Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10-Hexabromocyclododecane, 17386-17394 [2012-7207]
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which participated in the regional
planning process, Connecticut will
provide notification to the EPA
Administrator and to those other
State(s). Connecticut will also
collaborate with the other State(s)
through the regional planning process
for the purpose of developing additional
strategies to address any such
deficiencies in Connecticut’s plan.
• If Connecticut determines that its
implementation plan is or may be
inadequate to ensure reasonable
progress as a result of emissions from
sources in another country, Connecticut
will provide notification, along with
available information, to the EPA
Administrator.
• If Connecticut determines that the
implementation plan is or may be
inadequate to ensure reasonable
progress as a result of emissions from
sources within the State, Connecticut
will revise its implementation plan to
address the plan’s deficiencies within
one year from this determination.
IV. What action is EPA proposing to
take?
EPA is proposing approval of
Connecticut’s November 18, 2009 SIP
revision as meeting the applicable
requirements of the Regional Haze Rule
found in 40 CFR 51.308. In addition,
EPA is proposing approval of
Connecticut’s RCSA Section 22a–174–
19a, ‘‘Control of sulfur dioxide
emissions from power plants and other
large stationary sources of air pollution’’
and revisions to RCSA Section 22a–
174–22, ‘‘Control of Nitrogen Oxides
Emissions,’’ including subdivision 22a–
174–22(e)(3), and CGS 16a–21a, ‘‘Sulfur
content of home heating oil and off-road
diesel fuel. Suspension of requirements
for emergency.’’ Furthermore, pursuant
to CT DEEP’s request under parallel
processing, EPA is proposing approval
of Connecticut’s proposed RCSA
Section 22a–174–22d, ‘‘Post-2011
Connecticut Ozone Season NOX Budget
Program.’’ Under this procedure, EPA
prepared this action before the State’s
final adoption of this regulation.
Connecticut has already held a public
hearing on the proposed regulation and
received public comment. Connecticut
may revise the regulation in response to
comments. After Connecticut submits
its final adopted regulation, EPA will
review this regulation to determine
whether it is significantly different from
the proposed regulation. EPA will
determine whether it is appropriate to
approve the final rule with a description
of any changes since the proposal,
re-propose action based on the final
adopted regulations, or take other
actions as appropriate.
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RCSA 22a–174–22d is a replacement
for RCSA 22a–174–22c, ‘‘The Clean Air
Interstate Rule (CAIR) Nitrogen Oxides
(NOX) Ozone Season Trading Program,’’
which is federally approved by EPA and
currently being implemented in
Connecticut.
V. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA’s role is to approve
State choices, provided that they meet
the criteria of the Clean Air Act.
Accordingly, this proposed action
merely approves State law as meeting
Federal requirements and does not
impose additional requirements beyond
those imposed by State law. For that
reason, this proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
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In addition, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the State, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: March 15, 2012.
Ira W. Leighton,
Acting Regional Administrator, EPA
Region 1.
[FR Doc. 2012–7216 Filed 3–23–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2011–0489; FRL–9341–6]
RIN 2070–AJ88
Significant New Use Rule for
Hexabromocyclododecane and
1,2,5,6,9,10-Hexabromocyclododecane
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for two chemical
substances: Hexabromocyclododecane
(Chemical Abstracts Service Registry
Number (CASRN) 25637–99–4) and
1,2,5,6,9,10-hexabromocyclododecane
(CASRN 3194–55–6), hereinafter
collectively referred to as HBCD. This
proposed rule would designate ‘‘use in
consumer textiles, other than for use in
motor vehicles’’ as a significant new
use. This action would require persons
who intend to manufacture (including
import) or process HBCD for use in
covered consumer textiles to notify EPA
at least 90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if appropriate, to prohibit or
limit that activity before it occurs. For
this proposed rule, the general SNUR
article exemption for persons who
SUMMARY:
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import or process chemical substances
as part of an article would not apply.
DATES: Comments must be received on
or before May 25, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2011–0489, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East, Rm.
6428, 1201 Constitution Ave. NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2011–0489.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2011–0489. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
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Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Sue
Slotnick, National Program Chemicals
Division, Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 566–1973; email address:
slotnick.sue@epa.gov.
For general information contact: The
TSCA–Hotline, ABVI–Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture (defined
by statute to include import) or process
HBCD for consumer textiles. Potentially
affected entities may include, but are
not limited to organizations identified
by the following North American
Industry Classification System (NAICS)
codes:
• Chemical Manufacturing (NAICS
code 325).
• Painting and Wall Covering
Contractors (NAICS code 238320).
• Textile and Fabric Finishing (except
Broadwoven Fabric) Mills (NAICS code
313312).
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• Curtain and Drapery Mills (NAICS
code 314121).
• Other Household Textile Product
Mills (NAICS code 314129).
• All Other Miscellaneous Textile
Product Mills (NAICS code 314999).
• Upholstered Household Furniture
Manufacturing (NAICS code 337121).
• Household Furniture (except Wood
and Metal) Manufacturing (NAICS code
337125).
• Mattress Manufacturing (NAICS
code 337910).
• Blind and Shade Manufacturing
(NAICS code 337920).
• Furniture Merchant Wholesalers
(NAICS code 423210).
• Home Furnishing Merchant
Wholesalers (NAICS code 423220).
• Reupholstery and Furniture Repair
(NAICS code 811420).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
In addition, chemical importers are
subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28 (the corresponding EPA policy
appears at 40 CFR part 707, subpart B).
Chemical importers must certify that
shipments of chemical substances
comply with all applicable rules and
orders under TSCA, including SNURs.
In addition, any persons who export or
intend to export a chemical substance
that is the subject of a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
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you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
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EPA is proposing a SNUR for HBCD
which would require persons to notify
EPA at least 90 days before commencing
the manufacture (including import) or
processing of HBCD for use in consumer
textiles other than for use in motor
vehicles. EPA is considering future
regulatory action on additional uses of
HBCD.
B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering ‘‘all relevant factors
including:
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• The projected volume of
manufacturing and processing of a
chemical substance,
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance,
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance, and
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.’’
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture or process the
chemical substance for that use (15
U.S.C. 2604(a)(1)(B)). As described in
Unit II.C., the general SNUR provisions
are found at 40 CFR part 721, subpart
A.
C. Applicability of General Provisions
General provisions for SNURs appear
under 40 CFR part 721, subpart A.
These provisions describe persons
subject to the rule, recordkeeping
requirements, exemptions to reporting
requirements, and applicability of the
rule to uses occurring before the
effective date of the final rule.
Provisions relating to user fees appear at
40 CFR part 700. Additional provisions
appear at § 721.1(c) which describe how
persons subject to SNURs must comply
with the same notice requirements and
EPA regulatory procedures as submitters
of Premanufacture Notices (PMNs)
under TSCA section 5(a)(1)(A). In
particular, these requirements include
the information submission
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
the Agency may take regulatory action
under TSCA section 5(e), 5(f), 6, or 7 to
control the activities on which it has
received the SNUN. If EPA does not take
action, the Agency is required under
TSCA section 5(g) to explain in the
Federal Register its reasons for not
taking action.
EPA proposes that a person who
imports or processes HBCD as part of an
article for use in consumer textiles
(except for use in motor vehicles) would
not be exempt from submitting a SNUN.
(See rationale at Unit VI.C.) For this
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reason, § 721.45(f), which exempts
persons importing or processing a
chemical substance as part of an article,
would not apply to this proposed
SNUR.
Persons who export or intend to
export a chemical substance(s)
identified in a proposed or final SNUR
are subject to the export notification
provisions of TSCA section 12(b). The
regulations that interpret TSCA section
12(b) appear at 40 CFR part 707, subpart
D. Persons who import chemical
substances are subject to the TSCA
section 13 import certification
requirements, codified at 19 CFR 12.118
through 12.127; see also 19 CFR 127.28.
Such persons must certify that the
shipment of the chemical substance(s)
comply with all applicable rules and
orders under TSCA, including any
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B.
III. Overview of HBCD
A. What chemicals are included in the
proposed SNUR?
This proposed SNUR would apply to
two chemical substances:
Hexabromocyclododecane (CASRN
25637–99–4) and 1,2,5,6,9,10hexabromocyclododecane (CASRN
3194–55–6). Hexabromocyclododecane
is manufactured by adding bromine to
technical grade 1,5,9-cyclododecatriene
to make a chemical substance where the
positions of the six bromine atoms are
not specified on the cyclododecane ring,
corresponding to CASRN 25637–99–4.
The specific 1,2,5,6,9,10hexabromocyclododecane isomer
(CASRN 3194–55–6) is the major
component of CASRN 25637–99–4.
Throughout this proposed rule, the term
‘‘HBCD’’ represents both chemical
substances, unless a specific CASRN is
also noted.
B. What is the production volume of
HBCD?
The Inventory Update Rule (IUR) 1
submissions to EPA reported annual
U.S. import/production volumes of 10–
50 million pounds (lb) in both 2002 and
2006 for CASRN 3194–55–6 (EPA,
2006). IUR submissions to EPA reported
annual U.S. import/production volumes
of 10,000 to 500,000 lb in 2002 for
CASRN 25637–99–4; no import/
production was reported in 2006 (EPA,
2006).
1 As of August 16, 2011, the Inventory Update
Rule (IUR) was renamed ‘‘Chemical Data Reporting
rule (CDR).’’ See the TSCA Inventory Update
Reporting Modifications; Chemical Data Reporting
final rule in the Federal Register issue of August
16, 2011 (76 FR 50816) (FRL–8872–9).
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C. What are the uses of HBCD?
Based on information gathered from
research, industry, and government,
EPA believes that HBCD is not used in
consumer textiles other than for use in
motor vehicles. The major use of HBCD
is in polystyrene foam insulation boards
used in construction. It is also used to
a minor extent in high-impact
polystyrene in electronic products and
in textile coatings in carpets, vehicles,
furniture, and upholstery, such as
draperies (Posner, 2006). In the IUR
data, one manufacturer/importer of
HBCD (CASRN 3194–55–6) reported the
use of the chemical substance under the
NAICS code for textile and fabric
finishing mills (EPA, 2006). For this use,
1% of the total production volume of
the chemical substance was in
consumer and commercial products.
