U.S. Environmental Protection Agency


### Documentation of OMB Review Under Executive Order 12866 Title of Action:

Docket#: FRL#: RIN: This action was submitted to the Office of Management and Budget (OMB) for review under Executive Order (E.O.) 12866 , titled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Whenever EPA makes publicly available a regulatory action that was reviewed under E.O. 12866, sect ion 6(a)(3)(E) of the E.O. directs the Agency to also: (1) Make available to the public a copy of the information that was provided to OMB’s Office of Information and Regulatory Affairs (OIRA) for review under the E.O., i.e. , the text of the draft regulatory action and, if applicable, an assessment of the potential costs an d benefits, as well as additional information for those actions that are determined to be economically significant under the E.O. (Information requirements are described in sections 6(a)(3)(B) and (C)). (2) Identify for the public any substa ntive changes between the draft submitt ed to OIRA and the action that was subsequently issued, using a method that is complete, clear, and simple. (3) Identify for the public those subs tantive changes made at the sugges tion or recommendation of OIRA. For this regulatory action, were substantive changes made to information reviewed under E.O. 12866? [Please check the appropriate answer.] No. [In the docket, include the information identified in item (1) below.] Yes. [In the docket, include the information identified in items (1) – (3) below.] Accordingly, the Agency has included this fo rm and the following information in the public docket for this regulatory action: [Please check the appropriate information.] (1) A copy of the information that was prov ided to OIRA for review under the E.O. (2) Documentation of any substantive changes made to the draft regul atory text that was submitted to OIRA when compared with what was subsequently made publ icly available. The documentation is provided on the pages fo llowing this form. Changes made at the suggestion or recommendation of OIRA, if any, ar e clearly identified through attribution to OIRA. EPA has used one or more of the following methods to note changes: [Select the appropriate option(s).] (a) Redline-Strikeout – A copy of the draft regulatory action submitted, using redlinestrikeout to show the substantive changes that were made. (b) Hand Markup – A copy of the draft regulatory action submitted, using handwritten notes to show the substantive c hanges that were made. (c) Note to the file - A document that identifies the s ubstantive changes that were made, with page and paragraph references to the draft regulatory action that was submitted. If you have any questions about this regulator y action or this documentation, please call the contact: Name: Em ail: Phone: Revised 05/05/2010 bushman.daniel@epa.gov 202-566-0743 Addition of National Toxicology Program Carcinogens; Community Right-to-Know Toxic Chemical Release Reporting - Final Rule

EPA--HQ-TRI-2010-0006 2025-AA28

Daniel R. BushmanInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 1 of 25 ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372 [EPA

- HQ

- TRI
- 2010

- 0006; FRL

– XXXX
- X]
RIN 2025

- AA28 Addition of National Toxicology Program Carcinogens; Community Right

- to
- Know Toxic Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
SUMMARY: EPA is adding 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) of 1986 and section 6607 of the Pollution Prevention Act of 1990 (PPA). These 16 chemicals have been classified by the N ational Toxicology Program in t heir Report on Carcinogens as “reasonably anticipated to be a human carcinogen.” EPA has determined that these 16 chemicals meet the EPCRA section 313(d)(2)(B) cri teria because they can reasonably be anticipated to cause cancer in humans.
DATES: This final rule is effective November 30, 2010, and shall apply for the reporting year beginning January 1, 2011 (reports due July 1, 2012).
ADDRESSES: EPA has establish ed a docket for this action under Docket ID No. EPA

- HQ

TRI
- 2010

- 0006

. All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly ava ilable, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the OEI Docket,Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 2 of 25 EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566

- 1744, and the telephone number for the OEI Docket is (202) 566

- 1752.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Environmental Analysis Division, Office of Information Analysis and Access (2842T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number:
202

- 566

- 0743; fax number: 202

- 566

- 0677; e

- mail: bushman.dan iel@epa.gov , for specific information on this notice. For general information on EPCRA section 313, contact the Emergency Planning and Community Right

- to

- Know Hotline, toll free at (800) 424

- 9346 or (703) 412

- 9810 in Virginia and Alaska or toll free, TDD (800) 553

- 7672, http://www.epa.gov/epaoswer/hotline/.
SUPPLEMENTARY INFORMATION:
I. General Information A. Does this Notice Apply to Me? You may be potentially affected by this action if you manufacture, process, or otherwise use any of the chem icals included in this final rule. Potentially affected categories and entities may include, but are not limited to:

Category Examples of Potentially Affected Entities Industry Facilities included in the following NAICS manufacturing codes (corresponding to S IC codes 20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191, 511199, 51 2220, 512230*, 519130*, 541712*, or 811490*. *Exceptions and/or limitations exist for these NAICS codes.Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 3 of 25 Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 212111, 212112, 212113 (correspond t o SIC 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234, 212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221119, 221121, 221122, 221330 (Limited to facilities that combust coal and/or oi l for the purpose of generating power for distribution in commerce) (correspond to SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (Limited to facilities previously classified in SIC 5169, Chemicals and Allied Products, Not Elsewhe re Classified); or 424710 (corresponds to SIC 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC 7389, Business Services, N EC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse Systems). Federal Government Federal facilities

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Some of the entities listed in the table have exemptions and/or limitations regarding coverage, and other types of en tities not listed in the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If y ou have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding "FOR FURTHER INFORMATION CONTACT" section.
II. Introduction A. What is the Statutory Authority for this Final Rule? This rule is issued under EPCRA section 313(d) and section 328, 42 U.S.C. 11023 et
seq. . EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986.Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 4 of 25 B. What is the Background for this Action? Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. The se facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of the PPA, 42 U.S.C. 13106. Congress established an initial list of toxic chemicals that comprised more than 300 chemicals and 20 chemical categories. EPCRA section 313(d) authorizes EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that EPA may add a chemical to the list if any of the listing criteria in Section 313(d)(2) ar e met. Therefore, to add a chemical, EPA must demonstrate that at least one criterion is met, but need not determine whether any other criterion is met. Conversely, to remove a chemical from the list, EPCRA section 313(d)(3) dictates that EPA must demons trate that none of the listing criteria in Section 313(d)(2) are met. The EPCRA section 313(d)(2) criteria are: (A) The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration l evels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases. (B) The chemical is known to cause or can reasonably be anticipated to cause in humans

– (i) cancer or teratogenic effect s, or (ii) serious or irreversible

– (I) reproductive dysfunctions,Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 5 of 25 (II) neurological disorders, (III) heritable genetic mutations, or (IV) other chronic health effects. (C) The chemical is known to cause or can be reasonably anticipated to cause, becau se of (i) its toxicity, (ii) its toxicity and persistence in the environment, or (iii) its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administ rator, to warrant reporting under this section. EPA often refers to the section 313(d)(2)(A) criterion as the “acute human health effects criterion;” the section 313(d)(2)(B) criterion as the “chronic human health effects criterion;” and the section 313(d )(2)(C) criterion as the “environmental effects criterion.” EPA has published in the Federal Register of November 30, 1994 (59 FR 61432) a statement clarifying its interpretation of the section 313(d)(2) and (d)(3) criteria for modifying the section 313 l ist of toxic chemicals. III. Summary of Propose d Rule A. What Chemicals Did EPA Propose to Add to the EPCRA Section 313 List of Toxic Chemicals? As discussed in the proposed rule (75 FR 17333, April 6, 2010) EPA proposed to add 16 chemicals to the EPCRA s ection 313 list of toxic chemicals. These 16 chemicals had been classified as “ Reasonably Anticipated To Be Human Carcinogen” by the National Toxicology Program (NTP) in their 11 th Report on Carcinogens (RoC) document. In addition, based on a review of t he available production and use information, EPA determined that these 16 chemicalsInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 6 of 25 are expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds. The NTP is an interagency program within the Department of Health and Human Services (DHHS) headquartered at the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH). As part of their cancer evaluation work, the NTP periodically publishes the RoC document which contains cancer classification s from the NTP’s most recent chemical evaluations as well as the classifications from previous versions of the RoC . There is an extensive review process for the RoC which includes evaluations by scient ists from the NTP, other Federal health research and regulatory agencies (including EPA), and nongovernmental institutions. The RoC review process also includes external peer review and several opportunities for public comment. B. What was EPA’s Rational e for Proposing to List the NTP Carcinogens? As EPA stated in the proposed rule (75 FR 17334, April 6, 2010), the NTP RoC document undergoes significant scientific review and public comment and mirrors the review EPA has historically done to assess chemic als for listing under EPCRA section 313 on the basis of carcinogenicity. The conclusions regarding the potential for chemicals in the NTP RoC to cause cancer in humans are based on established sound scientific principles. EPA believes that the NTP RoC is an excellent and reliable source of information on the potential for chemicals covered therein to cause cancer in humans. Based on EPA’s review of the data contained in the
11 th NTP RoC (Ref. 1) for the 16 chemicals , the Agency agreed that the chemicals can reasonably be anticipated to cause cancer. Therefore, EPA determined that the evidence was sufficient for listing all of the chemicals in the proposed rule on the EPCRA section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) based on th e availabl e carcinogenicity data for the chemicals as presented in the 11 th RoC (Ref. 2).Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 7 of 25 IV. Summary of Final Rule EPA is finalizing the addition of the 16 chemicals to the EPCRA section 313 list of toxic chemicals. This final rule contains no chan ges to the list of chemicals EPA included in the proposed rule

