington DC 20009 2029399157 Irvington NY 10533 9146740622 9146744560 4159831590

Washington DC Newark DE 197140030 Harrisburg PA 17101 New York NY 10011 2127274579 2127271773

Farmington Hills MI 483342374 2488514111 2488510100 Albany NY 12237 5184027650 Boston MA 2108

### Sacramento CA 95899 9164495577

Baltimore MD 21230 4105373000 Phoenix AZ 85008

Olympia WA 985047890 3602364501 3605867424 Austin TX 787113087 5122391000 Oklahoma City OK 731171299 Trenton NJ 86250402 6092922885 6092927695 Dover DE 19901 3027399000 3027396242 Albany NY 122331010 Harrisburg PA 171052063 7177872814 St. Paul MN 551554194 6512966300 Albany NY 12237 Nashville TN 372430435 Helena MT 596200901 4064442544 Springfield IL 627949276 2177823397 Bismarck ND 585011947 7013285152 Hartford CT 6134

Newark DE 19714 Washington DC 20002 2028423204 2028420439 Sarasota FL 34236

### EMAIL

dosterhoudt@asdwa.org

breslaw1@gmail.com

emanuela.testai@iss.it

chane@njc.org

### mjmwells@tntech.edu

olga@ewg.org hconnor@waterkeeper.org

kknowlton@nrdc.org

### rda@rushmore.com

dglatt@nd.gov

### CLINE_ID COMMENT_ID LETTER_ID BEGINNING_LINE_NUMBER ENDING_LINE_NUMBER

19751 17287 6083 6 21 19752 17288 6082 6 9 19754 17289 6082 12 107 19755 17290 6081 6 23 19756 17291 6081 26 44 19757 17292 6084 6 30 19759 17293 6084 33 49 19760 17294 6084 52 60 19761 17295 6084 63 101 19763 17297 6084 104 214 19764 17298 6084 217 227 19765 17299 6084 229 233 21363 18840 6534 6 8 21364 18841 6534 11 25 21365 18842 6534 28 48 21366 18843 6534 51 83 21367 18844 6534 86 104 21368 18845 6534 107 182 21369 18846 6534 185 191 21370 18847 6534 194 220 21371 18848 6534 223 227 21372 18849 6535 6 23 21373 18850 6535 26 45 21374 18851 6535 48 61 21375 18852 6535 68 121 21376 18853 6535 124 143 21377 18854 6535 146 153 21378 18855 6535 156 181 21379 18856 6535 184 201 21380 18857 6535 204 240 21381 18858 6535 243 250 21382 18859 6535 253 272 21384 18861 6535 332 405 21385 18862 6535 408 437 21386 18863 6535 440 445 21387 18864 6535 448 479 21388 18865 6535 482 744 21389 18866 6535 747 839 21390 18867 6536 6 9 21391 18868 6536 12 29 21392 18869 6536 32 380 21393 18870 6536 383 596 21394 18871 6537 6 20 21395 18872 6537 23 28 21396 18873 6537 31 40 21397 18874 6537 43 11121398 18875 6537 114 123

21399 18876 6537 126 157 21400 18877 6555 6 17 21401 18878 6544 6 35 21402 18879 6544 38 174 21403 18880 6544 177 230 21404 18881 6544 233 247 21405 18882 6544 250 264 21406 18883 6545 6 21 21407 18884 6545 24 106 21408 18885 6545 109 121 21409 18886 6552 6 25 21410 18887 6552 28 44 21411 18888 6552 47 52 21412 18889 6552 55 74 21413 18890 6552 77 94 21414 18891 6552 97 112 21415 18892 6552 115 121 21416 18893 6552 124 153 21417 18894 6552 156 380 21420 18897 6552 472 491 21421 18898 6552 494 579 21422 18899 6552 582 733 21423 18900 6552 736 744 21424 18901 6552 747 769 21425 18902 6552 772 800 21426 18903 6552 803 810 21427 18904 6552 813 822 21428 18905 6552 825 831 21429 18906 6552 834 879 21430 18907 6552 882 889 21431 18908 6552 892 901 21432 18909 6552 904 907 21433 18910 6552 910 943 21434 18911 6552 946 974 21435 18912 6553 6 25 21436 18913 6553 28 261 21437 18914 6553 264 311 21438 18915 6553 314 325 21439 18916 6553 328 419 21440 18917 6554 6 24 21443 18918 6554 27 43 21446 18919 6554 46 58 21448 18920 6554 67 71 21450 18921 6554 327 347 21451 18922 6554 350 381 21452 18923 6554 384 39521453 18924 6554 398 415

21454 18925 6554 418 540 21456 18927 6554 710 718 21457 18928 6554 721 769 21459 18929 6554 772 893 21460 18930 6554 896 914 21462 18931 6558 6 20 21464 18932 6558 23 35 21465 18933 6558 38 59 21466 18934 6502 6 24 21467 18935 6503 6 8 21468 18936 6503 11 19 21469 18937 6503 22 22 21470 18938 6504 6 17 21471 18939 6505 6 21 21472 18940 6509 6 6 21473 18941 6510 6 12 21474 18942 6510 15 16 21475 18943 6549 6 14 21478 18944 6549 17 59 21479 18945 6549 70 111 21480 18946 6549 114 193 21481 18947 6549 224 241 21482 18948 6538 6 14 21484 18949 6538 17 19 21487 18950 6538 22 35 21490 18951 6539 6 11 21492 18952 6539 14 88 21493 18953 6540 6 10 21494 18954 6540 13 16 21495 18955 6540 19 28 21496 18956 6540 31 55 21497 18957 6541 6 22 21499 18958 6541 25 120 21500 18959 6542 6 15 21502 18960 6542 18 54 21503 18961 6543 6 12 21505 18962 6543 15 27 21507 18963 6547 6 14 21509 18964 6547 17 29 21510 18965 6548 6 8 21511 18966 6550 6 17 21513 18967 6550 20 28 21515 18968 6550 55 69 21516 18969 6550 72 87 21517 18970 6551 6 24 21519 18971 6551 27 3721521 18972 6551 40 78

21522 18973 6546 6 22 21525 18974 6546 25 42 21526 18975 6546 108 127 21528 18977 6507 6 27 21529 18978 6507 30 30 21530 18979 6508 6 12 21531 18980 6518 6 9 21533 18981 6518 12 38 21534 18982 6518 47 48 21535 18983 6519 6 9 21537 18984 6519 12 33 21538 18985 6520 6 27 21539 18986 6520 30 57 21540 18987 6520 60 60 21541 18988 6521 6 9 21542 18989 6521 12 36 21543 18990 6521 39 61 21544 18991 6521 64 73 21545 18992 6521 76 85 21546 18993 6522 6 15 21547 18994 6522 18 119 21548 18995 6522 122 129 21549 18996 6523 6 25 21550 18997 6523 28 123 21551 18998 6523 126 135 21552 18999 6524 6 11 21553 19000 6524 14 108 21554 19001 6524 111 116 21555 19002 6525 6 11 21556 19003 6525 14 115 21557 19004 6525 118 126 21558 19005 6526 6 11 21559 19006 6526 14 109 21560 19007 6526 112 120 21561 19008 6527 6 11 21562 19009 6527 14 109 21563 19010 6527 112 123 21564 19011 6527 126 128 21569 19016 6530 6 13 21570 19017 6530 16 30 21571 19018 6531 6 24 21572 19019 6531 27 131 21573 19020 6531 134 162 21574 19021 6531 165 212 21575 19022 6531 215 235 21576 19023 6531 238 24021578 19025 6532 17 26

21579 19026 6533 6 9 21580 19027 6506 6 20 21581 19028 6506 23 31 21582 19029 6506 34 40 21583 19030 6506 43 53 21584 19031 6511 6 16 21585 19032 6511 19 27 21586 19033 6511 30 45 21587 19034 6511 48 52 21588 19035 6511 55 59 21589 19036 6511 62 65 21590 19037 6511 68 69 21591 19038 6511 72 87 21592 19039 6511 90 95 21593 19040 6511 98 109 21594 19041 6511 112 141 21595 19042 6511 144 166 21597 19044 6511 169 210 21598 19045 6511 213 226 21599 19046 6511 229 255 21600 19047 6511 258 296 21601 19048 6511 299 306 21602 19049 6511 309 386 21603 19050 6512 6 44 21604 19051 6512 47 47 21605 19052 6513 6 8 21606 19053 6514 6 20 21607 19054 6514 23 55 21608 19055 6514 58 61 21609 19056 6515 6 10 21610 19057 6515 13 18 21611 19058 6515 21 100 21612 19059 6515 103 108 21613 19060 6516 6 11 21614 19061 6516 14 86 21615 19062 6516 89 96 21616 19063 6517 6 19 21617 19064 6517 22 24 21618 19065 6517 27 40 21619 19066 6517 43 46 21620 19067 6517 49 103 21621 19068 6517 106 165 21622 19069 6517 168 175 21623 19070 6517 178 182 21624 19071 6517 204 204 21625 19072 6517 207 22421626 19073 6517 227 257

21627 19074 6517 260 274 21628 19075 6517 277 289 21629 19076 6557 6 17 21630 19077 6557 19 51 21631 19078 6557 54 69 21632 19079 6557 71 90 21633 19080 6557 93 106 21634 19081 6557 109 126 21635 19082 6557 129 148 21636 19083 6557 151 158 21637 19084 6557 161 236 21638 19085 6557 239 246 21639 19086 6557 249 284 21640 19087 6557 287 305 21641 19088 6557 308 363 21643 19090 6557 366 385 21644 19091 6557 391 415 21645 19092 6556 6 24 21646 19093 6556 27 41 21647 19094 6556 44 51 21648 19095 6556 54 66 21649 19096 6556 69 81 21653 19100 6556 131 153 21654 19101 6556 156 190 21655 19102 6556 198 208 21656 19103 6084 236 246 21657 19104 6082 110 117 21658 19105 6518 41 44 21659 19106 6519 36 39 21660 19107 6563 6 21 21661 19108 6563 24 51 21662 19109 6563 54 89 21663 19110 6563 92 99 21664 19111 6563 102 107 21665 19112 6563 116 121 21666 19113 6563 124 134 21667 19114 6563 137 195 21668 19115 6563 198 206 21669 19116 6564 6 20 21670 19117 6564 23 37 21671 19118 6564 40 45 21672 19119 6564 48 51 21673 19120 6564 54 70 21674 19121 6564 73 77 21675 19122 6565 6 17 21676 19123 6565 20 4921677 19124 6565 52 103

21678 19125 6565 106 122 21679 19126 6565 125 134 21680 19127 6566 6 41 21681 19128 6566 44 81 21682 19129 6566 84 107 21683 19130 6566 110 145 21684 19131 6566 148 168 21685 19132 6566 171 197 21686 19133 6566 200 219 21687 19134 6566 222 232 21688 19135 6568 6 17 21689 19136 6568 20 25 21690 19137 6568 28 69 21691 19138 6568 72 154 21692 19139 6568 157 182 21693 19140 6568 185 202 21694 19141 6568 205 209 21695 19142 6569 6 26 21696 19143 6569 29 68 21698 19145 6569 71 81 21699 19146 6569 84 114 21700 19147 6569 117 134 21701 19148 6569 137 165 21702 19149 6569 168 250 21703 19150 6569 253 283 21704 19151 6569 286 327 21705 19152 6569 330 350 21706 19153 6569 353 372 21707 19154 6569 375 386 21708 19155 6570 6 29 21709 19156 6570 32 50 21710 19157 6570 53 87 21711 19158 6570 90 95 21712 19159 6570 98 120 21713 19160 6571 6 13 21714 19161 6571 16 17 21715 19162 6571 20 26 21716 19163 6571 29 41 21717 19164 6571 44 57 21718 19165 6571 60 64 21719 19166 6572 6 26 21720 19167 6572 29 39 21721 19168 6572 42 46 21722 19169 6572 49 52 21723 19170 6572 55 62 21724 19171 6572 65 7521725 19172 6546 45 105

21726 19173 6546 130 571 21727 19174 6546 574 588 21728 19175 6572 78 78 21729 19176 6572 81 82 21730 19177 6572 85 92 21731 19178 6572 94 94 21732 19179 6572 96 99 21733 19180 6572 102 109 21734 19181 6572 112 123 21735 19182 6572 126 192 21736 19183 6572 195 394 21737 19184 6572 397 523 21738 19185 6572 526 534 21739 19186 6572 537 610 21740 19187 6572 613 703 21741 19188 6572 706 710 21742 19189 6572 713 722 21743 19190 6572 725 759 21744 19191 6572 762 929 21745 19192 6572 932 1058 21746 19193 6572 1061 1093 21747 19194 6572 1096 1209 21748 19195 6572 1750 1838 21749 19196 6572 1841 1973 21750 19197 6572 2164 2316 21751 19198 6572 2319 2366 21752 19199 6572 2369 2376 21753 19200 6572 2378 2381 21754 19201 6572 2384 2387 21755 19202 6572 2390 2393 21756 19203 6547 32 41 21757 19204 6573 6 7 21758 19205 6573 10 21 21759 19206 6573 24 37 21760 19207 6573 40 67 21761 19208 6573 70 87 21763 19210 6573 200 202 21764 19211 6573 205 287 21765 19212 6573 290 300 21766 19213 6573 303 380 21767 19214 6573 383 407 21768 19215 6573 410 416 21769 19216 6573 419 429 21770 19217 6573 432 451 21771 19218 6573 454 507 21772 19219 6573 510 52821773 19220 6573 531 920

21774 19221 6574 6 47 21775 19222 6574 50 62 21776 19223 6574 65 72 21777 19224 6574 75 145 21778 19225 6574 148 204 21779 19226 6574 207 216 21780 19227 6549 62 67 21781 19228 6549 196 221 21782 19229 6574 219 225 21783 19230 6574 228 233 21784 19231 6574 236 265 21785 19232 6574 268 295 21786 19233 6574 298 312 21787 19234 6574 315 350 21788 19235 6574 353 362 21789 19236 6574 365 1130 21794 19241 6574 1133 1248 21795 19242 6574 1250 1290 21796 19243 6574 1292 1308 21797 19244 6574 1311 1331 21798 19245 6550 31 42 21799 19246 6550 45 52 21800 19247 6551 81 94 21801 19248 6551 97 104 21802 19249 6575 6 23 21803 19250 6575 26 106 21804 19251 6575 109 116 21805 19252 6576 6 22 21806 19253 6576 35 47 21807 19254 6576 50 77 21808 19255 6577 6 19 21809 19256 6577 22 31 21810 19257 6577 34 166 21811 19258 6578 6 17 21812 19259 6578 20 32 21813 19260 6578 35 50 21814 19261 6578 53 59 21815 19262 6578 62 73 21816 19263 6578 76 85 21817 19264 6578 88 101 21818 19265 6554 102 104 21819 19266 6554 107 158 21820 19267 6554 161 179 21821 19268 6554 182 194 21823 19270 6554 238 324 21824 19271 6579 6 2421825 19272 6579 27 63

21826 19273 6579 66 71 21827 19274 6580 6 19 21828 19275 6580 22 50 21829 19276 6580 53 58 21830 19277 6580 61 71 21831 19278 6554 689 707 21832 19279 6554 917 922 21833 19280 6581 6 11 21834 19281 6581 14 25 21835 19282 6581 28 46 21836 19283 6581 49 57 21837 19284 6581 60 128 21838 19285 6581 131 165 21839 19286 6581 168 176 21840 19287 6581 179 185 21841 19288 6581 188 192 21842 19289 6581 195 204 21843 19290 6582 6 21 21844 19291 6582 24 49 21845 19292 6582 52 73 21846 19293 6582 76 81 21847 19294 6582 84 96 21848 19295 6583 6 19 21849 19296 6583 22 31 21850 19297 6583 33 39 21851 19298 6583 42 50 21852 19299 6583 53 62 21853 19300 6583 65 84 21854 19301 6584 6 18 21855 19302 6584 21 45 21856 19303 6584 48 56 21857 19304 6584 59 67 21858 19305 6584 70 75 21859 19306 6584 78 106 21860 19307 6584 109 124 21861 19308 6584 127 142 21862 19309 6584 145 161 21863 19310 6584 164 172 21864 19311 6585 6 20 21865 19312 6585 22 35 21866 19313 6585 37 71 21867 19314 6585 73 184 21868 19315 6585 187 211 21869 19316 6558 62 93 21870 19317 6567 6 20 21871 19318 6567 23 3321872 19319 6567 36 58

21873 19320 6567 61 70 21874 19321 6567 73 85 21875 19322 6567 88 120 21876 19323 6567 123 157 21877 19324 6567 160 166 21878 19325 6567 169 189 21879 19326 6567 192 195 21880 19327 6567 198 234 21881 19328 6567 237 246 21882 19329 6567 249 273 21883 19330 6567 276 281 21884 19331 6567 284 288 21885 19332 6567 291 300 21886 19333 6561 6 35 21887 19334 6562 6 13 21888 19335 6562 16 59 21889 19336 6562 62 69 21890 19337 6562 72 93 21891 19338 6562 96 132 21892 19339 6562 135 139 21893 19340 6562 142 145 21894 19341 6562 148 155 21895 19342 6562 158 173 21896 19343 6562 175 193 21897 19344 6562 195 197 21898 19345 6572 2396 2404 21899 19346 6577 169 177 21900 19347 6577 180 187 21901 19348 6539 91 95 21902 19349 6538 38 56 21903 19350 6538 59 79 21904 19351 6538 82 95 21905 19352 6538 98 121 21906 19353 6538 124 142 21907 19354 6543 30 112 21908 19355 6543 115 132 21909 19356 6542 57 66 21910 19357 6541 123 137 21923 19360 6587 6 28 21924 19361 6587 30 63 21925 19362 6587 65 80 21926 19363 6587 82 94 21927 19364 6587 96 115 21928 19365 6588 6 19 21929 19366 6588 21 82 21930 19367 6588 84 9321931 19368 6586 6 51

21932 19369 6586 55 84 21933 19370 6586 87 93 21934 19371 6586 96 98 21935 19372 6586 101 109 21936 19373 6586 112 115 21937 19374 6586 118 127 21938 19375 6586 130 303 21939 19376 6586 306 366 21940 19377 6586 369 440 21941 19378 6586 443 514 21942 19379 6586 517 610 21943 19380 6586 613 645 21944 19381 6586 648 714 21945 19382 6586 717 742 21946 19383 6586 745 851 21947 19384 6586 854 880 21948 19385 6586 883 903 21949 19386 6586 906 1007 21950 19387 6586 1010 1038 21951 19388 6586 1041 1111 21952 19389 6586 1114 1141 21953 19390 6586 1144 1320 21954 19391 6586 1323 1329 21955 19392 6586 1332 1415 21956 19393 6586 1418 1430 21957 19394 6586 1433 1437 21958 19395 6586 1439 1445 21959 19396 6586 1448 1589 21960 19397 6586 1592 1647 21961 19398 6586 1650 1789 21962 19399 6586 1792 1810 21963 19400 6586 1813 1885 21964 19401 6586 1888 1933 21965 19402 6586 1936 1986 21966 19403 6586 1989 2012 21967 19404 6586 2015 2057 21968 19405 6586 2060 2072 21969 19406 6586 2074 2084 21970 19407 6586 2087 2118 21971 19408 6586 2121 2150 21972 19409 6586 2153 2188 21973 19410 6586 2191 2237 21974 19411 6586 2240 2275 21975 19412 6586 2278 2310 21976 19413 6586 2313 2375 21977 19414 6586 2378 243021978 19415 6586 2433 2453

21979 19416 6586 2456 2475 21980 19417 6586 2478 2491 21981 19418 6586 2494 2776 21983 19420 6601 5 5 21984 19421 6601 7 9 21985 19422 6602 6 6 21986 19423 6602 9 9 21987 19424 6603 6 13 21988 19425 6603 15 51 21989 19426 6603 54 79 21990 19427 6603 81 235 21991 19428 6604 6 14 21992 19429 6604 16 20 21993 19430 6604 23 40 21994 19431 6604 42 76 21995 19432 6604 79 89 21996 19433 6605 6 13 21997 19434 6605 15 20 21998 19435 6605 22 27 21999 19436 6606 6 35 22000 19437 6606 38 54 22001 19438 6606 57 69 22002 19439 6606 72 85 22003 19440 6606 89 228 22004 19441 6607 6 17 22005 19442 6607 20 39 22006 19443 6607 42 84 22007 19444 6607 87 149 22008 19445 6607 152 169 22009 19446 6607 172 192 22010 19447 6607 195 195 22011 19448 6608 6 16 22012 19449 6608 18 158 22013 19450 6608 161 169 22014 19451 6609 6 14 22015 19452 6609 16 53 22016 19453 6609 56 61 22017 19454 6609 62 129 22018 19455 6609 132 139 22019 19456 6610 6 14 22020 19457 6610 16 123 22021 19458 6610 126 144 22022 19459 6611 6 16 22023 19460 6611 19 90 22024 19461 6611 92 110 22025 19462 6612 6 1222026 19463 6612 14 55

22027 19464 6612 58 67 22028 19465 6613 6 16 22029 19466 6613 18 60 22030 19467 6613 63 75 22031 19468 6614 6 15 22032 19469 6614 17 128 22033 19470 6614 131 142 22034 19471 6615 6 15 22035 19472 6615 17 52 22036 19473 6615 55 73 22037 19474 6615 76 88 22038 19475 6615 91 110 22039 19476 6615 113 129 22040 19477 6616 6 27 22041 19478 6616 30 43 22042 19479 6616 46 52 22043 19480 6616 55 152 22044 19481 6616 155 169 22045 19482 6506 34 40 22063 19500 6563 108 113 22064 19501 6554 61 64 22065 19502 6554 74 93 22066 19503 6554 96 99 22067 19504 6554 232 235 22068 19505 6554 210 229 22073 19510 6554 197 200 22075 19512 6621 6 9 22076 19513 6621 12 115 22077 19514 6621 118 123 22083 19520 6554 203 207 22084 19521 6554 543 575 22085 19522 6554 578 603 22086 19523 6554 606 686 22087 19524 6535 275 319 22088 19525 6535 320 329 22089 19526 6532 6 13 22090 19527 6532 14 14 22091 19528 6552 399 420 22092 19529 6552 423 469 22093 19530 6552 383 391 22094 19531 6552 392 396 22095 19532 6573 90 115 22096 19533 6573 118 155 22097 19534 6573 158 197 22098 19535 6084 63 101 22099 19536 6081 26 4422100 19537 6544 177 230

22101 19538 6554 418 540 22102 19539 6554 721 769 22103 19540 6534 51 83 22104 19541 6534 86 104 22105 19542 6535 408 437 22106 19543 6537 114 123 22107 19544 6554 27 43 22110 19547 6554 772 893 22111 19548 6554 896 914 22112 19549 6502 6 24 22113 19550 6549 6 14 22114 19551 6550 55 69 22115 19552 6511 68 69 22117 19554 6563 124 134 22118 19555 6565 20 49 22119 19556 6612 14 55 22120 19557 6616 30 43 22121 19558 6616 46 52 22122 19559 6616 55 152 22123 19560 6563 92 99 22125 19562 6557 129 148 22126 19563 6604 16 20 22127 19564 6604 42 76 22128 19565 6554 74 93 22129 19566 6554 96 99 22130 19567 6554 232 235 22131 19568 6554 210 229 22132 19569 6572 2384 2387 22133 19570 6607 42 84 22134 19571 6613 18 60 22135 19572 6565 106 122 22136 19573 6574 365 1130 22137 19574 6614 17 128 22138 19575 6615 17 52 22139 19576 6615 91 110 22140 19577 6554 61 64 22141 19578 6610 16 123 22142 19579 6568 20 25 22143 19580 6568 157 182 22144 19581 6554 689 707 22145 19582 6554 917 922 22146 19583 6554 197 200 22149 19586 6556 156 190 22150 19587 6574 148 204 22151 19588 6574 207 216 22154 19591 6573 90 11522155 19592 6573 118 155

22156 19593 6573 158 197 22158 19595 6572 112 123 22159 19596 6556 44 51 22161 19598 6585 37 71 22162 19599 6587 30 63 22163 19600 6587 82 94 22164 19601 6573 432 451 22165 19602 6573 510 528 22166 19603 6583 53 62 22167 19604 6603 15 51 22168 19605 6603 81 235 22169 19606 6608 18 158 22170 19607 6611 19 90 22171 19608 6554 203 207 22172 19609 6576 35 47 22173 19610 6573 205 287 22174 19611 6573 410 416 22175 19612 6574 315 350 22176 19613 6574 1292 1308 22177 19614 6549 62 67 22178 19615 6549 196 221 22179 19616 6554 102 104 22180 19617 6554 161 179 22182 19619 6584 59 67 22183 19620 6563 108 113 22184 19621 6586 118 127 22185 19622 6556 84 128 22186 19623 6556 84 128 22204 19641 6641 1 13 22205 19642 6641 16 116 22206 19643 6641 119 127 22218 19655 6535 64 67 22219 19656 6556 193 195 22220 19657 6576 25 32 22221 19658 6517 185 201 22384 19821 6565 52 103 22397 19834 6574 65 72 22874 20316 6572 1212 1301 22875 20317 6572 1304 1389 22876 20318 6572 1392 1516 22877 20319 6572 1519 1569 22878 20320 6572 1572 1657 22879 20321 6572 1660 1747 22880 20322 6572 1976 2033 22881 20323 6572 2036 2104 22882 20324 6572 2107 216128209 25320 6616 170 235

28225 25336 8582 17 32 28226 25337 8582 34 166 28227 25338 8582 168 171 28228 25339 8583 17 27 28229 25340 8583 31 50 28230 25341 8583 52 72

### COMMENT_ID LETTER_ID 17287 6083

17288 6082

17289 6082 17290 6081 17291 6081

17292 6084

17293 6084

17294 6084 17295 6084

17297 6084

17298 6084 17299 6084

18840 6534

18841 6534

18842 653418843 6534

18844 6534

18845 6534

18846 653418847 6534

18848 6534

18849 6535

18850 6535

18851 6535

18852 6535

18853 6535 18854 6535 18855 6535

18856 6535 18857 6535

18858 653518859 6535

18861 6535

18862 6535 18863 6535 18864 6535 18865 6535

18866 653518867 6536 18868 6536

18869 6536

18870 6536

18871 6537

18872 6537 18873 6537 18874 6537

18875 6537

18876 6537

18877 6555 18878 654418879 6544

18880 6544

18881 6544

18882 6544

18883 654518884 6545 18885 6545

18886 6552

18887 6552

18888 6552 18889 6552 18890 6552 18891 6552

18892 6552 18893 6552 18894 6552 18897 6552

18898 6552

18899 6552

18900 655218901 6552

18902 6552

18903 6552 18904 6552 18905 6552 18906 6552

18907 6552 18908 6552 18909 6552

18910 6552

18911 6552

18912 655318913 6553

18914 6553

18915 6553

18916 6553

18917 6554

18918 6554

18919 6554

18920 6554 18921 6554

18922 6554 18923 6554 18924 655418925 6554

18927 6554

18928 6554

18929 6554

18930 6554

18931 6558

18932 6558 18933 6558 18934 6502

18935 650318936 6503

18937 6503

18938 6504 18939 6505

18940 6509 18941 6510 18942 6510

18943 6549 18944 6549

18945 6549 18946 6549 18947 6549 18948 6538

18949 6538

18950 6538

18951 6539

18952 6539

18953 654018954 6540

18955 6540

18956 6540

18957 6541

18958 6541

18959 6542

18960 6542

18961 6543

18962 6543

18963 654718964 6547

18965 6548 18966 6550

18967 6550

18968 6550

18969 6550

18970 6551

18971 6551

18972 6551

18973 6546 18974 654618975 6546

18977 6507

18978 6507

18979 6508 18980 6518

18981 6518

18982 6518

18983 6519

18984 6519 18985 6520

18986 6520 18987 6520

18988 6521 18989 652118990 6521

18991 6521

18992 6521 18993 6522

18994 6522

18995 6522

18996 6523

18997 6523

18998 6523

18999 6524

19000 6524 19001 6524

19002 6525

19003 6525 19004 6525

19005 6526

19006 6526 19007 6526

19008 652719009 6527 19010 6527

19011 6527

19016 6530

19017 6530

19018 6531

19019 6531

19020 6531 19021 6531

19022 6531 19023 6531

19025 6532

19026 6533 19027 6506

19028 650619029 6506

19030 6506

19031 6511

19032 6511

19033 6511

19034 6511

19035 6511 19036 6511 19037 6511 19038 6511

19039 6511

19040 6511 19041 651119042 6511

19044 6511

19045 6511

19046 6511

19047 6511

19048 6511 19049 6511

19050 6512

19051 6512

19052 6513 19053 651419054 6514

19055 6514

19056 6515

19057 6515

19058 6515

19059 6515

19060 6516

19061 6516

19062 6516

19063 6517

19064 6517 19065 651719066 6517 19067 6517

19068 6517

19069 6517 19070 6517 19071 6517

19072 6517 19073 6517

19074 6517 19075 6517

19076 655719077 6557

19078 6557 19079 6557

19080 6557

19081 6557

19082 6557

19083 655719084 6557

19085 6557

19086 6557

19087 6557

19088 6557

19090 6557 19091 6557

19092 6556

19093 655619094 6556

19095 6556 19096 6556 19100 6556 19101 6556

19102 6556

19103 6084

19104 6082

19105 6518

19106 6519

19107 6563

19108 6563

19109 6563

19110 6563 19111 6563 19112 6563 19113 656319114 6563

19115 6563

19116 6564

19117 6564

19118 6564

19119 6564

19120 6564

19121 6564 19122 6565

19123 6565 19124 6565

19125 6565

19126 6565

19127 656619128 6566

19129 6566

19130 6566

19131 6566

19132 6566

19133 6566

19134 6566

19135 656819136 6568

19137 6568

19138 6568

19139 6568

19140 6568 19141 6568

19142 656919143 6569

19145 6569

19146 6569

19147 6569 19148 6569 19149 6569 19150 6569

19151 656919152 6569

19153 6569

19154 6569

19155 6570

19156 6570 19157 6570

19158 6570

19159 6570

19160 6571

19161 6571 19162 6571 19163 6571 19164 6571 19165 6571

19166 6572

19167 657219168 6572 19169 6572 19170 6572 19171 6572

19172 6546 19173 6546

19174 6546

19175 6572 19176 6572

19177 6572

19178 6572

19179 6572

19180 6572 19181 6572

19182 6572 19183 6572

19184 6572 19185 6572 19186 6572 19187 6572 19188 657219189 6572

19190 6572

19191 6572

19192 6572

19193 6572

19194 657219195 6572

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### INDIVIDUAL_COMMENT_RESPONSE

Please see response to comment ID 18977 under comment code 1000. EPA also evaluates chemicals under several other programs to determine their registration status and uses. The Agency considered all public comments and the best available information and science for the chemicals considered on CCL 3. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840. No response necessary. Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: enteroviruses, adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba histolytica. EPA disagrees with the commenter on removing Helicobacter pylori. H. pylori has a total score of 8.0 (out of a possible 10) and is well above the cut off of 6.1, therefore, this pathogen remains on the CCL 3. EPA also disagrees with the commenter on adding rotavirus to the CCL 3. Rotavirus scored 5.5 due to no CDC WBDO and relatively low health effects (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process for more information on all the scores). Furthermore, EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The Agency agrees with the commenter that the established protocol to identify potential contaminants for regulations provides greater transparency and scientific rigor than an ad-hoc process. Please see the response to comment ID 18969 under comment code 6100. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its See the response to comment ID 19338 under comment code 7200. The Agency has also provided a CCL 3 Universe List in the CCL 3 docket at www.regulations.gov. This list contains all the contaminants considered for the CCL 3 and their status in the evaluation. Information collected for individual chemicals on the PCCL and CCL 3 are listed in the Contaminant Information Sheets also available at www.regulations.gov. See response to comment ID 19198 under comment code 7150. Please see responses to comment IDs 19338 and 17297 under comment code 7200. EPA included carbamazepine in the CCL 3 Universe; however, although carbamazepine is frequently detected in studies of emerging contaminants, it occurs at low levels, and it did not pass screening to the PCCL and did not make the Methanol has been included on the final CCL 3. EPA has responded to the specific information and comments provided by the Methanol Institute on methanol occurrence under comment code 3860 (see the response to comment ID 18847) and on methanol health under comment code 3855 (see the response to comment IDs Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human health. Methanol did pass the occurrence and health effects criteria and based upon these and other data, EPA has determined that methanol is known or anticipated to occur in drinking water and may require regulation. Therefore, EPA has included methanol on the third CCL. The inclusion of a contaminant on the CCL 3 does not necessarily mean that the contaminant will be regulated. As with all contaminants included on the CCL 3, methanol will be further evaluated under the regulatory determinations process.

