[Federal Register Volume 69, Number 233 (Monday, December 6, 2004)]
[Proposed Rules]
[Pages 70404-70412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26731]
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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: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. 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: [email protected].
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
http://www.epa.gov/edocket/, 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 http://www.epa.gov/edocket/. 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: [email protected].
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: [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) 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:
Manufacturers (defined by statute to include importers) of
PBDEs (NAICS 325 and 324110), e.g. chemical manufacturing and petroleum
refineries.
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 at 40 CFR 721.5 for
SNUR-related obligations. 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.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 721
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. How Do I Submit Confidential Business Information?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. 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 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 rulemaking 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?
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.
C. Applicability of General Provisions
General provisions for SNURs appear under subpart A of 40 CFR part
721. 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. Persons subject to this SNUR, when finalized, would be
required to 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
SNUR notice, EPA may take regulatory action under TSCA sections 5(e),
5(f), 6, or 7, if appropriate, to control the activities on which it
has received the SNUR notice. If EPA does not take action, EPA is
required under TSCA section 5(g) to explain in the Federal Register its
reasons for not taking action.
Persons who intend to export a chemical substance 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 intend
to import a chemical substance identified in a final SNUR are subject
to the TSCA section 13 import certification requirements, which appear
at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify
that they are in compliance with SNUR requirements. The EPA policy in
support of import certification appears at 40 CFR part 707, subpart B.
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,
EPA believes it is unlikely that companies would incur the costs
associated with establishing new manufacturing capacity for these
chemicals in order to enter this market. This proposed rule, when
finalized, would require persons who intend to manufacture or import
the chemical substances listed in Unit II.A. to submit a SNUN at least
90 days before commencing the manufacture or importation of any of
these chemicals for any use on or after January 1, 2005. The required
notice would provide EPA with the opportunity to evaluate the intended
use, and, if necessary, to prohibit or limit that use before it occurs.
In the event that the phase-out of these chemicals does not progress as
described in this proposed rule, EPA may pursue additional regulatory
action as appropriate under TSCA sections 4, 6, and 8.
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).
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.
VI. Significant New Use Determination
In making a determination that a use of a chemical substance is a
significant new use, the Agency must consider all relevant factors,
including those listed in section 5(a)(2) of TSCA. Those factors are:
The projected volume of manufacturing and processing of
the chemical substance.
The extent to which the use changes the type or form of
exposure to human beings or the environment to a chemical substance.
The extent to which the use changes the magnitude and
duration of exposure to human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
Given that no companies other than Great Lakes Chemical Corporation
are currently manufacturing or importing commercial pentaBDE or octaBDE
in the U.S., the negative commercial and regulatory environment
associated with these chemicals (including the EU ban on marketing and
use of pentaBDE and octaBDE (Ref. 27) and similar restrictions enacted
by certain States in the U.S. (Ref. 28)), and the expectation that
viable substitutes will be available including those being considered
in the Design for Environment Furniture Flame Retardancy Partnership
(Ref. 29), EPA believes it is unlikely that companies would incur the
costs associated with establishing new manufacturing capacity for these
chemicals in order to enter this market. 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 and that
any new manufacture or import, for any use, subsequent to Great Lakes
Chemical Corporation's December 31, 2004 phase-out date would result in
a significant increase in the magnitude and duration of exposures to
humans and the environment over that which would otherwise exist. Based
on these considerations, EPA has determined that any manufacture or
import of the chemical substances listed in Unit II.A. for any use on
or after January 1, 2005 is a significant new use.
VII. Alternatives/Other Options Considered
Before proposing this SNUR, EPA considered the following
alternative regulatory actions for the chemical substances that are the
subject of this proposed rule.
1. Promulgate a TSCA section 8(a) reporting rule. Under a TSCA
section 8(a) rule, EPA could generally require any person to report
information to the Agency when they intend to manufacture, import or
process the chemical substances listed in Unit II.A. However, the use
of TSCA section 8(a) rather than the SNUR authority, would not provide
the opportunity for EPA to review human and environmental hazards and
exposures associated with the new uses of these substances and, if
necessary, to take immediate regulatory action under TSCA section 5(e)
or section 5(f) to prohibit or limit the activity before it begins. In
addition, EPA may not receive important information from small
businesses, because those firms generally are exempt from TSCA section
8(a) reporting requirements. In view of EPA's concerns about the
chemical substances and its interest in having the opportunity to
review these substances and regulate them as appropriate, pending the
development of exposure and/or hazard information should a significant
new use be initiated, the Agency believes that a TSCA section 8(a) rule
for certain PBDEs would not meet all of EPA's regulatory objectives.
