Addition of Hexabromocyclododecane (HBCD) Category; Community Right-to-Know Toxic Chemical Release Reporting, 85440-85445 [2016-28102]
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action will have no net regulatory
burden for all directly regulated small
entities.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local, or
tribal governments or the private sector.
The costs involved in this action are
imposed only by voluntary participation
in a federal program.
E. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175. The EPA has concluded
that this action will have no new tribal
implications, nor would it present any
additional burden on the tribes. It will
neither impose substantial direct
compliance costs on tribal governments,
nor preempt tribal law. Thus, Executive
Order 13175 does not apply to this
action.
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G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045, because it is not
economically significant as defined in
Executive Order 12866, and because the
EPA does not believe the environmental
health or safety risks addressed by this
action present a disproportionate risk to
children. Washington has incorporated
those requirements from the Federal
MSWLF landfill criteria (40 CFR part
258) not found in Washington’s existing
program and EPA has determined that
Washington’s program includes terms
and conditions that are at least as
protective as the MSWLF landfill
criteria for municipal solid waste
landfills, to assure protection of human
health and the environment.
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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 (NTTAA)
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 purpose of this action is to
approve amendments to Washington’s
MSWLF permitting program which
result in it meeting all of the statutory
and regulatory requirements established
by RCRA. The EPA believes that the
human health and environmental risk
addressed by this action will not have
a new disproportionately high and
adverse human health or environmental
effects on minority, low-income or
indigenous populations.
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
40 CFR Part 239
Environmental protection,
Administrative practice and procedure,
Intergovernmental relations, Waste
treatment and disposal.
40 CFR Part 258
Environmental protection, Reporting
and recordkeeping requirements, Waste
treatment and disposal, Water pollution
control.
Authority: This action is issued under the
authority of section 2002, 4005 and 4010(c)
of the Solid Waste Disposal Act, as amended,
42 U.S.C. 6912, 6945 and 6949(a).
Dated: October 20, 2016.
Dennis J. McLerran,
Regional Administrator, EPA Region 10.
[FR Doc. 2016–26754 Filed 11–25–16; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[EPA–HQ–TRI–2015–0607; FRL–9953–28]
RIN 2025–AA42
Addition of Hexabromocyclododecane
(HBCD) Category; Community Rightto-Know Toxic Chemical Release
Reporting
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is adding a
hexabromocyclododecane (HBCD)
category to the list of toxic chemicals
subject to reporting under section 313 of
the Emergency Planning and
Community Right-to-Know Act (EPCRA)
and section 6607 of the Pollution
Prevention Act (PPA). EPA is adding
this chemical category to the EPCRA
section 313 list because EPA has
determined that HBCD meets the
EPCRA section 313(d)(2)(B) and (C)
toxicity criteria. Specifically, EPA has
determined that HBCD can reasonably
be anticipated to cause developmental
and reproductive effects in humans and
is highly toxic to aquatic and terrestrial
organisms. In addition, based on the
available bioaccumulation and
persistence data, EPA has determined
that HBCD should be classified as a
persistent, bioaccumulative, and toxic
(PBT) chemical and assigned a 100pound reporting threshold.
DATES: Effective Date: This final rule is
effective November 30, 2016.
Applicability date: This final rule will
apply for the reporting year beginning
January 1, 2017 (reports due July 1,
2018).
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–HQ–TRI–2015–0607. All
documents in the docket are listed on
https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., Confidential
Business Information 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.
Additional instructions on visiting the
docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
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For technical information contact:
Daniel R. Bushman, Toxics Release
Inventory Program Division (7410M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 566–0743; email:
bushman.daniel@epa.gov.
For general information contact: The
EPCRA Hotline; telephone numbers:
Toll free at (800) 424–9346 (select menu
option 3) or (703) 412–9810 in
Washington DC and International; or
toll free, TDD (800) 553–7672; or go to
https://www.epa.gov/superfund/
contacts/infocenter/.
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this document apply to me?
You may be potentially affected by
this action if you manufacture, process,
or otherwise use HBCD. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Facilities included in the following
NAICS manufacturing codes
(corresponding to Standard Industrial
Classification (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
(corresponds to SIC code 12, Coal
Mining (except 1241)); or 212221,
212222, 212231, 212234, 212299
(corresponds to SIC code 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 codes 4911, 4931, and 4939,
Electric Utilities); or 424690, 425110,
425120 (Limited to facilities previously
classified in SIC code 5169, Chemicals
and Allied Products, Not Elsewhere
Classified); or 424710 (corresponds to
SIC code 5171, Petroleum Bulk
Terminals and Plants); or 562112
(Limited to facilities primarily engaged
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in solvent recovery services on a
contract or fee basis (previously
classified under SIC code 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 code 4953, Refuse
Systems).
• Federal facilities.
To determine whether your facility
would be affected by this action, you
should carefully examine the
applicability criteria in part 372, subpart
B of Title 40 of the Code of Federal
Regulations. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What action is the Agency taking?
EPA is adding an HBCD category to
the list of toxic chemicals subject to
reporting under EPCRA section 313 and
PPA section 6607. EPA is adding this
chemical category to the EPCRA section
313 list because EPA has determined
that HBCD meets the EPCRA section
313(d)(2)(B) and (C) toxicity criteria.
EPA is also adding the HBCD category
to the list of chemicals with special
concern (see 40 CFR 372.28(a)(2)) and
establishing a 100-pound reporting
threshold.
C. What is the Agency’s authority for
taking this action?
This action is issued under EPCRA
sections 313(d) and 328, 42 U.S.C.
11023 et seq., and PPA section 6607, 42
U.S.C. 13106. EPCRA is also referred to
as Title III of the Superfund
Amendments and Reauthorization Act
of 1986.
Section 313 of EPCRA, 42 U.S.C.
11023, requires certain facilities that
manufacture, process, or otherwise use
listed toxic chemicals in amounts above
reporting threshold levels to report their
environmental releases and other waste
management quantities of such
chemicals annually. These facilities
must also report pollution prevention
and recycling data for such chemicals,
pursuant to section 6607 of the PPA, 42
U.S.C. 13106. Congress established an
initial list of toxic chemicals that
comprised 308 individually listed
chemicals and 20 chemical categories.