### The commenter is correct in noting that a severity score of 6 indicates significant, irreversible, nonlethal

conditions or disordersfor some organs. However, the severity score for methanol was not based on alterations to serum enzymes or liver, but is based on the health effect of decrease in brain weight. Appendix A of the PCCL to CCL Process Report contains a Compendium of Critical Effects Table that lists a severity score of 6 for significant decreases in brain weight, separate from scores given to other organs and the irreversible effects. Therefore, the severity score for methanol was correctly applied. Based upon these data, EPA concludes that methanol is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to occur in drinking water (as described in the FR notice for the draft CCL 3). For methanol, there was no occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. EPA disagrees with the commenter that consideration for listing [methanol] is likely not based on these health effects attributes, but simply because methanol scores highly on the occurrence attributes. The attributes for occurrence and adverse health effects taken together were used to evaluate the potential of methanol to occur In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to occur in drinking water (as described in the FR notice for the draft CCL 3). For methanol, there was no occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. These attributes taken together were used to evaluate the potential of methanol to occur in drinking water.

The commenter provides statistics on the environmental release of methanol from the 2006 TRI reporting. The Agency agrees that the amount of methanol released decreased from the 2004 reports. (Surface water: 5,584,425 lbs in 39 States Total: 175,205,861 lbs in 52 States) The Agency also notes that the attribute scores and the model results would not change based on the 2006 TRI data.

EPA also conducted a sensitivity analysis to evaluate whether using physical and chemical properties combined EPA considered a wide range of health effects, potency values, and occurrence data and scored each chemical according to the protocol as discussed in the FR notice and support documents. The data sources used to generate scores for methanol are consistent with the protocol and account for the differences in effects at specific dosing levels cited by the commenter. The Malcolm Pirnie study cited by the commenter did not meet the CCL data requirements based on the hierarchy of data used for the CCL process as discussed in 73 FR 9628.

Therefore, EPA used the IRIS assessment based on the CCL 3 protocols. This assessment is being reviewed by the Agency and will provide an assessment of the most up to date information available for methanol and provide additional toxicity information that EPA can use to evaluate contaminants on the CCL 3. Based upon these data, EPA concludes that methanol is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this compound on the CCL 3.

### EPA disagrees with the commenter that an analysis indicating that methanol appears to be a more

environmentally benign fuel compared to conventional gasoline" and Toxic Release Inventory (TRI) data are not sufficient to anticipate that methanol can occur in PWS. The Agency uses the best available national occurrence data to determine if contaminants are known or anticipated to occur in public water systems. The Agency collected data and information that methanol can be anticipated to occur in PWS. TRI data showed total releases (200 million pounds) in every state. CUSIUR production data also indicated that over a billion pounds of methanol was produced. EPA selected the TRI data as the best available data based on the hierarchy described in the FR notice (FR vol 73 no 35). Based on these and other data, EPA has determined that methanol is known or anticipated to occur in drinking water and may require regulation. Therefore EPA has included methanol on the third CCL. EPA has responded in more detail to the information and comments provided by the Methanol Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements 1,3-butadiene has been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the ACC on 1,3-butadiene under the response to comment IDs 18861 and 19524 in comment code 2630 (1,3-butadiene occurrence) and the response to comment ID 19525 in comment code 6146 EPA disagrees with the commenter that EPA inappropriately used total TRI releases to determine 1,3- butadienes potential to occur in drinking water and that EPA should define 1,3-butadienes potential to occur in drinking water based on surface water releases. EPA believes that it is appropriate to use total environmental release data rather than the total quantity released to surface water to evaluate the potential of a contaminant to occur in drinking water, as the use of total environmental release data accounts for any releases to groundwater and for the propensity of a compound to migrate within the environment; whereas the use of only surface water release data would not take into account the release of a contaminant to groundwater or the migration or mobility of a compound. Discussion in the National Drinking Water Advisory Council (NDWAC) 2004 report supports this: In surface waters, which are exposed to the air, compounds that volatilize will not be persistent, simply because they evaporate into the air and are not found in the water. However, in ground Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 18850 under comment code 2620. Please see response to comment ID 18851 under comment code 2630. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 18850 under comment code 2620. The commenter correctly identifies the major criteria set forth in SDWA to evaluate unregulated contaminants for inclusion on the CCL and the subsequent determination of whether or not to regulate a contaminant. EPA disagrees with the commenters assertion that a contaminant must remain on the CCL until a regulatory determination is made. The CCL process allows for the re-screening and re-classification of the contaminants after publication for public comment. New toxicological and/or occurrence data resulting from changes in registration status, production and use, or the best available science may warrant a re-evaluation of the contaminant. EPA also notes that there is no procedure set forth in SDWA requiring a contaminant to remain on subsequent CCLs. EPA has re-evaluated chemicals on CCL 2 and the draft CCL 3 based upon additional toxicological and/or occurrence data. The Agency did not include contaminants on the CCL 3 that the Agency does not anticipate or know occurs in PWS and may require regulation under SDWA. In addition, a CCL is The Agency disagrees that 1,3-butadiene should not be included on the final CCL3. Please see the response to comment ID 18850 under comment code 2620.

### EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to

occur in drinking water (as described in the FR notice for the draft CCL 3). For 1,3-butadiene, there was no occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute and the number of States reporting releases (total) for the prevalence attribute. These attributes taken together were used to evaluate the potential of 1,3-butadiene to occur in drinking water.

EPA disagrees with the commenter that because 1,3-butadiene is a highly volatile gas and is expected to partition predominantly to the atmosphere that EPA should consider using surface water releases in determining whether 1,3-butadiene should be listed. EPA believes that it is appropriate to use total environmental release data rather than the total quantity released to surface water to evaluate the potential of a contaminant to occur in drinking water, as the use of total environmental release data accounts for any releases to groundwater and for the propensity of a compound to migrate within the environment; whereas the use of only surface water release data would not take into account the release of a contaminant to groundwater or the migration or mobility of a compound. Discussion in the National Drinking Water Advisory Council (NDWAC) 2004 report EPA disagrees with the commenter that Reliance on TRI release data without considering 1,3-butadiene's physical properties and fate has led, however, to the erroneous conclusion that 1,3-butadiene might occur in drinking water.

In developing the draft CCL 3, EPA conducted a sensitivity analysis evaluating options using physical and chemical properties combined with environmental fate parameters to consider chemicals. These analyses are described in the support documents available in the docket and are the basis for the screening and attribute scoring protocols (Contaminant Candidate List 3 Chemicals: Screening to a PCCL. EPA 815-R-08-003 and Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL, EPA 815-R-08-004).

The commenter also suggested that EPA consider 1,3- butadiene and its physical properties. EPA evaluated 1,3- butadiene using physical and chemical properties combined with environmental fate parameters for the magnitude attribute score instead of using total environmental release data. For this analysis, EPA followed the CCL 3 protocol for those chemicals with only production data and used the persistence and mobility protocols as the basis for the magnitude attribute scoring as described in the FR notice and support documents. The model results for 1,3- butadiene using the environmental parameter protocols were the same as the results developed for the draft CCL 3 using TRI data.

Please see response to comment IDs 18851 and 18861 under comment code 2630. Please see the responses to comment IDs 18858 and 18850 under comment code 2620. Please see response to comment ID 18857 under comment code 9100. Please see the response to comment IDs 18851 and 18861 under comment code 2630. The commenter states that, In most cases, groundwater will also be treated before consumption and discusses the estimated removal of 1,3-butadiene from several treatment technologies such as aeration. EPA disagrees that standard treatment for groundwater includes air stripping and other methods to remove volatile contaminants. Only 13 percent of community groundwater system plants reported using aeration (See EPA Table 2A of the 2000 Community Water System Survey). EPA also believes that it is not appropriate to assume that an unregulated contaminant will be removed by all drinking water treatment plants. The Agency notes that there is a wide variation in the type of treatment that may be used by systems. Selection of treatment to meet SDWA standards are made by systems themselves after consideration of factors such as source water, watershed characteristics, Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment ID 18869 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA will consider the information provided by the commenter in its analysis for the regulatory determination process. As discussed in the preamble to the Draft CCL 3, (see page 9962) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL 3 selection process (for example treatment). EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3.

Please see response to comment ID 19058 under topic code 7840. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements No response necessary. Please see the response to comment ID 18874 under comment code 4005. The CCL process was developed to identify known or possible drinking water contaminants of potential health concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the data used at each step and were applied uniformly for all chemical contaminants, including molybdenum. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL.] Molybdenum was selected for the draft CCL 3 based on these uniformly applied processes.

Placement on the CCL enables EPA to examine the available database for toxicity in a more refined process than was used for the CCL in order to determine if a contaminant has sufficient data for regulatory determination. This will be the next stage for molybdenum. During this process EPA will have the opportunity to examine molybdenums full toxicity database. The information available on concentrations in finished water across the nation and effective treatment technologies are equally important during regulatory determination.

The IOM assessment for molybdenum was included in the database used in the PCCL and CCL processes as EPA used the best available data which was the National Inorganic and Radionuclides Survey (NIRS) in which the prevalence (nine) and magnitude (eight) scores for Molybdenum warranted inclusion on the CCL 3 list. NIRS measured finished water concentrations and found that Molybdenum had detections in 77 public water systems. The 90th percentile concentration was at 30 ug/l. Additionally, EPA provides a detailed response to your specific comments on the health effects under comment code 4005. Please see the response to comment 18874 and 19146. Based upon these data, EPA concludes that Molybdenum is known to occur in public water systems and may require regulation. Therefore, EPA is including Molybdenum on the third CCL. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19338 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA did not include the health effects for individuals with marked immunosuppression in its health effects

scoring protocol. EPAs approach used the most common clinical presentation for the specific pathogen for the population category under consideration. EPA also considered the adverse health effects associated with the following sensitive sub-populations: infants, children, pregnant women, the elderly, and individuals with a history of serious illness as directed by SDWA. The SDWA does not direct EPA to specifically consider individuals with marked immunosuppression. As stated in the draft CCL 3 FRN, nearly all pathogens have very high health effects for the markedly immunosuppressed individuals. EPA continues to believe that to prioritize among the 29 pathogens on the preliminary CCL based on the health effects on the severely immunosuppressed subpopulation is not a useful criterion. Based on public comment submitted on the Draft CCL 3, EPA reconsidered all the PCCL organisms for their health effects in the markedly immunosuppressed and found that health effects information on the severely immunosuppressed was not available for many (11 of 29) of the PCCL microorganisms. Of the 18 EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the scoring criteria considered for CCL 3 inclusion. Criteria described by the commenter do not apply to the CCL 3 Selection process. They apply to the regulatory determination process. As discussed in the preamble to the Draft CCL3, (see page 9962) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL3 selection process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3.

EPA disagrees with the comment on meaningful opportunity for health risk reduction. The SDWA language cited by the commenter does not apply to the CCL process, but rather to the decision whether to regulate.

Certain pathogens may be well controlled by drinking water treatment (primarily disinfection), however, not all public water systems are required to treat. Ground water systems make up the greatest portion of public water systems and most of them do not treat. As discussed in detail in the draft CCL 3 (see page 9648), EPA did not preclude pathogens from CCL 3 based on their potential to be controlled by existing treatment technique regulations. As discussed in the preamble to the Draft CCL 3, (see page 9629) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL 3 selection process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3.

EPA disagrees with the comment and believes that the adequacy and effectiveness of regulating N. fowleri cannot be determined this early stage of the process. EPA acknowledges the particular conditions in which N. fowleri thrives in the environment, however, N. fowleri is on the CCL 3 due to its high score under the CCL 3 scoring process. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Pathogens scored high in these factors resulted in a decision to list on CCL 3. N. fowleri has most severe health effects and it has been the cause of a WBDO as documented by CDC (CDC MMWR 2001 2002).

EPA will evaluate pathogens regarding the potential effectiveness of regulation as part of regulatory determination process. Finally, using the CWA to issue guidance as the commenter recommended is not within the scope of this CCL action (required under the SDWA).

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see the responses to comments 18874 and 19146 under comment code 4005.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements As discussed in the preamble to the Draft CCL 3, (see page 9962) a Regulatory Determination requires more information and analyses (for example treatment) than the analyses used to support the CCL 3 selection process. EPA will conduct further analyses to support regulatory determinations. The Agency will evaluate contaminants on the final CCL 3 to determine whether or not they require a national drinking water regulation based upon the criteria specified in the SDWA which requires the Agency to promulgate a national primary drinking water regulation if EPA determines that: (1) The contaminant may have an adverse effect on the health of Persons; (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) 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. The Agency also recognizes the amount of effort and resources required to develop risk assessments for chemicals that occur in drinking water with a frequency and at levels of public health concern. As the Agency considers whether or not regulation of a contaminant provides a meaningful Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements No response necessary. Please see response to comment ID 18886 under comment code 2100. Please see response to comment ID 19065 under comment code 9100. Please see response to comment ID 18886 under comment code 2100. Thank you for the information on PFOA. Based upon these and other data the Agency has determined that PFOA is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3. PFOA will be further evaluated under the regulatory determinations process. Please see response to comment ID 19138 under comment code 4515. See response to comment 18891 under comment code 4520. Please see response to comment ID 19138 under comment code 4515. EPA is developing a new risk assessment for 1,2,3-trichloropropane, which will consider the available cancer data including the NTP study results. EPA is committed to using sound science in the preparation of its IRIS risk assessments. The 1,2,3-trichloropropane IRIS Risk assessment will be available once the Agency has completed the appropriate reviews to assure the quality of the assessment, and it will be used to further evaluate this Based upon these and other data evaluated for the CCL, EPA concludes that 1,2,3- trichloropropane is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this The Commenter is correct in noting that the EPA Health Advisory from 1989 and the current IRIS summary have not provided a cancer grouping or quantitative risk value for 1,2,3-trichloropropane. The Agency will update the Drinking Water Regulations and Health Advisory Tables to correspond with the updated IRIS risk assessment following the completion of the peer-review process and uploading of the final assessment for 1,2,3- trichloropropane on the IRIS database. While the EPA has been completing its risk assessment, some state agencies have established risk values based on the cancer endpoint. The CCL 3 protocol places the existing EPA assessments higher in the data hierarchy than those from other organizations because regulatory determination for chemicals on the CCL has used an EPA health risk assessment. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3, including any updates to the IRIS risk assessment. The Agency will then determine if the information is sufficient for the Agency to make a regulatory determination.

Also, see the response to comment ID 18897 under comment code 2595. See the response to comment IDs 18897 and 18899 under comment code 2595.

### The Agency is including MTBE on the CCL 3. EPA identified information gaps needed to make further

determinations for MTBE in the July 30 2008 Federal Register notice announcing the Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant List (FR Vol 73. No. 147, p. 44260). EPA has not yet made any regulatory determination for MTBE. EPA is currently preparing an IRIS risk assessment for MTBE. EPA published a drinking water Advisory for MTBE in 1997. EPA also published a summary of the status of the regulatory determination from MTBE in May 2007(FR vol72 No 83 p24049) . Based upon these data, EPA concludes that MTBE is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this compound on the CCL 3. EPA identified health effects information gaps needed to make further determinations for MTBE in the July 30, 2008 Federal Register notice announcing the Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List(73 FR 44260). EPA has not yet made any regulatory determination for MTBE. EPA is currently preparing an IRIS risk assessment for MTBE that includes a review of the Belpoggi et al. (1998) study and the other available studies on MTBE relevant to its drinking water exposure. EPA also published a summary of the status of the regulatory determination for MTBE in the preliminary regulatory determinations for contaminants on the CCL 2 published in May 2007 (72 FR 24049).

The Agency will continue to use the best available science and information to evaluate contaminants on the CCL Please see comment ID 18901 under comment code 3910. Please see the response to comment ID 19068 under comment code 4450. Please see the response to comment ID 19068 under comment code 4450. In October 2008, EPA published a proposed determination that developing a National Primary Drinking Water Regulation for perchlorate was not necessary. Based upon the comments that were received in response to that notice, and because of evolving science on perchlorate, EPA is revisiting this determination. A notice was published in August 2009 requesting public comments on key issues regarding the evaluation of perchlorate. The appropriate life stage upon which to base the assessment of perchlorate was one of the issues included in that Please see the response to comment ID 19068 under comment code 4450. No response necessary Ethylene Glycol is not subject to a federal MCL and is thus eligible for the CCL process. The Agency uses the best available science and information to evaluate and list drinking water candidate contaminants. The Agency also notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on anyone. (73 FR 9629). Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminants before proposing and promulgating a National primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the IRIS risk assessment to determine if the information is sufficient for the Agency to make a EPA appreciates the information that the NJDEP provided on their risk assessment for 1,1-dichloroethane. U.S. EPA has not set a reference dose for this chemical. The information that NJDEP has provided on the derivation of their RfD and MCL will be useful in EPAs post- CCL 3 evaluation of the toxicity of this chemical and discussion of Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19136 under comment code 4510 and comment ID 18914 under comment code 4520 PFOA occurrence.

### Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009

to provide technical information to State and local officials and PWSs for consideration in addressing local contamination of drinking water to protect public health. This basis for the provisional Health Advisory is a LOAEL 0.460 mg/kg day (Lau et al 2006), not the 1 mg/kg day-1 LOAEL from EPAs draft risk assessment that was used for the draft CCL 3. EPA also derived extrapolation factors for toxicokinetics to better approximate internal doses for PFOA in the Provisional Health Advisory. EPA included this step because of the marked differences in retention time among humans and the test species in which toxicologic data were collected as noted by the commenter. [Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS): Provisional Health Advisory http://www.epa.gov/waterscience/criteria/drinking/]. This information has been used to develop the Final Contaminant Candidate List (CCL) 3 and is included in the docket and Contaminant Information Sheets for PFOA.

EPA disagrees that the relative source contribution (RSC) value that EPA used to calculate the health reference level (HRL) for PFOA does not follow EPA guidance and that EPA's calculation approach could influence future regulatory activity. EPA notes that the commenter stated and recognizes that EPA used this HRL for CCL The Agency disagrees that an inappropriate measure was used to include PFOA on the draft CCL 3. The Agency uses the best available science and information to evaluate and list drinking water candidate contaminants. The commenter states that In using Minnesota prevalence data and West Virginia magnitude data, EPA has derived a measure of occurrence for PFOA that does not actually exist in the environment, which creates an artificial and inaccurate impression of the extent of PFOAs occurrence in drinking water. The commenter suggested that the Agency should use occurrence and magnitude data that actually occur simultaneously in the environment. The contaminant information sheets correctly cite that the Minnesota data was used to derive both the prevalence and magnitude attribute scores for the models. The CCL process also employs consistent development of a health reference level/concentration ratio for all contaminants that had been detected in water, either ambient or finished water, in addition to the models. As described in the supporting materials, Please see the response to comment ID 19136 under comment code 4510 and comment ID 18914 under comment code 4520 PFOA occurrence. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and Ethylene oxide has been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene oxide under the respective comment codes: 3585 ethylene oxide health (comment ID 18925) and 3590 ethylene oxide occurrence (comment IDs Please see response to comment ID 18928 under comment code 3555. The Agency has responded to the specific information and comments provided by the ACC on ethylene oxide and ethylene glycol under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), and 3590 Ethylene Oxide occurrence (comment IDs 19521 and Please see response to comment ID 18857 under comment code 9100. See response to comment ID 18919 under comment code 3580. No response needed to the commenters characterization of the CCL 3 process.

### The commenter reports that EPA used the oral slope factor of 0.31 per mg/kg/day currently available from the

California Office of Environmental Human Health Agency (OEHHA) Toxicity Criteria Database in scoring for potency for ethylene oxide. However, the commenter questions the above slope factor in light of the recent assessment from the Office of Pollution Prevention and Toxic Substance and the Office of Research Development (ORD). The commenter makes a point that EPA should use the new unit risk numbers that have been derived by ORD for the lung tumors observed in male mice and brain tumors observed in male rats, after correcting these numbers to a slope factor that is appropriate for an oral route of administration.

For the draft CCL 3, EPA followed the CCL 3 protocol in the scoring for the health effects for ethylene oxide. Ethylene oxide received a score of 6 for potency and 8 for severity. The commenter is correct that EPA used the oral slope factor of 0.31 per mg/kg/day based on rat mononuclear cell leukemia (MCL) available from OEHHA Toxicity Criteria Database at the time the CCL 3 analysis was done. This oral slope factor was derived from the extrapolation of inhalation slope factor of 8.80E-05 per μg/cubic meter, for MCL in rats.

Ethylene glycol has been included on the final CCL 3. EPA disagrees with the commenter that ethylene glycol should not have moved from the Universe to the PCCL. This is discussed in more detail under the respective responses to comment codes: 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), and 3560 Ethylene Glycol occurrence (comment ID 18929). EPA disagrees with the commenters opinion that ethylene glycol should be categorized as toxicity category 5 rather than toxicity category 4 and removed from further consideration. EPA developed the screening protocol and toxicity categories to create a framework that was versatile and as simple as possible to identify chemicals with categorical or limited data for further evaluation. In using the most conservative toxicological value in the screening step the Agency believes that public health is protected and additional resources can then be applied to evaluate compounds that passed the screening framework to determine the best available scientific information for that compound.

As the commenter notes, for ethylene glycol, the World Health Organization (WHO) TDI was used for the screening as indicated in the protocol described in Contaminants Candidate List 3 Chemicals: Screening to PCCL. That value falls in toxicity category 4. It is also correct that EPA used the IRIS RfD as the toxicological value to to assign the potency and severity scores used in evaluating the PCCL. This too is consistent with the protocols. The use of the WHO TDI for screening had no impact on the selection of ethylene glycol for inclusion on CCL 3 since it ***Cadmus: Please move response from "response to comment code" section to this comment ID***

Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 18933 under comment code 4005. Please see the response to comment IDs 18874 and 19146 under comment code 4005. EPA agrees that there are long term sequelae associated with Legionella and consequently scored Legionella very high on health effects (including long term sequelae) as well as the overall score. Therefore, Legionella The likelihood that a contaminant may be anticipated to occur in a public water system (PWS) is one of the criteria required by the Safe Drinking Water Act (SDWA). EPA evaluated over 6,000 chemicals to identify those that the Agency anticipates may occur in PWSs and require regulation. Under SDWA 1412 (b) (1)(B)(ii), EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National primary drinking water rule. The Agency will continue to use the best available science and information

### EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency did not consider including

broad groups of chemicals to the CCL 3 due to variability in chemical composition and how that variability may affect occurrence and toxicological profiles within the group of chemicals. Therefore, the Agency did not evaluate large groups such as endocrine disruptors or pharmaceuticals. However, the EPA did evaluate individual chemicals within those groups. The Agency also evaluated data and information provided by commenters and added nine hormones to the CCL 3 because these hormones were detected in drinking water and may require regulation. The Agency did not include bisphenol A or any of the polyalkoxalated phenolics on the CCL 3 due to the limited occurrence and health effects information. For additional information on the Agencys evaluation of pharmaceuticals please see the response to comment ID 19338 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 18939 under comment code 2100. The Agency will consider your concerns to protect public health as it further evaluates contaminants on the final CCL 3. The Agency agrees that the protection of public health is a primary goal of the Drinking water program. The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to provide information it needs to determine which potential drinking water contaminants present the greatest danger to human health and therefore, represent the highest priorities for future drinking water regulation. The CCL is the primary mechanism for the identification of these contaminants that may require regulation. Every 5 years, the UCMR provides EPA with the national occurrence data in public water systems necessary to determine if a contaminant occurs with a frequency and at a level of public health concern. The SDWA also provides EPA with the authority to require monitoring of unregulated contaminants under the UCMR. However, SDWA limits the list of Please see response to comment ID 18939 under comment code 2100. Please see response to comment ID 18939 under comment code 2100. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19136 and 19139 under comment code 4510. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment IDs 19137 and 19580 under comment code 7180. Please see response to comment ID 19138 under comment code 4515. Please see the response to comment ID 19136 and 19139 under comment code 4510. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA concludes that three types of cyanotoxins: microcystin, cylindrospermopsin and anatoxin-a, are known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including these EPA thanks the commenter for the information provided. The work of WHO is being considered as part of an ongoing toxicological review of several Cyanotoxins by EPA. Please see response to comment ID 19016 under Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under topic code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA did not include chloramine in the universe of contaminants considered for CCL 3 because it is regulated

under 40 CFR 141.65. The Safe Drinking Water Act specifies that CCL contain only unregulated contaminants. The Agency also notes that monochloramine, dichloramine, and trichloramine are included in the regulation of chloramine. Please see the response to comment ID 18956 under comment code 6180. SDWA, as amended in 1996, requires the EPA to develop a list of currently unregulated contaminants that may require regulation. Chloramine is a regulated disinfectant (40 CFR 141.65) and was therefore not considered for the CCL. EPA provided a list of the Universe of Contaminants considered in the docket and that list is available at EPA did not consider chloramine in the universe for the CCL 3. Chloramines are regulated under 40 CFR. The Safe Drinking Water Act (SDWA) specifies that the CCL contain only unregulated contaminants. The Agency also notes that monochloramine, dichloramine, and trichloramine are included in the regulation of chloramine. Please see response to comment ID 18956 under comment code 6180. The Agency does have a similar process to evaluate regulated contaminants. SDWA Section 1412(b)(9) requires the Agency to review and revise, as appropriate, each national primary drinking water regulation every six years. SDWA also requires that the revision maintain, or provide for greater, protection of the health of persons. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under topic code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under topic code 7840.

Please see the response to comment ID 19388 under comment code 6166. EPA only used mobility and persistence data to evaluate contaminants when measured occurrence or environmental release data were not available. As discussed in support documents available in the docket (Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCLat www.regulations.gov EPA-HQ-OW-2007-1189), the Agency selected the highest scores for both persistence and mobility unless those values were not representative of environmental conditions in drinking water. The Agency believes that by using the highest scores for these surrogate data to evaluate the possible occurrence of chemicals, it has taken a conservative approach that brings more chemicals into the Agencys evaluation and accounts for the commenter's recommendation that using a pH-dependent value for mobility may bring more hydrophilic contaminants under the evaluation. The Agency also believes that choosing the highest possible scores accounts for the variability in scoring pH-dependent factors across the Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment ID 19338 under comment code 7200.

