[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Proposed Rules]
[Pages 19862-19899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7195]
[[Page 19861]]
Vol. 77
Monday,
No. 63
April 2, 2012
Part V
Environmental Protection Agency
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40 CFR Parts 721, 795, and 799
Certain Polybrominated Diphenylethers; Significant New Use Rule and
Test Rule; Proposed Rule
Federal Register / Vol. 77 , No. 63 / Monday, April 2, 2012 /
Proposed Rules
[[Page 19862]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721, 795, and 799
[EPA-HQ-OPPT-2010-1039; FRL-8889-3]
RIN 2070-AJ08
Certain Polybrominated Diphenylethers; Significant New Use Rule
and Test Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Agency is proposing to amend the Toxic Substances Control
Act (TSCA) section 5(a) Significant New Use Rule (SNUR), for certain
polybrominated diphenylethers (PBDEs) by: Designating processing of six
PBDEs, or any combination of these chemical substances resulting from a
chemical reaction, as a significant new use; designating manufacturing,
importing, and processing of a seventh PBDE, decabromodiphenyl ether
(decaBDE) for any use which is not ongoing after December 31, 2013, as
a significant new use; and making inapplicable the article exemption
for SNURs for this action. A person who intends to import or process
any of the seven PBDEs included in the proposed SNUR, as part of an
article for a significant new use would be required to notify EPA at
least 90 days in advance to ensure that the Agency has an opportunity
to review and, if necessary, restrict or prohibit a new use before it
begins. EPA is also proposing a test rule under TSCA that would require
any person who manufactures or processes commercial pentabromodiphenyl
ether (c-pentaBDE), commercial octabromodiphenyl ether (c-octaBDE), or
commercial decaBDE (c-decaBDE), including in articles, for any use
after December 31, 2013, to conduct testing on their effects on health
and the environment. EPA is proposing to designate all discontinued
uses of PBDEs as significant new uses. The test rule would be
promulgated if EPA determines that there are persons who intend to
manufacture, import, or process c-pentaBDE, c-octaBDE, or c-decaBDE,
for any use, including in articles, after December 31, 2013.
DATES: Comments must be received on or before June 1, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-1039, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-1039. 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 DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-1039. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, 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 regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, 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 email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the 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.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information on the SNUR,
contact: John Bowser, Chemical Control Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8082; email addresses: [email protected].
For technical information on the test rule, contact: Catherine
Roman, Chemical Control Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8708; email
addresses: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be affected by this action if you manufacture or process
tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether
(pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether
(heptaBDE), octabromodiphenyl ether (octaBDE), nonabromodiphenyl ether
(nonaBDE), or decaBDE, or intend to, including as part of a mixture or
article. TSCA defines manufacture to include import. Unless otherwise
noted in this preamble, use of the term ``manufacture'' includes
import. Manufacturers and processors in certain industries to whom this
action may apply include, but are not limited to:
Manufacturers and processors of subject chemical
substances and
[[Page 19863]]
mixtures (NAICS codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries.
Textile manufacturers and processors (NAICS codes 313,
314, and 315).
Furniture manufacturers (NAICS code 337).
Manufacturers and processors of polyurethane foam (NAICS
code 326150).
Manufacturers of high impact polystyrene (HIPS) and
acrylonitrile-butadiene-styrene (ABS) plastics (NAICS codes 325,
326140, and 3261).
Manufacturers of electronics equipment (NAICS codes 334
and 335).
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. If you have any
questions regarding the applicability of this action to a particular
entity, consult the appropriate technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. See
Units VII. and VIII. for a discussion of how this action may affect
import certification and export notification requirements.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. 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 document 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.
C. Can I request an opportunity to present oral comments to the Agency?
You may submit a request for an opportunity to present oral
comments on this proposed test rule. This request must be made in
writing. If such a request is received on or before July 2, 2012, EPA
will hold a public meeting on this proposed test rule in Washington,
DC. This written request must be submitted to the mailing or hand
delivery addresses provided under ADDRESSES. If such a request is
received, EPA will announce the scheduling of the public meeting in a
subsequent document in the Federal Register. If a public meeting is
announced, and if you are interested in attending or presenting oral
and/or written comments at the public meeting, you should follow the
instructions provided in the subsequent Federal Register document
announcing the public meeting.
II. Background
A. What action is the Agency taking?
The Agency is proposing to amend the SNUR at 40 CFR 721.10000 (Ref.
1) that requires any person who intends to manufacture or import
tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether
(pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether
(heptaBDE), octabromodiphenyl ether (octaBDE), or nonabromodiphenyl
ether (nonaBDE), or any combination of these chemical substances that
results from a chemical reaction, for any use on or after January 1,
2005, to notify EPA at least 90 days in advance. EPA is proposing to
amend the SNUR by:
1. Designating processing of any of the six PBDEs after December
31, 2013, for any use which is not ongoing as a significant new use.
2. Designating manufacturing, importing, and processing of a
seventh PBDE, decabromodiphenyl ether (decaBDE) (Chemical Abstracts
Service Registry Number (CASRN) 1163-19-5) for any use which is not
ongoing after December 31, 2013, as a significant new use.
3. Making inapplicable for this SNUR, the article exemption for
SNURs at 40 CFR 721.45(f).
A person that imports or processes any of the chemical substances
identified in the proposed SNUR for a significant new use as part of an
article would be subject to the significant new use notification
requirements. No person would be able to begin manufacturing,
importing, or processing, including as contained in an article, any of
the chemical substances identified in the proposed SNUR for a
significant new use without first submitting a significant new use
notification (SNUN) to EPA. Ongoing uses would be excluded from the
SNUR.
EPA will not designate ongoing uses as significant new uses.
Persons who manufacture, import, or process any of the chemicals
included in the proposed SNUR, including as contained in an article,
for an ongoing use, would be free to continue without submitting a
SNUN. Note, however, that uses not already ongoing as of April 2, 2012
would not be considered ongoing uses if they later arise, even if they
are in existence upon the issuance of a final rule. Furthermore, uses
that are ongoing as of April 2, 2012 would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule. (See
Unit V.C. for further discussion of what constitutes an ongoing use.)
Persons who intend to begin (or resume) commercial manufacture or
processing of the chemical substance(s), including in articles, for a
significant new use, would have to comply with all applicable SNUN
requirements. Under TSCA section 5(b)(1)(A), any person who is required
to submit a SNUN for a chemical substance and who is also required to
submit test data under a final test rule, must submit the test data at
the time that the SNUN is submitted.
In this document, EPA is also proposing to issue a test rule under
TSCA section 4(a)(1)(A) that would require any person who manufactures,
imports, or processes c-pentaBDE, c-octaBDE, or c-decaBDE including in
articles for any use after December 31, 2013 to conduct testing of such
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commercial PBDE mixtures to obtain data on health effects,
environmental effects, and chemical fate in accordance with the test
rule. The effective date of the test rule will be after December 31,
2013; see 40 CFR 799.5350(k) of this proposed rule. The proposed test
rule specifies that testing of c-pentaBDE, c-octaBDE, and c-decaBDE be
conducted on representative forms of the relevant commercial mixtures.
The commercial mixture, c-pentaBDE, typically contains tetraBDE,
pentaBDE, and hexaBDE as the predominant components; the commercial
mixture, c-octaBDE, typically contains hexaBDE, heptaBDE, octaBDE, and
nonaBDE as the predominant components; and the commercial mixture, c-
decaBDE, typically contains decaBDE in the highest percent composition.
If EPA finds that manufacture, import, or processing of c-pentaBDE,
c-octaBDE, or c-decaBDE for any purpose, including as contained in an
article other than as an impurity, will occur after December 31, 2013,
EPA will promulgate a final test rule to require persons who
manufacture or process those mixtures to conduct testing to obtain data
on health effects, environmental effects, and chemical fate of those
mixtures. The test rule would apply to all uses, new or ongoing. The
existence or absence of a SNUR does not affect a person's obligations
under a test rule. The required testing would provide EPA with data
necessary to determine the effects on health and the environment if the
manufacture and processing of those mixtures and their associated use,
distribution in commerce and disposal are not discontinued.
EPA is seeking public comment on both the proposed SNUR and test
rule. Comments may address any aspect of the action being proposed.
Unit XI. contains a list of specific issues for which the Agency is
seeking comment. The actions EPA is proposing are generally described
in the ``Polybrominated Diphenyl Ethers (PBDEs) Action Plan Summary''
(PBDE Action Plan) (Ref. 2).
B. Why is the Agency taking this action?
EPA is concerned about the effects PBDEs may have on human health
and the environment. As discussed in Unit III. and the PBDE Action Plan
(Ref. 2), there is evidence that PBDEs may be toxic to both humans and
wildlife. PBDEs have been found in human tissue, wildlife and the
environment (Refs. 3-6). However, a panel of experts in the Voluntary
Children's Chemical Evaluation Program (VCCEP) reported to EPA that
there were insufficient data to fully evaluate the significance of
exposure to pentaBDE, octaBDE, and decaBDE (Refs. 7 and 8).
EPA is also concerned that the PBDEs included in these proposed
actions are highly persistent in the environment. Some lower brominated
PBDEs are both toxic and highly bioaccumulative. Other, more highly
brominated forms such as decaBDE may debrominate to the more toxic and
bioaccumulative lower brominated forms. However, the overall impact of
debromination of decaBDE as a source of the lower brominated PBDE
congeners in the environment has not been fully characterized. DecaBDE
has been found at high levels in predators such as peregrine falcons.
The environmental significance of such accumulations of decaBDE has not
been fully characterized. The exact mechanisms or pathways by which the
PBDEs, including those contained in articles, move into and through the
environment and allow humans and wildlife to become exposed are not
fully understood. The data produced by some of the tests included in
the proposed test rule would be necessary to determine the effects on
the environment if manufacturing and processing of c-pentaBDE, c-
octaBDE, and c-decaBDE and their associated use, distribution in
commerce, and disposal are not discontinued.
In December 2009, EPA received voluntary commitments from the
principal manufacturers and importer of c-decaBDE to phase out
manufacture and import for all uses by December 31, 2013 (Refs. 9-11).