EPCRA section 313(d) authorizes EPA
to add or delete chemicals from the list
and sets criteria for these actions.
EPCRA section 313(d)(2) states that EPA
may add a chemical to the list if any of
the listing criteria in EPCRA section
313(d)(2) are met. Therefore, to add a
chemical, EPA must demonstrate that at
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least one criterion is met, but need not
determine whether any other criterion is
met. Conversely, to remove a chemical
from the list, EPCRA section 313(d)(3)
dictates that EPA must demonstrate that
none of the criteria in EPCRA section
313(d)(2) are met. The listing criteria in
EPCRA section 313(d)(2)(A)–(C) are as
follows:
• 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: Cancer or teratogenic effects,
or serious or irreversible reproductive
dysfunctions, neurological disorders,
heritable genetic mutations, or other
chronic health effects.
• The chemical is known to cause or
can be reasonably anticipated to cause,
because of its toxicity, its toxicity and
persistence in the environment, or its
toxicity and tendency to bioaccumulate
in the environment, a significant
adverse effect on the environment of
sufficient seriousness, in the judgment
of the Administrator, to warrant
reporting under this section.
EPA often refers to the EPCRA section
313(d)(2)(A) criterion as the ‘‘acute
human health effects criterion;’’ the
EPCRA section 313(d)(2)(B) criterion as
the ‘‘chronic human health effects
criterion;’’ and the EPCRA section
313(d)(2)(C) criterion as the
‘‘environmental effects criterion.’’
EPA published in the Federal
Register of November 30, 1994 (59 FR
61432) (FRL–4922–2), a statement
clarifying its interpretation of the
EPCRA section 313(d)(2) and (d)(3)
criteria for modifying the EPCRA
section 313 list of toxic chemicals.
II. Summary of Proposed Rule
A. What chemical did EPA propose to
add to the EPCRA section 313 list of
toxic chemicals?
As discussed in the proposed rule
June 2, 2016 (81 FR 35275) (FRL–9943–
55), EPA proposed to add HBCD which
is a cyclic aliphatic hydrocarbon
consisting of a 12-membered carbon ring
with 6 bromine atoms attached
(molecular formula C12H18Br6). HBCD
has 16 possible stereoisomers. HBCD
may be designated as a non-specific
mixture of all isomers
(hexabromocyclododecane, Chemical
Abstracts Service Registry Number
(CASRN) 25637–99–4) or as a mixture of
the three main diastereomers
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(1,2,5,6,9,10-hexabromocyclododecane,
CASRN 3194–55–6). EPA proposed to
create an HBCD category that would
cover these two chemical names and
CASRNs and would be defined as:
Hexabromocyclododecane, includes
those chemicals covered by the
following CAS numbers:
• 3194–55–6; 1,2,5,6,9,10Hexabromocyclododecane
• 25637–99–4;
Hexabromocyclododecane.
As a category, facilities that
manufacture, process, or otherwise use
HBCD covered under both of these
names and CASRNs would file just one
report.
B. What reporting threshold did EPA
propose to establish for the HBCD
category?
As EPA stated in the proposed rule
June 2, 2016 (81 FR 35275) (FRL–9943–
55), EPA proposed to add the HBCD
category to the list of chemicals of
special concern (see 40 CFR
372.28(a)(2)). There are several
chemicals and chemical categories on
the EPCRA section 313 chemical list
that have been classified as chemicals of
special concern because they are PBT
chemicals. In a final rule published in
the Federal Register of October 29, 1999
(64 FR 58666) (FRL–6389–11), EPA
established the PBT classification
criteria for chemicals on the EPCRA
section 313 chemical list. The data
presented in the proposed rule
supported classifying the HBCD
category as a PBT chemical category
with a 100-pound reporting threshold.
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C. What was EPA’s rationale for
proposing to list the HBCD category?
As discussed in the proposed rule
June 2, 2016 (81 FR 35275) (FRL–9943–
55), HBCD has been shown to cause
developmental effects at doses as low as
146.3 milligrams per kilogram per day
(mg/kg/day) lowest-observed-adverseeffect level (LOAEL) in male rats.
Developmental effects have also been
observed with a benchmark dose lower
bound confidence limit (BMDL) of 0.056
mg/kg/day (benchmark dose (BMD) of
0.18 mg/kg/day) based on effects in
female rats and a BMDL of 0.46 mg/kg/
day (BMD of 1.45 mg/kg/day) based on
effects in male rats. HBCD also causes
reproductive toxicity at doses as low
138 mg/kg/day (LOAEL) in female rats.
Based on the available developmental
and reproductive toxicity, EPA stated
that HBCD can be reasonably
anticipated to cause moderately high to
high chronic toxicity in humans. EPA
stated that the evidence was sufficient
for listing the HBCD category on the
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EPCRA section 313 toxic chemical list
pursuant to EPCRA section 313(d)(2)(B)
based on the available developmental
and reproductive toxicity data.
As also discussed in the proposed
rule, HBCD has been shown to be highly
toxic to both aquatic and terrestrial
species with acute aquatic toxicity
values as low as 0.009 milligrams per
liter (mg/L) and chronic aquatic toxicity
values as low as 0.0042 mg/L. HBCD is
highly toxic to terrestrial species as well
with observed toxic doses as low as 0.51
and 2.1 mg/kg/day. In addition to being
highly toxic, HBCD is also
bioaccumulative and persistent in the
environment, which further supports a
high concern for the toxicity to aquatic
and terrestrial species. EPA stated that
HBCD meets the EPCRA section
313(d)(2)(C) listing criteria on toxicity
alone but also based on toxicity and
bioaccumulation as well as toxicity and
persistence in the environment.
Therefore, EPA stated that the evidence
is sufficient for listing the HBCD
category on the EPCRA section 313 toxic
chemical list pursuant to EPCRA section
313(d)(2)(C) based on the available
ecological toxicity data as well as the
bioaccumulation and persistence data.
