80_FR_20261 80 FR 20189 - Addition of 1-Bromopropane; Community Right-To-Know Toxic Chemical Release Reporting

80 FR 20189 - Addition of 1-Bromopropane; Community Right-To-Know Toxic Chemical Release Reporting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range20189-20195
FR Document2015-08664

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 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.

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015)
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Proposed Rules]
[Pages 20189-20195]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: oei.docket@epa.gov.
     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: bushman.daniel@epa.gov, for specific information on 
this notice. For general information on EPCRA section 313, contact the 
Emergency Planning and Community Right-to-Know Hotline, toll free at 
(800) 424-9346 (select menu option 3) or (703) 412-9810 in Virginia and 
Alaska or toll free, TDD (800) 553-7672, http://www.epa.gov/superfund/contacts/infocenter/.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or otherwise use 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]
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                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules                                                 20189

                                                       b. How does a crew monitor and                       tower owner, turfing vendor,                           approaches had on work practices and
                                                    respond to changing weather                             subcontractor, and contractors hired by                climber safety in those states?
                                                    conditions, including storms?                           the subcontractor all have some role in                   36. Should an OSHA standard be
                                                       20. Fatigue: OSHA believes that                      the project) impacts employee safety at                limited to work performed on
                                                    fatigue can affect communication tower                  communication tower worksites?                         communication towers, or should it also
                                                    workers in several ways. Climbing a                       26. What practices might companies                   cover towers used for other purposes?
                                                    communication tower is physically                       in the contracting chain adopt to                         37. If OSHA does not initiate a
                                                    demanding, and OSHA is concerned                        encourage communication and                            dedicated rulemaking for work on
                                                    that fatigue due to exertion can be                     coordination among employers at tower                  communication towers, what other
                                                    hazardous for tower workers.                            work sites? What obstacles stand in the                types of regulatory actions might be
                                                    Accelerated work timelines can also                     way of communication and                               necessary and appropriate?
                                                    result in tower workers working very                    coordination between different parties                    38. What non-regulatory approaches
                                                    long hours. And OSHA understands that                   in the contracting chain?                              could OSHA take to address hazards
                                                    communication tower workers may                                                                                faced by employees working on
                                                    travel long distances to reach remote                   Economic Issues                                        communication towers?
                                                    worksites, which can result in workers                     27. The Agency seeks information on                 Authority and Signature
                                                    being fatigued before they even begin                   the number and size of firms that are
                                                    work.                                                   engaged in communication tower work                       This document was prepared under
                                                       a. What hazards are faced by a worker                and on the number of employees                         the direction of David Michaels, Ph.D.,
                                                    who finds it physically challenging to                  employed by those firms.                               MPH, Assistant Secretary of Labor for
                                                    perform expected tasks, such as                            28. The Agency seeks information                    Occupational Safety and Health, U.S.
                                                    climbing a tower or performing a self-                  about wage and turnover rates for                      Department of Labor. It is issued
                                                    rescue? What impact can this have on                    employees who work on                                  pursuant to sections 3704 et seq., Public
                                                    other crew members?                                     communication towers. The Agency is                    Law 107–217, 116 STAT. 1062 (40
                                                       b. What are the common causes of                     also interested in information about the               U.S.C. 3704 et seq.); sections 4, 6, and
                                                    worker fatigue at communication tower                   experience possessed by workers                        8, Public Law 91–596, 84 STAT. 1590
                                                    worksites?                                              currently doing communication tower                    (29 U.S.C. 653, 655, 657); 29 CFR part
                                                       c. What are the effects of fatigue on                work. Are they usually experienced in                  1911; and Secretary of Labor’s Order No.
                                                    tower worker safety, and what types of                  this type of work? Are there many new                  1–2012 (77 FR 3912 (Jan. 25, 2012)).
                                                    incidents occur as a result of worker                   or inexperienced employees working on                    Signed at Washington, DC, on March 27,
                                                    fatigue?                                                communication towers?                                  2015.
                                                       21. Other common hazards:                               29. What types of equipment are used                David Michaels,
                                                       a. What other hazards are present in
                                                                                                            in tower work and how often is this                    Assistant Secretary of Labor for Occupational
                                                    communication tower work, and what
                                                                                                            equipment repaired and/or replaced?                    Safety and Health.
                                                    types of incidents are resulting from
                                                                                                               30. The Agency seeks information                    [FR Doc. 2015–08633 Filed 4–14–15; 8:45 am]
                                                    those hazards? What can be done to
                                                                                                            from all employers in the contracting                  BILLING CODE 4510–26–P
                                                    protect employees from those hazards?
                                                       b. What are some health and safety                   chain about the extent to which
                                                    considerations involved in working                      employees directly engaged in tower
                                                    with communications equipment                           work are covered by workers’                           ENVIRONMENTAL PROTECTION
                                                    installed on non-dedicated tower                        compensation and/or an employer                        AGENCY
                                                    structures, such as water towers,                       liability insurance policy.
                                                    buildings, silos, electrical transmission                                                                      40 CFR Part 372
                                                                                                            Tower Design
                                                    towers, etc.?                                                                                                  [EPA–HQ–TRI–2015–0011; FRL–9925–29–
                                                                                                               31. Can towers be designed and built                OEI]
                                                    Contracting and Work Oversight                          with elevators for lifting personnel or
                                                                                                            materials? Can towers be built with                    RIN 2025–AA41
                                                       22. Describe your role in the contract
                                                    chain and the key safety-related                        booms or davits aloft to aid in hoisting
                                                                                                            materials?                                             Addition of 1-Bromopropane;
                                                    provisions typically included in your                                                                          Community Right-To-Know Toxic
                                                    contracts. How do contracting parties                      32. How would elevators or davits
                                                                                                            affect productivity/efficiency, e.g., the              Chemical Release Reporting
                                                    oversee or enforce those provisions?
                                                    What are the consequences if a party                    amount of time spent on the tower?                     AGENCY:  Environmental Protection
                                                    fails to fulfill those contractual                      How would elevators or davits address                  Agency (EPA).
                                                    requirements?                                           or cause any safety hazards at the site?               ACTION: Proposed rule.
                                                       23. What characteristics of past safety              For example, would elevators or davits
                                                    performance does your company use in                    address hazards related to employee                    SUMMARY:   The Environmental Protection
                                                    selecting potential contractors and                     fatigue?                                               Agency (EPA) is proposing to add 1-
                                                    subcontractors? What safety-related                        33. What are the industry standards                 bromopropane to the list of toxic
                                                    criteria does your company use in this                  for providing fall protection anchor                   chemicals subject to reporting under
                                                    selection process?                                      points on new towers?                                  section 313 of the Emergency Planning
                                                       24. Are safety-related factors                                                                              and Community Right-to-Know Act
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                                                                                                            Regulatory/Non-Regulatory Approaches
                                                    considered in determining whether to                                                                           (EPCRA) of 1986 and section 6607 of the
                                                    remove a contractor/subcontractor from                    34. What would be the advantages                     Pollution Prevention Act (PPA) of 1990.
                                                    an ongoing project or from future                       and disadvantages of an OSHA standard                  1-Bromopropane has been classified by
                                                    selection processes? If so, what specific               that covers both construction and                      the National Toxicology Program in
                                                    factors are considered?                                 maintenance activities on                              their 13th Report on Carcinogens as
                                                       25. What are the ways in which the                   communication towers?                                  ‘‘reasonably anticipated to be a human
                                                    multi-leveled contracting environment                     35. What effects have the North                      carcinogen.’’ EPA believes that 1-
                                                    (i.e., where entities such as the carrier,              Carolina and Michigan regulatory                       bromopropane meets the EPCRA section


