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E-M:/ EPA TSCA rulemaking on poly brominated diphenyl ethers

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[Federal Register: December 6, 2004 (Volume 69, Number 233)]
[Proposed Rules]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPT-2004-0085; FRL-7688-1]
RIN 2070-AJ02

Certain Polybrominated Diphenylethers; Proposed Significant New
Use Rule

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
tetrabromodiphenyl ether (CAS No. 40088-47-9; Benzene, 1,1'-oxybis-,
tetrabromo deriv.), pentabromodiphenyl ether (CAS No. 32534-81-9;
Benzene, 1,1'-oxybis-, pentabromo deriv.), hexabromodiphenyl ether (CAS
No. 36483-60-0; Benzene, 1,1'-oxybis-, hexabromo deriv.),
heptabromodiphenyl ether (CAS No. 68928-80-3; Benzene, 1,1'-oxybis-,
heptabromo deriv.), octabromodiphenyl ether (CAS No. 32536-52-0;
Benzene, 1,1'-oxybis-, octabromo deriv.), or nonabromodiphenyl ether
(CAS No. 63936-56-1; Benzene, pentabromo(tetrabromophenoxy)-), and any
combination of these substances resulting from a chemical reaction.
This proposed rule would require manufacturers and importers to notify
EPA at least 90 days before commencing the manufacture or import of any
one or more of these chemical substances on or after January 1, 2005
for any use. EPA believes that this action is necessary because these
chemical substances may be hazardous to human health and the
environment. The required notice would provide EPA with the opportunity
to evaluate an intended new use and associated activities and, if
necessary, to prohibit or limit that activity before it occurs.

DATES: Comments, identified by docket identification (ID) number OPPT-
2004-0085, must be received on or before February 4, 2005.

ADDRESSES: Submit your comments, identified by docket (ID) number OPPT-
2004-0085, by one of the following methods:
? Federal eRulemaking Portal: <A HREF="http://www.regulations.gov/";>http://www.regulations.gov/</A>.
Follow the on-line instructions for submitting comments.
? Agency Website: <A HREF="http://www.epa.gov/edocket/";>http://www.epa.gov/edocket/</A>. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
? E-mail: <A HREF="mailto:oppt.ncic@epa.gov";>oppt.ncic@epa.gov</A>.
? Mail: Document Control Office (DCO) (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, EPA East
Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number OPPT-2004-0085. 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 Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
Instructions: Direct your comments to docket ID number OPPT-2004-
0085. EPA's policy is that all comments received will be included in
the public docket without change and may be made available on-line at
<A HREF="http://www.epa.gov/edocket/";>http://www.epa.gov/edocket/</A>, 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 EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, 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 e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).

[[Page 70405]]

Docket: All documents in the docket are listed in the EDOCKET index
at <A HREF="http://www.epa.gov/edocket/";>http://www.epa.gov/edocket/</A>. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the OPPT Docket, EPA Docket Center, EPA West, Rm. B102, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The EPA Docket Center Reading Room telephone number is (202)
566-1744, and the telephone number for the OPPT Docket, which is
located in the EPA Docket Center, is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: <A HREF="mailto:TSCA-Hotline@epa.gov";>
TSCA-Hotline@epa.gov</A>.
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (303) 312-6700; e-mail
address: <A HREF="mailto:moss.kenneth@epa.gov";>moss.kenneth@epa.gov</A>.

