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[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Rules and Regulations]
[Pages 72727-72734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29627]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2010-0006; FRL-9231-5]
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.

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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-HQ-TRI-2010-0006. All documents in the docket are listed in the 
http://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 http://www.regulations.gov or in hard copy at the OEI Docket, 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:

[[Page 72728]]

------------------------------------------------------------------------
                                      Examples of potentially affected
             Category                             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.
                                    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.

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,
    (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 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.

[[Page 72729]]

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).

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 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. EPA does 
not believe that issues raised about one NTP technical report mean that 
the scientific validity of all NTP technical reports should be in 
question. As EPA discussed in the proposed rule, the NTP review process 
for the Report on Carcinogens is extensive and 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 specific basis to question any of the NTP 
documents used to support the listing of the 16 chemicals included in 
this rule based on these comments.
    Regarding the commenter's suggestion that EPA only add those 
chemicals that have been 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 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

[[Page 72730]]

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/m\3\) 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.
    EPA disagrees with the IISRP that EPA should use the IARC 
``possible'' human carcinogen classification for isoprene rather than 
the ``reasonably anticipated'' categorization by NTP. Since isoprene is 
an analog of 1,3-butadiene, the NTP provided data on 1,3-butadiene 
under the section on ``Additional Information Relevant to 
Carcinogenicity'' (Ref. 4). The commenter pointed out differences 
between isoprene and butadiene, however, the NTP also recognizes that 
there are differences in the data for isoprene and 1,3-butadiene as 
evidenced by the NTP's classification of 1,3-butadiene as a ``known to 
be a human carcinogen'' (Ref. 2). For isoprene, the NTP found evidence 
of tumor formation at multiple organ sites in multiple species of 
experimental animals (Ref. 4). 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.
    EPA also disagrees with IISRP's characterization that the NTP 
classification is a trigger for TRI listing. According to EPCRA Sec.  
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.
    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 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 
[mu]g/L) (Cailleux et al. 1992). Humans produce isoprene 
endogenously at a rate of 0.15 [mu]mol/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 [mu]mol/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 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 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 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 [mu]g/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% 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

[[Page 72731]]

smoke. Isoprene was found to be the major component of hydrocarbons in 
the air of a smoky caf[eacute] (10 smoking patrons, 10 not smoking) 
(16.7%) and sidestream smoke (29.2%) (Barrefors and Petersson 1993). A 
monitoring survey in November 1992 in homes and workplaces in the 
greater Philadelphia area found mean isoprene concentrations in 
personal air samples of 4.65 [mu]g/m\3\ in nonsmoking homes (n = 60), 
18.15 [mu]g/m\3\ in smoking homes (n = 29), 5.29 [mu]g/m\3\ in 
nonsmoking workplaces (n = 51), and 22.80 [mu]g/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 [mu]g/m\3\ in indoor air (n = 3; no 
information on whether occupants were smokers or nonsmokers) compared 
to 0.40 [mu]g/m\3\ in outdoor air (n = 1) in the Lower Rio Grande 
Valley of Texas (Muerjee 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. 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 locating documents 
that are referenced in documents that EPA has placed in the docket, but 
that are not electronically or 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 
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 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

[[Page 72732]]

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 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 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 
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.
    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 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

    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 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.

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 low-income 
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

[[Page 72733]]

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 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: November 18, 2010.
Lisa P. Jackson,
Administrator.

0
Therefore, 40 CFR part 372 is amended as follows:

PART 372--[AMENDED]

0
1. The authority citation for part 372 continues to read as follows:

    Authority:  42 U.S.C. 11023 and 11048.

0
2. In Sec.  372.28 the table in paragraph (a)(2) is amended 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:

Sec.  372.28  Lower thresholds for chemicals of special concern.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Reporting
                       Category name                          threshold
------------------------------------------------------------------------
 
                                * * * * *
Polycyclic aromatic compounds (PACs): (This category                 100
 includes 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...............................
 
                                * * * * *
------------------------------------------------------------------------

0
3. Section 372.65 is amended as follows:
0
a. In the table to paragraph (a) by adding new entries in alphabetical 
order.

0
b. In the table to paragraph (b) by adding new entries in numerical 
order.

0
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.

Sec.  372.65  Chemicals and chemical categories to which the part 
applies.

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                                               Effective
                Chemical name                      CAS No.        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
 
                                * * * * *
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) * * *

[[Page 72734]]

------------------------------------------------------------------------
                                                             Effective
            CAS No.                   Chemical name            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-                       1/11
                                  dibromoanthraquinone.
 
                              * * * * * * *
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)-              1/11
                                  1,3-propanediol.
 
                              * * * * * * *
------------------------------------------------------------------------

    (c) * * *

------------------------------------------------------------------------
                                                              Effective
                       Category name                             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
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-29627 Filed 11-24-10; 8:45 am]
BILLING CODE 6560-50-P
```