2. Regulate the chemical substances subject to this proposed rule
under TSCA section 6. EPA must regulate under TSCA section 6 if there
is a reasonable basis to conclude that the manufacture, import,
processing, distribution in commerce, use, or disposal of a chemical
substance or mixture ``presents or will present'' an unreasonable risk
of injury to human health or the environment. Based on EPA's findings
that after December 31, 2004 there would be no manufacture or import of
the chemical substances subject to this proposed rule, EPA concluded
that risk management action under TSCA section 6 is not necessary at
this time. This proposed SNUR would allow the Agency to address the
potential risks associated with any intended significant new use of
these chemical substances.
3. Require persons that import certain PBDEs as part of articles to
comply with the requirements of this proposed SNUR. Under the general
SNUR exemption provisions at 40 CFR 721.45, a person that imports or
processes a substance covered by a SNUR identified in subpart E of part
721 is not generally subject to the notification requirements of Sec.
721.25 for that substance, if the person imports or processes the
substance as part of an article. See 40 CFR 721.45(f). EPA considered
requiring persons that import (processors are not covered by this
proposed SNUR) the PBDEs subject to this proposed rule as part of
articles to comply with the requirements of this proposed SNUR, due to
concerns that exempting articles would render the SNUR less effective
[[Page 70409]]
because of the possibility that upholstered products or plastics-
containing articles treated with these PBDEs could be imported. The
current import status of articles treated with PBDEs, i.e., whether or
not import of these articles is presently ongoing, is not known at this
time. However, given the negative commercial and regulatory environment
associated with these chemicals (including the EU ban on marketing and
use of pentaBDE and octaBDE, the EU ban on placing on the market
articles containing these substances (Ref. 27)), similar restrictions
enacted by certain states in the U.S. (Ref. 28), and the expectation
that viable substitutes will be available, EPA believes it would be
unlikely that these chemical substances will be imported as part of
articles. Based on this belief, and the resultant low likelihood of
exposure to pentaBDE and octaBDE imported as part of an article, EPA is
not proposing to amend the general SNUR exemption provisions for the
purpose of this proposed SNUR. EPA is specifically seeking comments on
the issue of whether persons that import the chemical substances listed
in Unit II.A. as part of articles should be subject to the reporting
requirements of this proposed SNUR.
VIII. 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 believes that the intent of section 5(a)(1)(B) of TSCA is
best served by designating a use as a significant new use as of the
proposal date of the SNUR, rather than as of the effective date of the
final rule. If uses begun after publication of the proposed SNUR were
considered to be ongoing, rather than new, it would be difficult for
EPA to establish notification requirements, because any person could
defeat the SNUR by initiating the proposed significant new use before
the proposed rule became final, and then argue that the use was ongoing
as of the effective date of the final rule.
Any person who, after publication of this proposed SNUR, begins
commercial manufacture or import of the chemical substances listed in
Unit II.A. must stop such activity before the effective date of the
final rule. Persons who cease those activities will have to meet all
SNUR notice requirements and wait until the end of the notice review
period, including all extensions, before engaging in any activities
designated as significant new uses. If, however, persons who begin
commercial manufacture or import of the chemical substances listed in
Unit II.A. between the proposal and the effective date of the final
SNUR meet the conditions of advance compliance as codified at 40 CFR
721.45(h), those persons would be considered to have met the
requirements of the final SNUR for those activities.
IX. Test Data and Other Information
EPA recognizes that section 5 of TSCA does not require the
development of any particular test data before submission of a SNUN.
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 (15 U.S.C. 2604(d); 40 CFR 721.25).
However, in view of the potential health or environmental risks
posed by any manufacture or importation of the chemical substances
listed in Unit II.A., EPA would recommend in the final rule that
potential SNUN submitters include data that would permit a reasoned
evaluation of risks posed by these chemical substances during their
manufacture, processing, use, distribution in commerce, or disposal.
EPA encourages persons to consult with the Agency before submitting a
SNUN for these substances, and, for commercial pentaBDE and octaBDE, to
take advantage of the data needs assessments as reviewed under the
Agency's VCCEP (see VCCEP Peer Consultation meeting reports - Refs. 5
and 6 - and any forthcoming Agency decision under the VCCEP process).
As part of this optional pre-notice consultation, EPA would discuss
specific data it believes are necessary to evaluate a significant new
use. EPA also encourages SNUN submitters to provide all available
information that is relevant to assessing the potential for
environmental or consumer exposure, as well as information on risks
posed by these substances compared to risks posed by possible
substitutes. A SNUN submitted without sufficient data to reasonably
evaluate risks posed by a significant new use of the chemical
substances listed in Unit II.A. may increase the likelihood that EPA
will take action under TSCA section 5(e) to prohibit or limit
activities associated with these chemicals.