The phase out of c-decaBDE will be accomplished in two steps. No later
than December 31, 2012, the manufacturers and the importer of c-decaBDE
would cease manufacture and import for all uses, including in articles,
with the exception of military and transportation uses. No later than
December 31, 2013, they would cease manufacture and import for all uses
including military and transportation uses, including in articles. The
principal manufacturers and importer of c-decaBDE stated that the
additional time required for phasing out military and transportation
uses was due to the stringent engineering requirements and risks
associated with these applications as well as the multiple levels of
testing and certification required for such product changes. EPA
believes manufacture and processing for most uses of decaBDE will have
ceased by December 31, 2013, and is proposing to use its authority
under TSCA section 5 to designate discontinued uses as significant new
uses. Once an activity has been determined, by a rule published in the
Federal Register, to be a significant new use, persons may not
manufacture or process the chemical substance for that activity without
first submitting a SNUN to EPA. The Agency would then have an
opportunity to review and, if necessary, take action to restrict or
prohibit the new use.
C. How would the proposed SNUR and test rule affect PBDEs contained in
articles?
The proposed SNUR includes a proposal to eliminate the article
exemption for SNURs at 40 CFR 721.45(f), for the covered PBDEs. See 40
CFR 721.10000(c)(1) of this proposed rule. In general, persons who
import or process chemical substances contained in articles are exempt
from significant new use notification requirements. However, as
discussed in Unit III. and the PBDE Action Plan (Ref. 2), there is
growing evidence that people and the environment are exposed to PBDEs
contained in articles, and that those PBDEs may have adverse effects on
human health and the environment. The Agency is concerned that
commencement of new uses of PBDEs or resumption of discontinued uses,
including in articles, may lead to increased exposure of humans and the
environment to these chemicals. Making the article exemption for SNURs
inapplicable for this proposed SNUR would ensure that the Agency has an
opportunity to review and, if necessary, take action to restrict or
prohibit significant new uses of PBDEs in articles before they resume.
Thus, anyone who intends to manufacture or process a PBDE for a
significant new use, including persons who intend to import or process
articles containing a PBDE for a significant new use, would have to
submit a SNUN at least 90 days before commencing such activity. Any
ongoing uses identified at the point of finalization, including import
or processing of articles containing PBDEs, would not be designated as
significant new uses. These activities would be allowed to continue
without the submission of a SNUN. Eliminating article importers' and
article processors' exemption from the requirement to submit a SNUN, as
described in this proposed rule, would have no effect on article
importers' general exemption from import certification requirements, or
on the articles exemption described at 40 CFR 707.60(b), respecting
export notifications.
The proposed test rule applies to certain commercial PBDE mixtures,
including those contained in articles. See 40 CFR 799.5350(b)(1) of
this proposed rule. Importers of articles containing c-pentaBDE, c-
octaBDE, or c-
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decaBDE are considered manufacturers of these mixtures and would be
subject to the proposed test rule, along with persons who domestically
manufacture these chemicals in bulk or as part of a mixture. Persons
who process c-pentaBDE, c-octaBDE, or c-decaBDE, including persons who
process articles containing these mixtures, would also be subject to
the proposed test rule. (These testing requirements apply even in
circumstances where the manufacture [including import] or processing is
for purposes of export from the United States.) Persons who do not know
or cannot reasonably ascertain that they manufacture or process a
listed test rule mixture (based on all information in their possession
or control, as well as all information that a reasonable person
similarly situated might be expected to possess, control, or know, or
could obtain without unreasonable burden), would not be subject to this
proposed test rule for the listed mixtures. The proposed test rule
would not require testing of articles themselves. The testing would be
required of a representative commercial form of the c-PBDE contained in
the article. See 40 CFR 799.5350(a)(1) of this proposed rule.
Eliminating article importers' and article processors' exemption from
the requirement to conduct testing of c-PBDEs, as described in this
proposed rule, would have no effect on article importers' general
exemption from import certification requirements, or on the articles
exemption described at 40 CFR 707.60(b), respecting export
notifications.
This proposed rule would not affect the article exemption at 40 CFR
707.60(b) for notices of export under TSCA section 12(b). Thus, persons
who export PBDEs contained in articles would remain exempt from the
requirement to submit a notice of export respecting such PBDEs. See
Unit VII.
Furthermore, this proposed rule would not alter the application of
the import certification regulations at 19 CFR 12.118 through 12.127.
PBDEs contained in articles would therefore continue to be exempt from
import certification requirements under TSCA section 13(b). PBDEs
imported in bulk or as part of a mixture would continue to be subject
to import certification requirements under TSCA section 13(b),
consistent with 19 CFR 12.120(b). See Unit VIII.
D. Why is EPA proposing both a SNUR and a test rule?
EPA has found no evidence of manufacture or processing of c-
pentaBDE or c-octaBDE except as impurities. The principal manufacturers
and importer of c-decaBDE have informed the Agency that they intend to
phase out manufacture and import of the chemical no later than December
31, 2013 (Refs. 9-11). EPA believes that other manufacturers and
importers of decaBDE will also cease their activities by that date. EPA
is proposing to amend the SNUR to ensure that after these activities
have been discontinued, no one resumes them without notifying EPA in
advance, thereby providing EPA with an opportunity to review the new
uses before they commence. Before promulgating the amended SNUR, EPA
will verify through comments on this action, or by other means, that
the proposed significant new uses have ceased. EPA seeks comment on
whether anyone intends to manufacture, import or process any of the
PBDEs included in the proposed SNUR, including in articles, for any of
the proposed significant new uses.
EPA is proposing a test rule to obtain information needed to assess
the effects on humans and the environment of manufacture, import, or
processing of c-pentaBDE, c-octaBDE, or c-decaBDE in the event these
activities do not cease by December 31, 2013.
E. Why does the proposed test rule include three commercial PBDE
mixtures while the SNUR includes seven PBDE congeners?
The test rule is designed to provide the Agency with data relevant
to commercial PBDE products actually in use or intended for use. There
are three commercial PBDE products: c-PentaBDE, c-octaBDE, and c-
decaBDE. The test rule proposes that testing be conducted on a
representative form of each commercial mixture to better understand
their potential effects on health and the environment. Some of the data
obtained by the test rule would address unmet data needs identified by
EPA through the VCCEP. All three of the commercial PBDE products are
mixtures, but have different predominant components. Other PBDE
congeners may be present in the mixtures in lesser amounts.
The SNUR is designed to provide the Agency with advance notice of
manufacture or processing of any one or any combination of the seven
PBDEs for a significant new use. Since the composition of any future
commercial PBDE products may vary in terms of congener composition, the
Agency determined that it would be more effective to include all seven
of the individual PBDE congeners in the SNUR. Thus, all congeners in
any future commercial PBDE product would be subject to the SNUR
reporting requirements.
F. Will EPA promulgate both the test rule and the SNUR?
EPA could promulgate both the test rule and the SNUR. EPA's focus
in this proposed rule is on the phase-out of the manufacture and import
of PDBEs for all uses, including in articles. EPA's final action would
depend on whether the manufacture or processing of c-pentaBDE, c-
octaBDE, or c-decaBDE will continue after December 31, 2013, as
explained in Units II.F.1. and II.F.2. The existence or absence of a
SNUR does not affect a person's obligations under a test rule.
1. Reporting obligations if continuing existing uses of PBDEs. If
EPA were to learn through comments on this proposed action, or through
other means, that a person intended to manufacture or process c-
pentaBDE, c-octaBDE, or c-decaBDE after December 31, 2013, EPA would
promulgate the test rule. If a person indicated his intention to
continue to engage in an activity proposed as a significant new use for
any of these c-PBDEs, EPA would promulgate the proposed amendments to
the SNUR designating all other uses of that PBDE as significant new
uses. EPA would exclude the ongoing uses from the final SNUR.
Therefore, a person who is manufacturing, importing or processing the
c-PBDEs for an ongoing use after the effective date of the test rule
would not need to submit a SNUN for that use and would be allowed to
continue those activities while complying with the test rule. (See Unit
V.C. for further discussion of what constitutes an ongoing use.)
However, if EPA were to learn that the only persons that would be
subject to the test rule would be persons that process (rather than
manufacture) c-pentaBDE, c-octaBDE, or c-decaBDE as impurities
contained in articles, EPA would not require testing because EPA has
not determined whether this activity alone may present an unreasonable
risk of injury to health or the environment. For example, persons who
grind old plastic pallets containing decaBDE for the purpose of reusing
the ground material in the fabrication of ``new'' plastic pallets would
be considered processors of decaBDE as an impurity, if the decaBDE is
unintentionally present in the recycled product (see Unit II.C.). If
decaBDE is still being used as a flame retardant in a recycled product,
it would have been considered to be processed.
2. Reporting obligations if initiating new uses of PBDEs, including
resumption of discontinued uses. Uses
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not ongoing at the time of the proposal would be designated significant
new uses in the final SNUR. Uses ongoing at the time of this proposed
rule, but discontinued at the time the SNUR is finalized, would also be
designated significant new uses. As required under TSCA section
5(b)(1)(A), if EPA has promulgated a final test rule for a chemical
substance, any person who is required to submit a SNUN before beginning
the manufacture or processing of that chemical substance is also
required to submit test data under the final test rule for that
chemical substance at the time that the SNUN is submitted. Persons who
intend to begin (or resume) commercial manufacture, import, or
processing of the chemical substance(s), including in articles, for
such uses would have to comply with all applicable SNUN requirements,
including submission of data if a test rule is in effect, and wait
until EPA's statutorily-defined time period for its review of the SNUN
expires before commencing those activities.
EPA expects that the manufacture and processing of the PBDEs
identified in this proposed rule, except as impurities, including these
PBDEs when contained in articles, will have been discontinued for most
uses by the date indicated in the proposed amendments to the SNUR. EPA
intends to promulgate amendments to the SNUR designating manufacturing
and processing for any use which is not ongoing (including uses first
arising after April 2, 2012 and uses discontinued since April 2, 2012)
as a significant new use. The proposed SNUR would not apply to any
ongoing uses identified at the point of finalization (i.e., uses
arising before April 2, 2012 and which have not been discontinued as of
the date of finalization). All other uses, including discontinued uses,
would be designated as significant new uses. EPA recognizes that
certain portions of the proposed significant new use may be still
ongoing as of April 2, 2012, and will verify whether they have been
discontinued (i.e., whether they are indeed ongoing) before issuing a
final SNUR that incorporates them.
