Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting, 72906-72914 [2015-29799]
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Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations
EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued
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[FR Doc. 2015–29680 Filed 11–20–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[EPA–HQ–TRI–2015–0011; FRL–9937–12–
OEI]
RIN 2025–AA41
Addition of 1-Bromopropane;
Community Right-to-Know Toxic
Chemical Release Reporting
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is adding 1bromopropane 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
SUMMARY:
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11/23/15 [Insert Federal
Register citation].
11/23/15 [Insert Federal
Register citation].
Added.
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the National Toxicology Program in
their 13th Report on Carcinogens as
‘‘reasonably anticipated to be a human
carcinogen.’’ The EPA has determined
that 1-bromopropane meets the EPCRA
section 313(d)(2)(B) criteria because it
can reasonably be anticipated to cause
cancer in humans.
DATES: This final rule is effective
November 30, 2015, and shall apply for
the reporting year beginning January 1,
2016 (reports due July 1, 2017).
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–TRI–2015–0011. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
Explanation
[former SIP
citation]
EPA approval date
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, https://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 affected entities
Industry ...........................................
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Category
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, 221118, 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 facilities.
Federal Government .......................
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
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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.
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To determine whether your facility
would be affected by this action, you
should carefully examine the
applicability criteria in part 372 subpart
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B of Title 40 of the Code of Federal
Regulations. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
II. Introduction
A. What is the statutory authority for
this final rule?
This rule is issued under EPCRA
section 313(d) and section 328, 42
U.S.C. 11023 et seq. EPCRA is also
referred to as Title III of the Superfund
Amendments and Reauthorization Act
of 1986.
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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 the
EPA to add or delete chemicals from the
list and sets criteria for these actions.
EPCRA section 313(d)(2) states that the
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, the 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 the EPA must
demonstrate that none of the listing
criteria in Section 313(d)(2)(A)-(C) are
met. The EPCRA section 313(d)(2)(A)–
(C) criteria are:
• The chemical is known to cause or
can reasonably be anticipated to cause
significant adverse acute human health
effects at concentration levels that are
reasonably likely to exist beyond facility
site boundaries as a result of
continuous, or frequently recurring,
releases.
• The chemical is known to cause or
can reasonably be anticipated to cause
in humans:
Æ Cancer or teratogenic effects, or
Æ serious or irreversible—
D Reproductive dysfunctions,
D neurological disorders,
D heritable genetic mutations, or
D other chronic health effects.
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• The chemical is known to cause or
can be reasonably anticipated to cause,
because of:
Æ Its toxicity,
Æ its toxicity and persistence in the
environment, or
Æ 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.
The 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.’’
The EPA published in the Federal
Register of November 30, 1994 (59 FR
61432), a statement clarifying its
interpretation of the section 313(d)(2)
and (d)(3) criteria for modifying the
section 313 list of toxic chemicals.
III. Summary of Proposed Rule
A. What chemical did the EPA propose
to add to the EPCRA section 313 list of
toxic chemicals?
As discussed in the proposed rule (80
FR 20189, April 15, 2015), the EPA
proposed to add 1-bromopropane to the
EPCRA section 313 list of toxic
chemicals. 1-Bromopropane had been
classified as ‘‘reasonably anticipated to
be a human carcinogen’’ by the National
Toxicology Program (NTP) in its 13th
Report on Carcinogens (RoC) document.
In addition, based on a review of the
available production and use
information, the EPA determined that 1bromopropane is expected to be
manufactured, processed, or otherwise
used in quantities that would exceed the
EPCRA section 313 reporting
thresholds. The NTP is an interagency
program within the Department of
Health and Human Services (DHHS)
headquartered at the National Institute
of Environmental Health Sciences
(NIEHS) of the National Institutes of
Health (NIH). As part of the NTP’s
cancer evaluation work, it periodically
publishes the RoC document which
contains cancer classifications from the
NTP’s most recent chemical evaluations
as well as the classifications from
previous versions of the RoC. There is
an extensive review process for the RoC
which includes evaluations by scientists
from the NTP, other Federal health
research and regulatory agencies
(including the EPA), and
nongovernmental institutions. The RoC
review process also includes external
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peer review and several opportunities
for public comment.
B. What was the EPA’s rationale for
proposing to list 1-bromopropane?
As the EPA stated in the proposed
rule (80 FR 20189, April 15, 2015), the
NTP RoC document undergoes
significant scientific review and public
comment and mirrors the review the
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. The EPA believes
that the NTP RoC is an excellent and
reliable source of information on the
potential for chemicals covered therein
to cause cancer in humans. Based on the
EPA’s review of the data contained in
the 13th NTP RoC (Reference (Ref.) 1)
for 1-bromopropane, the Agency agreed
that 1-bromopropane can reasonably be
anticipated to cause cancer. Therefore,
the EPA determined that the evidence
was sufficient for listing 1bromopropane on the EPCRA section
313 toxic chemical list pursuant to
EPCRA section 313(d)(2)(B) based on
the available carcinogenicity data for 1bromopropane as presented in the 13th
RoC (Ref. 2).
IV. What comments did the EPA receive
on the proposed rule?
The EPA received four comments on
the proposed rule to add 1bromopropane to the EPCRA section
313 chemical list. Three of the
comments were supportive of the EPA’s
proposed addition of 1-bromopropane
while one commenter objected to the
addition. The commenters that
supported the proposed rule included
two anonymous comments from the
general public (Refs. 3 and 4) and a
comment from the Halogenated Solvents
Industry Alliance, Inc. (HSIA) (Ref. 5).
Members of the HSIA include The Dow
Chemical Company, INEOS Chlor
Americas, Inc., Occidental Chemical,
and Axiall Corporation. The commenter
who objected to the addition was the
Albemarle Corporation (Ref. 6). The
most significant comments are
summarized and responded to below.
The complete set of comments and the
EPA’s responses can be found in the
response to comment document in the
docket for this rulemaking (Ref. 7). Note
that in some of the comments 1bromopropane is referred to as nPB,
which is the acronym for the alternative
chemical name n-propyl bromide.
The HSIA (Ref. 5) stated that the
proposed rule presented substantial
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evidence to support the conclusion that
1-bromopropane is known to cause or
can reasonably be anticipated to cause
cancer in humans. The HSIA also noted
that other published studies indicate
that 1-bromopropane is neurotoxic, may
cause reproductive dysfunction, and is
acutely or chronically toxic. The HSIA
concluded that clearly, the scientific
literature supports the addition of 1bromopropane to the list of chemicals
subject to reporting under EPCRA
section 313.
EPA agrees with the commenter’s
statement that the EPA provided
substantial evidence to support the
conclusion that 1-bromopropane is
known to cause or can reasonably be
anticipated to cause cancer in humans.
The EPA also agrees with the
commenter’s conclusion that the
scientific literature supports the
addition of 1-bromopropane to the
EPCRA section 313 chemical list. The
EPA acknowledges that there may be
other toxicological effects that may also
be a basis for listing. However, the EPA
believes the available cancer data are
sufficient for adding 1-bromopropane to
the EPCRA section 313 chemical list.
The first anonymous commenter (Ref.
3) supported the addition of 1bromopropane to the EPCRA section
313 list and cited additional toxicity
information, neurotoxicity and
reproductive toxicity, as being of
concern.
EPA agrees that 1-bromopropane
should be added to the EPCRA section
313 chemical list. The EPA also
acknowledges that there may be other
toxicological effects (such as
neurotoxicity) that may also be a basis
for listing. However, the available
cancer data are sufficient for adding 1bromopropane to the EPCRA section
313 chemical list.
The second anonymous commenter
(Ref. 4) supported the listing of 1bromopropane as long as the benefits
substantially outweigh the costs. The
commenter also expressed concern that
there may be ‘‘significant costs to local
businesses, i.e., laundry services, that
have to update or replace their
equipment as well as significant costs
and time spent in order to comply with
the rule.’’
EPA’s cost-benefit analysis was
contained in the economic analysis for
the proposed rule ‘‘Economic Analysis
of the Proposed Rule to add 1Bromopropane to the EPCRA Section
313 List of Toxic Chemicals’’ (Ref. 8),
which was reference 8 in the proposed
rule (80 FR 20189, April 15, 2015). The
economic analysis contains a
quantitative estimate of the costs and a
qualitative discussion of the benefits of
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the rule. The EPA considers the benefits
of reporting under this rule to be
primarily reflected by the purposes
served by reporting of information
under EPCRA section 313. The EPA
believes the benefits provided by the
information to be reported under this
rule outweigh the costs.
With regard to laundry services (such
as dry cleaners) these facilities are not
subject to reporting under EPCRA
section 313. Even if such facilities were
subject to reporting, listing a chemical
under EPCRA section 313 does not
require covered facilities to update or
replace any equipment. EPCRA section
313 only requires the reporting of
release and waste management
information, it does not impose any
restrictions on the use of chemicals.
The majority of comments provided
by the Albemarle Corporation (Ref. 6)
are the same comments they submitted
in response to the ‘‘Receipt of a
complete petition’’ to add 1bromopropane to the Hazardous Air
Pollutant (HAP) List (80 FR 6676,
February 6, 2015). The only comments
submitted by the Albemarle Corporation
specific to the EPA’s proposed rule to
add 1-bromopropane to the EPCRA
section 313 chemical list were provided
in a letter from Charles R. Nestrud of the
law firm Chisenhall, Nestrud & Julian,
P.A. dated June 10, 2015 (Nestrud
letter). The EPA is providing responses
to all of the comments in the Nestrud
letter.