The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to provide the information it needs to determine which potential drinking water contaminants present the greatest danger to human health and therefore, represent the highest priorities for future drinking water regulation. The CCL is the primary mechanism for the identification of these contaminants that may require regulation. Every 5 years, the UCMR provides EPA with the national occurrence data in public water systems necessary to determine if a contaminant occurs with a frequency and at a level of public health concern. The SDWA also provides EPA with the authority to require monitoring of unregulated contaminants under the UCMR. As discussed in the preamble to the Draft CCL3, (see page 9962) a Regulatory Determination requires more information and analyses (for example treatment) than the analyses used to support the CCL3 selection process. The Agency will evaluate contaminants Please see response to comment ID 18977 under comment code 1000. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA acknowledges receipt of your comment attachment and has responded to your specific information and comments under the respective comment codes: 7200 Pharmaceuticals and Personal Care Products (not on CCL3) (comment ID 19551) and 6100 Classification Approach for Chemicals (comment ID 18969). This comment also appears under topic code 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its EPA agrees that the CCL is an important step in the regulatory development process. EPA acknowledges the potential for synergistic effects, as well as antagonistic effects, from co-occurring contaminants and is working to improve the methodologies to consider such effects. However, at this time, the methodologies are not robust enough to permit the consideration of potential cumulative health effects for the CCL process. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA acknowledges the commenters concern about the two metolachlor metabolites [(Metolachlor ethanesulfonic acid (ESA) and Metolachlor oxanilic acid (OA)] listed on the Draft CCL 3. Please see response to comment ID 19247 under comment code 3940. Please also see the response to comment ID 19247 under comment code 3940 (Metolachlor and its degradates ESA and OA). EPA uses the best available science and information to evaluate and list drinking water candidate contaminants. The CCL 3 process for the chemicals, that comprised the universe, relied on readily accessible sources of health effects and occurrence data, which could be retrieved for the evaluation. The Agency then used the hierarchy described for the screening and classification steps in 73 FR 9636 and 73 FR 9369, respectively, to further evaluate potential contaminants. Accordingly, the data cited by the commenter was not included in the evaluation. The agency relied on final Office of Pesticide Programs (OPP) registration eligibility documents or IRIS risk assessments when available, rather than submitting individual studies to the OPP for evaluation.

The Agency also notes that the health risk evaluations for the metolachlor degradates do recognize their lower toxicity than the parent pesticide. The potency score for each of the two metolachlor degradates is 2, and the severity score for each is 1. In the case of metolachlor, the potency score is 4 and the severity score is 3. EPA has kept Helicobacter pylori on the CCL 3. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Comment is not germane to the CCL but in response EPA provides the following information. As an outcome of

the recommendations from the M/DBP FAC EPA, in collaboration with industry partners, developed a series of distribution system white papers to better understand the potential public health risks from a range of drinking water distribution system issues. Following the development of the white papers, EPA convened an exposure assessment expert workshop to identify some of the key influences that may lead to exposures and potential public health risks from drinking water distribution system issues, as well as the establishment of a National Academy of Sciences (NAS) panel, which assessed the potential risks from drinking water distribution systems. The NAS provided research recommendations in their final report. Between July 2007 and September 2009, EPA convened the Total Coliform Rule/Distribution Systems Advisory Committee (TCRDSAC) to advise and make recommendations on what information is needed to better understand the public health impact from the Based upon the best available data EPA identified contaminants for the final CCL 3 that are known or anticipated to occur in public water systems and may require regulation. EPA considered the potential for the contaminants to cause adverse health effects including cancer. Under SDWA 1412(b)(1)(B)(ii)EPA makes a separate determination on whether or not to regulate a contaminant. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 to determine if the information is sufficient for the Agency to make a regulatory determination. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 18939 under comment code 2100. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Chloramine is regulated under the Safe Drinking Water Act (SDWA); thus it is not a candidate for the CCL 3. The Agency is aware of the heath concerns regarding chloramine use as a disinfectant and is in the process of updating the 1994 Criteria Document to include recent literature on health effects. The 1994 document is available on the EPA website at http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. EPA will review the updated information in its regulations regarding limits for chloramine and take appropriate action. No water supply is required to use chloramine. Water suppliers may choose effective disinfection treatment to meet federal standards based on local water quality and cost considerations. Chloramine is regulated under the Safe Drinking Water Act (SDWA); thus it is not a candidate for the CCL3. The Agency is aware of the continued health concerns regarding chloramine use as a disinfectant and is in the process of updating the 1994 Criteria Document to include recent literature on health effects. The 1994 document is available on the EPA Web site at http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. In addition EPA has just released an updated version of frequently asked Questions and Answers on chloramine as a disinfectant in drinking water; it is available online at: http://www.epa.gov/ogwdw/disinfection/chloramine/index.html. EPA will review the updated information regarding chloramine and take appropriate action as part of its periodic review of existing Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements See comment 18981 under comment code 7130 for response Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19050 under comment code 2460. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 18939 under comment code 2100. The commenter correctly summarizes the CCL 3 process and no further response is necessary.

### EPA evaluated substances registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Acts

as required by SDWA for the CCL 3. The draft CCL 3 contained 42 pesticides and or degradates. The first CCL listed 23 pesticides and degradates. The draft FR notice (62 FR 52195) identified, but did not list, an additional 35 pesticides that were deferred for further evaluation. EPA concluded that 40 pesticides and/or their degradates are known or anticipated to occur in PWSs and may require regulation. Therefore, EPA has included them on the The Agency disagrees with the commenter that the Agency has failed to enforce testing or set standards for unregulated contaminants. The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to provide the information it needs to determine which potential drinking water contaminants present the greatest danger to human health and therefore, represent the highest priorities for future drinking water regulation. The CCL is the primary mechanism for the identification of these potential health hazards. Health effect is not the only criterion EPA must consider for making a CCL listing or regulatory determination. Page 9629 of the draft CCL 3 Notice in the Federal Register discusses the three SDWA criteria to determine whether a contaminant may require regulation. The UCMR provides EPA with the national occurrence data in public water systems necessary to determine if a contaminant occurs with a frequency and at levels of health concern. The Agency completed The commenter correctly summarizes the process to comment on the draft CCL 3 and no further response is Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements. EPA is developing toxicological reviews for three cyanotoxins: anatoxin-a, cylindrospermopsin and microcystins. [Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins (LR, RR, YR and LA) (External Review Drafts).] The peer review drafts of these documents are available at: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=161263. All three documents have been peer reviewed and EPA is making revisions to the documents in response to the peer review comments and information from recent publications. Based upon these and other data, EPA concludes that cyanotoxins are known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this group of compounds Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA disagrees with the statement: DAS believes existing regulation of tebufenozide by EPA under FIFRA and FEPCA is adequate to protect the environment and human health, including drinking water, and does not believe additional regulation under SDWA is warranted.As part of the SDWA, Section 1412 (b) (1)(B)(i) requires EPA to consider pesticides that are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Regulation of a pesticide product under EPAs pesticide program does not exempt it from consideration for the CCL. While the label restrictions reduce the likelihood that it will contaminate water, they do not prevent contamination. Tebufenozide was listed because the best available health effects and occurrence data showed that it was known or anticipated to occur in drinking water and it may require regulation. See the response to comment 19019 under comment code 4720. EPA disagrees with the commenter. Tebufenozide is included in the CCL 3 on the basis of its chronic toxicity, potential occurrence in drinking water estimated from annual release (lbs/year), and number of States with releases. An RfD of 0.018 mg/kg/day was established on the basis of a NOAEL of 1.8 mg/kg/day from a chronic toxicity study in dogs and the use of a total uncertainty factor of 100 to account for intra- (10 x) and interspecies (10 x) variations. Growth retardation, alterations in hematological parameters, changes in organ weights, and histopathological lesions in the bone, spleen and liver were observed at the LOAEL of 8.7 mg/kg/day in this study (64 FR 56690: Tebufenozide; Benzoic Acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl) hydrazide; Pesticide Tolerance). Based upon these data, EPA concludes that Tebufenozide is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this compound on the CCL 3.

See the response to comment ID 19019 under comment code 4720. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 18939 under comment code 2100. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Based upon these and other data evaluated by the Agency, EPA concludes that the ESA and OA metabolites of alachlor, acetochlor and metolachlor are known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3.

### EPA acknowledges the commenters request to add dimethanamid and its ESA and OA metabolites to the CCL3.

Dimethanamid was among over 6,000 contaminants considered for inclusion on the CCL. However, dimethenamid did not pass the screen to move on to the PCCL. The release data from the National Center for Food and Agricultural Policy and available health effects data did not meet the criteria for dimethenamid to be considered for the PCCL. EPA has not received any additional data on the occurrrence or health effects for dimethenamid. Therefore the Agency is not including dimethenamid on the CCL 3. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements For purposes of the CCL 3 evaluation process, fenamiphos will remain on the CCL 3 based on its health reference level to occurrence in water ratio. EPA used the reference dose of 0.0001 mg/kg/ day to produce an HRL of 0.7 ug/L for fenamiphos. When the HRL was compared to the modeled occurrence estimate in water (13.7 ppb for surface water and 0.47 ppb for ground water) the ratio is less than 10. These protocols and data are included in the CCL 3 docket [See CCL 3 Chemicals: Classification of the PCCL and CCL 3 Contaminant Information Sheets Docket ID EPA-HQ-OW-2007-1189-0042]

The registrant has voluntarily withdrawn the registration and existing stock of fenamiphos containing products will no longer be distributed or sold after November 30, 2008 (73 FRN 34742 June 18, 2008). The fate properties of fenamiphos indicate that it biodegrades slowly, has a moderate octanol-water partitions coefficient and can accumulate in sediment. Since fenamiphos is persistent in the environment and it will take some time before all of the existing stock of fenamiphos containing products are depleted, it still has the EPA continued to incorporate elements of the National Drinking Water Advisory Council (NDWAC) recommendations and adopted the guiding inclusionary principles in developing the Drinking Water Contaminant Candidate List 3 (CCL 3).

The commenter accurately summarizes the data sources and contaminants in the CCL universe considered by EPA. No response necessary. The commenter accurately summarizes the screening steps for CCL. No response necessary. No response necessary. No response necessary. The CCL process allows for the re-screening and re-classification of the contaminants after publication for public comment. New toxicological and/or occurrence data resulting from changes in registration status would warrant a re-evaluation of the contaminant. EPA has re-evaluated chemicals on the draft CCL 3 based upon additionaltoxicological and/or occurrence data. In addition, the list is reissued every 5 years allowing for periodic rescreening of contaminants based on new information.

EPA re-evaluated fenamiphos based on information provided by commenters. Please see the response to comment ID 19032 under comment code 3640 for a detailed response. Based upon the new evaluation, EPA concludes that fenamiphos is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this compound on the CCL 3. The commenter accurately summarizes the data sources and number of contaminants in those sources initially considered by EPA. No response necessary. The commenter accurately summarizes the screening steps for CCL. No response necessary. The commenter correctly summarizes the types of toxicological data evaluated in the CCL 3 process and the toxicity categories used to screen contaminants to the PCCL.

### EPA agrees with commenters statement that the Agencys multi-step process of identification, screening, and

evaluation of chemical contaminants, has been successful at encompassing a balanced scope as well as satisfying the inclusionary principle of toxicological data in the 'draft CCL' for the Organophosphorus class of compounds. The final CCL reflects this process. Please see responses to comment IDs 19032 and 19045 under comment code 3640. EPA also notes that Population Adjusted Dose (PAD) developed under the Food Quality Protection Act, as cited by the commenter, was 1. Therefore, the PADs are identical to the RfDs used in the analyses for the draft and final CCL 3 and provided in the Contaminant Information Sheet available in the docket at www.regulations.gov. Therefore the Agency anticipates that fenamiphos may occur in PWSs and may require regulation. Therefore fenamiphos is The toxicity category 2 would not be changed by mitigating all dietary risks of fenamiphos. All of the toxicity data for fenamiphos: RfD, NOAEL, LOAEL and LD50 place fenamiphos in Toxicity Category 2 following the guidelines used for screening to the PCCL. The dietary exposure from residues does not have an impact on the Toxicity Category It is based the dose-response related toxicity data such as the parameters listed above. These protocols and data are included in the CCL 3 docket [See CCL 3 Chemicals: Screening to a PCCL. The commenter correctly identified the categories of occurrence data used to evaluate unregulated contaminants for the CCL 3. In developing the draft CCL 3 the Agency relied on modeled estimates for the environmental concentration of fenamiphos and health effects data developed for the registration eligibility document. EPAs evaluation is discussed in detail in the response to comment IDs 19032 and 19045 under comment code 3640. Based upon these data, EPA concludes that fenamiphos is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3. See the response to comment ID 19032 under comment code 3640. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Among chemicals considered for the third Contaminant Candidate List (CCL 3) several disinfection byproducts (DBPs) believed to be associated with the use of chloramine were evaluated. Based on available toxicity andmonitoring information, N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine NDEA, N-nitroso-di-npropylamine (NDPA), N-Nitrosodiphenylamine, N-nitrosopyrrolidine (NPYR) and hydrazine were placed on the CCL 3. (N-nitrosodimethylamine (NDMA) has been determined to be a probable human carcinogen based on evidence of its carcinogenicity in animals; the cancer risk profile for NDMA, as well as the other N-nitrosamines listed on the CCL 3, is available online on EPAs website in the Integrated Risk Information System (IRIS) at http://cfpub.epa.gov/ncea/iris/index.cfm. Hydrazine has also been deemed a probable human carcinogen based on evidence of its carcinogenicity in animals, and the cancer risk profile for Hydrazine is also available on IRIS.) Of the N-nitrosamines listed on CCL 3 all but one, N-nitrosodiphenylamine, are being monitored for under the second Unregulated Contaminant Monitoring Regulation (UCMR 2). N-nitrosodiphenylamine lacks a monitoring method. The Contaminant Candidate List (CCL) is intended as a list of potential candidates for regulation and future research. When the CCL 3 list becomes final, EPA will use this list of unregulated contaminants to help prioritize research and data collection efforts to help the Agency determine whether it should regulate specific Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19068 under comment code 4450. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### The SDWA requires EPA to publish a list of unregulated contaminants that may require regulation. Chloramine is

regulated under the Safe Drinking Water Act (SDWA), and thus is not a candidate for placement on the CCL. The Agency is aware of the continued heath concerns regarding chloramine use as a disinfectant and is in the process of updating the 1994 Criteria Document to include recent literature on health effects. The 1994 document is available on the EPA Web site at http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. In addition EPA has just released an updated version of frequently asked Questions and Answers on chloramine as a disinfectant in drinking water; it is available online at: http://www.epa.gov/ogwdw/disinfection/chloramine/index.html. EPA will review the updated information regarding chloramine and take appropriate action as part of its periodic review of existing regulations. Please see Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19412 under comment code 2260.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA notes that there is no EPA effort to monitor M. avium in the water supply at this time. Monitoring, required by EPA, generally would only begin for pathogens placed on the UCMR, or for compliance purposes after promulgation. For more information on these actions, please see page 9629 9630 of the draft CCL 3. The information provided by the commenter on increasing cases of NTM (due to M. avium) was not considered because EPA did not factor in the frequency of disease as a criterion for the CCL 3. In addition, the information provided by the commenter on individual cases with severe health effects were not considered by EPA because EPA considered the common clinical manifestation of the disease (see page 9646 of the draft CCL 3 for more detail) rather than the extreme manifestation. EPA may consider such information during the Regulatory Determination process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3 (see page 9629 and 9962 of the draft CCL 3 notice).

Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19068 under comment code 4450. The commenter correctly identifies the three criteria EPA uses to make regulatory determinations. The Agency also notes that under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the health effects or occurrence information the Agency used in selecting contaminants for the CCL to determine if the information is sufficient for the Agency to make regulatory determinations.

### Please see the response to comment ID 19068 under comment code 4450.

EPA sought and used the best available occurrence data to evaluate perchlorate and whether or not to include it on the final CCL 3. EPA used the Unregulated Contaminant Monitoring Regulation (UCMR 1) data of perchlorate occurrence in public water systems (PWS) because these data are developed to be nationally representative of an anlaytes occurrence in public water systems in the US. UCMR data are also developed by using standardized analytic methods and quality assurance procedures that may differ among other site specific studies and different laboratories. UCMR occurrence data indicated that approximately 4.1 percent (or 160) of 3,858 PWSs that sampled and reported under UCMR 1 had at least 1 analytical detection of perchlorate at levels greater than or equal to the minmum reporting level of 4 μg/L. EPA will evaluate other data to determine if they are sufficient to include in its evaluations of perchlorate, including those data provided by the commenter and other regional monitoring data. However, EPA believes that the UCMR data is a best available of perhclorate occurrence in PWS EPA included perchlorate on the first CCL in 1998 and on the second CCL in 2005. EPA is including perchlorate on CCL 3 because it is known or anticipated to occur in public water systems and may require regulation. Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a national primary drinking water rule. SDWA requires the Agency to evaluate three criteria in order to determine whether a NPDWR should be developed. Those criteria are:

(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 health concern; and (iii) in the sole judgment of the Administrator, regulation of such a contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.

The Agency continues to evaluate the best available scientific information on the occurrence and health effects of perchlorate. On October 10, 2008, EPA published a FR Notice requesting public comment on its preliminary determination not to regulate perchlorate in drinking water. The October 2008 notice also described the basis for EPAs preliminary determination. EPA received comments from over 32,000 individuals and organizations on Please see the response to comment ID 19068 under comment code 4450. Please see response to comment ID 19065 under comment code 9100. Please see the response to Comment ID 19073 and 18906, under comment code 4455. EPA will continue to evaluate the available science related to perchlorate as the Agency makes a regulatory determination for Please see the response to comment IDs 19067 and 19333 under comment code 4460. Based upon the occurrence and health effects data and information evaluated, EPA concludes that perchlorate is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3. Under SDWA 1412 (b)(1)(B)(ii), EPA makes a separate determination of whether or not to regulate a contaminant before proposing and promulgating a national primary drinking water rule from the decision to include a contaminant on the CCL. The Agency will continue to seek and use the best available science and information to evaluate contaminants on the CCL 3. In Oct. 2008 (FR Vol. 73 60262), EPA published a proposed determination that developing a national primary drinking water regulation for perchlorate was not necessary. Based upon the comments that were received in response to that notice, and because of evolving science on perchlorate, EPA is revisiting this determination. A notice was published in August 19, 2009 (FR Vol. 74 Page 41883) requesting public comments on key issues regarding the evaluation of perchlorate. EPA will Please see the response to comment ID 19068 under comment code 4450. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA's listing of vanadium on CCL 3 does not apply to elemental vanadium; it applies to the soluble forms of

vanadium found in drinking water including a variety of vanadium ions from vanadium salts. The health effects data that were used for potency and severity came from a study of vanadate ion in rats (Domingo et al., 1985). The best available national occurrence data which were the National Inorganic and Radionuclides Survey indicated that vanadium occurs with high prevalence. Therefore, its prevalence in drinking water, persistence in the environment and its solubility in water warranted its inclusion on the CCL 3. Please see the response to comment ID 19622 under comment code 4125. The toxicity categories and the attributes are used in different stages of the CCL 3 process. The toxicity categories were used in the screening process in conjunction with the water concentration data from the NIRS study. Based on application of the screening protocol, the combination of toxicity and concentration were sufficient to place vanadium on the PCCL. The commenter is incorrect in the assumption that category 3 was the first grouping in which toxicological effects were observed. All five toxicity categories were associated with adverse noncancerous effects. Attribute scores for potency and severity of the toxicological endpoint plus prevalence of vanadiums detection in the NIRS survey and magnitude of the concentrations detected were considered when determining if vanadium should remain on the PCCL or be selected for the CCL. The application of the classification model tools determined that vanadium met the criteria for the CCL as did the ratio between its health reference level and the concentration detected in drinking water in some locations. Based upon these The critical effects for the ATSDR MRL for vanadium included evidence of cellular damage in the kidney and functional impairment as reflected by increased plasma urea and uric acid. These effects are of sufficient concern to justify the severity score assigned following the protocols for the PCCL attributes. Severity is scored based on observed effects and not the measured endpoints that show no significant change in the critical study. The best available national occurrence data were those from the National Inorganic and Radionuclides Survey and indicated that vanadium occurs with high prevalence. Prevalence in drinking water, persistence in the environment, and its solubility in water warranted its inclusion on the CCL 3. The Agency disagrees that EPAs evaluation of Vanadium occurrence makes little sense. EPA used the best available national occurrence data which was the National Inorganic and Radionuclides Survey. This survey provided nationally representative information on the occurrence of vanadium in public water systems. EPA then applied these data to the protocols described in the Federal Register Notice (FR Vol 73. no 35 p.9629). EPA used the finished drinking water data in public water systems as the basis for vanadium occurrence. EPA believes these data warrants including vanadium on the CCL 3. The data that were used to score the occurrence attributes for vanadium (see the response to comment 19079 under comment code 5025) were the number of states where it had been detected in the NIRS survey and the concentrations detected. Persistence did not play any direct role in vanadiums selection for the CCL, although the fate data are described in the contaminants information sheet for vanadium in the CCL 3 docket (Contaminant Candidate List (CCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). EPAs listing of a L? for Vanadium indicated that this contaminant contain attributes that made it more similar to contaminants that should be on the CCL. The best available national occurrence data which was that from National Inorganic and Radionuclides Survey indicated that vanadium occurs with high prevalance. Therefore, its prevalence in drinking water, persistence in the environment and its solubility in water warranted its inclusion

### The Agency disagrees with the commenter. The CCL process was developed to identify known or possible

drinking water contaminants of potential health concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the data used at each step and were applied uniformly for all chemical contaminants, including vanadium. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL.] Vanadium was selected for the draft CCL 3 based on these uniformly applied processes. EPA has not established an RfD for soluble vanadium salts, the vanadium forms that are of greatest interest as drinking water contaminants. According to the protocol, the ATSDR MRL is the available benchmark that ranks highest in the established hierarchy for data sources and became the basis for the PCCL scoring of vanadiums health effects attributes as the Agency in Chapter 5 of the CCL3 Chemicals: Classification The commenter is citing the Contaminant Information Sheet for vanadium pentoxide. Vanadium pentoxide was included in the CCL Universe and was evaluated as part of the CCL process. It failed to meet the criteria for inclusion on the CCL. The toxicological data for vanadium pentoxide were not used to evaluate vanadium. The data responsible for the inclusion of vanadium on the CCL applied to the vanadate ion and are cited on theVanadium Contaminant Information Sheet and are available in the CCL 3 docket at www.regulations.gov (EPAThe CCL 3 process collected data from a large variety of data sources that met specified criteria. The designation of vanadium pentoxide as a teratogen came from the list of chemicals considered by the state of California to cause developmental effects. This particular designation is part of the dataset for vanadium, but in accordance with the protocols for attribute scoring and developing the HRL/concentration ratio, data characterizing vanadium pentoxide were not used to evaluate vanadium. The Agency relied on measured occurrence data from the National Inorganic Radionuclides Survey and not the relative persistence cited by the commenter. Therefore, the contaminants Information sheets identified all the data the Agency collected for contaminants considered in the CCL 3 process. The Agency has reviewed the contaminants information sheets to make sure that they indicated data that were used to support the listing The SDWA requires that contaminants included on the CCL are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation.The data used to evaluate vanadium meets these criteria. Additionally, the Agency described the protocol, assumptions factors, and equations in Chapter 5 of the CCL 3 Chemicals: Classification of the PCCL to CCL. In order to develop the HRL concentration ratio, the Agency used the 90th percentile concentration level as a conservative benchmark that may identify a possible need for a health advisory for areas of the country that may have higher concentrations in drinking water than others.The occurrence data, assumptions, and procedures provided by the commenter were not used for the CCL. EPA also included the Institute of Medicine nutritional guidelines as part of its dataset for vanadium and recognized that traces of vanadium in drinking water can contribute to dietary intake. The relative contributions of vanadium in Please see response to comment ID 19077 under comment code 5020. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Based upon the data and information reviewed, the Agency has determined that N-Methyl-2-Pyrrolidone is known or anticipated to occur to public water systems and may require regulation. Therefore, N-Methyl-2- pyrrolidone has been included on the final CCL 3. EPA has responded to your specific comments on N-methyl-2- pyrrolidone in the response to comment IDs 19094, 19101, and 19622 under comment code 4125 (N-Methyl-2-

### The CCL process was developed to identify known or potential drinking water contaminants of possible health

concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for thedata used at each step of the process and were applied uniformly for all chemical contaminants, including Nmethyl-2-pyrrolidone. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL.] N-methyl-2-pyrrolidone was selected for the draft CCL 3 based on these uniformly applied processes.

N-methyl-2-pyrrolidone was screened as Toxicity Category 4 following the protocol requirements for screening. That protocol places a chemical in the highest toxicity category assigned to a toxicity value in the universe for a given chemical. Scoring of toxicity for the PCCL to CCL process was done using the World Health Organizations (WHO's) Tolerable Daily Intake value as included in the ITER database. The WHO assessment has been peer Please see the response to comment ID 19622 under comment code 4125. The commenter accurately summarizes the screening steps for CCL. No response necessary. EPA ensured the objectivity, utility, and quality of the information disseminated as part of the CCL. The ITER database, which was the source of the value used by EPA in the PCCL to the CCL process is a database that only includes peer reviewed assessments. In the case of N-methyl-2-pyrrolidone, the data came from the peer-reviewed Concise International Chemical Assessment Document from the World Health Organization. The draft SIDS report provided by the commenter was not in the Data compilation that comprised the working Universe nor were SIDS reports for any other chemicals. However, even if the report had been included in the universe, a completed health risk assessment such the CICAD that was used ranked higher in the data hierarchy than a compilation of available data as reported in a SIDS report and final documents are used rather than draft Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The Agency has responded to the specific information and comments provided by PhRMA under the respective comment codes: 6100 Classification Approach for Chemicals (comment IDs 19109, 19110, 19111, and 19112), 7200 Pharmaceuticals and Personal Care Products (not on CCL 3) (comment IDs 19620, 19554, 19114), and 4090 The Agency agrees that the methodology and factors incorporated into the CCL process are important in developing a reproducible and transparent process. The NAS, NDWAC, and subsequent reviews and public input provided information that the Agency incorporated to improve the CCL process. Please see the response to comment ID 19109 under comment code 6100. Please see the response to comment ID 19109 under comment code 6100. Please see the response to comment ID 19109 under comment code 6100. See the response to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care Products (not on CCL3)).

### Please see response to comment ID 19338 under comment code 7200. EPA evaluated data for pharmaceuticals

in the USGS article cited by the commenter (Focazio et al., 2008) based on the hierarchal approach to select the data used to evaluate a chemical as described in the draft CCL 3 FR notice (73 FR 9652). While the Schwab et al., 2005 study used modeled surface water concentrations to evaluate contaminants, EPA used actual available water concentration data to evaluate the 26 active pharmaceutical ingredients presented in the Schwab et al., 2005 study based on the hierarchal approach to select the best available data described in the draft CCL 3 FR notice. The information collected and evaluated for individual contaminants is available in the CCL 3 docket in Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19412 under comment code 2260.

EPA agrees that there is more information available for the four pathogens listed above than for many of the other pathogens on CCL3; however, EPA disagrees that a regulatory decision [determination] could be made on them at this moment. As discussed in the preamble to the Draft CCL3, (see page 9962) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL3 selection process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the Please see response to comment ID 19412 under comment code 2260.

EPA disagrees with the commenter that number of chemicals and microbes on the draft CCL 3 suggests that a wildly disproportionate increase in EPA resources will be going to chemicals, compared to, and at the expense of, pathogens.Neither the statute nor the list dictate resource allocation, and the number of contaminants in any category does not determine how EPA will prioritize further research or regulatory action.

In addition, the CCL is not a comprehensive list of all possible agents of concern to public health. EPA listed the microbial contaminants that are the most important agents (or potential agents) of waterborne disease. While the processes for chemical and microbial contaminants use different criteria, the Agency has listed contaminants that are currently unregulated and may require regulation as required by statute. The Agency developed and presented reasonable criteria for selecting contaminants and believes that the process for developing the current CCL for chemicals and microorganisms was reasonable and credible.

