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[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Proposed Rules]
[Pages 20189-20195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08664]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2015-0011; FRL-9925-29-OEI]
RIN 2025-AA41

Addition of 1-Bromopropane; Community Right-To-Know Toxic 
Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to add 
1-bromopropane 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. 1-Bromopropane has been classified by the National 
Toxicology Program in their 13th Report on Carcinogens as ``reasonably 
anticipated to be a human carcinogen.'' EPA believes that 1-
bromopropane meets the EPCRA section

[[Page 20190]]

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, 1-bromopropane 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 June 15, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
TRI-2015-0011, 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-
2015-0011. 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 (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 1-bromopropane. Potentially affected 
categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                             Examples of potentially
                Category                        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) (corresponds 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.) (corresponds 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.

[[Page 20191]]

II. Introduction

A. What is the statutory authority for this proposed 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 308 individually listed 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) 
through (C) are met. The EPCRA section 313(d)(2)(A) through (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. 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 13th RoC having been 
released on October 2, 2014 (79 FR 60169, October 6, 2014). The 13th 
RoC contains the NTP cancer classifications from the most recent 
chemical evaluations, as well as the classifications from previous 
versions of the RoC (Reference (Ref.) 1).

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. 2) 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

[[Page 20192]]

study of tissues or cells from humans exposed to the substance 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. 3).

C. What is the review process for the RoC?

    Specific details of the nomination and review process for the 
development of the 13th RoC are described in the Process for 
Preparation of the Report on Carcinogens section of the 13th RoC (Ref. 
4). 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 13th RoC, during the entire nomination, 
selection, and review process there were seven opportunities for public 
comment. For each candidate substance, an expert panel was convened to 
peer review the NTP monograph document prepared for each candidate 
substance. The RoC Monograph on 1-Bromopropane consists of the 
following components: (Part 1) the cancer evaluation component that 
reviews the relevant scientific information, assesses its quality, 
applies the RoC listing criteria to the scientific information, and 
gives the RoC listing status for 1-bromopropane, and (Part 2) the RoC 
monograph's substance profile containing the NTP's listing status 
decision, a summary of the scientific evidence considered key to 
reaching that decision, and data on properties, use, production, 
exposure, and Federal regulations and guidelines to reduce exposure to 
1-bromopropane. The expert panel members had the following major 
responsibilities in reviewing the draft RoC monograph:

    (1) to comment on the draft cancer evaluation components for 1-
bromopropane, specifically, whether they are technically correct and 
clearly stated, whether the NTP has objectively presented and 
assessed the scientific evidence, and whether the scientific 
evidence is adequate for applying the RoC listing criteria, and (2) 
to comment on the draft substance profile for 1-bromopropane, 
specifically, whether the scientific justification presented in the 
substance profile supports the NTP's preliminary policy decision on 
the RoC listing status of 1-bromopropane. The panel was also asked 
to vote on the following questions: (1) Whether the scientific 
evidence supports the NTP's conclusion on the level of evidence for 
carcinogenicity from experimental animal studies on 1-bromopropane 
and (2) whether the scientific evidence supports the NTP's 
preliminary listing decision for 1-bromopropane in the RoC. The 
panel agreed with the NTP conclusions that 1-bromopropane should be 
listed in the RoC based on sufficient evidence of carcinogenicity 
from studies in experimental animals, which found skin tumors in 
male rats, large intestine tumors in female and male rats, and lung 
tumors in female mice.'' (Ref. 5)

Based upon the peer-review comments, the Office of the Report on 
Carcinogens (ORoC) prepared a revised draft RoC Monograph, which was 
then reviewed by the NTP Board of Scientific Counselors. The ORoC, in 
concert with the NTP Director, then finalized the RoC monographs and 
submitted the newly reviewed substances to the NTP Executive Committee 
for consultation. The final draft of the 13th RoC was then submitted to 
the Secretary of Health and Human Services (HHS) for review and 
approval. Once approved, the Secretary submitted the 13th RoC to the 
U.S. Congress as a final document and published the document on the RoC 
Web site (http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html).