The vast majority of the comments
submitted by the Albemarle Corporation
on the HAP listing petition dealt with
issues of emissions, exposure, risk
values, and risk assessment, which are
not relevant to the proposed addition of
1-bromopropane to the EPCRA section
313 chemical list since the addition is
based on hazard and not risk. The
addition of 1-bromopropane to the
EPCRA section 313 chemical list is
based on the cancer hazard evaluation
carried out by the NTP and reviewed by
the EPA to ensure its consistency with
the EPA Guidelines for Carcinogen Risk
Assessment (Ref. 9). Consistent with the
EPA guidelines (Ref. 9), the NTP 13th
RoC (Ref. 2) evaluates the scientific
literature and publicly available, peerreviewed technical reports of human
and laboratory studies to evaluate
whether substances are possible human
carcinogens. The NTP RoC does not
present a quantitative assessment of the
risks of cancer associated with a given
chemical. Rather, it indicates the
potential hazard associated with
chemicals but does not establish the
exposure conditions that would pose
cancer risks to individuals. In the 13th
RoC, the NTP classified 1-
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bromopropane as ‘‘reasonably
anticipated to be a human carcinogen.’’
The conclusions of the NTP 13th RoC
for 1-bromopropane were consistent
with how the EPA would consider the
carcinogenicity data available for 1bromopropane. Therefore, for the
purposes of listing 1-bromopropane on
the EPCRA section 313 chemical list,
the EPA concluded that 1bromopropane can reasonably be
anticipated to cause cancer in humans.
Since the listing of 1-bromopropane
under EPCRA section 313 is based on
the available cancer data, the EPA is not
responding to the comments from
Albemarle Corporation on the HAP
listing petition that dealt with issues of
emissions, exposure, risk values, and
risk assessment.
While not specific to the materials the
EPA cited to support the addition of 1bromopropane to the EPCRA section
313 chemical list, there were some
comments on the cancer data for 1bromopropane in the materials that the
Albemarle Corporation submitted in
response to the HAP listing petition
(Ref. 6). Specifically, these comments
are contained in sections 2.2 and 2.3 of
the document ‘‘Comments on the
Petition to Add n-Propyl Bromide to the
List of Hazardous Air Pollutants
Regulated under § 112 of the Clean Air
Act’’ prepared by the Gradient
Corporation (Gradient Corp.). Since
these comments dealt with the toxic
endpoint (cancer) that is the basis for
the addition of 1-bromopropane to the
EPCRA section 313 chemical list, the
EPA has addressed these comments as
well.
In the Nestrud letter, the commenter
stated that:
The comments prepared by Albemarle and
its consultants demonstrate that the technical
information submitted to support the
Proposed Rule is out of date, incorrect, and
insufficient to support the Proposed Rule.
Furthermore, when all toxicological data is
considered, and current emission data is
considered, the weight of the evidence does
not support adding 1-bromopropane to the
list of toxic chemicals.
EPA disagrees that the information
submitted to support the proposed rule
to add 1-bromopropane to the EPCRA
section 313 chemical list is ‘‘out of date,
incorrect, and insufficient to support the
Proposed Rule.’’ The EPA provided
information from the NTP 13th RoC
which was released on October 2, 2014
(Ref. 2). The EPA’s evaluation of the
data used to support the findings for 1bromopropane was conducted shortly
after the release of the 13th RoC and
completed on November 3, 2014 (Ref.
1). The EPA’s economic analysis of the
potential costs of the proposed rule
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including the estimate of the number of
facilities expected to file reports was
completed on February 17, 2015 (Ref. 8).
The EPA notes that the commenter did
not provide any comments specific to
the EPA’s evaluation of the NTP 13th
RoC data and findings for 1bromopropane (Ref. 1), which was
reference 6 in the proposed rule (80 FR
20189, April 15, 2015), or specific to the
NTP 13th RoC materials prepared for 1bromopropane (Refs. 10 and 11), which
were references 5 and 7 in the proposed
rule (80 FR 20189, April 15, 2015), or
on the EPA’s economic analysis for the
addition of 1-bromopropane (Ref. 8),
which was reference 8 in the proposed
rule (80 FR 20189, April 15, 2015). It is,
therefore, unclear which technical
information that the EPA submitted to
support the proposed rule that the
commenter believes is out of date,
incorrect, or insufficient to support the
proposed rule. Comments regarding the
available cancer data and relevance of
emissions data are discussed in other
responses below.
The Nestrud letter also provided
comments concerning screening criteria
that the EPA had used in a previous
rulemaking:
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In its 1994 rulemaking EPA identified
certain criteria it had developed to evaluate
chemicals for additions to the list of toxic
chemicals. This included a toxicity and
production volume screen, and a hazard
evaluation based on the initial screen.
Addition of Certain Chemicals; Toxic
Chemical Release Reporting; Community
Right-to-Know; Final Rule (59 FR No. 229;
Doc. No. 94–29376, November 30, 1994;
OPPTS–400082B.
Toxicity Screen. Through the toxicity
screen a chemical is assigned a ‘‘high
priority,’’ ‘‘medium priority,’’ or ‘‘low
priority.’’ The attached comments submitted
to EPA as part of the nPB Petition
demonstrate that there is insufficient toxicity
information to support assigning a ‘‘high
priority,’’ or ‘‘medium priority’’ to nPB.
The information that the commenter
cited regarding the criteria the EPA
identified for evaluating chemicals for
addition to the EPCRA section 313
chemical list are the criteria the EPA
used for its 1994 chemical expansion
rulemaking to evaluate large numbers of
chemicals for potential addition. These
screening criteria are not the criteria
used to determine whether or not a
chemical can be added to the EPCRA
section 313 chemical list, that criteria is
established under EPCRA section
313(d)(2). As the EPA noted in the 1994
chemical expansion rule:
A toxicity screen is a limited review of
readily available toxicity data that is used for
a preliminary categorization of a chemical
during the process of selecting candidates for
possible listing under EPCRA section 313.
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The toxicity screen is used to identify
chemicals for further consideration and does
not reflect a final determination for listing a
chemical under EPCRA section 313. Such a
determination can only be made after a
hazard assessment is conducted (See Unit
11.3. of this preamble).
(59 FR 61433, November 30, 1994)
EPA did not screen 1-bromopropane
for addition, but rather conducted a
hazard evaluation of the available
cancer data and based on the
classification by the NTP in their 13th
RoC as ‘‘reasonably anticipated to be a
human carcinogen’’ and our review of
that data, concluded 1-bromopropane
should be added to the EPCRA section
313 chemical list. As noted in the
proposed rule, the EPA reviewed the
data used by the NTP to make this
determination and agreed with the
NTP’s classification (Ref. 1), which was
reference 6 in the proposed rule (80 FR
20189, April 15, 2015). As the EPA
noted in the 1994 chemical expansion
rule, cancer is an extreme toxic effect:
In some cases the effects are extreme, such
as cancer or death.
(59 FR 61433, November 30, 1994)
If the EPA had conducted a toxicity
screen like that used in the 1994
chemical expansion rule, the available
cancer data would have been sufficient
to classify 1-bromopropane as a high
priority for listing. In fact, the NTP’s 6th
RoC was a primary source reviewed for
chemicals for potential addition (59 FR
1789, January 12, 1994). As previously
noted, the commenter did not provide
any comments specifically on the NTP’s
classification of 1-bromopropane as
‘‘reasonably anticipated to be a human
carcinogen’’ in the 13th RoC, nor did
they provide any comments on the
EPA’s evaluation of the NTP cancer data
and classification (Ref. 1), as provided
in reference 6 of the proposed rule (80
FR 20189, April 15, 2015).
The Nestrud letter also commented on
the issue of a production volume screen:
Production Volume Screen. When use of
the chemical is less than the reporting
thresholds, the chemical is ‘‘not considered
further.’’ The attached comments submitted
to EPA as part of the nPB Petition
demonstrate that there are no facilities in the
dry cleaning or spray adhesives industries
that use more 1-bromopropane than the
reporting threshold of 10,000 pounds (5
tons). Although the nPB Petition identified
one facility in the metal cleaning industry
that used more 1-bromopropane than the
reporting threshold of 10,000 pounds (5
tons), that facility reported its use of nPB
pursuant to its Title V Air Permit.
Reference 8 in the proposed rule was
the economic analysis for the addition
of 1-bromopropane to the EPCRA
section 313 chemical list (Ref. 8). As
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indicated in the economic analysis, the
EPA estimates that 140 reports (126
Form Rs and 14 Form As) from 23
different industry sectors will be filed
for 1-bromopropane. Therefore, the EPA
has determined that there is sufficient
production and use of 1-bromopropane
such that reports will be filed. As
previously noted, the commenter
provided no specific comments on the
EPA’s economic analysis. Certain spray
adhesives industries may be required to
report under EPCRA section 313, but
dry cleaning facilities are not a covered
industry sector and thus are not
required to file reports under EPCRA
section 313. While it has been the EPA’s
policy to focus on the addition of
chemicals for which reports are
expected to be filed, it is not a statutory
requirement. As the EPA noted in the
2010 proposed rule for the addition of
16 NTP carcinogens to the EPCRA
section 313 chemical list:
Section 313(d)(2) of EPCRA provides EPA
the discretion to add chemicals to the TRI list
when there is sufficient evidence to establish
any of the listing criteria. EPA can add a
chemical that meets one criterion regardless
of its production volume.
(75 FR 17336, April 6, 2010)
The Nestrud letter also commented on
the issue of conducting a hazard
evaluation to support the listing of 1bromopropane to the EPCRA section
313 list:
Hazard Evaluation. Based on the results of
the screen, EPA should conduct a Hazard
Evaluation for 1-bromopropane. The attached
comments submitted to EPA as part of the
nPB Petition demonstrate that the weight of
the evidence is not sufficient to add 1bromopropane to the list of toxic chemicals.
In particular, the individual lifetime cancer
risk at maximally impacted census receptors
near the facilities that use 1-bromopropane is
less than 1 in 1 million for all the facilities
identified by EPA in the nPB Petition, with
the exception of a narrow tube manufacturing
facility, for which the maximum individual
lifetime cancer risk is less than 1 in 100,000.
