1 

## Response to Comments Received on the April 6, 2010 , Federal Register Proposed Rule (75 FR 17333):

Addition of National Toxicology Program Carcinogens; Community Right

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- Know Toxic Chemical Release Reporting

August 12 , 2010 U.S. Environmenta l Protection Agency Office of Information Analysis and Access Ariel Rios Building 1200 Pennsylvania Ave., NW Washington, DC 204602 Comment Number Commenter

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- 0142 Anonymous

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- 0143 Steven A Paulus

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- 0144 Jeff Brubaker

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- 0145 Richard Cogliano

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- 0146 Chemical Products Corporation

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- 0147 International Institute of Synthetic Rubber Producers, Inc.

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- 0148 OMB Watch

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- 0149 Gretchen Brewer, PT AirWatchers

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- 0150 Darlene Schanfald3 Commenter: Anonymous [EPA

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# PUBLIC SUBMISSION **As of:** July 22, 2010 **Received:** April 07, 2010 **Status:** Posted **Posted:** April 09, 2 010 **Tracking No.** 80ad2918 **Comments Due:** June 07, 2010 **Submission Type:** Web

Docket: EPA

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- 0006 Addition of National Toxicology Program Carcinogens; Community Right

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Comment On: EPA

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Document: EPA

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Submitter Information

General Comment

For your non

- chemist audience, the list of chem icals is difficult to discern. Please consider adding 'shelf name' trade names, or names of products these chemicals are in, and the possible side effects if known. Thanks.

EPA Response: Most of the chemicals being proposed for listing do not have simple trade names or “shelf names” as they are not commonly used in consumer products. EPA uses the specific chemical names so that facilities that manufacture, process, or otherwise use them can readily identify if they have them. In some cases, where there i s a common less technical name, EPA will include that name as well. EPA does maintain a document of common synonyms that contains other names for the chemicals included on the Toxics Release Inventory. The commenter requested additional information on th e chemicals proposed for listing which isn’t relevant to the current rulemaking. EPA’s Substance Registry Services ( http://iaspub.epa.gov/sor_internet/registry/substreg/home/overview/home.do) contains information on other EPA programs, as well as non

- EPA sources, that may have additional information about the chemicals.4 Commenter: Steven A Paulus [EPA

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Comment: Name: Steven A Paulus


## Addition of National Toxicology Program Carcinogens; Community Right

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After reading this listing of chemical that needs to be added into the National Toxicology Program Carcinogens and the side effects of the chemical themselves toward human health I Steven A Paulus supports this proposed ruling. This ruling provi ded a new addition of chemical that the EPA (Environmental Protection Agency) proposed to be added into the NTPC (National Toxicology Program Carcinogens) based on the EPCRA (Emergency Planning and Community Right

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- Know Act of 1986) and the PPA (Pollutio n Prevention Act of 1990). This National Toxicology Programs Carcinogens listed the entire chemical that has the ability to trigger a cell mutation in human in turn caused cancer. In order to be listed in the NTPC the chemical have to fulfill a certain

re quirement based on the EPCRA section 313(d)(2) in which states that the chemical is known to cause a significant adverse acute human health effects at concentration level. Secondly the chemical is known to cause variation of mutations such as cancer, tumor
, and other irreversible mutations.

Asides from being a carcinogen, the EPA needs also to inform the public whether the chemical that they proposed to be listed in the EPCRA or already listed can contaminated the environments, and also from where does th e production of the chemical comes into being. The EPA also needs to list a potential contamination into the public drinking water and also food source before the chemical is listed. For example the EPA need to include the uses of Phenolphthalein, for cent ury the chemical that is known as Phenolphthalein was used as a laxative medicine, only just recently (2003) it is removed from being used as a laxatives due to the side effect it has such as diarrhea and skin rashes. This side effect may not be much but s till important enough to be listed, after all according to the EPCRA section 313(d)(2) a chemical that shown to cause a significant adverse acute human health effects at concentration level deserve to be listed along as its possibility of causing cancer. T he EPA also needs to include what other uses of the chemical so that the public understand what the possible causes of their illness and also the contamination of the environment around them. What it is meant by other uses, is that for vinyl fluoride one f orm of the chemical is used to make rain coats, while phenolphthalein is used for a pH testing in a chemistry lab. Although this other information is not included during the formation of this ruling, I highly insist that the EPA also include them in the NT PC listing, that the public may be better informed on what chemicals are around them. And also the EPA need to stop labeling their status as a possible caused for cancer and start labeling them as a caused for cancer, not just a half answer. Also EPA needs to make the list available to the public and made them an easy access, right now just to find the list you need to look all over the place and if you don’t know what word you use you won’t be able to find them. As for now the list can be found5 at http://ntp.niehs.nih.gov/index.cfm?objectid=32BA9724

- F1F6

- 975E

7FCE50709CB4C932

EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcino gens on the Toxics Release Inventory. The commenter’s suggestions for additional information on the 16 NTP carcinogens or for changing how carcinogens are categorized are outside of the scope of this rulemaking. EPA notes that some of the requested infor mation may be available through other EPA programs ( http://iaspub.epa.gov/sor_internet/registry/substreg/home/overview/home.do ) or in the economic analysis document prepared for this rulemaking. The economic analysis document contains information on the uses of the chemicals and the types of facilities that may manufacture, process, or otherwise use the chemicals.6 Commenter: Jeff Brubaker [EPA

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Comment:

Jeffery Brubaker <jsbrubaker@gmail.com> 04/12/2010 06:22 PM

To Docket OEI@EPA

cc bcc Subject Comment on Docket ID No. EPA

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I am submitting this comment as an individual citizen. I support the proposed rule, because disseminating information to the public about chemicals that may be carcinogens is important to public health. Firms that release these chemicals should be encouraged to develop alternatives that are found to be of less risk to the public.