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) one or more of the following
polybrominated diphenyl ethers (PBDEs): tetrabromodiphenyl ether
(``tetraBDE'') (CAS No. 40088-47-9; Benzene, 1,1'-oxybis-, tetrabromo
deriv.), pentabromodiphenyl ether (``pentaBDE'') (CAS No. 32534-81-9;
Benzene, 1,1'-oxybis-, pentabromo deriv.), hexabromodiphenyl ether
(``hexaBDE'') (CAS No. 36483-60-0; Benzene, 1,1'-oxybis-, hexabromo
deriv.), heptabromodiphenyl ether (``heptaBDE'') (CAS No. 68928-80-3;
Benzene, 1,1'-oxybis-, heptabromo deriv.), octabromodiphenyl ether
(``octaBDE'') (CAS No. 32536-52-0; Benzene, 1,1'-oxybis-, octabromo
deriv.), or nonabromodiphenyl ether (``nonaBDE'') (CAS No. 63936-56-1;
Benzene, pentabromo(tetrabromophenoxy)-), and any combination of these
substances resulting from a chemical reaction. Persons who intend to
import any chemical substance governed by a final SNUR are subject to
the TSCA section 13 (15 U.S.C. 2612) import certification requirements,
and to the regulations codified at 19 CFR 12.118 through 12.127 and
127.28. Those persons must certify that they are in compliance with the
SNUR requirements (see TSCA section 13 (15 U.S.C. 2612) and 19 CFR
12.118 through 12.127 and 127.28). The EPA policy in support of import
certification appears at 40 CFR part 707, subpart B. In addition, any
persons who export or intend to export a chemical substance that is the
subject of this proposed rule on or after January 5, 2005 are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see 40 CFR 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D. Potentially
affected entities may include, but are not limited to:

[snip]


II. Background

A. What Action is the Agency Taking?

    This proposed rule, when finalized, would require persons to notify
EPA at least 90 days before commencing the manufacture (including
importation) of tetrabromodiphenyl ether (``tetraBDE'') (CAS No. 40088-
47-9; Benzene, 1,1'-oxybis-, tetrabromo deriv.), pentabromodiphenyl
ether (``pentaBDE'') (CAS No. 32534-81-9; Benzene, 1,1'-oxybis-,
pentabromo deriv.), hexabromodiphenyl ether (``hexaBDE'') (CAS No.
36483-60-0;

[[Page 70406]]

Benzene, 1,1'-oxybis-, hexabromo deriv.), heptabromodiphenyl ether
(``heptaBDE'') (CAS No. 68928-80-3; Benzene, 1,1'-oxybis-, heptabromo
deriv.), octabromodiphenyl ether (``octaBDE'') (CAS No. 32536-52-0;
Benzene, 1,1'-oxybis-, octabromo deriv.), or nonabromodiphenyl ether
(``nonaBDE'') (CAS No. 63936-56-1; Benzene,
pentabromo(tetrabromophenoxy)-), and any combination of these
substances resulting from a chemical reaction, for any use on or after
January 1, 2005.

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 those listed in TSCA section 5(a)(2). 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 notice to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use (15 U.S.C. 2604 (a)(1)(B). The
mechanism for reporting under this requirement is established under 40
CFR 721.5.

[SNIP]