G. What is the Agency's authority for taking this action?
1. SNURs. 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 SNUN to
EPA at least 90 days before they manufacture or process the chemical
substance for that use (15 U.S.C. 2604(a)(1)(B)). For purposes of TSCA
section 5, the terms ``manufacture'' and ``process'' mean manufacturing
or processing for commercial purposes.
2. Test rule. Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states
that it is the policy of the United States that ``adequate data should
be developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture [which is
defined by statute to include import] and those who process such
chemical substances and mixtures[.]'' To implement this policy, TSCA
section 4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) provides that EPA shall
require by a rule published in the Federal Register manufacturers or
processors or both of chemical substances and mixtures conduct testing,
if the EPA Administrator makes the findings under either or both TSCA
section 4(a)(1)(A) (an ``A'' finding) and/or TSCA section 4(a)(1)(B) (a
``B'' finding) in a final rule. Under TSCA section 4(a)(1)(A), the EPA
Administrator must find that:
(i) the manufacture, distribution in commerce, processing, use,
or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or any combination of
such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data[.]
Under TSCA section 4(a)(1)(B), the EPA Administrator must find that:
(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture, (ii) there are insufficient data and
experience upon which the effects of the manufacture, distribution
in commerce, processing, use, or disposal of such substance or
mixture or of any combination of such activities on health or the
environment can reasonably be determined or predicted, and (iii)
testing of such substance or mixture with respect to such effects is
necessary to develop such data.
Under TSCA section 4(a)(2), if the EPA Administrator finds that, in
the case of a mixture, the effects which the mixture's manufacture,
distribution in commerce, processing, use, or disposal or any
combination of such activities may have on health or the environment
may not be reasonably and more efficiently determined or predicted by
testing the chemical substances which comprise the mixture; the EPA
Administrator shall by rule require that testing be conducted on such
mixture.
The purpose of the testing would be to develop data with respect to
the health and environmental effects for which there is an
insufficiency of data and experience, and which are relevant to a
determination that the manufacture, distribution in commerce,
processing, use, or disposal of the chemical substance or mixture, or
that any combination of such activities, does or does not present an
unreasonable risk of injury to health or the environment.
The extent to which such activities may affect health or the
environment is dependent in part upon the human and environmental
exposures to the chemical substance or mixture occasioned by those
activities. As an example, TSCA section 4(b)(2)(A) specifically
addresses testing for persistence of a substance. Testing to identify
where and in what concentrations a chemical substance or mixture may
become present in the environment contributes to an understanding of
human and environmental exposures resulting from those activities.
Once the EPA Administrator has made the relevant findings under
TSCA section 4(a), EPA may require any health or environmental effects
testing for which data are insufficient and which are necessary to
develop the data. EPA need not limit the scope of testing required to
the factual basis for the TSCA section 4(a)(1)(A)(i) or 4(a)(1)(B)(i)
finding as long as EPA also finds that there are insufficient data and
experience upon which the effects of the manufacture, distribution in
commerce, processing, use, or disposal of such substance or mixture or
of any combination of such activities on health or the environment can
reasonably be determined or predicted, and that testing is necessary to
develop such data. This approach is explained in more detail in EPA's
TSCA section 4(a)(1)(B) Final Statement of Policy (B Policy) published
in the Federal Register issue of May 14, 1993 (Ref. 12).
In this proposed test rule, based on a preliminary ``A'' finding,
EPA would use its authority under TSCA section 4(a) to require the
development of data ``which are relevant to a determination that the
manufacture, processing,
[[Page 19867]]
distribution in commerce, use, or disposal * * * or any combination of
such activities'' of any or all of the three c-PBDE mixtures, i.e., c-
pentaBDE, c-octaBDE, and c-decaBDE, does or does not present an
unreasonable risk of injury to health or the environment.
Pursuant to TSCA section 12(a)(2), EPA is also proposing to use its
authority under TSCA section 4(a) to require testing of mixtures named
in this proposed test rule which would otherwise be exempted from TSCA
under section 12(a)(1). Section 12(a)(1) of TSCA exempts from TSCA the
manufacture, processing, or distribution in commerce of a mixture for
export from the United States in certain situations. Such testing would
be for the purpose of determining whether or not the mixture presents
an unreasonable risk of injury to health within the United States or to
the environment of the United States.
H. How are the general provisions applicable?
1. SNUR. General provisions for SNURs appear under 40 CFR part 721,
subpart A. These provisions describe persons subject to the rule,
recordkeeping requirements, and exemptions to reporting requirements.
However, the article exemption for SNURs at 40 CFR 721.45(f) would
not apply to this proposed SNUR. A person who imports or processes a
chemical substance that would be covered by this action as part of an
article would be subject to SNUN reporting requirements. A person who
manufactures or processes a PBDE only as an impurity would be exempt
from the SNUR under 40 CFR 721.45(d).
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must 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
submissions 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
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.
2. Test rule. General provisions for test rules appear under 40 CFR
part 790 (subparts A, B, C, and E), part 791, part 792, and part 799
(subpart A). These provisions describe persons subject to the rule,
procedures for developing test rules, implementation, enforcement, and
modification of test rules, exemption from testing, data reimbursement,
and good laboratory practice standards. 40 CFR 791.48(b) would not
apply to this proposed test rule for the purpose of defining production
volume to determine fair reimbursement shares. Production volume would
be defined as including amounts of the test chemical substance imported
in bulk form, in mixtures, in articles, and the total domestic
production of the chemical substance including that produced as a
byproduct or as an impurity. See 40 CFR 799.5350(f) of this proposed
rule. Also, persons described in 40 CFR 790.2 as subject to a test rule
include, among others, importers and processors of a chemical substance
or mixture as part of an article. Submission of a SNUN would not affect
a person's obligations under a test rule.
III. Overview of PBDEs
A. Chemistry of PBDEs
The PBDEs are a family of chemical substances with a common
structure of a brominated diphenyl ether molecule which may have
anywhere from 4 to 10 bromine atoms attached (Figure 1).
[GRAPHIC] [TIFF OMITTED] TP02AP12.003
Each individual PBDE variant, distinguished from others by both the
number of bromine atoms and the placement of those atoms, is referred
to as a congener. For example, there are 42 tetrabromodiphenyl ether
congeners, each with 4 bromine atoms in different configurations.
Specific congeners, also known as isomers, in which both the number and
location of bromine atoms is specified are given numbers, e.g., BDE-47.
In theory, there could be as many as 209 PBDE congeners, but a much
smaller number of congeners are commonly found in the commercial PBDE
products and in measurements of PBDEs in humans and the environment
(Table 1 of this unit). Scientific studies, particularly those
measuring presence of PBDEs in tissues and the environment, often
report their findings by BDE number.
PBDE congeners can be grouped as homologs, i.e., according to the
number of bromine atoms present in the molecule. The TSCA Chemical
Substances Inventory (TSCA Inventory) listings and regulations for
PBDEs are based on these homolog groups. (Table 1 of this unit). The
PBDE homologs used in flame retardants have between 4 and 10 bromine
atoms. EPA regulations of PBDEs generally apply to congeners grouped
according to homolog groups rather than specific congener/isomers
designated by BDE number.
There are three types of commercial PBDE (c-PBDE) products, c-
pentaBDE, c-octaBDE, and c-decaBDE; each commercial product is a
mixture of PBDE congeners (see Table 2 of this unit).
[[Page 19868]]
Table 1--PBDE Homolog Groups
----------------------------------------------------------------------------------------------------------------
Chemical abstracts Number of
Common name Chemical abstracts (CA) index name service registry bromine (Br)
number (CASRN) atoms
----------------------------------------------------------------------------------------------------------------
TetraBDE.......................... Benzene, 1,1'-oxybis-, tetrabromo 40088-47-9 4
deriv..
PentaBDE.......................... Benzene, 1,1'-oxybis-, pentabromo 32534-81-9 5
deriv.
HexaBDE........................... Benzene, 1,1'-oxybis-, hexabromo deriv 36483-60-0 6
HeptaBDE.......................... Benzene, 1,1'-oxybis-, heptabromo 68928-80-3 7
deriv.
OctaBDE........................... Benzene, 1,1'-oxybis-, octabromo deriv 32536-52-0 8
NonaBDE........................... Benzene, 1,1'-oxybis-, 1,2,3,4,5- 63936-56-1 9
pentabromo-6- (tetrabromophenoxy)-.
DecaBDE........................... Benzene, 1,1'-oxybis [2,3,4,5,6- 1163-19-5 10
pentabromo-.
----------------------------------------------------------------------------------------------------------------
Table 2--Congeners in Commercial PBDE Mixtures
----------------------------------------------------------------------------------------------------------------
Commercial mixture Major components Minor components
----------------------------------------------------------------------------------------------------------------
c-PentaBDE............................... TetraBDE................... HexaBDE.
PentaBDE...................
c-OctaBDE................................ HeptaBDE................... HexaBDE.
OctaBDE.................... NonaBDE.
DecaBDE.
c-DecaBDE................................ DecaBDE.................... NonaBDE.