Other than STC, there are no identified
populations that would have a lifetime
cancer risks from exposure to nPB in excess
of 1 in 1 million.
Accordingly, there is no information that
would support adding 1-bromopropane to the
list of toxic chemicals.
The commenter states that the EPA
should conduct a ‘‘Hazard Evaluation’’
for 1-bromopropane, but that is exactly
what the EPA did. The EPA’s hazard
evaluation included the NTP’s
classification of 1-bromopropane as
‘‘reasonably anticipated to be a human
carcinogen’’ (Refs. 2 and 10) and the
EPA’s review of the data used by the
NTP to support that classification (Ref.
1). As noted in the proposed rule, the
NTP conducted an extensive review
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(including public comment and peer
review) of the cancer data for 1bromopropane in making the
classification for the NTP 13th RoC. The
EPA’s review of that information, as
discussed in reference 6 of the proposed
rule, concluded that:
The conclusions of the NTP RoC for 1bromopropane were consistent with how the
Agency would consider the carcinogenicity
data available for 1-bromopropane.
Therefore, it would be appropriate for the
Agency, for the purposes of listing 1bromopropane on the Toxics Release
Inventory, to conclude that 1-bromopropane
can reasonably be anticipated to cause cancer
in humans.
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(80 FR 20189, April 15, 2015)
EPA believes the cancer data for 1bromopropane sufficiently support
listing under EPCRA section
313(d)(2)(B). None of the information
concerning the cancer data that the
commenter submitted in their response
to the petition to add 1-bromopropane
to the hazardous air pollutant (HAP) list
changes the EPA’s conclusion with
regard to the potential for 1bromopropane to cause cancer in
humans. Responses to the specific
comments on certain portions of the
hazard evaluation are addressed in other
responses.
With regard to the commenter’s
conclusions concerning the cancer risks
from facilities identified in the HAP
petition, this information is not relevant
to the addition of 1-bromopropane to
the EPCRA section 313 chemical list.
The EPA did not base the proposed
addition of 1-bromopropane to the
EPCRA section 313 chemical list on any
exposure or risk evaluation. 1Bromopropane meets the EPCRA section
313(d)(2)(B) listing criteria based on the
cancer data alone and there are no
statutory requirements to consider
exposure or risk under EPCRA section
313(d)(2)(B). While the statutory criteria
of EPCRA section 313(d)(2)(B) do not
require consideration of exposure or
risk, the EPA has a policy concerning
when it may be appropriate to consider
potential exposures when adding
chemicals under EPCRA section
313(d)(2)(B). As the EPA stated in the
proposed rule:
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
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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).
(80 FR 20189, April 15, 2015)
The EPA disagrees with the
conclusion of the commenter that there
is no information that would support
adding 1-bromopropane to the EPCRA
section 313 chemical list. In fact, it is
the EPA’s position that there are
extensive cancer data that support this
addition as discussed and referenced in
the proposed rule.
In the comments the Albemarle
Corporation submitted on the HAP
listing petition (Ref. 6), the report by
Gradient Corp. included section ‘‘2.2
Human Relevance of the Petitioner’s
Inhalation Unit Risk Factor.’’ In that
section, issues regarding the cancer data
for 1-bromopropane were raised. These
issues include the petitioners’ use of
alveolar/bronchiolar adenomas and
carcinomas in B6C3F1 mice for their
risk assessment. The commenter took
issue with the petitioners’ suggestion
that ‘‘there are no reasons to assume that
the mode, or modes, of action by which
tumors are induced by nPB are not
relevant to man.’’ The commenter stated
that the petitioners’ supporting
information lacked an analysis of the
human relevance of the mouse lung
tumors or any other cancer endpoint
and cited recommendations in the
EPA’s Guidelines for Carcinogen Risk
Assessment for collecting relevant
information on the mode of action. The
commenter stated that alveolar/
bronchiolar adenomas and carcinomas
have been reviewed and debated for a
number of chemical compounds and
were the subject of a 2014 technical
workshop sponsored by the EPA. The
commenter also provided summaries of
relevant information that they claim are
available for 1-bromopropane to explore
mode of action questions. The
commenter concluded that there is
evidence that the mode of action for the
endpoint selected to predict risks for 1bromopropane may not be relevant for
humans. The commenter stated that,
considering the state-of-the-science
surrounding this health endpoint, the
EPA should not rely on the data for
alveolar/bronchiolar adenomas and
carcinomas in B6C3F1 mice for
characterizing cancer risks in humans
from exposure to 1-bromopropane.
As the EPA previously noted, the
proposed addition of 1-bromopropane to
the EPCRA section 313 chemical list is
based on hazard alone and not on any
consideration of exposures or potential
risks. For the purposes of listing under
EPCRA section 313(d)(2)(B), the EPA is
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not relying on the data for alveolar/
bronchiolar adenomas and carcinomas
in B6C3F1 mice for characterizing
cancer risks in humans from exposure to
1-bromopropane. While the EPA
convened a technical workshop on the
state-of-the-science for chemicallyinduced mouse lung tumors, there was
no consensus on the relevance of this
tumor to humans (Ref. 12). Rather, one
of the workshop outcomes included the
future application of the information
discussed during the workshop to
develop a mode of action framework on
a chemical by chemical basis. As stated
in the EPA Guidelines for Carcinogen
Risk Assessment (Ref. 9):
The default option is that positive effects
in animal cancer studies indicate that the
agent under study can have carcinogenic
potential in humans. Thus, if no adequate
human or mode of action data are present,
positive effects in animal cancer studies are
a basis for assessing the carcinogenic hazard
to humans.
The NTP monograph for 1bromopropane (Ref. 10) discussed the
issue of mode of action in the section on
mechanistic considerations:
5.3 Mechanistic considerations
The biological events associated with
chemically induced cancer are not
completely understood even for chemicals
that have been extensively studied and are
known to cause cancer in humans (e.g.,
benzene and arsenic) (Guyton et al. 2009). It
is important to recognize that chemicals can
act through multiple toxicity pathways and
mechanisms to induce cancer or other health
effects, and the relative importance of the
various pathways may vary with life stage,
genetic background, and dose. Thus, it is
unlikely that for any chemical a single
mechanism or mode of action will fully
explain the multiple biological alterations
and toxicity pathways that can cause normal
cells to transform and ultimately form a
tumor.
Although no studies were identified that
were specifically designed to investigate
possible modes of action for 1bromopropane-induced carcinogenesis, the
available data indicate that metabolic
activation, genetic damage, and oxidative
stress from glutathione depletion are
important factors. As discussed in the
previous section, these factors were linked to
several of the primary non-neoplastic toxic
effects of 1-bromopropane, including
immunosuppression, neurotoxicity,
reproductive toxicity, and hepatotoxicity.
Other factors that have been associated with
carcinogenesis and may be relevant for 1bromopropane are discussed and include
immune-response modulation, altered cell
signaling and gene expression, inflammation,
and cytotoxicity and compensatory cell
proliferation.
(Ref. 10, page 40)
After considering the mode of action
issues, the NTP classified 1-
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bromopropane as ‘‘reasonably
anticipated to be a human carcinogen.’’
The EPA believes that this classification
is consistent with how the data would
be evaluated under the EPA’s
Guidelines for Carcinogen Risk
Assessment (Ref. 9).
In the comments the Albemarle
Corporation submitted on the HAP
listing petition, the report by Gradient
Corp. included section ‘‘2.3 Human
Relevance of NTP Results.’’ In that
section, issues regarding the cancer data
for 1-bromopropane were raised. The
commenter stated that the petitioners
cited NTP results for the mouse and rat
bioassays as evidence of the potential
carcinogenic activity of 1-bromopropane
(Ref. 13). The commenter claims that the
petitioner did not consider potential
uncertainties that the commenter
believes are found in the underlying
mutagenicity, genotoxicity, and
carcinogenicity data for 1bromopropane. The commenter claimed
that this was not consistent with the
EPA’s cancer guidelines, which
recommend evaluating the weight of
evidence prior to determining the
carcinogenic potential of a chemical
substance. The commenter went on to
summarize information from studies
they believe show potential
uncertainties that are apparent in the
toxicological information for 1bromopropane.
Since the publication of the NTP
bioassay cited by the commenter (Ref.
13), the NTP published its 13th RoC
(Ref. 2). In this report, the NTP
concluded that there is sufficient
evidence of carcinogenicity for 1bromopropane based on (1) skin tumors
in male rats, (2) tumors of the large
intestine in female and male rats, and
(3) lung tumors in female mice. The
report also cited malignant
mesothelioma of the abdominal cavity
and pancreatic islet tumors in male rats
and skin tumors (squamous-cell
papilloma, keratoacanthoma, and basalcell adenoma or carcinoma) in female
rats as supporting evidence. The NTP’s
monograph for 1-bromopropane
addresses all of the data issues that the
commenter raised (Ref. 10).
According to the EPA’s Guidelines for
Carcinogen Risk Assessment (Ref. 9), an
agent can be classified as ‘‘Likely to Be
Carcinogenic to Humans’’ if it ‘‘has
tested positive in animal experiments in
more than one species, sex, strain, site,
or exposure route, with or without
evidence of carcinogenicity in humans.’’
Inconsistencies between how the data
were interpreted by the NTP and how
that same data might be interpreted
under the EPA’s Guidelines for
Carcinogen Risk Assessment (Ref. 9)
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were not identified (see reference 6 in
the proposed rule). The EPA Guidelines
for Carcinogen Risk Assessment
reference the NTP criteria for assessing
individual studies in the assessment of
carcinogenicity, stating ‘‘(c)riteria for
the technical adequacy of animal
carcinogenicity studies have been
published and should be used as
guidance to judge the acceptability of
individual studies, e.g., NTP, 1984 . . .’’