X. Economic Considerations
EPA has evaluated the potential costs of establishing a SNUR for
the chemical substances listed in Unit II.A. These potential costs are
related to the submission of SNUNs, the export notification
requirements of TSCA section 12(b) and the development of test data. If
the firm undertakes testing to support the submission of a SNUN, costs
could range from roughly $339,000 to over $1.4 million per chemical,
but could be substantially lower if not all recommended tests are
performed. EPA notes that, with the possible exception of export
notification requirements, the costs of submission of SNUNs will not be
incurred by any company unless that company decides to pursue a
significant new use as defined in this SNUR. The Agency's economic
analysis is available in the public docket for this proposed rule (Ref.
30).
A. SNUNs
The Agency has analyzed the potential costs of compliance with the
proposed SNUR (Ref. 30). EPA's complete economic analysis is available
in the public docket. The Agency has estimated the average cost of
compliance with the SNUR per chemical (e.g., cost of submitting a SNUN)
to be $6,956 based on 105 burden hours or a total cost of $13,912 or
210 hours for both chemicals. These estimates do not include the costs
of testing or submission of other information to permit a reasoned
evaluation of potential risks (see Unit IX.).
B. Export Notification
As noted in Unit II.C. of this document, persons who intend to
export a chemical substance identified in a proposed or final SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)). These provisions require that, for chemicals subject
to a proposed or final SNUR, a company notify EPA of the first shipment
to a particular country in a calendar year of an affected chemical
substance. EPA estimated that the one-time cost of preparing and
submitting an export notification to be $89.29. The total costs of
export notification will vary per chemical, depending on the number of
required notifications (i.e., number of countries to which the chemical
is exported).
EPA is unable to estimate the total number of TSCA section 12(b)
notifications that will be received as a result of this proposed SNUR,
or the total number of companies that will file these notices. However,
EPA expects that the total cost of complying with the export
notification provisions of TSCA section 12(b) will be limited based on
historical experience with TSCA section 12(b) notifications and the
fact that no companies have currently been identified that currently
market any of the chemical substances that are the subject of this
proposed rule commercially. If companies were to
[[Page 70410]]
manufacture for export only any of the chemical substances covered by
this proposed SNUR, such companies would incur the minimal costs
associated with export notification despite the fact they would not be
subject to the SNUR notification requirements. See TSCA section 12(a)
and 40 CFR 721.45(g). EPA is not aware of any companies in this
situation.
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 http://ecb.jrc.it/existing-chemicals/
, ``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 http://ecb.jrc.it/existing-chemicals/,
``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. http://www.bsef-site.com/docs/BFR_vols_2001.doc. 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.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that proposed or final SNURs are not a
``significant regulatory action'' subject to review by OMB, because
they do not meet the criteria in section 3(f) of the Executive Order.
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 the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
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 the PRA under OMB control
number 2070-0038 (EPA ICR No. 1188.07). 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 between
30 and 170 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, including
through the use of automated collection techniques, 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. Regulatory Flexibility Act
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 proposed SNUR will not have a significant adverse economic
impact on a substantial number of small entities. The rationale
supporting this conclusion is as follows. A SNUR applies to any person
(including small or large entities) who intends to engage in any
activity described in the rule as a ``significant new use.'' By
definition of the word ``new,'' and based on all information currently
available to EPA, it appears that no small or large entities will be
engaged in such activity on or after January 1, 2005. Since a SNUR only
requires that any person who intends to engage in such activity in the
future must first notify EPA by submitting a SNUN, no economic impact
will even occur until someone decides to engage in those activities.
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 over 1,000 SNURs, the Agency receives on average only
10 notices per year. Of those SNUNs submitted, none appear to be from
small entities in response to any SNUR. In addition, the estimated
reporting cost for submission of a SNUN (see Unit X.), are minimal
regardless of the size of the firm. Therefore, EPA believes that the
potential economic impact of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented it's general determination that proposed
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 Reform Act
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 reasons to believe that any
State, local, or Tribal government will be impacted by this rulemaking.
As such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).
E. Executive Order 13132: Federalism
This action will not 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. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
This proposed rule does not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
does not significantly or uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000), do not apply to this
proposed rule.
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
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. Although the chemicals that are
addressed in this significant new use rule might present such risks to
children, significant new use rules are administrative actions that
require chemical manufacturers to submit a significant new use notice
to EPA before a chemical may be manufactured or imported. Therefore,
this action does not in and of itself affect children's health.
H. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply,
[[Page 70412]]
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.
I. National Technology Transfer Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does 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).
K. Executive Order 12630: Governmental Actions and Interference with
Constitutionally Protected Property Rights (Takings)
EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 15, 1988), by examining the takings
implications of this proposed rule in accordance with the ``Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings'' issued under the Executive Order.
L. Executive Order 12988: Civil Justice Reform
In issuing this proposed rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
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