----------------------------------------------------------------------------------------------------------------
B. Actions Taken to Understand and Limit Risk from Use of PBDEs
EPA has been concerned about the reported health and environmental
effects of PBDEs and potential exposure to PBDEs for some time, and has
taken several actions to fully understand their effects and to reduce
exposure to them. Of particular note are the VCCEP, which was announced
in 2000 (Ref. 13), and the 2006 PBDE SNUR (Ref. 1). More recently, EPA
articulated its concerns regarding these effects in the PBDE Action
Plan (Ref. 2).
c-PentaBDE, c-octaBDE, and c-decaBDE were among the chemical
substances evaluated in VCCEP. VCCEP was designed to collect health
effects information on chemicals to which children had a high
likelihood of being exposed and to characterize the risk to children
from that exposure. Sponsors in VCCEP provided health effects and
exposure information on a voluntary basis. Through VCCEP the Agency
identified data needs for all three c-PBDEs that were beyond what was
provided by the sponsors in the initial chemical assessments. The
sponsors of c-pentaBDE and c-octaBDE, however, declined to conduct
testing to address the identified data needs because of plans to
discontinue manufacture of these chemicals in 2004. Later the sponsors
of c-decaBDE also declined to conduct testing to provide the data needs
identified through VCCEP and subsequently decided to phase out their
activities with c-decaBDE. As a result, the sponsoring companies did
not meet the additional data needs identified through VCCEP for any of
the three c-PBDEs. Tests addressing those data needs are among the
tests proposed for c-pentaBDE, c-octaBDE, and c-decaBDE in this
proposed rule. c-PentaBDE and c-octaBDE had been widely used as
additive flame retardants in a number of applications until their sole
U.S. manufacturer, the Great Lakes Chemical Corporation (now Chemtura
Corporation) voluntary phased out their production in 2004. c-PentaBDE
was used primarily in flexible polyurethane foams. c-OctaBDE was used
in acrylonitrile-butadiene-styrene (ABS) plastic which was used in
applications such as casing for certain electric and electronic devices
used in both offices and homes. When manufacture of c-pentaBDE and c-
octaBDE was discontinued, EPA promulgated a SNUR (Ref. 1) which
requires that any person who intends to manufacture or import a
chemical substance containing any of the congeners present in c-
pentaBDE or c-octaBDE (namely tetraBDE, pentaBDE, hexaBDE, heptaBDE,
octaBDE, and nonaBDE), or any combination of these chemical substances
resulting from a chemical reaction, to notify EPA at least 90 days in
advance of manufacture or import for any use on or after January 1,
2005. The SNUR does not address processing of PBDEs, nor does it apply
to import of articles which contain any of the congeners present in c-
pentaBDE or c-octaBDE.
c-DecaBDE is still manufactured and widely used in the United
States as an additive flame retardant. The three major product
categories in which c-decaBDE is used are: Textiles, electronic
equipment, and building and construction materials. Its primary use is
in high impact polystyrene (HIPS) based products. However as a result
of the voluntary phase-out announced on December 17, 2009 (Refs. 9-11),
EPA expects manufacture and processing for most uses of c-decaBDE to be
discontinued by the end of 2013.
Other actions EPA has taken with PBDEs include:
1. Supporting the inclusion in voluntary consensus standards of
criteria restricting PBDE use as a product component (e.g., in carpets,
electronics, and furniture) or use in manufacturing processes.
2. Working with and through programs (i.e., Furniture Flame
Retardancy Partnership and the Green Suppliers Network) to identify
environmentally safer approaches to meeting fire standards and to
improve awareness of concerns related to PBDEs.
C. Human Health Effects
In 2008, EPA published peer-reviewed toxicological reviews of
tetraBDE (BDE-47), pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE
(BDE-209) (Refs. 14-17), to support summary information on EPA's
Integrated Risk Information System (IRIS) database (http://www.epa.gov/iris). Developmental neurotoxicity was identified as the critical
effect for each of the four chemicals. EPA also concluded that the
database for decaBDE (BDE-209) provides ``suggestive evidence of
carcinogenic potential'' (Ref. 17).
Through EPA's VCCEP, industry-sponsored screening level risk
assessments for c-pentaBDE, c-octaBDE, and c-decaBDE were developed to
[[Page 19869]]
evaluate the potential risks to children and prospective parents from
PBDE exposures (Ref. 13). EPA's evaluation of these assessments
considered adverse neurobehavioral effects to be the most sensitive
health endpoint following postnatal exposure to PBDEs (Refs. 7 and 8).
Effects on spontaneous motor behavior (locomotion, rearing, and total
activity) were observed in adult rats after postnatal exposure.
Additional effects due to higher exposures to c-pentaBDE were observed
in the following studies:
Repeated-dose toxicity studies for c-pentaBDE showed
changes in liver enzyme activity, increased liver weight, and
histologic changes in the liver.
Changes in thyroid hormone T4 levels and
thyroid hyperplasia were noted in oral adult rat studies.
In limited prenatal developmental studies, decreases in
T4 levels were reported for dams and offspring (Ref. 7).
Additional effects due to higher exposures to c-octaBDE were
observed in the following studies:
Repeated-dose toxicity studies showed changes in liver
enzyme activity and increased liver weights.
In prenatal developmental studies, decreased maternal and
pup bodyweight and decreases in thyroid hormone T4 levels
were reported for rat dams and their offspring (Ref. 7).
EPA concluded there was evidence of developmental and reproductive
effects from exposure to c-pentaBDE and c-octaBDE, but that additional
studies are needed to better characterize potential risks to children
(Ref. 7). Through VCCEP, EPA identified 2-generation reproductive
toxicity studies with a satellite group for body burden determinations
as a data need for both c-pentaBDE and c-octaBDE (Ref. 7). Also through
VCCEP, EPA identified anaerobic debromination in aquatic sediments,
anaerobic debromination in sludge digesters, and photolysis in the
indoor environment as data needs for c-decaBDE to better understand the
chemical fate and thereby the potential exposure to decaBDE and lower
brominated congeners (Ref. 8).
D. Environmental Hazard
Laboratory studies have shown that c-pentaBDE is capable of
producing adverse effects in a variety of organisms including birds,
mammals, fish, and invertebrates (Refs. 3 and 18-28). In some cases,
these effects were observed at exposure levels similar to levels found
in the environment.
E. Environmental Releases and Fate
The exact mechanisms or pathways by which the PBDEs move into and
through the environment and allow humans to become exposed are not
fully understood, but are likely to include releases from manufacturing
of the chemicals, processing c-PBDEs into products like plastics or
textiles, aging and wear of products like sofas and electronics, and
releases at the end of product life (disposal or recycling). In
general, levels of PBDE congeners in humans and the environment are
higher in North America than in other regions of the world, which may
be attributed to the greater use of c-PBDEs in North America (Refs. 29
and 30). The concentration and distribution of congeners detected in
the environment appear to depend on the proximity to a source of the
congener and the media tested (Ref. 31).
PBDE congeners with four to ten bromine atoms are highly
persistent, based on a large body of environmental monitoring data in
both the United States and abroad (Refs. 4, 32, and 33). Available data
also indicate that the tetra-, penta-, hexa- and heptaBDE congeners are
highly bioaccumulative (Ref. 34). After reviewing the available
information, EPA has concluded that decaBDE is a likely contributor to
the formation of bioaccumulative and/or potentially bioaccumulative
transformation products, such as lower brominated PBDEs, in organisms
and in the environment see, e.g., (Refs. 35-38), but the overall impact
of this process as a source of the more toxic, lower brominated PBDE
congeners has not been fully characterized. DecaBDE undergoes
photolytic and possibly microbial debromination under certain
conditions (Refs. 33 and 38). Photolysis is expected to be a
significant transformation process for decaBDE whenever the substance
is significantly exposed to light. For example, it has been found that
decaBDE undergoes photolytic debromination in house dust (Ref. 39).
DecaBDE would also be exposed to light when waste sludge containing
PBDEs is used as a soil amendment, albeit only on the soil surface
(Ref. 40). Studies have shown that photodegradation of decaBDE may
result in PBDEs from tri- to nona-, although most photolysis studies
were done under conditions that do not allow direct extrapolation to
environmental conditions. Metabolism of decaBDE in organisms results
predominantly in nona-, octa- and heptaBDE formation (as reviewed in
Ref. 33). Stapleton (Ref. 38) summarized the effects of decaBDE
debromination, noting that the formation potential for the pentaBDE and
lower congeners was low, but that the formation of the hepta, octa and
nonaBDE congeners was environmentally relevant.
The atmosphere and marine currents can transport PBDEs over
relatively long distances (> 1,000 kilometer (km)). Evidence for this
comes from the presence of PBDEs in the tissues of deep ocean-dwelling
whales and other marine mammals far from anthropogenic sources (Ref.
4), as well as from modeling (Ref. 40). The body burdens of PBDE
congeners in a wide variety of biota, indigenous to geographical areas
ranging from the equator to the poles also substantiate the PBDE
propensity for long-range transport (LRT), and constitute evidence of
environmental persistence (Ref. 34).
F. Human Exposure
The use of c-PBDEs as flame retardants in consumer products is
believed to be a source of exposure. Dermal exposure may occur through
direct contact with c-PBDE-containing products such as computer
housings and textiles (Ref. 5). The lower brominated tetra- and penta-
congeners have also been detected in the vapor phase of air samples
while the higher brominated congeners are found in associated
particulate matter, including house dust (Refs. 41 and 42). Lorber
(Ref. 42) and EPA (Ref. 5) reported that a significant source of human
exposures to PBDEs appears to be their use in commercial products that
are part of the indoor environment (computer circuitry, foam cushions,
fabrics in curtains, etc). They found that food/water ingestion and
inhalation explained less than 20% of the body burden, based upon the
estimate of total exposure derived using a pharmacokinetic model. They
stated that the remainder of the estimated exposure likely came from
house dust through the pathways of ingestion and dermal contact, or
some other, unknown source. Other literature indicates that inhalation
may be a significant potential route of exposure for the general
population (Ref. 5). In addition, PBDE exposure can occur by ingestion
of foods that are contaminated (Ref. 43). PBDEs have been detected in
human tissue, blood (usually serum), and breast milk (Ref. 44).
Exposure to PBDEs in some occupational settings, such as in computer
recycling, can be higher than those of the general population (Ref.
45). PBDE use as flame retardants in many household products, and
subsequent exposure to indoor house dust containing PBDEs, coupled with
the elevated ingestion potential due to increased intakes of food,
water, and air per pound of body weight, as well as childhood-specific
exposure pathways
[[Page 19870]]
such as breast milk consumption and increased contact with the floor,
make children especially vulnerable.
Recent human biomonitoring data on PBDEs are available in the
Centers for Disease Control and Prevention's (CDC) ``Fourth National
Report on Human Exposure to Environmental Chemicals'' (Ref. 46). The
PBDE data have also been published in the peer-reviewed literature
(Ref. 45). The data were obtained from samples from participants in the
2003-2004 National Health and Nutrition Examination Survey (Ref. 46).
Ten PBDE congeners (containing from three to seven bromines) were
included in the analysis: BDE-17, BDE-28, BDE-47, BDE-66, BDE-85, BDE-
99, BDE-100, BDE-153, BDE-154, and BDE-183; decaBDE was not included.
