[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Proposed Rules]
[Pages 15913-15920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05812]


-----------------------------------------------------------------------

 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2012-0111; FRL-9785-9]
RIN 2025-AA35


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to add 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 
their 12th Report on Carcinogens as ``reasonably anticipated to be a 
human carcinogen.'' EPA believes that o-nitrotoluene meets the EPCRA 
section 313(d)(2)(B) criteria because it can reasonably be anticipated 
to cause cancer in humans. Based on a review of the available 
production and use information, o-nitrotoluene is expected to be 
manufactured, processed, or otherwise used in quantities that would 
exceed the EPCRA section 313 reporting thresholds.

DATES: Comments must be received on or before May 13, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
TRI-2012-0111, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     Email: [email protected]
     Mail: Office of Environmental Information (OEI) Docket, 
Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room 
3334, 1301 Constitution Ave., NW., Washington, DC 20460. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-TRI-
2012-

[[Page 15914]]

0111. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through www.regulations.gov or email. The 
www.regulations.gov Web site is an ``anonymous access'' system, which 
means EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through www.regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the public docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, avoid any form of 
encryption, and be free of any defects or viruses.
    Docket: 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: [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 o-nitrotoluene. Potentially affected 
categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                      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.

B. How should I submit CBI to the agency?

    Do not submit CBI information to EPA through www.regulations.gov or 
email. Clearly mark the part or all of the information that you claim 
to be CBI. For CBI information in a disk or CD-ROM that you mail to 
EPA, mark the outside of the disk or CD-ROM as CBI and then identify 
electronically within the disk or CD-ROM the specific information that 
is claimed as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.

II. Introduction

    Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities 
that manufacture, process, or otherwise use

[[Page 15915]]

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. Background Information

A. What is the NTP and the report on Carcinogens?

    The National Toxicology Program (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). The mission of the NTP is to 
evaluate chemicals of public health concern by developing and applying 
tools of modern toxicology and molecular biology. The NTP program 
maintains an objective, science-based approach in dealing with critical 
issues in toxicology and is committed to using the best science 
available to prioritize, design, conduct, and interpret its studies. 
The mission of the NTP includes the evaluation of chemicals for their 
potential to cause cancer in humans.
    As part of their cancer evaluation work, the NTP periodically 
publishes a Report on Carcinogens (RoC) document. The RoC was mandated 
by the U.S. Congress, as part of the Public Health Service Act (Section 
301(b)(4), as amended). The NTP describes the RoC as an informational 
scientific and public health document that identifies and discusses 
agents, substances, mixtures, or exposure circumstances that may pose a 
hazard to human health by virtue of their carcinogenicity. The NTP RoC 
serves as a meaningful and useful compilation of data on (1) the 
carcinogenicity (ability to cause cancer), genotoxicity (ability to 
damage genes), and biologic mechanisms (modes of action in the body) of 
the RoC-listed substances in humans and/or in animals, (2) the 
potential for human exposure to these substances, and (3) the 
regulations and guidelines promulgated by Federal agencies to limit 
exposures to RoC-listed substances. The NTP RoC is published 
periodically, with the most recently published 12th RoC having been 
released on June 10, 2011. The 12th RoC contains the NTP cancer 
classifications from the most recent chemical evaluations as well as 
the classifications from previous versions of the RoC.