D. What was EPA’s rationale for
lowering the reporting threshold for
HBCD?
EPA stated in the proposed rule that
the available bioaccumulation and
persistence data for HBCD support a
classification of HBCD as a PBT
chemical June 2, 2016 (81 FR 35275)
(FRL–9943–55). HBCD has been shown
to be highly bioaccumulative in aquatic
species and to also biomagnify in
aquatic and terrestrial food chains.
While there is limited data on the halflife of HBCD in soil and sediment, the
best available data supports a
determination that the half-life of HBCD
in soil and sediment is at least 2
months. This determination is further
supported by the data from
environmental monitoring studies,
which indicate that HBCD has
significant persistence in the
environment. The widespread presence
of HBCD in numerous terrestrial and
aquatic species also supports the
conclusion that HBCD has significant
persistence in the environment.
Therefore, consistent with EPA’s
established policy for PBT chemicals
(See 64 FR 58666, October 29, 1999)
(FRL–6389–11) EPA proposed to
establish a 100-pound reporting
threshold for the HBCD category.
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III. What comments did EPA receive on
the proposed rule?
EPA received three comments on the
proposed rule, two from individuals
(Refs. 1 and 2) and one from a coalition
of environmental and public interest
groups and individuals (the coalition)
(Ref. 3). All commenters supported the
addition of the HBCD category to the
EPCRA section 313 toxic chemical list.
However, in their comments the
coalition stated that HBCD is highly
bioaccumulative and highly persistent
and based on EPA’s PBT classification
criteria, a reporting threshold of 10
pounds should be established for the
HBCD category. EPA provided the
following background information in
the proposed rule:
‘‘In a final rule published in the
Federal Register of October 29, 1999 (64
FR 58666) (FRL–6389–11), EPA
established the PBT classification
criteria for chemicals on the EPCRA
section 313 chemical list. For purposes
of EPCRA section 313 reporting, EPA
established persistence half-life criteria
for PBT chemicals of 2 months in water/
sediment and soil and 2 days in air, and
established bioaccumulation criteria for
PBT chemicals as a bioconcentration
factor (BCF) or bioaccumulation factor
(BAF) of 1,000 or higher. Chemicals
meeting the PBT criteria were assigned
100-pound reporting thresholds. With
regards to setting the EPCRA section 313
reporting thresholds, EPA set lower
reporting thresholds (10 pounds) for
those PBT chemicals with persistence
half-lives of 6 months or more in water/
sediment or soil and with BCF or BAF
values of 5,000 or higher, these
chemicals were considered highly PBT
chemicals. The data presented in this
proposed rule support classifying the
HBCD category as a PBT chemical
category with a 100-pound reporting
threshold.’’ June 2, 2016 (81 FR 35277)
(FRL–9943–55).
EPA agrees with the commenter that
HBCD is highly bioaccumulative but
does not agree that HBCD meets the
established criteria for highly persistent.
The commenter stated that ‘‘While halflife data is limited, several studies
estimate the half-life in sediment and
soil to be greater than 120 days, while
one study estimates a half-life of 190
days in abiotic sediment.’’ The study
that the commenter cited as estimating
a half-life of 190 days in abiotic
sediment was Davis et al. 2005 (Ref. 4),
which, as EPA discussed in the
proposed rule, is a study that had a
number of problems. For example, EPA
noted that:
‘‘Additionally, the Davis et al. 2005
study (Ref. 96) was considered to be of
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uncertain reliability for quantifying
HBCD persistence because of concerns
regarding potential contamination of
sediment samples, an interfering peak
corresponding to g-HBCD in the liquid
chromatography/mass spectrometry
(LC/MS) chromatograms, and poor
extraction of HBCD leading to HBCD
recoveries of 33–125% (Refs. 44 and
101).’’ June 2, 2016 (81 FR 35284).
A better-conducted subsequent study
by the same authors Davis et al. 2006
(Ref. 5) resulted in longer overall halflife values but no specific value equal to
or above 180 days. As stated in the
proposed rule, ‘‘While there is limited
data on the half-life of HBCD in soil and
sediment, the best available data
supports a determination that the halflife of HBCD in soil and sediment is at
least 2 months.’’ EPA does not believe
that it would be appropriate to set a
lower reporting threshold based on one
half-life value of 190 days from a study
that had a number of identified
problems.
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IV. Summary of Final Rule
EPA is finalizing the addition of an
HBCD category to the EPCRA section
313 list of toxic chemicals. EPA has
determined that HBCD meets the listing
criteria under EPCRA section
313(d)(2)(B) and (C). The HBCD category
will be defined as:
Hexabromocyclododecane (This
category includes only those chemicals
covered by the CAS numbers listed
here)
• 3194–55–6; 1,2,5,6,9,10Hexabromocyclododecane
• 25637–99–4;
Hexabromocyclododecane.
EPA is also finalizing the addition of
the HBCD category to the list of
chemicals with special concern (see 40
CFR 372.28(a)(2)) and establishing a
100-pound reporting threshold. EPA has
determined that the data support
classifying the HBCD category as a PBT
chemical category with a 100-pound
reporting threshold.
V. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not itself physically located
in the docket. For assistance in locating
these other documents, please consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
1. Comment submitted by M. Clark. July
22, 2016. EPA–HQ–TRI–2015–0607–0217.
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2. Anonymous public comment. July 31,
2016. EPA–HQ–TRI–2015–0607–0218.
3. Comment submitted by E. Gartner, Staff
Attorney, Earthjustice et al. Re: Addition of
Hexabromocyclododecane (HBCD) Category;
Community Right-to-Know Toxic Chemical
Release Reporting, August 1, 2016. EPA–HQ–
TRI–2015–0607–0219.
4. Davis, J.W., Gonsior, S.J., Marty, G.T., et
al. 2005. The transformation of
hexabromocyclododecane in aerobic and
anaerobic soils and aquatic sediments. Water
Res. 39:1075–1084.
5. Davis, J.W., Gonsior, S.J., Markham,
D.A., et al. 2006. Biodegradation and product
identification of
[14C]hexabromocyclododecane in wastewater
sludge and freshwater aquatic sediment.