IV. EPA's Review of the 13th 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 12th RoC 
(March 13, 2013, 78 FR 15913). Each new version of the RoC adds newly 
classified chemicals to the existing list. EPA's present review of the 
13th RoC identified 1-bromopropane as the only newly listed chemical 
that is not on the EPCRA section 313 list.
    EPA reviewed the NTP 13th RoC chemical profile and supporting 
materials for 1-bromopropane (Ref. 6). 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 1-
bromopropane 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. 3). Therefore, EPA agrees with the 
hazard conclusions of the NTP 13th RoC for 1-bromopropane.

B. What technical data supports the NTP RoC classification and EPA's 
proposed addition of 1-bromopropane to the EPCRA section 313 list?

    This section presents the data that supported the NTP 13th RoC 
classification of 1-bromopropane and why EPA believes the data support 
the addition of this chemical to the EPCRA section 313 list. The RoC 1-
Bromopropane Profile document (Ref. 7), the RoC Monograph on 1-
Bromopropane (Ref. 5), and the available references cited within the 
portion of the 13th 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 below from the 13th RoC 1-Bromopropane 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 13th RoC 1-Bromopropane Profile 
document (Ref. 7).
    1. 1-Bromopropane (Chemical Abstracts Service Registry Number 106-
94-5) (Refs. RoC Monograph and Profile documents (Refs. 5 and 7)). The 
NTP has classified 1-bromopropane 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 RoC substance profile for 1-
bromopropane (Ref. 7) included the following summary information of the 
evidence of carcinogenicity:

Carcinogenicity

    1-Bromopropane is reasonably anticipated to be a human 
carcinogen based on sufficient evidence of carcinogenicity from 
studies in experimental animals. 1-Bromopropane, either directly or 
via reactive metabolites, causes molecular alterations that 
typically are associated with carcinogenesis, including 
genotoxicity, oxidative stress, and glutathione depletion. These 
alterations, observed mainly in vitro and in toxicity studies in 
rodents, are relevant to possible mechanisms of human 
carcinogenicity and support the relevance of the cancer studies in 
experimental animals to human carcinogenicity.

[[Page 20193]]

Cancer Studies in Experimental Animals

    Inhalation exposure to 1-bromopropane caused tumors in two 
rodent species and at several different tissue sites, including one 
tissue site in rats at which tumors are rare (NTP 2011).
    In male rats, 1-bromopropane caused significant dose-related 
increases in the incidences of several types of benign and/or 
malignant skin tumors (keratoacanthoma; keratoacanthoma and 
squamous-cell carcinoma combined; and keratoacanthoma, squamous-cell 
carcinoma, basal-cell adenoma, and basal-cell carcinoma combined). 
Both female and male rats showed an increased incidence of large-
intestine tumors (adenoma of the colon and rectum), which are rare 
tumors in rats. In females, the incidence was dose-related and 
statistically significantly higher than in concurrent controls, and 
it exceeded the historical control range for all routes of exposure 
used in studies, including inhalation exposure. In males, the 
incidence of large-intestine adenoma was not significantly 
increased, but exceeded the historical control range for inhalation-
exposure studies, and its occurrence was considered to be 
biologically significant because of the rarity of these tumors 
(which occurred in less than 0.2% of the historical controls). 
Although no carcinoma of the large intestine was observed in male or 
female rats in this study, adenoma of the large intestine has been 
shown to progress to carcinoma in other studies, and forms a 
morphologic continuum with carcinoma (Deschner 1983, Chang 1984, 
Nigro 1985).
    In female mice, 1-bromopropane caused significant dose-related 
increases in the incidence of benign and malignant lung tumors 
combined (alveolar/bronchiolar adenoma and carcinoma).
    These findings are supported by the observation of additional 
tumors in rats that may have been related to 1-bromopropane 
exposure, including malignant mesothelioma of the abdominal cavity 
and pancreatic islet tumors in males and skin tumors (squamous-cell 
papilloma, keratoacanthoma, and basal-cell adenoma or carcinoma) in 
females.