However, based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC Please see the response to comment ID 19349 under comment code 3310. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19338 under comment code 7200. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment ID 19065 under comment code 9100. The commenter is correct that EPA must

evaluate substances from several sources, including those registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") and previously made determinations to not develop NPDWRs for seven pesticides on CCL 1 and CCL 2. The PPC accurately summarizes the steps EPA took to develop the draft CCL 3. Please see the responses to comment IDs 19130, 19131, and 19132 under comment code 2420 Pesticides on the CCL 3. EPA does not agree that there is a selection bias for pesticides listed on the CCL. EPA has a peer-reviewed process developed to evaluate contaminants for the CCL taken from a broad universe of chemicals. The chemicals are subject to screening, and evaluated based on factors such as physical properties, health effects data, and their potential to occur in public water systems. The manufacture of Ethion containing products was discontinued as of October 1 2003, and existing stocks were prohibited for use after 12/31/2004 (67 FR 13327). All remaining ethion tolerances have been revoked, as of 10/1/2008 (69 FR 43918). Therefore, based on ethions current use profile, this pesticide will not be included on the CCL 3. Regarding commenters concern about fenamiphos, please see response to comment ID 19032 under comment code 3640 (Fenamiphos). Regarding the commenters concern about nitrofen, please see response to comment ID 19167 under comment The premise of the comment is incorrect. EPA did not simply sweep all of the UCMR 2 chemicals into the draft CCL3, even though the UCMR 2 monitoring wont be completed for several years. EPA evaluated contaminants for the CCL 3 using a multi-step, data-driven process to determine whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human health as described in the draft CCL 3 FR notice. The chemicals on UCMR 2 are also among those that were evaluated in the CCL 3 process based on their best available data and information. No contaminants were added to the CCL 3 based on anticipated occurrence results from UCMR 2, and not all of the contaminants on UCMR 2 are on the CCL 3. Data collected under UCMRs are an important source of occurrence information for the CCL process, and UCMR 2 data will be appropriately The Agency disagrees with the commenter that EPA should limit its CCL3 selection to those with high certainty, high quality data.The SDWA does not direct the Agency to limit or reduce the number of contaminants listed on the CCL. The Agency also notes that the neither the NRC or NDWAC recommendations on the CCL provide any recommendations on reducing the number of contaminants on the CCL. The Agency uses the best available science and information to evaluate and list potential drinking water candidate contaminants. Based upon these data EPA concludes that these contaminants are known or anticipated to occur in public water systems and may require regulation. Therefore EPA included them on the final CCL 3. EPA has implemented a reproducible and transparent process developed to evaluate contaminants for the CCL taken from a broad universe of chemicals. The chemicals are screened based on health effects data and their potential to occur in public water systems. All chemicals, including pesticides identified in the universe go through the same screening process and EPA does not discriminate as to the number of pesticides or any other Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### PFOA has been included on the final CCL 3. PFOS was not included on the draft CCL 3, but has been included on

the final CCL 3. EPA evaluated PFOS in the CCL 3 process, and as cited in the Drinking Water Contaminant Candidate List 3-Draft Federal Register Notice PFOS was not included on the draft CCL 3 based on the limited occurrence data, combined with the phase out of production of PFOS in the U.S. between 2000 and 2002. EPAs decision to list PFOS on the final CCL 3 is based on information from a 2007 Significant New Use Rule (SNUR) that shows there are ongoing uses of PFOS that could lead to its potential to occur in water. In the SNUR (Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235)), EPA granted an exemption, for reporting to TSCA, for the use of tetraethylammonium perfluorooctanesulfonate for specified industrial uses (particularly metal plating). This perfluorinated compound is of concern to EPA because PFOS is the anionic portion of this chemical. PFOS is also appearing in Minnesota wastewater treatment plant influent, effluent, and sludge associated with its use in the fume/mist suppressant in metal finishing and plating baths (Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235))). A major factor in EPAs decision to not include PFOS on the draft CCL 3 was the phase out of production of PFOS. Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009 to provide technical information to State and local officials and PWSs for consideration in addressing local contamination of drinking water to protect public health. (Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS): Provisional Health Advisory http://www.epa.gov/waterscience/criteria/drinking/). This information has been used to develop the Final Contaminant Candidate List (CCL) 3 and is included in the docket and Contaminant Information Sheets for PFOA at regulations.gov. Based upon these and other data provided by commenters, EPA concludes that PFOS is known or anticipated to occur in public water systems and may require Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009 to provide technical information to state and local officials and PWSs for consideration in addressing local contamination of drinking water to protect public health. [Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS): Provisional Health Advisory http://www.epa.gov/waterscience/criteria/drinking/]. This information has been used to develop the Final Contaminant Candidate List (CCL) 3 and is included in the docket and Contaminant Information Sheets for PFOA at www.regulations.gov. Based upon these and other data provided by commenters EPA concludes that PFOA is known or anticipated to occur in public water systems and Please see response to comment ID 19136 under comment code 4510 for a more detailed discussion on the listing of PFOS. EPA concludes that PFOA and PFOS are known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including these compounds on the CCL 3. Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National Primary Drinking Water Rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the health effects or occurrence information to determine if the information is sufficient for the Agency to make a regulatory Please see the response to comment ID 19136 and 19139 under comment code 4510. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### The Agency disagrees with the commenter that there is insufficient information to include molybdenum, cobalt,

vanadium, strontium, and germanium on the draft CCL 3. The data and information collected and evaluated for each of these contaminants are described in the contaminant information sheets in the CCL 3 docket (Contaminant Candidate List (PCCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). Based upon these data EPA concludes that they are known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including molybdenum, cobalt, vanadium, strontium and germanium on the CCL 3. The Agency has responded to the specific information and comments provided by the NMA under the respective comment codes: 3255 (Cobalt health comment ID 19150), 3700 (Germanium comment ID 19153), 4005 (Molybdenum health comment ID 19146, 19148, and 19149), 4010 (Molybdenum occurrence comment ID EPA used the best available national occurrence data which was the National Inorganic and Radionuclides Survey. NIRS measured finished water concentrations and found that Molybdenum had detections in 77 public water systems. The 90th percentile concentration was at 30 ug/l. Additionally EPA provides a detailed response to your specific comments on the health effects under comment code 4005. Please see the response to comment 18874 and 19146. Based upon these data, EPA concludes that Molybdenum is known to occur in public water systems and may require regulation. Therefore EPA is including Molybdenum on the third CCL. Please see the response to comment ID 18874 under comment code 4005. Subsequent to the publication of the draft CCL 3, the OW conducted a literature search for new studies of molybdenum (nutritional and toxicological) and has identified several recent publications that will be evaluated in deciding which of the CCL contaminants will be considered for Regulatory Determination 3. Please see response to comment 19145 under comment code 4010. Please see the responses to comments 18874 and 19146 under comment code 4005. Please see the response to comment IDs 18874 and 19146 under comment code 4005. The CCL process was developed to identify known or possible drinking water contaminants of potential health concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the data used at each step and were applied uniformly for all chemical contaminants, including cobalt. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL ]. Cobalt was selected for the draft CCL3 based on these uniformly applied processes. The Agency used the ATSDR MRL to evaluate the adverse health effects of cobalt and occurrence data from NIRS.

Placement on the CCL enables EPA to examine the available database for toxicity in a more refined process than was used for the CCL in order to determine if a contaminant has sufficient data for regulatory determination. This will be the next stage for cobalt. During this process, EPA will have the opportunity to examine cobalts full toxicity database. The information available on concentrations in finished water across the nation and treatment technologies are equally important during regulatory determination.

The best available national occurrence data, which were the National Inorganic and Radionuclides Survey, indicated that vanadium occurs with high prevalence. Therefore, its prevalence in drinking water, persistence in the environment, and its solubility in water warranted its inclusion on the CCL 3. EPA welcomes any data that you may have that can help in the process of determining the occurrence of vanadium in drinking water. The ATSDR (1992) and IOM (2001) used the same critical study for their quantitative assessment of risk. The IOM (2001) data, although not on the dossier, were considered by EPA. Part of the difference in the outcomes of the two assessments relates to the way dose was interpreted and the fact that the ATSDR used a NOAEL as the point of departure in their assessment while IOM used the LOAEL. The ATSDR assessment was selected for scoring of the health attributes based on the hierarchy for data sources defined by the protocol for selecting the PCCL but is also justified because it is the more conservative of the two values derived from the same study. The agency

### While the Agency places great value on ATSDR assessments, the Agencys Contaminant Candidate List (CCL)

process follows a protocol that ranks EPA assessments higher in hierarchy to the ATSDR process for hazard assessment. The CCL process was developed to identify known or possible drinking water contaminants of potential health concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of CCL 3. The protocols established hierarchies for the data used at each step and were applied uniformly for all chemical contaminants, including strontium. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL]. Strontium was selected for the CCL 3 based on these uniformly applied processes. Placement on the CCL enables EPA to examine the available data for toxicity in a more refined process than was used for the CCL in order to determine if a contaminant has sufficient data for regulatory determination. This will be the next stage for strontium. EPA calculated the ratio of the health reference level (HRL) divided by the occurrence in water, not the DWS/MCGL of 2226 ug/L cited by the commenter. The oral chronic LOAEL (0.318 mg/kg/day) was the basis for the HRL (0.744 ug/L) that was then divided by the 90th % detection from the National Inorganic Radionuclides Survey (220 ug/L). This information was also provided in the contaminant information sheets in the docket. The Agency described the protocol, assumptions factors, and equations in the CCL3 Chemicals: Classification of the PCCL to CCL document. The Agency also notes that including a contaminant on the draft or final CCL 3 does not Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA looks forward to participation from SFIREG members for future CCLs. EPA understands that state lead agencies may lack infrastructure to readily develop standards for pesticides in drinking water or risk-based guidance values, communicate potential risks or make risk management decisions. EPA endeavors to provide such information as part of the CCL/HA/Regulatory Determination process where possible. As described in the draft CCL notice, all pesticides identified in the universe of chemicals must go through this screening process and EPA does not discriminate as to the number of pesticides or any other group The Agency notes that HRLs were developed for over 500 chemicals listed on the PCCL. These contaminants passed through the screening criteria and were subjected to further scrutiny by the Agency. These HRLs are listed on the contaminant information sheets that are available in the CCL 3 Docket at regulations.gov. The Agency hopes to continue to work with stakeholders as future CCLs are developed. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19136 and 19139 under comment code 4510. Please see the response to comment ID 18891 under comment code 4520. Please see response to comment ID 19138 under comment code 4515. Please see the response to comment ID 19136 and 19139 under comment code 4510. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA is not including nitrofen on the Final CCL3. EPA used total Toxic Release Inventory data to anticipate the occurrence of nitrofen in PWSs as described in the FR notice announcing the draft CCL 3. After further evaluation of these data the Agency notes that stockpiles identified by the TRI data were disposed of in RCRA Subtitle C (hazardous waste) landfills. Based on these data, EPA does not anticipate that nitrofen will occur in PWSs and does not require regulatory consideration under the SDWA. Therefore EPA is not including nitrofen on

### Please see the response to comment ID 19068 under comment code 4450.

Please see the response to comment ID 19136 and 19139 under comment code 4510. Please see the response to comment ID 19190 under comment code 7150. Please see response to comment ID 19338 under comment code 7200. The data the Agency used to evaluate these antibiotics are provided in the Contaminant information sheets in the CCL 3 docket at EPA has kept Helicobacter pylori on the CCL 3. Helicobacter pylori is on the final CCL 3. EPA will review and consider the information provided by the commenter together with other relevant data as we conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID# 19192 under comment code 7140 Bisphenol A (and related-phenols). Please see response to comment ID 19412 under comment code 2260.

Please see the response to comment for each compound in the following list of comment IDs and individual contaminants: Aldicarb (CAS # 116-06-3): See response to Comment ID 19194 under comment code 7110. Azinphos-methyl (CAS # 86-50-0): See response to Comment ID 20316 under comment code 7110. Carbaryl (CAS # 63-25-2): See response to Comment ID 20317 under comment code 7110. Chlorpyrifos (CAS # 2921-88-2): See response to Comment ID 20318 under comment code 7110. Dichlorvos (DDVP) (CAS # 62-73-7): See response to Comment ID 20319 under comment code 7110. Dicofol (CAS # 115-32-2): See response to Comment ID 20320 under comment code 7110. In the Agencys Contaminant Candidate List (CCL) process, linuron screened to the PCCL but failed to move to the CCL. See the response to comment 19195 under comment code 7630. Please see the response to comment for each compound in the following list of comment IDs and individual contaminants: Phosmet (CAS # 732-11-6): See response to Comment ID 19196 under comment code 7110.

Trichlorfon (CAS # 52-68-6): See response to Comment ID 20322 under comment code 7110.

Triclocarban (CAS # 101-20-2): See response to Comment ID 20323 under comment code 7110.

Triclosan (CAS # 3380-34-5): See response to Comment ID 20324 under comment code 7110. See response to comment ID 19197 under comment code 7210. Please see response to comment ID 19338 under comment code 7200. EPA concluded that nine hormones (17 alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, mestranol, and norethindrone) should be included on the CCL 3 because these contaminants are known or anticipated to occur in public water systems and may require regulation. The specific data used to evaluate these contaminants can be found in the supporting documents and CCL Contaminant Information Sheets in the docket at Please see the response to comment ID 19167 under comment code 4070. Please see the response to Comment ID 19073 and 18906, under comment code 4455. EPA will continue to evaluate the available science related to perchlorate as the Agency makes a regulatory determination for Please see the response to comment IDs 19067 and 19333 under comment code 4460. Please see the response to comment ID 19068 under comment code 4450. Please see response to comment ID 19138 under comment code 4515. See response to comment 18891 under comment code 4520. Please see the response to comment ID 19136 and 19139 under comment code 4510.

### EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency uses the best available science

and information to evaluate and list potential drinking water candidate contaminants. The Agency has responded to each of the individual chemicals provided by commenter under separate comment IDs. EPA considered alkylphenol polyethoxylates in the universe of chemicals evaluated for the CCL 3. The commenter provided health effect assay and limited occurrence data that EPA received and evaluated during the nominations process and in developing the draft CCL 3. The available occurrence and health effects information, provided by the commenter and additional information collected by the Agency, were not sufficient for these chemicals to pass from the CCL 3 universe to the PCCL for further evaluation. Therefore, the Agency does not anticipate that they will occur in a public water system and require regulation. Therefore, the Agency did not include them on the CCL 3. Additional information on these chemicals is available in the CCL 3 docket at www.regulations.gov in the support documents (Contaminant Candidate List 3: Identifying the Universe and A Summary of Nominations for the Third Contaminant Candidate List). For more information on the Agency's efforts to evaluate endocrine disruptors including alkylphenol ethoxylates (APEs) and other endocrine disrupting Please see response to comment ID 19338 under comment code 7200. EPA is listing erythromycin on the final CCL 3 because it anticipates that the antibiotic may occur in PWS and may require regulation. The commenter provided news reports and citations that summarize the potential for other antibiotics to occur in aquatic environments and possible public health concerns caused by antibiotic resistant bacteria. EPA relied on quantitative occurrence and health effects data to evaluate the antibiotics identified by the commenter. EPA has provided these data in the supporting documents and the contaminants information sheets in the CCL 3 docket EPA used a reference dose for bisphenol A of 0.05 mg/kg/day based on decreased body weight gain which was verified in 1988 and was used in the screening process. EPA has not updated its risk assessment since that time, but does acknowledge that there are several new studies under development. Several other government agencies are in the process of reassessing the health effects of bisphenol A (National Institute of Environmental Health Sciences and the Food and Drug Administration). Those assessments are not yet complete . EPA is following the work being done on the health risks for bisphenol A and will incorporate any quantitative exposure guidelines developed for BPA into the CCL process for future CCLs. However, it is important to note that occurrence data are equally as important as the health data in determining whether a chemical may occur in public drinking water systems and require regulation . Regarding commenters statement A study in Germany found BPA in surface water (0.0005 to 0.41 ug/L), in sewage effluents (0.018 to 0.702 ug/L), in sediments (0.01 to 0.19 mg/kg) and in sewage sludge (0.004 to 1.363mg/kg dw), occurrence information from other countries was not used to evaluate chemicals for the Please see response to comment ID 19412 under comment code 2260.

Aldicarb (CAS # 116-06-3): As noted in the first CCL notice, 63 FR 10278 (March 2, 1998), EPA does not believe that it is appropriate to include Aldicarb and its two degradation products of toxicological concern, the sulfoxide and sulfone, on the CCL. These contaminants are already required to be regulated by statute. An updated HA (1996) is also available for aldicarb and its degradation products.

### Linuron was included in the universe of CCL3 contaminants and screened to the PCCL. In EPAs evaluation of

linuron, the best available data on occurrence was considered from the following sources: US Geologic Survey National Ambient Water Quality Assessments, EPA Unregulated Contaminant Monitoring Rule, USDAs Pesticide Data Program, and a California Department of Health occurrence study. The data sources are described in the contaminant information sheet for linuron, which can be found in the CCL 3 docket (Preliminary Contaminant Candidate List (PCCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0043).

EPA acknowledges commenters concern about the Agencys drinking water assessment for linuron. However, for purposes of evaluation for the CCL, EPA used the best available information on occurrence at the national level, which was taken from NAWQA data. EPA also used the RfD of 0.008 mg/ kg-day, to calculate a health reference level of 56 ug/L. When EPA compared the health reference level to the occurrence value of 0.26 ug/L (NAWQA 90th percentile), linuron did not pass the screening criteria to move from the PCCL to draft CCL 3. Based upon the information available at this time, EPA concludes that linuron has limited potential to occur in Phosmet (CAS# 732-11-6): Phosmet was in the Universe of chemicals and it was screened to the PCCL. EPA used the best available data to evaluate this contaminant. EPA used the RfD of 0.011 mg/kd-day for health and ~1.3 million lbs/year application data for exposure. EPA did not use the IRED drinking water assessment to decide whether to place phosmet on the CCL. While Phosmet was screened to the PCCL, it was not listed on the CCL 3 based on a review of its toxicity profile and data on occurrence. The methodology used by EPA to make this decision can be found in the following support document, located in the CCL Docket: CCL Chemicals: Classification of the PCCL to CCL (EPA 815-R-08-004). Although phosmet did not get listed on the CCL 3, EPA will EPA evaluated the information provided by the commenter with respect to the contribution of drinking water to overall exposure (includes exposure due to consumer products) of phthalates, particularly in regards to the CDC NHANES dataset. However, EPA determined that the EPA data used to screen each phthalate compound were more relevant to the CCL process. EPA developed assessment factors to evaluate data sources to ensure they are relevant to the CCL process, complete in basic documentation, not redundant with other data sources, and are formatted for automated retrieval. The commenter submitted ambient water data from the Storage and Retrieval System (STORET) data warehouse. Data from STORET is supplemental and does not meet the assessment factors for retrievability. In the evaluation of the phthalates, EPA used production and release data, which met all assessment factors. The following is a brief summary of the results of EPAs evaluation of each phthalate compound that commenter proposed for listing onto the CCL (more detailed analysis is available in the Final CCL 3 Contaminant Information Sheets and chemical background documents, which can be found in the CCL Docket, ID No. EPA-HQ-OW-2007- 1189): 1. Benzyl butyl phthalate (BzBP) (CAS # 85-68-7): Butyl benzyl phthalate was screened to the PCCL. Based on an analysis of the toxicity and production data, it did not meet EPAs screening criteria to be listed on the PCCL and undergo further evaluation. 2. Di-isononyl phthalate (DiNP) (CAS # 28553-12-0): Di-iso-nonyl phthalate was identified in the universe of chemicals, but did not meet EPAs screening criteria to be listed on the PCCL and undergo further evaluation.

### Since the draft CCL 3 was published, several publications have focused on the occurrence of pharmaceuticals in

ambient water and drinking water. Commenters identified quantitative occurrence data from several of these publications in their comments on the CCL 3. Other commenters identified summary reports and publications that discuss potential public health concerns of pharmaceuticals in general terms. In response to these comments, EPA has conducted additional data collection efforts to comprehensively review recent published information from the U.S. Geological Survey (USGS) and other sources, including those cited by commenters, to identify the best available occurrence information for pharmaceuticals. EPA identified new occurrence data for 81 contaminants from 22 sources. The Agency also conducted additional literature reviews to identify the best available health effects information and identified data from sources including: EPA Office of Pesticide Programs, the Food and Drug Administration (FDA) Center for Veterinary Medicine, the Joint Food and Agriculture Organization/World Health Organization (WHO) Expert Committee on Food Additives, the European Medicines Agency in addition to the FDA Center for Drug Evaluation and Research maximum recommended therapeutic doses. The Agency assessed this new data and used the same hierarchal approach described in the draft CCL 3 FR EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency uses the best available science and information to evaluate and list potential drinking water candidate contaminants. All contaminants that are part of the final CCL 3 were known or anticipated to occur in public water systems and may require regulation. The Agency has responded to each of the individual chemicals provided by the commenter under separate Please see the response to comment ID 19167 under comment code 4070. Please see the response to comment ID 19136 and 19139 under comment code 4510 for PFOA and the response to comment ID 19068 under comment code 4450 for perchlorate. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The agency has responded to the specific information and comments provided by the EWG under the respective comment codes: 2100 General Comments on the List (comment ID 19207), 4510 PFOA (comment ID 19532), 4515 PFOA health (comment IDs 19533 and 19213), 4520 PFOA occurrence (comment ID 19214), 7180 Perfluorinated compounds (not on CCL 3) (comment IDs 19591, 19592, 19593, 19610, 19611, 19601, and 19219), and 7200 Pharmaceuticals and Personal Care Products (not on CCL3) (comment IDs 19208, 19210, 19218, and 19602). The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The Agency will evaluate contaminants on the final CCL 3 to determine whether or not they require a national drinking water regulation in accordance with the criteria specified in SDWA 1412 (b) (1). The Agency will Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment 19205 under comment code 2100 regarding perfluorinated chemicals and

pharmaceuticals. EPA disagrees with the commenters conclusion that populations are not protected from toxic chemicals in drinking water.EPAs conducted evaluations using SDWA risk management provisions and these analyses were similar to the results reached by EWG. EPA compared the list of 142 unregulated contaminants that were detected in tap water from EWGs National Tap Water Quality Database to those contaminants considered in the CCL 3 process. 132 of the 142 contaminants on EWGs unregulated contaminants list were included in the CCL 3 Universe and evaluated in the CCL 3 process. Of the 10 contaminants that were not included in the CCL 3 Universe, 8 have National Primary Drinking Water Regulations therefore, they were removed from consideration for the CCL 3. EWG did not detect the two remaining contaminants above any health limit and both of the contaminants were only detected in one system. EWG identified 29 unregulated contaminants at concentrations above a health limit. All of these contaminants that EWG identified were included in the CCL 3 Universe except for two contaminants that have NPDWRs and Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see the responses to comment ID 19136 and 19139 under comment code 4510 for a more detailed discussion on the listing of PFOA and PFOS. PFBA was not included on the final CCL 3. PFBA was included in the CCL 3 Universe. However the Agency only had limited data on PFBA and other PFC potential occurrence in public water systems and environmental releases. Based upon these data EPA concludes that PFBA does not meet the critieria for the CCL at this time. Therefore EPA is not including this compound on the CCL 3.

Please see the response to comment ID 19384 in comment code 6900 (The interrelation between CCL and UCMR for specific chemicals) regarding the selection of contaminants for the UCMR.

See response to comment ID 19136 and 19139 under comment code 4510. Please see response to comment ID 19138 under comment code 4515. See response to comment ID 19211 in comment code 4510 PFOA. See response to comment ID 19211 in comment code 4510 PFOA. See response to comment ID 19136 and 19139 under comment code 4510. See response to comment ID 19136, 19139, and 19211 under comment code 4510. Please see response to comment ID 19338 under comment code 7200. The Agency evaluated contaminants for the CCL 3 based on a data-driven approach to determine whether contaminants are known or anticipated to occur in PWS and may require regulation. The Agency used data from the Kolpin et al. 2002 study cited by the commenter to evaluate pharmaceuticals for the final CCL 3 using the process described in the draft CCL 3 FR notice and final CCL 3 FR notice. For those contaminants with ambient or finished drinking water occurrence data, EPA used a health reference level to water concentration ratio to evaluate contaminants for the CCL 3. Contaminants were selected for the CCL 3 when the ratio was ¡Ü10, representing occurrence in water at a level Please see the response to comment ID 19211 under comment code 4510 and the response to comment ID 19338 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Please see response to comment IDs 18977 and 19373 under comment code 1000. EPA is actively working to

promote and improve the security of our public water systems and infrastructure. Significant actions are underway to assess and reduce vulnerabilities to potential terrorist attacks; to plan for and practice response to emergencies and incidents; and to develop new security technologies to detect and monitor contaminants and prevent security breaches. The Agency is working with water utilities, state and local governments, public health officials, emergency responders and planners, assistance and training providers, environmental professionals, researchers and engineers, and law enforcement, among others to promote water security. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see response to comment ID 19065 under comment code 9100. The Agency believes that the regulatory development process described by the commenter is one of the many proactive avenues the Agency uses to EPA acknowledges your comments about public participation in the listing process. However, EPA respectfully disagrees with your comments that an additional public comment period be included in the selection process. EPA sought public involvement in the CCL 3 process by receiving input at a public stakeholder meeting in September 2004 and as part of the public nominations process in May 2006. Both opportunities were announced and published in the Federal Register. EPA also sought public comment on the draft CCL 3 following its publication in February 2008. We believe that EPA has provided ample opportunity for the public to provide This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see the response to comment ID 19136 and 19139 under comment code 4510. Please see the response to comment ID 19137 under comment code 7180 and 19139 under comment code EPA agrees that the listed pathogens have adverse health effects. Nonetheless, health effect is not the only criterion EPA must consider for making a CCL listing or regulatory determination. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3. Page 9629 of the draft CCL 3 discusses the three SDWA criteria to determine whether a contaminant for making the regulation Chemical contaminants are included on the Contaminant Candidate List because they are anticipated or known to occur in PWSs and may require regulation. Under SDWA 1412b(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National primary drinking water rule. The Agency will continue to use the best available science and information to further evaluate contaminants on the CCL 3. For more information on EPAs process of regulation determination, please refer to Drinking Water: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate ListPreliminary Determinations; Proposed Rule (Federal Register. Vol. 72, No. 83, Pg. 24018 May 1, 2007) or the Agency Web site (www.epa.gov/safwater/ccl). This publication can be found in the EPA has not yet determined which of the listed pesticides should be regulated as contaminants under the SDWA; that decision is part of the regulatory determination process, rather than the CCL process. EPA does not agree with the commenter regarding the list still missing a number of especially hazardous pesticides. EPA has a reproducible and transparent process developed to evaluate contaminants for the CCL taken from a broad universe of chemicals. The chemicals are subject to screening, and evaluated based on health effects data and their potential to occur in public water systems. All pesticides identified in the universe of chemicals must go through the same screening process and EPA does not discriminate as to the number of pesticides or any other group of chemicals that get listed on the CCL. EPA believes that the final CCL contains the hazardous pesticides that meet the CCL statutory criteria, based on the best information available at this time. Please see response to comment ID 19338 under comment code 7200.

### EPA acknowledges your comment, but further evaluation is needed before a determination can be made to

regulate the draft CCL 3 contaminants. A regulatory determination is a formal decision on whether EPA should initiate a rulemaking process to develop a national primary drinking water regulation for a specific contaminant. The law requires that we make regulatory determinations for at least five contaminants from the most recent CCL every five years.

As the next step in the regulatory process, EPA will evaluate CCL 3 contaminants based upon the criteria above and determine whether there is sufficient data to decide if a contaminant should be regulated or not. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its See response to comment ID 19198 under comment code 7150. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see the response to comment ID 19198 under comment code 7150. EPA agrees that it is important to properly manage chemicals that have the potential to contaminate public water supplies and encourages public comment from all interested parties on the Endocrine Disruptor Screening Program (EDSP) and the CCL, including the drinking water industry. The first round of screening in the EDSP will assist the Agency in understanding the health effects associated with specific pesticides. Nine of the 73 pesticides included in the first round of screening are currently regulated by national primary drinking water regulations. The Agency will be able to use information from the screening program in determining whether existing regulations need to be revised to address health endpoints associated with endocrine disruption. The Agency will also be able to use results from the screening program in considering other contaminants for future regulation. All of the 73 pesticides in the first round of screening were included in the universe of contaminants that EPA evaluated. Thirty-three of them were moved to the preliminary CCL 3 and 9 were included on the CCL 3.

Please see the response to comment ID 19233 under comment code 6100. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 18967 under comment code 2100. The health risk evaluations of the metolachlor degradates do recognize their lower toxicity than the parent pesticide. The potency scores for the two metolachlor degradates are 2 for each one, and the severity scores are 1 for each one. In the case of metolachlor, the potency score is 4 and the severity score is 3. If metolachlor is selected for regulatory determination, the final decision concerning whether or not there is a need for aregulation will strongly consider the results of the UCMR2 monitoring data and the extent with which there is cooccurrence of metolachlor and its two degradates as well as the relative concentrations of each. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19068 under comment code 4450. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter

Background and Introductory Statements. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its EPA disagrees with your comment and has decided to keep Naegleria fowleri on the CCL 3. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Neither treatability nor rareness/frequency of disease or methods availability were criteria considered for CCL 3 inclusion. Given the severe health effects associated with Naegleria fowleri, EPA believes it is appropriate to include in CCL 3 to further assess the occurrence and exposure risks posed by this organism which has been detected in drinking water in the US (Blair et al., 2008) and has also been the cause of at least one WBDO as documented by CDC (CDC MMWR 2001 2002). EPA commends the different Arizona organizations that have taken the initiative to further study N. fowleri as well as the State and County developing the Proposed Operational Practices and look forward to the finalized document. Inclusion of N. fowleri on the CCL 3 is a factor EPA considers when prioritizing research needs as well Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The Agency acknowledges receipt of Riverkeepers comments and has responded to the specific comments submitted by Riverkeeper under the respective comment codes: 6550 Nominations and Surveillance (comment ID 19346) and 7200 pharmaceuticals and personal care products (not on CCL3) (comment ID 19257). Please see response to comment ID 19338 under comment code 7200. The commenter notes that they provided nominations for the CCL 3 in response to the October 16 FR Notice requesting nominations (71 FR 60705). EPA evaluated all the contaminants nominated and provides the CCL 3 status in the docket in the Summary of Nominations for the Third CCL at www.regulations.gov. The Agency also reviewed the data and information cited by the commenter to develop the final CCL 3. The commenter also notes that the Agency should promote a precautionary principle approach and list additional contaminants on the CCL. The Agency disagrees that EPA is reactively listing contaminants on the draft and final CCL 3. The Agency actively sought out data and information on the potential for contaminants to occur in PWSs that have adverse health effects. The Agency used concentrations of contaminants in ambient and finished water, estimated concentrations of pesticides, environmental release and application, production, use, and environmental fate parameters to evaluate over 6,000 chemical contaminants and their potential to occur in PWSs. A wide array of health effects information was also collected under this effort. The Agency documented Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA did develop and implement a systematic strategy and set of criteria for selecting the pathogens for CCL 3 after the 2006 Nominations request. This is the screening and scoring process described in detail in the support documents in the docket of the Final CCL 3 (e.g.,see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process for more information on all the scores). The final CCL 3 continues to list the three pathogens mentioned: E. coli 0157:H7, Campylobacteria jejuni, and Naegleria folweri.