III. Summary of the Proposed Rule

    PBDEs are members of a broader class of brominated chemicals used
as flame retardants; these are called brominated flame retardants, or
BFRs. There are commercial PBDE products with different average amounts
of bromination: penta-, octa-, and decaBDE. These chemicals are major
components of commercial products often used as fire retardants in
furniture foam (pentaBDE), plastics for personal computers and small
appliances (octaBDE), and plastics for TV cabinets, consumer
electronics, wire insulation, and backcoatings for draperies and
upholstery (decabromodiphenylether, or decaBDE). The value of these
chemicals is their ability to slow ignition and rate of fire growth,
and as a result increase available escape time in the event of a fire
involving the above products.
    Although use of these chemicals is intended to save lives and
property, there have been unintended consequences, such as, releases to
and accumulation in the environment. Environmental monitoring programs
in Europe, Asia, North America, and the Arctic have detected several
PBDEs in human breast milk, fish, aquatic birds, and elsewhere in the
environment. The human health toxicological endpoints of concern for
these chemical substances are liver toxicity, thyroid toxicity, and
neurodevelopmental toxicity. More needs to be understood about the
environmental fate and the exposure pathways that lead to PBDE presence
in wildlife and people. The lower brominated PBDEs (tetraBDE, pentaBDE,
and hexaBDE) found in the commercial pentaBDE and octaBDE products are
the congeners most often detected in the environment and for which
human health and environmental concerns are greater (see Unit IV.B. and
C.). These factors, taken together, raise concerns for potential
adverse effects in people and wildlife over time if these substances
should continue to be produced, released, and built up in the environment.
    EPA believes that the commercial products pentaBDE and octaBDE are
manufactured in the United States (U.S.) only by Great Lakes Chemical
Corporation. Great Lakes has committed to phase-out these chemicals
voluntarily by discontinuing their manufacture by the end of 2004 (Ref.
1). EPA is aware of no ongoing production of tetra-, hexa-, hepta- or
nonaBDE except as components of the commercial pentaBDE and octaBDE
commercial products. EPA believes that any manufacture or import of
these chemicals occurring after Great Lakes' phase-out dates would
increase the magnitude and duration of exposure to these chemicals.
Therefore, EPA is proposing to designate as a significant new use any
manufacture or import of the chemical substances listed in Unit II.A.
for any use on or after January 1, 2005. Because decaBDE is not
included in the voluntary phase-out and therefore remains in commerce
after January 1, 2005, it would not be subject to this proposed rule.
    Given that, based on information available to EPA, no companies
other than Great Lakes Chemical Corporation are currently manufacturing
or importing the commercial pentaBDE or octaBDE products, or the PBDE
congeners that comprise these products, and given the negative
commercial and regulatory environment associated with these chemicals,

[snip]



IV. Overview of PBDEs

    See Unit XI. for selected primary references for the information
summarized in this unit. For a more complete treatment of PBDEs and
comprehensive lists of relevant articles, see the risk assessments
developed under EPA's Voluntary Children's Chemical Evaluation Program
(VCCEP)

[[Page 70407]]

and the reports from the VCCEP Peer Consultation meetings held for
these chemicals (Refs. 2-7), in addition to the overview articles
(Refs. 8 and 9).


[SNIP]

A. Defining the PBDEs Subject to this Proposed SNUR

    The chemical substances that are subject to this proposed rule are
listed on the TSCA Inventory. Each individual chemical substance is
actually a reaction product of diphenyl ether with a brominating agent.
The different products, each having different numbers of bromines
depending on reaction stoichiometry, are a normal distribution of
possible polybrominated diphenyl ethers. For example, the commercially
available ``pentaBDE'' product, sold under the single CAS No. (32534-
81-9), is predominantly an almost equal mixture of tetraBDE and
pentaBDE congeners, along with smaller amounts of the higher brominated
congeners. It is a reaction product combination of aromatic brominated
compounds in which 4-6 hydrogen atoms in the diphenyl oxide structure
are replaced by bromine atoms (Refs. 2 and 10). The ``octaBDE'' product
(CAS No. 32536-52-0) consists predominantly of heptaBDE and octaBDE
congeners with small amounts of hexa- and nonaBDE. It is a reaction
product combination of aromatic brominated compounds in which 6-9
hydrogen atoms in the diphenyl oxide structure are replaced by bromine
atoms (Refs. 3 and 10). In order to insure that the PBDEs listed in
Unit II.A. would be subject to review before manufacture or import for
commercial purposes, this proposed rule would require the reporting for
any manufacture or importation of these chemical substances.