(pages 2–16).
While the EPA acknowledges that
uncertainties exist when evaluating any
agent, the EPA agrees with NTP’s
assessment of the data and conclusions
regarding the carcinogenicity of 1bromopropane. Indeed, according to the
EPA’s Guidelines for Carcinogen Risk
Assessment (Ref. 9) ‘‘The default option
is that positive effects in animal cancer
studies indicate that the agent under
study can have carcinogenic potential in
humans. Thus, if no adequate human or
mode of action data are present, positive
effects in animal cancer studies are a
basis for assessing the carcinogenic
hazard to humans.’’ The EPA believes
that the evaluation of the available data
are consistent with the EPA’s guidelines
including the EPA’s ‘‘Supplemental
guidance for assessing susceptibility
from early-life exposure to carcinogens
(Final)’’ (Ref. 14).
The NTP in its monograph of 1bromopropane (Ref. 10), which
supported the 13th RoC listing (Ref. 2),
concluded the following:
Studies in vivo show that 1-bromopropane
can covalently bind to protein in exposed
rats and occupationally exposed workers.
The available data provide some support that
1-bromopropane is genotoxic as it induced
mutations in bacterial and mammalian cells
and DNA damage in human cells. There is
limited evidence that DNA damage was
induced in leukocytes from 1-bromopropaneexposed workers. 1-Bromopropane did not
induce chromosomal damage in exposed
rodents (micronucleus induction assay) or
gene-cell mutations (dominant lethal
mutation assay). Several known or postulated
metabolites of 1-bromopropane have been
identified as mutagens and two, glycidol and
propylene oxide (proposed), were shown to
cause chromosomal and DNA damage in
cultured mammalian cells. Both metabolites
caused chromosomal damage in cells from
rodents exposed in vivo, and propylene
oxide induced DNA damage in cells from
exposed workers. Three other 1bromopropane metabolites (a-bromohydrin,
3-bromo-1-propanol, and 1-bromo-2propanol) were mutagenic or caused DNA
damage in bacteria.
The EPA agrees with the NTP’s
conclusions regarding the mutagenicity
of 1-bromopropane and its metabolites.
With the exception of the summary
information provided by the commenter
for one unpublished study, all of the
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studies cited by the commenter in their
assessment of the mutagenicity data for
1-bromopropane were cited by the NTP
in their monograph for 1-bromopropane
(Ref. 10). Also, the commenter focused
on the mutagenicity data for 1bromopropane, but the data on the
mutagenicity of the metabolites of 1bromopropane are an important part of
the assessment as well. The summarized
results of the unpublished study
provided by the commenter do not
change the conclusion regarding the
mutagenicity of 1-bromopropane and its
metabolites.
V. Summary of Final Rule
The EPA is finalizing the addition of
1-bromopropane to the EPCRA section
313 list of toxic chemicals. The EPA has
determined that 1-bromopropane meets
the listing criteria under EPCRA section
313(d)(2)(B) based on the available
carcinogenicity data.
VI. References
The 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 the 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 the
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 the 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. USEPA, OEI, 2014. 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 1bromopropane.
2. 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. (https://
ntp.niehs.nih.gov/pubhealth/roc/roc13/
index.html).
3. Anonymous public comment. April 15,
2015. EPA–HQ–TRI–2015–0011–0048.
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4. Anonymous public comment. April 16,
2015. EPA–HQ–TRI–2015–0011–0049.
5. Comment submitted by Faye Graul,
Executive Director, Halogenated Solvents
Industry Alliance Incorporated (HSIA).
Re: Docket ID No. EPA–HQ–TRI–2015–
0011. June 15, 2015. EPA–HQ–TRI–
2015–0011–0051.
6. Comment submitted by Niomi
Krzystowczyk, Vice President, Health,
Safety and Environment, Albemarle
Corporation. Re: Proposed Rule:
Addition of 1-Bromopropane;
Community Right-to-Know Toxic
Chemical Release Reporting; Docket ID
No. EPA–HQ–TRI–2015–0011 [FRL–
9925–29–OEI, 80 FR 20189 (April 15,
2015). June 10, 2015. EPA–HQ–TRI–
2015–0011–0050.
7. USEPA, OEI, 2015. Response to Comments
Received on the April 15, 2015, Federal
Register Proposed Rule (80 FR 20189):
Addition of 1-Bromopropane;
Community Right-to-Know Toxic
Chemical Release Reporting. U.S.
Environmental Protection Agency Office
of Environmental Information, Office of
Information Analysis and Access. August
20, 2015.
8. USEPA, OEI, 2015. Economic Analysis of
the Proposed Rule to add 1Bromopropane to the EPCRA Section 313
List of Toxic Chemicals. February 17,
2015.
9. USEPA, 2005. Guidelines for Carcinogen
Risk Assessment. Risk Assessment
Forum, U.S. Environmental Protection
Agency, Washington, DC, March 2005.
EPA/630/P–03/001F.
10. 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.
11. 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.
12. USEPA, 2014. Summary Report of the
State-of-the-Science Workshop on
Chemically-induced Mouse Lung
Tumors: Applications to Human Health
Assessments. National Center for
Environmental Assessment, Washington,
DC, December 2014. EPA/600/R–14/002.
13. NTP, 2011. Technical Report on the
Toxicology and Carcinogenesis Studies
of 1-Bromopropane (CAS No. 106–94–5)
in F344/N Rats and B6C3F1 Mice
(Inhalation Studies). Toxicity Report
Series No. 564. NIH Publication No. 11–
5906. Department of Health and Human
Services, Public Health Service, Research
Triangle Park, NC.
14. USEPA, 2005. Supplemental guidance for
assessing susceptibility from early-life
exposure to carcinogens (Final). Risk
Assessment Forum, Washington, DC,
March 2005. EPA/630/R–03/003F.
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VII. What are the statutory and
Executive Order reviews associated
with this action?
Additional information about these
statutes and Executive Orders can be
found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders.
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,
the 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
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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
the 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 small entities
subject to the requirements of this
action are small manufacturing
facilities. The Agency has determined
that of the 140 entities estimated to be
impacted by this action, 136 are small
businesses; no small 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 the 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.
1531–1538, 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. The 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
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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
K. Congressional Review Act (CRA)
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, the 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, lowincome populations, and children.
This action is subject to the CRA, and
the EPA will submit a rule report to
each House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 372
Environmental protection,
Community right-to-know, Reporting
and recordkeeping requirements, and
Toxic chemicals.
Dated: November 9, 2015.
Gina McCarthy,
Administrator.
For the reasons set forth in the
preamble, the EPA amends 40 CFR part
372 as follows:
PART 372—TOXIC CHEMICAL
RELEASE REPORTING: COMMUNITY
RIGHT-TO-KNOW
1. The authority citation for part 372
continues to read as follows:
■
Authority: 42 U.S.C. 11023 and 11048.
2. In § 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:
■
§ 372.65 Chemicals and chemical
categories to which this part applies.
*
*
*
*
(a) * * *
Chemical name
CAS No.
*
*
*
*
*
1-Bromopropane ......................................................................................................................................................
*
*
*
*
*
*
*
*
*
*
*
Effective date
106–94–5
*
1/1/16
*
*
*
(b) * * *
Chemical name
Effective date
*
*
106–94–5 ..................................................
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CAS No.
*
*
*
*
1-Bromopropane ..........................................................................................................
*
1/1/16
*
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2015–29799 Filed 11–20–15; 8:45 am]
BILLING CODE 6560–50–P
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Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
49 CFR Parts 171, 172, 173, 175, 176,
177, 178 and 180
[Docket No. PHMSA–2015–0103 (HM–260)]
RIN 2137–AF11
Hazardous Materials: Editorial
Corrections and Clarifications (RRR)
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Final rule.
AGENCY:
This final rule corrects
editorial errors, makes minor regulatory
changes and, in response to requests for
clarification, improves the clarity of
certain provisions in the Hazardous
Materials Regulations. The intended
effect of this rule is to enhance the
accuracy and reduce misunderstandings
of the regulations. The amendments
contained in this rule are nonsubstantive changes and do not impose
new requirements.
DATES: This regulation is effective
December 23, 2015.
FOR FURTHER INFORMATION CONTACT:
Aaron Wiener, Standards and
Rulemaking Division, (202) 366–8553,
Pipeline and Hazardous Materials Safety
Administration, U.S. Department of
Transportation, 1200 New Jersey
Avenue SE., 2nd Floor, Washington, DC
20590–0001.
SUPPLEMENTARY INFORMATION:
SUMMARY:
wgreen on DSK2VPTVN1PROD with RULES
I. Background
II. Section-by-Section Review
III. Regulatory Analyses and Notices
A. Statutory/Legal Authority for the
Rulemaking
B. Executive Orders 12866 and 13563 and
DOT Regulatory Policies and Procedures
C. Executive Order 13132
D. Executive Order 13175
E. Regulatory Flexibility Act, Executive
Order 13272, and DOT Policies and
Procedures
F. Executive Order 13563 Improving
Regulation and Regulatory Review
G. Paperwork Reduction Act
H. Regulatory Identifier Number (RIN)
I. Unfunded Mandates Reform Act
J. Environmental Assessment
K. Privacy Act
I. Background
The Pipeline and Hazardous Materials
Safety Administration (PHMSA)
annually reviews the Hazardous
Materials Regulations (HMR; 49 CFR
parts 171–180) to identify typographical
errors, outdated addresses or other
VerDate Sep<11>2014
17:35 Nov 20, 2015
Jkt 238001
contact information, and similar errors.