However, the reporting does not
distinguish between commercial and
consumer use (EPA, 2006).
Information available to EPA
indicates that the use of HBCD in
textiles is as a backcoating to function
as a flame retardant. EPA conducted
preliminary research to determine
whether HBCD was used in textile
applications for end products sold to
consumers. In 2010, an HBCD expert
with the Consumer Product Safety
Commission (CPSC) expressed to EPA
his understanding that HBCD is used
only in non-consumer textiles such as
firefighters’ suits (CPSC, 2010). In 2011,
EPA requested information from current
and former manufacturers of HBCD. The
responses indicate that only one
manufacturer sells HBCD for textile
uses. The company does not know
whether the end use of any of those
textiles is a consumer article. (ACC,
2011). Additionally, a representative of
the furniture manufacturing company
Herman Miller told EPA that HBCD is
not in their products (Herman Miller,
2011). EPA also received information
from a group of textile formulators that
the end uses of HBCD-containing
textiles are for military, institutional,
and aviation uses only (EPP, 2011). EPA
solicits comment on whether any of
these uses could be considered
consumer textile uses. (See definition of
‘‘consumer textile’’ at § 721.10281 in the
regulatory language of this proposed
rule).
EPA found that a small amount of
HBCD is used in floor mats, headliners,
and possibly other interior fabrics in
motor vehicles made in the United
States, including passenger vehicles.
The automotive industry plans to phase
out these uses in 2015. This phase-out
is consistent with the addition of HBCD
to the Annex XIV List of Substances
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Subject to Authorisation under the
European Union’s Registration,
Evaluation, Authorisation and
Restriction of Chemical Substances
(REACH) regulations (REACH, 2011).
See https://echa.europa.eu/reach_en.asp.
The REACH regulations are expected to
effectively ban the use of HBCD by
major U.S. automotive companies
unless authorized for use in the
European Union (EU) after July 21,
2015. The companies are not likely to
manufacture a different set of products
for sale in the EU and for sale in the
United States. Because the use of HBCD
in textiles in motor vehicles is currently
ongoing, that use is not included in this
proposed rule.
Based on the sum of available
information, EPA believes HBCD is not
used in consumer textiles other than
those used in motor vehicles. The
Agency also believes HBCD could
potentially be used in the future in
consumer textiles in the United States
because the chemical substance:
1. Is used in non-consumer textile
applications in the United States
including institutional, military, and
aviation uses.
2. Is used in textiles in motor vehicles
in the United States.
3. Has been used in residential
consumer textile applications.
See more information on uses of
HBCD in EPA’s ‘‘Economic Analysis of
the Proposed Significant New Use Rule
for Hexabromocyclododecane (HBCD)’’
(EPA, 2011).
D. What are the potential health and
environmental effects of HBCD?
1. Human health effects. Repeated
exposure of HBCD to rats showed
disturbances in thyroid hormone system
and effects on the thyroid in males and
females (Chengelis, 2001). A study by
Eriksson, et al. (2006), concluded that
neonatal exposure of HBCD to mice
affected spontaneous motor behavior,
learning and memory processes in adult
mice. However, this study was not
conducted according to established
Organization for Economic Cooperation
and Development (OECD) Test
Guidelines.
In a recently conducted, more robust,
2-generation reproductive toxicity study
in rats conducted according to
established OECD test guidelines, HBCD
showed treatment-related reproductive
effect (a significant decrease in the
number of primordial follicles in the F1
females) (Ema, et al., 2008). Although
this decrease in ovarian follicles did not
affect any reproductive parameters in
this study, this effect is suggestive of
potential reproductive toxicity.
Developmental effects were observed
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including delays in eye opening in the
second (F2) generation and transient
changes in learning and memory in F1
males, but exposure did not cause any
changes in spontaneous behavior. In
addition, there was high and dosedependent pup mortality during
lactation (Ema, et al., 2008).
2. Environmental effects. Laboratory
studies have shown that HBCD is
capable of producing adverse effects in
a variety of organisms including algae,
fish, invertebrates, and soil-dwelling
organisms at environmentally relevant
concentrations. HBCD is toxic to algae
and acutely toxic to fish embryos
(Desjardins, et al., 2004 and Deng, et al.,
2009). A number of sub-lethal effects
(e.g., altered thyroid status, protein
metabolism, oxidative stress,
reproductive activity) have also been
observed in fish (Palace, et al., 2008;
Kling et al., 2009; Zhang, et al., 2008;
and Ronisz, et al., 2004). One study
reported a reduced number and size of
daphnid offspring in first and second
generations (Drottar, 1998). Thyroid
hormone-dependent developmental
effects were observed in tadpoles
(Xenopus laevis) exposed to HBCD
(Schriks, et al., 2006). HBCD has been
reported to reduce egg production and
lower biomass in soil dwelling
organisms (Lumbriculus variegatus)
(Oetken, et al., 2001). HBCD
administered to chicken (Gallus
domesticus) embryonic hepatocytes in
vitro resulted in significant alterations
in expression of genes (mRNA)
associated with liver and thyroid
function (Crump, et al., 2008). Thinner
egg shells were measured in American
kestrels exposed to a combination of
polybrominated diphenyl ethers
(PBDEs) and HBCD (Fernie, et al., 2009).
E. What are the potential sources and
routes of exposure to HBCD?
Because HBCD is not chemically
bound to its substrate (the protected
textile material), there is potential for
HBCD to be released at any point in the
lifecycle. There is potential for release
when the HBCD is initially
manufactured, when it is being
formulated into the material that is
commonly used in textile back coatings,
as well as when it is being combined
with the textile material to which it is
added. In addition, HBCD can be
released during the service life of the
textile material containing it, including
release into water used to wash the
treated textiles or into the air via dust
particulates. Workers and the general
population can be exposed to HBCD
through direct contact as it migrates
across land, in air, and in water by
diffusion or environmental transport.
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Other opportunities for release can
occur at the end of the lifecycle of the
consumer articles when they are
transported as waste and disposed of,
although incineration at high
temperatures destroys the HBCD
(Posner, 2006).
Evidence strongly suggests there is
potential for exposure to the general
population from HBCD in the
environment and also from products
and dust in the home and workplace.
HBCD is found world-wide in the
environment and wildlife. Human
exposure is evidenced from its presence
in breast milk, adipose tissue, and blood
(Covaci, et al., 2006). The chemical
substance bioaccumulates and
biomagnifies in food chains. The
frequent detection of HBCD over a large
geographic area, with increasing
exposure in remote locations such as the
Arctic, where no demonstrable local
sources exist that can account for these
exposures, suggest that HBCD is
persistent and undergoes long-range
transport (UNEP, 2007).
To the extent HBCD is present in
household applications (e.g., building
foam, furniture upholstery, carpeting),
children could be exposed, especially
given children’s increased exposure via
dust and the hand-to-mouth ingestion
pathway. In vitro experiments
conducted to demonstrate leaching of
HBCD from textiles showed that the
presence of simulated biological fluids
(sweat, saliva) and fruit juices enhances
the leaching of HBCD from back-coated
samples (Ghanem, 2009). Children’s
exposure to HBCD from mouthing of
textiles and from ingestion of dust has
been estimated (EC, 2008).
HBCD has been measured in air and
sediment in Scandinavian countries,
North America and Asia (Covaci, et al.,
2006 and Arnot, et al., 2009). HBCD has
also been measured in marine and arctic
mammals, freshwater and marine fish,
aquatic invertebrates, birds and bird
eggs, and one plant species (Covaci, et
al., 2006 and Arnot, et al., 2009). HBCD
has been detected in Arctic air in
northern Scandinavia and in Arctic
birds and bird eggs, Arctic fish, ringed
seals and polar bears (UNEP, 2009). It
has been detected in freshwater, marine,
and avian organisms, and in upper
trophic-level mammals (polar bears and
seals).
For more information on HBCD
concerning its physical-chemical
properties, fate, releases, and human
and environmental exposure, see EPA’s
‘‘Hexabromocyclododecane (HBCD)
Action Plan’’ dated August 18, 2010
(HBCD Action Plan, 2010).
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IV. Summary of Proposed Rule
EPA is proposing to designate as a
significant new use any use of HBCD in
consumer textiles other than for use in
motor vehicles. EPA believes the only
current use of HBCD for consumer
textiles is in motor vehicles. Thus any
use of HBCD in consumer textiles (other
than for textiles in motor vehicles)
would be a significant new use. A
proposed definition of ‘‘consumer
textile’’ can be found at § 721.10281 of
the regulatory text of this proposed rule.
The proposed definition of ‘‘motor
vehicle’’ refers to 40 CFR 85.1703.2
This proposed rule would add a
section to 40 CFR part 721 to require
persons who intend to manufacture
(including import) or process HBCD for
an activity preliminarily designated as a
significant new use by this action to
notify EPA at least 90 days before
commencing that activity. The required
notification would provide EPA with
the opportunity to evaluate the intended
use and, if appropriate, to prohibit or
limit that activity before it occurs. For
this proposed rule, the general SNUR
exemption for persons that import or
process chemical substances as part of
an article at § 721.45(f) would not apply.
(See discussion at Unit VI.C.)
with that use, if such manufacturing or
processing were to be commenced in the
future. The required notification
provided by a SNUN would provide
EPA with the opportunity to evaluate
activities associated with the significant
new use and an opportunity to protect
against unreasonable risks, if any, from
exposure to HBCD.
Consistent with EPA’s past practice
for issuing SNURs under TSCA section
5(a)(2), EPA’s decision to propose a
SNUR for a particular chemical use
need not be based on an extensive
evaluation of the hazard, exposure, or
potential risk associated with that use.