Environ. Sci. Technol. 40:5395–5401.
Including supporting information document.
6. USEPA, OCSPP. 2016. Economic
Analysis of the Final Rule to add HBCD to
the List of TRI Reportable Chemicals. August
10, 2016.
VI. What are the Statutory and
Executive Orders 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 under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not contain any new
information collection requirements that
require additional approval by OMB
under the PRA, 44 U.S.C. 3501 et seq.
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 section 313
and PPA section 6607 may use either
EPA Toxic Chemicals Release Inventory
Form R (EPA Form 1B9350–1), or EPA
Toxic Chemicals Release Inventory
Form A (EPA Form 1B9350–2). The
Form R must be completed if a facility
manufactures, processes, or otherwise
uses any listed chemical above
threshold quantities and meets certain
other criteria. For the Form A, EPA
established an alternative threshold for
facilities with low annual reportable
amounts of a listed toxic chemical. A
facility that meets the appropriate
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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. Since the HBCD category
would be classified a PBT category, it is
designated as a chemical of special
concern, for which Form A reporting is
not allowed. In addition, respondents
may designate the specific chemical
identity of a substance as a trade secret
pursuant to EPCRA section 322, 42
U.S.C. 11042, 40 CFR part 350.
OMB has approved the reporting and
recordkeeping requirements related to
Forms A and R, supplier notification,
and petitions under OMB Control
number 2025–0009 (EPA Information
Collection Request (ICR) No. 1363) and
those related to trade secret designations
under OMB Control 2050–0078 (EPA
ICR No. 1428). As provided in 5 CFR
1320.5(b) and 1320.6(a), an Agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.
The OMB control numbers relevant to
EPA’s regulations are listed in 40 CFR
part 9 or 48 CFR chapter 15, and
displayed on the information collection
instruments (e.g., forms, instructions).
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. The
small entities subject to the
requirements of this action are small
manufacturing facilities. The Agency
has determined that of the 55 entities
estimated to be impacted by this action,
42 are small businesses; no small
governments or small organizations are
expected to be affected by this action.
All 42 small businesses affected by this
action are estimated to incur annualized
cost impacts of less than 1%. Thus, this
action is not expected to have a
significant adverse economic impact on
a substantial number of small entities. A
more detailed analysis of the impacts on
small entities is located in EPA’s
economic analysis (Ref. 6).
D. Unfunded Mandates Reform Act
(UMRA)
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
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Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
of UMRA because it contains no
regulatory requirements that might
significantly or uniquely affect small
governments. Small governments are
not subject to the EPCRA section 313
reporting requirements. EPA’s economic
analysis indicates that the total cost of
this action is estimated to be $372,973
in the first year of reporting (Ref. 6).
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not a significant
regulatory action under Executive Order
12866.
E. Executive Order 13132: Federalism
I. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards and is therefore not
subject to considerations under section
12(d) of NTTAA, 15 U.S.C. 272 note.
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999). It will not have substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). This action relates to toxic
chemical reporting under EPCRA
section 313, which primarily affects
private sector facilities. Thus, Executive
Order 13175 does not apply to this
action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997) as
applying only to those regulatory
actions that concern environmental
health or safety risks that 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.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
EPA has determined that this action
will not have disproportionately high
and adverse human health or
environmental effects on minority or
low-income populations as specified in
Executive Order 12898 (59 FR 7629,
February 16, 1994). This action does not
address any human health or
environmental risks and does not affect
the level of protection provided to
human health or the environment. This
action adds an additional chemical to
the EPCRA section 313 reporting
requirements. By adding a chemical to
the list of toxic chemicals subject to
reporting under section 313 of EPCRA,
EPA would be providing communities
across the United States (including
minority populations and low income
populations) with access to data which
they may use to seek lower exposures
and consequently reductions in
chemical risks for themselves and their
children. This information can also be
used by government agencies and others
to identify potential problems, set
priorities, and take appropriate steps to
reduce any potential risks to human
health and the environment. Therefore,
the informational benefits of the action
will have positive human health and
environmental impacts on 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 15, 2016.
Gina McCarthy,
Administrator.
Therefore, 40 CFR chapter I is
amended as follows:
PART 372—[AMENDED]
1. The authority citation for part 372
continues to read as follows:
■
Authority: 42 U.S.C. 11023 and 11048.
2. In § 372.28, amend the table in
paragraph (a)(2) as follows:
■ a. Revise the second column header to
read ‘‘Reporting threshold (in pounds
unless otherwise noted)’’, and
■ b. Alphabetically add the category
‘‘Hexabromocyclododecane (This
category includes only those chemicals
covered by the CAS numbers listed
here)’’ and entries ‘‘3194–55–6
(1,2,5,6,9,10Hexabromocyclododecane)’’ and
‘‘25637–99–4
(Hexabromocyclododecane)’’.
The additions read as follows:
■
§ 372.28 Lower thresholds for chemicals
of special concern.
(a) * * *
(2) * * *
Reporting
threshold (in
pounds unless
otherwise
noted)
Category name
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*
*
*
*
*
*
Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here)
3194–55–6 1,2,5,6,9,10-Hexabromocyclododecane
25637–99–4 Hexabromocyclododecane
*
*
*
*
*
*
*
*
3. In § 372.65, paragraph (c) is
amended by adding alphabetically an
■
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entry for ‘‘Hexabromocyclododecane
(This category includes only those
chemicals covered by the CAS numbers
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100
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listed here)’’ to the table to read as
follows:
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§ 372.65 Chemicals and chemical
categories to which this part applies.
*
*
*
*
(c) * * *
*
Category name
Effective date
*
*
*
*
*
*
Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here)
3194–55–6 1,2,5,6,9,10-Hexabromocyclododecane
25637–99–4 Hexabromocyclododecane
*
*
*
[FR Doc. 2016–28102 Filed 11–25–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 435
[EPA–HQ–OW–2014–0598; FRL–9955–65–
OW]
RIN 2040–AF68
Effluent Limitations Guidelines and
Standards for the Oil and Gas
Extraction Point Source Category—
Implementation Date Extension
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
Because the Environmental
Protection Agency (EPA) received
comments that could be construed as
adverse, the EPA is withdrawing the
direct final rule issued on September 30,
2016, to extend the implementation date
for certain facilities subject to the EPA’s
final rule establishing pretreatment
standards under the Clean Water Act
(CWA) for discharges of pollutants into
publicly-owned treatment works
(POTWs) from unconventional oil and
gas extraction.
