Document ID: EPA-HQ-TRI-2012-0111-0022
Agency: epa
Document Type: Rule
Title: Addition of ortho-Nitrotoluene; Community Right-to-Know Toxic Chemical Release Reporting; Final Rule
Posted Date: 2013-11-07T05:00Z

[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Rules and Regulations]
[Pages 66848-66851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26475]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2012-0111; FRL-9902-12-OEI]
RIN 2025-AA35

Addition of ortho-Nitrotoluene; Community Right-to-Know Toxic 
Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is adding ortho-nitrotoluene (o-nitrotoluene) 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 (PPA) of 1990. o-
Nitrotoluene has been classified by the National Toxicology Program in 
its 12th Report on Carcinogens as ``reasonably anticipated to be a 
human carcinogen.'' EPA has determined that o-nitrotoluene meets the 
EPCRA section 313(d)(2)(B) criteria because it can reasonably be 
anticipated to cause cancer in humans.

DATES: This final rule is effective November 29, 2013, and shall apply 
for the reporting year beginning January 1, 2014 (reports due July 1, 
2015).

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-TRI-2012-0111. All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or in hard copy at the OEI Docket, 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; email: 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 (select menu option 3) or (703) 412-9810 in Virginia and 
Alaska or toll free, TDD (800) 553-7672, http://www.epa.gov/superfund/contacts/infocenter.

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 o-nitrotoluene. Potentially affected 
categories and entities may include, but are not limited to:

----------------------------------------------------------------------------------------------------------------
                      Category                                 Examples of potentially affected entities
----------------------------------------------------------------------------------------------------------------
Industry............................................  Facilities included in the following NAICS manufacturing
                                                       codes (corresponding to SIC codes 20 through 39): 311*,
                                                       312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*,
                                                       326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*,
                                                       111998*, 211112*, 212324*, 212325*, 212393*, 212399*,
                                                       488390*, 511110, 511120, 511130, 511140*, 511191, 511199,
                                                       512220, 512230*, 519130*, 541712*, or 811490*.
                                                      *Exceptions and/or limitations exist for these NAICS
                                                       codes.
                                                      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

[[Page 66849]]

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)(A)-
(C) are met. The EPCRA section 313(d)(2)(A)-(C) criteria are:

 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.
 The chemical is known to cause or can reasonably be 
anticipated to cause in humans:
    [cir] cancer or teratogenic effects, or
    [cir] serious or irreversible-
    [ssquf] reproductive dysfunctions,
    [ssquf] neurological disorders,
    [ssquf] heritable genetic mutations, or
    [ssquf] other chronic health effects.

 The chemical is known to cause or can be reasonably 
anticipated to cause, because of:
    [cir] its toxicity,
    [cir] its toxicity and persistence in the environment, or
    [cir] 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 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 chemical did EPA propose to add to the EPCRA section 313 list 
of toxic chemicals?

    As discussed in the proposed rule (78 FR 15913, March 13, 2013) EPA 
proposed to add o-nitrotoluene to the EPCRA section 313 list of toxic 
chemicals. o-Nitrotoluene had been classified as ``Reasonably 
Anticipated To Be Human Carcinogen'' by the National Toxicology Program 
(NTP) in its 12th Report on Carcinogens (RoC) document. In addition, 
based on a review of the available production and use information, EPA 
determined that o-nitrotoluene is 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 the NTP's cancer 
evaluation work, it periodically publishes the RoC document which 
contains cancer classifications from the NTP's most recent chemical 
evaluations as well as the classifications from previous versions of 
the RoC. There is an extensive review process for the RoC which 
includes evaluations by scientists from the NTP, other Federal health 
research and regulatory agencies (including EPA), and nongovernmental 
institutions. The RoC review process also includes external peer review 
and several opportunities for public comment.

B. What was EPA's rationale for proposing to list o-nitrotoluene?

    As EPA stated in the proposed rule (78 FR 15913, March 13, 2013), 
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 12th NTP RoC (Reference (Ref. 1)) for o-
nitrotoluene, the Agency agreed that o-nitrotoluene can reasonably be 
anticipated to cause cancer. Therefore, EPA determined that the 
evidence was sufficient for listing o-nitrotoluene on the EPCRA section 
313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) based on 
the available carcinogenicity data for o-nitrotoluene as presented in 
the 12th RoC (Ref. 2).

IV. What comments did EPA receive on the proposed rule?

    EPA did not receive any comments on the proposed rule to add o-
nitrotoluene to the EPCRA section 313 list of toxic chemicals.

