Document ID: EPA-HQ-OPPT-2004-0085-0053
Agency: epa
Document Type: Rule
Title: Certain Polybrominated Diphenylethers; Significant New Use Rule
Posted Date: 2006-06-13T04:00Z

[Federal Register: June 13, 2006 (Volume 71, Number 113)]
[Rules and Regulations]               
[Page 34015-34021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn06-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2004-0085; FRL-7743-2]
RIN 2070-AJ02

 
Certain Polybrominated Diphenylethers; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is promulgating 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.), and nonabromodiphenyl ether 
(CAS No. 63936-56-1; Benzene, pentabromo(tetrabromophenoxy)-), or any 
combination of these substances resulting from a chemical reaction. 
This rule requires 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 will 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: This final rule is effective on August 14, 2006.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2004-0085. All documents in the 
docket are listed on the regulations.gov Web site. Although listed in 
the index, some information is not publicly available, i.e., 
Confidential Business Information (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 at http://www.regulations.gov
 or in hard copy at the OPPT Docket, EPA Docket 

Center (EPA/DC), 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 telephone 
number for the Public Reading Room is (202) 566-1744

[[Page 34016]]

and the telephone number for the OPPT Docket 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: 
TSCA-Hotline@epa.gov.

    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: (202) 564-9232; e-mail 
address: moss.kenneth@epa.gov.

SUPPLEMENTARY INFORMATION: EPA proposed this SNUR on certain 
polybrominated diphenylethers on December 6, 2004 (69 FR 70404) (FRL-
7688-1). The Agency's responses to public comments received on the 
proposed rule are in Unit VI. Please consult the December 6, 2004 
Federal Register document for further background information for this 
final rule.

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
or 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.), and nonabromodiphenyl ether 
(``nonaBDE'') (CAS No. 63936-56-1; Benzene, 
pentabromo(tetrabromophenoxy)-), or 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. 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 final 
rule are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D (see 40 CFR 721.20). 
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. Note that for this action, 40 CFR 721.5(a)(2) 
does not apply. 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 721 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

II. Background

A. What Action is the Agency Taking?

    This rule requires 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; 
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.), and nonabromodiphenyl ether 
(``nonaBDE'') (CAS No. 63936-56-1; Benzene, 
pentabromo(tetrabromophenoxy)-), or 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)).

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, and exemptions to reporting requirements. 
Note that for this action, 40 CFR 721.5(a)(2) does not apply. 
Provisions relating to user fees appear at 40 CFR part 700. Persons 
that are subject to this SNUR will need to comply with the same notice 
requirements and EPA regulatory procedures as submitters of 
premanufacture notices (PMNs) under section 5(a)(1)(A) of TSCA. 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 significant new use 
notice (SNUN), EPA may take regulatory action under TSCA section 5(e), 
5(f), 6, or 7 to control the activities on which it has received the 
SNUN. If EPA does not take action, 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

[[Page 34017]]

TSCA section 12(b). The regulations that implement 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 are codified 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 the import certification appears at 40 CFR part 707, subpart 
B.

III. Objectives and Rationale of the Rule

    As summarized in Unit IV. of the proposed rule, 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, 
and the other PBDE congeners that comprise these products and are also 
subject to this rule. Great Lakes Chemical Corporation, formerly the 
sole manufacturer of the commercial pentaBDE and octaBDE products in 
the United States, voluntarily discontinued their manufacture for all 
uses by December 31, 2004. With Great Lakes Chemical Corporation's exit 
from the market, EPA believes that all production in and import into 
the United States of these chemicals has ceased. 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 
situation prior to January 1, 2005, 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 that date is expected to significantly 
increase exposures now that manufacture and import have been 
discontinued, over that which could otherwise exist. The notice 
required by this SNUR will provide EPA with the opportunity to evaluate 
activities associated with a significant new use 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 rule. The Agency wants to ensure that:
     It will receive notice of any person's intent to 
manufacture or import the chemical substances subject to this rule for 
a designated significant new use before that activity begins.
     It will 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.
     It will 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.
    The mechanisms or pathways by which the PBDEs move into and through 
the environment and humans are not fully understood, but are likely to 
include releases from manufacturing of the chemicals, manufacturing of 
products like plastics or textiles, aging and wear of products like 
sofas and electronics, and releases at the end of product life 
(disposal, recycling). EPA believes that information provided in SNUNs 
will help the Agency review any new uses and take action, as needed, to 
regulate releases of PBDEs into the environment.