B. Health and Environmental Effects

    Existing health hazard information on the subject chemical
substances is incomplete (Ref. 8). The currently available toxicity
test data indicate the potential for adverse effects in humans,
especially for lower brominated congeners (Refs. 8 and 9). The major
findings from subchronic and chronic pentaBDE toxicity studies in
rodents are induction of hepatic enzymes and effects on thyroid
homeostasis. The effects on thyroid homeostasis have raised concerns
for the potential for developmental neurotoxicity (Ref. 5). The
toxicity database for octaBDE is similar to that of pentaBDE, but less
complete (Ref. 6).
    With regards to environmental hazards of the subject chemical
substances, the European Union (EU) risk assessment for pentaBDE
concludes for aquatic and terrestrial ecosystems that there is a need
for specific measures to limit risks. This conclusion is reached
because of ``concerns for effects on the local aquatic (sediment) and
terrestrial environment as a consequence of exposure arising from
polyurethane foam production [and]
concerns for secondary poisoning to
the environmental spheres mentioned in Unit IV.B. both locally and
regionally as a consequence of exposure arising from production and/or
use of polyurethane foams.'' (Ref. 11). For octaBDE, the EU concluded
that there is a risk of ``secondary poisoning via the earthworm route
for the hexabromodiphenyl ether component in the commercial
octabromodiphenyl ether product from the use in polymer applications.''
There was a need identified for further monitoring to determine whether
findings in top predators (including birds' eggs) is a widespread or
localized phenomenon, and for avian reproduction tests (Ref. 12).

C. Exposure and Environmental Fate Data

    Current information suggests strongly that PBDEs as a class are
persistent and may bioaccumulate. Environmental monitoring programs in
Europe, Asia, North America, and the Arctic have detected many PBDE
congeners in human blood and breast milk, fish, aquatic birds, and
elsewhere in the environment (Refs. 9, 13, 14, 15, 16, 17, and 18).
This widespread presence, combined with persistence, bioaccumulative
potential, and toxicity from low level exposures, raises concerns for
potential adverse effects to people and wildlife over time should the
chemical substances that are subject to this proposed rule continue to
be produced, released, and accumulated in the environment.
    Of the congeners found in the commercial products, tetraBDE,
pentaBDE, and hexaBDE are the PBDEs most frequently detected in
wildlife and humans (Refs. 8 and 9). The octanol-water partition
coefficient, which is an important property in determining the
environmental fate of hydrophobic organic chemicals, particularly in
biota, has been measured for a number of PBDEs, and shown to be in the
range of optimum bioaccumulation potential (Ref. 19). With the present
data, the Agency can only speculate on environmental transport and
partitioning of PBDEs in general and specifically regarding the
chemical substances that are subject to this proposed rule. While the
exact mechanisms or pathways by which the various PBDE congeners end up
in the environment and humans are not known yet, they could include
direct releases from manufacturing or processing of the chemicals into
products like plastics or textiles, aging and wear of these consumer
products (Ref. 20), photolytic breakdown of higher brominated congeners
(Ref. 21), and direct exposure during use or via indoor air or house
dust (Refs. 22 and 23), as well as bioaccumulation up the food chain
(Ref. 24). The small amount of environmental information on octaBDE
shows it does not readily degrade, although an exception is in fish,
where there is evidence that octaBDE could have the potential to be
metabolized to pentaBDE (Ref. 25).

D. Use Information

    The chemical substances subject to this proposed rule, listed in
Unit II.A., are the commercial products pentaBDE and octaBDE, and other
PBDE congeners that comprise these products and are separately listed
on the TSCA Inventory. PentaBDE (often formulated with nonhalogenated
organophosphates) has been widely used in formulations for flexible
polyurethane foams used in upholstered products ranging from home
furniture to seats in airplanes and automobiles. OctaBDE has been
primarily used as an additive to a type of plastic known as
acrylonitrile-butadiene-styrene (ABS), used in housings for office and
medical electronics, the interior and exterior trim of automobiles,
telephone handsets, and other products. It is also incorporated into
resins (polyamide and polybutylene terephthalate) in the manufacture of
electrical connectors and components and automotive interior parts.
    World-wide demand for pentaBDE and octaBDE in 2001 was estimated to
be 7,500,000 and 3,790,000 kilograms (kg), respectively; demand for
these chemicals in the Americas was 7,100,000 kg for pentaBDE and
1,500,000 kg for octaBDE (Ref. 26). On November 3, 2003, Great Lakes
Chemical Corporation, the only U.S. manufacturer of pentaBDE and
octaBDE, announced a voluntary phase-out of both those commercial
products by the end of 2004. According to the information currently
available to EPA, Great Lakes is the sole U.S. manufacturer of
commercial pentaBDE and octaBDE and EPA also understands that currently
there is no import of these commercial products into the U.S.
Furthermore, based on available information, none of the other PBDE
congeners subject to this proposed rule are currently manufactured or
imported into the U.S.