Jeff Brubaker Carrboro, NC

EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcinogens on the Toxics Release Inventory.7 Commenter: Richard Cogliano [EPA

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Comment:



# PUBLIC SUBMISSION **As of:** July 22, 2010 **Received:** Apri l 18, 2010 **Status:** Posted **Posted:** April 20, 2010 **Tracking No.** 80adad2d **Comments Due:** June 07, 2010 **Submission Type:** Web

Docket: EPA

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- 0006 Addition of National Toxicology Program Carcinogens; Community Right

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- Know Toxic Chemical Release Report ing

Comment On: EPA

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Document: EPA

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- 0145 Comment submitted by R. Cogliano

Submitter Information Submitter's Representative: Richard Cogliano

General Comment

Adding these 16 chemicals to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right

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- Know Act (EPCRA) is warranted and will result in the safety o f United States Citizens. Adding chemicals to the list based on the years of research by the National Toxicology Program. Of the sixteen proposed chemicals, all of them are “reasonably anticipated to be a human carcinogen” and are used currently in the Uni ted States. By adding these to the EPCRA reporting chemical list, firefighters in communities which have them chemicals will be better informed of them and their possible carcinogenic effects. Industries using these chemicals will now have to report their use and pay added administrative fees to states, increasing funding to Local Emergency Planning Commissions thus enabling better planning and preparedness for the communities they serve. As a firefighter and Hazmat Technician, I know firsthand the hazards chemicals pose and the need for increased planning and preparedness.

EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcinogens on the Toxics Release Inventory.8 Commenter: Chemical Products Corporation [EPA

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Comment:

May 21, 2010

Office of Environmental Information (OEI) Docket Environmental Protection Agency, Mail Code : 28221T 1200 Pennsylvania Ave ., NW. Washington, DC 20460

Re : Docket I .D . No . EPA

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Classification by NT P as "reasonably anticipated to be a human carcinogen" is not an adequate scientific justification for the addition of 16 chemicals to EPA's list of toxic chemicals subject to the reporting requirements of section 313 of EPCRA

Dear Sir or Madam;

The following comments are submitted by Chemical Products Corporation (CPC), a Georgia corporation located at 102 Old Mill Road SE, Cartersville, Georgia.

EPA has proposed the addition of 16 chemicals to its list of toxic chemicals subject to the reporting requirements of section 313 of EPCRA as a result of classification by the National Toxicology Program (NTP) of these chemicals as "reasonably anticipated to be a human carcinogen". NTP's classification of these 16 chemicals is shown in the 75FR65 notice to be primarily based upon evidence from animal studies presented in NTP technical reports. CPC will demonstrate below that NTP technical reports cannot be relied upon to reflect sound science and, therefore, should not be the basis for EPA to add these 16 c hemicals to its list of toxic chemicals subject to the reporting requirements of section 313.

Only 2 of the 16 chemicals proposed for addition by EPA are included in the International Agency for Research on Cancer (IARC) Group 2A list (Probably Carcinog enic to Humans); we suggest that EPA should rely upon the IARC Group 2A list and add only these 2 chemicals

- Glycidol (CAS No . 556

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- 5) and Vinyl Fluoride (CAS No . 75

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- 5).

This letter will document the failure of the National Institute of Environm ental Health Sciences (NIEHS) and the NTP to assure research integrity in the preparation of NTP technical reports. Classification of the 16 chemicals as "reasonably anticipated to be a human carcinogen" in NTP's Report on Carcinogens is based to a large e xtent on NTP technical reports according to the information provided for each chemical in EPA's proposed rule published in 75FR65 (April 6, 2010, 17333). The deficiencies documented9 below in one technical report

- NTP Technical Report 494 (the only one eva luated exhaustively by CPC) demonstrate that NTP technical reports cannot be relied upon to represent sound science and should not be the basis for EPA listing proposals.

Factually incorrect information was presented to the NTP Board of Scientific Couns elors Technical Reports Review Subcommittee on December 9, 2004 to achieve acceptance of the conclusions presented in NTP Technical Report 494 (TR494).

Animal studies were conducted in the mid

- 1990's on the TR494 test article, Anthraquinone produced by the nitric acid oxidation of anthracene (a production method that is no longer used). Contamination of the non

- mutagenic anthaquinone with the potent mutagen 9

- nitroanthracene was discovered several years after completion of the TR494 animal studies . The 9

- nitroanthacene contamination of the test article confounds interpretation of the animal studies in which cancers were observed. TR494 contains factually incorrect information which hides the biological significance of the potent mutagenic contamination in the TR494 test article, thus the conclusions presented in TR494 do not represent sound science.

NTP scientists stated that "Sample A07496" was an aliquot of the TR494 Anthraquinone test article, "Lot 5893" at the December 9, 2004 TR494 peer review an d cited a negative mutagenicity assay of "Sample A07496" as a definitive demonstration that contamination of the TR494 test article by the potent mutagen 9

- nitroanthracene had not confounded interpretation of the TR494 studies. CPC determined, through FOIA requests, that NTP had no records associating "Sample A07496" with the TR494 test article, "Lot 5893". CPC submitted a Request for Correction of TR494 following the Department of Health and Human Services Information Quality Guidelines on May 31, 2006 (se e "a. Request for Correction (RFC)" at "28. NTP

- Technical Report 494 [Anthraquinone]", http://aspe.hhs.gov/infoQuality/reguests.shtml).