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                                                    20190                       Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules

                                                    313(d)(2)(B) criteria because it can                        claimed to be Confidential Business                    either electronically in
                                                    reasonably be anticipated to cause                          Information (CBI) or other information                 www.regulations.gov or in hard copy at
                                                    cancer in humans. Based on a review of                      whose disclosure is restricted by statute.             the OEI Docket, EPA/DC, EPA West,
                                                    the available production and use                            Do not submit information that you                     Room 3334, 1301 Constitution Ave.
                                                    information, 1-bromopropane is                              consider to be CBI or otherwise                        NW., Washington, DC. This Docket
                                                    expected to be manufactured, processed,                     protected through www.regulations.gov                  Facility is open from 8:30 a.m. to 4:30
                                                    or otherwise used in quantities that                        or email. The www.regulations.gov Web                  p.m., Monday through Friday, excluding
                                                    would exceed the EPCRA section 313                          site is an ‘‘anonymous access’’ system,                legal holidays. The telephone number
                                                    reporting thresholds.                                       which means EPA will not know your                     for the Public Reading Room is (202)
                                                    DATES: Comments must be received on                         identity or contact information unless                 566–1744, and the telephone number for
                                                    or before June 15, 2015.                                    you provide it in the body of your                     the OEI Docket is (202) 566–1752.
                                                    ADDRESSES: Submit your comments,                            comment. If you send an email
                                                                                                                comment directly to EPA without going                  FOR FURTHER INFORMATION CONTACT:
                                                    identified by Docket ID No. EPA–HQ–                                                                                Daniel R. Bushman, Environmental
                                                    TRI–2015–0011, by one of the following                      through www.regulations.gov, your
                                                                                                                email address will be automatically                    Analysis Division, Office of Information
                                                    methods:                                                                                                           Analysis and Access (2842T),
                                                      • www.regulations.gov: Follow the                         captured and included as part of the
                                                                                                                                                                       Environmental Protection Agency, 1200
                                                    on-line instructions for submitting                         comment that is placed in the public
                                                                                                                docket and made available on the                       Pennsylvania Ave. NW., Washington,
                                                    comments.                                                                                                          DC 20460; telephone number: 202–566–
                                                      • Email: oei.docket@epa.gov.                              Internet. If you submit an electronic
                                                      • Mail: Office of Environmental                           comment, EPA recommends that you                       0743; fax number: 202–566–0677; email:
                                                    Information (OEI) Docket,                                   include your name and other contact                    bushman.daniel@epa.gov, for specific
                                                    Environmental Protection Agency, Mail                       information in the body of your                        information on this notice. For general
                                                    Code: 28221T, 1200 Pennsylvania Ave.                        comment and with any disk or CD–ROM                    information on EPCRA section 313,
                                                    NW., Washington, DC 20460.                                  you submit. If EPA cannot read your                    contact the Emergency Planning and
                                                      • Hand Delivery: EPA Docket Center                        comment due to technical difficulties                  Community Right-to-Know Hotline, toll
                                                    (EPA/DC), EPA West, Room 3334, 1301                         and cannot contact you for clarification,              free at (800) 424–9346 (select menu
                                                    Constitution Ave. NW., Washington, DC                       EPA may not be able to consider your                   option 3) or (703) 412–9810 in Virginia
                                                    20460. Such deliveries are only                             comment. Electronic files should avoid                 and Alaska or toll free, TDD (800) 553–
                                                    accepted during the Docket’s normal                         the use of special characters, avoid any               7672, http://www.epa.gov/superfund/
                                                    hours of operation, and special                             form of encryption, and be free of any                 contacts/infocenter/.
                                                    arrangements should be made for                             defects or viruses.                                    SUPPLEMENTARY INFORMATION:
                                                    deliveries of boxed information.                               Docket: All documents in the docket
                                                      Instructions: Direct your comments to                     are listed in the www.regulations.gov                  I. General Information
                                                    Docket ID No. EPA–HQ–TRI–2015–                              index. Although listed in the index,                   A. Does this notice apply to me?
                                                    0011. EPA’s policy is that all comments                     some information is not publicly
                                                    received will be included in the public                     available, e.g., CBI or other information                You may be potentially affected by
                                                    docket without change and may be                            whose disclosure is restricted by statute.             this action if you manufacture, process,
                                                    made available online at                                    Certain other material, such as                        or otherwise use 1-bromopropane.
                                                    www.regulations.gov, including any                          copyrighted material, will be publicly                 Potentially affected categories and
                                                    personal information provided, unless                       available only in hard copy. Publicly                  entities may include, but are not limited
                                                    the comment includes information                            available docket materials are available               to:

                                                             Category                                                              Examples of potentially affected entities

                                                    Industry .......................   Facilities included in the following NAICS manufacturing codes (corresponding to SIC codes 20 through 39): 311 *,
                                                                                          312 *, 313 *, 314 *, 315 *, 316, 321, 322, 323 *, 324, 325 *, 326 *, 327, 331, 332, 333, 334 *, 335 *, 336, 337 *, 339 *,
                                                                                          111998 *, 211112 *, 212324 *, 212325 *, 212393 *, 212399 *, 488390 *, 511110, 511120, 511130, 511140 *, 511191,
                                                                                          511199, 512220, 512230 *, 519130 *, 541712 *, or 811490 *.
                                                                                       * Exceptions and/or limitations exist for these NAICS codes.
                                                                                       Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39):
                                                                                          212111, 212112, 212113 (correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234,
                                                                                          212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221119,
                                                                                          221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for
                                                                                          distribution in commerce) (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.
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                                                       This table is not intended to be                         To determine whether your facility                     listed in the preceding FOR FURTHER
                                                    exhaustive, but rather provides a guide                     would be affected by this action, you                  INFORMATION CONTACT    section.
                                                    for readers regarding entities likely to be                 should carefully examine the
                                                    affected by this action. Some of the                        applicability criteria in part 372 subpart
                                                    entities listed in the table have                           B of Title 40 of the Code of Federal
                                                    exemptions and/or limitations regarding                     Regulations. If you have questions
                                                    coverage, and other types of entities not                   regarding the applicability of this action
                                                    listed in the table could also be affected.                 to a particular entity, consult the person