B. What are the NTP cancer classifications and criteria?

    The NTP RoC classifies chemicals as either ``known to be a human 
carcinogen'' or ``reasonably anticipated to be a human carcinogen.'' 
The criteria that the NTP uses to list an agent, substance, mixture, or 
exposure circumstance under each classification in the RoC (Ref. 1) are 
as follows:
    ``Known To Be Human Carcinogen:
    There is sufficient evidence of carcinogenicity from studies in 
humans*, which indicates a causal relationship between exposure to the 
agent, substance, or mixture, and human cancer.
    Reasonably Anticipated To Be Human Carcinogen:
    There is limited evidence of carcinogenicity from studies in 
humans*, which indicates that causal interpretation is credible, but 
that alternative explanations, such as chance, bias, or confounding 
factors, could not adequately be excluded,
    or
    there is sufficient evidence of carcinogenicity from studies in 
experimental animals, which indicates there is an increased incidence 
of malignant and/or a combination of malignant and benign tumors (1) in 
multiple species or at multiple tissue sites, or (2) by multiple routes 
of exposure, or (3) to an unusual degree with regard to incidence, 
site, or type of tumor, or age at onset,
    or
    there is less than sufficient evidence of carcinogenicity in humans 
or laboratory animals; however, the agent, substance, or mixture 
belongs to a well-defined, structurally related class of substances 
whose members are listed in a previous Report on Carcinogens as either 
known to be a human carcinogen or reasonably anticipated to be a human 
carcinogen, or there is convincing relevant information that the agent 
acts through mechanisms indicating it would likely cause cancer in 
humans.
    Conclusions regarding carcinogenicity in humans or experimental 
animals are based on scientific judgment, with consideration given to 
all relevant information. Relevant information includes, but is not 
limited to, dose response, route of exposure, chemical structure, 
metabolism, pharmacokinetics, sensitive sub-populations, genetic 
effects, or other data relating to mechanism of action or factors that 
may be unique to a given substance. For example, there may be 
substances for which there is evidence of carcinogenicity in laboratory 
animals, but there are compelling data indicating that the agent acts 
through mechanisms which do not operate in humans and would therefore 
not reasonably be anticipated to cause cancer in humans.
    *This evidence can include traditional cancer epidemiology studies, 
data from clinical studies, and/or data derived from the study of 
tissues or cells from humans exposed to the substance

[[Page 15916]]

in question, which can be useful for evaluating whether a relevant 
cancer mechanism is operating in humans.''
    The NTP classifications for the potential for a chemical to cause 
cancer are very similar to the EPCRA section 313(d)(2)(B) statutory 
criteria for listing a chemical on the list of toxic chemicals subject 
to reporting under EPCRA section 313: ``(B) The chemical is known to 
cause or can reasonably be anticipated to cause in humans--(i) cancer * 
* *'' The specific data used by the NTP to classify a chemical as 
``Known To Be Human Carcinogen'' or ``Reasonably Anticipated To Be 
Human Carcinogen'' are consistent with data used by EPA to evaluate 
chemicals for their potential to cause cancer and classify chemicals as 
either ``Carcinogenic to Humans'' or ``Likely to Be Carcinogenic to 
Humans'' (Ref. 2).

C. What is the review process for the RoC?

    Specific details of the nomination and review process for the 
development of the 12th RoC are described in the NTP Report on 
Carcinogens Review Process section of the 12th RoC (Ref. 1). In 
general, the RoC review process includes evaluations by scientists from 
the NTP, other Federal health research and regulatory agencies 
(including EPA), and nongovernmental institutions. The RoC review 
process includes external peer review and several opportunities for 
public comment. For the 12th RoC, during the entire nomination, 
selection, and review process there were four opportunities for public 
comment. For each candidate substance, an expert panel was convened to 
peer review the NTP background document prepared for each candidate 
substance. The NTP also asked the expert panels to (1) apply the RoC 
listing criteria to the relevant scientific evidence and make a 
recommendation regarding the listing status for the candidate substance 
and (2) to provide the scientific justification for that 
recommendation. For the 12th RoC, the next step was a review by the 
Interagency Scientific Review Group (which included an EPA 
representative) followed by a review by the NIEHS/NTP Scientific Review 
Group. After these reviews, the NTP prepared a draft substance profile 
for each candidate substance which was peer reviewed by the NTP Board 
of Scientific Counselors which then prepared and submitted a peer 
review report to the NTP. The NTP then drafted the 12th RoC and 
submitted it to the NTP Director for review. The Director distributed 
the draft 12th RoC to the NTP Executive Committee for consultation, 
review, and comment. After approval of the draft 12th RoC by the NTP 
Director, the final draft of the 12th RoC was prepared and was 
submitted to the Secretary, DHHS, for review and approval. Once 
approved, the Secretary submitted the 12th RoC to the U.S. Congress as 
a final document. The 12th RoC was released to the public on June 10, 
2011.