V. Summary of Final Rule

    EPA is finalizing the addition of o-nitrotoluene to the EPCRA 
section 313 list of toxic chemicals. EPA has determined that o-
nitrotoluene meets the listing criteria under EPCRA section 
313(d)(2)(B) based on the available carcinogenicity data.

VI. References

    EPA has established an official public docket for this action under 
Docket ID No. EPA-HQ-TRI-2012-0111. 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 Martin Gehlhaus, Toxicologist, 
Analytical Support Branch to Larry Reisman, Chief, Analytical 
Support Branch. June 30, 2011. Subject: Review of National 
Toxicology Program (NTP) Cancer Classification Data for o-
nitrotoluene.
2. NTP, 2011. National Toxicology Program. Report on Carcinogens, 
Twelfth Edition. Released June 10, 2011. U.S. Department of Health 
and Human Services, Public Health Service, National Toxicology 
Program, Research Triangle Park, NC 27709.
3. USEPA, OEI. Economic Analysis of the Proposed Rule to add ortho-
Nitrotoluene to the EPCRA Section 313 List of Toxic Chemicals. 
February 9, 2012.

[[Page 66850]]

VIII. What are the Statutory and Executive Order reviews associated 
with this action?

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is 
therefore not subject to review under Executive Orders 12866 and 13563 
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This final rule does not contain any new information collection 
requirements that require additional approval by the Office of 
Management and Budget (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 Forms A and R, supplier notification, and petitions under 
OMB Control number 2025-0009 (EPA Information Collection Request (ICR) 
No. 1363) and those related to trade secret designations under OMB 
Control 2050-0078 (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 the 17 Form Rs and 5 Form As expected to be filed, EPA 
estimates the industry reporting and recordkeeping burden for 
collecting this information to average, in the first year, 
approximately $3,461 per form (for a total first year cost of $76,143 
based on 1,506 total burden hours). In subsequent years, the burden for 
collecting this information is estimated to average approximately 
$1,648 per form (for a total cost of $36,252 based on 717 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 
these estimates depending on whether they file a Form R or Form A, the 
complexity of the facility's operations and the profile of the releases 
at the facility. Upon promulgation of a final rule, the Agency may 
determine that the existing burden estimates in the ICRs need to be 
amended in order to account for an increase in burden associated with 
the final action. If so, the Agency will submit an information 
collection worksheet (ICW) to OMB requesting that the total burden in 
each ICR be amended, as appropriate.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et 
seq.

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant 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.
    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. Of the 22 
entities estimated to be impacted by this rule, 6 are small businesses. 
Of the affected small businesses, all 6 have cost-to-revenue 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 in the first 
year of 1% or greater. Facilities eligible to use Form A (those meeting 
the appropriate activity threshold which have 500 pounds per year or 
less of reportable amounts of the chemical) will have a lower burden. 
No small governments or small organizations are expected to be affected 
by this action. Thus this rule is not expected to have a significant 
adverse economic impact on a substantial number of small entities. A 
more detailed analysis of the impacts on small entities is located in 
EPA's economic analysis support document (Ref. 3).

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 $76,143 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.

[[Page 66851]]

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
the Executive Order has the potential to influence the regulation. This 
action is not subject to Executive Order 13045 because it does not 
establish an environmental standard intended to mitigate health or 
safety risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355 
(May 22, 2001)), because it is not a significant regulatory action 
under Executive Order 12866.

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 an additional chemical to the EPCRA section 
313 reporting requirements. By adding a chemical 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 29, 2013.

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, and Toxic chemicals.

    Dated: October 29, 2013.
Gina McCarthy,
Administrator.
    Therefore, 40 CFR part 372 is amended as follows:

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW

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.  372.65, paragraph (a) is amended by adding in the table the 
entry for ``o-Nitrotoluene'' in alphabetical order and in paragraph (b) 
by adding in the table the entry for ``00088-72-2'' in numerical order 
to read as follows:

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

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                                              Effective
                Chemical name                     CAS No.        date
------------------------------------------------------------------------
 
                                * * * * *
o-Nitrotoluene...............................    00088-72-2       1/1/14
 
                                * * * * *
------------------------------------------------------------------------

    (b) * * *

------------------------------------------------------------------------
                                                              Effective
                Chemical name                     CAS No.        date
------------------------------------------------------------------------
 
                                * * * * *
o-Nitrotoluene...............................    00088-72-2       1/1/14
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-26475 Filed 11-5-13; 4:15 pm]
BILLING CODE 6560-50-P