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                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules                                                20191

                                                    II. Introduction                                        significant adverse effect on the                      periodically, with the most recently
                                                                                                            environment of sufficient seriousness,                 published 13th RoC having been
                                                    A. What is the statutory authority for
                                                                                                            in the judgment of the Administrator, to               released on October 2, 2014 (79 FR
                                                    this proposed rule?
                                                                                                            warrant reporting under this section.                  60169, October 6, 2014). The 13th RoC
                                                      This rule is issued under EPCRA                          EPA often refers to the section                     contains the NTP cancer classifications
                                                    section 313(d) and section 328, 42                      313(d)(2)(A) criterion as the ‘‘acute                  from the most recent chemical
                                                    U.S.C. 11023 et seq. EPCRA is also                      human health effects criterion;’’ the                  evaluations, as well as the
                                                    referred to as Title III of the Superfund               section 313(d)(2)(B) criterion as the                  classifications from previous versions of
                                                    Amendments and Reauthorization Act                      ‘‘chronic human health effects                         the RoC (Reference (Ref.) 1).
                                                    of 1986.                                                criterion;’’ and the section 313(d)(2)(C)
                                                                                                                                                                   B. What are the NTP cancer
                                                    B. What is the background for this                      criterion as the ‘‘environmental effects
                                                                                                                                                                   classifications and criteria?
                                                    action?                                                 criterion.’’
                                                                                                               EPA published in the Federal                           The NTP RoC classifies chemicals as
                                                       Section 313 of EPCRA, 42 U.S.C.                      Register of November 30, 1994 (59 FR                   either ‘‘known to be a human
                                                    11023, requires certain facilities that                 61432), a statement clarifying its                     carcinogen’’ or ‘‘reasonably anticipated
                                                    manufacture, process, or otherwise use                  interpretation of the section 313(d)(2)                to be a human carcinogen.’’ The criteria
                                                    listed toxic chemicals in amounts above                 and (d)(3) criteria for modifying the                  that the NTP uses to list an agent,
                                                    reporting threshold levels to report their              section 313 list of toxic chemicals.                   substance, mixture, or exposure
                                                    environmental releases and other waste                                                                         circumstance under each classification
                                                    management quantities of such                           III. Background Information                            in the RoC (Ref. 2) are as follows:
                                                    chemicals annually. These facilities                    A. What is the NTP and the report on
                                                    must also report pollution prevention                                                                             Known To Be Human Carcinogen: There is
                                                                                                            carcinogens?                                           sufficient evidence of carcinogenicity from
                                                    and recycling data for such chemicals,                                                                         studies in humans *, which indicates a causal
                                                    pursuant to section 6607 of the PPA, 42                   The National Toxicology Program
                                                                                                                                                                   relationship between exposure to the agent,
                                                    U.S.C. 13106. Congress established an                   (NTP) is an interagency program within                 substance, or mixture, and human cancer.
                                                    initial list of toxic chemicals that                    the Department of Health and Human                        Reasonably Anticipated To Be Human
                                                    comprised 308 individually listed                       Services (DHHS) headquartered at the                   Carcinogen: There is limited evidence of
                                                    chemicals and 20 chemical categories.                   National Institute of Environmental                    carcinogenicity from studies in humans *,
                                                       EPCRA section 313(d) authorizes EPA                  Health Sciences (NIEHS) of the National                which indicates that causal interpretation is
                                                    to add or delete chemicals from the list                Institutes of Health (NIH). The mission                credible, but that alternative explanations,
                                                    and sets criteria for these actions.                    of the NTP is to evaluate chemicals of                 such as chance, bias, or confounding factors,
                                                                                                                                                                   could not adequately be excluded, or there is
                                                    EPCRA section 313(d)(2) states that EPA                 public health concern by developing
                                                                                                                                                                   sufficient evidence of carcinogenicity from
                                                    may add a chemical to the list if any of                and applying tools of modern toxicology                studies in experimental animals, which
                                                    the listing criteria in Section 313(d)(2)               and molecular biology. The NTP                         indicates there is an increased incidence of
                                                    are met. Therefore, to add a chemical,                  program maintains an objective,                        malignant and/or a combination of malignant
                                                    EPA must demonstrate that at least one                  science-based approach in dealing with                 and benign tumors (1) in multiple species or
                                                    criterion is met, but need not determine                critical issues in toxicology and is                   at multiple tissue sites, or (2) by multiple
                                                    whether any other criterion is met.                     committed to using the best science                    routes of exposure, or (3) to an unusual
                                                    Conversely, to remove a chemical from                   available to prioritize, design, conduct,              degree with regard to incidence, site, or type
                                                    the list, EPCRA section 313(d)(3)                                                                              of tumor, or age at onset, or there is less than
                                                                                                            and interpret its studies. The mission of
                                                                                                                                                                   sufficient evidence of carcinogenicity in
                                                    dictates that EPA must demonstrate that                 the NTP includes the evaluation of                     humans or laboratory animals; however, the
                                                    none of the listing criteria in Section                 chemicals for their potential to cause                 agent, substance, or mixture belongs to a
                                                    313(d)(2)(A) through (C) are met. The                   cancer in humans.                                      well-defined, structurally related class of
                                                    EPCRA section 313(d)(2)(A) through (C)                    As part of their cancer evaluation                   substances whose members are listed in a
                                                    criteria are:                                           work, the NTP periodically publishes a                 previous Report on Carcinogens as either
                                                       • The chemical is known to cause or                  Report on Carcinogens (RoC) document.                  known to be a human carcinogen or
                                                    can reasonably be anticipated to cause                  The RoC was mandated by the U.S.                       reasonably anticipated to be a human
                                                    significant adverse acute human health                  Congress, as part of the Public Health                 carcinogen, or there is convincing relevant
                                                    effects at concentration levels that are                                                                       information that the agent acts through
                                                                                                            Service Act (Section 301(b)(4), as                     mechanisms indicating it would likely cause
                                                    reasonably likely to exist beyond facility              amended). The NTP describes the RoC                    cancer in humans.
                                                    site boundaries as a result of                          as an informational scientific and public                 Conclusions regarding carcinogenicity in
                                                    continuous, or frequently recurring,                    health document that identifies and                    humans or experimental animals are based
                                                    releases.                                               discusses agents, substances, mixtures,                on scientific judgment, with consideration
                                                       • The chemical is known to cause or                  or exposure circumstances that may                     given to all relevant information. Relevant
                                                    can reasonably be anticipated to cause                  pose a hazard to human health by virtue                information includes, but is not limited to,
                                                    in humans:                                              of their carcinogenicity. The NTP RoC                  dose response, route of exposure, chemical
                                                       Æ Cancer or teratogenic effects; or                                                                         structure, metabolism, pharmacokinetics,
                                                                                                            serves as a meaningful and useful                      sensitive sub-populations, genetic effects, or
                                                       Æ Serious or irreversible—                           compilation of data on (1) the
                                                       D Reproductive dysfunctions,                         carcinogenicity (ability to cause cancer),
                                                                                                                                                                   other data relating to mechanism of action or
                                                       D Neurological disorders,                                                                                   factors that may be unique to a given
                                                       D Heritable genetic mutations; or                    genotoxicity (ability to damage genes),                substance. For example, there may be
                                                                                                            and biologic mechanisms (modes of                      substances for which there is evidence of
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                                                       D Other chronic health effects.
                                                       • The chemical is known to cause or                  action in the body) of the RoC-listed                  carcinogenicity in laboratory animals, but
                                                                                                            substances in humans and/or in                         there are compelling data indicating that the
                                                    can be reasonably anticipated to cause,                                                                        agent acts through mechanisms which do not
                                                    because of:                                             animals, (2) the potential for human
                                                                                                                                                                   operate in humans and would therefore not
                                                       Æ Its toxicity;                                      exposure to these substances, and (3)                  reasonably be anticipated to cause cancer in
                                                       Æ Its toxicity and persistence in the                the regulations and guidelines                         humans.
                                                    environment; or                                         promulgated by Federal agencies to                        * This evidence can include traditional
                                                       Æ Its toxicity and tendency to                       limit exposures to RoC-listed                          cancer epidemiology studies, data from
                                                    bioaccumulate in the environment, a                     substances. The NTP RoC is published                   clinical studies, and/or data derived from the