Participants were aged 12 years and older. BDE-47 was detected in
serum from almost all of the participants and it was highest in 12-19
years old, and those over 59 years old.
Furthermore, serum levels were highest in 12-19 year olds for other
lower-brominated congeners. In addition, these congeners were
significantly correlated with each other--concentration of individual
congeners and total PBDE content in blood serum steadily increased
annually over a 5-year period, suggesting a similar pathway of exposure
via diet, or via direct inhalation or dermal contact.
G. Environmental Exposure
The food chain is likely a large contributor to environmental
exposures. In general, PBDE concentrations are highest in sediment
samples collected downstream from industrial/urban areas, outfalls from
sewage treatment plants, and urban locations without heavy industries.
The lowest PBDE concentrations are generally found in sediments
collected in remote and agricultural areas. DecaBDE (BDE-209) appears
to dominate congener profiles of aquatic sediments. Researchers have
determined concentrations of PBDEs in waterways, sediments, and biota
from various locations such as the Great Lakes, the San Francisco Bay,
and near an unnamed polyurethane foam manufacturing facility for which
PBDE contamination was known or suspected (Ref. 5).
Some studies show evidence that concentrations of PBDEs in biota
have doubled every 3 to 6 years, the doubling time depending on
species, life stage, and location. PBDE levels in trout from the Great
Lakes rose from non-detectable in 1975, to approximately 50 nanograms/
gram (ng/g) in 1990, and to approximately 200 ng/gm in 2000 (Ref. 47).
PBDE concentrations in marine biota in North America are the highest in
the world, and are increasing (Ref. 4). After reviewing the available
information, EPA has concluded that the extent of accumulation of
congeners in biota is directly related to dietary levels of PBDEs.
Observed differences in PBDE congener profiles in marine mammals from
California, Alaska, and the Gulf of Mexico indicate that diet is a
significant source of PBDE exposure in marine wildlife (Ref. 4).
DecaBDE has been found at high levels in predators such as
peregrine falcons (Ref. 6). Biomonitoring studies of wild mink from the
Great Lakes region revealed that margins of safety for mink are small,
and that PBDE concentrations in mink from Hamilton Harbor exceeded the
no-observed-adverse-effect concentrations (Ref. 3).
Biomagnification is the process in which the concentration of a
chemical in an organism achieves a level that exceeds that in the
organism's diet, due to dietary absorption (Ref. 48). Biomagnification
occurs as predators up the food chain ingest the accumulated PBDEs in
the bodies of their prey (Refs. 4 and 49-51). Environment Canada
concluded that the greatest potential risks from PBDEs in the Canadian
environment are the secondary poisoning of wildlife from the
consumption of prey containing elevated concentrations of PBDEs, and
effects on benthic organisms that may result from elevated
concentrations of certain PBDEs in sediments (Ref. 32).
Biomagnification of PBDEs has been observed in fish; PBDE levels in
sediment were directly related to increases and decreases in the PBDE
levels measured in fish (Ref. 52). Environment Canada concluded that
decaBDE is available for uptake in organisms, and may accumulate to
high and potentially problematic levels in certain species such as
birds of prey or mammalian predators (Ref. 33).
Although not conclusive, some data suggests that PBDEs may
debrominate in the bodies of wild birds. Park, et al., (Ref. 47) found
that younger peregrine falcons had higher levels of BDE-209 and other
highly brominated congeners, whereas older birds had higher levels of
the less brominated (hexa) BDE-153, which could not be explained by the
BDE-153 levels in diet. Further, in eggs that were collected yearly
from the same bird, PBDE congener concentrations changed yearly, with
levels of BDE-209 decreasing, and levels of BDE 153 increasing in the
last 2 years relative to the former 4 years (but no such obvious
changes in polychlorinated biphenyl (PCB) levels). The chemical
measurements and comparison in this study are valuable because a
similar laboratory study would take many years in similar long-lived
avian species (peregrines live 7-15 years or longer), and environmental
variables that affect PBDE uptake and biomagnifications, including
exposure to other chemicals, might be difficult to simulate. Similar
evidence of debromination of decaBDE has been observed in carp (Refs.
38 and 53) and British starlings (Ref. 53).
IV. Proposed Findings
A. SNUR
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of 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.
To determine what would constitute a significant new use of PBDEs,
EPA also considered other relevant factors including information about
the toxicity of PBDEs as well as exposures and environmental presence
resulting from past use.
As discussed in Unit III., there is evidence that PBDEs may be
toxic to humans and wildlife. However, there is insufficient data to
fully evaluate the significance of observed exposures. EPA is also
concerned that the PBDEs included in these proposed amendments to the
SNUR are highly persistent in the environment. Some lower brominated
PBDEs are highly bioaccumulative, and others may debrominate to the
lower brominated forms. In general, levels of PBDEs in humans and the
environment are higher in North America than in other regions of the
world, which may be attributed to the greater use of PBDEs in North
America. Some monitoring data show a steady increase from non-
detectable levels when PBDEs first came into use to current levels. The
exact mechanisms or pathways by which the PBDEs move into and through
the environment and allow humans and wildlife to become exposed are not
fully understood, but are likely to include releases from manufacturing
of the chemicals,
[[Page 19871]]
processing PBDEs into products like plastics or textiles, aging and
wear of products like sofas and electronics, and releases at the end of
product life (disposal or recycling).
Once the manufacture and processing of PBDEs have been
discontinued, EPA expects their presence in humans and the environment
to decline over time as has been observed in the past when production
and use of other persistent chemicals has ceased.
EPA is concerned that if manufacture and processing of PBDEs were
to resume, the anticipated decline in levels in humans and the
environment will be disrupted as PBDEs are introduced into the
environment at levels greater than would otherwise occur. The result
would be that the magnitude and duration of exposure of humans and the
environment in the future would likely increase.
B. Test Rule
Based on the data cited in Units III.C. through III.G., EPA has
made the following preliminary determinations. First, c-pentaBDE, c-
octaBDE, and c-decaBDE may present a hazard to human health. c-
PentaBDE, c-octaBDE, and c-decaBDE were all reviewed under EPA's VCCEP.
Members of the peer consultation panel for c-pentaBDE and c-octaBDE
noted that there are indications of thyroid toxicity in some rodent
studies, and thyroid toxicity can have adverse effects on reproductive
success and fetal development (Ref. 7). For c-decaBDE, VCCEP identified
anaerobic debromination in aquatic sediments, anaerobic debromination
in sludge digesters, and photolysis in the indoor environment as a
potential source of human and environmental exposure to lower
brominated congeners (Ref. 8). Debromination of decaBDE to form lower
brominated, more toxic congeners is potentially relevant to effects on
both human health and the environment. EPA's IRIS database indicates
that neurobehavioral effects are critical endpoints of concern for
components of c-pentaBDE and c-decaBDE. EPA has also concluded that
there is suggestive evidence of carcinogenic potential for decaBDE
(BDE-209), which is the main component of c-decaBDE.
Second, c-pentaBDE and c-decaBDE may present a hazard to the
environment. Laboratory studies have shown that c-pentaBDE is capable
of producing adverse effects in a variety of organisms including birds,
mammals, fish, and invertebrates. In some cases these effects were
observed at exposure levels similar to levels found in the environment.
c-DecaBDE may contribute to these levels by debrominating to lower,
more toxic brominated congeners in the environment.
Third, pentaBDE, octaBDE, and decaBDE congeners, which are among
the predominant components of c-pentaBDE, c-octaBDE, and c-decaBDE
respectively, are ubiquitous in soil, sediments and living organisms
(Ref. 54). PentaBDE, octaBDE, and decaBDE congeners have been found in
human tissue, blood and breast milk (Ref. 55). These chemicals persist
in the environment and accumulate in organisms that ingest or inhale
them. For example, high levels of decaBDE have been found in high
trophic level animals, e.g., predatory animals such as the peregrine
falcon. However, the predominant congeners present in living organisms
tend to be the lower brominated, more toxic forms, which include
pentaBDE (Refs. 56 and 57). Infants and children, as well as people who
are occupationally exposed, may be exposed at higher levels than the
general public.
Based on the evidence of human and environmental exposure to
pentaBDE, octaBDE, and decaBDE congeners, which derive from c-pentaBDE,
c-octaBDE, and c-decaBDE, coupled with the evidence of human and/or
environmental hazard of c-pentaBDE, c-octaBDE, and c-decaBDE, EPA
preliminarily finds under TSCA section 4(a)(1)(A)(i) that the
manufacture, processing, distribution in commerce, use, and disposal of
c-pentaBDE, c-octaBDE, and c-decaBDE, or any combination of such
activities, may present an unreasonable risk of injury to human health
and the environment.
Through the testing of c-pentaBDE and c-octaBDE in VCCEP, EPA
identified 2-generation reproductive toxicity studies with a satellite
group for body burden determinations as a data need for c-pentaBDE and
c-octaBDE (Ref. 7). For c-decaBDE, VCCEP identified anaerobic
debromination in aquatic sediments, anaerobic debromination in sludge
digesters, and photolysis in the indoor environment as data needs (Ref.
8). Therefore, EPA also preliminarily finds under TSCA section
4(a)(1)(A)(ii) that there are insufficient data upon which the effects
of such manufacture, processing, distribution in commerce, use, and
disposal of c-pentaBDE, c-octaBDE, and c-decaBDE, or any combination of
such activities, on health or the environment can reasonably be
determined or predicted. Under TSCA section 4(a)(1)(A)(iii), EPA
preliminarily finds that testing of c-pentaBDE, c-octaBDE, and c-
decaBDE with respect to these and other toxic effects is necessary to
develop such data.
EPA has determined in accordance with TSCA section 4(a)(2) that the
effects of the mixtures, c-pentaBDE, c-octaBDE, and c-decaBDE, may be
reasonably and more efficiently determined by testing the commercial
products themselves rather than the individual chemical substances
which comprise these mixtures. EPA believes that testing of the
individual chemical substances that are present in the commercial
mixtures at different percentages would be less efficient and less
predictive of the effects of the commercial mixtures than testing of
representative forms of commercial products as they are manufactured.