After CPC submitted its Request for Correction of TR494 on May 31, 2006, a false Bulk Chemical Shipment Report was generated by NTP in June 2006 purporting to demonstrate that the TR494 test article, labeled "Anthraquinone Lot 5893", had been shipped from the repository for all retained TR494 test article, Battelle Columbus Laboratories, to BioReliance Testing Laborato ries on June 1, 2004 (for mutagenicity assay). Months later, through a FOIA appeal, CPC obtained a copy of the BioReliance Testing Laboratories (BTL) Test Article Receipt and Transfer Report showing that the sample in question, received by BioReliance on J une 2, 2004, was labeled only "A07496 store at RT No Exp Date given Sieved 8 mesh" upon arrival

- not "Anthraquinone Lot No. 5893" as shown on the false Bulk Chemical Shipment Report (see the attachment to "c.2 Amended RFR" under "28. NTP

- Technical Repor t 494 [Anthraquinone]" at http://aspe.hhs gov/infoQualitly/requests.shtml ). Yet NIEHS ignored this information in its final response to CPC's Request for Reconsideration which states in part, "The samples were labeled by lot number, the standard informati on that is included on samples. BioReliance received the materials on June 2, 2004. You were sent this record previously. Battelle sent NTP the Bulk Chemical Shipment Report dated June 22, 2004 verifying it had shipped samples of the 4 anthraquinone lots t o BioReliance on June 1,10 2004. This document also was provided by NTP to you in NTP's Response to the Request for Correction. BioReliance confirmed assignment of each test article aliquot number to the correct lot of anthraquinone ." (underline added, the r esponse letter from Dr. Joyce Martin at NIEHS is available at "d.9 HHS response to RFC" under "28. NTP

- Technical Report 494 [Anthraquinone]", http://aspe.hhs .gov/infoQuality/requests.shtml).

NTP's only evidence that "Sample A07496" is an aliquot of t he TR494 test article "Lot 5893" is an email from the project manager at BioReliance giving a positive response to an NTP staff member's request that BioReliance "please confirm that Sample A07496 is Lot 5893". Thus, NIEHS contends that BioReliance confirm ed "assignment of each test article aliquot number to the correct lot of anthraquinone"

- for a sample which was not labeled with a lot number when received by BioReliance . Further evidence that NTP fabricated a Bulk Chemical Shipment Report in June 2006 i n response to CPC's Request for Correction of TR494 is provided by the final response to CPC's September 30, 2008 FOIA request (dated October 27, 2008) which states that the Office of Management and the National Toxicology Program searched their files and no records of any parcels sent from Battelle Columbus Laboratories or Battelle Columbus Operations during the period May 24, 2004 through June 4, 2004 related to NTP activities were found (FOI Case No . 35487).

NTP Technical Report 494 also misrepresent s the scientific record regarding mutagenicity assay results for Anthraquinone's primary metabolite, 2

- hydroxyanthraquinone. In attempting to defend TR494, NTP has cited its own preincubation assay purporting to show that metabolite 2

- hydroxyanthraquinone is a strong mutagen for Salmonella typhimurium strain TA98 in the absence of metabolic activation (see "d.9 HHS response to RFC" at "28. NTP

- Technical Report 494 [Anthraquinone]", http://aspe.hhs.gov/infoQuality/requests.shtml). The existence of a confli cting mutagenicity assay for 2

- hydroxyanthraquinone which was negative for TA98 in the absence of metabolic activation is omitted from TR494. TR494 states at page 91 that Tikkanen et al. (1983) did not perform testing in the absence of S9 metabolic activat ion ; in fact, negative preincubation assays of 2

- hydroxyanthraquinone in strains TA98, TA100 and TA2637 in the absence of S9 activation were reported by Tikkanen et al. (Tikkanen, L.; Matsushima, T.; Natori, S.; Mutagenicity of anthraquinones in the Salm onella preincubation test; Mutation Research; 116[3

- 4]:297

- 304; March 1983).

A negative assay of 2

- hydroxyanthraquinone in TA98 without metabolic activation has also been reported by Butterworth et al . (Butterworth, B.E ., Mathre, O.B., and Ballinger, K .E., Adalsteinsson, O.; Contamination is a Frequent Confounding Factor in Toxicology Studies with Anthraquinone and Related Compounds; Int a Toxicol; 23; No. 5; 335

- 344; 2004).

A lengthy and involved investigation was required to determine that TR494 d oes not represent sound science and to expose possible coordinated misconduct on the part of NTP scientists Dr. Richard Irwin, Dr. John Bucher, and Dr. Cynthia Smith; an investigation of this magnitude is far beyond the capabilities of a NTP peer review pa nel or a NTP Report on Carcinogens review panel, so the number of other NTP technical11 reports which do not represent sound science is unknown

- and the number of subsequent scientifically unsound classifications of substances as "reasonably anticipated to be a human carcinogen" in NTP's Reports on Carcinogens is also unknown.

Fortunately, in the case of NTP Technical Report 494, the broader scientific community has recognized that the report is deficient and the scientific record is being corrected . Pro fessor Alan R. Boobis et al. recently stated in the journal Toxicologic Pathology , " The data for anthraquinone {in NTP Technical Report 494} are considered suspect because other carcinogenicity studies were negative, and the NTP carcinogenicity study used a batch of anthraquinone contaminated with the potent mutagen 9

- nitroanthracene at a level of 1,200 ppm (Butterworth, Mathre, and Ballinger 2001). (A purified sample was negative in the Ames test.) Certainly, it can be said that the material used by the N TP was mutagenic" [Alan R . Boobis, Samuel M. Cohen, Nancy G. Doerrer, Sheila M. Galloway, Patrick J. Haley, Gordon C. Hard, Frederick G. Hess James S. Macdonald, Stephane Thibault, Douglas C. Wolf and Jayne Wright; A Data

- Based Assessment of Alternative S trategies for Identification of Potential Human Cancer Hazards; Toxicol Pathol; 37; 714

- 732; 2009

- see page 719] . Professor Boobis of Imperial College London, the first

- named author, received an OBE for his work on the risk assessment of pesticides in 20 03. He is an Honorary Member of EUROTOX, a Fellow of the British Toxicology Society and a Fellow of the Institute of Biology. It is this broader scientific community represented by the IARC that EPA should reply upon for a determination that a substance is probably carcinogenic to humans.