. EPA has determined that each of these 16 chemicals meets the listing criteria under EPCRA section 313(d)(2) (B)

. The chemicals being added as individual chemical listings on the EPCRA section 313 list in this final rule include the following: 1

- amino

- 2, 4

- dibromoanthraquinone ; 2,2

- bis(bromomet hyl)

- 1,3

- propanediol; furan; glycidol; isoprene; methyleugenol ; o - ni troanisole; nitromethane; phenolphthalein; tetrafluoroethylene; tetranitromethane; and vinyl fluoride . In addition, the following chemicals are being added to the EPCRA section 313 chemical category for polycyclic aromatic compounds (PACs) : 1,6

- dinitropyrene; 1,8

- dinitropyrene; 6

- nitrochrysene; and 4

- nitropyrene . The PACs category is a

ca tegory of persistent, bioaccumulative, toxic (PBT) chemicals and as such has a lower reporting threshold of 100 pounds ( 40 CFR 372.28(a)(2) )

. V. What Comments Did EPA Receive on the Proposed Rule and What Are EPA’s Responses to Those Comments? EPA receive d nine comments on the proposed rule to add the 16 NTP carcinogens to the EPCRA section 313 list. Seven of the comments were supportive of EPA’s proposed listings while two comments contained objections to the addition of these chemicals. The commenters that supported the proposed rule included; five individuals, OMB Watch, and PT AirWatchers. The two commenters that did not support the proposed rule were the Chemical Products Corporation and the International Institute of Synthetic Rubber Producers. Th e most significant comments are summarized and responded to below

. T he complete set of comments and EPA’sInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 8 of 25 responses can be found in the response to comment document in the docket for this rulemaking (Ref. 3). The Chemical Products Corporation provided e xtensive comments on their review of the NTP technical report on anthraquinone, a chemical that was not included in those EPA proposed to list. The comments documented the issues and problems they believe exist with that technical report and their attempt s to have the report revised. Their issues primarily concerned the identity of the materials tested. Based on their review and experience with NTP technical report for anthraquinone, the commenter believes that the NTP technical reports that were a prima ry basis for the NTP classification of the chemicals in the proposed rule as "reasonably anticipated to be a human carcinogen" should no t be relied upon by EPA for making decisions regarding the addition of chemicals to the EPCRA section 313 toxic chemical list. The commenter also suggested that EPA rely on the International Agency for Research on Cancer (IARC) Group 2A list (i.e., chemicals classified as p robably carcinogenic to humans ) and add only those chemicals which have IARC Group 2A classifications . That would include two chemicals, glycidol and vinyl fluoride out of the 16 at issue in this action