Rather, the Agency’s action is based on
EPA’s determination that if the use
begins or resumes, it may present a risk
that EPA should evaluate before the
manufacturing or processing for that use
begins. Since the new use does not
currently exist, deferring a detailed
consideration of potential risks or
hazards related to that use is an effective
use of resources. If a person decides to
begin manufacturing or processing the
chemical for the new use, the SNUN to
EPA allows EPA to evaluate the use
according to the specific parameters and
circumstances surrounding that
intended use.
V. Significant New Use Determination
B. Objectives
Based on the considerations in Unit
V.A., EPA has the following objectives
with regard to the significant new use
that is preliminarily designated in this
proposed rule:
1. EPA would receive notification of
any person’s intent to manufacture
(including import) or process HBCD for
the described significant new use before
that activity begins.
2. EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the SNUN submitter
begins manufacturing or processing of
HBCD for the described significant new
use.
3. EPA would be able to regulate
prospective manufacturers or processors
of HBCD before the described significant
new use of the chemical substance(s)
occur, provided that regulation is
warranted pursuant to TSCA sections
5(e), 5(f), 6, or 7.
A. Rationale
As summarized in Unit III.D. and E.,
EPA has concerns regarding the
potential exposure to and human health
and environmental effects of HBCD.
EPA believes that HBCD could be
manufactured or processed for
consumer textiles other than for use in
motor vehicles in the future.
Accordingly, EPA wants the
opportunity to evaluate and control,
where appropriate, activities associated
2 The definition at 40 CFR 85.1703 is: ‘‘a vehicle
which is self-propelled and capable of transporting
a person or persons or any material or any
permanently or temporarily affixed apparatus shall
be deemed a motor vehicle, unless any one or more
of the criteria set forth below are met, in which case
the vehicle shall be deemed not a motor vehicle and
excluded from the operation of the [Clean Air] Act:
(1) The vehicle cannot exceed a maximum speed
of 25 miles per hour over level, paved surfaces; or
(2) The vehicle lacks features customarily
associated with safe and practical street or highway
use, such features including, but not being limited
to, a reverse gear (except in the case of
motorcycles), a differential, or safety features
required by state and/or federal law; or
(3) The vehicle exhibits features which render its
use on a street or highway unsafe, impractical, or
highly unlikely, such features including, but not
being limited to, tracked road contact means, an
inordinate size, or features ordinarily associated
with military combat or tactical vehicles such as
armor and/or weaponry.’’
40 CFR 85.1703 is available online at: https://
www.gpo.gov/fdsys/pkg/CFR–2000-title40-vol12/
xml/CFR–2000-title40-vol12-sec85–1703.xml.
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C. Relevant Factors Considered for This
Proposed SNUR
TSCA states that EPA’s determination
that a use of a chemical substance is a
significant new use must be made after
consideration of all relevant factors,
including those listed at TSCA section
5(a)(2) (see list at Unit II.B.). EPA has
preliminarily determined that
manufacturing or processing of HBCD
for use in consumer textiles other than
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for use in motor vehicles is a significant
new use. This determination is based
primarily on the following factor listed
at TSCA section 5(a)(2): ‘‘The extent to
which a use increases the magnitude
and duration of exposure of human
beings or the environment to a chemical
substance.’’ The latest information
available to EPA indicates that the only
ongoing use of HBCD in consumer
textiles is for use in motor vehicles.
Initiation of new uses of HBCD in
consumer textiles could increase the
magnitude and duration of exposure to
the general population from HBCD in
the environment and from products and
dust in the home and workplace.
Workers could be exposed to HBCD at
facilities of all types involved in the
lifecycle of the products, as described in
greater detail in Unit III.E. Releases to
the environment are expected to occur
during the service life of the textiles
containing HBCD. Such increase in
releases could contribute additional
HBCD to the atmosphere, long-range
transport, and greater concentrations in
water, which could be detrimental to
overall environmental and human
health. Thus, EPA believes that
initiating the use of HBCD in consumer
textiles other than for use in motor
vehicles would increase the magnitude
and duration of exposure to humans and
the environment over that which would
otherwise exist.
D. Request for Comment
EPA welcomes comment on all
aspects of this proposed rule, including:
1. The basis for the significant new
use determination presented for this
proposed rule.
2. Information about any ongoing
manufacture, import, or processing of
HBCD for use in consumer textiles.
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VI. Alternative Regulatory Approaches
Before proposing this SNUR, EPA
considered the following alternative
regulatory actions:
A. Promulgate a TSCA Section 8(a)
Reporting Rule
Under a TSCA section 8(a) rule, EPA
could, among other things, generally
require persons to report information to
the Agency when they intend to
manufacture or process a listed
chemical for a specific use or any use.
However, for HBCD in consumer
textiles, the use of TSCA section 8(a)
rather than SNUR authority would have
several limitations. First, if EPA were to
require reporting under TSCA section
8(a) instead of TSCA section 5(a), EPA
would not have the opportunity to
review human and environmental
hazards and exposures associated with
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the use in consumer textiles and, if
necessary, take immediate follow-up
regulatory action under TSCA sections
5(e) or 5(f) to prohibit or limit the
activity before it begins, if warranted. In
addition, EPA might not receive
important information from small
businesses, because such firms generally
are exempt from TSCA section 8(a)
reporting requirements. In view of
health and environmental concerns
related to HBCD, if used for the
proposed significant new use, EPA
believes that a TSCA section 8(a) rule
for these chemical substances would not
meet EPA’s regulatory objectives.
B. Regulate HBCD in Consumer Textiles
Under TSCA Section 6
EPA may regulate under TSCA
section 6 if ‘‘the Administrator finds
that there is a reasonable basis to
conclude that the manufacture,
processing, distribution in commerce,
use or disposal of a chemical substance
or mixture . . . presents or will present
an unreasonable risk of injury to health
or the environment.’’ (TSCA section
6(a)). EPA concluded that risk
management action under TSCA section
6 is not necessary at this time because
EPA:
1. Believes HBCD is not being used in
consumer textiles in the United States,
other than for use in motor vehicles.
2. Has not determined as of this date
that use of HBCD in motor vehicles
presents unreasonable risk.
3. Expects the use in motor vehicles
to end within a few years. This
proposed SNUR would allow the
Agency to address the potential risks
associated with the proposed significant
new use.
C. Allow the Exemption for Persons Who
Import or Process HBCD as Part of
Articles That Would Be Subject to the
Proposed SNUR
Under the SNUR exemption provision
at § 721.45(f), a person who imports or
processes a chemical substance covered
by a SNUR identified in 40 CFR part
721, subpart E, as part of an article is
not generally subject to the notification
requirements of § 721.25 for that
chemical substance. However, EPA is
concerned that exempting HBCD as part
of articles would render the SNUR less
effective because of the possibility that
consumer textile articles containing
HBCD, the primary concern of EPA
associated with this proposed rule,
could be imported or processed for uses
subject to this proposed SNUR without
the submission of a SNUN. This
proposed rule would not include the
exemption at § 721.45(f).
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VII. Applicability of Rule to Uses
Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of this
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule were considered ongoing rather
than new, it would be difficult for EPA
to establish SNUR notification
requirements, because a person could
defeat the SNUR by initiating the
proposed significant new use before the
rule became final, and then argue that
the use was ongoing as of the effective
date of the final rule. Thus, persons who
begin commercial manufacture or
processing of the chemical substance(s)
(including manufacturing or processing
the chemical substance(s) as part of an
article) for a use that would be regulated
through this proposed rule, if finalized,
would have to cease any such activity
before the effective date of the rule if
and when finalized. To resume their
activities, these persons would have to
comply with all applicable SNUR
notification requirements and wait until
the notification review period,
including all extensions, expires. EPA
has promulgated provisions
(§ 721.45(h)) to allow persons to submit
a SNUN before the effective date of the
SNUR. If a person were to meet the
conditions of § 721.45(h), that person
would be considered to have met the
requirements of the final SNUR for
those activities. If persons who begin
commercial manufacture, import, or
processing of the chemical substance
between publication of the proposed
rule and the effective date of the final
SNUR do not meet the conditions of
advance compliance, they must cease
that activity before the effective date of
the final rule. To resume their activities,
these persons would have to comply
with all applicable SNUN requirements
and wait until the notification review
period, including all extensions,
expires.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require the development of any
particular test data before submission of
a SNUN. There are two exceptions:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
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2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (TSCA
section 5(d); 40 CFR 720.50 and 40 CFR
721.25). However, as a general matter,
EPA recommends that SNUN submitters
include data that would permit a
reasoned evaluation of risks posed by
the chemical substance during its
manufacture, processing, use,
distribution in commerce, or disposal.
EPA encourages persons to consult with
the Agency before submitting a SNUN.
As part of this optional pre-SNUN
consultation, EPA would discuss
specific data it believes may be useful
in evaluating a significant new use.
SNUNs submitted for significant new
uses without any test data may increase
the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or
limit activities associated with this
chemical.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs that provide detailed
information on:
• Human exposure and
environmental releases that may result
from the significant new use of the
chemical substance.
• Potential benefits of the chemical
substance.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be on EPA
Form No. 7710–25, generated using ePMN software, and submitted to the
Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 40 CFR 721.25. The e-PMN software
is available electronically at https://
www.epa.gov/opptintr/newchems.
X. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUR reporting
requirements for potential
manufacturers and processors of HBCD
in consumer textiles. The evaluation is
in the ‘‘Economic Analysis of the
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Proposed Significant New Use Rule for
Hexabromocyclododecane (HBCD)’’
(EPA, 2011). It is briefly summarized
here and is available in the docket for
this proposed rule.
Because there appears to be no use of
HBCD in consumer textiles in the
United States at the current time, other
than for use in motor vehicles, EPA
expects very few, if any, entities would
submit a SNUN. As a result, the
economic impact of this rule is
anticipated to be either zero or very low.
In the event that a SNUN is
submitted, costs are estimated at
approximately $8,300 per SNUN
submission for large businesses and
$5,900 for small businesses, and include
the cost to prepare and submit the
SNUN and the payment of a user fee.