### EPA used the CDC surveillance system as the primary source of data for the waterborne disease outbreaks

protocol. EPA acknowledges that the WBDOs reported in the surveillance system represent only a portion of the burden of illness associated with drinking water exposure. The surveillance information does not include endemic waterborne disease risks. EPA believes the CDC WBDO data is the best source of occurrence data to compare and rank pathogen-occurrence on because the data is collected with the same epidemiologic criteria for every outbreak, i.e., the data can be used to compare and prioritize the pathogens on the CCL. EPA acknowledges that a few of the CCL pathogens cause diseases that must be reported to CDC; however the CDC endemic disease database does not cover all the CCL pathogens nor does it provide the source of the illness (ie., drinking water). There is no national database on endemic illness due to drinking water nor are there estimates specifically for individual pathogens pathogens due to drinking water exposure. EPA rejected using CDCs notifiable diseases data as a criterion because it does not distinguish between exposure through drinking water versus other routes of exposure (e.g., food, secondary spread, sewage, and nosocomial exposure) also, many of the PCCL pathogens are not on CDCs list (see http://www.cdc.gov/ncphi/disss/nndss/phs/infdis2009.htm). EPA found it difficult to compare and prioritize the PCCL pathogens based on a data set that does not include half of the PCCL pathogens. Please see response to comment ID 19412 under comment code 2260.

EPA has retained Salmonella enterica and Shigella sonnei on the CCL 3 based on the scoring process. EPA notes that there was a WBDO of Salmonella just this year (unpublished data from Colorado). EPA continues to believe that there is a potential need for regulation of these two pathogens.

EPA agrees that the data on occurrence in drinking water is limited. Please see Comment ID 19261 under comment code 6300 for the response to the comment on endemic disease.

EPA agrees that for some pathogens fecal contamination of drinking water due to sewage is an important route of exposure for many pathogens. EPA can not assume that sewage is the only route of exposure EPA needs to consider for occurrence of a pathogen. For example, biofilms in distribution systems may pose significant risks. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and See response to comment 18919 under comment code 3580. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA used the best available data including occurrence data from the Unregulated Contaminant Monitoring Rule

and health effects data developed for the registration of diuron as a pesticide to evaluate diuron for the CCL3. These data are provided in the CCL 3 docket [see Contaminant Candidate List (CCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). Based upon these data, EPA concludes that diuron is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The oral Reference dose from the Agencys Integrated Risk Information System (0.005 mg/kg/day) was the basis for the HRL (35 ug/L) that was then divided by the 90th% detection from the National Inorganic Radionuclides Survey (30 ug/L). This information was also provided in the contaminant information sheets in the docket. The Agency described the protocol, assumptions factors, and equations in the CCL 3 Chemicals: Classification of the PCCL to CCL document. The activity by the Pennsylvania DEP related to a discharge permit is not related to the CCL. That activity involves establishing an Ambient Water Quality Criterion for Human Health under the Clean Water Act and is a prerogative granted to the state under the conditions of that Act.

Based on these and other data, EPA has determined that molybdenum is known or anticipated to occur in drinking water and may require regulation. Therefore, EPA has included molybdenum on the third CCL. The Agency also notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on Please see the response to comment ID 19143 under comment code 2100. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see responses to comment ID 19501 under comment code 6160. Ethylene oxide has been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the ACC on ethylene oxide under the respective comment codes: 3585 ethylene oxide health (comment ID 18925) and 3590 ethylene oxide occurrence (comment IDs 19521 and 19523). Please see the response to comment ID 19265 under comment code 3580. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19065 under comment code 9100. Please see the response to comment ID 19349 under comment code 3310. Please see response to comment ID 19412 under comment code 2260.

EPA recognizes the potential health risks associated with Vibrio cholerae, however, there has been only one V. cholerae WBDO in the US since 1990. Therefore, EPA will continue to assess any potential or increased health risks posed by Vibrio cholerae and other pathogens and consider any new information in future CCLs.

Please see the response to comment ID 19349 under comment code 3310. Please see response to comment ID 19283 under comment code 2340. Please see the response to comment ID 19349 under comment code 3310. Please see response to comment ID 19283 under comment code 2340. Please see the response to comment ID 18939 under comment code 2100. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter

Background and Introductory Statements The Agency disagrees that it would not be appropriate or necessary to include 1,4-dioxane on the final CCL3 and is therefore including 1,4-dioxane on the final CCL 3. EPA is aware that there is an assessment under development by the Office of Research and Developments IRIS program. The Agency uses the best available science and information to evaluate and list drinking water candidate contaminants. The Agency also notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on anyone. (FR Vol 73. no 35 p.9629). Under SDWA 1412(b)(1)(B) EPA makes a separate determination to regulate a CCL contaminant before proposing and promulgating a national primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the IRIS risk assessment to determine if the information is sufficient for the Agency to make a regulatory determination. The Agency uses the best available national occurrence data to evaluate contaminants to determine if a contaminant is known or anticipated to occur in public water systems. EPA has also evaluated the information provided by the commenter for the occurrence of 1,4-dioxane in 50 public water systems in Michigan. The Agency collected data and information that 1,4-dioxane can be anticipated to occur in PWS. Data from Toxic release inventory showed total release ( 800 thousand pounds) in 22 states. Production data also indicated that 1-10 million pounds of 1,4-dioxane was produced and 1,4-dioxane may be prevalent in the environment due to its slow biodegradation. EPA selected the TRI data based on the hierarchy described in the FR notice (FR vol 73 no35). Based upon these and other data, The Agency has determined that 1,4-dioxane is known and See response to comment 19291 under comment code 2680. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19376 under comment code 6550. EPA agrees that expert review was an important component of the CCL 3 and improved the process. Please see the response to comment ID 19376 under comment code 6550. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The Agency has responded to the specific comments submitted by MADEP on MTBE and perchlorate under the respective comment codes: 3910 MTBE (comment ID 19307), and 4450 perchlorate (comment ID 19308). RDX, 1,4-dioxane, NDMA, and PFOA were all included on the final CCL 3. The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The Agency will evaluate contaminants on the final CCL 3 to determine whether or not they require a national drinking water regulation. The Agency will publish the preliminary regulatory determinations and seek comment at that time. EPA considered both TAME and TBA in the universe of chemicals for the Draft CCL 3. Both chemicals had limited occurrence information. Based upon these data, EPA did not include either chemical on the CCL 3. Please see response to comment ID 19338 under comment code 7200.

### The CCL universe included 8 haloacetonitriles: bromoacetonitrile, bromochloroacetonitrile,

bromodichloroacetonitrile, chloroacetonitrile, dibromochloroacetonitrile, dichloroacetonitrile, tribromoacetonitrile and trichloroacetonitrile. The first 7 did not initially pass to the PCCL because of a lack of sufficient occurrence data. All seven were re-screened using the DBP Information Collection Rule (ICR) data and none of them met the criteria for inclusion on CCL 3. The CCL process evaluated three halogenated nitromethanes. Two: bromodichloronitromethane and dibromonitromethane were included in the universe, but did not pass to the PCCL because of a lack of sufficient occurrence data. Bromonitromethane lacked both health effects and occurrence data. Chloronitromethane, dibromochloronitromethane, and dichloronitromethane were not part of the DBP-database that was the main source of information on DBPs and were not nominated to the universe. For additional information on DBPs in the universe please see the response to comment ID 19342 under comment code 7130. EPA encourages the nomination of chemicals to be included in the universe for the next CCL process. Both health EPA disagrees with the commenter. In developing the Draft CCL 3, the Agency implemented a different process from that used for CCL 1 and CCL 2. This new process builds on evaluations used for previous CCLs and was based on substantial expert input and recommendations from the National Academy of Sciences National Research Council (NRC), the National Drinking Water Advisory Council (NDWAC), other groups, and public comments on CCL 1 and CCL 2, including MassDEP and other states, to make the process more transparent and reproducible.

Based upon the available data and information EPA concludes that the contaminants included on the final CCL 3 are known or anticipated to occur in public water systems and may require regulation. Therefore, EPA has included additional contaminants on the CCL 3 than those listed on CCL 2. EPA also notes that it evaluated all the contaminants on CCL 2 as it developed a new process for CCL 3.

The Agency uses the best available science and information to evaluate and list drinking water candidate contaminants. The Agency also notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on anyone. (73 FR 9629). Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminants before proposing and promulgating a national primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the IRIS risk assessment to determine if the information is sufficient for the Agency to make a regulatory determination.

EPA is including perchlorate and MTBE on the CCL 3. EPA identified information gaps needed to make further EPA is committed to using sound science in the preparation of its IRIS Risk Assessments. The MTBE Risk Assessment will be made available once The Agency has completed the appropriate reviews to assure the quality and integrity of the risk assessment. EPA published an Interim Health Advisory for perchlorate in January 2009. The Interim Health Advisory is established based on the most sensitive population identified by the NAS, the fetus of the iodide-deficient pregnant woman. EPA's August 2009, supplemental FR notice does not change the Interim Health Advisory; however, in this notice, EPA requested comment on alternative analyses that result in lower health based levels for other sensitive life stages such as infants and children. EPA will consider the comments on these alternative approaches as it makes a final regulatory determination and as it decides what modifications are needed to the Interim Health Advisory for perchlorate.

### Based upon the available data and information EPA concludes that perchlorate and MTBE are known or

anticipated to occur in public water systems and may require regulation. Therefore the Agency has included them on the final CCL 3. EPA makes a separate determination using more rigorous evaluation criteria specified under SDWA 1412(b)(1)(B)(ii) on whether or not to regulate a contaminants before proposing and promulgating a national primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 to determine if the information is sufficient for the Agency to make a regulatory determination. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment 18929 under comment code 3560. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see response to comment ID 17297 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The commenter correctly summarizes the CCL and regulatory determination process and no further response is The Agency disagrees with the commenter that EPA should reduce the number of substance included in each CCL.The SDWA does not limit the Agency to a particular number of contaminants for the CCL. The Agency also notes that the neither the NRC or NDWAC recommendations on the CCL provide any recommendations on reducing the number of contaminants in successive CCLs. However, the Agency does recognize the need to communicate data needs for contaminants included on the final CCL. The EPAs Office of Water coordinates with the Office of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OW is working with ORD to incorporate the results from these discussions in the next drinking water multi-year plan. The Contaminant Candidate List is the first step in identifying contaminants that may require regulation and contaminants that need additional data in order to determine the appropriate Agency action. The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA agrees with the commenter that public input into the development of the CCL 3 improved the overall EPA agrees that expert review was an important component of the CCL 3 process. Please refer to the Chemical Expert Input and Review for the Third CCLlocated in the CCL Docket (EPA-HQ-OW-2007-1189). EPA disagrees that the discussion of treatment as a criteria considered for listing and scoring microbes was not discussed. The FR notice (73 FR 9628) discusses organisms possibly covered by existing regulations and those possibly covered by treatment technique regulations on page 9548. The Agency noted the variability of treatment across systems and noted the viruses and Legionella were not excluded from consideration. The Agency also noted that E. Coli 0157 was not excluded from consideration and stated that including these pathogens on the CCL emphasizes their importance in protecting public health.Therefore, Agency opted to not include treatment as a factor for removing pathogens from inclusion on the CCL 3. The FR notice and the support documents provide additional discussion of consideration of treatment as a factor for removing pathogens from further consideration and why

### The EPAs Office of Water (OW) coordinates with the Office of Research and Development (ORD) to prioritize

research needs for the CCL 3 contaminants. OW is working with ORD to incorporate these research needs in the next drinking water multi-year plan. The Contaminant Candidate List is the first step in identifying contaminants that may require further evaluation in order to determine the appropriate Agency action (development of health advisories, or regulations, or no action).

The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for contaminants on the final CCL 3. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs in three categories; health effects, occurrence, and analytical method. The data needs were characterized as no data needs, specific data needs, or substantial data needs. The summary identifies which contaminants have research efforts under way within the Agency. It also identifies those contaminants that need additional information to characterize the health effects, occurrence, and analytic methods. By identifying those contaminants that need additional research and information, the Agency is communicating to stakeholders both research priorities and gaps for these contaminants. The health effects, occurrence, and analytical methods data/information used to select contaminants for the CCL 3 are EPA believes it is appropriate to consider and list Legionella and viruses on CCL 3. As discussed on page 9648 of the draft CCL 3, EPA did not exclude specific viruses and Legionella from consideration for the CCL. There are several reasons discussed for listing Legionella and viruses, including numerous WBDOs (e.g., CDC MMWR reports, 2006). Even though there is an MCLG, there are no monitoring, treatment or notification requirements within the National Primary Drinking Water Regulations that are specific to viruses or Legionella particularly for public water systems using ground water as a source. As a result, EPA believes that these contaminants are appropriately considered for specific NPDWR regulation through the CCL process rather than through the Six EPA disagrees with the commenters concern that EPA should reduce the number of substances on the CCL to better focus its resources. EPA assessed the data and information gathered on the CCL 3 chemical contaminants and developed a summary of the types of data and information available to help identify needs for regulatory determination evaluations and included the summary in the Federal Register notice. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs in three categories; health effects, occurrence, and analytical method. The data needs were characterized as no data needs, specific data needs, or substantial data needs. The health effects, occurrence, and analytical methods data/information used to classify data needs are featured in the supporting documentation and in the Final Contaminant Candidate List (CCL) 3 Contaminant Information Sheets in the docket (USEPA, 2009d). The summary identifies which contaminants have research efforts under way within the Agency. It also identifies those contaminants No response necessary to this summary of EPA information. EPAs Office of Ground Water and Drinking Water (OGWDW) and the Office of Water coordinate with the Office of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OGWDW is working with ORD to incorporate the results from these discussions in the next drinking water multi-year plan. The Contaminant Candidate List identifies contaminants that may require regulation and includes contaminants that need additional data in order to determine the appropriate Agency action (development of health advisories, or regulations, or no action).

The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for contaminants on the final CCL 3. EPA assessed the data and information gathered on the CCL 3 chemical contaminants and developed a summary of the types of data and information available to help identify needs for regulatory determination evaluations and included the summary in the Federal Register notice. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs

### EPA disagrees with commenters concern regarding the use of data and information from the High Production

Volume (HPV) program to screen the PCCL chemicals that did not have detected occurrence data in water. The Agency believes it used the best available data to evaluate a broad universe of chemicals and included those that the Agency anticipates may occur in PWS and require regulation in accordance with SDWA requirements. The Agency notes that the unregulated contaminants only with HPV occurrence information were not included on the draft or final CCL 3. EPA summarizes the protocols for different types of occurrence in the support documents available at www.regulations.gov (Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL). The Agency uses the best available science and information to evaluate and list potential drinking water candidate contaminants and will continue to use HPV data and information as EPA collects more See response to Comment 19384 under comment code 6900 regarding the general relationship between the CCL and UCMR programs. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19373 under comment code 1000. Please see response to comment ID 19338 under comment code 7200 for a discussion of the Agencys efforts on stewardship and drug take back programs. EPA addressed the sources of perchlorate in the May 1, 2007 Federal Register Notice entitled "Drinking Water:Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate ListPreliminary Determinations" (72 FR 24039). The Agency will continue to use the best available data and information to evaluate the occurrence of perchlorate in public water systems. The Agency will evaluate other data to determine if they are sufficient to include in its evaluation of perchlorate, including those sources of Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19341 under comment code 2460. The Agency uses the best available science and information to evaluate and list potential drinking water candidate contaminants. All contaminants that are part of the final CCL 3, including those cited by the commenter, were included on the CCL 3 because these contaminants are known or anticipated to occur in public water systems and may require regulation. EPA also notes that as the Agency learns from previous CCLs it will

use an adaptive management approach to modify the process of evaluating contaminants for the CCL. As new data and information become available the Agency will consider how to include the best available information Please see response to comment ID # 19342 under comment code 7130 ***Cadmus please move response from "response to comment code" section to this individual response when preparing comment response document.*** EPA is conducting several on going and continuing efforts to better understand the potential risks and benefits of nanotechnology and agrees with the commenter's assessment of the limited toxicological information available for these types of contaminants and therefore, has not included nanoparticles or nanomaterials on the CCL 3. EPA will continue to evaluate the best available science and information that describes the occurrence and health effects information on nanomaterials as it becomes available. EPA provides many forums to meet with researchers and experts on occurrence, exposure, and toxicology issues and develop information that is needed to evaluate potential drinking water contaminants and will include the commenter as we communicate those opportunities to the public in future.

### In the first attachment (DBP-1), the commenter mentioned N-chloramines as frequent disinfection by products

that should be considered when evaluating frequent water contaminants. However, N-chloroamines were neither in the Universe data compilation nor nominated during the nominations period, and the commenter did not submit data values to support their assertion that N-chloramines should be included on the CCL. Information on how EPA narrowed the list of possible DBPs to the CCL is available in a document on the EPA Web site titled Contaminant Candidate List 3 chemicals: screening to a PCCL at http://www.epa.gov/ogwdw/ccl/pdfs/report_ccl3_chemicals_screening.pdf. EPA also provided a list of contaminants considered for CCL 3 showing the status of the chemicals in the CCL process and the contaminant information sheets for the PCCL. Both of the references are available in the docket at regulations.gov. All information provided in Attachment DBP-1 (Disinfection as a Source of Diverse By-Products of Potential Concern) had been considered by the Agency in determining the draft final CCL 3. Specifically, the drinking water monitoring data submitted by the commenter were the Krasner 2006 and Weinberg 2002 studies. EPA used the Krasner 2006 study, which is an intensive summary of the Weinberg 2002 data, as a supplemental data set as The CCL3 process evaluated 8 haloacetonitriles, 7 halonitriles, 3 haloaldehydes, 11 halopropanones, 2 halopicrins, 2 haloacetic acids, 2 halonitromethanes, 8 N-nitrosamines and 8 halo-furanones (Mx-likecompounds) in the groups identified by the commenter. (Others, including the haloquinones, and Nchloroamines were neither in the Universe data compilation nor nominated during the nominations period.)Among the DBPs in the universe benzoic acid, bromochloromethane, dibromomethane, N-nitroso-Ndibutylamine and chloropicrin advanced to the PCCL but did not initially advance to the CCL based on the outcome of the classification models and their attribute scores. The drinking water monitoring data submitted by the commenter were the Krasner 2006 and Weinberg 2002 studies. EPA used the Krasner 2006 study, which is an intensive summary of the Weinberg 2002 data, as a supplemental data set as part of the CCL process. Reevaluation of the universe chemicals using the DBP ICR or Krasner occurrence data moved Bromochloroacetonitrile and Dichloroacetonitrile from the universe to the PCCL.3-Chloro-4-(bromochloromethyl)-5-hydroxy-2(5H)-furanone, BMX-1; 3-Chloro-4-(dibromomethyl)-5-hydroxy2(5H)-furanone, BMX-2; and 3-Bromo-4-(dibromomethyl)-5-hydroxy-2(5H)-furanone, BMX-3 will all now pass the screen to the PCCL based on their carcinogenicity probability. Reevaluation of the chemicals using 90th percentile water data for the HRL/water ratio, as opposed to the median, moved Bromochloromethane onto the Please see response to comment ID 19338 under comment code 7200. EPA has reviewed these summaries of published literature and has collected the cited data for use in the CCL 3 evaluations. The information collected and evaluated for individual contaminants is available in the CCL 3 docket in the Contaminant Information Sheets EPA reviewed the information provided by the commenter summarizing data from 38 data sets from wastewater treatment facilities. While the data provides information on the concentration of constituents in wastewater at different points in the treatment train, it does not provide the citation or reference the studies summarized. EPA also compiled extensive occurrence data using the protocols and data sources described in the Draft CCL 3 FR notice (73 FR 9628). The Agency considered the unregulated contaminants in the summary. The Agency uses the best available science and information to evaluate and list potential drinking water candidate contaminants. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment IDs 19600 under comment code 7200 and 19376 under comment code Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Based upon these and other data submitted by commenters, EPA concludes that the cyanotoxins included on

the draft CCL 3 are known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is including these compounds on the CCL 3. Additional information is available in the Contaminants Information Sheets included in the docket at www.regulations.gov.

EPA recognizes that primary public exposure to algal biotoxins can come from drinking water, recreational water, and dietary supplements. Secondary human exposure may come from algal biotoxin residue on fruits and vegetables from contaminated irrigation water and consumption of animal tissue. While EPA does not have statutory authority to regulate for dietary supplements or residues on foods for cyanotoxins, the Agency actively participates in the efforts to better protect public health from exposure to cyanotoxins in committees like Interagency International Symposium on Cyanobacterial Harmful Algal Blooms.

EPA also notes that under SDWA 1412 (b)(1)(B)(ii), the Agency makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National primary drinking water rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 Please see response to comment ID 19016 under comment code 3315. Please see the response to comment ID 19349 under comment code 3310. Please see response to comment ID 19016 under comment code 3315. EPA disagrees with the commenter. The toxicological data that were used in evaluating anatoxin-a for the CCL were derived from a peer reviewed publication. The occurrence data applies to ambient water concentrations from Lake Champlain in New York. This information for anatoxin, and the other cyanotoxins, is available in the docket at www.regulations.gov (Contaminant Information Sheets for the CCL 3). Based on this information EPA anticipates that cyanotoxins may occur in PWS and may require regulation. Therefore EPA has included Cyanotoxins on the CCL 3. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment IDs 19388 and 18961 under comment code 6166. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its EPA conducted literature reviews to identify LOAELs or NOAELs for pharmaceutical compounds and only used MRDDs when other data were not available. EPA treated MRDD values and applied uncertainty factors as described in the support documents available at www.regulations.gov (see Contaminants Candidate List 3 Chemicals: Classification o the PCCL to CCL, section 5). EPA is actively working with other agencies and stakeholders to collect and use the best available scientific data and information to evaluate active pharmaceutical ingredients. Please see the responses to comments under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA has included Bromomethane; 1,4-Dioxane; Chloromethane; Methyl Tert-butyl Ether; 1,1,1,2-

Tetrachloroethane; 1,1-Dichloroethane; and Perchlorate on the final CCL 3 because the Agency anticipates or knows these chemicals occur in PWSs and may require regulation. As part of the regulatory determination for CCL 3, EPA will decide whether to establish MCLs for these contaminants; whether or not to establish such MCLs has not yet been decided. The next steps for evaluating chemicals included on the CCL 3 are discussed in the Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA acknowledges and agrees with your comments. Please see response to comment ID 19378 under comment code 9100. EPA will review suggestions for revision of the CCL process when work on CCL4 begins. EPA has published several documents describing and outlining the selection process used for CCL 3. These documents are available online for public perusal at http://www.epa.gov/OGWDW/ccl/ccl3.html See the response to comment ID 19379 under comment code 7130 for more information. EPA also plans to conduct a comprehensive review of regulatory needs for DBPs at an appropriate time as part of the 6-year review process. EPA acknowledges the commenter's concern on developing research and information needed to evaluate contaminants in a timely manner. The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for contaminants on the final CCL 3. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs in three categories; health effects, occurrence, and analytical method. The data needs were characterized as no data needs, specific data needs, or substantial data needs. The summary identifies which contaminants have research efforts under way within the Agency. It also identifies those contaminants that need additional information to characterize the health effects, occurrence, and analytic methods. By identifying those contaminants that need additional research and information the Agency is communicating to stakeholders both research priorities and gaps for these contaminants. The health effects, occurrence, and analytical methods data/information used to select contaminants for the CCL 3 are featured in the supporting documentation and in the final CCL 3 contaminant information sheets in the docket. The Agency agrees that protecting sources of drinking water is an important part of providing safe drinking water to the public. Protecting drinking water sources usually requires the combined efforts of many partners such as public water systems, communities, resource managers and the public. The Agency continues to work with stakeholders from states, water and wastewater utilities, the agricultural community, and the chemical and manufacturing industries to evaluate potential contaminants and protect source waters. One example of the Agencys efforts to protect source waters is the Source Water Collaborative (SWC). The SWC includes twentythree national organizations in the water and wastewater industries.The SWC recognizes that resources are extremely limited and authorities are split among the actors who can actually protect source waters. EPA also develops makes available a variety of tools to aid community planners, public water supply operators, and members of local source water protection teams in developing source water assessments. The tools include Please see response to comment ID 19417 under comment code 2200.

### Please see the response to comment ID 19372 under comment code 6000. EPA acknowledges and appreciates

your commendation of our process. As part of the CCL 3 process, EPA worked with many stakeholders, including AWWA, and hopes to continue to develop these partnerships as we evaluate potential drinking water contaminants. EPA evaluated thousands of chemicals from different classes and sources, including 1,200 pharmaceuticals. EPA identified contaminants that have sufficient occurrence and health effects data and information to be evaluated in the CCL process. EPA also recognizes that analytical methods and health effects research will continue to evolve and will require the same scientific rigor the Agency has applied to contaminants on the CCL 3. EPA also notes the commenters recommendations for additional transparency. The Agency has updated the support documents, including the contaminant information sheets identified by the commenter, to improve the transparency and clarity of data used to support the decisions made in the development of the CCL 3. The EPA has reviewed the commenter's recommendations on the Summary of Nomination for the Third Contaminant Candidate List in the docket and made changes to clarify the decisions to list or not list the nominated contaminants in that document. Additional information on the status of nominated contaminants is provided in the list of contaminants considered in the CCL Universe. For those contaminants that passed from the universe to the PCCL the Contaminant Information Sheets provide all the data collected and considered by the Agency. Both of these supporting documents are in the docket and can be downloaded from www.regulations.gov. EPA agrees with the commenter that nominations and public input are a central component of the CCL. EPA will review and consider the commenters recommendations to seek nominations EPA recognizes that the amount of information and documents describing the newly developed process for the CCL 3 was greatly increased above that for past CCLs and thus may have required more time and effort for the public to review all the material. However, EPA believes that it is important to provide detailed information so that the process can be viewed as transparent and reproducible. EPA has endeavored to improve the transparency and availability of the support documents for the final CCL 3. The Agency also recognizes the valuable information provided by stakeholders who participated in the development of the CCL 3 process. The Agency will consider the commenter's recommendations to increase the availability and transparency of the information and decisions made on the contaminants consider for future CCLs to facilitate public participation EPAs Office of Ground Water and Drinking Water (OGWDW) and the Office of Water coordinate with the Office of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OGWDW is working with ORD to incorporate the results from these discussions in the next drinking water multi-year plan. The Contaminant Candidate List is the first step in identifying contaminants that may require regulation and contaminants that need additional data in order to determine the appropriate Agency action (development of health advisories, or regulations, or no action). The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for contaminants on the final CCL 3. EPA assessed the data and information gathered on the CCL 3 chemical contaminants and developed a summary of the types of data and information available to help identify needs for regulatory determination evaluations and included the summary in the Federal Register notice. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs

### The commenter identifies several concerns regarding the CCL 3 process many related to the lack of DBPs on CCL

3. A need for clarity regarding the relationship between the CCL and the six-year review of regulations was also expressed. The major database that introduced the DBPs into the CCL 3 Universe was the DSS-Tox database. This database provides qualitative characterization of the tumorigenic potential for a large number of DBPs based on QSAR projections and expert judgment. The data from the DSS-Tox data base are categorical and were screened based on the description of a chemicals probability to cause cancer. All chemicals with a high and high-medium probability for the cancer endpoint should have screened to the PCCL regardless of their monitoring data. There were three chemicals that should have passed to the PCCL because of their high-medium cancer probability, but did not; they are: 3-Chloro-4-(bromochloromethyl)-5-hydroxy-2(5H)-furanone, BMX-1; 3-Chloro-4- (dibromomethyl)-5-hydroxy-2(5H)-furanone, BMX-2; and 3-Bromo-4-(dibromomethyl)-5-hydroxy-2(5H)- furanone, BMX-3. They will be included on the PCCL. In response to public comments EPA reevaluated these chemicals relative to available occurrence information and found that the available data did not support their inclusion on CCL 3. Please see response to comment ID 19378 under comment code 9100. The Agency disagrees that the number of contaminants included on a CCL 3 should be commensurate with what can be supported by EPAs drinking water research budget.The Agency described a process to identify contaminants from a broad universe based on the best available science and information to evaluate the anticipated occurrence in PWS and adverse health effects a contaminant may pose from drinking water exposure.