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                                                    20192                  Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules

                                                    study of tissues or cells from humans                   specifically, whether they are technically             EPA’s review of the 1-bromopropane
                                                    exposed to the substance in question, which             correct and clearly stated, whether the NTP            chemical profile and supporting
                                                    can be useful for evaluating whether a                  has objectively presented and assessed the             material found no inconsistencies
                                                    relevant cancer mechanism is operating in               scientific evidence, and whether the
                                                    humans.                                                 scientific evidence is adequate for applying
                                                                                                                                                                   between how the data were interpreted
                                                                                                            the RoC listing criteria, and (2) to comment           by the NTP and how that same data
                                                       The NTP classifications for the                      on the draft substance profile for 1-                  would be interpreted under EPA’s
                                                    potential for a chemical to cause cancer                bromopropane, specifically, whether the                Guidelines for Carcinogen Risk
                                                    are very similar to the EPCRA section                   scientific justification presented in the              Assessment (Ref. 3). Therefore, EPA
                                                    313(d)(2)(B) statutory criteria for listing             substance profile supports the NTP’s                   agrees with the hazard conclusions of
                                                    a chemical on the list of toxic chemicals               preliminary policy decision on the RoC                 the NTP 13th RoC for 1-bromopropane.
                                                    subject to reporting under EPCRA                        listing status of 1-bromopropane. The panel
                                                    section 313: ‘‘(B) The chemical is known                was also asked to vote on the following                B. What technical data supports the
                                                    to cause or can reasonably be                           questions: (1) Whether the scientific evidence         NTP RoC classification and EPA’s
                                                                                                            supports the NTP’s conclusion on the level             proposed addition of 1-bromopropane
                                                    anticipated to cause in humans—(i)                      of evidence for carcinogenicity from
                                                    cancer . . .’’ The specific data used by                                                                       to the EPCRA section 313 list?
                                                                                                            experimental animal studies on 1-
                                                    the NTP to classify a chemical as                       bromopropane and (2) whether the scientific               This section presents the data that
                                                    ‘‘Known To Be Human Carcinogen’’ or                     evidence supports the NTP’s preliminary                supported the NTP 13th RoC
                                                    ‘‘Reasonably Anticipated To Be Human                    listing decision for 1-bromopropane in the             classification of 1-bromopropane and
                                                    Carcinogen’’ are consistent with data                   RoC. The panel agreed with the NTP
                                                                                                            conclusions that 1-bromopropane should be
                                                                                                                                                                   why EPA believes the data support the
                                                    used by EPA to evaluate chemicals for                                                                          addition of this chemical to the EPCRA
                                                    their potential to cause cancer and                     listed in the RoC based on sufficient evidence
                                                                                                            of carcinogenicity from studies in                     section 313 list. The RoC 1-
                                                    classify chemicals as either                            experimental animals, which found skin                 Bromopropane Profile document (Ref.
                                                    ‘‘Carcinogenic to Humans’’ or ‘‘Likely to               tumors in male rats, large intestine tumors in         7), the RoC Monograph on 1-
                                                    Be Carcinogenic to Humans’’ (Ref. 3).                   female and male rats, and lung tumors in               Bromopropane (Ref. 5), and the
                                                    C. What is the review process for the                   female mice.’’ (Ref. 5)                                available references cited within the
                                                    RoC?                                                    Based upon the peer-review comments,                   portion of the 13th RoC chemical profile
                                                       Specific details of the nomination and               the Office of the Report on Carcinogens                quoted here, are all included in the
                                                    review process for the development of                   (ORoC) prepared a revised draft RoC                    docket for this rulemaking. While they
                                                    the 13th RoC are described in the                       Monograph, which was then reviewed                     are contained in the docket and are part
                                                    Process for Preparation of the Report on                by the NTP Board of Scientific                         of the rulemaking record, the references
                                                    Carcinogens section of the 13th RoC                     Counselors. The ORoC, in concert with                  within the quotation cited below from
                                                    (Ref. 4). In general, the RoC review                    the NTP Director, then finalized the RoC               the 13th RoC 1-Bromopropane Profile
                                                    process includes evaluations by                         monographs and submitted the newly                     document are not included in the list of
                                                    scientists from the NTP, other Federal                  reviewed substances to the NTP                         references in Unit VI. of this Federal
                                                    health research and regulatory agencies                 Executive Committee for consultation.                  Register notice. The full citations for the
                                                    (including EPA), and nongovernmental                    The final draft of the 13th RoC was then               references contained in the quotation
                                                    institutions. The RoC review process                    submitted to the Secretary of Health and               can be found in the NTP 13th RoC 1-
                                                    includes external peer review and                       Human Services (HHS) for review and                    Bromopropane Profile document (Ref.
                                                    several opportunities for public                        approval. Once approved, the Secretary                 7).
                                                    comment. For the 13th RoC, during the                   submitted the 13th RoC to the U.S.                        1. 1-Bromopropane (Chemical
                                                    entire nomination, selection, and review                Congress as a final document and                       Abstracts Service Registry Number 106–
                                                    process there were seven opportunities                  published the document on the RoC                      94–5) (Refs. RoC Monograph and Profile
                                                    for public comment. For each candidate                  Web site (http://ntp.niehs.nih.gov/                    documents (Refs. 5 and 7)). The NTP
                                                    substance, an expert panel was                          pubhealth/roc/roc13/index.html).                       has classified 1-bromopropane as
                                                    convened to peer review the NTP                                                                                ‘‘reasonably anticipated to be a human
                                                                                                            IV. EPA’s Review of the 13th RoC
                                                    monograph document prepared for each                                                                           carcinogen.’’ The classification is based
                                                    candidate substance. The RoC                            A. How did EPA select the NTP RoC                      on sufficient evidence of carcinogenicity
                                                    Monograph on 1-Bromopropane consists                    chemical being proposed for addition?                  in experimental animals and supporting
                                                    of the following components: (Part 1)                     The most recent version of the NTP                   data on mechanisms of carcinogenesis.
                                                    the cancer evaluation component that                    RoC that EPA previously reviewed for                   The RoC substance profile for 1-
                                                    reviews the relevant scientific                         possible additions to the EPCRA section                bromopropane (Ref. 7) included the
                                                    information, assesses its quality, applies              313 list was the 12th RoC (March 13,                   following summary information of the
                                                    the RoC listing criteria to the scientific              2013, 78 FR 15913). Each new version                   evidence of carcinogenicity:
                                                    information, and gives the RoC listing                  of the RoC adds newly classified                       Carcinogenicity
                                                    status for 1-bromopropane, and (Part 2)                 chemicals to the existing list. EPA’s                     1-Bromopropane is reasonably anticipated
                                                    the RoC monograph’s substance profile                   present review of the 13th RoC                         to be a human carcinogen based on sufficient
                                                    containing the NTP’s listing status                     identified 1-bromopropane as the only                  evidence of carcinogenicity from studies in
                                                    decision, a summary of the scientific                   newly listed chemical that is not on the               experimental animals. 1-Bromopropane,
                                                    evidence considered key to reaching                     EPCRA section 313 list.                                either directly or via reactive metabolites,
                                                    that decision, and data on properties,                    EPA reviewed the NTP 13th RoC                        causes molecular alterations that typically
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                                                    use, production, exposure, and Federal                  chemical profile and supporting                        are associated with carcinogenesis, including
                                                    regulations and guidelines to reduce                    materials for 1-bromopropane (Ref. 6).                 genotoxicity, oxidative stress, and
                                                    exposure to 1-bromopropane. The                         Given the extensive scientific reviews                 glutathione depletion. These alterations,
                                                    expert panel members had the following                                                                         observed mainly in vitro and in toxicity
                                                                                                            conducted by the NTP for their RoC                     studies in rodents, are relevant to possible
                                                    major responsibilities in reviewing the                 documents, EPA’s review focused on                     mechanisms of human carcinogenicity and
                                                    draft RoC monograph:                                    ensuring that there were no                            support the relevance of the cancer studies in
                                                      (1) to comment on the draft cancer                    inconsistencies with how the Agency                    experimental animals to human
                                                    evaluation components for 1-bromopropane,               would consider the available data.                     carcinogenicity.