Businesses that submit a SNUN would
be subject to either a $2,500 user fee
required by 40 CFR 700.45(b)(2)(iii), or,
if they are a small business with annual
sales of less than $40 million when
combined with those of the parent
company (if any), a reduced user fee of
$100 (40 CFR 700.45(b)(1)). In its
evaluation of this proposed rule, EPA
also considered the potential costs a
company might incur by avoiding or
delaying the significant new use in the
future, but these costs have not been
quantified.
XI. References
The following documents are
specifically referenced in the preamble
for this proposed rule. In addition to
these documents, other materials may
be available in the docket established
for this proposed rule under docket ID
number EPA–HQ–OPPT–2011–0489,
which you can access through https://
www.regulations.gov. Those interested
in the information considered by EPA in
developing this proposed rule, should
also consult documents that are
referenced in the documents that EPA
has placed in the docket, regardless of
whether the other documents are
physically located in the docket.
1. EPA. 2006. Inventory Update Reporting
(IUR): Non-Confidential 2006 TSCA
Inventory Update Rule (IUR) Records.
Available online at: https://cfpub.epa.gov/
iursearch (accessed March 8, 2012).
2. Posner. 2006. Survey and technical
assessment of alternatives to TBBPA and
HBCDD. Kemi Report. January 2006.
3. CPSC. 2010. Personal communication
with Dr. Michael Babich, Chemist, United
States Consumer Product Safety Commission
(CPSC). March 16, 2010.
4. ACC. 2011. Personal communication
with Jackson Morrill, Director of Chemical
Products of the American Chemistry Council
(ACC). February 16, 2011.
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5. Herman Miller. 2011. Personal
communication with Gabe Wing of Herman
Miller, Inc. March 30, 2011.
6. EPP. 2011. Personal communication
with John Friddle, President of Eagle
Performance Products. March 3, 2011.
7. REACH. 2011. Available online at:
https://echa.europa.eu/reach_en.asp.
8. EPA. 2011. Economic Analysis of the
Proposed Significant New Use Rule for
Hexabromocyclododecane (HBCD).
Washington, DC. OPPT/Environmental
Economics and Technology Division (EETD)/
Economic and Policy Analysis Branch
(EPAB). February 6, 2012.
9. Chengelis. 2001. An oral (gavage) 90 day
toxicity study of HBCD in rats. Study No.
WIL–186012. WIL Research Laboratories, Inc.
Ashland, Ohio, USA.
10. Eriksson, et al. 2006. Impaired
behaviour, learning and memory, in adult
mice neonatally exposed to
hexabromocyclododecane (HBCDD).
Environmental Toxicology and
Pharmacology. May 2006. 21(3), pp. 317–322.
11. Ema, M., et al. 2008. Two-generation
reproductive toxicity study of the flame
retardant hexabromcyclododecane in rats.
Reproductive Toxicology. April 2008. 25(3),
pp. 335–351.
12. Desjardins, et al. 2004.
Hexabromocyclododecane (HBCD): A 72hour toxicity test with the marine diatom
(Skeletonema costatum). Final Report.
Wildlife International, Ltd. Easton, Maryland,
USA. pp. 66.
13. Deng, et al. 2009.
Hexabromocyclododecane-induced
developmental toxicity and apoptosis in
zebrafish embryos. Aquatic Toxicology. June
2009. 93(1), pp. 29–36.
14. Palace, et al. 2008. Biotransformation
enzymes and thyroid axis disruption in
juvenile rainbow trout (Oncorhynchus
mykiss) exposed to hexabromocyclododecane
diastereoisomers. Environmental Science and
Technology. February 2008. 42(6), pp. 1967–
1972.
15. Kling, et al. 2009. Proteomic studies in
zebrafish liver cells exposed to the
brominated flame retardants HBCD and
TBBPA. Ecotoxicology and Environmental
Safety. November 2009. 72, pp. 985–1993.
16. Zhang, et al. 2008. Induction of hepatic
enzymes and oxidative stress in Chinese rare
minnow (Gobiocypris rarus) exposed to
waterborne hexabromocyclododecane
(HBCD). Aquatic Toxicology. January 2008.
86(1), pp. 4–11.
17. Ronisz, et al. 2004. Sublethal effects of
the flame retardants
hexabromocyclododecane (HBCDD), and
tetrabromobisphenol A (TBBPA), on hepatic
enzymes and other biomarkers in juvenile
rainbow trout and feral eelpout. Aquatic
Toxicology. August 2004. 69(3), pp. 229–245.
18. Drottar, et al. 1998.
Hexabromocyclododecane (HBCD): A flowthrough life-cycle toxicity test with the
cladoceran (Daphnia magna). Final Report.
439A–108, Wildlife International, Ltd.
Easton, Maryland, USA. 1998. pp. 78.
19. Schriks, et al. 2006. Disruption of
thyroid hormone-mediated Xenopus laevis
tadpole tail tip regression by
hexabromocyclododecane (HBCD) and
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2,2’,3,3’,4,4’,5,5’, 6-nona brominated
diphenyl ether (BDE206). Chemosphere.
December 2006. 65(10), pp. 1904–1908.
20. Oetken, et al. 2001. Validation of the
preliminary EU-concept of assessing the
impact of chemicals to organisms in
sediment by using selected substances. UBA–
FB 299 67 411, Institute of Hydrobiology,
Dresden University of Technology, Dresden,
Germany. 2001. pp. 97.
21. Crump, et al. 2008. Effects of
hexabromocyclododecane and
polybrominated diphenyl ethers on mRNA
expression in chicken (Gallus domesticus)
hepatocytes. Toxicological Sciences.
December 2008. 106(2), pp. 479–487.
22. Fernie, et al. 2009. Environmentally
relevant concentrations of DE–71 and HBCD
alter eggshell thickness and reproductive
success of American kestrels. Environmental
Science and Technology. March 2009. 43(6),
pp. 2124–30.
23. Covaci, et al. 2006.
Hexabromocyclododecanes (HBCDs) in the
Environment and Humans: A Review.
Environmental Science and Technology. May
2006. 40(12), pp. 3679–3688.
24. UNEP. 2007. Stockholm Convention on
Persistent Organic Pollutants. Persistent
Organic Pollutants Review Committee, Third
meeting, Geneva. pp. 19–23, November 2007,
Item 7 of the provisional agenda,
Presentation on environmental transport and
modeling. The OECD screening tool for
overall persistence and long-range transport
potential. UNEP/POPS/POPRC.3/INF/7.
25. Ghanem, R. 2009. Kinetics of Thermal
and Photolytic Segregation of
Hexabromocyclododecane in Backcoated
Textile Samples. Jordan Journal of
Chemistry. April 2009. 4(2), pp. 171–181.
26. EC. 2008. European Commission (EC).
Risk Assessment: Hexabromocyclododecane
CAS–No.: 25637–99–4 EINECS–No.: 247–
148–4, Final Report. Office for Official
Publications of the European Communities:
Luxembourg. May 2008.
27. Arnot, et al. 2009. An evaluation of
hexabromocyclododecane (HBCD) for
Persistent Organic Pollutant (POP) properties
and the potential for adverse effects in the
environment. Submitted to European
Brominated Flame Retardant Industry Panel
(EBFRIP). May 2009.
28. UNEP. 2009. Stockholm Convention on
Persistent Organic Pollutants. Summary of
the proposal for the listing of
hexabromocyclododecane (HBCDD) in Annex
A to the Convention. July 2009.
29. HBCD Action Plan. 2010. EPA’s
Hexabromocyclododecane (HBCD) Action
Plan. August 2010. Available online at https://
www.epa.gov/oppt/existingchemicals/pubs/
actionplans/hbcd.html (accessed March 8,
2012).
XII. Statutory and Executive Order
Reviews
A. Regulatory Planning and Review
Under Executive Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993),
this action has been designated a
‘‘significant regulatory action.’’
Accordingly, EPA submitted this action
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to the Office of Management and Budget
(OMB) for review under Executive
Orders 12866 and 13563, entitled
‘‘Improving Regulation and Regulatory
Review’’ (76 FR 3821, January 21, 2011),
and any changes made in response to
OMB recommendations have been
documented in the docket for this action
as required by section 6(a)(3)(E) of the
Executive Order.
EPA has prepared an economic
analysis of this action, entitled
‘‘Economic Analysis of the Proposed
Significant New Use Rule for
Hexabromocyclododecane (HBCD)’’
(EPA, 2011). A copy of the document is
available in the docket for this proposed
rule and is summarized in Unit X.
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for certain EPA regulations in
title 40 of the CFR, after appearing in
the Federal Register, are listed in 40
CFR part 9, and included on the related
collection instrument, or form, if
applicable.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0038 (EPA ICR No. 1188).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average 97 hours per response. This
burden estimate includes the time
needed to review instructions; search
existing data sources; gather and
maintain the data needed; and
complete, review, and submit the
required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden to the Director,
Collection Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Small Entity Impacts
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
PO 00000
Frm 00034
Fmt 4702
Sfmt 4702
17393
would not have a significant adverse
economic impact on a substantial
number of small entities. The rationale
supporting this conclusion is as follows.
Under RFA, small entities include
small businesses, small organizations,
and small governmental jurisdictions.
Small entity is defined in accordance
with section 601 of RFA as: A small
business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; a small
governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and a
small organization that is any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field. For purposes of
assessing the impacts of this proposed
rule on small entities, EPA has
determined that this proposed rule is
not expected to impact any small notfor-profit organizations or small
governmental jurisdictions. As such, the
Agency estimated potential impacts on
small business.
A SNUR applies to any person
(including small or large entities) who
intends to manufacture, import, or
process a chemical substance for a use
the EPA has designated as a ‘‘significant
new use.’’ By definition of the word
‘‘new,’’ and based on information
currently available to EPA, it appears
that no small or large entities presently
engage in such activity. Since this
proposed SNUR would require a person
who intends to engage in such activity
in the future to first notify EPA by
submitting a SNUN, no economic
impact will occur unless someone files
a SNUN to pursue a significant new use
in the future or forgoes profits by
avoiding or delaying the significant new
use. Although some small entities may
decide to conduct such activities in the
future, EPA cannot presently determine
how many, if any, there may be.