. 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 li sting. The report in question concerns anthraquinone, a chemical that was not the subject of the proposed rule, is not on the EPCRA section 313 list of toxic chemicals , and is not classified as a carcinogen in the NTP’s
11 th Report on Carcinogens. The co mmenter 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 spec ific issues the commenter has with the report or the NTP’s responses to the commenter.Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 9 of 25 However, even if there are errors with the report in question, EPA does not believe that errors in one NTP technical report means that the scientific validity of all NT P 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 includes both peer review and public comment (75 FR 17335, April 6, 2010). In addition, as discussed i n 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 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 classified as Group 2A (probably carcinogenic to humans) by IARC, EPA notes that the scientific data for a numbe r of chemicals classified as Group 2B ( possibly carcinogenic to humans ) under IARC has been found to 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 - b y - 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 an EPCRA section 313 listing determination. The International Institute of Synthetic Rubber Producers, Inc. (IISRP) stated that they found that overall there are no factual inaccuracies in EPA’s to xicology summaries , but that there were interpretations of the data they believed should be noted , plus certain environmentalInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 10 of 25 data which they thought should be included in the record. The IISRP noted that the proposed rule refers to similarities between i soprene and butadiene and stated that isoprene also differs from 1,3

- butadiene in that for isoprene, there ha ve been no elevations in thymic lymphoma in exposed mice at any concentrations tested. The commenter stated that the absence of this response in m ice with isoprene is noteworthy since the basis of butadiene's IARC Group1 classification is all hemolytic organs (which the commenter stated would include lymphomas). The commenter stated that the various other tumor types occurring with isoprene or buta diene in mice are not seen in epidemiology studies of butadiene

- exposed populations. The commenter also stated that there were no elevations in tumors found in mice at the lowest exposure tested (10 ppm; 28 mg/m 3 ) and this coupled with the fact that isopr ene is produced endogenously in humans suggests that there is a threshold for such a response. The commenter stated that this information supports the IARC 2B categorization of isoprene as a "possible" human carcinogen rather than the "reasonably anticipa ted" categorization by NTP, which triggers the TRI listing. The IISRP also stated that EPA omitted certain environmental data that should be included in the record. The commenter stated that IARC notes that isoprene occurs in the environment as emissions from vegetation, particularly from deciduous forests . The commenter cited sources that state that isoprene is the dominant hydrocarbon released by vegetation in most ecosystems. The commenter also cited sources that state that isoprene release by vegeta tion, particularly trees, exceeds anthropogenic hydrocarbon release to the atmosphere. The

commenter stated that isoprene has also been found in tobacco smoke, gasoline, turbine and automobile exhaust and in emissions from wood pulping, biomass combustion and rubber abrasion.Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 11 of 25 EPA disagrees with the IISRP that isoprene should be categorized as an IARC "possible" human carcinogen rather than the "reasonably anticipated" categorization by NTP and with IISRP’s characterization that the NTP classification is 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 th e NTP, are useful 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 section 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 ca ncer 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. EPA notes that the NTP found evidence of tumor formation at multiple organ sites in multiple species of experimental animals

. Nothing in the commenter’s statements leads EPA to believe that isoprene is not correctly classified by NTP as “reasonably anticipate d 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. The environmental data that the commenter suggests is missing from the rulemaking record actua lly is discussed in detail in the support ing documents cited in the proposed rule. ForInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 12 of 25 example, reference number 13 in the proposed rule (Ref. 4 in today’s final rule) contains the following discussion: Exposure Isoprene is formed endogenously in humans and is generally the major hydrocarbon (up 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, equiv alent 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 and 0.4 μmol/kg/h, respectively (Peter et al. 1987). Ambient air concentrations of isoprene are generally less tha n 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 than 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 industrie s 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 wide ly present in the environment at low concentrations (Taalman 1996). Isoprene global emissions, estimated at 175 to 503 million Mg per year, represent 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 isInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 13 of 25 approximately 3 mg/m 2 /h. Isoprene concentrations in biogenic emissions range from 8% to 91% of total VOCs, with a 58% average. Since isoprene biosynthesis is associated wi th photosynthesis, isoprene emissions are negligible at night (Guenther et al. 1994). The south central and southeastern areas of the United States have 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 production 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 concentrations of isoprene range from 0.003 to 0.06 mg/m 3 (1 to 21 ppb), with isoprene representing less than 10% o f 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 b e 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 natural products found in foods such as terpenes and vitamins A and K (IARC 1994). Its occurrence has been repo rted 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 is environmental tobacco smoke. Isoprene was found to be the major component of hydrocarbons in the air of a smoky café (10 smoking patrons, 10 not smoking) (16.7%) and sidestream smoke (29.2%) (BarreforsInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 14 of 25 and Petersson 1993). A monitoring survey in November 1992 in homes and workplaces in the greater Philadelphia area found mean isoprene concentrations in perso nal 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 22.80 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 environmental 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 under EPCRA section 313, it was not included in the text of the Federal Register notice for the proposed rule.
VI. References EPA has established an official publ ic docket for this action under Docket ID No. EPA

