[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Rules and Regulations]
[Pages 72727-72734]
From the Federal Register Online via the Government Publishing 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: [email protected], 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]]
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Examples of potentially affected
Category entities
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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.
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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