In this final rule, we are correcting
typographical errors, incorrect
references to the Code of Federal
Regulations (CFR) and international
standards citations, inconsistent use of
terminology, misstatements of certain
regulatory requirements, and
inadvertent omissions of information,
and making revisions to clarify the
regulations. Of the corrections and
clarifications made in this final rule, a
significant number originate from three
recent final rules under the following
dockets: PHMSA–2009–0063 (HM–250)
[79 FR 40590]; PHMSA–2009–0095
(HM–224F)] [79 FR 46012]; and
PHMSA–2013–0260 (HM–215M) [80 FR
1075]. Because these amendments do
not impose new requirements, notice
and public comment are unnecessary.
II. Section-by-Section Review
The following is a section-by-section
summary of the minor editorial
corrections and clarifications made in
this final rule.
Part 171
Section 171.22
This section prescribes the
authorization and conditions for use of
international standards and regulations.
The wording at the end of paragraph
(f)(4) applicable to shipping paper
retention, states ‘‘§ 172.201(e) of this
part’’, which incorrectly assigns it to 49
CFR part 171. As § 172.201(e), is not in
part 171, in this final rule, the text is
revised to read ‘‘§ 172.201(e) of this
subchapter.’’
Section 171.23
Section 171.23 prescribes
requirements for specific materials and
packagings transported under various
international standards. Paragraph
(a)(4)(ii) contains a grammatical error
stating the word ‘‘drive’’ instead of
‘‘device.’’ In this final rule, we are
correcting this grammatical error.
Additionally, the text in the middle of
paragraph (a)(5), applicable to cylinders
not equipped with pressure relief
devices, states the cylinders must be
‘‘tested and marked in accordance with
part 178 of this subchapter and
otherwise conforms to the requirements
of part 173 for the gas involved’’, but
does not reference that part 173 belongs
to subchapter C. In this final rule, we
are revising (a)(5) to make this
clarification.
Section 171.24
Section 171.24 provides additional
requirements for the use of the
International Civil Aviation
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Organization’s Technical Instructions
(ICAO TI) for the Safe Transport of
Dangerous Goods by Air. The text at the
end of paragraph (c), applicable to
transportation by highway prior to or
after transportation by aircraft, states a
‘‘motor vehicle must be placarded in
accordance with subpart F of part 172’’,
but does not reference that part 172
belongs to Subchapter C. In this final
rule, we are revising paragraph (c) to
make this clarification.
Part 172
Section 172.101
This section prescribes the purpose
and instructions for use of the § 172.102
Hazardous Materials Table (HMT). We
are making a number of editorial
corrections to several entries in the
HMT. The editorial corrections are as
follows:
• In a final rule published under
Docket Number PHMSA–2012–0080
(HM–244E) [77 FR 60935], the entry for
‘‘Aminophenols (o-; m-; p-), UN2512’’
was amended to correct a publication
error in Column (2). In making the
correction, the text in Columns (3)
through (10B) was inadvertently
removed and left blank. This final rule
corrects that error by reinstating the text
in Columns (3) through (10B) for
UN2512 as it read on prior to the HM–
244E rulemaking October 5, 2012.
Amendments to Column (1) Symbols
• For the entry ‘‘Environmentally
hazardous substances, solid, n.o.s,
UN3077,’’ the symbol ‘‘G’’ is added to
Column (1) as it was inadvertently
removed when the entry was amended
in a final rule published under Docket
Number PHMSA 2011–0158 (HM–233C)
[79 FR 15033].
• For the entry ‘‘Self-heating solid,
organic, n.o.s, UN3088,’’ the symbol
‘‘G’’ is added to Column (1) as it was
inadvertently removed when the entry
was amended in a final rule published
under Docket Number PHMSA 2011–
0158 (HM–233C) [79 FR 15033].
Amendments to Column (2) Hazardous
Materials Descriptions and Proper
Shipping Names
• For the entry ‘‘N-Aminoethyl
piperazine, UN2815,’’ the space
between ‘‘N-Aminoethyl’’ and
‘‘piperazine’’ is removed to read ‘‘NAminoethylpiperazine’’ as the space
was inadvertently introduced in the
HM–215M final rule.
E:\FR\FM\23NOR1.SGM
23NOR1
Agencies
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Rules and Regulations]
[Pages 72906-72914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29799]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2015-0011; FRL-9937-12-OEI]
RIN 2025-AA41
Addition of 1-Bromopropane; Community Right-to-Know Toxic
Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is adding 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.'' The EPA has determined that 1-bromopropane
meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably
be anticipated to cause cancer in humans.
DATES: This final rule is effective November 30, 2015, and shall apply
for the reporting year beginning January 1, 2016 (reports due July 1,
2017).
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-TRI-2015-0011. All documents in the docket are
listed on the https://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.
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, https://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 affected
Category entities
------------------------------------------------------------------------
Industry.......................... Facilities included in the following
NAICS manufacturing codes
(corresponding to SIC codes 20
through 39): 311*, 312*, 313*,
314*, 315*, 316, 321, 322, 323*,
324, 325*, 326*, 327, 331, 332,
333, 334*, 335*, 336, 337*, 339*,
111998*, 211112*, 212324*, 212325*,
212393*, 212399*, 488390*, 511110,
511120, 511130, 511140*, 511191,
511199, 512220, 512230*, 519130*,
541712*, or 811490*.
*Exceptions and/or limitations exist
for these NAICS codes.
Facilities included in the following
NAICS codes (corresponding to SIC
codes other than SIC codes 20
through 39): 212111, 212112, 212113
(correspond to SIC 12, Coal Mining
(except 1241)); or 212221, 212222,
212231, 212234, 212299 (correspond
to SIC 10, Metal Mining (except
1011, 1081, and 1094)); or 221111,
221112, 221113, 221118, 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
[[Page 72907]]
B of Title 40 of the Code of Federal Regulations. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section.
II. Introduction
A. What is the statutory authority for this final rule?
This rule is issued under EPCRA section 313(d) and section 328, 42
U.S.C. 11023 et seq. EPCRA is also referred to as Title III of the
Superfund Amendments and Reauthorization Act of 1986.
B. What is the background for this action?
Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to section 6607 of the PPA,
42 U.S.C. 13106. Congress established an initial list of toxic
chemicals that comprised 308 individually listed chemicals and 20
chemical categories.
EPCRA section 313(d) authorizes the EPA to add or delete chemicals
from the list and sets criteria for these actions. EPCRA section
313(d)(2) states that the 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, the 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 the EPA must demonstrate that none of the listing criteria in
Section 313(d)(2)(A)-(C) are met. The EPCRA section 313(d)(2)(A)-(C)
criteria are:
The chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
The chemical is known to cause or can reasonably be
anticipated to cause in humans:
[cir] Cancer or teratogenic effects, or
[cir] serious or irreversible--
[ssquf] Reproductive dysfunctions,
[ssquf] neurological disorders,
[ssquf] heritable genetic mutations, or
[ssquf] other chronic health effects.
The chemical is known to cause or can be reasonably
anticipated to cause, because of:
[cir] Its toxicity,
[cir] its toxicity and persistence in the environment, or
[cir] its toxicity and tendency to bioaccumulate in the
environment, a significant adverse effect on the environment of
sufficient seriousness, in the judgment of the Administrator, to
warrant reporting under this section.
The 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.''
The EPA published in the Federal Register of November 30, 1994 (59
FR 61432), a statement clarifying its interpretation of the section
313(d)(2) and (d)(3) criteria for modifying the section 313 list of
toxic chemicals.
III. Summary of Proposed Rule
A. What chemical did the EPA propose to add to the EPCRA section 313
list of toxic chemicals?
As discussed in the proposed rule (80 FR 20189, April 15, 2015),
the EPA proposed to add 1-bromopropane to the EPCRA section 313 list of
toxic chemicals. 1-Bromopropane had been classified as ``reasonably
anticipated to be a human carcinogen'' by the National Toxicology
Program (NTP) in its 13th Report on Carcinogens (RoC) document. In
addition, based on a review of the available production and use
information, the EPA determined that 1-bromopropane is expected to be
manufactured, processed, or otherwise used in quantities that would
exceed the EPCRA section 313 reporting thresholds. The NTP is an
interagency program within the Department of Health and Human Services
(DHHS) headquartered at the National Institute of Environmental Health
Sciences (NIEHS) of the National Institutes of Health (NIH). As part of
the NTP's cancer evaluation work, it periodically publishes the RoC
document which contains cancer classifications from the NTP's most
recent chemical evaluations as well as the classifications from
previous versions of the RoC. There is an extensive review process for
the RoC which includes evaluations by scientists from the NTP, other
Federal health research and regulatory agencies (including the EPA),
and nongovernmental institutions. The RoC review process also includes
external peer review and several opportunities for public comment.
B. What was the EPA's rationale for proposing to list 1-bromopropane?
As the EPA stated in the proposed rule (80 FR 20189, April 15,
2015), the NTP RoC document undergoes significant scientific review and
public comment and mirrors the review the 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. The EPA believes that the NTP RoC is an
excellent and reliable source of information on the potential for
chemicals covered therein to cause cancer in humans. Based on the EPA's
review of the data contained in the 13th NTP RoC (Reference (Ref.) 1)
for 1-bromopropane, the Agency agreed that 1-bromopropane can
reasonably be anticipated to cause cancer. Therefore, the EPA
determined that the evidence was 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 for 1-
bromopropane as presented in the 13th RoC (Ref. 2).
IV. What comments did the EPA receive on the proposed rule?
The EPA received four comments on the proposed rule to add 1-
bromopropane to the EPCRA section 313 chemical list. Three of the
comments were supportive of the EPA's proposed addition of 1-
bromopropane while one commenter objected to the addition. The
commenters that supported the proposed rule included two anonymous
comments from the general public (Refs. 3 and 4) and a comment from the
Halogenated Solvents Industry Alliance, Inc. (HSIA) (Ref. 5). Members
of the HSIA include The Dow Chemical Company, INEOS Chlor Americas,
Inc., Occidental Chemical, and Axiall Corporation. The commenter who
objected to the addition was the Albemarle Corporation (Ref. 6). The
most significant comments are summarized and responded to below. The
complete set of comments and the EPA's responses can be found in the
response to comment document in the docket for this rulemaking (Ref.