HQ

- TRI

- 2010

- 0006. The public docket includes information considered by EPA in developing this action, including the documents listed below, which are electronically or physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are electronically or physically located in the docket. For assistance in locat ing documents that are referenced in documents that EPA has placed in the docket, but that are not electronically orInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 15 of 25 physically located in the docket, please consult the person listed in the above FOR FURTHER INFORMATION CONTACT section.
1. USEPA, OEI. Memorandum from Mark Miller, Ph.D., Toxicologist, Analytical Support Branch to Nicole Paquette, Ph.D., Chief, Analytical Support Branch. January 28, 2010. Subject: Review of National Toxicology Program (NTP) Cancer Classification Data for Sixteen Chemica ls.
2. NTP, 2005. National Toxicology Program. Introduction: Report on Carcinogens, Eleventh Edition. Released January 31, 2005. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709. 3. USEPA, OEI. Response to Comments Received on the April 6, 2010, Federal Register Proposed Rule (75 FR 17333): Addition of National Toxicology Program Carcinogens; Community Right

- to

- Know Toxic Chemical Release Reporting. U.S. Environmental P rotection Agency, Office of Environmental Information, Office of Information Analysis and Access. August 12, 2010.
4. NTP, 2005. National Toxicology Program. 11th Report on Carcinogens

— Isoprene Substance Profile. Released January 31, 2005. U.S. Departmen t of Health and Human Services, Public Health Service, National Toxicology Program, R esearch Triangle Park, NC 27709. VII. Statutory and Executive Order Reviews Associated With This Action? A. Executive Order 12866, Regulatory Planning and Review Under E xecutive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action.” The Office of Management and Budget (OMB) determined that this action raises novel legal or policy issues arising out of legal mandates, the Presid ent'sInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 16 of 25 priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to OMB for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
B. P aperwork Reduction Act This final rule does not contain any new information collection requirements that require additional approval by the OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et. seq. Currently, the facilities subject to the repo rting requirements under EPCRA 313 and PPA 6607 may use either the EPA Toxic Chemicals Release Inventory Form R (EPA Form 1B9350

- 1), or the EPA Toxic Chemicals Release Inventory Form A (EPA Form 1B9350

- 2). The Form R must be completed if a facility manuf actures, processes, or otherwise uses any listed chemical above threshold quantities and meets certain other criteria. For the Form A, EPA established an alternative threshold for facilities with low annual reportable amounts of a listed toxic chemical.
A facility that meets the appropriate reporting thresholds, but estimates that the total annual reportable amount of the chemical does not exceed 500 pounds per year, can take advantage of an alternative manufacture, process, or otherwise use threshold of 1 million pounds per year of the chemical, provided that certain conditions are met, and submit the Form A instead of the Form R. In addition, respondents may designate the specific chemical identity of a substance as a trade secret pursuant to EPCRA secti on 322 42 U.S.C. 11042: 40 CFR part 350. OMB has approved the reporting and recordkeeping requirements related to Form R, supplier notification, and petitions under OMB Control number 2025

- 0009 (EPA Information Collection Request ( ICR) No. 1363.15); thos e related to Form A under OMB control number
2025

- 0010 (EPA ICR No. 1704.09); and those related to trade secret designations under OMB Control 2070