IV. EPA's review of the 12th RoC

A. How did EPA select the NTP RoC chemical being proposed for addition?

    The most recent version of the NTP RoC that EPA previously reviewed 
for possible additions to the EPCRA section 313 list was the 11th RoC 
(April 6, 2010, 75 FR 17333). Each new version of the RoC adds newly 
classified chemicals to the existing list. EPA's present review of the 
12th RoC identified four newly listed chemicals that are not on or 
covered by the EPCRA section list (aristolochic acids, captafol, o-
nitrotoluene, and riddelliine). Of the four chemicals, only o-
nitrotoluene is commercially produced and thus would be an appropriate 
candidate for listing under EPCRA section 313 since no reports would be 
expected for the other chemicals.
    Section 313(d)(2) of EPCRA provides EPA the discretion to add 
chemicals to the TRI list when there is sufficient evidence to 
establish any of the listing criteria. EPA can add a chemical that 
meets one criterion regardless of its production volume or whether any 
reports would be filed. But as in past chemical reviews (e.g., January 
12, 1994, 59 FR 1788), EPA adopted a production volume screen for the 
development of this proposed rule to make sure that reports would be 
expected to be submitted for the chemicals proposed to be listed. If a 
chemical that did not meet the production volume screen was listed, 
there would be an economic burden for firms that would have to 
determine that they did not exceed the reporting threshold. Yet, as no 
reports would be filed, there would be no information to the public on 
such a chemical. EPA feels it is appropriate at this time to focus on 
chemicals for which reports are likely to be filed.
    EPA reviewed the NTP 12th RoC chemical profile and supporting 
materials for o-nitrotoluene (Ref. 3). Given the extensive scientific 
reviews conducted by the NTP for their RoC documents, EPA's review 
focused on ensuring that there were no inconsistencies with how the 
Agency would consider the available data. EPA's review of the o-
nitrotoluene chemical profile and supporting material found no 
inconsistencies between how the data were interpreted by the NTP and 
how that same data would be interpreted under EPA's Guidelines for 
Carcinogen Risk Assessment (Ref. 2). Therefore, EPA agrees with the 
hazard conclusions of the NTP 12th RoC for o-nitrotoluene.

B. What technical data supports the NTP RoC classification and EPA's 
proposed addition of o-nitrotoluene to the EPCRA section 313 list?

    This section presents the data that supported the NTP 12th RoC 
classification of o-nitrotoluene and why EPA believes the data support 
the addition of this chemical to the EPCRA section 313 list. The NTP 
chemical profile, the NTP chemical background document, and the 
references cited within the portion of the NTP 12th RoC chemical 
profile quoted here, are all included in the docket for this 
rulemaking. While they are contained in the docket and are part of the 
rulemaking record, the references within the quotation cited from the 
NTP 12th RoC profile document are not included in the list of 
references in Unit VI. of this Federal Register notice. The full 
citations for the references contained in the quotation can be found in 
the NTP 12th RoC profile document (Ref. 4).
    1. o-Nitrotoluene (CAS No. 88-72-2) (Refs. NTP Profile/Background 
document (Refs. 4 and 5)). The NTP has classified o-nitrotoluene as 
``reasonably anticipated to be a human carcinogen.'' The classification 
is based on sufficient evidence of carcinogenicity in experimental 
animals and supporting data on mechanisms of carcinogenesis. The NTP 
substance profile for o-nitrotoluene (Ref. 4) included the following 
summary information of the evidence of carcinogenicity:
``Carcinogenicity
    o-Nitrotoluene is reasonably anticipated to be a human carcinogen 
based on sufficient evidence of carcinogenicity from studies in 
experimental animals and supporting data on mechanisms of 
carcinogenesis.
Cancer Studies in Experimental Animals
    Oral exposure to o-nitrotoluene caused tumors at several different 
tissue sites in rats and mice and early onset of cancer in male rats. 
Malignant mesothelioma and mesothelial-cell hyperplasia of the tunica 
vaginalis of the epididymis were observed in male rats administered o-
nitrotoluene in their feed for 13 weeks (NTP 1992). Bile-duct cancer 
(cholangiocarcinoma) was observed after 26 weeks, both in rats