7). Note that in some of the comments 1-bromopropane is referred to as
nPB, which is the acronym for the alternative chemical name n-propyl
bromide.
The HSIA (Ref. 5) stated that the proposed rule presented
substantial
[[Page 72908]]
evidence to support the conclusion that 1-bromopropane is known to
cause or can reasonably be anticipated to cause cancer in humans. The
HSIA also noted that other published studies indicate that 1-
bromopropane is neurotoxic, may cause reproductive dysfunction, and is
acutely or chronically toxic. The HSIA concluded that clearly, the
scientific literature supports the addition of 1-bromopropane to the
list of chemicals subject to reporting under EPCRA section 313.
EPA agrees with the commenter's statement that the EPA provided
substantial evidence to support the conclusion that 1-bromopropane is
known to cause or can reasonably be anticipated to cause cancer in
humans. The EPA also agrees with the commenter's conclusion that the
scientific literature supports the addition of 1-bromopropane to the
EPCRA section 313 chemical list. The EPA acknowledges that there may be
other toxicological effects that may also be a basis for listing.
However, the EPA believes the available cancer data are sufficient for
adding 1-bromopropane to the EPCRA section 313 chemical list.
The first anonymous commenter (Ref. 3) supported the addition of 1-
bromopropane to the EPCRA section 313 list and cited additional
toxicity information, neurotoxicity and reproductive toxicity, as being
of concern.
EPA agrees that 1-bromopropane should be added to the EPCRA section
313 chemical list. The EPA also acknowledges that there may be other
toxicological effects (such as neurotoxicity) that may also be a basis
for listing. However, the available cancer data are sufficient for
adding 1-bromopropane to the EPCRA section 313 chemical list.
The second anonymous commenter (Ref. 4) supported the listing of 1-
bromopropane as long as the benefits substantially outweigh the costs.
The commenter also expressed concern that there may be ``significant
costs to local businesses, i.e., laundry services, that have to update
or replace their equipment as well as significant costs and time spent
in order to comply with the rule.''
EPA's cost-benefit analysis was contained in the economic analysis
for the proposed rule ``Economic Analysis of the Proposed Rule to add
1-Bromopropane to the EPCRA Section 313 List of Toxic Chemicals'' (Ref.
8), which was reference 8 in the proposed rule (80 FR 20189, April 15,
2015). The economic analysis contains a quantitative estimate of the
costs and a qualitative discussion of the benefits of the rule. The EPA
considers the benefits of reporting under this rule to be primarily
reflected by the purposes served by reporting of information under
EPCRA section 313. The EPA believes the benefits provided by the
information to be reported under this rule outweigh the costs.
With regard to laundry services (such as dry cleaners) these
facilities are not subject to reporting under EPCRA section 313. Even
if such facilities were subject to reporting, listing a chemical under
EPCRA section 313 does not require covered facilities to update or
replace any equipment. EPCRA section 313 only requires the reporting of
release and waste management information, it does not impose any
restrictions on the use of chemicals.
The majority of comments provided by the Albemarle Corporation
(Ref. 6) are the same comments they submitted in response to the
``Receipt of a complete petition'' to add 1-bromopropane to the
Hazardous Air Pollutant (HAP) List (80 FR 6676, February 6, 2015). The
only comments submitted by the Albemarle Corporation specific to the
EPA's proposed rule to add 1-bromopropane to the EPCRA section 313
chemical list were provided in a letter from Charles R. Nestrud of the
law firm Chisenhall, Nestrud & Julian, P.A. dated June 10, 2015
(Nestrud letter). The EPA is providing responses to all of the comments
in the Nestrud letter.
The vast majority of the comments submitted by the Albemarle
Corporation on the HAP listing petition dealt with issues of emissions,
exposure, risk values, and risk assessment, which are not relevant to
the proposed addition of 1-bromopropane to the EPCRA section 313
chemical list since the addition is based on hazard and not risk. The
addition of 1-bromopropane to the EPCRA section 313 chemical list is
based on the cancer hazard evaluation carried out by the NTP and
reviewed by the EPA to ensure its consistency with the EPA Guidelines
for Carcinogen Risk Assessment (Ref. 9). Consistent with the EPA
guidelines (Ref. 9), the NTP 13th RoC (Ref. 2) evaluates the scientific
literature and publicly available, peer-reviewed technical reports of
human and laboratory studies to evaluate whether substances are
possible human carcinogens. The NTP RoC does not present a quantitative
assessment of the risks of cancer associated with a given chemical.
Rather, it indicates the potential hazard associated with chemicals but
does not establish the exposure conditions that would pose cancer risks
to individuals. In the 13th RoC, the NTP classified 1-bromopropane as
``reasonably anticipated to be a human carcinogen.'' The conclusions of
the NTP 13th RoC for 1-bromopropane were consistent with how the EPA
would consider the carcinogenicity data available for 1-bromopropane.
Therefore, for the purposes of listing 1-bromopropane on the EPCRA
section 313 chemical list, the EPA concluded that 1-bromopropane can
reasonably be anticipated to cause cancer in humans. Since the listing
of 1-bromopropane under EPCRA section 313 is based on the available
cancer data, the EPA is not responding to the comments from Albemarle
Corporation on the HAP listing petition that dealt with issues of
emissions, exposure, risk values, and risk assessment.
While not specific to the materials the EPA cited to support the
addition of 1-bromopropane to the EPCRA section 313 chemical list,
there were some comments on the cancer data for 1-bromopropane in the
materials that the Albemarle Corporation submitted in response to the
HAP listing petition (Ref. 6). Specifically, these comments are
contained in sections 2.2 and 2.3 of the document ``Comments on the
Petition to Add n-Propyl Bromide to the List of Hazardous Air
Pollutants Regulated under Sec. 112 of the Clean Air Act'' prepared by
the Gradient Corporation (Gradient Corp.). Since these comments dealt
with the toxic endpoint (cancer) that is the basis for the addition of
1-bromopropane to the EPCRA section 313 chemical list, the EPA has
addressed these comments as well.
In the Nestrud letter, the commenter stated that:
The comments prepared by Albemarle and its consultants
demonstrate that the technical information submitted to support the
Proposed Rule is out of date, incorrect, and insufficient to support
the Proposed Rule. Furthermore, when all toxicological data is
considered, and current emission data is considered, the weight of
the evidence does not support adding 1-bromopropane to the list of
toxic chemicals.
EPA disagrees that the information submitted to support the
proposed rule to add 1-bromopropane to the EPCRA section 313 chemical
list is ``out of date, incorrect, and insufficient to support the
Proposed Rule.'' The EPA provided information from the NTP 13th RoC
which was released on October 2, 2014 (Ref. 2). The EPA's evaluation of
the data used to support the findings for 1-bromopropane was conducted
shortly after the release of the 13th RoC and completed on November 3,
2014 (Ref. 1). The EPA's economic analysis of the potential costs of
the proposed rule
[[Page 72909]]
including the estimate of the number of facilities expected to file
reports was completed on February 17, 2015 (Ref. 8). The EPA notes that
the commenter did not provide any comments specific to the EPA's
evaluation of the NTP 13th RoC data and findings for 1-bromopropane
(Ref. 1), which was reference 6 in the proposed rule (80 FR 20189,
April 15, 2015), or specific to the NTP 13th RoC materials prepared for
1-bromopropane (Refs. 10 and 11), which were references 5 and 7 in the
proposed rule (80 FR 20189, April 15, 2015), or on the EPA's economic
analysis for the addition of 1-bromopropane (Ref. 8), which was
reference 8 in the proposed rule (80 FR 20189, April 15, 2015). It is,
therefore, unclear which technical information that the EPA submitted
to support the proposed rule that the commenter believes is out of
date, incorrect, or insufficient to support the proposed rule. Comments
regarding the available cancer data and relevance of emissions data are
discussed in other responses below.
The Nestrud letter also provided comments concerning screening
criteria that the EPA had used in a previous rulemaking:
In its 1994 rulemaking EPA identified certain criteria it had
developed to evaluate chemicals for additions to the list of toxic
chemicals. This included a toxicity and production volume screen,
and a hazard evaluation based on the initial screen. Addition of
Certain Chemicals; Toxic Chemical Release Reporting; Community
Right-to-Know; Final Rule (59 FR No. 229; Doc. No. 94-29376,
November 30, 1994; OPPTS-400082B.
Toxicity Screen. Through the toxicity screen a chemical is
assigned a ``high priority,'' ``medium priority,'' or ``low
priority.'' The attached comments submitted to EPA as part of the
nPB Petition demonstrate that there is insufficient toxicity
information to support assigning a ``high priority,'' or ``medium
priority'' to nPB.
The information that the commenter cited regarding the criteria the
EPA identified for evaluating chemicals for addition to the EPCRA
section 313 chemical list are the criteria the EPA used for its 1994
chemical expansion rulemaking to evaluate large numbers of chemicals
for potential addition. These screening criteria are not the criteria
used to determine whether or not a chemical can be added to the EPCRA
section 313 chemical list, that criteria is established under EPCRA
section 313(d)(2). As the EPA noted in the 1994 chemical expansion
rule:
A toxicity screen is a limited review of readily available
toxicity data that is used for a preliminary categorization of a
chemical during the process of selecting candidates for possible
listing under EPCRA section 313. The toxicity screen is used to
identify chemicals for further consideration and does not reflect a
final determination for listing a chemical under EPCRA section 313.
Such a determination can only be made after a hazard assessment is
conducted (See Unit 11.3. of this preamble).