[[Page 70408]]

V. Objectives and Rationale of the Rule

    As summarized in Unit IV., EPA has concerns regarding the
environmental fate and the exposure pathways that lead to PBDE presence
in wildlife and people, and the persistence, bioaccumulation, and
toxicity (PBT) potential of pentaBDE and octaBDE. Great Lakes Chemical
Corporation, the sole manufacturer of these chemicals in the U.S., has
chosen voluntarily to discontinue their manufacture for all uses by
December 31, 2004. With Great Lakes Chemical Corporation's exit from
the market, EPA believes that all U.S. manufacture and import of these
chemicals likely will cease. However, EPA is concerned that manufacture
or import could be reinitiated in the future, and wants the opportunity
to evaluate and control, if appropriate, exposures associated with
those activities. Based on the current situation, including substantial
production volume, number of uses, potential for widespread release and
exposure, as well as the PBT nature of the chemical substances, any new
manufacture or import after January 1, 2005 is expected to
significantly increase exposures after manufacture and import are
discontinued, over that which could otherwise exist. The notice that
would be required by this proposed SNUR would provide EPA with the
opportunity to evaluate activities associated with a significant new
use as proposed herein and an opportunity to protect against
unreasonable risks, if any, from exposure to the substances.
    Based on these considerations, EPA wants to achieve the following
objectives with regard to the significant new uses that are designated
in this proposed rule. EPA wants to ensure that:
    1. EPA would receive notice of any person's intent to manufacture
or import the chemical substances subject to this proposed rule for a
designated significant new use before that activity begins.
    2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
importing these chemical substances for a significant new use.
    3. EPA would be able to regulate prospective manufacturers and
importers of these chemical substances before a significant new use
occurs, provided such regulation is warranted pursuant to TSCA sections
5(e), 5(f), 6 or 7.

[SNIP]


[SNIP]