However, EPA’s experience to date is
that, in response to the promulgation of
SNURs covering over 1,000 chemical
substances, the Agency receives only a
handful of SNUNs per year. For
example, the number of SNUNs was
four in Federal fiscal year 2005, eight in
FY2006, six in FY2007, eight in FY2008,
and seven in FY2009. During this 5-year
period, three small entities submitted a
SNUN. Therefore, EPA believes that the
potential economic impact of complying
with a SNUR is not expected to be
significant or adversely impact a
substantial number of small entities. In
a SNUR that published as a final rule on
August 8, 1997 (62 FR 42690) (FRL–
5735–4), the Agency presented its
general determination that proposed
E:\FR\FM\26MRP1.SGM
26MRP1
17394
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Proposed Rules
and final SNURs are not expected to
have a significant economic impact on
a substantial number of small entities,
which was provided to the Chief
Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reason to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this regulatory action
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any effect on small
governments subject to the requirements
of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1531–1538).
H. Effect on Energy Supply, Distribution,
or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), because this action is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy.
I. Technical Standards
Because this action would not involve
any technical standards, section 12(d) of
the National Technology Transfer and
Advancement Act of 1995 (NTTAA) (15
U.S.C. 272 note), does not apply to this
action.
E. Federalism
This action would not have
federalism implications because it is not
expected to have a substantial direct
effect on States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, as
specified in Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999).
J. Environmental Justice
This action would not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
F. Indian Tribal Governments
This action would not have tribal
implications as specified in Executive
Order 13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000). This action is not expected to
have substantial direct effects on Indian
Tribes, would not significantly or
uniquely affect the communities of
Indian Tribal governments, and would
not involve or impose any requirements
that affect Indian Tribes. Thus,
Executive Order 13175 does not apply
to this action.
tkelley on DSK3SPTVN1PROD with PROPOSALS
G. Protection of Children
This action is not subject to Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
VerDate Mar<15>2010
16:40 Mar 23, 2012
Jkt 226001
Dated: March 20, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR
part 721 be amended as follows:
1. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10281 to subpart E to
read as follows:
§ 721.10281 Hexabromocyclododecane
and 1,2,5,6,9,10-hexabromocyclododecane.
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
as hexabromocyclododecane (CASRN
25637–99–4) and 1,2,5,6,9,10hexabromocyclododecane (CASRN
3194–55–6) are subject to reporting
under this section for the significant
new use described in paragraph (a)(2) of
this section.
(2) The significant new use is use in
consumer textiles, other than for use in
motor vehicles.
(b) Specific requirements. The
provisions of subpart A of this part
Frm 00035
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Sfmt 4702
[FR Doc. 2012–7207 Filed 3–23–12; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
49 CFR Part 173
[Docket No. PHMSA–2010–0201 (HM–254)]
PART 721—[AMENDED]
PO 00000
apply to this section except as modified
by this paragraph.
(1) Definitions. The definitions in
§ 721.3 apply to this section. In
addition, the following definitions
apply:
Consumer textile means any cloth,
fabric, or other item produced during
the milling process (including spinning,
weaving, knitting, felting, or finishing),
consisting in whole or in part as a
product that is sold to or made available
to a private individual who uses the
product in or around a permanent or
temporary household or residence,
during recreation, or for any personal
use or enjoyment. Consumer textiles
include, but are not limited to,
upholstered household furniture,
mattresses, and draperies.
Motor vehicle has the meaning found
at 40 CFR 85.1703.
(2) Revocation of article exemption.
The provisions of § 721.45(f) do not
apply to this section. A person who
imports or processes the chemical
substances identified in paragraph (a)(1)
of this section as part of an article for
the significant new use described in
paragraph (a)(2) of this section must
submit a significant new use notice
(SNUN).
RIN 2137–AE62
Hazardous Materials: Approval and
Communication Requirements for the
Safe Transportation of Air Bag
Inflators, Air Bag Modules, and SeatBelt Pretensioners
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
In this NPRM, PHMSA is
proposing to revise the Hazardous
Materials Regulations applicable to air
bag inflators, air bag modules, and seatbelt pretensioners. The proposed
changes would incorporate the
provisions of two special permits into
the regulations. In addition, PHMSA
proposes to revise the current approval
and documentation requirements for a
material appropriately classified as a
SUMMARY:
E:\FR\FM\26MRP1.SGM
26MRP1
Agencies
[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Proposed Rules]
[Pages 17386-17394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7207]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0489; FRL-9341-6]
RIN 2070-AJ88
Significant New Use Rule for Hexabromocyclododecane and
1,2,5,6,9,10-Hexabromocyclododecane
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two
chemical substances: Hexabromocyclododecane (Chemical Abstracts Service
Registry Number (CASRN) 25637-99-4) and 1,2,5,6,9,10-
hexabromocyclododecane (CASRN 3194-55-6), hereinafter collectively
referred to as HBCD. This proposed rule would designate ``use in
consumer textiles, other than for use in motor vehicles'' as a
significant new use. This action would require persons who intend to
manufacture (including import) or process HBCD for use in covered
consumer textiles to notify EPA at least 90 days before commencing that
activity. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if appropriate, to
prohibit or limit that activity before it occurs. For this proposed
rule, the general SNUR article exemption for persons who
[[Page 17387]]
import or process chemical substances as part of an article would not
apply.
DATES: Comments must be received on or before May 25, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0489, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2011-0489. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0489. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Sue
Slotnick, National Program Chemicals Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 566-1973; email address: slotnick.sue@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process HBCD for consumer
textiles. Potentially affected entities may include, but are not
limited to organizations identified by the following North American
Industry Classification System (NAICS) codes:
Chemical Manufacturing (NAICS code 325).
Painting and Wall Covering Contractors (NAICS code
238320).
Textile and Fabric Finishing (except Broadwoven Fabric)
Mills (NAICS code 313312).
Curtain and Drapery Mills (NAICS code 314121).
Other Household Textile Product Mills (NAICS code 314129).
All Other Miscellaneous Textile Product Mills (NAICS code
314999).
Upholstered Household Furniture Manufacturing (NAICS code
337121).
Household Furniture (except Wood and Metal) Manufacturing
(NAICS code 337125).
Mattress Manufacturing (NAICS code 337910).
Blind and Shade Manufacturing (NAICS code 337920).
Furniture Merchant Wholesalers (NAICS code 423210).
Home Furnishing Merchant Wholesalers (NAICS code 423220).
Reupholstery and Furniture Repair (NAICS code 811420).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
In addition, chemical importers are subject to the TSCA section 13
(15 U.S.C. 2612) import certification requirements promulgated at 19
CFR 12.118 through 12.127; see also 19 CFR 127.28 (the corresponding
EPA policy appears at 40 CFR part 707, subpart B). Chemical importers
must certify that shipments of chemical substances comply with all
applicable rules and orders under TSCA, including SNURs. In addition,
any persons who export or intend to export a chemical substance that is
the subject of a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec. 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that
[[Page 17388]]
you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then
identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing a SNUR for HBCD which would require persons to
notify EPA at least 90 days before commencing the manufacture
(including import) or processing of HBCD for use in consumer textiles
other than for use in motor vehicles. EPA is considering future
regulatory action on additional uses of HBCD.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering ``all
relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance,
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance,
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance, and
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.''
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
Once EPA determines that a use of a chemical substance is a
significant new use, TSCA section 5(a)(1)(B) requires persons to submit
a significant new use notice (SNUN) to EPA at least 90 days before they
manufacture or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)). As described in Unit II.C., the general SNUR provisions
are found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
Additional provisions appear at Sec. 721.1(c) which describe how
persons subject to SNURs must comply with the same notice requirements
and EPA regulatory procedures as submitters of Premanufacture Notices
(PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, the Agency may take regulatory action under TSCA
section 5(e), 5(f), 6, or 7 to control the activities on which it has
received the SNUN. If EPA does not take action, the Agency is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
EPA proposes that a person who imports or processes HBCD as part of
an article for use in consumer textiles (except for use in motor
vehicles) would not be exempt from submitting a SNUN. (See rationale at
Unit VI.C.) For this reason, Sec. 721.45(f), which exempts persons
importing or processing a chemical substance as part of an article,
would not apply to this proposed SNUR.
Persons who export or intend to export a chemical substance(s)
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import chemical substances are subject to the TSCA section
13 import certification requirements, codified at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Such persons must certify that the
shipment of the chemical substance(s) comply with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B.
III. Overview of HBCD
A. What chemicals are included in the proposed SNUR?
This proposed SNUR would apply to two chemical substances:
Hexabromocyclododecane (CASRN 25637-99-4) and 1,2,5,6,9,10-
hexabromocyclododecane (CASRN 3194-55-6). Hexabromocyclododecane is
manufactured by adding bromine to technical grade 1,5,9-
cyclododecatriene to make a chemical substance where the positions of
the six bromine atoms are not specified on the cyclododecane ring,
corresponding to CASRN 25637-99-4. The specific 1,2,5,6,9,10-
hexabromocyclododecane isomer (CASRN 3194-55-6) is the major component
of CASRN 25637-99-4. Throughout this proposed rule, the term ``HBCD''
represents both chemical substances, unless a specific CASRN is also
noted.
B. What is the production volume of HBCD?
The Inventory Update Rule (IUR) \1\ submissions to EPA reported
annual U.S. import/production volumes of 10-50 million pounds (lb) in
both 2002 and 2006 for CASRN 3194-55-6 (EPA, 2006). IUR submissions to
EPA reported annual U.S. import/production volumes of 10,000 to 500,000
lb in 2002 for CASRN 25637-99-4; no import/production was reported in
2006 (EPA, 2006).
---------------------------------------------------------------------------
\1\ As of August 16, 2011, the Inventory Update Rule (IUR) was
renamed ``Chemical Data Reporting rule (CDR).'' See the TSCA
Inventory Update Reporting Modifications; Chemical Data Reporting
final rule in the Federal Register issue of August 16, 2011 (76 FR
50816) (FRL-8872-9).