(59 FR 61433, November 30, 1994)
EPA did not screen 1-bromopropane for addition, but rather
conducted a hazard evaluation of the available cancer data and based on
the classification by the NTP in their 13th RoC as ``reasonably
anticipated to be a human carcinogen'' and our review of that data,
concluded 1-bromopropane should be added to the EPCRA section 313
chemical list. As noted in the proposed rule, the EPA reviewed the data
used by the NTP to make this determination and agreed with the NTP's
classification (Ref. 1), which was reference 6 in the proposed rule (80
FR 20189, April 15, 2015). As the EPA noted in the 1994 chemical
expansion rule, cancer is an extreme toxic effect:
In some cases the effects are extreme, such as cancer or death.
(59 FR 61433, November 30, 1994)
If the EPA had conducted a toxicity screen like that used in the
1994 chemical expansion rule, the available cancer data would have been
sufficient to classify 1-bromopropane as a high priority for listing.
In fact, the NTP's 6th RoC was a primary source reviewed for chemicals
for potential addition (59 FR 1789, January 12, 1994). As previously
noted, the commenter did not provide any comments specifically on the
NTP's classification of 1-bromopropane as ``reasonably anticipated to
be a human carcinogen'' in the 13th RoC, nor did they provide any
comments on the EPA's evaluation of the NTP cancer data and
classification (Ref. 1), as provided in reference 6 of the proposed
rule (80 FR 20189, April 15, 2015).
The Nestrud letter also commented on the issue of a production
volume screen:
Production Volume Screen. When use of the chemical is less than
the reporting thresholds, the chemical is ``not considered
further.'' The attached comments submitted to EPA as part of the nPB
Petition demonstrate that there are no facilities in the dry
cleaning or spray adhesives industries that use more 1-bromopropane
than the reporting threshold of 10,000 pounds (5 tons). Although the
nPB Petition identified one facility in the metal cleaning industry
that used more 1-bromopropane than the reporting threshold of 10,000
pounds (5 tons), that facility reported its use of nPB pursuant to
its Title V Air Permit.
Reference 8 in the proposed rule was the economic analysis for the
addition of 1-bromopropane to the EPCRA section 313 chemical list (Ref.
8). As indicated in the economic analysis, the EPA estimates that 140
reports (126 Form Rs and 14 Form As) from 23 different industry sectors
will be filed for 1-bromopropane. Therefore, the EPA has determined
that there is sufficient production and use of 1-bromopropane such that
reports will be filed. As previously noted, the commenter provided no
specific comments on the EPA's economic analysis. Certain spray
adhesives industries may be required to report under EPCRA section 313,
but dry cleaning facilities are not a covered industry sector and thus
are not required to file reports under EPCRA section 313. While it has
been the EPA's policy to focus on the addition of chemicals for which
reports are expected to be filed, it is not a statutory requirement. As
the EPA noted in the 2010 proposed rule for the addition of 16 NTP
carcinogens to the EPCRA section 313 chemical list:
Section 313(d)(2) of EPCRA provides EPA the discretion to add
chemicals to the TRI list when there is sufficient evidence to
establish any of the listing criteria. EPA can add a chemical that
meets one criterion regardless of its production volume.
(75 FR 17336, April 6, 2010)
The Nestrud letter also commented on the issue of conducting a
hazard evaluation to support the listing of 1-bromopropane to the EPCRA
section 313 list:
Hazard Evaluation. Based on the results of the screen, EPA
should conduct a Hazard Evaluation for 1-bromopropane. The attached
comments submitted to EPA as part of the nPB Petition demonstrate
that the weight of the evidence is not sufficient to add 1-
bromopropane to the list of toxic chemicals. In particular, the
individual lifetime cancer risk at maximally impacted census
receptors near the facilities that use 1-bromopropane is less than 1
in 1 million for all the facilities identified by EPA in the nPB
Petition, with the exception of a narrow tube manufacturing
facility, for which the maximum individual lifetime cancer risk is
less than 1 in 100,000. Other than STC, there are no identified
populations that would have a lifetime cancer risks from exposure to
nPB in excess of 1 in 1 million.
Accordingly, there is no information that would support adding
1-bromopropane to the list of toxic chemicals.
The commenter states that the EPA should conduct a ``Hazard
Evaluation'' for 1-bromopropane, but that is exactly what the EPA did.
The EPA's hazard evaluation included the NTP's classification of 1-
bromopropane as ``reasonably anticipated to be a human carcinogen''
(Refs. 2 and 10) and the EPA's review of the data used by the NTP to
support that classification (Ref. 1). As noted in the proposed rule,
the NTP conducted an extensive review
[[Page 72910]]
(including public comment and peer review) of the cancer data for 1-
bromopropane in making the classification for the NTP 13th RoC. The
EPA's review of that information, as discussed in reference 6 of the
proposed rule, concluded that:
The conclusions of the NTP RoC for 1-bromopropane were
consistent with how the Agency would consider the carcinogenicity
data available for 1-bromopropane. Therefore, it would be
appropriate for the Agency, for the purposes of listing 1-
bromopropane on the Toxics Release Inventory, to conclude that 1-
bromopropane can reasonably be anticipated to cause cancer in
humans.
(80 FR 20189, April 15, 2015)
EPA believes the cancer data for 1-bromopropane sufficiently
support listing under EPCRA section 313(d)(2)(B). None of the
information concerning the cancer data that the commenter submitted in
their response to the petition to add 1-bromopropane to the hazardous
air pollutant (HAP) list changes the EPA's conclusion with regard to
the potential for 1-bromopropane to cause cancer in humans. Responses
to the specific comments on certain portions of the hazard evaluation
are addressed in other responses.
With regard to the commenter's conclusions concerning the cancer
risks from facilities identified in the HAP petition, this information
is not relevant to the addition of 1-bromopropane to the EPCRA section
313 chemical list. The EPA did not base the proposed addition of 1-
bromopropane to the EPCRA section 313 chemical list on any exposure or
risk evaluation. 1-Bromopropane meets the EPCRA section 313(d)(2)(B)
listing criteria based on the cancer data alone and there are no
statutory requirements to consider exposure or risk under EPCRA section
313(d)(2)(B). While the statutory criteria of EPCRA section
313(d)(2)(B) do not require consideration of exposure or risk, the EPA
has a policy concerning when it may be appropriate to consider
potential exposures when adding chemicals under EPCRA section
313(d)(2)(B). As the EPA stated in the proposed rule:
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).
(80 FR 20189, April 15, 2015)
The EPA disagrees with the conclusion of the commenter that there
is no information that would support adding 1-bromopropane to the EPCRA
section 313 chemical list. In fact, it is the EPA's position that there
are extensive cancer data that support this addition as discussed and
referenced in the proposed rule.
In the comments the Albemarle Corporation submitted on the HAP
listing petition (Ref. 6), the report by Gradient Corp. included
section ``2.2 Human Relevance of the Petitioner's Inhalation Unit Risk
Factor.'' In that section, issues regarding the cancer data for 1-
bromopropane were raised. These issues include the petitioners' use of
alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for their
risk assessment. The commenter took issue with the petitioners'
suggestion that ``there are no reasons to assume that the mode, or
modes, of action by which tumors are induced by nPB are not relevant to
man.'' The commenter stated that the petitioners' supporting
information lacked an analysis of the human relevance of the mouse lung
tumors or any other cancer endpoint and cited recommendations in the
EPA's Guidelines for Carcinogen Risk Assessment for collecting relevant
information on the mode of action. The commenter stated that alveolar/
bronchiolar adenomas and carcinomas have been reviewed and debated for
a number of chemical compounds and were the subject of a 2014 technical
workshop sponsored by the EPA. The commenter also provided summaries of
relevant information that they claim are available for 1-bromopropane
to explore mode of action questions. The commenter concluded that there
is evidence that the mode of action for the endpoint selected to
predict risks for 1-bromopropane may not be relevant for humans. The
commenter stated that, considering the state-of-the-science surrounding
this health endpoint, the EPA should not rely on the data for alveolar/
bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing
cancer risks in humans from exposure to 1-bromopropane.
As the EPA previously noted, the proposed addition of 1-
bromopropane to the EPCRA section 313 chemical list is based on hazard
alone and not on any consideration of exposures or potential risks. For
the purposes of listing under EPCRA section 313(d)(2)(B), the EPA is
not relying on the data for alveolar/bronchiolar adenomas and
carcinomas in B6C3F1 mice for characterizing cancer risks in humans
from exposure to 1-bromopropane. While the EPA convened a technical
workshop on the state-of-the-science for chemically-induced mouse lung
tumors, there was no consensus on the relevance of this tumor to humans
(Ref. 12). Rather, one of the workshop outcomes included the future
application of the information discussed during the workshop to develop
a mode of action framework on a chemical by chemical basis. As stated
in the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9):
The default option is that positive effects in animal cancer
studies indicate that the agent under study can have carcinogenic
potential in humans. Thus, if no adequate human or mode of action
data are present, positive effects in animal cancer studies are a
basis for assessing the carcinogenic hazard to humans.
The NTP monograph for 1-bromopropane (Ref. 10) discussed the issue
of mode of action in the section on mechanistic considerations:
5.3 Mechanistic considerations
The biological events associated with chemically induced cancer
are not completely understood even for chemicals that have been
extensively studied and are known to cause cancer in humans (e.g.,
benzene and arsenic) (Guyton et al. 2009). It is important to
recognize that chemicals can act through multiple toxicity pathways
and mechanisms to induce cancer or other health effects, and the
relative importance of the various pathways may vary with life
stage, genetic background, and dose. Thus, it is unlikely that for
any chemical a single mechanism or mode of action will fully explain
the multiple biological alterations and toxicity pathways that can
cause normal cells to transform and ultimately form a tumor.