EPA believes that testing the mixture will best reflect the effects of
exposure due to the possible additive, synergistic, and/or antagonistic
effects resulting from the possible interaction of congeners in a
mixture. EPA believes that testing the commercial products will be more
efficient than testing the individual components because fewer tests
would be needed to address the Agency's concerns. Nonetheless, EPA is
still requesting comment in Units XI.B.4. through XI.B.7. on what the
test substance should be and how it should be defined.
V. Proposed Amendments to the SNUR
A. Summary of Proposed Amendments to the SNUR
This proposed rule would amend the SNUR at 40 CFR 721.10000. Under
the existing SNUR, any person who intends to manufacture certain PBDEs
must notify EPA at least 90 days before commencing the manufacture of
any one or more of those chemical substances after January 1, 2005, for
any use. The following chemicals substances are subject to reporting
under the existing SNUR: TetraBDE, pentaBDE, hexaBDE, heptaBDE,
octaBDE, and nonaBDE, or any combination of these chemical substances
resulting from a chemical reaction.
Among other activities, the use of a PBDE in the manufacture of an
article is considered processing of the PBDE. In the existing SNUR, the
Agency did not designate processing of the subject PBDEs as a
significant new use because it believed that such activities were
ongoing. The Agency now believes that processing of tetraBDE, pentaBDE,
hexaBDE, heptaBDE, octaBDE, and nonaBDE has been discontinued and
therefore is proposing to amend the SNUR to include processing as a
significant new use. EPA believes that resumption of the practice of
processing
[[Page 19872]]
PBDEs would increase exposure to PBDEs and releases of PBDEs to the
environment. However, as explained in Unit II.F., if a person indicated
that he is engaged in an activity proposed as a significant new use for
these PBDEs, EPA would promulgate the proposed amendments to the SNUR
designating all other uses of that PBDE as significant new uses. EPA
would exclude the ongoing use(s) from the final SNUR. The Agency
requests comments on whether there is existing, ongoing processing of
these chemical substances.
On December 19, 2009, the principal U.S. manufacturers and importer
of decaBDE committed to end production, and importation of decaBDE in
the United States for all uses except military uses and transportation
uses by December 31, 2012, and for all uses including military and
transportation uses by the end of 2013 (Refs. 9-11). The Agency also
expects other manufacturers to discontinue manufacture of decaBDE by
the end of 2013. Therefore, the Agency is proposing to amend the SNUR
by adding, after December 31, 2013, decaBDE to the list of chemical
substances subject to reporting and by designating (again, after
December 31, 2013) manufacture and processing of decaBDE for any
discontinued use as a significant new use. The Agency understands that
some downstream users of decaBDE would like the manufacture and
processing of decaBDE for some uses to continue after December 31,
2013. The Agency understands that these downstream users believe that
there will continue to be critical military and aeronautical uses of
decaBDE (some examples are use in insulation, ducting, electronic
components) after December 31, 2013. The Agency seeks comments on the
extent to which these uses will continue despite the phase-out in the
manufacture and import of decaBDE and whether there are any other uses
which will not be discontinued by December 31, 2013. Persons who
comment are asked to specify both the functional application of the
article containing decaBDE, e.g., ductwork for aircraft, and the
material to which the decaBDE is added, e.g., high impact polystyrene.
Persons who comment should also include definitions of terms, where
appropriate.
EPA's objective in proposing these amendments to the PBDE SNUR is
to enable the Agency to review and, if necessary, limit or prohibit
resumption of any activities which could result in increasing the
amount of PBDEs in commerce in the United States.
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 40 CFR part 721 is not generally subject to
the notification requirements of 40 CFR 721.25 for that chemical
substance, if the person imports or processes the chemical substance as
part of an article. However, EPA is concerned that if PBDEs contained
in articles are exempt, they could be imported without a SNUN and
thereby increase the amount of PBDEs in commerce in the United States
without a review by EPA. Therefore, the Agency is proposing that the
article exemption for SNURs at 40 CFR 721.45(f) not apply to the rule.
B. Alternatives to the SNUR
Before proposing these amendments to the PBDE SNUR, EPA considered
the following alternative regulatory actions:
1. Promulgate a TSCA section 8(a) reporting rule. Under a TSCA
section 8(a) rule, EPA could, among other things, generally require
persons to report information to the Agency when they intend to
manufacture or process a listed chemical substance for a specific use
or any use. However, for PBDEs the use of TSCA section 8(a) rather than
SNUR authority would have several limitations. First, if EPA were to
require reporting under TSCA section 8(a) instead of TSCA section 5(a),
EPA would not have the opportunity to review human and environmental
hazards and exposures associated with the proposed significant new uses
and, if necessary, take immediate follow-up regulatory action under
TSCA section 5(e) or 5(f) to prohibit or limit the activity before it
begins. In view of the level of health and environmental concerns about
the chemical substances subject to this proposed rule, if they were
used for the proposed significant new uses, EPA believes that a TSCA
section 8(a) rule for this chemical substance would not meet EPA's
regulatory objectives.
2. Regulate under TSCA section 6. EPA may regulate under TSCA
section 6 if ``the Administrator finds that there is a reasonable basis
to conclude that the manufacture, processing, distribution in commerce,
use or disposal of a chemical substance or mixture [...] presents or
will present an unreasonable risk of injury to health or the
environment.'' (TSCA section 6(a)). Given that the chemical substances
named in this proposed rule are no longer being manufactured or
processed for the proposed significant new uses, or the activities are
scheduled to be discontinued, EPA concluded that risk management action
under TSCA section 6 is not necessary at this time. These proposed
amendments to the SNUR would allow the Agency to address the potential
risks associated with the proposed significant new use. EPA is
proposing to require that persons who manufacture, import, or process
c-pentaBDE, c-octaBDE, or c-decaBDE after December 31, 2013, conduct
testing in accordance with the proposed test rule which accompanies
these proposed amendments to the SNUR. The data obtained through such
testing will assist the Agency in determining whether additional
regulatory action is appropriate.
C. Applicability of the SNURs to Uses Begun After the Publication of
This Proposed Rule and Uses Begun Prior to the Publication of This
Proposed Rule
With respect to uses that are not ongoing as of the date of
publication of the proposed rule, as discussed in the Federal Register
of April 24, 1990 (55 FR 17376) (1990 Decision), EPA has decided that
the intent of TSCA section 5(a)(1)(B) is best served by designating a
use as a significant new use as of the date of publication of the
proposed rule rather than as of the effective date of the final rule.
If uses begun after publication of the proposed rule were considered
ongoing rather than new, it would be difficult for EPA to establish
SNUR requirements, because a 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. Thus, persons who begin commercial manufacture or
processing of the chemical substance(s), or articles containing those
chemical substances that would be regulated through the proposed rule,
if finalized, would have to cease any such activity before the
effective date of the final rule if and when finalized, where such
manufacture or processing was not ongoing at the time of proposal. This
applies to all entities that do not currently engage in these
activities; it does not apply to entities that are currently engaged in
these activities. To resume their activities, these persons would have
to comply with all applicable SNUR notice requirements and wait until
the notice review period, including all extensions, expires. EPA has
promulgated provisions (40 CFR 721.45(h)) to allow persons to submit a
SNUN before the effective date of the SNUR. If a person were to meet
the conditions of 40 CFR 721.45(h), that person would be considered to
have met the requirements of the final SNUR for
[[Page 19873]]
those activities, when that final SNUR became effective.
In this action, EPA proposes to designate as significant new uses
certain uses that are ongoing as of the date of publication of the
proposed rule, but for which there is a reasonable expectation that the
use will be discontinued in the near future. Such uses would not be
designated as significant new uses if they remain ongoing at the time
the SNUR is finalized. EPA's 1990 Decision regarding uses commenced
after proposal and ongoing at the time the SNUR is finalized (i.e.,
that they may be designated as significant new uses, notwithstanding
the fact that they are ongoing at the time of finalization) is
inapplicable to uses that are ongoing as of the date of publication of
the proposed rule.
D. Test Data and Other Information
EPA recognizes that TSCA section 5 generally does not require the
development of any particular test data before submission of a SNUN,
however EPA is also proposing a test rule for c-pentaBDE, c-octaBDE,
and c-decaBDE under TSCA section 4(a)(1)(A). Under TSCA section
5(b)(1), if a chemical is subject to a test rule, persons submitting a
SNUN are required to submit test data in accordance with the test rule
at the time the SNUN is submitted. In the absence of a test rule or a
TSCA section 5(b)(4) rule (see TSCA section 5(b)(2)) covering the
chemical substance, persons are required to submit test data in their
possession or control and to describe any other data known to or
reasonably ascertainable by them (see 40 CFR 720.50). As a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, processing, or use. EPA encourages persons to
consult with the Agency before submitting a SNUN. As part of this
optional pre-notice consultation, EPA would discuss specific data it
believes may be useful in evaluating a significant new use. SNUNs
submitted for significant new uses without any test data may increase
the likelihood that EPA will take action under TSCA section 5(e) to
prohibit or limit activities associated with this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
2. Potential benefits of the chemical substance.
3. Information on risks posed by the chemical substances resulting
from the significant new use compared to risks posed by potential
substitutes.
E. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the chemical substance. According to 40 CFR
721.1(c), persons submitting a SNUN must comply with the same notice
requirements and EPA regulatory procedures as persons submitting a PMN,
including submission of test data on health and environmental effects
as described in 40 CFR 720.50.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in 40 CFR 720.50. SNUNs must be
on EPA Form No. 7710-25, generated using e-PMN software, and submitted
to the EPA in accordance with the procedures set forth in 40 CFR 721.25
and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
VI. Proposed Test Rule
A. What testing is being proposed?
EPA is proposing specific testing and reporting requirements for c-
pentaBDE, c-octaBDE, and c-decaBDE. These requirements are presented in
Table 3 of this unit.
Table 3--Proposed Testing and Reporting Requirements for c-PentaBDE, c-OctaBDE, and c-DecaBDE
----------------------------------------------------------------------------------------------------------------
Test proposed for: Deadline for
------------------------------------------ submitting
final report
(number of
months after
Proposed test Test guideline the effective
c-penta BDE c-octa BDE c-deca BDE date in
proposed 40
CFR
799.5350(k))
----------------------------------------------------------------------------------------------------------------
Toxicity to freshwater ASTM International X X X 12
invertebrates of sediment- (ASTM) E 1706-05e1
associated contaminants. and ASTM E 1391-03
\1\.
