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, section 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 and 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 substantive changes between the draft submitted to OIRA and the action that was 

subsequently issued, using a method that is complete, clear, and simple. 

(3) Identify for the public those substantive changes made at the suggestion 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 form 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 provided to OIRA for review under the E.O. 

(2) Documentation of any substantive changes made to the draft regulatory text that was 

submitted to OIRA when compared with what was subsequently made publicly available. 

The documentation is provided on the pages following this form. Changes made at the 

suggestion or recommendation of OIRA, if any, are 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 changes that were made. 

(c) Note to the file - A document that identifies the substantive changes that were made, 

with page and paragraph references to the draft regulatory action that was submitted. 

If you have any questions about this regulatory action or this documentation, please call the 

contact: 

Name: Email: 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. Bushman
Internal 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 National Toxicology Program in their 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) criteria 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 established a docket for this action under Docket ID No. EPA-HQTRI-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 available, 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.daniel@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 chemicals 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 SIC 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, 

512220, 512230*, 519130*, 541712*, or 811490*.

*Exceptions and/or limitations exist for these NAICS codes.
Internal Draft Document Only; Do Not Cite, Quote or Release.

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Facilities included in the following NAICS codes (corresponding to SIC 

codes other than SIC codes 20 through 39): 212111, 212112, 212113 

(correspond to 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 oil 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 Elsewhere 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, 

NEC)); 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 entities 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 you 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.

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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. These 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) are 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 demonstrate 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 levels 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 effects, 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, because 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 Administrator, 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 list of toxic chemicals.

III. Summary of Proposed 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 section 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 11th Report on Carcinogens (RoC) document. In addition, based on a 

review of the available production and use information, EPA determined that these 16 chemicals 
Internal 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 classifications 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 scientists 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 Rationale 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 chemicals 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 

11th 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 the available carcinogenicity 

data for the chemicals as presented in the 11th RoC (Ref. 2). 
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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 changes 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(bromomethyl)-1,3-propanediol; furan; glycidol; isoprene; 

methyleugenol; o-nitroanisole; 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 

category 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 received 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. The most significant 

comments are summarized and responded to below. The complete set of comments and EPA’s 
Internal 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 extensive 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 attempts 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 primary basis 

for the NTP classification of the chemicals in the proposed rule as "reasonably anticipated to be a 

human carcinogen" should not 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 probably 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 technical 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 proposed rule, is not on the 

EPCRA section 313 list of toxic chemicals, and is not classified as a carcinogen in the NTP’s 

11th 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. 
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 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 includes 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 materials 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 number 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-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 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 toxicology summaries, but that 

there were interpretations of the data they believed should be noted, plus certain environmental 
Internal 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 isoprene and butadiene and stated that isoprene also differs 

from 1,3-butadiene in that for isoprene, there have been no elevations in thymic lymphoma in 

exposed mice at any concentrations tested. The commenter stated that the absence of this 

response in mice 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 butadiene 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/m3) and this coupled with the fact that isoprene 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 anticipated" 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 vegetation, 

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.

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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 the 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 Group 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 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. 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 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.

The environmental data that the commenter suggests is missing from the rulemaking 

record actually is discussed in detail in the supporting documents cited in the proposed rule. For 
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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, 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 and 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/m3. Based on estimated human intake of 15 to 20 m3 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 

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, 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 is 
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Page 13 of 25

approximately 3 mg/m2/h. Isoprene concentrations in biogenic emissions 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 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/m3 (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 natural 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 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%) (Barrefors 
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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 personal air 

samples of 4.65 μg/m3 in nonsmoking homes (n = 60), 18.15 μg/m3 in smoking homes (n 

= 29), 5.29 μg/m3 in nonsmoking workplaces (n = 51), and 22.80 μg/m3 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/m3 in indoor air 

(n = 3; no information on whether occupants were smokers or nonsmokers) compared to 

0.40 μg/m3 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 public docket for this action under Docket ID No. EPAHQ-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 locating documents that 

are referenced in documents that EPA has placed in the docket, but that are not electronically or 
Internal 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 

Chemicals.

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 Protection 

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. Department of Health and Human Services, 

Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

VII. Statutory and Executive Order Reviews Associated With This Action? 

A. Executive Order 12866, Regulatory Planning and Review

Under Executive 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 President's 
Internal 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. Paperwork 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 reporting 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 manufactures, 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 section 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); those 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), an 
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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 information 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 year 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 the 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 information. 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 existing 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 ICR 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 analysis 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 significant 
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Page 18 of 25

economic impact on a substantial number of small entities. 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 business’’ 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 that is any notfor-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 impacts 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 impact 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 

organizations 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 Act

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 in 
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Page 19 of 25

any one year. EPA’s economic analysis indicates that the total cost 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 implications. 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 Order 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 with 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 sector facilities. Thus, Executive Order 

13175 does not apply to this action. 

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 

Risks 
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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 reporting 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 defined 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 effects 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) directs 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 methods, 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 voluntary consensus standards. 

This rulemaking does not involve technical standards. Therefore, EPA did not consider

the use of any voluntary consensus standards.
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J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority 

Populations 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 make 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 lowincome populations in the United States. 

EPA has 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 communities 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 also 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 informational 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 Fairness Act of 1996, generally provides that before a rule may take 
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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, Community right-to-know, Reporting and recordkeeping 

requirements, and Toxic chemicals

Dated:___________________

_____________________________________

Lisa P. Jackson, 

Administrator.

Therefore, 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 includes 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) * * *

______________________________________________________________________________
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Category Name Reporting Threshold

______________________________________________________________________________

* * * * * *

Polycyclic aromatic compounds (PACs): (This category includes 100

only those chemicals listed 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. Section 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

* * * * * *
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Methyleugenol 00093-15-2 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

* * * * * *
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(c) * * *

____________________________________________________________________________

Category Name Effective Date

______________________________________________________________________________

* * * * * *

Polycyclic aromatic compounds (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

* * * * * *

57835-92-4 4-Nitropyrene 1/11

* * * * * *