[[Page 15917]]

exposed to o-nitrotoluene for 26 weeks and in rats exposed for 13 weeks 
and then observed for 13 more weeks without exposure (NTP 1996). o-
Nitrotoluene caused cancer at several tissue sites in two-year chronic 
exposure studies of rats and mice of both sexes and in a study in which 
male rats were exposed to o-nitrotoluene for 13 weeks and evaluated at 
two years (NTP 2002). In rats, o-nitrotoluene caused (1) subcutaneous 
skin tumors and mammary-gland tumors (fibroadenoma) in both sexes, (2) 
malignant mesothelioma and benign or malignant tumors of the liver 
(hepatocellular adenoma or carcinoma or cholangiocarcinoma) and lung 
(alveolar/bronchiolar adenoma or carcinoma) in males, and (3) benign 
liver tumors (hepatocellular adenoma) in females. In mice, it caused 
malignant blood-vessel tumors (hemangiosarcoma) in both sexes, 
malignant tumors of the large intestine (cecal carcinoma) in males, and 
benign or malignant liver tumors (hepatocellular adenoma or carcinoma) 
in females (NTP 2002).
Studies on Mechanisms of Carcinogenesis
    Following oral administration to rats and mice, o-nitrotoluene is 
absorbed into the blood and rapidly cleared; the serum half-life is 1.5 
hours in rats (NTP 2002). In the rat liver, o-nitrotoluene is 
metabolized to o-nitrobenzyl alcohol and can follow several metabolic 
pathways: (1) glucuronidation to o-nitrobenzyl glucuronide, (2) 
sulfation and subsequent reaction with glutathione and acetylcysteine 
to o-nitrobenzyl sulfate, S-(o-nitrobenzyl)glutathione, and S-(o-
nitrobenzyl)-N-acetylcysteine, or (3) metabolism to o-aminobenzyl 
alcohol followed by oxidation to o-aminobenzoic acid. The metabolites 
are eliminated primarily in the urine. The major metabolites are o-
nitrobenzyl glucuronide and o-nitrobenzoic acid major metabolites in 
rats and mice and o-aminobenzyl alcohol and S-(o-nitrobenzyl)-N-
acetylcysteine in rats. Female rats excrete less than half as much of 
the dose in the form of o-aminobenzyl alcohol, o-nitrobenzyl alcohol, 
or S-(o-nitrobenzyl)-N-acetylcysteine as male rats (NTP 2002). The 
glucuronidated form can also be excreted in the bile; when the 
glucuronidated form in the bile is excreted into the small intestine, 
intestinal bacteria can deconjugate it and reduce the nitro group to an 
amino group, forming aminobenzyl alcohol. Aminobenzyl alcohol can be 
reabsorbed from the intestine and further metabolized by the liver to 
reactive compounds (carbonium and nitrenium ions) that can covalently 
bind to DNA or to proteins (Chism and Rickert 1985, NTP 2002, 2008). 
Thus, microbial metabolism in the intestine is an important step in the 
carcinogenicity of o-nitrotoluene. However, neither o-aminobenzyl 
alcohol nor its metabolites have been detected in mouse urine after 
exposure to o-nitrotoluene (NTP 2002); therefore, other unidentified 
biochemical pathways leading to tumor formation most likely are 
involved.
    o-Nitrotoluene did not cause mutations in bacteria. In studies of 
its ability to cause genetic damage in cultured mammalian cells, the 
results were mixed. o-Nitrotoluene caused (1) sister chromatid exchange 
in Chinese hamster ovary (CHO) cells, (2) chromosomal aberrations in 
Chinese hamster lung (CHL) cells and human peripheral lymphocytes but 
not in CHO cells, (3) micronucleus formation in CHL cells but not in 
CHO-K1 cells, and (4) DNA damage in L5178Y mouse lymphoma cells (NTP 
2008). It did not induce DNA repair in rat or human hepatocytes (NTP 
2008). In rats and mice exposed in vivo, o-nitrotoluene caused a slight 
increase in micronucleus formation in peripheral normochromatic 