EPA identified those contaminants that it knows or anticipates may occur in PWS and may require regulation. Implementing the program to identify potential contaminant provides the public and stakeholders with an opportunity to provide comment, additional data, and assist the Agency to prioritize research needs on the CCL. The Agency also collaborates and coordinates with other agencies and organizations to leverage resources to complete the research needed to evaluate drinking water contaminants.

The Agency has also described the linkages between the CCL and the UCMR in the FR notice and in the responses to comments under comment code 6900. Please see the response to comment ID 19372 under comment code 6000. EPA acknowledges that data gaps exist for CCL 3 contaminants and that research is needed to gather data for regulatory consideration. EPA sees value in communicating those needs and described the research status of health effects, occurrence, and analytical methods in the final CCL 3 Federal Register notice. The Agency believes that this table will help to identify future research needs. The Agency has identified which contaminants and the type of research currently being evaluated by the EPA so that other research organizations may engage in drinking water research, provide valuable participation, and, as a whole research community, better leverage resources. The Agency also notes that the table identifies those contaminants that require longer-term research and those that have shorter-term research needs. EPA looks forward to the results of AWWAs retrospective analysis of the arsenic and DBP Please see responses to comment IDs 19378 and 19380 under comment code 9100.

### Please see the response to comment IDs 19372 and 19381 under comment code 6000. EPA believes that the

supporting documentation in the docket sufficiently identifies the types of information the Agency needed to consider contaminants for the CCL 3. EPA identified the kinds of occurrence and health effects information and the criteria the Agency used to uniformly evaluate individual contaminants. EPA and other Agencies are actively developing additional occurrence and health effects data for many of the contaminants initially considered in the CCL process that were not included on the final CCL 3. While the Agency recognizes the complexity and breadth of evaluating data not only from EPA, but multiple Agencies, we disagree that a formal process or specific document identifying data gaps for the numerous contaminants in the universe would provide additional valuable information to set research priorities at this time. EPA continues to work both internally and with other Agencies, both federal and otherwise, to gather the best available science and information for CCL 3 and future The 1996 amendments to SDWA instituted the CCL and UCMR programs to prioritize and focus data collection and regulatory consideration on the potential drinking water contaminants that present the highest priorities for future drinking water regulation. The CCL is the primary mechanism for the identification of this priority list of contaminants that may require regulation, while UCMR provides EPA with the national occurrence data necessary to determine if a contaminant occurs with a frequency and at levels of public health concern. The statute itself provides a direct linkage between the two programs by requiring EPA to consider the UCMR data in establishing the CCL. (Section 1412(b)(1)(B)(i)(I) and 1445(g)(3)). As a result, these two programs support and inform each other. While EPA uses the CCL as a primary source to select contaminants that need additional occurrence data for monitoring through the UCMR, UCMR occurrence data also informs the CCL process by identifying contaminants that occur in drinking water. Data from the UCMR is used by EPA to determine whether a contaminant may be anticipated or known to occur in drinking water and may require regulation. Based on this and other analysis, contaminants can be added to the CCL. Because the two programs operate Please see response to comment ID 19373 under comment code 1000. EPA agrees with the commenter and is also working to improve water quality standards and protect source water from animal feeding and production operations and other non-point sources of pollution. The Agency is working on protecting source waters form the potential sources identified by the commenter under the Water Standards Program, developing and improving Concentrated Animal Feeding Operations regulations, and storm water regulations. EPA notes that AWWA staff and members participated in many of the efforts conducted by the Agency to develop the CCL 3. The Agency also acknowledges AWWAs conclusion about the need for more robust analytic methods and occurrence data to better inform the CCL process on which chemicals can be anticipated to occur in a PWS. In accordance with the NDWAC report and recommendations the Agency anticipates that additional information and improvements may be made to future CCLs using an adaptive management approach. Information from AWWAs efforts and the proposed publications will assist the Agency to identify potential EPA agrees with the commenter's suggestion that it is appropriate to not include treatability considerations in the CCL 3 criteria for chemicals. As described in the FR notice (73 FR 9628), EPA only used release or production data as a surrogate measure for occurrence data when detected occurrence data were not available. EPA recognizes that environmental fate and transport data are also important factors for the Agency to consider. EPA used a suite of environmental fate parameters for those contaminants to evaluate contaminants that used production information as a surrogate measure for measured occurrence and did not solely rely on a single parameter such as the octanol-water coefficient as cited by the commenter. The protocol the Agency used is summarized in the FR notice for the draft CCL 3 (73 FR 9628) and described in detail in the support documents available in the docket (Contaminant Candidate List 3 Chemicals: Classification of the PCCL to CCLat www.regulations.gov EPA-HQ-OW-2007-1189). EPA also notes that chemicals with only production data as a surrogate for occurrence were not included on the Please see response to comment ID 19417 under comment code 2200.

### In addition to the Expert Panel summary referred to by the commenter, EPA put into the docket support

documents describing the selection criteria as well as all the data sources for every score and every decision. Please see responses to comment ID 19413 under comment code 2280 and comment ID 19390 under comment code 6760 for information.

EPA requested input from the Expert panels on the on the CCL selection process and the documents supporting th draft scores. EPA convened the panels to provide input on the CCL 3 selection process and data prior to EPAs final selection actions.

EPA does not request nor seek comment on the EPA personnel assigned to develop the documents supporting the process nor the external experts chosen for the panels. EPA does provide the names of external experts in panel summary documents.

The final of the three expert panels (March 2007) is the most relevant to the draft CCL 3 because of the iterative nature of the development of the CCL 3 process. All three expert panels (2005, 2006 and 2007) were general discussions providing input on the designing the CCL 3 selection process and as EPAs development progressed, some of the recommendations became moot. None of the expert panels were intended to provide final analysis or final selections of pathogens for the CCL 3. If EPA uses the same selection process for pathogens for the CCL 4 No response necessary for this description of the comment. Please see comment ID 19413 under comment code 2280 and comment ID 19390 under comment code 6760 for a response to this comment.

EPA did not intend for the external panel reviews to be a post-scoring consensus vote or reality/confirmation check.Rather, the panels were convened to provide input on the CCL 3 selection process and data prior to EPAs final selection of the Draft CCL 3.

The criteria for listing in the CCL 3 are occurrence and risk. The evaluation of treatment is not part of the CCL 3 process. As discussed in the Draft CCL 3, page 9649, the Regulatory Determination phase will address treatment issues. All materials used in the identification, evaluation, and selection process for the CCL 3 are publicly available in the docket for this notice. EPA relied on peer reviewed papers or academic manuals for all of the scores. A few non-peer reviewed articles were included for informational purposes, however they did not support a score. For more detailed information on the identification, evaluation and selection process for the CCL 3, please refer to the available supporting documents (listed below) and the final CCL 3 FRN.

Candidate Contaminant List Microbes: Identifying the Universe (EPA 815-R-08-005)

Contaminant Candidate List 3 Microbes: Screening to the PCCL (EPA 815-R-08-006)

Candidate Contaminant List 3 Microbes: PCCL to CCL Process (EPA 815-R-08-007)

Final Candidate Contaminant List 3 Microbes: PCCL to CCL Process

### EPA chose to list pathogens at the species level rather than by genus because EPA does not foresee regulation of

an entire genus. Regulation is usually dependent on the availability of method(s) which are usually species specific. Thus, EPA has decided to list organisms at a level that could be considered for regulation. However, EPA did consider additional species within a genus by grouping them during the screening step of the listing process. Criterion 11 and 12, used for screening microbes from the Universe to the PCCL, state particular cases where the Agency decided to use both the genus and specie(s) or serotype to represent a group of pathogens sharing essential biological properties in common with the group, for example, Legionella pneumophila, represents several other Legionella species. See the supporting document Contaminant Candidate List 3 Microbes: Screening to the PCCLfor more detailed information.

EPA recognizes that the pathogenic E. coli includes enterohemorrhagic serotypes other than E. coli O157:H7 as well as enterotoxigenic, enteroaggregative and other forms that can cause clinical disease. Severe clinical manifestations of enterohermorrhagic serotypes results in a form of kidney failure known as hemolytic uremic syndrome (HUS) which can be fatal in children and the elderly. Organ failure is a result of the accumulation of toxins that are produced only by E. coli with certain genes (e.g. stx gene). Another CCL organism, Shigella, has the same key genes as the enterohemorrhagic E. coli serotype, and produces the same toxins and causes similar clinical disease, including HUS. EPA does not believe that it is necessary to list all species, serotypes and genotypes that comprise a pathogenic microorganism. Rather, EPA believes that it is sufficient to list one organism, such as E. coli O157:H7 that represents a group of similar organisms, genera, serotypes or genotypes. As an example of this procedure, EPA lists calicicvirus to represent the noroviruses and sapoviruses. In this case, Due to the dynamic nature of microbial research and taxonomy, it is difficult to have an up-to- date list of microbial pathogens at all times. As discussed and noted in the support documents Candidate Contaminant List Microbes: Identifying the Universe and Contaminant Candidate List 3 Microbes: Screening to the PCCL (both are in the docket to the draft CCL 3), EPA made several decisions to group similar organisms, genera, serotypes or genotypes. As an example of this procedure, EPA lists calicicvirus to represent the noroviruses and sapoviruses. EPA does not believe that grouping Arcobacter with Camplyobacter is appropriate at this time due to ongoing research and academic debate. Of note is that neither the CDC WBDO database nor the academic references from which the health effects scores were taken group Arcobacter with Campylobacter. ***Cadmus to copy the umbrella response to here.*** Please see response to Comment ID 19400 under comment code 6363 for this summary of earlier comments. EPA recognizes the limitations associated with molecular detection methods and scored them lower than the CDC WBDOs (CDC relies on culture methods where available). If, however, there is no CDC data or no culture method (e.g., Norovirus) EPA used occurrence data based on molecular methods because it implies that pathogens are present in water and that they may be capable of causing illness in persons exposed to water by ingestion, inhalation, or dermal contact.

EPA does not distinguish between occurrence data based on molecular versus culture method. Rather EPA elevated CDC WBDO data above other occurrence data because of the epidemiological investigation supporting the monitoring results. CDC WBDO data that was based on a molecular detection method and linked to illnesses and the drinking water (e.g., Norovirus) is scored higher than data based solely on occurrence in drinking water. EPAs occurrence attribute is not meant to characterize the extent to which a pathogen poses a public health threat from drinking water exposure. Because viability and infectivity cannot be determined by non-cultural

### As the commenters approach suggests EPAs approach also used the most common clinical presentation for

the specific pathogen for the population category under consideration. Because it is recognized that pathogens may produce a range of illness from asymptomatic infection to fulminate illness progressing rapidly to death, scoring decisions are based upon the more common clinical presentation and clinical course for the population under consideration, rather than the extremes.

Consistent with the recommendation by the 2007 experts workshop EPA based its health effects scores on clinical microbiology manuals. EPA went first to The Manual of Clinical Microbiology, 9th. Edition (Murray, P., E. Baron, J. Jorgensen, M. Landry, and M. Pfaller) for information to provide a health score. The authors are medical clinicians. This manual was specifically recommended by members of the 2007 expert panel. If this clinical manual did not have the information needed to score the health effects for a pathogen, EPA moved on to other clinical manuals as described in detail in the support document, Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA believes this approach to be transparent as well as easily traceable/reproducible.

No response necessary for this summary. EPA relied on CDC reported outbreaks and peer reviewed literature when evaluating and scoring for WBDOs. The occurrence score for Naegleria fowleri, supported by Gerba et al., 2007 resulted in a score of 3 while the score for WBDOs was a 4. However, EPA selects the higher score between WBDO and Occurrence, therefore, the CDC WBDO score was selected and thus the occurrence score (based on Gerba et al., 2007) simply provides additional information and does not impact the final CCL overall score for the organism. EPA agrees that US outbreaks with epidemiological data linking the illness to drinking water is the most valuable information. That is why CDC WBDOs are given higher scores than occurrence research data. CDC only lists an incident as a WBDO if it is in the US (a developed country) and there is epidemiological evidence linking the illnesses to drinking water (i.e., not just serological data). Only when there is no CDC WBDO, does the CCL 3 microbial protocol use the lower-valued occurrence data. Some pathogens have very little occurrence information, EPA felt that it was better to include the information rather than to exclude it. EPA is unaware of any outbreak data from CDC based solely on serological data.

EPAs WBDO scoring protocol lowest possible score is 1 because of the potential for water-related illness to occur in the absence of recognized outbreaks. Furthermore, the use of 1 vs. 0 as the lowest scores of the protocol does not impact the end result of prioritizing the PCCL organisms.

EPA agrees with the commenter that there are differences in water quality between developed and developing countries (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL).

Selection of the higher score from the WBDO or occurrence protocol elevates pathogens that have been detected in drinking water or source water in the U.S. (occurrence score of 2 or 3) above pathogens that have

### Please see the response to comment ID 19261 under comment code 6300 for information on scientific papers

and comment ID 19400 under comment code 6363 for information on recreational water WBDO.

Most public water systems are ground water systems and ground water systems are not required to treat or disinfect. Certain pathogens may be well controlled by drinking water treatment (primarily disinfection). As discussed in detail in the draft CCL 3 (see page 9648), EPA did not preclude pathogens from CCL 3 based on their potential to be controlled by existing treatment technique regulations. As discussed in the preamble to the Draft CCL 3, (see page 9629) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL 3 selection process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3.

EPAs scoring protocol also used the most common clinical presentation for the specific pathogen for the population category under consideration. Because it is recognized that pathogens may produce a range of illness from asymptomatic infection to death, scoring decisions are based upon the more common clinical presentation and clinical course for the population under consideration, rather than the extremes (73 CFR 9646).

EPA used peer reviewed recently published clinical microbiology manuals as the primary data source to identify the most common clinical presentation which can be easily found and used to replicate the process. In contrast, the commenters approach seems to have relied on an expert consensus-based health effect scoring process which may not be consistently reproducible and is lacking in transparency. The commenter did not provide citations to allow for a reproducible process thus EPA is not able to comment on their health effects scoring process. The commenters approach also used criteria/sub-criteria (e.g. infectious dose (ID), secondary spread) EPA scored pathogens using the WBDO and occurrence protocols, and then selected the highest score between the two of them, to prevent double-counting. Selection of the higher score from the WBDO or occurrence protocol elevates pathogens that have been detected in drinking water or source water in the U.S. (occurrence score of 2 or 3) above pathogens that have caused WBDOs in other countries but not in the U.S. (WBDO score of 2).

The Final CCL 3 selection process considered pathogens causing recent waterborne outbreaks more important than pathogens detected in drinking water without documented disease from that exposure. As the commenter pointed out, EPA considered that occurrence of pathogens indicates the potential for waterborne transmission of disease. Documented waterborne disease outbreaks provide an additional weight of evidence that illness was transmitted and that there was a waterborne route of exposure. EPA also developed protocols to define a hierarchy of the relevance that each of these types of data provide in evaluating microbes for the CCL. Combining these two sources of occurrence information (molecular and culture methods) enabled EPA to Please see Comment ID: 18881 under comment code 2210 for the response to the comment on treatment; please see comment ID 19390 under comment code 6760. No response necessary to this summary of EPA information. No response necessary to this summary of EPA information. No response necessary for this summary. Please see response to comment ID 19412 under comment code 2260.

### Please see response to comment ID 19412 under comment code 2260.

EPA recognizes that enteroviruses are common human viruses associated with a variety of mild to severe clinical illnesses. EPA also recognizes that enterovirus is a cause of waterborne disease, and that outbreaks are uncommon, perhaps because of laboratory assay complexities which makes it exceedingly difficult to identify enterovirus in water samples except at highly specialized laboratories. EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the information presented in the scoring support document in the draft CCL 3 docket and as discussed in the draft CCL 3 Federal Register Notice. Enterovirus was not treated any differently in this process. Rather EPA excluded the enteroviruses from the draft CCL 3 because the enterovirus occurrence score was moderate and the overall score slightly below the draft CCL 3 pathogens. However, enterovirus was added to the final CCL 3 based on Please see response to comment ID 19412 under comment code 2260. EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the information presented in the scoring support document in the draft CCL 3 docket and as discussed in the draft CCL 3 Federal Register Notice.

EPA recognizes that rotavirus is a common childhood virus. The virus is common because it is highly infectious and easily transmitted among children in schools and day care centers by person to person transmission. EPA also recognizes that there is a significant but unknown component of waterborne rotaviral disease transmission among children and adults can also become ill due to waning immunity or exposure to new rotavirus types. Rotavirus remains on the PCCL but not on the final CCL 3 because of its health effects score - in both children and adults it is almost always mild and self-limiting. Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: enteroviruses, adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba EPA has kept Helicobactor pylori on the final CCL 3. Consistent with all pathogens evaluated for CCL 3, EPA did not consider the culturability (i.e., availability of a method), or route of transmission as a selection criterion for the CCL 3 pathogen list.

EPA scored every pathogen on its most severe health effect that is also commonly manifested. H. pylori does differ from the other CCL 3 pathogens in that the health effect score is based on a chronic effect (cancer), rather than its less severe acute effect. However, the use of the chronic health effect is discussed in the draft CCL 3 (see page 9653) as well as in the support document on microbial scoring. EPA chose gastric cancer rather than gastric ulcers because it is a common manifestation of disease from H. pylori (6,500 deaths per year, CDC see the Final Contaminant Candidate List 3: Microbial Scoring Support document for details).

EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the

### EPA disagrees with the comment. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3

included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Neither treatability nor rareness/frequency of disease were criteria considered for CCL 3 inclusion. EPA acknowledges the occurrence of N. fowleri in soils and recreational waters, however, this situation does not negate the severe health effects associated with N. fowleri, its occurrence in drinking water in the US (Gerba et al., 2007) and the fact that it has also been the cause of at least one WBDO as documented by CDC (CDC MMWR 2001 2002). EPA acknowledges the reference provided by the commenter regarding the 2007 Expert Panel recommendations on adding a frequency of disease parameter to the health effects scoring protocol for future CCLs to balance the consideration of more prevalent illnesses with the more severe but less prevalent responses, such as N. fowleri. EPA will take this comment into consideration for future CCLs. EPA does not agree with the comment that inclusion of Salmonella and Shigella on the CCL violates SDWA statutory requirements. They meet the criteria EPA has established for determining the CCL 3. Therefore, they will remain on the CCL 3 for the reasons stated below.

They pose high health risk, occur in drinking water and have caused WBDOs since 1990. Neither Salmonella nor Shigella are specifically regulated under the SDWA. Treatability is not a criterion for listing under the CCL 3. Ground water systems make up the greatest portion of public water systems and they are not required to treat under EPAs drinking water regulations and most of them do not treat

EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the scoring criteria considered for CCL 3 inclusion.

Please see response to comment ID 19412 under comment code 2260. EPA did not use the alternative approach proposed by the commenter because we could not evaluate the approach due to insufficient information on how the decisions were/could be made and a lack of citations for the source of the information used to score the pathogens. For example, it is unclear how a criterion is scored if that data is not available (infectious dose is not available for most pathogens). Another example would be in calculating the outbreak score -- were the cases of illness added for all outbreaks or were they averaged? There is no information given by the commenter on the source of scores for sequellae and secondary spread. Even if all the background information was available, EPA would hesitate to use a criterion for scoring pathogens (e.g., infectious dose) that is not available for every pathogen. EPA also avoided using professional judgment as part of a scoring process because it is difficult, if not impossible to describe for public comment and to reproduce in subsequent scoring exercises. EPA will consider AWWAs alternative approach as we develop the CCL 4 selection process. EPA disagrees with the commenter on adding rotavirus to the CCL 3 because of rotaviruses low score, specifically Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the response to comment ID 19068 under comment code 4450. EPA monitored perchlorate under the first Unregulated Contaminant Monitoring Rule (UCMR 1) from 2001-2005. The evaluation of perchlorate occurrence under UCMR 1 was published in the May 1, 2007 Federal Register (72 FR 83). Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment IDs 18977 and 19373 under comment code 1000.

### Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter

Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its EPA agrees that scientific, technical, and stakeholder involvement the Agency conducted in developing the CCL 3 has improved the process. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19338 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19338 under comment code 7200. EPA looks forward to considering this new information once it becomes available. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA looks forward to considering this new information once it becomes available. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The Agency is currently monitoring PWS for PBDEs under the UCMR 2. More information on the UCMR can be found on the EPAs safewater website at wwwepa.gov/safewater/ucmr. The Agency will use these occurrence data to inform decisions on future CCLs. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its EPA looks forward to considering this new information once it becomes available. The Agency has responded to the specific comments submitted by DNREC under the respective comment codes: 7100 Chemicals not on CCL 3 (comment ID 19444 and 19447), 7170 PBDEs flame retardants (and related PBBs) (comment ID 19442), and 7200 pharmaceuticals and personal care products (not on CCL3) (comment ID 19570). Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements No response needed. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19338 under code 7200. See response to comment ID 19198 under comment code 7150. Please see responses to comment IDs 19338, 17297, and 17299 under comment code 7200. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its

### EPA agrees that scientific, technical, and stakeholder involvement the Agency conducted in developing the CCL 3

has improved the process. Please see the response to comment ID 19384 under comment code 6900 on the inter-relationship between CCL and UCMR efforts. Please see response to comment ID 19065 under comment code 9100. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements This comment also appears under topic code 7200 - Pharmaceuticals and Personal Care Products (not on CCL3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see response to comment ID 19338 under comment code 7200. This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements EPA acknowledges the commenters request to add dimethanamid and its ESA and OA metabolites to the CCL 3. Dimethanamid was among over 6,000 contaminants considered for inclusion on the CCL. However, dimethenamid did not pass the screen to move on to the PCCL. The release data from the National Center for Food and Agricultural Policy and available health effects data did not meet the criteria for dimethenamid to be considered for the PCCL. EPA has not received any additional data on the occurrrence or health effects for dimethenamid. Therefore the Agency is not including dimethenamid of the CCL 3. Please see response to comment ID 19338 under comment code 7200 for more discussion of the evaluation of pharmaceutical compounds. EPA agrees that expert review was an important component of the CCL 3 process. EPA disagrees with the commenter that EPA has not made the models publicly available. The Agency describes the models and EPAs efforts to develop and use the models for the draft CCL 3 in the supporting documentation in Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL. This document is available at www.regulations.gov, document ID EPA-HQ-OW-2007-1189-0067. It provides a detailed discussion of the assumptions and data used to develop, train and use the models to evaluate contaminants for inclusion on the CCL. EPA specifically chose models that are publicly available at no cost so interested commenters could retrieve the models for evaluation. In addition to the description of EPAs steps, the Agency provided appendices that describe attribute scoring protocols, the hierarchy of data used in those protocols, and contaminants used to develop the scoring protocols. Appendix D provides the Web site that each model considered by the Agency is available for downloading. Appendix E provides the rules or solutions for each Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 19501 under comment code 6160. Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. Please see response to comment ID 19501 under comment code 6160. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840.

### Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter

Background and Introductory Statements Please see response to comment ID 18928 under comment code 3555. The commenter notes that there were limited occurrence data available for ethylene oxide. However, EPA disagrees with the commenter that the Agency made an erroneous conclusion that ethylene oxide might occur in drinking water. The Agency provided detailed support documents that discuss the CCL 3 process and the data and information used to evaluate contaminants for the CCL 3 that are available in the docket.

In developing the CCL 3, the Agency sought input from the National Academy of SciencesNational Research Council (NRC), the National Drinking Water Advisory Council (NDWAC), and the Science Advisory Board on how to improve the CCL process. Each of these panels recommends that EPA should identify and retrieve data from sources that have information about occurrence of contaminants in drinking water or source water including sources that have a link (pathway) to drinking water. The Toxics Release Inventory (TRI) was specifically included as a data source that could be reviewed as one of the sources that have a link (pathway) to drinking water.

EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to occur in drinking water (as described in the FR notice for the draft CCL 3). For ethylene oxide there was no occurrence information in finished or ambient water. So to be consistent with the CCL 3 protocol, EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute and the number of States reporting releases (total) of EO for the prevalence attribute. These attributes taken The commenter correctly notes that EPA used TRI surface water release greater than 400,000 pounds for CCL 1 to anticipate occurrence. However, in developing the draft CCL 3, the Agency implemented a different approach from that used for CCL 1 and CCL 2. This new approach builds on evaluations used for previous CCLs and was based on substantial expert input and recommendations from different groups including stakeholders, the National Research Council (NRC) and the National Drinking Water Advisory Council (NDWAC).

EPA disagrees with the commenter that the Agency erred in using a contaminants potential to occur in drinking water based on Total TRI releases rather than solely on surface water releases. EPA believes that it is appropriate to use total environmental release data rather than the total quantity released to surface water to evaluate the potential of a contaminant to occur in drinking water, as the use of total environmental release data accounts for any releases to groundwater, air, and any mobility the chemical may exhibit. Please see the response to comment ID 18929 under comment code 3560 for a more detailed discussion on the Agencys evaluation

### EPA disagrees with the commenter that EPA Should Define EO's Potential to Occur in Drinking Water Based on

Surface Water Release Data, Which Are the Most Relevant Data for Characterizing Potential Drinking Water Occurrence.

In developing the draft CCL 3, EPA conducted a sensitivity analysis evaluating options using physical and chemical properties combined with environmental fate parameters to consider chemicals. These analyses are described in the support documents available in the docket and are the basis for the screening and attribute scoring protocols (Contaminant Candidate List 3 Chemicals: Screening to a PCCL, EPA 815-R-08-003 and Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL, EPA 815-R-08-004).

The commenter also suggested that EPA consider ethylene oxide and its physical properties. EPA evaluated ethylene oxides using physical and chemical properties combined with environmental fate parameters for the magnitude attribute score instead of using total environmental release data. For this analysis, EPA followed the CCL 3 protocol for those chemicals with only production data and used the persistence and mobility protocols as the basis for the magnitude attribute scoring as described in the FR notice and support documents. The model results for ethylene oxide using the environmental parameter protocols were the same as the results developed Please see the response to comment IDs 18851, 18861, and 18865 under comment code 2630. EPA disagrees with the commenter that it treated chemicals known to occur in water the same as those with no evidence of occurrence in water. EPA described categories of occurrence data and how the Agency developed a hierarchical scale to select the best available occurrence data to evaluate contaminants and identify which contaminants the Agency anticipates or knows occur in PWSs and may require regulation. EPA summarizes the screening and classification protocols for different types of occurrence data in the FR notice for the Draft CCL 3 (73 FR 9628) and in the support documents available at www.regulations.gov (Contaminant Candidate List 3 Chemicals: Screening to a PCCL and Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL, respectively). These documents also describe the NDWAC deliberations and EPAs decision to use a hierarchical approach to select the best available occurrence data. Please see the response to comment ID 18865 under comment code 2630 butadiene occurrence for a detailed discussion on the use of total TRI data for Please see response to comment ID 18939 under comment code 2100. Please see the response to comment ID 19068 under comment code 4450. See the response to comment IDs 18897 and 18899 under comment code 2595. Based upon these and other data EPA concludes that 1,2,3- trichloropropane is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3. Please see response to comment ID 19138 under comment code 4515. Please see the response to comment ID 19136 and 19139 under comment code 4510. See response to comment ID 19211 under comment code 4510. Please see response to comment IDs 19137 under comment code 7180 and 19138 under comment code 4515. Please see the response to comment ID 19211 under comment code 4510. Please see response to comment ID 19338 under comment code 7200.

### Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne

disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: enteroviruses, adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba histolytica. EPA disagrees with the commenter on removing Helicobacter pylori. H. pylori has a total score of 8.0 (out of a possible 10) and is well above the cut off of 6.1, therefore, this pathogen remains on the CCL 3. EPA also disagrees with the commenter on adding rotavirus to the CCL 3. Rotavirus scored 5.5 due to no CDC WBDO and relatively low health effects (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process for more information on all the scores). Furthermore, EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health effects and occurrence information as recommended by the EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the scoring criteria considered for CCL 3 inclusion. Criteria described by the commenter do not apply to the CCL 3 Selection process. They apply to the regulatory determination process. As discussed in the preamble to the Draft CCL 3, (see page 9962) a Regulatory Determination requires more information and analyses than the analyses used to support the CCL 3 selection process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3. Please see response to comment ID 19412 under comment The commenter reports that EPA used the oral slope factor of 0.31 per mg/kg/day currently available from the California Office of Environmental Human Health Agency (OEHHA) Toxicity Criteria Database in scoring for potency for ethylene oxide. However, the commenter questions the above slope factor in light of the recent assessment from the Office of Pollution Prevention and Toxic Substance and the Office of Research Development (ORD). The commenter makes a point that EPA should use the new unit risk numbers that have been derived by ORD for the lung tumors observed in male mice and brain tumors observed in male rats, after correcting these numbers to a slope factor that is appropriate for an oral route of administration. For the draft CCL 3, EPA followed the CCL 3 protocol in the scoring for the health effects for ethylene oxide. Ethylene oxide received a score of 6 for potency and 8 for severity. The commenter is correct that EPA used the oral slope factor of 0.31 per mg/kg/day based on rat mononuclear cell leukemia (MCL) available from OEHHA Toxicity EPA disagrees with the commenters opinion that ethylene glycol should be categorized as toxicity category 5 rather than toxicity category 4 and removed from further consideration. EPA developed the screening protocol and toxicity categories to create a framework that was versatile and as simple as possible to identify chemicals with categorical or limited data for further evaluation. In using the most conservative toxicological value in the screening step the Agency believes that public health is protected and additional resources can then be applied to evaluate compounds that passed the screening framework to determine the best available scientific information for that compound. As the commenter notes, for ethylene glycol, the World Health Organization (WHO) TDI was used for the screening as indicated in the protocol described in Contaminants Candidate List 3 Chemicals: Screening to PCCL. That value falls in toxicity category 4. It is also correct that EPA used the IRIS RfD as the toxicological value to to assign the potency and severity scores used in evaluating the PCCL. This too is The commenter is correct in noting that a severity score of 6 indicates significant, irreversible, nonlethal conditions or disordersfor some organs. However, the severity score for methanol was not based on alterations to serum enzymes or liver, but is based on the health effect of decrease in brain weight. Appendix A of the PCCL to CCL Process Report contains a Compendium of Critical Effects Table that lists a severity score of 6 for significant decreases in brain weight, separate from scores given to other organs and the irreversible effects. Therefore, the severity score for methanol was correctly applied. Based upon these data, EPA concludes that methanol is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is

### In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine

whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to occur in drinking water (as described in 73 FR 9628, the FR notice for the draft CCL 3). For methanol, there was no occurrence information in finished or ambient water, so to be consistent with the CCL 3 protocol, EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. EPA disagrees with the commenter that consideration for listing [methanol] is likely not based on these health effects attributes, but simply because methanol scores highly on the occurrence attributes." The attributes for occurrence and adverse health effects taken together were used to evaluate the potential of methanol to occur Please see the response to comment IDs 18851 and 18861 under comment code 2630. Please see response to comment ID 19145 under comment code 4010 Molybdenum occurrence.