As demonstrated above, NTP technical reports cannot be relied upon to represent sound science. EPA should rely upon IARC inclusion of a substance on its Group 2A list ("Probably Carcinogenic to Humans") as the basis for addition to EPA's list of toxic chemicals subject to the reporting requirements of section 313 of EPCRA.

Of the 16 chemicals proposed by EPA for addition to EPA's list of toxic chemicals subject to the reporting requirements of Section 313, 14 have bee n evaluated by IARC and only 2 have been included on IARC's Group 2A list (Probably carcinogenic to humans)

- these are Glycidol (CAS No. 556

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- 5) and Vinyl Fluoride (CAS No . 75

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- 5) . 1

- Amino

- 2,4

- Dibromoanthraquinone (CAS No. 81

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- 2) and Methyleugenol (CAS No . 93

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- 2) have not yet been evaluated and classified by IARC.

CPC submits that a sound scientific basis exists for the addition of only 2 of the 16 substances proposed by EPA for addition to its list of toxic chemicals subject to reporting und er section 313 of EPCRA and section 6607 of the Pollution Prevention Act of 1990 (PPA); these are Glycidol (CAS No . 556

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- 5) and Vinyl Fluoride (CAS No. 75

- 02

- 5) because these chemicals are included in IARC's Group 2A listing.

In summary, the only NTP technical report carefully scrutinized by CPC (Technical Report 494) has been documented to contain factual errors underpinning the conclusions presented in this report . The demonstration that this NTP technical report presents scientifically untenable c onclusions, coupled with NIEHS's refusal to correct the scientific record, brings the scientific validity of all NTP technical reports into question.12 Not only has NIEHS refused to correct the scientific record for Anthraquinone, the TR494 test material, bu t the Office of Research Integrity has also stated that it lacks authority to investigate possible misconduct on the part of NTP scientists related to TR494; Dr. John E . Dahlberg stated in a letter to CPC dated January 16, 2009 that "ORI does not have the authority, to conduct the investigation you request. Our role is limited by departmental policy to conducting oversight review of investigations conducted by the institutions where the alleged misconduct took place." . We submit that the above illustrates that NTP technical reports, the primary basis for NTP classification of the chemicals addressed in the 75FR65 proposed rule as "reasonably anticipated to be a human carcinogen", should not be relied upon by EPA to make decisions regarding addition of chem icals to its list of toxic chemicals subject to reporting under section 313 of EPCRA. We suggest that EPA rely instead upon the IARC Group 2A list and add only those chemicals which appear on the IARC Group 2A list

- Glycidol (CAS No. 556

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- 5) and Vinyl Fluoride (CAS No . 75

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- 5).

If I can answer any questions about this letter or provide any further information, please email me at icook@cpc

- us.com or phone me at 770

- 382

- 2144 Ext. 272.

Sincerely,

Jerry A . Cook Technical Director

EPA Response: EPA notes that the commenter is questioning the validity of an NTP tech nical report that is unrelated to any of the chemicals that EPA proposed for listing. The report in question concerns anthraquinone, a chemical that was not the subject of the
propose d rule, is not on the EPCRA section 313 listof toxic chemicals , and is not classified as a carcinogen in the NTP’s 11 th Report on Carcinogens. The commenter believes that the scientific validity of all of the NTP technical reports is questionable because of problems they have with one of the NTP technical reports. As this report is outside the scope of the proposed rule, EPA is not addressing the specific issues the commenter has with the report or the NTP’s responses to the commenter. EPA does not beli eve that issues raised about one NTP technical report mean that the scientific validity of all NTP technical reports should be in question. As EPA discussed in the proposed rule, the NTP review process for the Report on Carcinogens is extensive and includ es both peer review and public comment (75 FR 17335, April 6, 2010). In addition, as discussed in the proposed rule (75 FR 17336, April 6, 2010), EPA reviewed the NTP chemical profiles and supporting m aterials for each chemical proposed for listing

. The commenter has provided no data that would suggest that the NTP reports for the 16 chemicals being added to the EPCRA section 313 list are flawed or any data that would suggest the chemicals do not meet the EPCRA section 313(d)(2)(B) listing criteria. The Agency finds no specific basis to question any of the NTP documents used to support the listing of the 16 chemicals included in this rule based on these comments.

Regarding the commenter’s suggestion that EPA only add those chemicals that have been class ified as Group 2A (probably carcinogenic to humans) by the International13 Agency for Research on Cancer (IARC), EPA notes that the scientific data for a number of chemicals classified as Group 2B ( possibly carcinogenic to humans ) under IARC has been found t o be sufficient to support listing under EPCRA section 313 (see for example, 59 FR 1788, January 12, 1994). These determinations were the result of a case

- by

- case analysis of the available cancer data, they were not based solely on the IARC cancer classif ication. Thus, EPA would not limit the listing of carcinogens to only chemicals with IARC Group 2A classifications and even for IARC 2A classified chemicals EPA would review the available cancer data before making a listing determination

.14 Commenter: Int ernational Institute of Synthetic Rubber Producers, Inc. [EPA

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Comment:

Office of Environmental Information Docket 1 June 2010 US Environmental Protection Agency Mail Code: 28221T 1200 Pennsylvania Ave. N.W. Washington, DC 20460

Sent via email to oeidocket@epa.gov

RE: Docket ID No. EPA

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Thank you for the opportunity to provide comments on the listing of isoprene in the list of substances subject to reporting under Section 313 of the Emergency Planning and Commun ity Right

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- Know Act of 1986. These comments are being made on behalf of the members of the International Institute of Synthetic Rubber Producers, Inc. (IISRP), a

non

- profit trade association representing the interest of the synthetic rubber industry. O ur members, who produce and/or consume isoprene, have a keen interest in this notice. We have conducted significant scientific research on this substance and have provided the findings to governments and/or regulatory bodies.