---------------------------------------------------------------------------
[[Page 17389]]
C. What are the uses of HBCD?
Based on information gathered from research, industry, and
government, EPA believes that HBCD is not used in consumer textiles
other than for use in motor vehicles. The major use of HBCD is in
polystyrene foam insulation boards used in construction. It is also
used to a minor extent in high-impact polystyrene in electronic
products and in textile coatings in carpets, vehicles, furniture, and
upholstery, such as draperies (Posner, 2006). In the IUR data, one
manufacturer/importer of HBCD (CASRN 3194-55-6) reported the use of the
chemical substance under the NAICS code for textile and fabric
finishing mills (EPA, 2006). For this use, 1% of the total production
volume of the chemical substance was in consumer and commercial
products. However, the reporting does not distinguish between
commercial and consumer use (EPA, 2006).
Information available to EPA indicates that the use of HBCD in
textiles is as a backcoating to function as a flame retardant. EPA
conducted preliminary research to determine whether HBCD was used in
textile applications for end products sold to consumers. In 2010, an
HBCD expert with the Consumer Product Safety Commission (CPSC)
expressed to EPA his understanding that HBCD is used only in non-
consumer textiles such as firefighters' suits (CPSC, 2010). In 2011,
EPA requested information from current and former manufacturers of
HBCD. The responses indicate that only one manufacturer sells HBCD for
textile uses. The company does not know whether the end use of any of
those textiles is a consumer article. (ACC, 2011). Additionally, a
representative of the furniture manufacturing company Herman Miller
told EPA that HBCD is not in their products (Herman Miller, 2011). EPA
also received information from a group of textile formulators that the
end uses of HBCD-containing textiles are for military, institutional,
and aviation uses only (EPP, 2011). EPA solicits comment on whether any
of these uses could be considered consumer textile uses. (See
definition of ``consumer textile'' at Sec. 721.10281 in the regulatory
language of this proposed rule).
EPA found that a small amount of HBCD is used in floor mats,
headliners, and possibly other interior fabrics in motor vehicles made
in the United States, including passenger vehicles. The automotive
industry plans to phase out these uses in 2015. This phase-out is
consistent with the addition of HBCD to the Annex XIV List of
Substances Subject to Authorisation under the European Union's
Registration, Evaluation, Authorisation and Restriction of Chemical
Substances (REACH) regulations (REACH, 2011). See https://echa.europa.eu/reach_en.asp. The REACH regulations are expected to
effectively ban the use of HBCD by major U.S. automotive companies
unless authorized for use in the European Union (EU) after July 21,
2015. The companies are not likely to manufacture a different set of
products for sale in the EU and for sale in the United States. Because
the use of HBCD in textiles in motor vehicles is currently ongoing,
that use is not included in this proposed rule.
Based on the sum of available information, EPA believes HBCD is not
used in consumer textiles other than those used in motor vehicles. The
Agency also believes HBCD could potentially be used in the future in
consumer textiles in the United States because the chemical substance:
1. Is used in non-consumer textile applications in the United
States including institutional, military, and aviation uses.
2. Is used in textiles in motor vehicles in the United States.
3. Has been used in residential consumer textile applications.
See more information on uses of HBCD in EPA's ``Economic Analysis
of the Proposed Significant New Use Rule for Hexabromocyclododecane
(HBCD)'' (EPA, 2011).
D. What are the potential health and environmental effects of HBCD?
1. Human health effects. Repeated exposure of HBCD to rats showed
disturbances in thyroid hormone system and effects on the thyroid in
males and females (Chengelis, 2001). A study by Eriksson, et al.
(2006), concluded that neonatal exposure of HBCD to mice affected
spontaneous motor behavior, learning and memory processes in adult
mice. However, this study was not conducted according to established
Organization for Economic Cooperation and Development (OECD) Test
Guidelines.
In a recently conducted, more robust, 2-generation reproductive
toxicity study in rats conducted according to established OECD test
guidelines, HBCD showed treatment-related reproductive effect (a
significant decrease in the number of primordial follicles in the F1
females) (Ema, et al., 2008). Although this decrease in ovarian
follicles did not affect any reproductive parameters in this study,
this effect is suggestive of potential reproductive toxicity.
Developmental effects were observed including delays in eye opening in
the second (F2) generation and transient changes in learning and memory
in F1 males, but exposure did not cause any changes in spontaneous
behavior. In addition, there was high and dose-dependent pup mortality
during lactation (Ema, et al., 2008).
2. Environmental effects. Laboratory studies have shown that HBCD
is capable of producing adverse effects in a variety of organisms
including algae, fish, invertebrates, and soil-dwelling organisms at
environmentally relevant concentrations. HBCD is toxic to algae and
acutely toxic to fish embryos (Desjardins, et al., 2004 and Deng, et
al., 2009). A number of sub-lethal effects (e.g., altered thyroid
status, protein metabolism, oxidative stress, reproductive activity)
have also been observed in fish (Palace, et al., 2008; Kling et al.,
2009; Zhang, et al., 2008; and Ronisz, et al., 2004). One study
reported a reduced number and size of daphnid offspring in first and
second generations (Drottar, 1998). Thyroid hormone-dependent
developmental effects were observed in tadpoles (Xenopus laevis)
exposed to HBCD (Schriks, et al., 2006). HBCD has been reported to
reduce egg production and lower biomass in soil dwelling organisms
(Lumbriculus variegatus) (Oetken, et al., 2001). HBCD administered to
chicken (Gallus domesticus) embryonic hepatocytes in vitro resulted in
significant alterations in expression of genes (mRNA) associated with
liver and thyroid function (Crump, et al., 2008). Thinner egg shells
were measured in American kestrels exposed to a combination of
polybrominated diphenyl ethers (PBDEs) and HBCD (Fernie, et al., 2009).
E. What are the potential sources and routes of exposure to HBCD?
Because HBCD is not chemically bound to its substrate (the
protected textile material), there is potential for HBCD to be released
at any point in the lifecycle. There is potential for release when the
HBCD is initially manufactured, when it is being formulated into the
material that is commonly used in textile back coatings, as well as
when it is being combined with the textile material to which it is
added. In addition, HBCD can be released during the service life of the
textile material containing it, including release into water used to
wash the treated textiles or into the air via dust particulates.
Workers and the general population can be exposed to HBCD through
direct contact as it migrates across land, in air, and in water by
diffusion or environmental transport.
[[Page 17390]]
Other opportunities for release can occur at the end of the lifecycle
of the consumer articles when they are transported as waste and
disposed of, although incineration at high temperatures destroys the
HBCD (Posner, 2006).
Evidence strongly suggests there is potential for exposure to the
general population from HBCD in the environment and also from products
and dust in the home and workplace. HBCD is found world-wide in the
environment and wildlife. Human exposure is evidenced from its presence
in breast milk, adipose tissue, and blood (Covaci, et al., 2006). The
chemical substance bioaccumulates and biomagnifies in food chains. The
frequent detection of HBCD over a large geographic area, with
increasing exposure in remote locations such as the Arctic, where no
demonstrable local sources exist that can account for these exposures,
suggest that HBCD is persistent and undergoes long-range transport
(UNEP, 2007).
To the extent HBCD is present in household applications (e.g.,
building foam, furniture upholstery, carpeting), children could be
exposed, especially given children's increased exposure via dust and
the hand-to-mouth ingestion pathway. In vitro experiments conducted to
demonstrate leaching of HBCD from textiles showed that the presence of
simulated biological fluids (sweat, saliva) and fruit juices enhances
the leaching of HBCD from back-coated samples (Ghanem, 2009).
Children's exposure to HBCD from mouthing of textiles and from
ingestion of dust has been estimated (EC, 2008).
HBCD has been measured in air and sediment in Scandinavian
countries, North America and Asia (Covaci, et al., 2006 and Arnot, et
al., 2009). HBCD has also been measured in marine and arctic mammals,
freshwater and marine fish, aquatic invertebrates, birds and bird eggs,
and one plant species (Covaci, et al., 2006 and Arnot, et al., 2009).
HBCD has been detected in Arctic air in northern Scandinavia and in
Arctic birds and bird eggs, Arctic fish, ringed seals and polar bears
(UNEP, 2009). It has been detected in freshwater, marine, and avian
organisms, and in upper trophic-level mammals (polar bears and seals).
For more information on HBCD concerning its physical-chemical
properties, fate, releases, and human and environmental exposure, see
EPA's ``Hexabromocyclododecane (HBCD) Action Plan'' dated August 18,
2010 (HBCD Action Plan, 2010).
IV. Summary of Proposed Rule
EPA is proposing to designate as a significant new use any use of
HBCD in consumer textiles other than for use in motor vehicles. EPA
believes the only current use of HBCD for consumer textiles is in motor
vehicles. Thus any use of HBCD in consumer textiles (other than for
textiles in motor vehicles) would be a significant new use. A proposed
definition of ``consumer textile'' can be found at Sec. 721.10281 of
the regulatory text of this proposed rule. The proposed definition of
``motor vehicle'' refers to 40 CFR 85.1703.\2\
---------------------------------------------------------------------------
\2\ The definition at 40 CFR 85.1703 is: ``a vehicle which is
self-propelled and capable of transporting a person or persons or
any material or any permanently or temporarily affixed apparatus
shall be deemed a motor vehicle, unless any one or more of the
criteria set forth below are met, in which case the vehicle shall be
deemed not a motor vehicle and excluded from the operation of the
[Clean Air] Act:
(1) The vehicle cannot exceed a maximum speed of 25 miles per
hour over level, paved surfaces; or
(2) The vehicle lacks features customarily associated with safe
and practical street or highway use, such features including, but
not being limited to, a reverse gear (except in the case of
motorcycles), a differential, or safety features required by state
and/or federal law; or
(3) The vehicle exhibits features which render its use on a
street or highway unsafe, impractical, or highly unlikely, such
features including, but not being limited to, tracked road contact
means, an inordinate size, or features ordinarily associated with
military combat or tactical vehicles such as armor and/or
weaponry.''
40 CFR 85.1703 is available online at: https://www.gpo.gov/fdsys/pkg/CFR-2000-title40-vol12/xml/CFR-2000-title40-vol12-sec85-1703.xml.