Other Relevant Data

    1-Bromopropane is well absorbed following ingestion, inhalation, 
or dermal exposure. Occupational exposure occurs primarily by 
inhalation and dermal contact. Unmetabolized 1-bromopropane has been 
detected in the urine of exposed workers at levels significantly 
correlated with exposure to 1-bromopropane in air (Kawai et al. 
2001, Ichihara et al. 2004).
    1-Bromopropane is metabolized via several pathways; 16 urinary 
metabolites have been detected in rodents, and several other 
metabolites have been proposed (Jones and Walsh 1979, Ishidao et al. 
2002, Garner et al. 2006). The primary metabolic pathways in rodents 
are oxidation reactions catalyzed by cytochrome P450 (primarily 
CYP2E1) and glutathione conjugation. The available data on human 
metabolism of 1-bromopropane, although limited, suggest that some of 
its metabolic pathways in humans are similar to those observed in 
rodents. Four mercapturic conjugates identified in the urine of 
rodents were also identified in the urine of workers exposed to 1-
bromopropane (Hanley et al. 2009). The major metabolite, N-acetyl-S-
(n-propyl)-L-cysteine, has been detected in the urine of exposed 
workers at levels that increased with increasing levels of 1-
bromopropane in ambient air (Hanley and Dunn 2006, Valentine et al. 
2007, Hanley et al. 2009, 2010). This metabolite is produced in 
humans by conjugation of 1-bromopropane with glutathione, and that 
reaction also releases free bromide ions, another useful biomarker 
for human exposure to 1-bromopropane (Jones and Walsh 1979, Hanley 
et al. 2006). No studies were identified that tested for the 
occurrence in humans of the oxidative metabolites that are obligate 
intermediates to the measured conjugates.