DATES: Effective November 28, 2016, the
EPA withdraws the direct final rule
published September 30, 2016 (81 FR
67191).
SUMMARY:
For
more information, see EPA’s Web site:
https://www.epa.gov/eg/
unconventional-oil-and-gas-extractioneffluent-guidelines. For technical
information, contact Karen Milam,
Engineering and Analysis Division
(4303T), Office of Water, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone: 202–566–1915; email:
milam.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
On September 30, 2016, the EPA
published a direct final rule that
mstockstill on DSK3G9T082PROD with RULES
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
16:28 Nov 25, 2016
Jkt 241001
*
*
extended the implementation date for
certain facilities to meet the
requirements of the final pretreatment
standards rule for unconventional oil
and gas extraction. (81 FR 67191;
September 30, 2016). In that direct final
rule, the EPA stated that if we received
adverse comments by October 31, 2016,
the EPA would publish a timely
withdrawal and address the comments
in a final rule based on the proposed
rule also published on September 30,
2016. (81 FR 67266; September 30,
2016).
The direct final rule specifically
indicated that ‘‘EPA will not consider
any comment submitted on the direct
final rule published today on any topic
other than the appropriateness of an
extension of the compliance date; any
other comments will be considered to be
outside the scope of this rulemaking.’’
(81 FR 67192; September 30, 2016).
Commenters supported the compliance
date being extended; the EPA did not
receive any comments opposing the
extension of the compliance date, and
thus maintains that there were no
adverse comments on the direct final
rule. As indicated in the direct final
rule, the EPA considers any comments
on topics other than the extension of the
compliance date—including comments
submitted on the applicability of the
underlying final pretreatment standards
rule—to be outside the scope of this
rulemaking. However, to the extent that
any of the comments could be broadly
interpreted as seeking an alternative
compliance period, and thus arguably
within scope, the EPA, in its discretion,
is withdrawing the direct final rule and
instead will issue a final action to
address the compliance date, which will
be based on the parallel proposed rule
also published on September 30, 2016.
(81 FR 67266; September 30, 2016). For
purposes of this withdrawal,
compliance date and implementation
date are used interchangeably. As stated
in the parallel proposal, we will not
institute a second comment period on
this proposed action.
PO 00000
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1/1/17
........................
........................
*
*
Withdrawal of this direct final rule
removes the extension of the
compliance date for the subset of
facilities identified in the direct final
rule. It does not withdraw, or otherwise
impact, the underlying final
pretreatment standards rule for
unconventional oil and gas extraction,
which continues to apply to all facilities
that meet the definition of
‘‘unconventional’’ in that rule.
List of Subjects in 40 CFR Part 435
Environmental protection,
Pretreatment, Waste treatment and
disposal, Water pollution control,
Unconventional oil and gas extraction.
Dated: November 17, 2016.
Michael H. Shapiro,
Deputy Assistant Administrator.
Accordingly, the direct final rule,
published in the Federal Register on
September 30, 2016, at 81 FR 67191, is
withdrawn as of November 28, 2016.
[FR Doc. 2016–28566 Filed 11–25–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 140819686–5999–02]
RIN 0648–XF045
Snapper-Grouper Fishery of the South
Atlantic; 2016 Recreational
Accountability Measure and Closure
for South Atlantic Greater Amberjack
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS implements
accountability measures (AMs) for the
recreational sector of greater amberjack
in the exclusive economic zone (EEZ) of
the South Atlantic for the current
SUMMARY:
E:\FR\FM\28NOR1.SGM
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Agencies
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85440-85445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28102]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2015-0607; FRL-9953-28]
RIN 2025-AA42
Addition of Hexabromocyclododecane (HBCD) Category; Community
Right-to-Know Toxic Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is adding a hexabromocyclododecane (HBCD) category to the
list of toxic chemicals subject to reporting under section 313 of the
Emergency Planning and Community Right-to-Know Act (EPCRA) and section
6607 of the Pollution Prevention Act (PPA). EPA is adding this chemical
category to the EPCRA section 313 list because EPA has determined that
HBCD meets the EPCRA section 313(d)(2)(B) and (C) toxicity criteria.
Specifically, EPA has determined that HBCD can reasonably be
anticipated to cause developmental and reproductive effects in humans
and is highly toxic to aquatic and terrestrial organisms. In addition,
based on the available bioaccumulation and persistence data, EPA has
determined that HBCD should be classified as a persistent,
bioaccumulative, and toxic (PBT) chemical and assigned a 100-pound
reporting threshold.
DATES: Effective Date: This final rule is effective November 30, 2016.
Applicability date: This final rule will apply for the reporting
year beginning January 1, 2017 (reports due July 1, 2018).
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-TRI-2015-0607. All documents in the docket are listed on
https://www.regulations.gov. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information 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. Additional instructions on visiting
the docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
[[Page 85441]]
For technical information contact: Daniel R. Bushman, Toxics
Release Inventory Program Division (7410M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 566-0743; email: bushman.daniel@epa.gov.
For general information contact: The EPCRA Hotline; telephone
numbers: Toll free at (800) 424-9346 (select menu option 3) or (703)
412-9810 in Washington DC and International; or toll free, TDD (800)
553-7672; or go to https://www.epa.gov/superfund/contacts/infocenter/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this document apply to me?
You may be potentially affected by this action if you manufacture,
process, or otherwise use HBCD. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
Facilities included in the following NAICS manufacturing
codes (corresponding to Standard Industrial Classification (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 (corresponds to SIC code 12, Coal Mining (except
1241)); or 212221, 212222, 212231, 212234, 212299 (corresponds to SIC
code 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 codes 4911, 4931, and
4939, Electric Utilities); or 424690, 425110, 425120 (Limited to
facilities previously classified in SIC code 5169, Chemicals and Allied
Products, Not Elsewhere Classified); or 424710 (corresponds to SIC code
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 code 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 code 4953,
Refuse Systems).