---------------------------------------------------------------------------
This proposed rule would add a section to 40 CFR part 721 to
require persons who intend to manufacture (including import) or process
HBCD for an activity preliminarily designated as a significant new use
by this action to notify EPA at least 90 days before commencing that
activity. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if appropriate, to
prohibit or limit that activity before it occurs. For this proposed
rule, the general SNUR exemption for persons that import or process
chemical substances as part of an article at Sec. 721.45(f) would not
apply. (See discussion at Unit VI.C.)
V. Significant New Use Determination
A. Rationale
As summarized in Unit III.D. and E., EPA has concerns regarding the
potential exposure to and human health and environmental effects of
HBCD. EPA believes that HBCD could be manufactured or processed for
consumer textiles other than for use in motor vehicles in the future.
Accordingly, EPA wants the opportunity to evaluate and control, where
appropriate, activities associated with that use, if such manufacturing
or processing were to be commenced in the future. The required
notification provided by a SNUN would provide EPA with the opportunity
to evaluate activities associated with the significant new use and an
opportunity to protect against unreasonable risks, if any, from
exposure to HBCD.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate
before the manufacturing or processing for that use begins. Since the
new use does not currently exist, deferring a detailed consideration of
potential risks or hazards related to that use is an effective use of
resources. If a person decides to begin manufacturing or processing the
chemical for the new use, the SNUN to EPA allows EPA to evaluate the
use according to the specific parameters and circumstances surrounding
that intended use.
B. Objectives
Based on the considerations in Unit V.A., EPA has the following
objectives with regard to the significant new use that is preliminarily
designated in this proposed rule:
1. EPA would receive notification of any person's intent to
manufacture (including import) or process HBCD for the described
significant new use before that activity begins.
2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the SNUN submitter begins manufacturing or
processing of HBCD for the described significant new use.
3. EPA would be able to regulate prospective manufacturers or
processors of HBCD before the described significant new use of the
chemical substance(s) occur, provided that regulation is warranted
pursuant to TSCA sections 5(e), 5(f), 6, or 7.
C. Relevant Factors Considered for This Proposed SNUR
TSCA states that EPA's determination that a use of a chemical
substance is a significant new use must be made after consideration of
all relevant factors, including those listed at TSCA section 5(a)(2)
(see list at Unit II.B.). EPA has preliminarily determined that
manufacturing or processing of HBCD for use in consumer textiles other
than
[[Page 17391]]
for use in motor vehicles is a significant new use. This determination
is based primarily on the following factor listed at TSCA section
5(a)(2): ``The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.'' The latest information available to EPA indicates that the
only ongoing use of HBCD in consumer textiles is for use in motor
vehicles. Initiation of new uses of HBCD in consumer textiles could
increase the magnitude and duration of exposure to the general
population from HBCD in the environment and from products and dust in
the home and workplace. Workers could be exposed to HBCD at facilities
of all types involved in the lifecycle of the products, as described in
greater detail in Unit III.E. Releases to the environment are expected
to occur during the service life of the textiles containing HBCD. Such
increase in releases could contribute additional HBCD to the
atmosphere, long-range transport, and greater concentrations in water,
which could be detrimental to overall environmental and human health.
Thus, EPA believes that initiating the use of HBCD in consumer textiles
other than for use in motor vehicles would increase the magnitude and
duration of exposure to humans and the environment over that which
would otherwise exist.
D. Request for Comment
EPA welcomes comment on all aspects of this proposed rule,
including:
1. The basis for the significant new use determination presented
for this proposed rule.
2. Information about any ongoing manufacture, import, or processing
of HBCD for use in consumer textiles.
VI. Alternative Regulatory Approaches
Before proposing this SNUR, EPA considered the following
alternative regulatory actions:
A. Promulgate a TSCA Section 8(a) Reporting Rule
Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture or process a listed chemical for a specific use
or any use. However, for HBCD in consumer textiles, the use of TSCA
section 8(a) rather than SNUR authority would have several limitations.
First, if EPA were to require reporting under TSCA section 8(a) instead
of TSCA section 5(a), EPA would not have the opportunity to review
human and environmental hazards and exposures associated with the use
in consumer textiles and, if necessary, take immediate follow-up
regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit
the activity before it begins, if warranted. In addition, EPA might not
receive important information from small businesses, because such firms
generally are exempt from TSCA section 8(a) reporting requirements. In
view of health and environmental concerns related to HBCD, if used for
the proposed significant new use, EPA believes that a TSCA section 8(a)
rule for these chemical substances would not meet EPA's regulatory
objectives.
B. Regulate HBCD in Consumer Textiles Under TSCA Section 6
EPA may regulate under TSCA section 6 if ``the Administrator finds
that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use or disposal of a chemical
substance or mixture . . . presents or will present an unreasonable
risk of injury to health or the environment.'' (TSCA section 6(a)). EPA
concluded that risk management action under TSCA section 6 is not
necessary at this time because EPA:
1. Believes HBCD is not being used in consumer textiles in the
United States, other than for use in motor vehicles.
2. Has not determined as of this date that use of HBCD in motor
vehicles presents unreasonable risk.
3. Expects the use in motor vehicles to end within a few years.
This proposed SNUR would allow the Agency to address the potential
risks associated with the proposed significant new use.
C. Allow the Exemption for Persons Who Import or Process HBCD as Part
of Articles That Would Be Subject to the Proposed SNUR
Under the SNUR exemption provision at Sec. 721.45(f), a person who
imports or processes a chemical substance covered by a SNUR identified
in 40 CFR part 721, subpart E, as part of an article is not generally
subject to the notification requirements of Sec. 721.25 for that
chemical substance. However, EPA is concerned that exempting HBCD as
part of articles would render the SNUR less effective because of the
possibility that consumer textile articles containing HBCD, the primary
concern of EPA associated with this proposed rule, could be imported or
processed for uses subject to this proposed SNUR without the submission
of a SNUN. This proposed rule would not include the exemption at Sec.
721.45(f).
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of this proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notification requirements, because
a person could defeat the SNUR by initiating the proposed significant
new use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
begin commercial manufacture or processing of the chemical substance(s)
(including manufacturing or processing the chemical substance(s) as
part of an article) for a use that would be regulated through this
proposed rule, if finalized, would have to cease any such activity
before the effective date of the rule if and when finalized. To resume
their activities, these persons would have to comply with all
applicable SNUR notification requirements and wait until the
notification review period, including all extensions, expires. EPA has
promulgated provisions (Sec. 721.45(h)) to allow persons to submit a
SNUN before the effective date of the SNUR. If a person were to meet
the conditions of Sec. 721.45(h), that person would be considered to
have met the requirements of the final SNUR for those activities. If
persons who begin commercial manufacture, import, or processing of the
chemical substance between publication of the proposed rule and the
effective date of the final SNUR do not meet the conditions of advance
compliance, they must cease that activity before the effective date of
the final rule. To resume their activities, these persons would have to
comply with all applicable SNUN requirements and wait until the
notification review period, including all extensions, expires.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
[[Page 17392]]
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (TSCA
section 5(d); 40 CFR 720.50 and 40 CFR 721.25). However, as a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, processing, use, distribution in commerce, or
disposal. EPA encourages persons to consult with the Agency before
submitting a SNUN. As part of this optional pre-SNUN consultation, EPA
would discuss specific data it believes may be useful in evaluating a
significant new use. SNUNs submitted for significant new uses without
any test data may increase the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or limit activities associated with
this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
Human exposure and environmental releases that may result
from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
40 CFR 720.40 and 40 CFR 721.25. The e-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
HBCD in consumer textiles. The evaluation is in the ``Economic Analysis
of the Proposed Significant New Use Rule for Hexabromocyclododecane
(HBCD)'' (EPA, 2011). It is briefly summarized here and is available in
the docket for this proposed rule.
Because there appears to be no use of HBCD in consumer textiles in
the United States at the current time, other than for use in motor
vehicles, EPA expects very few, if any, entities would submit a SNUN.
As a result, the economic impact of this rule is anticipated to be
either zero or very low.
In the event that a SNUN is submitted, costs are estimated at
approximately $8,300 per SNUN submission for large businesses and
$5,900 for small businesses, and include the cost to prepare and submit
the SNUN and the payment of a user fee. Businesses that submit a SNUN
would be subject to either a $2,500 user fee required by 40 CFR
700.45(b)(2)(iii), or, if they are a small business with annual sales
of less than $40 million when combined with those of the parent company
(if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its
evaluation of this proposed rule, EPA also considered the potential
costs a company might incur by avoiding or delaying the significant new
use in the future, but these costs have not been quantified.
XI. References
The following documents are specifically referenced in the preamble
for this proposed rule. In addition to these documents, other materials
may be available in the docket established for this proposed rule under
docket ID number EPA-HQ-OPPT-2011-0489, which you can access through
https://www.regulations.gov. Those interested in the information
considered by EPA in developing this proposed rule, should also consult
documents that are referenced in the documents that EPA has placed in
the docket, regardless of whether the other documents are physically
located in the docket.
1. EPA. 2006. Inventory Update Reporting (IUR): Non-Confidential
2006 TSCA Inventory Update Rule (IUR) Records. Available online at:
https://cfpub.epa.gov/iursearch (accessed March 8, 2012).
2. Posner. 2006. Survey and technical assessment of alternatives
to TBBPA and HBCDD. Kemi Report. January 2006.
3. CPSC. 2010. Personal communication with Dr. Michael Babich,
Chemist, United States Consumer Product Safety Commission (CPSC).
March 16, 2010.
4. ACC. 2011. Personal communication with Jackson Morrill,
Director of Chemical Products of the American Chemistry Council
(ACC). February 16, 2011.
5. Herman Miller. 2011. Personal communication with Gabe Wing of
Herman Miller, Inc. March 30, 2011.
6. EPP. 2011. Personal communication with John Friddle,
President of Eagle Performance Products. March 3, 2011.