XI. References

These references have been placed in the public docket that was
established under docket ID number OPPTS-2004-0085 for this rulemaking.
1. Noonan, Anne P. Phase-Out Plan for Pentabromodiphenyl-oxide and
Octabromodiphenyl-oxide Products. Great Lakes Chemical Corporation.
West Lafayette, IN. April 8, 2004.
2. Voluntary Children's Chemical Evaluation Program (VCCEP) Tier 1
Assessment of the Potential Health Risks to Children Associated with
Exposure to Commercial for Pentabromodiphenyl ether (CAS No. 32534-81-
9), April 21, 2003; Great Lakes Chemical Corporation.
3. Voluntary Children's Chemical Evaluation Program (VCCEP) Tier 1
Assessment of the Potential Health Risks to Children Associated with
Exposure to Commercial for Octabromodiphenyl ether (CAS No. 32536-52-
0), April 21, 2003; Great Lakes Chemical Corporation.
4. Voluntary Children's Chemical Evaluation Program (VCCEP) Data
Summary, Decabromodiphenyl ether (CAS No. 1163-19-5), December 17,
2002; American Chemistry Council's Brominated Flame Retardant Industry
Panel.
5. Report of the Peer Consultation Meeting (June 3 and 4, 2003) on
Pentabromodiphenyl ether; Great Lakes Chemical Corporation for the
Voluntary Children's Chemical Evaluation Program (VCCEP); January 22, 2004.
6. Report of the Peer Consultation Meeting (June 3 and 4, 2003) on
Octabromodiphenyl ether; Great Lakes Chemical Corporation for the
Voluntary Children's Chemical Evaluation Program (VCCEP); January 22, 2004.
7. Report of the Peer Consultation Meeting (April 2 and 3, 2003) on
Decabromodiphenyl ether; American Chemistry Council's Brominated Flame
Retardant Industry Panel for the Voluntary Children's Chemical
Evaluation Program (VCCEP); September 30, 2003.
8. Birnbaum, LS and DF Staskal. 2004. Brominated Flame Retardants:
Cause for Concern?; Environmental Health Perspectives 112:9-17.
9. CA de Wit; An overview of brominated flame retardants in the
environment. 2002. Chemosphere 46: 583-624.
10. National Toxicology Program Nomination Background Document:
Technical Pentabromodiphenyl Ether, Technical Octabromodiphenyl Ether,
2,2',4,4'-Tetrabromodiphenyl Ether, 2,2',4,4',5-Pentabromodiphenyl
Ether, 2,2',4,4',5,5'-Hexabromodiphenyl Ether; Review of Toxicological
Literature. March 2001. Prepared for National Institute of
Environmental Health Sciences.
11. Risk-Assessment Report Vol. 05, August 2000 on: diphenyl ether,
pentabromo derivative, CAS No.: 32534-81-9, EINECS #: 251-084-
2. Publication: EUR 19730 EN. See <A HREF="http://ecb.jrc.it/existing-chemicals/";>http://ecb.jrc.it/existing-chemicals/</A>,
``penta--bdereport015.''
12. Risk-Assessment Report Vol. 16, 2003 on: diphenyl ether,
octabromo derivativeCAS No.: 32536-52-0, EINECS #: 251-087-9.
Publication: EUR 20403 EN. See <A HREF="http://ecb.jrc.it/existing-chemicals/";>http://ecb.jrc.it/existing-chemicals/</A>,

``octareport014.''
13. Rayne S, MG Ikonomou. 2002. Reconstructing source
polybrominated diphenyl ether congener patterns from semipermeable
membrane devices in the Fraser River, British Columbia, Canada:
Comparison to commercial mixtures. Environ. Toxicol. Chem. 21:2292-2300.
14. Rice CP, Chernyak SM, Begnoche L, Quintal R, Hickey J. 2002.
Comparisons of PBDE composition and concentration in fish collected
from the Detroit River, MI and Des Plaines River, IL. Chemosphere
49:731-737.
15. Lindberg P, Sellstrom U, Haggberg L, deWit CA. 2004. Higher
brominated diphenyl ethers and hexabromocyclododecane found in eggs of
peregrine falcons (Falco peregrinus) breeding in Sweden. Environ. Sci.
Technol. 38:93-96.
16. Hale RC, M Alaee, JB Manchester-Neesvig, HM Stapleton, MG
Ikonomou. 2003. Polybrominated diphenyl ether flame retardants in the
North American environment. Environment International 29:771-779.
17. Hites RA. 2004. Polybrominated diphenyl ethers in the
environment and in people: a meta-analysis of concentrations. Environ.
Science Technol. 38 (4): 945-956.
18. Law RJ, M Alaee, CR Allchin, JP Boon, M Lebeuf, P Lepom, GA
Stern. 2003. Levels and trends of polybrominated diphenylethers and
other brominated flame retardants in wildlife. Environment
International 29: 757-770.
19. Braekevelt E, SA Tittlemier, GT Tomy. 2003. Direct measurement
of octanol-water partition coefficients of some environmentally
relevant brominated diphenyl ether congeners. Chemosphere 51:563-567.
20. Hale, RC, MJ La Guardia, E Harvey, TM Mainor. 2002. Potential
role of fire retardant-treated polyurethane foam as a source of
brominated diphenyl ethers to the US environment. Chemosphere 46:729-735.
21. Soderstrom, G, U Sellstr[ouml]m, C de Wit, M Tysklind. 2004.
Photolytic debromination of decabromodiphenylether (deBDE). Environ.
Science Technol. 38 (1): 127-132.
22. Rudel RA, DE Camann, JD Spengler, LR Korn, JG Brody. 2003.
Phthalates, alkylphenols, pesticides, polybrominated diphenyl ethers,
and other endocrine-disrupting compounds in indoor air and dust.
Environ. Science Technol. 37 (20): 4543-4553.
23. Butt CM, ML Diamond, J Truong, MG Ikonomou, AFH ter Schure.
2004. Spatial distribution of polybrominated diphenyl ethers in
southern Ontario as measured in indoor and outdoor window organic
films. Environ. Science Technol. 38 (3):724-731.
24. Tomy GT, VP Palace, T Halldorson, E Braekevelt, R Danell, K
Wautier, B Evans, L Brinkworth, AT Fisk. 2004. Bioaccumulation,
biotransformation, and biochemical effects of brominated diphenyl
ethers in juvenile lake trout (Salvelinus namaycush). Environ. Science
Technol. 38(5): 1496-1504.
25. Stapleton, H.M, R.J. Letcher, and J.E. Baker. 2004.
Debromination of polybrominated diphenyl Ether Congeners BDE99 and
BDE183 in the intestinal tract of the common carp (Cyprinus carpio).
Environmental Science and Technology, 38(4): 1054-1061.
26. <A HREF="http://www.bsef-site.com/docs/BFR_vols_2001.doc";>http://www.bsef-site.com/docs/BFR_vols_2001.doc</A>. 