Although no studies were identified that were specifically
designed to investigate possible modes of action for 1-bromopropane-
induced carcinogenesis, the available data indicate that metabolic
activation, genetic damage, and oxidative stress from glutathione
depletion are important factors. As discussed in the previous
section, these factors were linked to several of the primary non-
neoplastic toxic effects of 1-bromopropane, including
immunosuppression, neurotoxicity, reproductive toxicity, and
hepatotoxicity. Other factors that have been associated with
carcinogenesis and may be relevant for 1-bromopropane are discussed
and include immune-response modulation, altered cell signaling and
gene expression, inflammation, and cytotoxicity and compensatory
cell proliferation.
(Ref. 10, page 40)
After considering the mode of action issues, the NTP classified 1-
[[Page 72911]]
bromopropane as ``reasonably anticipated to be a human carcinogen.''
The EPA believes that this classification is consistent with how the
data would be evaluated under the EPA's Guidelines for Carcinogen Risk
Assessment (Ref. 9).
In the comments the Albemarle Corporation submitted on the HAP
listing petition, the report by Gradient Corp. included section ``2.3
Human Relevance of NTP Results.'' In that section, issues regarding the
cancer data for 1-bromopropane were raised. The commenter stated that
the petitioners cited NTP results for the mouse and rat bioassays as
evidence of the potential carcinogenic activity of 1-bromopropane (Ref.
13). The commenter claims that the petitioner did not consider
potential uncertainties that the commenter believes are found in the
underlying mutagenicity, genotoxicity, and carcinogenicity data for 1-
bromopropane. The commenter claimed that this was not consistent with
the EPA's cancer guidelines, which recommend evaluating the weight of
evidence prior to determining the carcinogenic potential of a chemical
substance. The commenter went on to summarize information from studies
they believe show potential uncertainties that are apparent in the
toxicological information for 1-bromopropane.
Since the publication of the NTP bioassay cited by the commenter
(Ref. 13), the NTP published its 13th RoC (Ref. 2). In this report, the
NTP concluded that there is sufficient evidence of carcinogenicity for
1-bromopropane based on (1) skin tumors in male rats, (2) tumors of the
large intestine in female and male rats, and (3) lung tumors in female
mice. The report also cited malignant mesothelioma of the abdominal
cavity and pancreatic islet tumors in male rats and skin tumors
(squamous-cell papilloma, keratoacanthoma, and basal-cell adenoma or
carcinoma) in female rats as supporting evidence. The NTP's monograph
for 1-bromopropane addresses all of the data issues that the commenter
raised (Ref. 10).
According to the EPA's Guidelines for Carcinogen Risk Assessment
(Ref. 9), an agent can be classified as ``Likely to Be Carcinogenic to
Humans'' if it ``has tested positive in animal experiments in more than
one species, sex, strain, site, or exposure route, with or without
evidence of carcinogenicity in humans.'' Inconsistencies between how
the data were interpreted by the NTP and how that same data might be
interpreted under the EPA's Guidelines for Carcinogen Risk Assessment
(Ref. 9) were not identified (see reference 6 in the proposed rule).
The EPA Guidelines for Carcinogen Risk Assessment reference the NTP
criteria for assessing individual studies in the assessment of
carcinogenicity, stating ``(c)riteria for the technical adequacy of
animal carcinogenicity studies have been published and should be used
as guidance to judge the acceptability of individual studies, e.g.,
NTP, 1984 . . .'' (pages 2-16).
While the EPA acknowledges that uncertainties exist when evaluating
any agent, the EPA agrees with NTP's assessment of the data and
conclusions regarding the carcinogenicity of 1-bromopropane. Indeed,
according to the EPA's Guidelines for Carcinogen Risk Assessment (Ref.
9) ``The default option is that positive effects in animal cancer
studies indicate that the agent under study can have carcinogenic
potential in humans. Thus, if no adequate human or mode of action data
are present, positive effects in animal cancer studies are a basis for
assessing the carcinogenic hazard to humans.'' The EPA believes that
the evaluation of the available data are consistent with the EPA's
guidelines including the EPA's ``Supplemental guidance for assessing
susceptibility from early-life exposure to carcinogens (Final)'' (Ref.
14).
The NTP in its monograph of 1-bromopropane (Ref. 10), which
supported the 13th RoC listing (Ref. 2), concluded the following:
Studies in vivo show that 1-bromopropane can covalently bind to
protein in exposed rats and occupationally exposed workers. The
available data provide some support that 1-bromopropane is genotoxic
as it induced mutations in bacterial and mammalian cells and DNA
damage in human cells. There is limited evidence that DNA damage was
induced in leukocytes from 1-bromopropane-exposed workers. 1-
Bromopropane did not induce chromosomal damage in exposed rodents
(micronucleus induction assay) or gene-cell mutations (dominant
lethal mutation assay). Several known or postulated metabolites of
1-bromopropane have been identified as mutagens and two, glycidol
and propylene oxide (proposed), were shown to cause chromosomal and
DNA damage in cultured mammalian cells. Both metabolites caused
chromosomal damage in cells from rodents exposed in vivo, and
propylene oxide induced DNA damage in cells from exposed workers.
Three other 1-bromopropane metabolites ([alpha]-bromohydrin, 3-
bromo-1-propanol, and 1-bromo-2-propanol) were mutagenic or caused
DNA damage in bacteria.
The EPA agrees with the NTP's conclusions regarding the
mutagenicity of 1-bromopropane and its metabolites. With the exception
of the summary information provided by the commenter for one
unpublished study, all of the studies cited by the commenter in their
assessment of the mutagenicity data for 1-bromopropane were cited by
the NTP in their monograph for 1-bromopropane (Ref. 10). Also, the
commenter focused on the mutagenicity data for 1-bromopropane, but the
data on the mutagenicity of the metabolites of 1-bromopropane are an
important part of the assessment as well. The summarized results of the
unpublished study provided by the commenter do not change the
conclusion regarding the mutagenicity of 1-bromopropane and its
metabolites.
V. Summary of Final Rule
The EPA is finalizing the addition of 1-bromopropane to the EPCRA
section 313 list of toxic chemicals. The EPA has determined that 1-
bromopropane meets the listing criteria under EPCRA section
313(d)(2)(B) based on the available carcinogenicity data.
VI. References
The 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 the 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 the 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 the 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. USEPA, OEI, 2014. 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.
2. 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. (https://ntp.niehs.nih.gov/pubhealth/roc/roc13/).
3. Anonymous public comment. April 15, 2015. EPA-HQ-TRI-2015-0011-
0048.
[[Page 72912]]
4. Anonymous public comment. April 16, 2015. EPA-HQ-TRI-2015-0011-
0049.
5. Comment submitted by Faye Graul, Executive Director, Halogenated
Solvents Industry Alliance Incorporated (HSIA). Re: Docket ID No.
EPA-HQ-TRI-2015-0011. June 15, 2015. EPA-HQ-TRI-2015-0011-0051.
6. Comment submitted by Niomi Krzystowczyk, Vice President, Health,
Safety and Environment, Albemarle Corporation. Re: Proposed Rule:
Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical
Release Reporting; Docket ID No. EPA-HQ-TRI-2015-0011 [FRL-9925-29-
OEI, 80 FR 20189 (April 15, 2015). June 10, 2015. EPA-HQ-TRI-2015-
0011-0050.
7. USEPA, OEI, 2015. Response to Comments Received on the April 15,
2015, Federal Register Proposed Rule (80 FR 20189): Addition of 1-
Bromopropane; Community Right-to-Know Toxic Chemical Release
Reporting. U.S. Environmental Protection Agency Office of
Environmental Information, Office of Information Analysis and
Access. August 20, 2015.
8. USEPA, OEI, 2015. Economic Analysis of the Proposed Rule to add
1-Bromopropane to the EPCRA Section 313 List of Toxic Chemicals.
February 17, 2015.
9. USEPA, 2005. Guidelines for Carcinogen Risk Assessment. Risk
Assessment Forum, U.S. Environmental Protection Agency, Washington,
DC, March 2005. EPA/630/P-03/001F.
10. 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.
11. 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.
12. USEPA, 2014. Summary Report of the State-of-the-Science Workshop
on Chemically-induced Mouse Lung Tumors: Applications to Human
Health Assessments. National Center for Environmental Assessment,
Washington, DC, December 2014. EPA/600/R-14/002.
13. NTP, 2011. Technical Report on the Toxicology and Carcinogenesis
Studies of 1-Bromopropane (CAS No. 106-94-5) in F344/N Rats and
B6C3F1 Mice (Inhalation Studies). Toxicity Report Series No. 564.
NIH Publication No. 11-5906. Department of Health and Human
Services, Public Health Service, Research Triangle Park, NC.
14. USEPA, 2005. Supplemental guidance for assessing susceptibility
from early-life exposure to carcinogens (Final). Risk Assessment
Forum, Washington, DC, March 2005. EPA/630/R-03/003F.
VII. What are the statutory and Executive Order reviews associated with
this action?
Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.
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, the 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 the 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
small entities subject to the requirements of this action are small
manufacturing facilities. The Agency has determined that of the 140
entities estimated to be impacted by this action, 136 are small
businesses; no small 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 the 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. 1531-1538, 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. The 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
[[Page 72913]]
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, the 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.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.
Dated: November 9, 2015.
Gina McCarthy,
Administrator.
For the reasons set forth in the preamble, the EPA amends 40 CFR
part 372 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) * * *
------------------------------------------------------------------------
Chemical name CAS No. Effective date
------------------------------------------------------------------------
* * * * * * *
1-Bromopropane........................ 106-94-5 1/1/16
* * * * * * *
------------------------------------------------------------------------
* * * * *
(b) * * *
------------------------------------------------------------------------
CAS No. Chemical name Effective date
------------------------------------------------------------------------
* * * * * * *
106-94-5....................... 1-Bromopropane........ 1/1/16
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2015-29799 Filed 11-20-15; 8:45 am]
BILLING CODE 6560-50-P