The IISRP has reviewed the t oxicology summary and overall there are no factual inaccuracies however there are interpretations of the data we believe should be noted plus there are certain environmental data which should be included in the record.

First the text refers to similaritie s between isoprene and butadiene. I should also point out that isoprene differs from 1,3

- butadiene in that for isoprene, there has been no elevations in thymic lymphoma in exposed mice at any concentrations tested (Placke et al 1996). While not necessarily ascribing to the view of Melnick & Sills (2001) to the relevance of lymphomas induced in mice to lymphatic/hematopoetic cancers in humans, the absence of this response in mouse with isoprene is noteworthy since the basis of butadiene's International Agen cy for Research on Cancer (IARC) Group1 classification is all hemolytic organs (which would include lymphomas).

The various other tumor types occurring with isoprene or butadiene in mice are not seen in epidemiology studies of butadiene exposed populatio ns. Further, there were no elevations in tumors found in mice at the lowest exposure tested (10 ppm; 28 mg/m 3 ) and this together with the fact that isoprene is produced endogenously in humans suggests that there is a threshold for such a response. Based o n the above, this supports the IARC 2B categorization of isoprene as a "possible" human carcinogen rather than the "reasonably anticipated" categorization by NTP, which triggers the TRI listing.15 Next we point to the omission of environmental data which sh ould be included in the record. The International Agency for Research on Cancer notes that isoprene occurs in the environment as emissions from vegetation, particularly from deciduous forests. In the United States the total emission rate of isoprene from deciduous forests has been estimated to be 4.9 tonnes per year, with the greatest emissions in the summer. The global annual emission of isoprene in 1988 was estimated to be 285 000 thousand tonnes.

Also, a paper by Sharkey et al., states with citations isoprene is the dominant hydrocarbon released by vegetation in most ecosystems (Guenther et al. 1994, Geron et al. 1994). Isoprene release by vegetation, particularly trees (Rasmussen1970), exceeds anthropogenic hydrocarbon release to the atmosphere (Lamb et al. 1987, 1993).

Isoprene is produced endogenously in humans. It has also been found in tobacco smoke, gasoline, turbine and automobile exhaust and in emissions from wood pulping, biomass combustion and rubber abrasion (United States National Library of Medicine 1997).

Thank you again for providing the opportunity for our comments. I will be pleased to address any questions you may have and can contact me at the address below.

Sincerely, Sent via email

James L. McGraw Managing Director & CEO IISRP 2077 S. Gesner Road # 133 Houston, TX 77063 Phone: 713.783.7511 ext 222 jlmcgraw@iisrp.com

References:

M.E. Placke, L. Griffis, M. Bird, J. Bus, R.L. Persing, & L. A. Cox (1996) Chronic Inhalation study of iso prene in B6C3F1 mice Toxicology, 110 (1

- 3), 253

- 262

R.L.Melnick & R.C.Sills (2001) Comparative carcinogenicity of 1,3

- butadiene, isoprene and chloroprene in rats and mice. Chemico

- Biological Interactions 135

- 136, 27

- 42

IARC Monograph (Vol 71, p1016, 1999)

Sharkey et al., Tree Physiology 16, 649

-- 654, 199616 EPA Response: EPA disagrees with the IISRP that EPA should use the IARC "possible" human carcinogen classification for isoprene rather than the "reasonably anticipated" categorization by NTP. S ince isoprene is an analog of 1,3

- butadiene, the NTP provided data on 1,3

- butadiene under the section on “Additional Information Relevant to Carcinogenicity” (NTP, 2005. National Toxicology Program. 11th Report on Carcinogens

— Isoprene Substance Profile. Re leased January 31, 2005. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709). The commenter pointed out differences between isoprene and butadiene, however, the NTP also recog nizes that there are differences in the data for isoprene and 1,3

- butadiene as evidenced by the NTP’s classification of 1,3

- butadiene as a “known to be a human carcinogen” (http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s025buta.pdf). For isoprene, th e NTP found evidence of tumor formation at multiple organ sites in multiple species of experimental animals (see NTP isoprene profile). Nothing in the commenter’s statements leads EPA to believe that isoprene is not correctly classified by NTP as “reasona bly anticipated to be a human carcinogen” or that the data underlying that classification suggests the isoprene does not meet the EPCRA section 313(d)(2)(B) listing criteria.

E PA also disagrees with IISRP’s characterization that the NTP classification i s a trigger for TRI listing. According to EPCRA § 313(d)(2), a chemical may be added to the TRI list if it “is known to cause or can reasonably be anticipated to cause in humans cancer.” Particular listings by scientific bodies, such as the NTP, are usef ul in determining whether that standard has been met but are not necessarily triggers for listing under EPCRA. EPA does not take an IARC G roup 2B classification to automatically mean that a chemical would not meet the EPCRA section 313 listing criteria. EPA again notes that in previous EPCRA section 313 listing decisions, the scientific data for a number of chemicals classified as Group 2B ( possibly carcinogenic to humans ) under the IARC has been found to be sufficient to support listing under EPCRA s ecti on 313 (see for example potassium bromate, sodium o

- phenylphenoxide, and other chemicals in 59 FR 1788, January 12, 1994). These determinations were the result of a case

- by

- case analysis of the available cancer data; they were not based solely on the IARC cancer classification. Thus, EPA would not limit the listing of carcinogens to only chemicals with IARC Group 2A classifications . Even for IARC 2A classified chemicals, EPA would review the available cancer data before making a listing determination.