Major Brominated Flame Retardants Volume Estimates, Total Market Demand
by Region in 2001. 21 January 2003.
    27. European Union. Directive 2003/11/EC of the European Parliament
and of the Council of 6 February 2003 amending for the 24th time
Council Directive 76/769/EEC relating to restrictions on the marketing
and use of certain dangerous substances and preparations
(pentabromodiphenyl ether, octabromodiphenyl ether).
    28. California Bill AB 302, bill text. ``An act to add Chapter 10
(commencing with Section 108920) to Part 3 of Division 104 of the
Health and Safety Code, relating to toxic substances.'' Signed by the
California Governor on August 9, 2003.

[[Page 70411]]

    29. Design for the Environment Program, USEPA. September 2004.
Environmentally Preferable Approaches for Achieving Fire Furniture
Safety Standards.
    30. Lehman, T., USEPA. June 18, 2004. Economic Analysis for Certain
Polybrominated Diphenylethers; Proposed Significant New Use Rule.

[SNIP]

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Premanufacture notification, Reporting and recordkeeping requirements.

    Dated: November 30, 2004.
Charles M. Auer,
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 would continue to read as
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).
    2. By adding new Sec.  721.10000 to subpart E to read as follows:

Sec. 721.10000 Certain polybrominated diphenylethers.

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified as tetrabromodiphenyl
ether (CAS No. 40088-47-9; Benzene, 1,1'-oxybis-, tetrabromo deriv.),
pentabromodiphenyl ether (CAS No. 32534-81-9; Benzene, 1,1'-oxybis-,
pentabromo deriv.), hexabromodiphenyl ether (CAS No. 36483-60-0;
Benzene, 1,1'-oxybis-, hexabromo deriv.), heptabromodiphenyl ether (CAS
No. 68928-80-3; Benzene, 1,1'-oxybis-, heptabromo deriv.),
octabromodiphenyl ether (CAS No. 32536-52-0; Benzene, 1,1'-oxybis-,
octabromo deriv.), and nonabromodiphenyl ether (CAS No. 63936-56-1;
Benzene, pentabromo(tetrabromophenoxy)-), and any combination of these
substances resulting from a chemical reaction are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new use is manufacture or import for any use on
or after January 1, 2005.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section
except for section 721.5(a)(2). A person who intends to manufacture or
import for commercial purposes the substances identified in paragraph
(a)(1) of this section and intends to distribute the substance in
commerce must submit a significant new use notice.
    (2) [Reserved]

[FR Doc. 04-26731 Filed 12-1-04; 2:54 pm]
BILLING CODE 6560-50-S


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