IV. 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 are currently manufacturing or importing 
commercial pentaBDE or octaBDE in the United States, the negative 
commercial and regulatory environment associated with these chemicals 
(including the EU ban on marketing and use of pentaBDE and octaBDE (see 
Ref. 27 of the proposed rule) and similar restrictions enacted by 
certain states in the United States (see Ref. 28 of the proposed rule), 
and the expectation that viable substitutes will be available including 
those being considered in the Design for Environment Furniture Flame 
Retardancy Partnership (see Ref. 29 of the proposed rule), 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 United States manufacture and import 
of these chemicals have ceased 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.

V. 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 the 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. Those persons 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.

[[Page 34018]]

VI. Discussion of the Final Significant New Use Rule and Response to 
Comments

    This action finalizes the SNUR proposed in the Federal Register of 
December 6, 2004 (69 FR 70404). This final rule requires 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 Agency reviewed and considered all 
comments received during the comment period (December 6, 2004 through 
February 4, 2005) for the proposed rule. Copies of all comments 
received are available in the public docket for this action. A 
discussion of the comments germane to the rulemaking and the Agency's 
response follows.

A. TSCA Section 12(b) Applicability

    Comment 1--Clarify the TSCA section 12(b) consequences of the 
proposed rule. One commenter requested clarification of TSCA section 
12(b) export notification requirements, especially as they relate to 
decaBDE under the proposed rule, or that EPA issue a technical 
correction notice that explicitly excludes those requirements for 
exported decaBDE.
    Response. DecaBDE itself is not subject to TSCA section 12(b) 
export notification requirements as a result of this action as it is 
not covered by this rulemaking. However, anyone who exports one of the 
PBDEs subject to this rule, on or after 30 days after the December 6, 
2004 date of publication of the proposed rule in the Federal Register 
(January 5, 2005), was and is subject to the export notification 
provisions of TSCA section 12(b). TSCA section 12(b) export 
notification requirements apply to chemical substances for which a 
proposed or final rule has been issued under TSCA section 5 (in this 
case, a TSCA section 5(a)(2) SNUR). Chemical substances exported as 
impurities are not exempt from this requirement, and in addition there 
is no de minimis level below which TSCA section 12(b) notification is 
not required (See 45 FR 82844, 82845; December 16, 1980). Therefore, 
any amount of the PBDEs subject to this SNUR that are contained in 
exported decaBDE, other than when exported as part of an article, will 
trigger TSCA section 12(b) reporting for those subject PBDEs. A notice 
of export is required for the first export or intended export to a 
particular country in a calendar year. See 40 CFR part 707, subpart D 
(45 FR 82850; December 16, 1980).