- 0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b) and 1320.6(a), anInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 17 of 25 Agency may not conduct or sponsor , and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers relevant to EPA’s regulations are listed in 40 CFR part 9, 48 CFR chapter 15, and displayed on the i nformation collection instruments (e.g., forms, instructions). For Form R, EPA estimates the industry reporting and recordkeeping burden for collecting this information to average, in the first year, approximately $4,615 per Form R (for a total first ye ar cost of $858,299 based on 16,069 total burden hours). In subsequent years, the burden for collecting this information is estimated to average $1,553 per Form R (for a total cost of $288,902 based on 5,517 total burden hours). These estimates include t he time needed to become familiar with the requirement (first year only); review instructions; search existing data sources; gather and maintain the data needed; complete and review the collection information; and transmit or otherwise disclose the informa tion. The actual burden on any facility may be different from this estimate depending on the complexity of the facility’s operations and the profile of the releases at the facility. Upon promulgation of a final rule, the Agency may determine that the exi sting burden estimates in the ICRs need to be amended in order to account for an increase in burden associated with the final action. If so, the Agency will submit an information collection worksheet (ICW) to OMB requesting that the total burden in each I CR be amended, as appropriate. C. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. The RFA generally requires an agency to prepare a regulatory flexibility ana lysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significantInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 18 of 25 economic impact on a substantial number of small entit ies. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today’s rule on small entities, small entity is defined as: (1) A business that is classified as a ‘‘small b usiness’’ by the Small Business Administration at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization th at is any not

for

- profit enterprise which is independently owned and operated and is not dominant in its field. Of the 109 entities estimated to be impacted by this rule, 41 are small businesses. Of the affected small businesses, all 41 have cost impact s of less than 1% in both the first and subsequent years of the rulemaking. No small businesses are projected to have a cost impact of 1% or greater. In the first year, of the 41 estimated cost impacts, there is a maximum impact of 0.616% and a minimum i mpact of less than 0.001%. Facilities eligible to use Form A (those meeting the appropriate activity threshold which have 500 pounds per year or less of reportable amounts of the chemical) will have a lower burden. No small governments or small organizat ions are expected to be affected by this action. Thus this rule is not expected to have a significant adverse economic impact on a substantial number of small entities. A more detailed analysis of the impacts on small entities is located in EPA’s economic analysis support document (Ref. 3). After considering the economic impacts of today’s rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform A ct This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector inInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 19 of 25 any one year. EPA’s economic analysis indicates that the total co st of this rule is estimated to be $859,072 in the first year of reporting. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. Small governments are not subject to the EPCRA section 313 reporting requirements. E. Executive Order 13132 (Federalism) This action does not have federalism implicati ons. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Orde r 13132. This action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private sector facilities. Thus, Executive Order 13132 does not apply to this action. F. Executive Order 13175: Consultation and Coordination wi th Indian Tribal
Governments This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private se ctor facilities. Thus, Executive Order 13175 does not apply to this action. G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety RisksInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 20 of 25 This action is not subject to EO 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in EO 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action relates to toxic chemical reporti ng under EPCRA section 313, which primarily affects private sector facilities. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a “significant energy action” as def ined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this action is not likely to have any adverse energy e ffects because it does not impact the production of energy. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104

- 113, 12(d) (15 U.S.C. 272 note) d irects EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test me thods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable volunta ry consensus standards. This rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 21 of 25 J

. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Population s and Low

- Income Populations Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to ma ke environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low

income popul ations in the United States. EPA ha s determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low

- income populations because it does not affect the level of protection provided to human health or the environment. This rule adds additional chemicals to the EPCRA section 313 reporting requirements. By adding chemicals to the list of toxic chemicals subject to reporting under section 313 of EPCRA, EPA would be providing communiti es across the United States (including minority populations and low income populations) with access to data which they may use to seek lower exposures and consequently reductions in chemical risks for themselves and their children. This information can als o be used by government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment. Therefore, the informa tional benefits of the rule will have a positive impact on the human health and environmental impacts of minority populations, low

- income populations, and children. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fai rness Act of 1996, generally provides that before a rule may takeInternal Draft Document Only; Do Not Cite, Quote or Release.