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                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules                                               20193

                                                    Cancer Studies in Experimental Animals                  were also identified in the urine of workers           Carcinogens as reasonably anticipated to be
                                                       Inhalation exposure to 1-bromopropane                exposed to 1-bromopropane (Hanley et al.               human carcinogens. These reactive and
                                                    caused tumors in two rodent species and at              2009). The major metabolite, N-acetyl-S-(n-            genotoxic metabolites may be responsible for
                                                    several different tissue sites, including one           propyl)-L-cysteine, has been detected in the           at least some of the carcinogenic effects of 1-
                                                    tissue site in rats at which tumors are rare            urine of exposed workers at levels that                bromopropane. As with 1-bromopropane,
                                                    (NTP 2011).                                             increased with increasing levels of 1-                 oral exposure to glycidol caused rare tumors
                                                       In male rats, 1-bromopropane caused                  bromopropane in ambient air (Hanley and                of the large intestine in rats, as did oral
                                                    significant dose-related increases in the               Dunn 2006, Valentine et al. 2007, Hanley et            exposure to two halogenated alkane
                                                    incidences of several types of benign and/or            al. 2009, 2010). This metabolite is produced           analogues of 1-bromopropane,
                                                    malignant skin tumors (keratoacanthoma;                 in humans by conjugation of 1-bromopropane             tribromomethane and bromodichloromethane
                                                    keratoacanthoma and squamous-cell                       with glutathione, and that reaction also               (NTP 1987, 1989, 1990).
                                                    carcinoma combined; and keratoacanthoma,                releases free bromide ions, another useful                Chronic exposure to 1-bromopropane may
                                                    squamous-cell carcinoma, basal-cell                     biomarker for human exposure to 1-                     produce levels of oxidative metabolites that
                                                    adenoma, and basal-cell carcinoma                       bromopropane (Jones and Walsh 1979,                    exceed the glutathione-conjugating capacity
                                                    combined). Both female and male rats                    Hanley et al. 2006). No studies were                   or may inhibit enzymes required for
                                                    showed an increased incidence of large-                 identified that tested for the occurrence in           glutathione synthesis. Because glutathione is
                                                    intestine tumors (adenoma of the colon and              humans of the oxidative metabolites that are           an important cellular defense mechanism,
                                                    rectum), which are rare tumors in rats. In              obligate intermediates to the measured                 reduced levels can lead to oxidative stress,
                                                    females, the incidence was dose-related and             conjugates.                                            increased toxicity, and carcinogenicity.
                                                    statistically significantly higher than in              Studies on Mechanisms of Carcinogenesis                Numerous studies have shown that 1-
                                                    concurrent controls, and it exceeded the                                                                       bromopropane induces both oxidative stress
                                                    historical control range for all routes of                 The mechanism(s) by which 1-                        and glutathione depletion (Lee et al. 2005,
                                                    exposure used in studies, including                     bromopropane causes cancer is not known.               2007, 2010a, Liu et al. 2009, 2010, Huang et
                                                    inhalation exposure. In males, the incidence            However, exposure to 1-bromopropane has                al. 2011). Studies with Cyp2e1–/– knockout
                                                    of large-intestine adenoma was not                      been shown to cause molecular alterations              mice, cytochrome P450 inhibitors, or a
                                                    significantly increased, but exceeded the               related to carcinogenicity, including                  glutathione synthesis inhibitor showed that
                                                    historical control range for inhalation-                genotoxicity (mutations and DNA damage),               this metabolic activation pathway is involved
                                                    exposure studies, and its occurrence was                oxidative stress, glutathione depletion, and           in 1-bromopropane-induced toxicity,
                                                    considered to be biologically significant               immunomodulation.                                      including neurological and reproductive
                                                    because of the rarity of these tumors (which               Studies have shown that 1-bromopropane              effects, hepatotoxicity, and
                                                    occurred in less than 0.2% of the historical            can bind to macromolecules; it formed S-               immunosuppression (NTP 2003, 2011, Lee et
                                                    controls). Although no carcinoma of the large           propylcysteine–globin adducts in exposed               al. 2007, 2010a,b). Neurological effects of 1-
                                                    intestine was observed in male or female rats           animals and humans (Valentine et al. 2007).            bromopropane exposure have also been
                                                    in this study, adenoma of the large intestine           Although 1-bromopropane did not induce                 reported in humans (Li et al. 2010, Ichihara
                                                    has been shown to progress to carcinoma in              mutations in bacteria under standard assay             et al. 2012).
                                                    other studies, and forms a morphologic                  conditions, it did induce mutations in                    It is unclear whether induction of
                                                    continuum with carcinoma (Deschner 1983,                bacteria both with and without exogenous               immunotoxicity by 1-bromopropane plays a
                                                    Chang 1984, Nigro 1985).                                mammalian metabolic activation in the only             role in tumor development. Recent studies