Studies on Mechanisms of Carcinogenesis

    The mechanism(s) by which 1-bromopropane causes cancer is not 
known. However, exposure to 1-bromopropane has been shown to cause 
molecular alterations related to carcinogenicity, including 
genotoxicity (mutations and DNA damage), oxidative stress, 
glutathione depletion, and immunomodulation.
    Studies have shown that 1-bromopropane can bind to 
macromolecules; it formed S-propylcysteine-globin adducts in exposed 
animals and humans (Valentine et al. 2007). Although 1-bromopropane 
did not induce mutations in bacteria under standard assay 
conditions, it did induce mutations in bacteria both with and 
without exogenous mammalian metabolic activation in the only 
reported study whose design was appropriate for testing a highly 
volatile chemical (Barber et al. 1981). It also caused mutations in 
cultured mammalian cells with or without mammalian metabolic 
activation (Elf Atochem 1996, as reviewed in NTP 2003) and DNA 
damage in cultured human cells without metabolic activation 
(Toraason et al. 2006). In addition, there is limited evidence of 
DNA damage in leukocytes from 1-bromopropane-exposed workers 
(Toraason et al. 2006). In rodents exposed in vivo, 1-bromopropane 
did not increase micronucleus formation in bone marrow (Kim et al. 
1998, as reviewed in NTP 2003) or peripheral blood erythrocytes (Elf 
Atochem 1996, cited in NTP 2003, NTP 2011) or cause dominant lethal 
mutations. However, the dominant lethal mutation assay is generally 
regarded as relatively insensitive for the detection of mutagenic 
agents (Saito-Suzuki et al. 1982, Yu et al. 2008).
    There is evidence that metabolic activation plays a role in the 
genotoxicity and toxicity of 1-bromopropane. Several reactive 
metabolites (or intermediates) of 1-bromopropane have been 
identified in rodents, including glycidol and [alpha]-bromohydrin, 
and propylene oxide has been proposed as a metabolite (Garner et al. 
2006). These compounds cause genotoxic effects in vitro, including 
DNA adduct formation, mutations, and DNA or chromosome damage 
(Stolzenberg and Hine 1979, IARC 1994, 2000). Glycidol and propylene 
oxide cause cytogenetic effects in vivo and are carcinogenic in 
experimental animals, and both substances are listed in the Report 
on Carcinogens as reasonably anticipated to be human carcinogens. 
These reactive and genotoxic metabolites may be responsible for at 
least some of the carcinogenic effects of 1-bromopropane. As with 1-
bromopropane, oral exposure to glycidol caused rare tumors of the 
large intestine in rats, as did oral exposure to two halogenated 
alkane analogues of 1-bromopropane, tribromomethane and 
bromodichloromethane (NTP 1987, 1989, 1990).
    Chronic exposure to 1-bromopropane may produce levels of 
oxidative metabolites that exceed the glutathione-conjugating 
capacity or may inhibit enzymes required for glutathione synthesis. 
Because glutathione is an important cellular defense mechanism, 
reduced levels can lead to oxidative stress, increased toxicity, and 
carcinogenicity. Numerous studies have shown that 1-bromopropane 
induces both oxidative stress and glutathione depletion (Lee et al. 
2005, 2007, 2010a, Liu et al. 2009, 2010, Huang et al. 2011). 
Studies with Cyp2e1-/- knockout mice, cytochrome P450 
inhibitors, or a glutathione synthesis inhibitor showed that this 
metabolic activation pathway is involved in 1-bromopropane-induced 
toxicity, including neurological and reproductive effects, 
hepatotoxicity, and immunosuppression (NTP 2003, 2011, Lee et al. 
2007, 2010a,b). Neurological effects of 1-bromopropane exposure have 
also been reported in humans (Li et al. 2010, Ichihara et al. 2012).
    It is unclear whether induction of immunotoxicity by 1-
bromopropane plays a role in tumor development. Recent studies have 
shown that 1-bromopropane causes immunosuppression in rodents (Lee 
et al. 2007, Anderson et al. 2010). In particular, it reduced the 
numbers of T cells and T-cell subpopulations. In addition, there is 
evidence that 1-bromopropane causes an inflammatory response. It 
induced dose-related increases in gene expression and production of 
proinflammatory cytokines in mouse macrophages (Han et al. 2008) and 
an inflammatory response in rats (NTP 2011). However, chronic 
respiratory inflammation and lung tumors were not associated in 
rodents; respiratory inflammation occurred in rats but not mice, 
whereas lung tumors occurred in mice but not rats.

Cancer Studies in Humans

    No epidemiological studies or case reports were identified that 
evaluated the relationship between human cancer and exposure 
specifically to 1-bromopropane.

    EPA has reviewed the NTP assessment for 1-bromopropane and agrees 
that 1-bromopropane can reasonably be anticipated to cause cancer in 
humans. EPA believes that the evidence is sufficient for listing 1-
bromopropane 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

[[Page 20194]]

comment. The NTP review 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 in the NTP RoC to cause cancer in humans (see Unit III). Based 
on EPA's review of the data contained in the NTP 13th RoC, EPA has 
determined that 1-bromopropane can reasonably be anticipated to cause 
cancer (Ref. 6). Therefore, EPA believes that the evidence is 
sufficient for listing 1-bromopropane 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 NTP 13th 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 1-
bromopropane 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-2015-0011. 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. For convenience, the docket also includes all of the Federal 
Register documents cited in this action.