7. REACH. 2011. Available online at: https://echa.europa.eu/reach_en.asp.
8. EPA. 2011. Economic Analysis of the Proposed Significant New
Use Rule for Hexabromocyclododecane (HBCD). Washington, DC. OPPT/
Environmental Economics and Technology Division (EETD)/Economic and
Policy Analysis Branch (EPAB). February 6, 2012.
9. Chengelis. 2001. An oral (gavage) 90 day toxicity study of
HBCD in rats. Study No. WIL-186012. WIL Research Laboratories, Inc.
Ashland, Ohio, USA.
10. Eriksson, et al. 2006. Impaired behaviour, learning and
memory, in adult mice neonatally exposed to hexabromocyclododecane
(HBCDD). Environmental Toxicology and Pharmacology. May 2006. 21(3),
pp. 317-322.
11. Ema, M., et al. 2008. Two-generation reproductive toxicity
study of the flame retardant hexabromcyclododecane in rats.
Reproductive Toxicology. April 2008. 25(3), pp. 335-351.
12. Desjardins, et al. 2004. Hexabromocyclododecane (HBCD): A
72-hour toxicity test with the marine diatom (Skeletonema costatum).
Final Report. Wildlife International, Ltd. Easton, Maryland, USA.
pp. 66.
13. Deng, et al. 2009. Hexabromocyclododecane-induced
developmental toxicity and apoptosis in zebrafish embryos. Aquatic
Toxicology. June 2009. 93(1), pp. 29-36.
14. Palace, et al. 2008. Biotransformation enzymes and thyroid
axis disruption in juvenile rainbow trout (Oncorhynchus mykiss)
exposed to hexabromocyclododecane diastereoisomers. Environmental
Science and Technology. February 2008. 42(6), pp. 1967-1972.
15. Kling, et al. 2009. Proteomic studies in zebrafish liver
cells exposed to the brominated flame retardants HBCD and TBBPA.
Ecotoxicology and Environmental Safety. November 2009. 72, pp. 985-
1993.
16. Zhang, et al. 2008. Induction of hepatic enzymes and
oxidative stress in Chinese rare minnow (Gobiocypris rarus) exposed
to waterborne hexabromocyclododecane (HBCD). Aquatic Toxicology.
January 2008. 86(1), pp. 4-11.
17. Ronisz, et al. 2004. Sublethal effects of the flame
retardants hexabromocyclododecane (HBCDD), and tetrabromobisphenol A
(TBBPA), on hepatic enzymes and other biomarkers in juvenile rainbow
trout and feral eelpout. Aquatic Toxicology. August 2004. 69(3), pp.
229-245.
18. Drottar, et al. 1998. Hexabromocyclododecane (HBCD): A flow-
through life-cycle toxicity test with the cladoceran (Daphnia
magna). Final Report. 439A-108, Wildlife International, Ltd. Easton,
Maryland, USA. 1998. pp. 78.
19. Schriks, et al. 2006. Disruption of thyroid hormone-mediated
Xenopus laevis tadpole tail tip regression by hexabromocyclododecane
(HBCD) and
[[Page 17393]]
2,2',3,3',4,4',5,5', 6-nona brominated diphenyl ether (BDE206).
Chemosphere. December 2006. 65(10), pp. 1904-1908.
20. Oetken, et al. 2001. Validation of the preliminary EU-
concept of assessing the impact of chemicals to organisms in
sediment by using selected substances. UBA-FB 299 67 411, Institute
of Hydrobiology, Dresden University of Technology, Dresden, Germany.
2001. pp. 97.
21. Crump, et al. 2008. Effects of hexabromocyclododecane and
polybrominated diphenyl ethers on mRNA expression in chicken (Gallus
domesticus) hepatocytes. Toxicological Sciences. December 2008.
106(2), pp. 479-487.
22. Fernie, et al. 2009. Environmentally relevant concentrations
of DE-71 and HBCD alter eggshell thickness and reproductive success
of American kestrels. Environmental Science and Technology. March
2009. 43(6), pp. 2124-30.
23. Covaci, et al. 2006. Hexabromocyclododecanes (HBCDs) in the
Environment and Humans: A Review. Environmental Science and
Technology. May 2006. 40(12), pp. 3679-3688.
24. UNEP. 2007. Stockholm Convention on Persistent Organic
Pollutants. Persistent Organic Pollutants Review Committee, Third
meeting, Geneva. pp. 19-23, November 2007, Item 7 of the provisional
agenda, Presentation on environmental transport and modeling. The
OECD screening tool for overall persistence and long-range transport
potential. UNEP/POPS/POPRC.3/INF/7.
25. Ghanem, R. 2009. Kinetics of Thermal and Photolytic
Segregation of Hexabromocyclododecane in Backcoated Textile Samples.
Jordan Journal of Chemistry. April 2009. 4(2), pp. 171-181.
26. EC. 2008. European Commission (EC). Risk Assessment:
Hexabromocyclododecane CAS-No.: 25637-99-4 EINECS-No.: 247-148-4,
Final Report. Office for Official Publications of the European
Communities: Luxembourg. May 2008.
27. Arnot, et al. 2009. An evaluation of hexabromocyclododecane
(HBCD) for Persistent Organic Pollutant (POP) properties and the
potential for adverse effects in the environment. Submitted to
European Brominated Flame Retardant Industry Panel (EBFRIP). May
2009.
28. UNEP. 2009. Stockholm Convention on Persistent Organic
Pollutants. Summary of the proposal for the listing of
hexabromocyclododecane (HBCDD) in Annex A to the Convention. July
2009.
29. HBCD Action Plan. 2010. EPA's Hexabromocyclododecane (HBCD)
Action Plan. August 2010. Available online at https://www.epa.gov/oppt/existingchemicals/pubs/actionplans/hbcd.html (accessed March 8,
2012).
XII. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993), this action has been
designated a ``significant regulatory action.'' Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under Executive Orders 12866 and 13563, entitled ``Improving
Regulation and Regulatory Review'' (76 FR 3821, January 21, 2011), and
any changes made in response to OMB recommendations have been
documented in the docket for this action as required by section
6(a)(3)(E) of the Executive Order.
EPA has prepared an economic analysis of this action, entitled
``Economic Analysis of the Proposed Significant New Use Rule for
Hexabromocyclododecane (HBCD)'' (EPA, 2011). A copy of the document is
available in the docket for this proposed rule and is summarized in
Unit X.
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for certain
EPA regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument, or form, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average 97 hours per
response. This burden estimate includes the time needed to review
instructions; search existing data sources; gather and maintain the
data needed; and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Small Entity Impacts
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows.
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. Small entity is
defined in accordance with section 601 of RFA as: A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field. For purposes of assessing the impacts of
this proposed rule on small entities, EPA has determined that this
proposed rule is not expected to impact any small not-for-profit
organizations or small governmental jurisdictions. As such, the Agency
estimated potential impacts on small business.
A SNUR applies to any person (including small or large entities)
who intends to manufacture, import, or process a chemical substance for
a use the EPA has designated as a ``significant new use.'' By
definition of the word ``new,'' and based on information currently
available to EPA, it appears that no small or large entities presently
engage in such activity. Since this proposed SNUR would require a
person who intends to engage in such activity in the future to first
notify EPA by submitting a SNUN, no economic impact will occur unless
someone files a SNUN to pursue a significant new use in the future or
forgoes profits by avoiding or delaying the significant new use.
Although some small entities may decide to conduct such activities in
the future, EPA cannot presently determine how many, if any, there may
be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemical substances, the
Agency receives only a handful of SNUNs per year. For example, the
number of SNUNs was four in Federal fiscal year 2005, eight in FY2006,
six in FY2007, eight in FY2008, and seven in FY2009. During this 5-year
period, three small entities submitted a SNUN. Therefore, EPA believes
that the potential economic impact of complying with a SNUR is not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published as a final rule on August 8,
1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general
determination that proposed
[[Page 17394]]
and final SNURs are not expected to have a significant economic impact
on a substantial number of small entities, which was provided to the
Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this regulatory action would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of
1995 (UMRA) (2 U.S.C. 1531-1538).
E. Federalism
This action would not have federalism implications because it is
not expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Indian Tribal Governments
This action would not have tribal implications as specified in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). This
action is not expected to have substantial direct effects on Indian
Tribes, would not significantly or uniquely affect the communities of
Indian Tribal governments, and would not involve or impose any
requirements that affect Indian Tribes. Thus, Executive Order 13175
does not apply to this action.
G. Protection of Children
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Effect on Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because this action is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.
I. Technical Standards
Because this action would not involve any technical standards,
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA) (15 U.S.C. 272 note), does not apply to this action.
J. Environmental Justice
This action would not entail special considerations of
environmental justice related issues as delineated by Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: March 20, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add Sec. 721.10281 to subpart E to read as follows:
Sec. 721.10281 Hexabromocyclododecane and 1,2,5,6,9,10-
hexabromocyclododecane.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified as
hexabromocyclododecane (CASRN 25637-99-4) and 1,2,5,6,9,10-
hexabromocyclododecane (CASRN 3194-55-6) are subject to reporting under
this section for the significant new use described in paragraph (a)(2)
of this section.
(2) The significant new use is use in consumer textiles, other than
for use in motor vehicles.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Definitions. The definitions in Sec. 721.3 apply to this
section. In addition, the following definitions apply:
Consumer textile means any cloth, fabric, or other item produced
during the milling process (including spinning, weaving, knitting,
felting, or finishing), consisting in whole or in part as a product
that is sold to or made available to a private individual who uses the
product in or around a permanent or temporary household or residence,
during recreation, or for any personal use or enjoyment. Consumer
textiles include, but are not limited to, upholstered household
furniture, mattresses, and draperies.
Motor vehicle has the meaning found at 40 CFR 85.1703.
(2) Revocation of article exemption. The provisions of Sec.
721.45(f) do not apply to this section. A person who imports or
processes the chemical substances identified in paragraph (a)(1) of
this section as part of an article for the significant new use
described in paragraph (a)(2) of this section must submit a significant
new use notice (SNUN).
[FR Doc. 2012-7207 Filed 3-23-12; 8:45 am]
BILLING CODE 6560-50-P