Certain Polybrominated Diphenylethers; Significant New Use Rule
[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 (59 FR 22951, 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.
? Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
? 1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
? 2. 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