The environmental data that the commenter suggests in miss ing from the rulemaking record actually is discussed in detail in the support ing documents cited in the proposed rule. For example, reference number 13 in the proposed rule (NTP, 2005. National Tox icology Program. 11th Report on Carcinogensbv

– Isoprene Substance Profile. Released January 31, 2005. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709) contains the followin g discussion:

“ Exposure

Isoprene is formed endogenously in humans and is generally the major hydrocarbon (up17 to 70% in human breath) (Gelmont et al. 1981). Concentrations in blood range from 15 to 70 nmol/L (1.0 to 4.8 μg/L) (Cailleux et al. 1992). Humans produce isoprene endogenously at a rate of 0.15 μmol/kg/h, equivalent to approximately 17 mg/day for a 150

- lb (70

- kg) person (Taalman 1996). Endogenous production rates reported for rats and mice are 1.9 an d 0.4 μmol/kg/h, respectively (Peter et al. 1987). Ambient air concentrations of isoprene are generally less than 10 ppb or approximately 0.03 mg isoprene/m 3 . Based on estimated human intake of 15 to 20 m 3 air per day, ambient air would contribute less tha n 0.45 to 0.6 mg/day to daily isoprene exposure.

NIOSH collected data on potential exposure to isoprene in the National Occupational Hazard Survey (NOHS) from 1972 to 1974 (NIOSH 1976) and in the National Occupational Exposure Survey (NOES) from 1981 to 1983 (NIOSH 1990). The first survey (NIOSH 1976) indicated that 58,000 employees in over 30 different industries were potentially exposed to isoprene. The more limited later survey of six industries showed that approximately 3,700 workers were potentially exposed to isoprene between 1981 and 1983 (NIOSH 1990). Isoprene is emitted from plants and trees and is widely present in the environment at low concentrations (Taalman 1996). Isoprene global emissions, estimated at 175 to 503 million Mg per year, repres ent approximately 44 to 51% of total global natural volatile organic compound emissions (Guenther et al. 1995). The average biogenic emission rate factor for isoprene in the United States is approximately 3 mg/m 2 /h. Isoprene concentrations in biogenic emis sions range from 8% to 91% of total VOCs, with a 58% average. Since isoprene biosynthesis is associated with photosynthesis, isoprene emissions are negligible at night (Guenther et al. 1994). The south central and southeastern areas of the United States ha ve the highest biogenic emissions. Summertime isoprene emissions are highest in each region and account for more than 50% of annual biogenic emissions (Lamb et al. 1993).

Sources of anthropogenic releases of isoprene to the atmosphere include ethylene
p roduction by cracking naphtha, wood pulping, oil fires, wood

- burning stoves and fireplaces, other biomass combustion, tobacco smoking (3,100 μg/cigarette), gasoline, and exhaust of turbines and automobiles (HSDB 2000).

Reported U.S. ambient air concentr ations of isoprene range from 0.003 to 0.06 mg/m 3 (1 to 21 ppb), with isoprene representing less than 10% of NMHCs (Arnts and Meeks 1980, Altschuller 1983, Lawrimore and Aneja 1997, Hagerman et al. 1997). During stagnation conditions, biogenic hydrocarbons may contribute more to total atmospheric hydrocarbons (Altschuller 1983).

Foods of plant origin would be expected to be a source of daily exposure to isoprene since it is emitted by agricultural crops and is the basic structural unit in countless natur al products found in foods such as terpenes and vitamins A and K (IARC 1994). Its occurrence has been reported in the essential oil of oranges, in the fruit of hops, and in the root of carrots (Duke 1992).

The primary source of isoprene in indoor air i s environmental tobacco smoke. Isoprene was found to be the major component of hydrocarbons in the air of a smoky café18 (10 smoking patrons, 10 not smoking) (16.7%) and sidestream smoke (29.2%) (Barrefors and Petersson 1993). A monitoring survey in November 1992 in homes and workplaces in the greater Philadelphia area found mean isoprene concentrations in personal air samples of 4.65 μg/m 3 in nonsmoking homes (n = 60), 18.15 μg/m 3 in smoking homes (n = 29), 5.29 μg/m 3 in nonsmoking workplaces (n = 51), and 2 2.80 μg/m 3 in smoking workplaces (n = 28). Differences in isoprene concentrations in personal air between nonsmoking and smoking sites were highly significant (Heavner et al. 1996). Another survey reported median summertime isoprene concentrations of 2.90 μg/m 3 in indoor air (n = 3; no information on whether occupants were smokers or nonsmokers) compared to 0.40 μg/m 3 in outdoor air (n = 1) in the Lower Rio Grande Valley of Texas (Mukerjee et al. 1997).”

As the text above clearly shows, information on env ironmental data was not omitted from the rulemaking record. However, as this information was not directly related to the hazard determination for isoprene being used as a basis to list the chemical, it was not included in the text of the Federal Register notice for the proposed rule.19 Commenter: OMB Watch [EPA

- HQ

- TRI

- 2010

- 0006

- 0148]

Comment:

June 7, 2010 Office of Environmental Information (OEI) Docket Environmental Protection Agency Mail Code: 28221T 1200 Pennsylvania Ave. NW Washington, DC 20460

Re: OMB Watch Comments on Docket ID No. EPA

– HQ

– TRI

– 2010

– 0006 "Addition of National Toxicology Program Carcinogens; Community Right

- to

Know Toxic Chemical Release Reporting"

Dear Sir/Madam:

OMB Watch is submitting these comments on the proposed rule t hat would add 16 chemicals to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right

- to

- Know Act (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA), 75 Fed. Reg. 17333

– 17349 (Apr il 6, 2010). 1

OMB Watch is a nonprofit research and advocacy organization whose core mission is to promote government accountability and improve citizen participation. Public access to government

- held information has been an important part of our work fo r more than 15 years, and we have both practical and policy experience with disseminating government information. For example, in 1989, we created the Right

- to

- Know Network (RTK NET), an online service providing public access to environmental data collecte d by the Environmental Protection Agency (EPA). Ever since, defending and enhancing the public's right to know about environmental and public health threats has been a leading cause at OMB Watch. Additionally, we are engaged in agency regulatory processes and encourage agency rules to be sensible and more responsive to public needs. The Toxics Release Inventory (TRI) has long been a prominent feature of RTK NET and the work of OMB Watch.

