[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Proposed Rules]
[Pages 17386-17394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7207]
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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.
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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: http://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 http://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 http://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 http://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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
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
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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?
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).
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\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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[[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 http://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\
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\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: http://www.gpo.gov/fdsys/pkg/CFR-2000-title40-vol12/xml/CFR-2000-title40-vol12-sec85-1703.xml.
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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 http://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
http://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:
http://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: http://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 http://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]
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