1. NTP, 2014. National Toxicology Program. Report on Carcinogens, 
Thirteenth Edition. Released October 2, 2014. U.S. Department of 
Health and Human Services, Public Health Service, National 
Toxicology Program, Research Triangle Park, NC 27709. (http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html)
2. NTP, 2014. National Toxicology Program. Report on Carcinogens, 
Thirteenth Edition, Introduction section. Released October 2, 2014. 
U.S. Department of Health and Human Services, Public Health Service, 
National Toxicology Program, Research Triangle Park, NC 27709.
3. USEPA. Guidelines for Carcinogen Risk Assessment. Risk Assessment 
Forum, U.S. Environmental Protection Agency, Washington, DC, March 
2005.
4. NTP, 2014. National Toxicology Program. Report on Carcinogens, 
Thirteenth Edition, Process for Preparation of the Report on 
Carcinogens section. Released October 2, 2014. U.S. Department of 
Health and Human Services, Public Health Service, National 
Toxicology Program, Research Triangle Park, NC 27709.
5. NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane. 
Office of the Report on Carcinogens, Division of the National 
Toxicology Program, National Institute of Environmental Health 
Sciences, U.S. Department of Health and Human Services. NIH 
Publication No. 13-5982, September 25, 2013
6. USEPA, OEI. Memorandum from Jocelyn Hospital, Toxicologist, 
Analytical Support Branch to Sandra Gaona, Acting Chief, Analytical 
Support Branch. November 3, 2014. Subject: Review of National 
Toxicology Program (NTP) Cancer Classification Data for 1-
bromopropane.
7. NTP, 2014. National Toxicology Program. Report on Carcinogens, 
Thirteenth Edition, Profile for 1-Bromopropane. Released October 2, 
2014. U.S. Department of Health and Human Services, Public Health 
Service, National Toxicology Program, Research Triangle Park, NC 
27709.
8. USEPA, OEI. Economic Analysis of the Proposed Rule to add 1-
Bromopropane to the EPCRA Section 313 List of Toxic Chemicals. 
February 17, 2015.

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 and was 
therefore not submitted to the Office of Management and Budget (OMB) 
for review.

B. Paperwork Reduction Act

    This action 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). 
OMB has previously approved the information collection activities 
contained in the existing regulations and has assigned OMB control 
numbers 2025-0009 and 2050-0078. 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).

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.

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. The 
Agency has determined that of the 140 entities estimated to be impacted 
by this action, 136 are small businesses; no small

[[Page 20195]]

governments or small organizations are expected to be affected by this 
action. All 136 small businesses affected by this action are estimated 
to incur annualized cost impacts of less than 1%. 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. Thus, this action 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. 8).

D. Unfunded Mandates Reform Act

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531 through 1538, and does not 
significantly or uniquely affect small governments. This action is not 
subject to the requirements 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. EPA's economic analysis indicates that the 
total cost of this action is estimated to be $531,002 in the first year 
of reporting (Ref. 8).

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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications, as specified in 
Executive Order 13175. 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

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive Order. This action is not subject to 
Executive Order 13045 because it does not concern an environmental 
health risk or safety risk.

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

    This action is not subject to Executive Order 13211, because it is 
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed 
by this action will not have potential disproportionately high and 
adverse human health or environmental effects on minority, low-income 
or indigenous populations. The results of this evaluation are contained 
below.
    This action does not address any human health or environmental 
risks and does not affect the level of protection provided to human 
health or the environment. This action 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 action 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: April 8, 2015.
Gina McCarthy,
Administrator.

    Therefore, 40 CFR part 372 is proposed to be 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 ``1-Bromopropane'' in alphabetical order and in paragraph (b) 
by adding in the table the entry for ``106-94-5'' 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
------------------------------------------------------------------------
 
                                * * * * *
1-Bromopropane.................................   106-94-5       1/1/16
 
                                * * * * *
------------------------------------------------------------------------

    (b) * * *

------------------------------------------------------------------------
                                                              Effective
                CAS No.                     Chemical name        date
------------------------------------------------------------------------
 
                                * * * * *
106-94-5...............................     1-Bromopropane       1/1/16
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-08664 Filed 4-14-15; 8:45 am]
 BILLING CODE 6560-50-P
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