Laboratory soil toxicity and ASTM E 1676-04 and X X X 12
bioaccumulation tests with ASTM E 1391-03 \2\.
the lumbricid earthworm
Eisenia fetida and the
enchytraeid potworm
Enchytraeus albidu.
Toxicity to polychaetous ASTM E 1611-00 and X X X 12
annilids of sediment- ASTM E 1391-03 \1\.
associated contaminants.
Laboratory soil toxicity to ASTM E 2172-01 and X X X 12
nematode Caenorhabditis ASTM E 1391-03 \2\.
elegans.
Toxicity to estuarine and ASTM E 1367-03, ASTM E X X X 12
marine invertebrates of 1676-04 \3\ and ASTM
sediment-associated E 1391-03 \1\.
contaminants.
Prenatal developmental 40 CFR 799.9370....... X X X 12
toxicity in rabbits.
2-Generation reproductive 40 CFR 799.9380....... X X X 29
toxicity with satellite group
for body burden
determinations.
Immunotoxicity................ 40 CFR 799.9780....... X X X 12
Neurotoxicity screening 40 CFR 799.9620....... X X X 21
battery, acute and subchronic.
[[Page 19874]]
Developmental neurotoxicity... 40 CFR 799.9630....... X X \4\ X 21
Chronic toxicity/ 40 CFR 799.9430....... X X ............ 60
carcinogenicity.
Anaerobic aquatic metabolism.. 40 CFR 795.25 ............ ............ X 60
(modified OCSPP
835.4400 \5\).
Biodegradation in Anaerobic 40 CFR 795.30 ............ ............ X 24
Digester Sludge. (modified OCSPP
835.3280 \5\).
Photolytic degradation in the 40 CFR 795.65......... ............ ............ X 24
indoor environment.
----------------------------------------------------------------------------------------------------------------
\1\ ASTM E 1391-03 provides guidance on the collection, storage, characterization, and manipulation of sediments
when toxicity to various organisms of sediment-associated contaminants is tested.
\2\ ASTM E 1391-03 provides general guidance.
\3\ ASTM E 1676-04 provides guidance for collecting laboratory soil.
\4\ A developmental neurotoxicity study of decaBDE (Ref. 58) conducted according to the Organization for
Economic Cooperation and Development (OECD) Guideline 426 and sponsored by the Bromine Science and
Environmental Forum (BSEF) was submitted to EPA. If EPA considers the study to be adequately conducted and the
study requirements of OECD Guideline 426 comparable to the study requirements of 40 CFR 799.9630, EPA will
most likely accept the study and not finalize the proposed requirement to conduct developmental neurotoxicity
testing of c-decaBDE.
\5\ Office of Chemical Safety and Pollution Prevention (OCSPP) test guidelines, formerly Office of Toxic
Substances and Pollution Prevention (OPPTS) test guidelines, are available online at http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm.
The proposed testing requirements are listed in 40 CFR 799.5350(h)
and (i) of the proposed regulatory text and include the specification
of test guidelines covering health effects testing, ecotoxicity
testing, and chemical fate testing. EPA's TSCA 799 test guidelines (40
CFR part 799, subpart H) and the Office of Chemical Safety and
Pollution Prevention (OCSPP) 835 series test guidelines (on which 40
CFR 795.25 and 40 CFR 795.30 are based) have been harmonized with the
OECD test guidelines. However, EPA is specifying that the 40 CFR parts
799 and 795 test guidelines, as well as ASTM International standards,
be used rather than OECD test guidelines because the language in 40 CFR
parts 799 and 795 test guidelines and the ASTM International standards
makes clear which steps are mandatory and which steps are only
recommended. Accordingly, in order to comply with the testing required
by a final rule, EPA is proposing that testing must be conducted in
accordance with the specified 40 CFR parts 799 and 795 test guidelines
and ASTM International standards. In addition, EPA is proposing a
guideline developed by the Agency, 40 CFR 795.65, to test for
photolytic degradation. Most of the proposed testing requirements for a
particular endpoint are specified in one test standard. In the case of
certain endpoints, however, additional guidance is provided in a second
guideline and possibly a third guideline (e.g., ASTM E 1391-03 provides
guidance in the collection, storage, characterization, and manipulation
of sediments when toxicity to various organisms of sediment-associated
contaminants is tested). The following testing endpoints and test
standards are proposed to be required for one or more of the test
substances in this proposed rule.
1. Ecotoxicity. a. Toxicity to freshwater invertebrates of
sediment-associated contaminants conducted in accordance with ASTM E
1706-05e1 (Ref. 59) and following the guidance of ASTM E 1391-03 (Ref.
60). EPA proposes this guideline as appropriate to evaluate the
toxicity to freshwater invertebrates of the test substance when
associated with whole sediments.
b. Laboratory soil toxicity and bioaccumulation tests with the
lumbricid earthworm Eisenia fetida and the enchytraeid potworm
Enchytraeus albidu conducted in accordance with ASTM E 1676-04 (Ref.
61) and following the general guidance of ASTM E 1391-03 (Ref. 60). EPA
proposes this guideline as appropriate to evaluate the adverse effects
and bioaccumulation in earthworms and potworms of the test substance
when associated with soils.
c. Toxicity to polychaetous annilids of sediment-associated
contaminants conducted in accordance with ASTM E 1611-00 (Ref. 62) and
following the guidance of ASTM E 1391-03 (Ref. 60). EPA proposes this
guideline as appropriate to evaluate the toxicity to polychaetous
annelids of the test substance when associated with sediment.
d. Laboratory soil toxicity to nematode Caenorhabditis elegans
conducted in accordance with ASTM E 2172-01 (Ref. 63) and following the
general guidance of ASTM E 1391-03 (Ref. 60). EPA proposes this
guideline as appropriate to evaluate the adverse effects on nematodes
of the test substance when associated with soils.
e. Toxicity to estuarine and marine invertebrates of sediment-
associated contaminants conducted in accordance with ASTM E 1367-03
(Ref. 64) and following the guidance of ASTM E 1391-03 (Ref. 60). EPA
proposes this guideline as appropriate to evaluate the toxicity to
estuarine or marine organisms of the test substance when associated
with whole sediments.
2. Mammalian toxicity. a. Prenatal developmental toxicity in
rabbits conducted in accordance with 40 CFR 799.9370. EPA proposes this
guideline as appropriate to provide general information concerning the
effects of exposure to the test substance on the pregnant test animal
and on the developing organism.
b. 2-Generation reproductive toxicity with a satellite group for
body burden determinations conducted in accordance with 40 CFR
799.9380. EPA proposes this guideline as appropriate to provide general
information concerning the effects of exposure to the
[[Page 19875]]
test substance on the integrity and performance of the male and female
reproductive systems, and on the growth and development of the
offspring.
c. Immunotoxicity conducted in accordance with 40 CFR 799.9780. EPA
proposes this guideline as appropriate to provide information on
suppression of the immune system which might occur as a result of
repeated exposure to a test substance.
d. Neurotoxicity screening battery, acute and subchronic, conducted
in accordance with 40 CFR 799.9620. EPA proposes this guideline as
appropriate to provide information on gross functional deficits, level
of activity, and histopathological changes in the central and
peripheral nervous systems of the test animals as a result of acute and
subchronic exposure to a test chemical.
e. Developmental neurotoxicity conducted in accordance with 40 CFR
799.9630. EPA proposes this guideline as appropriate to develop data on
the potential functional and morphological hazards to the nervous
system which may arise in the offspring from exposure of the mother
during pregnancy and lactation.
f. Chronic toxicity/carcinogenicity conducted in accordance with 40
CFR 799.9430. EPA proposes this guideline as appropriate to identify
the majority of chronic and carcinogenic effects and determine dose-
response relationships in a mammalian species following prolonged and
repeated exposure to a test substance.
3. Chemical fate. a. Anaerobic aquatic metabolism conducted in
accordance with OCSPP 835.4400 as modified for c-decaBDE in 40 CFR
795.25. EPA proposes this guideline as appropriate to assess
transformation of decaBDE in anaerobic aquatic sediment systems.
b. Biodegradation in anaerobic digester sludge conducted in
accordance with OCSPP 835.3280 as modified for c-decaBDE in 40 CFR
795.30. EPA proposes this guideline as appropriate to assess
biotransformation in anaerobic digester sludge.
c. Photolytic degradation of c-decaBDE conducted in accordance with
an EPA-developed guideline in 40 CFR 795.65. EPA proposes this
guideline as appropriate to assess whether PBDEs can migrate out of
plastics/fabrics by volatilization; and if photolytic degradation can
take place on the surfaces of plastics and fabrics.
B. When would any testing proposed by this rule begin?
The testing requirements contained in this proposed rule are not
effective until and unless the Agency issues a final rule. If any
manufacturer or processor of c-pentaBDE, c-octaBDE, or c-decaBDE is
subject to the test rule after December 31, 2013, the test sponsor may
plan the initiation of any required testing as appropriate to submit
the required final report by the deadline indicated as the number of
months, shown in 40 CFR 799.5350(j) of the proposed regulatory text,
after December 31, 2013.
C. How would the studies proposed under this test rule be conducted?
Persons required to comply with the final rule would have to
conduct the necessary testing in accordance with the testing and
reporting requirements established in the regulatory text of the final
rule, with 40 CFR part 790--Procedures Governing Testing Consent
Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f)
of 40 CFR 790.45; 40 CFR 790.48; paragraph (a)(2) and paragraph (b) of
40 CFR 790.80; paragraph (e)(1) of 40 CFR 790.82; and 40 CFR 790.85),
and with 40 CFR Part 792--Good Laboratory Practice Standards.
D. What forms of test mixtures would be tested under this rule?
The test rule proposes that the test mixtures be the representative
forms of pentaBDE-containing commercial mixtures, octaBDE-containing
commercial mixtures, and decaBDE-containing commercial mixtures. To
fully describe the three test mixtures, the percentage of each of the
seven congeners present in each of the three test mixtures must be
identified by the test sponsor(s).