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and ***Cadmus: Please move response from "response to comment code 3560" section to this comment ID*** Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. EPA agrees that there are long term sequelae associated with Legionella and consequently scored Legionella very high on health effects (including long term sequelae) as well as the overall score. Therefore, Legionella Please see the response to comment ID 19136 and 19139 under comment code 4510.

Please see response to comment ID 19338 under comment code 7200. No response necessary. See the response to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care Products (not on CCL3)).

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200. Please see the response to comment ID 19109 under comment code 6100.

### The data that were used to score the occurrence attributes for vanadium (see the response to comment 19079

under comment code 5025) were the number of states where it had been detected in the NIRS survey and the concentrations detected. Persistence did not play any direct role in vanadiums selection for the CCL, although the fate data are described in the contaminants information sheet for vanadium in the CCL 3 docket (Contaminant Candidate List (CCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 19501 under comment code 6160. Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence. Please see the response to comment IDs 19136 and 19139 under comment code 4510 for PFOA. Please see the response to comment IDs 19333 and 19067 under comment code 4460 perchlorate occurrence and the response to comment ID 19068 under comment code 4450 perchlorate. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. The commenter also provided newspaper articles and summaries of the scientific literature on the occurrence and adverse health effects associated with pharmaceuticals. The Agency provided a detailed summary of the types of data and information it used to evaluate contaminants for the CCL 3. The support documents describe the process for selecting the data to support the inclusion or omission of contaminants from the list and the data used for individual contaminants is also available in the docket at www.regulations.gov. The commenter also described a process the Agency could use to evaluate pharmaceuticals. The commenter provided a detailed discussion of cost-benefit analysis the Agency could undertake to support including pharmaceuticals on the CCL. As noted by the commenter, cost-benefit analysis is required under SDWA when proposing NPDWRs, but is not required when preparing a CCL. The EPA did not evaluate and did not exclude pharmaceuticals from the CCL 3 on the basis of cost-benefit analyses. The process described in the Draft FR notice and used to develop the Final CCL 3 evaluated whether or not the contaminants may occur in PWS and Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. EPA disagrees with the commenter that EPA has not made the models publicly available. The Agency describes the models and EPAs efforts to develop and use the models for the draft CCL 3 in the supporting documentation in Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL. This document is available at www.regulations.gov, document ID EPA-HQ-OW-2007-1189-0067. It provides a detailed discussion of the assumptions and data used to develop, train and use the models to evaluate contaminants for inclusion on the CCL. EPA specifically chose models that are publicly available at no cost so interested commenters could retrieve the models for evaluation. In addition to the description of EPAs steps, the Agency provided appendices that describe attribute scoring protocols, the hierarchy of data used in those protocols, and contaminants used to develop the scoring protocols. Appendix D provides the Web site that each model considered by the Agency is available for downloading. Appendix E provides the rules or solutions for each Please see responses to comment IDs 19338 and 17297 under comment code 7200.

### PFOA has been included on the final CCL 3. PFOS was not included on the draft CCL 3, but has been included on

the final CCL 3. EPA evaluated PFOS in the CCL 3 process, and as cited in the Drinking Water Contaminant Candidate List 3-Draft Federal Register Notice PFOS was not included on the draft CCL 3 based on the limited occurrence data, combined with the phase out of production of PFOS in the U.S. between 2000 and 2002. EPAs decision to list PFOS on the final CCL 3 is based on information from a 2007 Significant New Use Rule (SNUR) that shows there are ongoing uses of PFOS that could lead to its potential to occur in water. In the SNUR (Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235)), EPA granted an exemption, for reporting to TSCA, for the use of tetraethylammonium perfluorooctanesulfonate for specified industrial uses (particularly metal plating). This perfluorinated compound is of concern to EPA because PFOS is the anionic portion of this chemical. PFOS is also appearing in Minnesota wastewater treatment plant influent, effluent, and sludge associated with its use in the fume/mist suppressant in metal finishing and plating baths (Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235))). A major factor in EPAs decision to not include PFOS on the draft CCL 3 was the phase out of production of PFOS. Please see response to comment ID 19136 under comment code 4510 for a more detailed discussion on the listing of PFOS. EPA concludes that PFOA and PFOS are known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including these compounds on the CCL 3. Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a National Primary Drinking Water Rule. The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 including any updates to the health effects or occurrence information to determine if the information is sufficient for the Agency to make a regulatory Please see responses to comment ID 19501 under comment code 6160. Ethylene oxide has been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the ACC on ethylene oxide under the respective comment codes: 3585 ethylene oxide health (comment ID 18925) and 3590 ethylene oxide occurrence (comment IDs 19521 and 19523). Please see the response to comment ID 19265 under comment code 3580. Please see response to comment ID 19501 under comment code 6160. The ITER database, which was the source of the value used by EPA in the PCCL to the CCL process is a database that only includes peer reviewed assessments. In the case of N-methyl-2-pyrrolidone, the data came from the peer-reviewed Concise International Chemical Assessment Document from the World Health Organization. The draft SIDS report provided by the commenter was not in the Data compilation that comprised the working Universe nor were SIDS reports for any other chemicals. However, even if the report had been included in the universe, a completed health risk assessment such the CICAD that was used ranked higher in the data hierarchy than a compilation of available data as reported in a SIDS report and final documents are used rather than draft EPA acknowledges your comments about public participation in the listing process. However, EPA respectfully disagrees with your comments that an additional public comment period be included in the selection process. EPA sought public involvement in the CCL 3 process by receiving input at a public stakeholder meeting in September 2004 and as part of the public nominations process in May 2006. Both opportunities were announced and published in the Federal Register. EPA also sought public comment on the draft CCL 3 following its publication in February 2008. We believe that EPA has provided ample opportunity for the public to provide Please see responses to Comment IDs 19338 and 19573 under comment code 7200.

This comment also appears under topic code 4450 - Perchlorate. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety. See response to comment ID 19211 under comment code 4510. Please see response to comment IDs 19137 under comment code 7180 and 19138 under comment code 4515. Please see the response to comment ID 19211 under comment code 4510.

### Please see response to comment ID 19338 under comment code 7200. EPA concluded that nine hormones (17

alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, mestranol, and norethindrone) should be included on the CCL 3 because these contaminants are known or anticipated to occur in public water systems and may require regulation. The specific data used to evaluate these contaminants can be found in the supporting documents and CCL Contaminant Information Sheets in the docket at The CCL process was developed to identify known or potential drinking water contaminants of possible health concern. The process followed protocols that utilized health effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for thedata used at each step of the process and were applied uniformly for all chemical contaminants, including Nmethyl-2-pyrrolidone. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL.] N-methyl-2-pyrrolidone was selected for the draft CCL 3 based on these uniformly applied processes. N-methyl-2-pyrrolidone was screened as Toxicity Category 4 following the protocol requirements for screening. That protocol places a chemical in the highest toxicity category assigned to a toxicity value in the universe for a given chemical. Scoring of toxicity for the PCCL to CCL process was done using the World Health Organizations (WHO's) Tolerable Daily Intake value as included in the ITER database. The WHO assessment has Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. See response to comment ID 19136, 19139, and 19211 under comment code 4510. Please see the response to comment ID 19211 under comment code 4510 and the response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200. The Agency evaluates water quality under Section 304(a)(1) of the Clean Water Act and develops criteria for water quality that accurately reflects the latest and best available scientific knowledge. These criteria are based solely on data and scientific judgments on pollutant concentrations and environmental or human health effects. Section 304(a) also provides guidance to states and tribes in adopting water quality standards. Criteria are developed for the protection of aquatic life as well as for human health. More information on water quality criteria are available at: http://epa.gov/waterscience/criteria/. For more information on the Agency's efforts to evaluate PPCPs please Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 18928 under comment code 3555.

Please see responses to comment IDs 19338 and 19573 under comment code 7200. Please see the responses to comment ID 19136 and 19139 under comment code 4510 for a more detailed discussion on the listing of PFOA and PFOS. PFBA was not included on the final CCL 3. PFBA was included in the CCL 3 Universe. However the Agency only had limited data on PFBA and other PFC potential occurrence in public water systems and environmental releases. Based upon these data EPA concludes that PFBA does not meet the critieria for the CCL at this time. Therefore EPA is not including this compound on the CCL 3. Please see the response to comment ID 19384 in comment code 6900 (The interrelation between CCL and UCMR for specific See response to comment ID 19211 in comment code 4510 PFOA. Please see responses to comment IDs 19338 and 19573 under comment code 7200. Please see responses to comment IDs 19338 and 19573 under comment code 7200. Please see the response to comment ID 19136 and 19139 under comment code 4510. Please see the response to comment ID 19137 under comment code 7180 and 19139 under comment code

### Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and Please see response to comment ID 19338 under comment code 7200. Please see response to comment ID 19338 under comment code 7200 for more discussion of the evaluation of pharmaceutical compounds. EPA agrees that expert review was an important component of the CCL 3 process. Please see response to comment ID 19417 under comment code 2200. Please see response to comment ID 19094 under comment code 4125. As stated in the docket document on screening from the universe to the PCCL, a chemical is categorized for toxicity by the value in the universe data compilation that places it in the highest toxicity category. This decision was based on a desire to be conservativebecause of the coarse screen and limited data available for screening for many chemicals. The evaluation of Nmethyl-2-pyrrolidone followed the screening procedure developed for the PCCL process. Please see response to comment ID 19094 under comment code 4125. As stated in the docket document on screening from the universe to the PCCL, a chemical is categorized for toxicity by the value in the universe data compilation that places it in the highest toxicity category. This decision was based on a desire to be conservativebecause of the coarse screen and limited data available for screening for many chemicals. The evaluation of Nmethyl-2-pyrrolidone followed the screening procedure developed for the PCCL process. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see response to comment ID 19058 under comment code 7840. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements Please see the responses to comment IDs 18858 and 18850 under comment code 2620. See response to comment ID 19093 under comment code 4120. The Agency agrees with the commenter and also supports the use of sound scientific testing consistent with EPA methods. The Agency has responded to the specific information and comments provided by the City of Peoria, AZ under the respective comment codes: 2310 Naegleria fowleri (comment ID 19254) and 7200 pharmaceuticals and personal care products (not on CCL3) (comment ID 19573). Please see the response to comment ID 19068 under comment code 4450. Please see response to comment ID 19338 under comment code 7200. EPA is evaluating each of the seven components cited by the commenter with our stakeholders, regulatory partners, and the public. The response to comment ID 19338 also provides Web sites that provide updates to the Agencys progress. Please see responses to comment IDs 19338 and 19573 under comment code 7200.

### Azinphos-methyl (CAS # 86-50-0): Azinophos-methyl was included in the Universe for the CCl and was screened

to the PCCL. However, using the classification approach described in the selection of the CCL from the PCCL (refer to the document CCL 3 Chemicals: Classification of the PCCL to CCL which can be found in the CCL 3 Docket identified by the two document ID #s EPA-HQ-OW-2007-1189-0046 and EPA 815-R-08-004) , it was not listed on CCL3. This result was influenced, in part, by the low concentrations measured in monitoring of ambient water. EPA used the health effects information from the OPP RED and the USGS NAWQA data in scoring the attributes for azinphos-methyl. EPA also evaluated the data provided by the commenter using the protocols described in the draft CCL 3 FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes that azinphos-methyl does not meet the CCL statutory criteria at this time. Therefore EPA is not including this Carbaryl (CAS # 63-25-2): We agree with the commenter that the toxicity profile of Carbaryl allows for its consideration as a potential drinking water contaminant; however, being a carbamate, it is rapidly degraded, and not persistent in the environment. Being a ChE inhibitor, it may be considered for a cumulative carbamates approach. During the CCL 3 screening processes, EPA used the RFD of 0.01 mg/kg-day for carbaryl to produce a health reference level of 70 ug/L. This health reference level was compared to the best available finished water data, from the National Contaminant Occurrence Database Round 2 (median concentration value of 0.18 ug/L) for carbaryl and based on this screen, carbaryl did not get listed onto the CCL 3. EPA also evaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes carbaryl does not meet the CCL statutory criteria at this time. Therefore Chlorpyrifos (CAS # 2921-88-2): Chlorpyrifos was included in the universe for the CCL but, based on the CCL screening protocol, was not selected for the PCCL (refer to document Contaminant Candidate List 3 Chemicals: Screening to a PCCLwhich can be found in the CCL 3 Docket identified by the two document ID #s EPA-HQ-OW2007-1189-0044 and EPA 815-R-08-003). EPA agrees with the commenter that the toxicity profile of Chorpyrifos allows for its consideration as a potential drinking water contaminant; however, being an organophosphate, it is rapidly degraded, and not persistent in the environment, a fact that may have influenced its occurrence. EPA used the health effects potency information from OPP and release data in the screening of Chlorpyrifos for the PCCL. EPA also evaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes chlorpyrifos does not meet the CCL statutory criteria at this time. Therefore EPA is not including this compound on the CCL 3 but will consider it for Dichlorvos (DDVP) (CAS # 62-73-7): Dichlorvos was included in the working Universe for the CCL and was screened to the PCCL. However using the classification models applied in selection of the CCL from the PCCL, it was not chosen (refer to the document CCL 3 Chemicals: Classification of the PCCL to CCL which can be found in the CCL 3 Docket identified by the two document ID #s EPA-HQ-OW-2007-1189-0046 and EPA 815-R-08-004). The low priority for dichlorvos was strongly influenced by the low detection rate and low concentrations measured during unregulated contaminant monitoring. EPA used the health effects information from the OPP RED in scoring the health effects attributes for dichlorvos. EPA also evaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes dichlorvos does not meet the CCL statutory criteria at this time. Therefore EPA is not Dicofol (CAS # 115-32-2): Dicofol was included in the universe for the CCL but was not selected for the PCCL following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). EPA used the health effects potency information from OPP and release data in the screening of Dicofol for the PCCL. The commenter suggested that EPA had erred in not applying the FQPA factor in its evaluation of Dicofol. The FQPA is not applicable under the criteria of the Safe Drinking Water Act. Accordingly, consideration of the uncertainties represented by this factor would not be considered by OW during the CCL evaluation. EPA alsoevaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW2007-1189-0001). Based upon these data EPA concludes dicofol does not meet the CCL statutory criteria at this

### Endosulfan (CAS # 115-29-7): We agree with the commenter that the toxicity profile of Endosulfan allows for its

consideration as a potential drinking water contaminant of concern; this is a chlorinated pesticide and would be persistent in water. Endosulfan was identified in the universe of chemicals, screened to the PCCL, but was not listed on the CCL 3 based on a review of its toxicity profile and data on occurrence. The methodology used by EPA to make this decision can be found in the following support document, located in the CCL Docket: CCL Chemicals: Classification of the PCCL to CCL (EPA 815-R-08-004). Although endosulfan did not get listed on the CCL 3, endosulfan will be reconsidered for future CCLs. EPA also evaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA Trichlorfon (CAS# 52-68-6); Trichlorfon was included in the universe for the CCl but was not selected for the PCCl following the protocol described in the document: CCL 3 Chemicals: Screening to a PCCL (EPA 815-R-08-003). EPA used the health effects potency information from OPP and release data in the screening of Trichlorfon for Triclocarban (CAS# 110-20-2); Triclocarban was included in the universe for the CCL but was not selected for the PCCl following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). This chemical is an antimicrobial with endocrine disruption properties. OPP announced on 10/29/08 the availability of the RED for public comment. EPA will reevaluate triclocarban when the assessment has been finalized to assure the best available science is used to develop the CCL 3. EPA did evaluate the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes triclocarbon does not meet the CCL statutory criteria at this time. Triclosan (CAS# 3380-34-5); Triclosan was included in the universe for the CCL but was not selected for the PCCL following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). The commenter did identify publications regarding the occurrence of Triclosan in wastewater, storm water, raw and finished drinking water. Based upon the limited occurrence concentrations reported in these studies triclosan does not meet the CCL statutory criteria at this time. Therefore EPA is not including this compound on the CCL 3 EPA used occurrence data from the Toxics Release Inventory in addition to health effects information to evaluate nitroglycerin for the CCL 3. Based on these and other data, the Agency determined that nitroglycerin is known or anticipated to occur in public water systems and may require regulation. EPA notes that nitroglycerin has multiple uses, and it was not listed on the CCL 3 solely for its use as a pharmaceutical. EPA is not proposing to use nitroglycerin as an indicator of pharmaceutical contamination in drinking water. Please see the response to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care Products (not on CCL 3)) for a discussion of how pharmaceuticals have been further evaluated for the CCL 3. The Agency used data from the Kolpin et al. 2002 study cited by the commenter to evaluate pharmaceuticals for the final CCL 3 using the process described in the draft CCL 3 FR notice and final CCL 3 FR notice (73 FR 9628). Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements The evaluation of the toxicity data for Diuron was conducted using the protocols described in the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL. Following those guidelines as well as the agency guidelines for data quality, Diuron was scored based on the publically available assessment from the EPA published Reregistraion Eligibility Decision document (September 2003). The scores were based on the potency associated with the higher of the cancer and noncancer potency scores as described in the protocol document. In the case of Diuron, the potency associated with the RfD was higher than that based on the cancer slope factor. Regarding the commenter's statement: "The low frequency of detection and the low concentrations relative to the DWEL support a NL decision" - Diuron was listed on the CCL 3 because EPA concluded that Diuron is known or anticipated to occur in public water systems and may require regulation. This decision was upon a review of the best available occurrence data from the Unregulated Contaminant Monitoring Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter

Background and Introductory Statements Please see the response to comment ID 19084 under EPA comment code 5025. The CCL3 listing of vanadium applies to the water soluble forms of vanadium compounds that occur in public water supplies and not to elemental vanadium. As EPA refines its assessment of vanadium compounds in drinking water as part of a potential regulatory determination, consideration will be given to the relative toxicities of the oxidation state (i.e. +4 versus +5) as well as any changes in oxidation state that may occur during the water treatment process. Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter Background and Introductory Statements

### EPA_TEAM_MEMBER DRAFT_STATUS

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Lameka Smith

Meredith (MB upload) Lameka Smith Meredith (MB upload)

Meredith (MB upload) Meredith (MB upload) MB upload

Meredith (MB upload) Lameka Smith

### Meredith (MB upload)

Meredith (MB upload)

M. Benedict (uploaded by JLE) Final

Meredith (MB upload) Meredith (MB upload) Meredith (MB upload) Meredith (MB upload)

Meredith (MB upload) Meredith (MB upload) Meredith (MB upload) Lameka Smith

Meredith (MB upload)

### Lameka Smith

Lameka Smith

Meredith (MB upload)

### Meredith (MB upload)

Meredith (MB upload) Meredith (MB upload) Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload) Meredith (MB upload) Meredith (MB upload) Meredith (MB upload)

Meredith (MB upload) Lameka Smith

Meredith (MB upload)

Meredith (MB upload) Meredith (MB upload)

### Lameka Smith

Lameka Smith

Meredith (MB upload) Meredith (MB upload)

microbe Team by TB Final Joyce (MB upload)

Lameka Smith Lameka Smith Carpenter, Benedict Final

Meredith (MB upload)

Meredith (MB upload)

### JLE Final

JLE Final

JLE Final

JLE Final

JLE Final

### JLE Final

JLE Final

JLE Final

JLE Final

### NOTES

Other EPA Comment Code: 6760 - Microbial Expert Input Panels

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6166 - Occurrence Protocol for Chemicals

### Other EPA Comment Code: 6100 - Classification Approach for Chemicals

### Other EPA Comment Code: 4010 - Molybdenum occurrence

### Other EPA Comment Code: 6364 - Occurrence Protocol for Microbials

### Other EPA Comment Code: 3580 - Ethylene oxide

### Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6142 - Health Effects Criteria for Chemicals

Other EPA Comment Code: 6146 - Occurrence Criteria for Chemicals

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 6366 - Health Effects Protocol for Microbials

### Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

### Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)

### Note to Cadmus: Insert new chloramine info website when it gets posted. Verify this website:

http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf prior to submitting the draft comment response document.

### Other EPA Comment Code: 7110 - Pesticides not on CCL 3

Other EPA Comment Code: 6730 - Chemical Expert Input Panels

### Other EPA Comment Code: 5030 - Vanadium occurrence

### Other EPA Comment Code: 6142 - Health Effects Criteria for Chemicals

Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

### Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

### Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3).

### [The commenter recommends the addition of the following contaminants to CCL 3]

### Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

### Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products(not on CCL3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3) Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

### Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 3550 - Ethylene glycol

### Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 3550 - Ethylene glycol

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety.

### Other EPA Comment Code: 3910 - Methyl tert-butyl ether

This comment also appears under topic code 3910 - Methyl tert-butyl ether. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety. Other EPA Comment Code: 9100 - Background Statements Related to CCL and Statutory Requirements

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 6300 - Classification Approach for Microbial Contaminants

### moved to umbrella location

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3) Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

Other EPA Comment Code: 7120 - Degradates/metabolites not on CCL 3

Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3 Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3 Other EPA Comment Code: 3560 - Ethylene glycol occurrence Other EPA Comment Code: 6500 - Public Input

### Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

### Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3) Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 6300 - Classification Approach for Microbial Contaminants

Other EPA Comment Code: 2340 - Vibrio cholerae

Other EPA Comment Code: 3585 - Ethylene oxide health

Other EPA Comment Code: 3555 - Ethylene glycol health

Other EPA Comment Code: 3855 - Methanol health

### Other EPA Comment Code: 3860 - Methanol occurrence

Other EPA Comment Code: 2630 - 1,3-Butadiene occurrence Other EPA Comment Code: 4005 - Molybdenum health

This comment also appears under topic code 4005 - Molybdenum health. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety. Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 3560 - Ethylene glycol occurrence Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 2300 - Legionella pneumophila

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 6500 - Public Input Other EPA Comment Code: 4090 - Nitroglycerin This comment also appears under topic code 4090 - Nitroglycerin. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety. Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 4090 - Nitroglycerin This comment also appears under topic code 4090 - Nitroglycerin. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety.

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3) Other EPA Comment Code: 6100 - Classification Approach for Chemicals

### Other EPA Comment Code: 5025 - Vanadium health.

This comment also appears under topic code 5025 - Vanadium health. Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety.

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 3560 - Ethylene glycol occurrence Other EPA Comment Code: 6500 - Public Input Other EPA Comment Code: 6500 - Public Input Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL Other EPA Comment Code: 2100 - General Comments on the List - All Contaminants

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

### Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 3580 - Ethylene oxide Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3 Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 6100 - Classification Approach for Chemicals

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 9100 - Background Statements Related to CCL and Statutory Requirements Other EPA Comment Code: 4450 - Perchlorate

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid) Other EPA Comment Code: 4515 - PFOA (perfluorooctanoic acid) health Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

### Other EPA Comment Code: 7150 - Endocrine Disruptors (not on CCL 3)

Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid) Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 3560 - Ethylene glycol occurrence

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4520 - PFOA (perfluorooctanoic acid) occurrence Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid) Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

### Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 7150 - Endocrine Disruptors (not on CCL 3) Other EPA Comment Code: 6700 - External Expert Review and Input

Other EPA Comment Code: 6100 - Classification Approach for Chemicals Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

### DATE_UPLOADED

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25-JUN-09 17-JUL-09 25-JUN-09 01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