B. Importation of PBDEs

    Comment 2--Import of a formulation containing subject PBDEs. One 
commenter asked if a company were to import a formulated liquid resin 
(such as an epoxy for use in engineering adhesives or molding 
compounds) containing one or more of the subject PBDEs, would that 
company be required to submit a notice under the SNUR?
    Response. Yes, a chemical substance that is manufactured or 
imported as part of a mixture is subject to SNUR notification 
requirements. See footnote for 40 CFR 720.30(b), which would be 
relevant per 40 CFR 721.1(c).
    Comment 3--Import of articles. Commenters questioned the Agency's 
rationale for not having the SNUR apply to the import of articles 
containing the PBDEs subject to this rule, especially since they are 
both inexpensive and effective to use, and because the Agency 
acknowledged in the proposal that the quantity of imported articles 
containing these PBDEs is unknown. They suggested that with the 
cessation of octaBDE and pentaBDE production in the United States, 
suppliers outside of the United States, specifically in China or India, 
will seize the opportunity to continue supplying these chemicals to 
companies who will use them in articles that will then be shipped into 
the United States. This potential practice, the commenters continue, 
could have a negative impact on EPA's ability to prevent these 
chemicals from being introduced in the United States without its 
knowledge or oversight. Furthermore, commenters argue, overseas 
manufacturers may increase export of such articles to the United 
States, either to unload existing stock of products no longer 
acceptable to the European Union as of August 15, 2004, or to avoid the 
need for conversion of existing production capacity away from these 
substances. That is, by failing to adopt a SNUR that captures the 
subject PBDEs when imported as part of articles, EPA could 
inadvertently make the United States the market of choice for producers 
of these articles.
    Response. In the proposed SNUR, EPA specifically asked for comment 
on whether the subject substances when imported as part of articles 
should be included in the SNUR. While the Agency acknowledged in the 
proposal that the quantity of imported articles containing these PBDEs 
is unknown, there were factors weighing in favor of continuing to 
exempt these articles. First, the only known manufacturer or importer 
of those chemical substances in the United States had announced its 
intention to discontinue production and/or import of the chemical 
substances themselves. Second, there is a clear negative commercial and 
regulatory environment associated with these chemicals, worldwide. 
Third, there is an expectation that viable substitutes will be 
available. Based on these reasons, EPA proposed exempting from the 
reporting requirements of the SNUR the subject substances when imported 
as a part of articles.
    In consideration of the public comments received, however, EPA has 
re-evaluated this exemption. EPA agrees with commenters that if the 
subject substances when imported as a part of articles are not subject 
to the SNUR, EPA could miss the opportunity to obtain notifications 
that would provide information of potential regulatory and assessment 
value. In particular, the Agency recognizes that the low cost and 
effectiveness of the subject PBDEs, combined with the negative 
commercial and regulatory environment in certain parts of the world, 
could actually lead to continued or increasing use of the subject PBDEs 
in those countries where these chemicals are not controlled, and 
subsequent export of articles containing those chemicals to the United 
States. However, EPA has decided to promulgate the PBDE SNUR as 
initially proposed, with an exemption for imported articles that may 
contain the subject PBDEs. EPA may not issue a SNUR covering as a 
significant new use import of the subject PBDEs as a part of articles 
for any use if that activity is ongoing. EPA received no comments on 
the proposed rule suggesting import of the subject PBDEs as a part of 
articles was ongoing. However, comments received from the Polyurethane 
Foam Association (PFA) after the close of the comment period for the 
proposed rule indicate the potential for presence of the subject PBDEs 
in imported articles. In particular, PFA referred to Department of 
Commerce trend data that ``the U.S. imports a significant amount of 
products that contain flexible polyurethane foam, some of which are 
likely to contain pentaBDE.'' (see the PFA comment in the public docket 
for this rule at EPA-HQ-OPPT-2004-0085). While the Agency is not 
obligated to respond to a late comment, EPA intends to investigate this 
issue further and seeks further information on the presence of the 
subject PBDEs in imported articles. Such information can be submitted 
to the docket to this rule.

C. DecaBDE

    Comment 4--Rulemaking or other action is needed on decaBDE.

[[Page 34019]]

Comments dealt with the need for regulatory controls on decaBDE and 
concern about Federal inaction on decaBDE.
    Response. This SNUR follows up Great Lakes Chemical Corporation's 
voluntary phase out of production of pentaBDE and octaBDE, which are 
comprised of the other PBDE congeners subject to this rule. DecaBDE 
remains in commerce and it is not subject to this rule. However, EPA 
recognizes that there is extensive, ongoing research on decaBDE. Under 
the Agency's Voluntary Children's Chemical Evaluation Program (VCCEP), 
industry sponsored an assessment and data needs analysis for decaBDE. 
Sponsorship includes an assessment of the potential hazards, exposures, 
and risks to children and prospective parents and a data needs analysis 
to evaluate the need for additional toxicity and exposure information. 
Further, EPA is developing a proposed SNUR for 16 chemical substances/
categories, including decaBDE, which have been identified by the 
Consumer Product Safety Commission (CPSC) and evaluated by the National 
Academy of Sciences as candidates for use to meet the residential 
upholstered furniture (RUF) flammability standards under consideration 
by the state of California and the CPSC.
    Other comments were also submitted that related to research or 
potential environmental concerns associated with decaBDE. These 
comments were not considered germane to this rulemaking.