                                                       In female mice, 1-bromopropane caused                reported study whose design was appropriate            have shown that 1-bromopropane causes
                                                    significant dose-related increases in the               for testing a highly volatile chemical (Barber         immunosuppression in rodents (Lee et al.
                                                    incidence of benign and malignant lung                  et al. 1981). It also caused mutations in              2007, Anderson et al. 2010). In particular, it
                                                    tumors combined (alveolar/bronchiolar                   cultured mammalian cells with or without               reduced the numbers of T cells and T-cell
                                                    adenoma and carcinoma).                                 mammalian metabolic activation (Elf                    subpopulations. In addition, there is
                                                       These findings are supported by the                  Atochem 1996, as reviewed in NTP 2003)                 evidence that 1-bromopropane causes an
                                                    observation of additional tumors in rats that           and DNA damage in cultured human cells                 inflammatory response. It induced dose-
                                                    may have been related to 1-bromopropane                 without metabolic activation (Toraason et al.          related increases in gene expression and
                                                    exposure, including malignant mesothelioma              2006). In addition, there is limited evidence          production of proinflammatory cytokines in
                                                    of the abdominal cavity and pancreatic islet            of DNA damage in leukocytes from 1-                    mouse macrophages (Han et al. 2008) and an
                                                    tumors in males and skin tumors (squamous-              bromopropane-exposed workers (Toraason et              inflammatory response in rats (NTP 2011).
                                                    cell papilloma, keratoacanthoma, and basal-             al. 2006). In rodents exposed in vivo, 1-              However, chronic respiratory inflammation
                                                    cell adenoma or carcinoma) in females.                  bromopropane did not increase micronucleus             and lung tumors were not associated in
                                                                                                            formation in bone marrow (Kim et al. 1998,             rodents; respiratory inflammation occurred
                                                    Other Relevant Data                                     as reviewed in NTP 2003) or peripheral blood           in rats but not mice, whereas lung tumors
                                                       1-Bromopropane is well absorbed                      erythrocytes (Elf Atochem 1996, cited in NTP           occurred in mice but not rats.
                                                    following ingestion, inhalation, or dermal              2003, NTP 2011) or cause dominant lethal
                                                    exposure. Occupational exposure occurs                  mutations. However, the dominant lethal                Cancer Studies in Humans
                                                    primarily by inhalation and dermal contact.             mutation assay is generally regarded as                  No epidemiological studies or case reports
                                                    Unmetabolized 1-bromopropane has been                   relatively insensitive for the detection of            were identified that evaluated the
                                                    detected in the urine of exposed workers at             mutagenic agents (Saito-Suzuki et al. 1982,            relationship between human cancer and
                                                    levels significantly correlated with exposure           Yu et al. 2008).                                       exposure specifically to 1-bromopropane.
                                                    to 1-bromopropane in air (Kawai et al. 2001,               There is evidence that metabolic activation
                                                    Ichihara et al. 2004).                                  plays a role in the genotoxicity and toxicity            EPA has reviewed the NTP
                                                       1-Bromopropane is metabolized via several            of 1-bromopropane. Several reactive                    assessment for 1-bromopropane and
                                                    pathways; 16 urinary metabolites have been              metabolites (or intermediates) of 1-                   agrees that 1-bromopropane can
                                                    detected in rodents, and several other                  bromopropane have been identified in                   reasonably be anticipated to cause
                                                    metabolites have been proposed (Jones and               rodents, including glycidol and a-                     cancer in humans. EPA believes that the
                                                    Walsh 1979, Ishidao et al. 2002, Garner et al.          bromohydrin, and propylene oxide has been
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                                                                                                                                                                   evidence is sufficient for listing 1-
                                                    2006). The primary metabolic pathways in                proposed as a metabolite (Garner et al. 2006).         bromopropane on EPCRA section 313
                                                    rodents are oxidation reactions catalyzed by            These compounds cause genotoxic effects in
                                                                                                                                                                   pursuant to EPCRA section 313(d)(2)(B)
                                                    cytochrome P450 (primarily CYP2E1) and                  vitro, including DNA adduct formation,
                                                    glutathione conjugation. The available data             mutations, and DNA or chromosome damage                based on the available carcinogenicity
                                                    on human metabolism of 1-bromopropane,                  (Stolzenberg and Hine 1979, IARC 1994,                 data for this chemical.
                                                    although limited, suggest that some of its              2000). Glycidol and propylene oxide cause              V. Rationale for Listing
                                                    metabolic pathways in humans are similar to             cytogenetic effects in vivo and are
                                                    those observed in rodents. Four mercapturic             carcinogenic in experimental animals, and                The NTP RoC document undergoes
                                                    conjugates identified in the urine of rodents           both substances are listed in the Report on            significant scientific review and public


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                                                    20194                  Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules

                                                    comment. The NTP review mirrors the                     1. NTP, 2014. National Toxicology Program.             require additional approval by the
                                                    review EPA has historically done to                         Report on Carcinogens, Thirteenth                  Office of Management and Budget
                                                    assess chemicals for listing under                          Edition. Released October 2, 2014. U.S.            (OMB) under the Paperwork Reduction
                                                                                                                Department of Health and Human
                                                    EPCRA section 313 on the basis of                                                                              Act (PRA). OMB has previously
                                                                                                                Services, Public Health Service, National
                                                    carcinogenicity. The conclusions                            Toxicology Program, Research Triangle              approved the information collection
                                                    regarding the potential for chemicals in                    Park, NC 27709. (http://ntp.niehs.nih.             activities contained in the existing
                                                    the NTP RoC to cause cancer in humans                       gov/pubhealth/roc/roc13/index.html)                regulations and has assigned OMB
                                                    are based on established sound                          2. NTP, 2014. National Toxicology Program.             control numbers 2025–0009 and 2050–
                                                    scientific principles. EPA believes that                    Report on Carcinogens, Thirteenth                  0078. Currently, the facilities subject to
                                                    the NTP RoC is an excellent and reliable                    Edition, Introduction section. Released            the reporting requirements under
                                                    source of information on the potential                      October 2, 2014. U.S. Department of                EPCRA 313 and PPA 6607 may use
                                                    for chemicals covered in the NTP RoC                        Health and Human Services, Public                  either the EPA Toxic Chemicals Release
                                                                                                                Health Service, National Toxicology
                                                    to cause cancer in humans (see Unit III).                                                                      Inventory Form R (EPA Form 1B9350–
                                                                                                                Program, Research Triangle Park, NC
                                                    Based on EPA’s review of the data                           27709.                                             1), or the EPA Toxic Chemicals Release
                                                    contained in the NTP 13th RoC, EPA                      3. USEPA. Guidelines for Carcinogen Risk               Inventory Form A (EPA Form 1B9350-
                                                    has determined that 1-bromopropane                          Assessment. Risk Assessment Forum,                 2). The Form R must be completed if a
                                                    can reasonably be anticipated to cause                      U.S. Environmental Protection Agency,              facility manufactures, processes, or
                                                    cancer (Ref. 6). Therefore, EPA believes                    Washington, DC, March 2005.                        otherwise uses any listed chemical
                                                    that the evidence is sufficient for listing             4. NTP, 2014. National Toxicology Program.             above threshold quantities and meets
                                                    1-bromopropane on the EPCRA section                         Report on Carcinogens, Thirteenth                  certain other criteria. For the Form A,
                                                    313 toxic chemical list pursuant to                         Edition, Process for Preparation of the            EPA established an alternative threshold
                                                    EPCRA section 313(d)(2)(B) based on                         Report on Carcinogens section. Released            for facilities with low annual reportable
                                                                                                                October 2, 2014. U.S. Department of
                                                    the available carcinogenicity data                                                                             amounts of a listed toxic chemical. A
                                                                                                                Health and Human Services, Public
                                                    presented in the NTP 13th RoC.                              Health Service, National Toxicology                facility that meets the appropriate
                                                      EPA considers chemicals that can                          Program, Research Triangle Park, NC                reporting thresholds, but estimates that
                                                    reasonably be anticipated to cause                          27709.                                             the total annual reportable amount of
                                                    cancer to have moderately high to high                  5. NTP, 2013. Report on Carcinogens                    the chemical does not exceed 500
                                                    chronic toxicity. EPA does not believe                      Monograph on 1-Bromopropane. Office                pounds per year, can take advantage of
                                                    that it is appropriate to consider                          of the Report on Carcinogens, Division of          an alternative manufacture, process, or
                                                    exposure for chemicals that are                             the National Toxicology Program,                   otherwise use threshold of 1 million
                                                    moderately high to highly toxic based                       National Institute of Environmental                pounds per year of the chemical,
                                                    on a hazard assessment when                                 Health Sciences, U.S. Department of                provided that certain conditions are
                                                    determining if a chemical can be added                      Health and Human Services. NIH
                                                                                                                                                                   met, and submit the Form A instead of
                                                                                                                Publication No. 13–5982, September 25,
                                                    for chronic effects pursuant to EPCRA                                                                          the Form R. In addition, respondents
                                                                                                                2013
                                                    section 313(d)(2)(B) (see 59 FR 61440–                  6. USEPA, OEI. Memorandum from Jocelyn                 may designate the specific chemical
                                                    61442). Therefore, in accordance with                       Hospital, Toxicologist, Analytical                 identity of a substance as a trade secret
                                                    EPA’s standard policy on the use of                         Support Branch to Sandra Gaona, Acting             pursuant to EPCRA section 322, 42
                                                    exposure assessments (59 FR 61432),                         Chief, Analytical Support Branch.                  U.S.C. 11042, 40 CFR part 350.
                                                    EPA does not believe that an exposure                       November 3, 2014. Subject: Review of                  OMB has approved the reporting and
                                                    assessment is necessary or appropriate                      National Toxicology Program (NTP)                  recordkeeping requirements related to
                                                    for determining whether 1-                                  Cancer Classification Data for 1-                  Forms A and R, supplier notification,
                                                    bromopropane meets the criteria of                          bromopropane.                                      and petitions under OMB Control
                                                    EPCRA section 313(d)(2)(B).                             7. NTP, 2014. National Toxicology Program.             number 2025–0009 (EPA Information
                                                                                                                Report on Carcinogens, Thirteenth
                                                                                                                                                                   Collection Request (ICR) No. 1363) and
                                                    VI. References                                              Edition, Profile for 1-Bromopropane.
                                                                                                                Released October 2, 2014. U.S.                     those related to trade secret designations
                                                      EPA has established an official public                    Department of Health and Human                     under OMB Control 2050–0078 (EPA
                                                    docket for this action under Docket ID                      Services, Public Health Service, National          ICR No. 1428). As provided in 5 CFR
                                                    No. EPA–HQ–TRI–2015–0011. The                               Toxicology Program, Research Triangle              1320.5(b) and 1320.6(a), an Agency may
                                                    public docket includes information                          Park, NC 27709.                                    not conduct or sponsor, and a person is
                                                    considered by EPA in developing this                    8. USEPA, OEI. Economic Analysis of the                not required to respond to, a collection
                                                    action, including the documents listed                      Proposed Rule to add 1-Bromopropane to             of information unless it displays a
                                                    below, which are electronically or                          the EPCRA Section 313 List of Toxic                currently valid OMB control number.
                                                    physically located in the docket. In                        Chemicals. February 17, 2015.                      The OMB control numbers relevant to
                                                    addition, interested parties should                     VII. What are the Statutory and                        EPA’s regulations are listed in 40 CFR
                                                    consult documents that are referenced                   Executive Order reviews associated                     part 9, 48 CFR chapter 15, and
                                                    in the documents that EPA has placed                    with this action?                                      displayed on the information collection
                                                    in the docket, regardless of whether                                                                           instruments (e.g., forms, instructions).
                                                    these referenced documents are                          A. Executive Order 12866: Regulatory
                                                    electronically or physically located in                 Planning and Review and Executive                      C. Regulatory Flexibility Act (RFA), as
                                                    the docket. For assistance in locating                  Order 13563: Improving Regulation and                  Amended by the Small Business
                                                    documents that are referenced in                        Regulatory Review                                      Regulatory Enforcement Fairness Act of
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                                                    documents that EPA has placed in the                                                                           1996 (SBREFA), 5 U.S.C. 601 et seq.
                                                                                                              This action is not a significant
                                                    docket, but that are not electronically or              regulatory action and was therefore not                   I certify that this action will not have
                                                    physically located in the docket, please                submitted to the Office of Management                  a significant economic impact on a
                                                    consult the person listed in the above                  and Budget (OMB) for review.                           substantial number of small entities
                                                    FOR FURTHER INFORMATION CONTACT                                                                                under the RFA. The Agency has
                                                    section. For convenience, the docket                    B. Paperwork Reduction Act                             determined that of the 140 entities
                                                    also includes all of the Federal Register                 This action does not contain any new                 estimated to be impacted by this action,
                                                    documents cited in this action.                         information collection requirements that               136 are small businesses; no small


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                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules                                                     20195