erythrocytes in male mice at a high dose level; this finding was not 
considered conclusive. o-Nitrotoluene did not induce micronucleus 
formation in peripheral normochromatic erythrocytes in female mice or 
in polychromatic erythrocytes in the bone marrow of male rats or mice 
(NTP 2002). Following in vivo exposure of rats to o-nitrotoluene, DNA 
repair was increased in liver cells isolated from males, but not from 
females or germ-free males. These results, together with o-
nitrotoluene's inability to induce DNA repair in hepatocytes in vitro, 
suggest that activation of o-nitrotoluene to become genotoxic is sex-
specific and depends on both mammalian metabolism and metabolism by 
intestinal bacteria (Doolittle et al. 1983). However, o-nitrotoluene 
also caused tumors in other tissues in rats and mice of both sexes, 
suggesting that other activation mechanisms exist.
    In rats exposed to o-nitrotoluene in vivo, DNA adducts were 
detected in the liver of males but not females (NTP 2008). Formation of 
DNA adducts was consistent with the reaction of intermediate compounds 
derived from o-aminobenzyl alcohol with guanine or adenine bases (Jones 
et al. 2003). The pattern of mutations in oncogenes from o-
nitrotoluene-induced tumors was also consistent with guanine adduct 
formation: the majority of p53 mutations in hemangiosarcomas were G:C 
to A:T transitions, and almost all the K-ras mutations in cecal 
carcinomas were G:C to T:A transversions (Hong et al. 2003, Sills et 
al. 2004). Mutations in the p53, [beta]-catenin, and K-ras genes also 
were found in hemangiosarcomas from mice exposed to o-nitrotoluene, but 
not in spontaneously occurring hemangiosarcomas from unexposed mice 
(Hong et al. 2003).
    In factory workers exposed to o-nitrotoluene, o-nitrotoluene-
hemoglobin adducts were detected in the blood (Jones et al. 2005a), and 
o-nitrobenzoic acid and o-nitrobenzyl alcohol were detected in the 
urine (Jones et al. 2005b), providing evidence that human exposure to 
o-nitrotoluene results in production of a reactive metabolite(s). In 
addition, adducts between hemoglobin and 2-methylaniline (a metabolite 
of o-nitrotoluene) were identified in both exposed workers and exposed 
rats, and the level of 2-methylaniline-hemoglobin adducts in the blood 
of rats was proportional to the level of 2-methylaniline-DNA adducts in 
the livers of rats (Jones and Sabbioni 2003, Jones et al. 2003).
Cancer Studies in Humans
    The data available from epidemiological studies are inadequate to 
evaluate the relationship between human cancer and exposure 
specifically to o-nitrotoluene. One cohort study of workers involved in 
the manufacture of magenta dye mentioned exposure of workers to o-
nitrotoluene as part of the manufacturing process. A large excess of 
bladder cancer was reported; however, the workers were also exposed to 
other chemicals--o-toluidine (2-methylaniline) and 4,4'-methylenebis(2-
methylaniline)--that are suspected of causing bladder cancer (Rubino et 
al. 1982). Two other studies of magenta manufacturing workers also 
reported an excess of bladder cancer, but did not report whether the 
workers were exposed to o-nitrotoluene (Case and Pearson 1954, Vineis 
and Magnani 1985).''
    EPA has reviewed the NTP assessment for o-nitrotoluene and agrees 
that o-nitrotoluene can reasonably be anticipated to cause cancer in 
humans. EPA believes that the evidence is sufficient for listing o-
nitrotoluene on EPCRA section 313 pursuant to EPCRA section 
313(d)(2)(B) based on the available carcinogenicity data for this 
chemical.

