[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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
    <bullet> 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.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#90ffe0e0e4befef3f9f3d0f5e0f1bef7ffe6"><span class="__cf_email__" data-cfemail="016e7171752f6f626862416471602f666e77">[email protected]</span></a>.
    <bullet> Mail: Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics (OPPT), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#2a7e79696b0762455e4643444f6a4f5a4b044d455c"><span class="__cf_email__" data-cfemail="7b2f28383a5633140f1712151e3b1e0b1a551c140d">[email protected]</span></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="/cdn-cgi/l/email-protection#cda0a2bebee3a6a8a3a3a8b9a58da8bdace3aaa2bb"><span class="__cf_email__" data-cfemail="0865677b7b26636d66666d7c60486d7869266f677e">[email protected]</span></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:
    <bullet> 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:
    <bullet> The projected volume of manufacturing and processing of 
the chemical substance.
    <bullet> The extent to which the use changes the type or form of 
exposure to human beings or the environment to a chemical substance.
    <bullet> The extent to which the use changes the magnitude and 
duration of exposure to human beings or the environment to a chemical 
substance.
    <bullet> 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 <greek-i>: 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 <greek-i>: 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


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