Page 22 of 25 effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A Major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2010

. List of Subjects in 40 CFR Part 372 Environmental protection, C ommunity right

- to

- know, Reporting and recordkeeping requirements, and Toxic chemicals Dated:___________________

_____________________________________ Lisa P. Jackson, Administrator

. Th erefore, 40 CFR part 372 is amended as follows: PART 372_[AMENDED ] 1. The authority citation for part 372 continues to read as follows: Authority : 42 U.S.C. 11023 and 11048. § 372.28 [Amended]
2. In § 372.28 the table in paragraph (a)(2) under the heading “ Polycyclic aromatic compounds (PACs): (This category in cludes only those chemicals listed below)” by adding four new entries in alphabetical order to read as follows: § 372.28 Lower thresholds for chemicals of special concern. (a) * * * (2) * * *

________________________________________________________ ______________________Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 23 of 25 Category Name Reporting Threshold

______________________________________________________________________________ * * * * * * Polycyclic aromatic compounds (PACs): (This category includes 100 only those chemicals liste d below).

* * * * * * 42397

- 64

- 8 1,6

- Dinitropyrene 42397

- 65

- 9 1,8

- Dinitropyrene * * * * * * 07496

- 02

- 8 6

- Nitrochrysene * * * * * * 57835

- 92

- 4 4

- Nitropyrene * * * * * * § 372.65 [Amended]
3. Se ction 372.65 is amended as follows: a. In the table to paragraph (a) by adding new entries in alphabetical order. b. In the table to paragraph (b) by adding new entries in numerical order. c. In the table to paragraph (c) under the heading “ Polycyclic aromatic compounds (PACs): (This category includes only those chemicals listed below)” by adding four entries in alphabetical order. § 372.65 Chemicals and chemical categories to which the part applies.

* * * * * * (a) * * *

______________________ ________________________________________________________ Chemical Name CAS No. Effective Date

______________________________________________________________________________ * * * * * * 1

- Amino

- 2,4

- dibromoanthraquinone 00081

- 49

- 2 1/11 * * * * * * 2,2

- bis(Bromomethyl)

- 1,3

- propanediol 003296

- 90

- 0 1/11 * * * * * * Furan 00110

- 00

- 9 1/11 * * * * * * Glycidol 00556

- 52

- 5 1/11 * * * * * * Isoprene 00078

- 79

- 5 1/11 * * * * * *Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 24 of 25 Methyleugenol 000 93

- 15

- 2 1/11 * * * * * * o - Nitroanisole 00091

- 23

- 6 1/11 * * * * * * Nitromethane 00075

- 52

- 5 1/11 * * * * * * Phenolphthalein 00077

- 09

- 8 1/11 * * * * * * Tetrafluoroethylene 00116

- 14

- 3 1/11 * * * * * * Tetranitromethane 00509

- 14

- 8 1/11 * * * * * * Vinyl Fluoride 00075

- 02

- 5 1/11 * * * * * * (b) * * *

______________________________________________________________________________ CAS No. Chemical Name Effective Date

____ __________________________________________________________________________ * * * * * * 00075

- 02

- 5 Vinyl Fluoride 1/11 * * * * * * 00075

- 52

- 5 Nitromethane 1/11 * * * * * * 00077

- 09

- 8 Phenolphthalein 1/11 * * * * * * 00078

- 79

- 5 Isoprene 1/11 * * * * * * 00081

- 49

- 2 1

- Amino

- 2,4

- dibromoanthraquinone 1/11 * * * * * * 00091

- 23

- 6 o - Nitroanisole 1/11 * * * * * * 00093

- 15

- 2 Methyleugenol 1/11 * * * * * * 00110

- 00

- 9 Furan 1/11 * * * * * * 00116

- 14

- 3 Tetrafluoroethylene 1/11 * * * * * * 00509

- 14

- 8 Tetranitromethane 1/11 * * * * * * 00556

- 52

- 5 Glycidol 1/11 * * * * * * 03296

- 90

- 0 2,2

- bis(Bromomethyl)

- 1,3

- propanediol 1/11 * * * * * *Internal Draft Document Only; Do Not Cite, Quote or Release.

Page 25 of 25 (c) * * *

____________________________________________________________________________ Category Name Effective Date

______________________________________________________________________________ * * * * * * Polycyclic aromatic c ompounds (PACs): (This category includes only those chemicals listed below)

* * * * * * 42397

- 64

- 8 1,6

- Dinitropyrene 1/11 42397

- 65

- 9 1,8

- Dinitropyrene 1/11 * * * * * * 07496

- 02

- 8 6

- Nitrochrysene 1/11 * * * * * * 5 7835

- 92

- 4 4

- Nitropyrene 1/11 * * * * * *