OMB Watch strongly supports EPA's proposal to add to the TRI 16 chem icals classified by the National Toxicology Program (NTP) as reasonably anticipated to be human carcinogens. An expansion of the list of chemicals covered by the TRI program has been needed for years. The chemicals EPA has selected for this expansion are a ppropriate, and their inclusion will strengthen the TRI program. However, the agency is taking a very small step toward enhancing a vital right

- to

- know program, and additional steps should be taken to expand the number of chemicals reported to TRI and the types and number of industries covered by the program.

According to the Government Accountability Office (GAO), approximately 700 new chemicals are introduced into commerce each year. 2 However, no chemicals

– old or new20 –

have been added to the TRI progr am since 1999 (for reporting year 2000). 3 Therefore, in the last ten years, approximately 7,000 new chemicals have been introduced into commerce, and not one is reported to the TRI program.

Obviously, not every chemical is dangerous enough to merit being tracked in the TRI program. But with numerous new chemicals being introduced and new facts about the toxicity and risks of existing chemicals being discovered all the time, a ten

- year freeze on expanding TRI seems rather indefensible.

PREVIOUS TRI EXPAN SIONS MAY SERVE AS MODEL

At the time of the last expansion of TRI in 1999, only five years had passed since the previous expansion. In 1994, with one rulemaking, EPA added 286 chemicals and chemical categories to the TRI. 4 In the 1994 proposed rule, EPA stated, "EPA and State regulatory agencies have integrated TRI information as a critical component in their environmental decisionmaking and in many cases are constrained by the lack of similar information on chemicals of concern not covered by the TRI." 5 There is strong reason to believe such constraints continue to hinder the environmental decision making of state and federal agencies today.

The 1994 rulemaking involved a comprehensive review of possible additions to the TRI chemical list. The agency ex amined chemicals regulated under ten different federal or state statutes, such as the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Federal Insecticide, Fungicide, and Rodenticid e Act (FIFRA), the Resource Conservation and Recovery Act (RCRA), and the Toxic Substances Control Act (TSCA). In addition, EPA reviewed chemicals that were possible, probable, or known carcinogens according to the International Agency for Research on Canc er (IARC) and the sixth NTP Report on Carcinogens (RoC). To prioritize chemicals, EPA obviously first excluded all chemicals that were already on the TRI list, and then "applied a human health and ecotoxicity screen and a production volume screen." The tox icity screen involved a limited review of available toxicity data. For the production volume screen, EPA used production volume data primarily from the TSCA Inventory Update Rule reports (section 8) and FIFRA section 7.

EPA recognized the need for the TR I to evolve and change as changes in industry and advances in scientific knowledge warranted. The comprehensive review and evaluation process that EPA undertook for the 1994 rulemaking is a strong example of the kind of analysis that should be a regular fe ature of the agency's implementation of the TRI
program.
The state of California's chemical right

- to

- know law, commonly known as Proposition 65, offers another strong example of a regular process for evaluating chemicals. 6 Proposition 65 adds chemicals t o its list of substances known to the state to cause cancer, birth defects, or other reproductive harm every year. The program also updates toxicity information for numerous listed chemicals each year. Proposition 65 draws on chemical21 data supplied by the EPA, U.S. Food and Drug Administration, National Institute for Occupational Safety and Health, NTP, IARC, and other experts.

OTHER CRITERIA FOR EVALUATING ADDITIONS TO TRI

EPCRA Section 313(d)(2) lists several criteria by which a chemical may be added to TRI. The known or reasonably anticipated carcinogenicity of a chemical is just one criterion. The EPA may also add a chemical to TRI if it is known to cause or may be reasonably anticipated to cause birth defects, reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects. The EPA may also add a chemical if it is known to cause or reasonably anticipated to cause a significant adverse effect on the environment because of the chemical's toxicity. EPA nee d only demonstrate that a chemical meets just one of these criteria to be considered for addition to the TRI list.

In its first proposed addition of chemicals to the TRI program in ten years, the EPA has chosen to focus on just one of the criteria it is authorized to use to evaluate chemicals for addition to TRI. Although the agency's evaluation is sound and the 16 proposed chemicals are entirely appropriate for inclusion in the TRI, we believe that EPA should also review chemicals based on every other cr iterion, as well. For example, EPA should evaluate non

- TRI chemicals for their reproductive toxicity, genotoxicity, or their adverse environmental impacts. Chances are high that among the tens of thousands of chemicals in commerce today, a significant numb er would meet at least one of the Section 313(d)(2) criteria for inclusion in the TRI.

EPA NEEDS A REGULAR TRI REVIEW

OMB Watch recommends that EPA establish a regular, periodic process for the agency to review and identify chemicals for possible addit ion to the TRI. Currently, the program allows the public and state governors to petition for the addition or removal of specific chemicals. But that process is too passive. Many in the public trust the EPA to be the expert voice on the issue of toxicity or risk from chemicals. A regular review will prevent the excessive, ten

- year

- long dearth of activity we just experienced.

The regular review process we are recommending should draw on data and expertise possessed by states, other nations, other federal an d international authoritative bodies, and EPA's own experts. EPA should also consider the results of biomonitoring studies, such as those conducted by the Centers for Disease Control and Prevention's (CDC) National Biomonitoring Program. 7 Biomonitoring mea sures the presence of specific contaminants in human bodies. Such data could be used both to broaden the universe of chemicals under consideration for addition to the TRI program and to identify priority chemicals.