V. Rationale for listing

    The NTP RoC document undergoes significant scientific review and 
public comment. The NTP review mirrors the

[[Page 15918]]

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 in the NTP RoC to 
cause cancer in humans (see Unit III). Based on EPA's review of the 
data contained in the 12th NTP RoC, EPA has determined that o-
nitrotoluene can reasonably be anticipated to cause cancer (Ref. 3). 
Therefore, EPA believes that the evidence is 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 
presented in the 12th RoC.
    EPA considers chemicals that can reasonably be anticipated to cause 
cancer to have moderately high to high chronic toxicity. EPA does not 
believe that it is appropriate to consider exposure for chemicals that 
are moderately high to highly toxic based on a hazard assessment when 
determining if a chemical can be added for chronic effects pursuant to 
EPCRA section 313(d)(2)(B) (see 59 FR 61440-61442). Therefore, in 
accordance with EPA's standard policy on the use of exposure 
assessments (59 FR 61432), EPA does not believe that an exposure 
assessment is necessary or appropriate for determining whether o-
nitrotoluene meets the criteria of EPCRA section 313(d)(2)(B).

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. 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.
    2. USEPA. Guidelines for Carcinogen Risk Assessment. Risk 
Assessment Forum, U.S. Environmental Protection Agency, Washington, 
DC, March 2005.
    3. 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.
    4. NTP, 2011. National Toxicology Program. 12th Report on 
Carcinogens--o-Nitrotoluene Substance Profile. Released June 10, 
2011. U.S. Department of Health and Human Services, Public Health 
Service, National Toxicology Program, Research Triangle Park, NC 
27709.
    5. NTP, 2008. Report on Carcinogens Background Document for o-
Nitrotoluene. June 20, 2008. U.S. Department of Health and Human 
Services, Public Health Services, National Toxicology Program, 
Research Triangle Park, NC 27709.
    6. USEPA, OEI. Economic Analysis of the Proposed Rule to add 
ortho-Nitrotoluene to the EPCRA Section 313 List of Toxic Chemicals. 
February 9, 2012.

VII. 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 proposed 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, $76,143 
(based on 1,506 total burden hours). In subsequent years, the burden 
for collecting this information is estimated to average $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 this estimate depending on the 
complexity of the facility's operations and the profile of the releases 
at the facility. Upon promulgation of a final rule, the Agency may 
determine that the existing burden estimates in the ICRs need to be 
amended in order to account for an increase in burden associated with 
the final action. If so, the Agency will submit an information 
collection worksheet (ICW) to OMB requesting that the total burden in 
each ICR be amended, as appropriate.
    The Agency would appreciate any comments or information that could 
be used to: (1) Evaluate whether the proposed collection of information 
is necessary for the proper performance of the functions of the Agency, 
including

[[Page 15919]]

whether the information will have practical utility; (2) evaluate the 
reasonableness of the Agency's estimate of the burden of the propose 
collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and, (4) minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses. Please 
submit your comments within 90 days as specified at the beginning of 
this proposal. Copies of the existing ICRs may be obtained from Rick 
Westlund, Collection Strategies Division, U.S. Environmental Protection 
Agency (2822T), 1200 Pennsylvania Ave. NW., Washington, DC 20460 or by 
calling (202) 566-1672.

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 proposed 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 of the first year, of the 1% or greater. In 6 estimated cost 
impacts, there is a maximum impact of 0.204%. 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. 
6). We continue to be interested in the potential impacts of the 
proposed rule on small entities and welcome comments on issues related 
to such impacts.

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.
    In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicits comment on this proposed action 
from State and local officials.

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. In the spirit of Executive Order 
13175, and consistent with EPA policy to promote communications between 
EPA and Indian Tribal Governments, EPA specifically solicits additional 
comment on this proposed action from tribal officials.

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 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 proposed rulemaking does not involve technical standards. 
Therefore,

[[Page 15920]]

EPA is not considering 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 proposed 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 proposed 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 proposed rule will have a 
positive impact on the human health and environmental impacts of 
minority populations, low-income populations, and children.

List of Subjects in 40 CFR Part 372

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

    Dated: March 5, 2013.
Bob Perciasepe,
Acting Administrator.
    Therefore, it is proposed that 40 CFR part 372 be 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. Section 372.65 is amended by adding in the table of paragraph (a) 
``o-Nitrotoluene'' in alphabetical order and adding in the table of 
paragraph (b) ``00088-72-2'' in numerical order to read as follows:


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

* * * * *
    (a) * * *

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

    (b) * * *

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

[FR Doc. 2013-05812 Filed 3-12-13; 8:45 am]
BILLING CODE P