### 07-JUL-09

24-JUN-09 01-JUL-09

01-JUL-09

01-JUL-09

30-JUN-09

22-JUL-09 30-JUN-09

01-JUL-09

21-JUL-09

30-JUN-09

24-JUN-09

22-JUL-09 23-JUL-09 23-JUL-09 22-JUL-09 24-JUN-09 29-JUN-09

22-JUN-09

### 29-JUN-09

24-JUN-09 30-JUL-09

24-JUL-09

### 16-JUL-09

29-JUL-09 24-JUL-09

16-JUN-09 17-AUG-09 16-JUL-09 11-FEB-09

24-JUN-09 29-JUL-09 22-JUL-09 22-JUL-09 22-JUL-09 25-JUN-09

### 17-JUL-09

24-AUG-09

23-JUL-09

23-JUL-09

23-JUL-09

### 21-JUL-09

23-JUL-09 18-AUG-09

22-JUL-09

13-AUG-09 28-JUL-09

24-AUG-09

23-JUL-09

25-JUN-09 23-JUN-09 22-JUL-09

30-JUN-09

25-JUN-09 25-JUN-09 25-JUN-09

30-JUN-09 23-JUL-09

### 28-JUL-09

25-JUN-09 25-JUN-09 22-JUL-09 24-JUN-09 24-JUN-09 22-JUL-09 14-AUG-09

30-JUN-09 25-JUN-09 25-JUN-09 25-JUN-09

25-JUN-09 25-JUN-09 25-JUN-09 23-JUL-09

25-JUN-09

### 23-JUL-09

13-AUG-09

28-JUL-09

22-JUL-09 23-JUL-09 23-JUL-09

22-JUL-09

25-JUN-09 22-AUG-08 22-AUG-08

22-JUL-09 22-JUL-09 22-JUL-09

### 25-JUN-09

23-JUL-09

25-JUN-09 25-JUN-09 25-JUN-09 23-JUL-09 22-JUL-09

25-JUN-09 25-JUN-09 25-JUN-09 25-JUN-09

25-JUN-09 22-JUL-09

30-JUN-09 23-JUL-09

22-JUL-09 25-JUN-09 25-JUN-09 23-JUL-09 22-JUL-09

### 22-JUL-09

22-JUL-09

25-JUN-09 22-JUL-09

17-JUL-09 24-JUN-09

22-JUL-09

18-SEP-08

28-JUL-09 18-SEP-08

29-JUL-09 29-JUL-09 30-JUN-09

17-AUG-09 25-JUN-09

25-JUN-09

### 17-AUG-09

17-AUG-09

17-AUG-09

17-AUG-09

17-AUG-09

### 20-MAY-09

20-MAY-09

17-AUG-09

20-MAY-09

16-JUL-09

28-JUL-09

14-AUG-09

28-JUL-09

### 28-JUL-09

28-JUL-09

28-JUL-09

### EPA_COMMENT_CODE COMMENT_CODE_DESCRIPTION

1000 

### General Comments 1100 

### Statutory Requirements for CCL and Regulatory Determinations 1200 

### The First Contaminant Candidate List 1300 

### The Regulatory Determinations for CCL 1 1400 

### The Second Contaminant Candidate List 1500 

### The Regulatory Determinations for CCL 2 1600 

### The Unregulated Contaminant Monitoring Regulation 2000 

### The Draft CCL 3 2100 

### General Comments on the List  All Contaminants 2200 

### All Pathogens 2210 

### Bacteria 2220 

### Protozoa 2230 

### Viruses 2240 

### Caliciviruses 2250 

### Campylobacter jejuni 2260 

### Entamoeba histolytica 2270 

### Escherichia coli (0157) 2280 

### Helicobacter pylori 2290 

### Hepatitis A virus 2300 

### Legionella pneumophila 2310 

### Naegleria fowleri 2320 

### Salmonella enterica 2330 

### Shigella sonnei 2340 

### Vibrio cholerae 2400 

### All Chemical Contaminants 2420 

### Pesticides 2440 

### Degradates/metabolites 2460 

### DBPs 2480 

### Other Groups 2500 

### alpha-Hexachlorocyclohexane 2505 

### alpha-Hexachlorocyclohexane health 2510 

### alpha-Hexachlorocyclohexane occurrence 2530 

### 1,1,1,2-Tetrachloroethane 2535 

### 1,1,1,2-Tetrachloroethane health 2540 

### 1,1,1,2-Tetrachloroethane occurrence 2560 

### 1,1-Dichloroethane 2565 

### 1,1-Dichloroethane health 2570 

### 1,1-Dichloroethane occurrence 2590 

### 1,2,3-Trichloropropane 2595 

### 1,2,3-Trichloropropane health 2600 

### 1,2,3-Trichloropropane occurrence 2620 

### 1,3-Butadiene 2625 

### 1,3-Butadiene health 2630 

### 1,3-Butadiene occurrence 2650 

### 1,3-Dinitrobenzene2655 

### 1,3-Dinitrobenzene health 2660 

### 1,3-Dinitrobenzene occurrence 2680 

### 1,4-Dioxane 2685 

### 1,4-Dioxane health 2690 

### 1,4-Dioxane occurrence 2710 

### 1-Butanol 2715 

### 1-Butanol health 2720 

### 1-Butanol occurrence 2740 

### 2-Methoxyethanol 2745 

### 2-Methoxyethanol health 2750 

### 2-Methoxyethanol occurrence 2770 

### 2-Propen-1-ol 2775 

### 2-Propen-1-ol health 2780 

### 2-Propen-1-ol occurrence 2800 

### 3-Hydroxycarbofuran 2805 

### 3-Hydroxycarbofuran health 2810 

### 3-Hydroxycarbofuran occurrence 2830 

### 4,4'-Methylenedianiline 2835 

### 4,4'-Methylenedianiline health 2840 

### 4,4'-Methylenedianiline occurrence 2860 

### Acephate 2865 

### Acephate health 2870 

### Acephate occurrence 2890 

### Acetaldehyde 2895 

### Acetaldehyde health 2900 

### Acetaldehyde occurrence 2920 

### Acetamide 2925 

### Acetamide health 2930 

### Acetamide occurrence 2950 

### Acetochlor and degradates (ESA and OA) 2955 

### Acetochlor and degradates (ESA and OA) health 2960 

### Acetochlor and degradates (ESA and OA) occurrence 2980 

### Acrolein 2985 

### Acrolein health 2990 

### Acrolein occurrence 3010 

### Alachlor and degradates (ESA and OA) 3015 

### Alachlor and degradates (ESA and OA) health 3020 

### Alachlor and degradates (ESA and OA) occurrence 3040 

### Aniline 3045 

### Aniline health 3050 

### Aniline occurrence 3070 

### Bensulide 3075 

### Bensulide health 3080 

### Bensulide occurrence 3100 

### Benzyl chloride 3105 

### Benzyl chloride health 3110 

### Benzyl chloride occurrence3130 

### Butylated hydroxyanisole 3135 

### Butylated hydroxyanisole health 3140 

### Butylated hydroxyanisole occurrence 3160 

### Captan 3165 

### Captan health 3170 

### Captan occurrence 3190 

### Chloromethane (Methyl chloride) 3195 

### Chloromethane (Methyl chloride) health 3200 

### Chloromethane (Methyl chloride) occurrence 3220 

### Clethodim 3225 

### Clethodim health 3230 

### Clethodim occurrence 3250 

### Cobalt 3255 

### Cobalt health 3260 

### Cobalt occurrence 3280 

### Cumene hydroperoxide 3285 

### Cumene hydroperoxide health 3290 

### Cumene hydroperoxide occurrence 3310 

### Cyanotoxins (3) 3315 

### Cyanotoxins (3) health 3320 

### Cyanotoxins (3) occurrence 3340 

### Dicrotophos 3345 

### Dicrotophos health 3350 

### Dicrotophos occurrence 3370 

### Dimethipin 3375 

### Dimethipin health 3380 

### Dimethipin occurrence 3400 

### Dimethoate 3405 

### Dimethoate health 3410 

### Dimethoate occurrence 3430 

### Disulfoton 3435 

### Disulfoton health 3440 

### Disulfoton occurrence 3460 

### Diuron 3465 

### Diuron health 3470 

### Diuron occurrence 3490 

### Ethion 3495 

### Ethion health 3500 

### Ethion occurrence 3520 

### Ethoprop 3525 

### Ethoprop health 3530 

### Ethoprop occurrence 3550 

### Ethylene glycol 3555 

### Ethylene glycol health3560 

### Ethylene glycol occurrence

3580 

### Ethylene oxide 3585 

### Ethylene oxide health 3590 

### Ethylene oxide occurrence 3610 

### Ethylene thiourea 3615 

### Ethylene thiourea health 3620 

### Ethylene thiourea occurrence 3640 

### Fenamiphos 3645 

### Fenamiphos health 3650 

### Fenamiphos occurrence 3670 

### Formaldehyde3675 

### Formaldehyde health 3680 

### Formaldehyde occurrence 3700 

### Germanium 3705 

### Germanium health 3710 

### Germanium occurrence 3730 

### HCFC-22 3735 

### HCFC-22 health 3740 

### HCFC-22 occurrence 3760 

### Hexane 3765 

### Hexane health 3770 

### Hexane occurrence 3790 

### Hydrazine 3795 

### Hydrazine health 3800 

### Hydrazine occurrence 3820 

### Methamidophos 3825 

### Methamidophos health 3830 

### Methamidophos occurrence 3850 

### Methanol 3855 

### Methanol health 3860 

### Methanol occurrence 3880 

### Methyl bromide (Bromomethane) 3885 

### Methyl bromide (Bromomethane) health 3890 

### Methyl bromide (Bromomethane) occurrence 3910 

### Methyl tert-butyl ether 3915 

### Methyl tert-butyl ether health 3920 

### Methyl tert-butyl ether occurrence 3940 

### Metolachlor and its degradates ESA and OA 3945 

### Metolachlor and its degradates ESA and OA health 3950 

### Metolachlor and its degradates ESA and OA occurrence 3970 

### Molinate 3975 

### Molinate health 3980 

### Molinate occurrence 4000 

### Molybdenum 4005 

### Molybdenum health 4010 

### Molybdenum occurrence 4030 

### Nitrobenzene 4035 

### Nitrobenzene health 4040 

### Nitrobenzene occurrence 4060 

### Nitrofen 4065 

### Nitrofen health 4070 

### Nitrofen occurrence 4090 

### Nitroglycerin 4095 

### Nitroglycerin health 4100 

### Nitroglycerin occurrence 4120 

### N-Methyl-2-pyrrolidone 4125 

### N-Methyl-2-pyrrolidone health 4130 

### N-Methyl-2-pyrrolidone occurrence4150 

### N-nitrosodiethylamine (NDEA) 4155 

### N-nitrosodiethylamine (NDEA) health 4160 

### N-nitrosodiethylamine (NDEA) occurrence 4180 

### N-nitrosodimethylamine (NDMA) 4185 

### N-nitrosodimethylamine (NDMA) health 4190 

### N-nitrosodimethylamine (NDMA) occurrence 4210 

### N-nitroso-di-n-propylamine (NDPA) 4215 

### N-nitroso-di-n-propylamine (NDPA) health 4220 

### N-nitroso-di-n-propylamine (NDPA) occurrence 4240 

### N-Nitrosodiphenylamine 4245 

### N-Nitrosodiphenylamine health 4250 

### N-Nitrosodiphenylamine occurrence 4270 

### N-nitrosopyrrolidine (NPYR) 4275 

### N-nitrosopyrrolidine (NPYR) health 4280 

### N-nitrosopyrrolidine (NPYR) occurrence 4300 

### n-Propylbenzene 4305 

### n-Propylbenzene health 4310 

### n-Propylbenzene occurrence 4330 

### o-Toluidine 4335 

### o-Toluidine health 4340 

### o-Toluidine occurrence 4360 

### Oxirane, methyl4365 

### Oxirane, methyl- health 4370 

### Oxirane, methyl- occurrence 4390 

### Oxydemeton-methyl 4395 

### Oxydemeton-methyl health 4400 

### Oxydemeton-methyl occurrence 4420 

### Oxyfluorfen 4425 

### Oxyfluorfen health 4430 

### Oxyfluorfen occurrence 4450 

### Perchlorate 4455 

### Perchlorate health 4460 

### Perchlorate occurrence 4480 

### Permethrin 4485 

### Permethrin health 4490 

### Permethrin occurrence 4510 

### PFOA (perfluorooctanoic acid) 4515 

### PFOA (perfluorooctanoic acid) health 4520 

### PFOA (perfluorooctanoic acid) occurrence 4540 

### Profenofos 4545 

### Profenofos health 4550 

### Profenofos occurrence 4570 

### Quinoline 4575 

### Quinoline health 4580 

### Quinoline occurrence 4600 

### RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine) 4605 

### RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine) health4610 

### RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine) occurrence 4630 

### Sec-Butylbenzene 4635 

### Sec-Butylbenzene health 4640 

### Sec-Butylbenzene occurrence 4660 

### Strontium 4665 

### Strontium health 4670 

### Strontium occurrence 4690 

### Tebuconazole 4695 

### Tebuconazole health 4700 

### Tebuconazole occurrence 4720 

### Tebufenozide 4725 

### Tebufenozide health 4730 

### Tebufenozide occurrence 4750 

### Tellurium 4755 

### Tellurium health 4760 

### Tellurium occurrence 4780 

### Terbufos and its degradate terbufos sulfone 4785 

### Terbufos and its degradate terbufos sulfone Health 4790 

### Terbufos and its degradate terbufos sulfone Occurrence 4810 

### Thiodicarb 4815 

### Thiodicarb health 4820 

### Thiodicarb occurrence 4840 

### Thiophanate-methyl 4845 

### Thiophanate-methyl health 4850 

### Thiophanate-methyl occurrence 4870 

### Toluene diisocyanate 4875 

### Toluene diisocyanate health 4880 

### Toluene diisocyanate occurrence 4900 

### Tribufos 4905 

### Tribufos health 4910 

### Tribufos occurrence 4930 

### Triethylamine 4935 

### Triethylamine health 4940 

### Triethylamine occurrence 4960 

### Triphenyltin hydroxide (TPTH) 4965 

### Triphenyltin hydroxide (TPTH) health 4970 

### Triphenyltin hydroxide (TPTH) occurrence 4990 

### Urethane 4995 

### Urethane health 5000 

### Urethane occurrence 5020 

### Vanadium 5025 

### Vanadium health 5030 

### Vanadium occurrence 5050 

### Vinclozolin 5055 

### Vinclozolin health 5060 

### Vinclozolin occurrence 5080 

### Ziram5085 

### Ziram health 5090 

### Ziram occurrence 6000 

### What Analyses Did EPA Use To Develop the Draft CCL 3? 6100 

### Classification Approach for Chemicals 6120 

### Identifying the Chemical Universe 6122 

### health effects data sources 6126 

### occurrence data sources 6140 

### Screening Chemicals from the Universe to a PCCL 6142 

### Health Effects Criteria for Chemicals 6146 

### Occurrence Criteria for Chemicals 6160 

### Using Classification Models to Develop the Chemical CCL 3 6162 

### Health Effects Protocol for Chemicals 6166 

### Occurrence Protocol for Chemicals 6180 

### Selection of the Draft CCL 3--Chemicals 6300 

### Classification Approach for Microbial Contaminants 6320 

### Developing the Microbial Universe 6340 

### Screening Microbials from the Universe to a PCCL 6360 

### The PCCL to Draft CCL Process for Microbials 6363 

### Waterborne Disease Outbreak Protocol

6364 

### Occurrence Protocol for Microbials 6366 

### Health Effects Protocol for Microbials 6368 

### Combining Protocol Scores to Rank Pathogens 6370 

### Other Criteria Considered for Listing and Scoring Microbes on the Dra ft CCL 3 6380 

### Selection of the Draft CCL 3 Microbes From the PCCL 6500 

### Public Input 6550 

### Nominations and Surveillance 6700 

### External Expert Review and Input6730 

### Chemical Expert Input Panels 6760 

### Microbial Expert Input Panels 6900 

### The Interrelation Between CCL and UCMR for Specific Chemicals and Groups? 7000 

### Contaminants NOT Listed On The CCL 3 7100 

### Chemicals not on CCL 3 7110 

### Pesticides not on CCL 3 7120 

### Degradates/metabolites not on CCL 3 7130 

### DBPs not on CCL 3 7140 

### Bisphenol A (and related - phenols) (not on CCL 3) 7150 

### Endocrine Disruptors (not on CCL 3) 7160 

### PAHs 7170 

### PBDEs flame retardants (and related PBBs) (not on CCL 3) 7180 

### Perfluorinated compounds (not on CCL 3) 7190 

### Personal Care Products (not on CCL 3) 7200 

### Pharmaceuticals and Personal Care Products (not on CCL 3)7210 

### Pthalates (not on CCL 3)7220 

### Miscellaneous Groupings 7400 

### Microbes (not on CCL 3) 7410 

### Specific bacteria 7420 

### Specific fungi 7430 

### Specific helminths 7440 

### Specific protozoa 7450 

### Specific viruses and prions (not on CCL 3) 7500 

### CCL 2 Contaminants not on CCL 3 7510 

### 2,4-Dinitrophenol 7520 

### p,p-DDE 7530 

### 1,1,2,2-tetrachlorothane 7540 

### 2,4,6-trichlorophenol 7550 

### o-Cresol 7560 

### 1,2,4-trimethylbenzene 7570 

### p-cymene 7580 

### bromobenzene 7590 

### 2,4-dichlorophenol 7600 

### 2,4-dinitrotoluene 7610 

### 1,2-diphenylhydrazine 7620 

### 1,3-dichloropropane 7630 

### Linuron (not on CCL 3) 7640 

### Diazinon 7650 

### 1,3-dichloropropene 7660 

### 1,1-dichloropropene 7670 

### 2,2-dichloropropane 7680 

### 2,6-dinitrotoluene 7690 

### EPTC 7700 

### DCPA mono-acid degradate 7710 

### DCPA di-acid degradate 7720 

### Prometon 7730 

### Fonofos 7740 

### Terbacil 7750 

### Aluminum 7760 

### Boron 7770 

### Organotins 7780 

### Triazines (total) 7790 

### Adenoviruses 7800 

### Aeromonas hydrophila 7810 

### Coxsackieviruses 7820 

### Echoviruses 7830 

### Microsporidia 7840 

### Mycobacterium avium intracellulare (MAC)9000 

### Commenter Background and Introductory Statements

9100 

### General Statements Related to CCL and Statutory Requirements

### COMMENT_CODE_ID

1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 1353 1354 1355 1356 1357 1358 1359 1360 1361 1362 1363 1364 13651366 1367 1368 1369 1370 1371 1372 1373 1374 1375 1376 1377 1378 1379 1380 1381 1382 1383 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 1399 1400 1401 1402 1403 1404 1405 1406 1407 1408 1409 1410 1411 14121413 1414 1415 1416 1417 1418 1419 1420 1421 1422 1423 1424 1425 1426 1427 1428 1429 1430 1431 1432 1433 1434 1435 1436 1437 1438 1439 1440 1441 1442 1443 1444 1445 1446 1447 1448 1449 1450 1451 1452 1453 1454 1455 14561457

1458 1459 1460 1461 1462 1463 1464 1465 1466 14671468 1469 1470 1471 1472 1473 1474 1475 1476 1477 1478 1479 1480 1481 1482 1483 1484 1485 1486 1487 1488 1489 1490 1491 1492 1493 1494 1495 1496 1497 1498 1499 1500 1501 1502 1503 1504 1505 1506 1507 1508 1509 1510 1511 1512 1513 15141515 1516 1517 1518 1519 1520 1521 1522 1523 1524 1525 1526 1527 1528 1529 1530 1531 1532 1533 1534 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1547 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1559 1560 15611562 1563 1564 1565 1566 1567 1568 1569 1570 1571 1572 1573 1574 1575 1576 1577 1578 1579 1580 1581 1582 1583 1584 1585 1586 1587 1588 1589 1590 1591 1592 1593 1594 1595 1596 1597 1598 1599 1600 1601 1602 1603 1604 1605 1606 1607 16081609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619 1620 1621 1622 1623 1624 1625 1626 1627

1628 1629 1630 1631

1632 1633 1634 16351636 1637 1638

1639 1640 1641 1642 1643 1644 1645 1646 1647 1648 1649 165016511652 1653 1654 1655 1656 1657 1658 1659 1660 1661 1662 1663 1664 1665 1666 1667 1668 1669 1670 1671 1672 1673 1674 1675 1676 1677 1678 1679 1680 1681 1682 1683 1684 1685 1686 1687 1688 1689 1690 1691 1692 16931694

1781

### RESPONSE

### The commenter notes that there were limited occurrence data available for ethylene glycol. However, EPA

disagrees with the commenter that the Agency made an erroneous conclusion that ethylene glycol might occur in drinking water. The Agency provided detailed support documents that discuss the CCL 3 process and the data and information used to evaluate contaminants for the CCL 3 that are available in the docket.

In developing the CCL 3, the Agency sought input from the National Academy of SciencesNational Research Council (NRC), the National Drinking Water Advisory Council (NDWAC), and the Science Advisory Board on how to improve the CCL process. Each of these panels recommends that EPA should identify and retrieve data from sources that have information about occurrence of contaminants in drinking water or source water including sources that have a link (pathway) to drinking water. The Toxics Release Inventory (TRI) was specifically included as a data source that could be reviewed as one of the sources that have a link (pathway) to drinking water.

EPA disagrees with the commenter that the Agency erred in defining ethylene glycols potential to occur in drinking water based on total TRI releases rather than on surface water releases. EPA believes that it is appropriate to use total environmental release data rather than the total quantity released to surface water to evaluate the potential of a contaminant to occur in drinking water, as the use of total environmental release data accounts for any releases to groundwater, air, and any mobility the chemical may exhibit. The use of only surface water release data would not take into account the release of a contaminant to groundwater or mobility of a contaminant that could reach surface or groundwater. ATSDR notes that ethylene glycol is expected to be highly mobile, particularly in moist soils, and it may leach into groundwater upon release to surface soils (http://www.atsdr.cdc.gov/toxprofiles/tp96.pdf Page 189). Discussion in the NDWAC 2004 report supports this: In surface waters, which are exposed to the air, compounds that volatilize will not be persistent, simply because they evaporate into the air and are not found in the water. However, in ground water, the same compounds may EPA disagrees with the commenter that “EPA Erroneously Used Total Environmental Releases As the Data Element for Characterizing EG's Potential to Occur in Drinking Water." The commenter also states that “Finally, should EPA nevertheless use total environmental releases rather than surface water releases for purposes of the screening step, EPA should consider the fact that according to the TRI Explorer, total environmental releases of EG in 2004 equaled 8,648,773 pounds, not 10,076,483 pounds.” EPA used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for screening ethylene glycol from the Universe to the PCCL and for scoring the magnitude attribute when screening from the PCCL to the CCL. EPA originally compiled the total environmental releases for 2004 for ethylene glycol as soon as they were made available on TRI as 10,076,483 lbs. However, the numbers in the TRI database can change over time because of amendments and/or additional submissions or corrections from States and/or individual industrial facilities. The commenter submitted that at the time they queried TRI Explorer, the total environmental releases of ethylene glycol in 2004 equaled 8,648,773 pounds. EPA queried TRI explorer on October 22, 2008 for the total environmental releases of ethylene glycol in 2004 and found that releases equaled 8,648,518 lbs. The commenter submitted that at the

### EPA supports and works collaboratively with CDC on the MMWR. Based on our review, EPA concludes that the

information in the MMWR is useful and reliable. EPA, therefore, continues to be confident in the quality of the information in the MMWR. EPA disagrees with the comment recommending the inclusion of frequency (or magnitude) as a criterion for scoring the CCL. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Neither treatability nor rareness/frequency of disease were criteria considered for CCL 3 inclusion. EPA acknowledges the reference provided by the commenter regarding the 2007 Expert Panel recommendations on adding a frequency of disease parameter to the health effects scoring protocol for future CCLs to balance the consideration of more prevalent illnesses with the more severe but less prevalent responses, such as N. fowleri or Vibrio cholerae. EPA did not directly factor in the magnitude of WBDO (frequency of disease) as a criterion for For those pathogens for which there is no US WBDO or occurrence data, EPA uses international information. EPA’s WBDO scoring protocol uses the CDC definition for outbreak as two or more persons epidemiologically linked by location of exposure to water, time, and illness (CDC, 2006). CDC excludes single cases of illness from the definition of WBDO except for single cases of Naegleria fowleri (causing primary amebic meningoencephalitis) and Vibrio cholerae. When CDC MMWR data was not used EPA relied on WHO publications and other peer reviewed publications for scoring purposes. EPA considered non-CDC data that showed a link between human illness defined by a common water source, a common time period of exposure and/or similar symptoms including molecular typing data. Only two pathogens were given a WBDO score on this basis, Mycobacterium avium and Arcobacter butzlerei. For more detailed information refer to the support document titled The Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. Serology data are typically acquired

### Under the CCL 3, EPA evaluated the potential adverse health effects of pharmaceuticals and their occurrence in

public drinking water systems to determine if pharmaceuticals are anticipated to occur in PWS and may require regulations under SDWA.

As described in the draft CCL 3 Federal Register (FR) Notice (73 FR 9652), the primary source of health effects information on pharmaceuticals in the Universe for the draft CCL 3 was the Food and Drug Administration Database on Maximum Recommended Daily Doses (MRDD). Occurrence information from USGS Toxics Substances Hydrology programs National Reconnaissance of Emerging Contaminants, and related efforts, provided ambient water concentration data for pharmaceuticals. Other data sources included TRI and high production volume chemical data. From this analysis, EPA included 287 pharmaceuticals in the Chemical Universe. These pharmaceuticals had MRDD information that EPA used to evaluate adverse health effects. EPA considered those pharmaceuticals for which MRDD values and occurrence information were available and pharmaceuticals that were in Toxicity Category 1, using the criteria discussed in Section III.A.2.a of the draft CCL 3 FR notice to screen contaminants for the preliminary CCL (PCCL).

The screening process moved 29 of the pharmaceuticals in the Universe to the PCCL. Only one of those chemicals (diazinon, a veterinary product as well as a pesticide) had water concentration data. Two other pharmaceuticals: phenytoin (an anticonvulsant) and nitroglycerin (treatment of angina), had release data. The remainder were

### Based upon this re-evaluation in response to comments, EPA concluded that one antibiotic (erythromycin) and

nine hormones (17 alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, mestranol, and norethindrone), should be included on the CCL 3 because these contaminants are known or anticipated to occur in public water systems and may require regulation. The specific data used to evaluate these contaminants can be found in the supporting documents (PCCL Contaminant Information Sheets in the appendix to “Contaminant Candidate List 3 Chemicals: Screening to a PCCL”, and the “Final Contaminant Candidate List (CCL) 3 Contaminant Information Sheets” in the docket at www.regulations.gov.)

Several commenters noted that pharmaceuticals should be included on the UCMR. The 1996 amendments to SDWA instituted the CCL and UCMR programs to prioritize and focus data collection and regulatory consideration on the potential drinking water contaminants that present the highest priorities for future drinking water regulation. The CCL is the primary mechanism for the identification of this priority list of contaminants that may require regulation, while UCMR provides EPA with the national occurrence data necessary to determine if a contaminant occurs with a frequency and at levels of public health concern. The statute itself provides a direct linkage between the two programs by requiring EPA to consider the UCMR data in establishing the CCL. (Section Strengthening Science - EPA has several activities underway to strengthen the science for understanding the behavior of PPCPs in water including, research, methods development, and occurrence (in fish tissue, wastewater and biosolids) studies. EPA's Office of Research and Development is engaged in a broad research portfolio to answer key questions associated with exposure pathways, health, and aquatic life effects of pharmaceuticals in water. An inventory of projects developed for the period from 1996 through 2014 is available at www.epa.gov/ppcp. The Agency also supports and cooperates with research efforts carried out by outside groups, such as the American Water Works Association Research Foundation (AwwaRF) and Water Environment Research Foundation (WERF). EPA has research underway to help understand whether very low levels of pharmaceuticals in water might present a risk to human health. EPA has commissioned the National Academy of Sciences to provide their ideas and opinions on how to determine potential risks to human health.

EPA commissioned the National Research Council (NRC) of the National Academy of Sciences (NAS) to convene an expert panel to provide their ideas and opinions on the potential human health risks that may be caused from exposure to low levels of pharmaceuticals in drinking water. EPA sought input on approaches to screen pharmaceuticals that occur in drinking water at low concentrations. EPA also sought the expert’s views on Improving Public Understanding - It is important to communicate with the public about available data and any associated uncertainty with the data. To help in this regard, EPA has developed a Web site focusing specifically on PPCPs in water (www.epa.gov/waterscience/ppcp), and a website with a primary focus on the Agency's research (www.epa.gov/ppcp).

Identifying Partnerships for Promoting Stewardship - Federal, state and local agencies, industry and others all have a role to play in better understanding and addressing issues regarding pharmaceuticals in water. Collaboration and building partnerships for stewardship are important components. Below are a few of the activities EPA is engaged in on this front.

EPA sent 112 letters to state public health and environmental departments in March, 2008 requesting information on the states’ activities and initiatives involving pharmaceuticals. The Agency specifically requested information on pharmaceuticals in the areas of occurrence, human health effects research, analytical methods development, and stewardship. EPA received 37 responses to those letters, 16 of which commented specifically on the CCL 3. Responses to those 16 letters are included in this response to public comment document.

### Comments included under this comment code are background and introductory statements provided by the

commenter to introduce the organization and its purpose, confirm that the comment is in reference to the draft CCL 3, provide the commenter's expertise, or provide an opening or closing of the cover letter. The complete references cited are also included under this comment code. EPA reviewed and evaluated the information in the references under the specific topic that the commenter cited. The complete list of references is included to provide the complete bibliographic citations. The Agency believes that no response is necessary for these comments and refers the reader to the specific comment code for the topic of interest and the Agency's

### EPA_TEAM_MEMBER DRAFT_STA TUS DATE_UPLOADED

26-SEP-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 12-NOV-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08

### 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08

### 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 James Sinclair 08-JUL-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08

### Meredith (uploaded by

MLB) 30-JUL-09

03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08

### 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08

### 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08

### 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08 02-JUL-08 02-JUL-08 03-JUN-08

### 02-JUL-08 02-JUL-08 03-JUN-08 08-JUL-08 08-AUG-08 03-JUN-08 03-JUN-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 03-JUN-08 03-JUN-08 08-AUG-08 08-AUG-08 08-AUG-08 24-AUG-09

08-AUG-08 08-AUG-08 03-JUN-08 03-JUN-08

03-JUN-08 06-AUG-08 03-JUN-08 03-JUN-08

### 03-JUN-08 03-JUN-08 03-JUN-08

03-JUN-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 08-AUG-08 03-JUN-08 08-AUG-08 08-AUG-08 08-AUG-08 Meredith (MB upload) 25-JUN-09

### 08-AUG-08

### 03-JUN-08 08-AUG-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 08-AUG-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 10-FEB-09 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08 03-JUN-08

### 17-AUG-09

26-SEP-08

### NOTES

### Cadmus: This is the response for comment ID 18929, but it was too long to fit in

that individual comment field. When developing the comment response document please move this response to comment ID 18929.

### ***Cadmus please move this response to comment ID 19338 when preparing

comment response document***

### COMMENT_ID LETTER_ID COMMENT_CODE_ID

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### 18945 6549 1648

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### 19138 6568 1552

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### 19294 6582 1694

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### 18995 6522 1694

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### 19381 6586 1611

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### 19582 6554 1455

19583 6554 1633 19586 6556 1620 19587 6574 1633 19588 6574 1650 19151 6569 1603 19591 6573 1648 19592 6573 1648 19593 6573 1648 19595 6572 1650 19596 6556 1617 19598 6585 1650 19599 6587 1650 19600 6587 1650 19601 6573 1648 19602 6573 1650 19603 6583 1650 19604 6603 1650 19605 6603 1650 19606 6608 1650 19607 6611 1650 19609 6576 1650 19610 6573 1648 19611 6573 1648 19612 6574 1650 19613 6574 1650 19614 6549 1648 19615 6549 1648 19616 6554 1455 19617 6554 1455 19619 6584 1650 19620 6563 1650 19621 6586 1623 19319 6567 1329 18903 6552 1491 19346 6577 1634 20316 6572 1641 20317 6572 1641 20318 6572 1641 20319 6572 1641 20320 6572 1641 20321 6572 1641 18965 6548 1321 18970 6551 1694 18971 6551 1494 18972 6551 1495 18980 6518 1694

### 18909 6552 1456

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### 19441 6607 1694

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### 19078 6557 1612

19079 6557 1603 19081 6557 1604 19088 6557 1603 19090 6557 1602 19091 6557 1694 19113 6563 1509 19114 6563 1650 19115 6563 1694 19122 6565 1694 19123 6565 1650 19126 6565 1694 19181 6572 1645 19182 6572 1508 19183 6572 1546 19184 6572 1547 19185 6572 1545 19186 6572 1552 19193 6572 1693 19194 6572 1641 19195 6572 1672 19196 6572 1641 19197 6572 1651 19235 6574 1645 19254 6576 1341 19255 6577 1694 19256 6577 1329 19257 6577 1650 19264 6578 1694 19280 6581 1694 19282 6581 1431 19283 6581 1344 19284 6581 1431 19285 6581 1344 19286 6581 1431 19287 6581 1344 19288 6581 1329 19289 6581 1694 19329 6567 1638 19330 6567 1650 19332 6567 1650 19340 6562 1633 19341 6562 1348 19342 6562 1643 19343 6562 1650 19344 6562 1639 19347 6577 1694

### 19356 6542 1694

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### 19395 6586 1335

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### 18999 6524 1694

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### 19339 6562 1639

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