Federal facilities.
To determine whether your facility would be affected by this
action, you should carefully examine the applicability criteria in part
372, subpart B of Title 40 of the Code of Federal Regulations. If you
have questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is adding an HBCD category to the list of toxic chemicals
subject to reporting under EPCRA section 313 and PPA section 6607. EPA
is adding this chemical category to the EPCRA section 313 list because
EPA has determined that HBCD meets the EPCRA section 313(d)(2)(B) and
(C) toxicity criteria. EPA is also adding the HBCD category to the list
of chemicals with special concern (see 40 CFR 372.28(a)(2)) and
establishing a 100-pound reporting threshold.
C. What is the Agency's authority for taking this action?
This action is issued under EPCRA sections 313(d) and 328, 42
U.S.C. 11023 et seq., and PPA section 6607, 42 U.S.C. 13106. EPCRA is
also referred to as Title III of the Superfund Amendments and
Reauthorization Act of 1986.
Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to section 6607 of the PPA,
42 U.S.C. 13106. Congress established an initial list of toxic
chemicals that comprised 308 individually listed chemicals and 20
chemical categories.
EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets criteria for these actions. EPCRA section 313(d)(2)
states that EPA may add a chemical to the list if any of the listing
criteria in EPCRA section 313(d)(2) are met. Therefore, to add a
chemical, EPA must demonstrate that at least one criterion is met, but
need not determine whether any other criterion is met. Conversely, to
remove a chemical from the list, EPCRA section 313(d)(3) dictates that
EPA must demonstrate that none of the criteria in EPCRA section
313(d)(2) are met. The listing criteria in EPCRA section 313(d)(2)(A)-
(C) are as follows:
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: Cancer or teratogenic effects, or
serious or irreversible reproductive dysfunctions, neurological
disorders, heritable genetic mutations, or other chronic health
effects.
The chemical is known to cause or can be reasonably
anticipated to cause, because of its toxicity, its toxicity and
persistence in the environment, or its toxicity and tendency to
bioaccumulate in the environment, a significant adverse effect on the
environment of sufficient seriousness, in the judgment of the
Administrator, to warrant reporting under this section.
EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the EPCRA section
313(d)(2)(B) criterion as the ``chronic human health effects
criterion;'' and the EPCRA section 313(d)(2)(C) criterion as the
``environmental effects criterion.''
EPA published in the Federal Register of November 30, 1994 (59 FR
61432) (FRL-4922-2), a statement clarifying its interpretation of the
EPCRA section 313(d)(2) and (d)(3) criteria for modifying the EPCRA
section 313 list of toxic chemicals.
II. Summary of Proposed Rule
A. What chemical did EPA propose to add to the EPCRA section 313 list
of toxic chemicals?
As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), EPA proposed to add HBCD which is a cyclic aliphatic
hydrocarbon consisting of a 12-membered carbon ring with 6 bromine
atoms attached (molecular formula
C12H18Br6). HBCD has 16 possible
stereoisomers. HBCD may be designated as a non-specific mixture of all
isomers (hexabromocyclododecane, Chemical Abstracts Service Registry
Number (CASRN) 25637-99-4) or as a mixture of the three main
diastereomers
[[Page 85442]]
(1,2,5,6,9,10-hexabromocyclododecane, CASRN 3194-55-6). EPA proposed to
create an HBCD category that would cover these two chemical names and
CASRNs and would be defined as: Hexabromocyclododecane, includes those
chemicals covered by the following CAS numbers:
3194-55-6; 1,2,5,6,9,10-Hexabromocyclododecane
25637-99-4; Hexabromocyclododecane.
As a category, facilities that manufacture, process, or otherwise use
HBCD covered under both of these names and CASRNs would file just one
report.
B. What reporting threshold did EPA propose to establish for the HBCD
category?
As EPA stated in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), EPA proposed to add the HBCD category to the list of
chemicals of special concern (see 40 CFR 372.28(a)(2)). There are
several chemicals and chemical categories on the EPCRA section 313
chemical list that have been classified as chemicals of special concern
because they are PBT chemicals. In a final rule published in the
Federal Register of October 29, 1999 (64 FR 58666) (FRL-6389-11), EPA
established the PBT classification criteria for chemicals on the EPCRA
section 313 chemical list. The data presented in the proposed rule
supported classifying the HBCD category as a PBT chemical category with
a 100-pound reporting threshold.
C. What was EPA's rationale for proposing to list the HBCD category?
As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), HBCD has been shown to cause developmental effects at doses
as low as 146.3 milligrams per kilogram per day (mg/kg/day) lowest-
observed-adverse-effect level (LOAEL) in male rats. Developmental
effects have also been observed with a benchmark dose lower bound
confidence limit (BMDL) of 0.056 mg/kg/day (benchmark dose (BMD) of
0.18 mg/kg/day) based on effects in female rats and a BMDL of 0.46 mg/
kg/day (BMD of 1.45 mg/kg/day) based on effects in male rats. HBCD also
causes reproductive toxicity at doses as low 138 mg/kg/day (LOAEL) in
female rats. Based on the available developmental and reproductive
toxicity, EPA stated that HBCD can be reasonably anticipated to cause
moderately high to high chronic toxicity in humans. EPA stated that the
evidence was sufficient for listing the HBCD category on the EPCRA
section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B)
based on the available developmental and reproductive toxicity data.
As also discussed in the proposed rule, HBCD has been shown to be
highly toxic to both aquatic and terrestrial species with acute aquatic
toxicity values as low as 0.009 milligrams per liter (mg/L) and chronic
aquatic toxicity values as low as 0.0042 mg/L. HBCD is highly toxic to
terrestrial species as well with observed toxic doses as low as 0.51
and 2.1 mg/kg/day. In addition to being highly toxic, HBCD is also
bioaccumulative and persistent in the environment, which further
supports a high concern for the toxicity to aquatic and terrestrial
species. EPA stated that HBCD meets the EPCRA section 313(d)(2)(C)
listing criteria on toxicity alone but also based on toxicity and
bioaccumulation as well as toxicity and persistence in the environment.