D. Ensuring All Potential Manufacturers are Accounted For

    Comment 5--Sources to determine potential manufacturers. One 
commenter asked that EPA confirm the accuracy of the assumption that 
Great Lakes is the sole domestic manufacturer and importer of pentaBDE 
and octaBDE.
    Response. EPA's conclusion that Great Lakes was the sole domestic 
manufacturer of both these chemical substances was based on the best 
available information. In order to identify current domestic 
manufacturers and importers of pentaBDE and octaBDE, EPA consulted 
several market buyers guides and proprietary reports, including 
Specialty Chemicals (SRI International, Specialty Chemicals: Flame 
Retardants, November 2002) and the Chemical Economics Handbook (SRI 
International: Bromine, 2003). The Agency reviewed each company's 
online product list (where available) or directly contacted the 
companies to determine if they currently sold pentaBDE or octaBDE and 
if so where the chemicals were produced. EPA also consulted information 
submitted under the Agency's TSCA section 8(a) Inventory Update Rule 
(IUR), which requires manufacturers and importers of certain chemical 
substances included on the TSCA Chemical Substances Inventory to report 
current data on the production volume, plant site, and site-limited 
status of these substances. Reporting under the IUR began in 1986 and 
takes place at four-year intervals. The most recent reporting year 
ended December 31, 2002. EPA reviewed IUR submissions for pentaBDE or 
octaBDE that were made up to the date of the proposed SNUR in order to 
help support the conclusion that there are no manufacturers or 
importers of the chemicals. Finally, the Agency received no public 
comments that suggested ongoing import or manufacture of the PBDEs 
subject to this rule.

E. True Cost of Compliance with this Rule

    Comment 6--Taking all costs into account. One commenter suggested 
that certain costs were not taken into account when estimating the 
burden to industry of complying with the rule, including identifying 
alternatives, finding a supplier, developing new shipping procedures, 
and making potential equipment changes.
    Response. EPA did not include the additional cost items noted by 
the commenter in estimating the burden to industry of complying with 
the rule. The economic analysis for a SNUR estimates the cost of 
complying with the SNUR only. The SNUR requires that those companies 
intending to manufacture or import any of the subject chemicals for the 
specified new use submit a SNUN. A SNUR does not prevent persons from 
manufacturing or importing a substance, nor stipulate a switch to an 
alternative.

VII. 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 and the export notification 
requirements of TSCA section 12(b). 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 
rule.

A. SNUNs

    The Agency has analyzed the potential costs of compliance with this 
rule. 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.

B. Export Notification

    As noted in Unit II.C. of this final rule, 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 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 rule commercially. 
If companies were to manufacture for export only any of the chemical 
substances covered by this 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.

VIII. 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 this final

[[Page 34020]]

SNUR is are not a ``significant regulatory action'' subject to review 
by OMB, because it does 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). 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 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 were engaged in such activity 
as of January 1, 2005. Since a SNUR only requires that any person who 
intends to engage in a significant new use 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 about 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. of the proposed rule), 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 its 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 rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
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 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 SNUR might present such risks to children, SNURs are 
administrative actions that require chemical manufacturers to submit a 
SNUN to EPA before a chemical may be made available for sale. 
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 rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not 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

[[Page 34021]]

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 12988: Civil Justice Reform

    In issuing this 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).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

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

    Dated: June 5, 2006.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
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)-), or 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 Sec.  721.5(a)(2). A person who intends to manufacture or 
import for commercial purposes a substance 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. E6-9207 Filed 6-12-06; 8:45 am]

BILLING CODE 6560-50-S