Given the vast number of chemicals wort hy of evaluation for inclusion in TRI, and the extreme resource constraints afflicting the EPA, it is incumbent upon the agency to work with public stakeholders to develop a system for prioritizing specific chemicals or classes22 of chemicals for review. EPA has taken an important and deliberate first step toward prioritizing chemicals by selecting certain chemicals in the NTP's most recent RoC. However, this step is a very small one. The addition of only 16 chemicals and no new industry sectors after so many years of stagnation in the TRI program is a miniscule step in relation to the potential new and additional threats faced by citizens from toxic releases. The agency should now be working to identify additional chemicals, without waiting for the publicatio n of the final rule regarding the NTP carcinogens.

SUMMARY

OMB Watch, although highly supportive of the agency's proposal, encourages the EPA to expand its review of new chemicals to include the resources consulted in the 1994 rulemaking and any additi onal resources the agency identifies. EPA has the authority to evaluate chemicals for inclusion into TRI based on several criteria, in addition to a substance's carcinogenicity. All criteria should be applied. The EPA should establish a regular process for the this review that will also set priorities that recognize the agency's limited staff and funding resources and the scale of the review. We also encourage the agency to regularly analyze whether new industry sectors warrant addition to the list of

cover ed industries. Finally, as the agency develops these processes, it should work with public stakeholders in a transparent and participatory manner.

We appreciate your consideration of our comments on this issue. Please do not hesitate to contact us at (20 2) 683

- 4840 if you have any questions.

Respectfully, Brian Turnbaugh Policy Analyst, Environmental Right

- to

- Know

1 http://www.epa.gov/tri/lawsandregs/ntp_chemicals/NTPchemicals_proposed%20Rule040 62010.pdf

. 2 GAO. Options for Enhancing the Effectivenes s of the Toxic Substances Control Act. GAO

- 09

- 428T. http://www.gao.gov/new.items/d09428t.pdf

. 3 EPA added seven chemicals and two chemical compound categories, known as persistent, bioaccumulative toxics, for reporting year (RY) 2000. 64 Fed. Reg. 58665

– 58 753, October 29, 1999, http://www.epa.gov/fedrgstr/EPA

- WASTE/1999/October/Day

29/f28169.htm

. 4 59 Fed. Reg. 61432

– 61502. http://www.epa.gov/tri/archive/dialogues/natdiagphase1_oct02/phase2/chemicalexpfrule. pdf

. 5 59 Fed. Reg. 1788

– 1859. http://www.epa.gov/ tri/lawsandregs/trichemical/59fr1788.pdf

. 6 Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) is administered by California's Office of Environmental Health Hazard Assessment (OEHHA), http://oehha.ca.gov/prop65.html

. 7 http://www.cdc.g ov/biomonitoring/index.html

. EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcinogens on the Toxics Release Inventory. Regarding the comments that are not23 directly related to the addition of the 16 NTP carcinogens, EPA w ill take these comments under consideration as the Agency reviews other possible expansions of the EPCRA section 313 chemical list or covered industry sectors.24 Commenter: Gretchen Brewer [EPA

- HQ

- TRI

- 2010

- 0006

- 0149]

Comment:

PTAW <ptairwatchers@mailhaven. com> 06/07/2010 09:03 PM To Docket OEI@EPA

cc bcc Subject Docket ID No. EPA

- HQ

- TRI

- 2010

- 0006; FRL

- 9134

- 1

Docket ID No. EPA

- HQ

- TRI

- 2010

- 0006; FRL

- 9134

- 1 Re: addition of 16 chemicals to TRI reporting

EPA should include the proposed 16 chemicals among EP A's regulated TRI chemicals. Reducing use of carcinogenic and hazardous chemicals such as these and knowing when and where they are being emitted is essential to environmental and public health.

However, do so with the knowledge that it's a stop

- gap with in a larger problem. For every few that can be scrutinized for regulation, modern industry creates thousands of new chemicals annually, often slightly modifying some chemical structures in order to avoid regulation, which means that despite our best attemp ts we will necessarily lose ground on this front in the quest to protect health and the environment. EPA should regulate TRI chemicals vigorously, but in order to progress faster than the addition of new chemicals to our total chemical exposure load, EPA must also develop strategies that address entire classes of compounds. More pointedly, EPA should require that before any given chemicals can be used or emitted, they must be proven a meaningful form and degree of “safe”, that processes for handling them t hrough entire lifecycle be well

- defined, and that meaningful financial protections be built into the usage of the chemicals: pre

- emptively putting the onus for safety on the industry.

Thank you, Gretchen Brewer PT AirWatchers PO Box 1653, Port Townsend WA 98368

EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcinogens on the Toxics Release Inventory. Regarding the evaluation of new industrial chemicals, under the Toxics S ubstances Control Act, EPA evaluate s new chemicals before they are manufactured

.25 Commenter: Darlene Schanfald [EPA

- HQ

- TRI

- 2010

- 0006

- 0150]

Comment:

Darlene Schanfald <darlenes@olympus.net> 06/07/2010 03:49 PM To Docket OEI@EPA

cc bcc Subject RE: adding 16 chemicals to the TRI list of reportable chemical s
I have just general comments.

Of course the list should be expanded, particularly so that they are "reasonably anticipated to be a human carcinogen" and are released into the environment. This gives the public even more information through the TRI.

The amount of carcinogenic compounds, not to mention what the synergy of these together mean, are ruining the public health and our natural resources. Anything steps to control these compounds and any steps to daylight what these are should be taken.

Res pectuflly,

Darlene Schanfald 481 Holgerson Rd Sequim WA† 98382

EPA Response: EPA appreciates the commenter’s support for listing the 16 NTP carcinogens on the Toxics Release Inventory.