Therefore, EPA stated that the evidence is sufficient for listing the
HBCD category on the EPCRA section 313 toxic chemical list pursuant to
EPCRA section 313(d)(2)(C) based on the available ecological toxicity
data as well as the bioaccumulation and persistence data.
D. What was EPA's rationale for lowering the reporting threshold for
HBCD?
EPA stated in the proposed rule that the available bioaccumulation
and persistence data for HBCD support a classification of HBCD as a PBT
chemical June 2, 2016 (81 FR 35275) (FRL-9943-55). HBCD has been shown
to be highly bioaccumulative in aquatic species and to also biomagnify
in aquatic and terrestrial food chains. While there is limited data on
the half-life of HBCD in soil and sediment, the best available data
supports a determination that the half-life of HBCD in soil and
sediment is at least 2 months. This determination is further supported
by the data from environmental monitoring studies, which indicate that
HBCD has significant persistence in the environment. The widespread
presence of HBCD in numerous terrestrial and aquatic species also
supports the conclusion that HBCD has significant persistence in the
environment. Therefore, consistent with EPA's established policy for
PBT chemicals (See 64 FR 58666, October 29, 1999) (FRL-6389-11) EPA
proposed to establish a 100-pound reporting threshold for the HBCD
category.
III. What comments did EPA receive on the proposed rule?
EPA received three comments on the proposed rule, two from
individuals (Refs. 1 and 2) and one from a coalition of environmental
and public interest groups and individuals (the coalition) (Ref. 3).
All commenters supported the addition of the HBCD category to the EPCRA
section 313 toxic chemical list. However, in their comments the
coalition stated that HBCD is highly bioaccumulative and highly
persistent and based on EPA's PBT classification criteria, a reporting
threshold of 10 pounds should be established for the HBCD category. EPA
provided the following background information in the proposed rule:
``In a final rule published in the Federal Register of October 29,
1999 (64 FR 58666) (FRL-6389-11), EPA established the PBT
classification criteria for chemicals on the EPCRA section 313 chemical
list. For purposes of EPCRA section 313 reporting, EPA established
persistence half-life criteria for PBT chemicals of 2 months in water/
sediment and soil and 2 days in air, and established bioaccumulation
criteria for PBT chemicals as a bioconcentration factor (BCF) or
bioaccumulation factor (BAF) of 1,000 or higher. Chemicals meeting the
PBT criteria were assigned 100-pound reporting thresholds. With regards
to setting the EPCRA section 313 reporting thresholds, EPA set lower
reporting thresholds (10 pounds) for those PBT chemicals with
persistence half-lives of 6 months or more in water/sediment or soil
and with BCF or BAF values of 5,000 or higher, these chemicals were
considered highly PBT chemicals. The data presented in this proposed
rule support classifying the HBCD category as a PBT chemical category
with a 100-pound reporting threshold.'' June 2, 2016 (81 FR 35277)
(FRL-9943-55).
EPA agrees with the commenter that HBCD is highly bioaccumulative
but does not agree that HBCD meets the established criteria for highly
persistent. The commenter stated that ``While half-life data is
limited, several studies estimate the half-life in sediment and soil to
be greater than 120 days, while one study estimates a half-life of 190
days in abiotic sediment.'' The study that the commenter cited as
estimating a half-life of 190 days in abiotic sediment was Davis et al.
2005 (Ref. 4), which, as EPA discussed in the proposed rule, is a study
that had a number of problems. For example, EPA noted that:
``Additionally, the Davis et al. 2005 study (Ref. 96) was
considered to be of
[[Page 85443]]
uncertain reliability for quantifying HBCD persistence because of
concerns regarding potential contamination of sediment samples, an
interfering peak corresponding to [gamma]-HBCD in the liquid
chromatography/mass spectrometry (LC/MS) chromatograms, and poor
extraction of HBCD leading to HBCD recoveries of 33-125% (Refs. 44 and
101).'' June 2, 2016 (81 FR 35284).
A better-conducted subsequent study by the same authors Davis et
al. 2006 (Ref. 5) resulted in longer overall half-life values but no
specific value equal to or above 180 days. As stated in the proposed
rule, ``While there is limited data on the half-life of HBCD in soil
and sediment, the best available data supports a determination that the
half-life of HBCD in soil and sediment is at least 2 months.'' EPA does
not believe that it would be appropriate to set a lower reporting
threshold based on one half-life value of 190 days from a study that
had a number of identified problems.
IV. Summary of Final Rule
EPA is finalizing the addition of an HBCD category to the EPCRA
section 313 list of toxic chemicals. EPA has determined that HBCD meets
the listing criteria under EPCRA section 313(d)(2)(B) and (C). The HBCD
category will be defined as: Hexabromocyclododecane (This category
includes only those chemicals covered by the CAS numbers listed here)
3194-55-6; 1,2,5,6,9,10-Hexabromocyclododecane
25637-99-4; Hexabromocyclododecane.
EPA is also finalizing the addition of the HBCD category to the
list of chemicals with special concern (see 40 CFR 372.28(a)(2)) and
establishing a 100-pound reporting threshold. EPA has determined that
the data support classifying the HBCD category as a PBT chemical
category with a 100-pound reporting threshold.
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. Comment submitted by M. Clark. July 22, 2016. EPA-HQ-TRI-
2015-0607-0217.
2. Anonymous public comment. July 31, 2016. EPA-HQ-TRI-2015-
0607-0218.
3. Comment submitted by E. Gartner, Staff Attorney, Earthjustice
et al. Re: Addition of Hexabromocyclododecane (HBCD) Category;
Community Right-to-Know Toxic Chemical Release Reporting, August 1,
2016. EPA-HQ-TRI-2015-0607-0219.
4. Davis, J.W., Gonsior, S.J., Marty, G.T., et al. 2005. The
transformation of hexabromocyclododecane in aerobic and anaerobic
soils and aquatic sediments. Water Res. 39:1075-1084.