                                                    governments or small organizations are                  subject to Executive Order 13045                         Dated: April 8, 2015.
                                                    expected to be affected by this action.                 because it does not concern an                         Gina McCarthy,
                                                    All 136 small businesses affected by this               environmental health risk or safety risk.              Administrator.
                                                    action are estimated to incur annualized
                                                    cost impacts of less than 1%. Facilities                H. Executive Order 13211: Actions                        Therefore, 40 CFR part 372 is
                                                    eligible to use Form A (those meeting                   Concerning Regulations That                            proposed to be amended as follows:
                                                    the appropriate activity threshold which                Significantly Affect Energy Supply,
                                                                                                            Distribution, or Use                                   PART 372—TOXIC CHEMICAL
                                                    have 500 pounds per year or less of                                                                            RELEASE REPORTING: COMMUNITY
                                                    reportable amounts of the chemical) will                                                                       RIGHT-TO-KNOW
                                                                                                              This action is not subject to Executive
                                                    have a lower burden. Thus, this action
                                                                                                            Order 13211, because it is not a
                                                    is not expected to have a significant                                                                          ■ 1. The authority citation for part 372
                                                    adverse economic impact on a                            significant regulatory action under
                                                                                                            Executive Order 12866.                                 continues to read as follows:
                                                    substantial number of small entities. A
                                                                                                                                                                       Authority: 42 U.S.C. 11023 and 11048.
                                                    more detailed analysis of the impacts on                I. National Technology Transfer and
                                                    small entities is located in EPA’s                      Advancement Act                                        ■  2. In § 372.65, paragraph (a) is
                                                    economic analysis support document                                                                             amended by adding in the table the
                                                    (Ref. 8).                                                 This rulemaking does not involve                     entry for ‘‘1-Bromopropane’’ in
                                                                                                            technical standards.                                   alphabetical order and in paragraph (b)
                                                    D. Unfunded Mandates Reform Act                                                                                by adding in the table the entry for
                                                      This action does not contain an                       J. Executive Order 12898: Federal                      ‘‘106–94–5’’ in numerical order to read
                                                    unfunded mandate of $100 million or                     Actions To Address Environmental                       as follows:
                                                    more as described in UMRA, 2 U.S.C.                     Justice in Minority Populations and
                                                    1531 through 1538, and does not                         Low-Income Populations                                 § 372.65 Chemicals and chemical
                                                    significantly or uniquely affect small                                                                         categories to which this part applies.
                                                    governments. This action is not subject                   The EPA believes the human health or                 *       *    *      *         *
                                                    to the requirements of UMRA because it                  environmental risk addressed by this                       (a) * * *
                                                    contains no regulatory requirements that                action will not have potential
                                                    might significantly or uniquely affect                  disproportionately high and adverse                        Chemical name            CAS No.       Effective
                                                                                                            human health or environmental effects                                                               date
                                                    small governments. Small governments
                                                    are not subject to the EPCRA section 313                on minority, low-income or indigenous
                                                    reporting requirements. EPA’s economic                  populations. The results of this                          *       *         *       *                   *
                                                    analysis indicates that the total cost of               evaluation are contained below.                        1-Bromopropane ..... 106–94–5               1/1/16
                                                    this action is estimated to be $531,002                   This action does not address any
                                                    in the first year of reporting (Ref. 8).                                                                            *        *          *             *        *
                                                                                                            human health or environmental risks
                                                    E. Executive Order 13132 (Federalism)                   and does not affect the level of
                                                                                                                                                                       (b) * * *
                                                                                                            protection provided to human health or
                                                      This action does not have federalism
                                                    implications. It will not have substantial              the environment. This action adds an                                                              Effective
                                                                                                            additional chemical to the EPCRA                           CAS No.       Chemical name
                                                    direct effects on the States, on the                                                                                                                        date
                                                    relationship between the national                       section 313 reporting requirements. By
                                                    government and the States, or on the                    adding a chemical to the list of toxic
                                                                                                                                                                      *       *      *        *                     *
                                                    distribution of power and                               chemicals subject to reporting under
                                                                                                                                                                   106–94–5 .. 1-Bromopropane                  1/1/16
                                                    responsibilities among the various                      section 313 of EPCRA, EPA would be
                                                    levels of government.                                   providing communities across the                            *        *          *             *        *
                                                                                                            United States (including minority
                                                    F. Executive Order 13175: Consultation                  populations and low income                             *        *    *     *         *
                                                    and Coordination With Indian Tribal
                                                                                                            populations) with access to data which                 [FR Doc. 2015–08664 Filed 4–14–15; 8:45 am]
                                                    Governments
                                                                                                            they may use to seek lower exposures                   BILLING CODE 6560–50–P
                                                      This action does not have tribal                      and consequently reductions in
                                                    implications, as specified in Executive                 chemical risks for themselves and their
                                                    Order 13175. This action relates to toxic               children. This information can also be                 FEDERAL COMMUNICATIONS
                                                    chemical reporting under EPCRA                          used by government agencies and others                 COMMISSION
                                                    section 313, which primarily affects                    to identify potential problems, set
                                                    private sector facilities. Thus, Executive              priorities, and take appropriate steps to              47 CFR Part 73
                                                    Order 13175 does not apply to this
                                                                                                            reduce any potential risks to human                    [MB Docket No. 15–88, RM–11747; DA 15–
                                                    action.                                                                                                        444]
                                                                                                            health and the environment. Therefore,
                                                    G. Executive Order 13045: Protection of                 the informational benefits of the action
                                                    Children From Environmental Health                      will have a positive impact on the                     Television Broadcasting Services;
                                                    Risks and Safety Risks                                  human health and environmental                         Bend, Oregon
                                                      The EPA interprets Executive Order                    impacts of minority populations, low-                  AGENCY:  Federal Communications
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                                                    13045 as applying only to those                         income populations, and children.                      Commission.
                                                    regulatory actions that concern                                                                                ACTION: Proposed rule.
                                                                                                            List of Subjects in 40 CFR Part 372
                                                    environmental health or safety risks that
                                                    the EPA has reason to believe may                         Environmental protection,                            SUMMARY:   The Commission has before it
                                                    disproportionately affect children, per                 Community right-to-know, Reporting                     a petition for rulemaking filed by TDS
                                                    the definition of ‘‘covered regulatory                  and recordkeeping requirements, and                    Broadcasting LLC (‘‘TDS’’), the licensee
                                                    action’’ in section 2–202 of the                        Toxic chemicals.                                       of KOHD, channel 51, Bend, Oregon,
                                                    Executive Order. This action is not                                                                            requesting the substitution of channel


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Document Created: 2015-12-18 11:13:18
Document Modified: 2015-12-18 11:13:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before June 15, 2015.
ContactDaniel 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/.
FR Citation80 FR 20189 
RIN Number2025-AA41
CFR AssociatedEnvironmental Protection; Community Right-To-Know; Reporting and Recordkeeping Requirements and Toxic Chemicals

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