5. Davis, J.W., Gonsior, S.J., Markham, D.A., et al. 2006.
Biodegradation and product identification of
[\14\C]hexabromocyclododecane in wastewater sludge and freshwater
aquatic sediment. Environ. Sci. Technol. 40:5395-5401. Including
supporting information document.
6. USEPA, OCSPP. 2016. Economic Analysis of the Final Rule to
add HBCD to the List of TRI Reportable Chemicals. August 10, 2016.
VI. What are the Statutory and Executive Orders 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 under Executive Orders 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not contain any new information collection
requirements that require additional approval by OMB under the PRA, 44
U.S.C. 3501 et seq. 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 section
313 and PPA section 6607 may use either EPA Toxic Chemicals Release
Inventory Form R (EPA Form 1B9350-1), or EPA Toxic Chemicals Release
Inventory Form A (EPA Form 1B9350-2). The Form R must be completed if a
facility manufactures, processes, or otherwise uses any listed chemical
above threshold quantities and meets certain other criteria. For the
Form A, EPA established an alternative threshold for facilities with
low annual reportable amounts of a listed toxic chemical. A facility
that meets the appropriate reporting thresholds, but estimates that the
total annual reportable amount of the chemical does not exceed 500
pounds per year, can take advantage of an alternative manufacture,
process, or otherwise use threshold of 1 million pounds per year of the
chemical, provided that certain conditions are met, and submit the Form
A instead of the Form R. Since the HBCD category would be classified a
PBT category, it is designated as a chemical of special concern, for
which Form A reporting is not allowed. In addition, respondents may
designate the specific chemical identity of a substance as a trade
secret pursuant to EPCRA section 322, 42 U.S.C. 11042, 40 CFR part 350.
OMB has approved the reporting and recordkeeping requirements
related to Forms A and R, supplier notification, and petitions under
OMB Control number 2025-0009 (EPA Information Collection Request (ICR)
No. 1363) and those related to trade secret designations under OMB
Control 2050-0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b)
and 1320.6(a), an Agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control numbers
relevant to EPA's regulations are listed in 40 CFR part 9 or 48 CFR
chapter 15, and displayed on the information collection instruments
(e.g., forms, instructions).
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are small manufacturing facilities. The Agency has
determined that of the 55 entities estimated to be impacted by this
action, 42 are small businesses; no small governments or small
organizations are expected to be affected by this action. All 42 small
businesses affected by this action are estimated to incur annualized
cost impacts of less than 1%. Thus, this action is not expected to have
a significant adverse economic impact on a substantial number of small
entities. A more detailed analysis of the impacts on small entities is
located in EPA's economic analysis (Ref. 6).
D. Unfunded Mandates Reform Act (UMRA)
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
[[Page 85444]]
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. Small governments
are not subject to the EPCRA section 313 reporting requirements. EPA's
economic analysis indicates that the total cost of this action is
estimated to be $372,973 in the first year of reporting (Ref. 6).
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action
relates to toxic chemical reporting under EPCRA section 313, which
primarily affects private sector facilities. Thus, Executive Order
13175 does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that 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 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards and is
therefore not subject to considerations under section 12(d) of NTTAA,
15 U.S.C. 272 note.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
EPA has determined that this action will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations as specified in Executive
Order 12898 (59 FR 7629, February 16, 1994). This action does not
address any human health or environmental risks and does not affect the
level of protection provided to human health or the environment. This
action adds an additional chemical to the EPCRA section 313 reporting
requirements. By adding a chemical to the list of toxic chemicals
subject to reporting under section 313 of EPCRA, EPA would be providing
communities across the United States (including minority populations
and low income populations) with access to data which they may use to
seek lower exposures and consequently reductions in chemical risks for
themselves and their children. This information can also be used by
government agencies and others to identify potential problems, set
priorities, and take appropriate steps to reduce any potential risks to
human health and the environment. Therefore, the informational benefits
of the action will have positive human health and environmental impacts
on 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 15, 2016.
Gina McCarthy,
Administrator.
Therefore, 40 CFR chapter I is amended as follows:
PART 372--[AMENDED]
0
1. The authority citation for part 372 continues to read as follows:
Authority: 42 U.S.C. 11023 and 11048.
0
2. In Sec. 372.28, amend the table in paragraph (a)(2) as follows:
0
a. Revise the second column header to read ``Reporting threshold (in
pounds unless otherwise noted)'', and
0
b. Alphabetically add the category ``Hexabromocyclododecane (This
category includes only those chemicals covered by the CAS numbers
listed here)'' and entries ``3194-55-6 (1,2,5,6,9,10-
Hexabromocyclododecane)'' and ``25637-99-4 (Hexabromocyclododecane)''.
The additions read as follows:
Sec. 372.28 Lower thresholds for chemicals of special concern.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Reporting
threshold (in
Category name pounds unless
otherwise
noted)
------------------------------------------------------------------------
* * * * * * *
Hexabromocyclododecane (This category includes only 100
those chemicals covered by the CAS numbers listed here)
3194-55-6 1,2,5,6,9,10-Hexabromocyclododecane ..............
25637-99-4 Hexabromocyclododecane ..............
* * * * * * *
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 372.65, paragraph (c) is amended by adding alphabetically
an entry for ``Hexabromocyclododecane (This category includes only
those chemicals covered by the CAS numbers listed here)'' to the table
to read as follows:
[[Page 85445]]
Sec. 372.65 Chemicals and chemical categories to which this part
applies.
* * * * *
(c) * * *
------------------------------------------------------------------------
Category name Effective date
------------------------------------------------------------------------
* * * * * * *
Hexabromocyclododecane (This category includes only 1/1/17
those chemicals covered by the CAS numbers listed here)
3194-55-6 1,2,5,6,9,10-Hexabromocyclododecane ..............
25637-99-4 Hexabromocyclododecane ..............
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-28102 Filed 11-25-16; 8:45 am]
BILLING CODE 6560-50-P