Each of the three proposed test mixtures is described by its
predominant components. c-PentaBDE is a mixture predominantly comprised
of pentaBDE, tetraBDE, and hexaBDE. c-OctaBDE is a mixture
predominantly comprised of octaBDE, hexaBDE, heptaBDE, and nonaBDE. c-
DecaBDE is a mixture with decaBDE being present in the highest
percentage. EPA believes that the proposed testing of c-pentaBDE, c-
octaBDE, and c-decaBDE will provide EPA with data necessary to
determine the effects of commercial PBDE products on human health and
the environment. EPA is seeking comment on whether testing of c-
pentaBDE, c-octaBDE, and c-decaBDE should be conducted with the pure
congener or each congener in each mixture instead of the commercial
products. EPA is also seeking comment on whether its descriptions of
the commercial mixtures to be tested accurately predict what commercial
forms of pentaBDE, octaBDE, and decaBDE might be produced. Finally, EPA
solicits comment on whether more than one commercial form each of c-
pentaBDE, c-octaBDE, and c-decaBDE should be tested.
E. Would I be required to test under this rule?
Under TSCA section 4(a)(1)(A)(ii), EPA has made preliminary
findings that there are insufficient data and experience to reasonably
determine or predict health and environmental effects resulting from
the manufacture, processing, use, and distribution in commerce of the
mixtures listed in this proposed rule. As a result, under TSCA section
4(b)(3)(B), manufacturers and processors of mixtures listed in this
proposed rule, and those who intend to manufacture or process them,
would be subject to the rule with regard to those listed mixtures which
they manufacture or process.
1. Would I be subject to this rule? You would be subject to this
rule and may be required to test if you manufacture (which is defined
by statute to include import) or process, or intend to manufacture or
process, one or more mixtures listed in this proposed test rule during
the time period discussed in Unit VI.E.2. You would also be subject to
this rule if you manufacture or process the subject mixtures for export
from the United States. For this rule, importers of articles which
include c-pentaBDE, c-octaBDE, or c-decaBDE would be considered
manufacturers and subject to this rule. If you do not know or cannot
reasonably ascertain that you manufacture or process a listed test rule
mixture (based on all information in your possession or control, as
well as all information that a reasonable person similarly situated
might be expected to possess, control, or know, or could obtain without
unreasonable burden), you would not be subject to the rule for that
listed mixture.
2. When would my manufacture or processing (or my intent to do so)
cause me to be subject to this rule? You would be subject to this rule
if you manufacture or process, or intend to manufacture or process, a
mixture listed in the rule at any time from the effective date in 40
CFR 799.5350(k) of the final test rule to the end of the test data
reimbursement period. The term ``reimbursement period'' is defined at
40 CFR 791.3(h) and may vary in length for each mixture to be tested
under a final TSCA section 4(a) test rule, depending on what testing is
required and when testing is completed. See Unit VI.E.4.
3. Would I be required to test if I were subject to the rule? It
depends on the nature of your activities. All persons who would be
subject to this TSCA
[[Page 19876]]
section 4(a) test rule, which, unless otherwise noted in the regulatory
text, incorporates EPA's generic procedures applicable to TSCA section
4(a) test rules (contained within 40 CFR part 790), would fall into one
of two groups, designated here as Tier 1 and Tier 2. Persons in Tier 1
(those who would have to initially comply with the final rule) would
either:
Submit to EPA letters of intent to conduct testing,
conduct this testing, and submit the test data to EPA, or
Apply to and obtain from EPA exemptions from testing.
Persons in Tier 2 (those who would not have to initially comply
with the final rule) would not need to take any action unless they are
notified by EPA that they are required to do so (because, for example,
no person in Tier 1 had submitted a letter of intent to conduct
testing), as described in Unit VI.E.3.d. Note that both persons in Tier
1 who obtain exemptions and persons in Tier 2 would nonetheless be
subject to providing reimbursement to persons who actually conduct the
testing, as described in Unit VI.E.4.
a. Who would be in Tier 1 and Tier 2? All persons who would be
subject to the final rule are considered to be in Tier 1 unless they
fall within Tier 2. Table 4 of this unit describes who is in Tier 1 and
Tier 2.
Table 4--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 1 (persons initially Tier 2 (persons not initially required to
required to comply) comply)
------------------------------------------------------------------------
Persons who manufacture (as A. Persons who manufacture (as defined at
defined at TSCA section TSCA section 3(7)) or intend to
3(7)), or intend to manufacture a test rule mixture solely
manufacture, a test rule as one or more of the following:
mixture and who are not --As a byproduct (as defined at 40 CFR
listed under Tier 2. 791.3(c));
Importers of articles --As an impurity (as defined at 40 CFR
containing polybrominated 790.3);
diphenyl ethers (PBDEs) are --As a naturally occurring chemical
manufacturers. substance (as defined at 40 CFR
710.4(b));
--As a non-isolated intermediate (as
defined at 40 CFR 704.3);
--As a component of a Class 2
substance (as described at 40 CFR
720.45(a)(1)(i));
--In amounts of less than 500
kilograms (kg) (1,100 pounds (lb))
annually (as described at 40 CFR
790.42(a)(4)); or
--In small quantities solely for
research and development (R&D) (as
described at 40 CFR 790.42(a)(5)).
B. Persons who process (as defined at
TSCA section 3(10)) or intend to process
a test rule mixture including in
articles (see 40 CFR 790.42(a)(2)).
------------------------------------------------------------------------
Under 40 CFR 790.2, EPA may establish procedures applying to
specific test rules that differ from the generic procedures governing
TSCA section 4(a) test rules in 40 CFR part 790. For purposes of this
proposed rule, EPA is proposing to establish certain requirements that
differ from those under 40 CFR part 790.
In this proposed test rule, EPA has configured the tiers in 40 CFR
790.42 as in certain previous test rules. In addition to processors,
manufacturers of less than 500 kilograms (kg) (1,100 pounds (lb)) per
year (``small-volume manufacturers''), and manufacturers of small
quantities for research and development (``R&D manufacturers''), EPA
has added the following persons to Tier 2: Manufacturers of byproducts,
manufacturers of impurities, manufacturers of naturally occurring
chemical substances, manufacturers of non-isolated intermediates, and
manufacturers of components of Class 2 chemical substances. The Agency
took administrative burden and complexity into account in determining
who was to be in Tier 1 in this proposed rule. EPA believes that those
persons in Tier 1 who would conduct testing under this proposed rule,
when finalized, would generally be large chemical manufacturers who, in
the experience of the Agency, have traditionally conducted testing or
participated in testing consortia under previous TSCA section 4(a) test
rules.
The Agency also believes that manufacturers of byproducts,
impurities, naturally occurring chemical substances, manufacturers of
non-isolated intermediates, and manufacturers of components of Class 2
chemical substances historically have not themselves participated in
testing or contributed to reimbursement of those persons who have
conducted testing. EPA understands that these manufacturers may include
persons for whom the marginal transaction costs involved in negotiating
and administering testing arrangements are deemed likely to raise the
expense and burden of testing to a level that is disproportional to the
additional benefits of including these persons in Tier 1. Therefore,
EPA is not proposing to burden these persons with Tier 1 requirements
(e.g., submitting requests for exemptions). Nevertheless, these
persons, along with all other persons in Tier 2, would be subject to
reimbursement obligations to persons who actually conduct the testing,
as described in Unit VI.E.4.
Section 4(b)(3)(B) of TSCA requires all manufacturers and/or
processors of a mixture to test that mixture if EPA has made findings
under TSCA sections 4(a)(1)(A)(ii) or 4(a)(1)(B)(ii) for that mixture,
and issued a TSCA section 4(a) test rule requiring testing. However,
practicality must be a factor in determining who is subject to a
particular test rule. Thus, persons who do not know or cannot
reasonably ascertain that they are manufacturing or processing a
mixture subject to this proposed rule, e.g., manufacturers or
processors of a mixture as a trace contaminant who are not aware of or
cannot reasonably ascertain these activities would not be subject to
the rule. See Unit VI.E.1. and 40 CFR 799.5350(b)(2) of this proposed
rule.
EPA believes it is possible that there will be no persons in Tiers
1 and 2A that will be subject to the test rule. If EPA learns that the
only persons that would be subject to the rule would be persons that
process c-pentaBDE, c-octaBDE, or c-decaBDE as impurities contained in
articles, EPA will not require testing because EPA has not determined
whether this activity alone may present an unreasonable risk of injury
to health or the environment. EPA is seeking comment on whether the
Agency should address persons who manufacture or process PBDEs as
impurities whether or not they are contained in articles, and whether
such persons should be required to conduct testing.
b. Subdivision of Tier 2 entities. The Agency is proposing to
prioritize which persons in Tier 2 would be required to
[[Page 19877]]
perform testing, if needed. Specifically, the Agency is proposing that
Tier 2 entities be subdivided into:
i. Tier 2A--manufacturers, i.e., those who manufacture, or intend
to manufacture, a test rule chemical substance including in articles
solely as one or more of the following: A byproduct, an impurity, a
naturally occurring chemical substance, a non-isolated intermediate, a
component of a Class 2 chemical substance, in amounts less than 1,100
lb annually, or in small quantities solely for research and
development.
ii. Tier 2B-processors, i.e., those who process, or intend to
process, a test rule mixture in any form including in articles. The
terms ``process'' and ``processor'' are defined by TSCA sections 3(10)
and 3(11), respectively.
If the Agency needs testing from persons in Tier 2, EPA would seek
testing from persons in Tier 2A before proceeding to Tier 2B. It is
appropriate to require manufacturers in Tier 2A to submit letters of
intent to test or exemption applications before processors are called
upon because the Agency believes that testing costs are traditionally
passed along by manufacturers to processors, enabling them to share in
the costs of testing (Ref. 65). In addition, ``[t]here are [typically]
so many processors [of a given test rule chemical] that it would be
difficult to include them all in the technical decisions about the
tests and in the financial decisions about how to allocate the costs''
(Ref. 66).
c. When would it be appropriate for a person who would be required
to comply with the rule to apply for an exemption rather than to submit
a letter of intent to conduct testing? You may apply for an exemption
if you believe that the required testing will be performed by another
person (or a consortium of persons formed under TSCA section
4(b)(3)(A)). You can find procedures relating to exemptions in 40 CFR
790.80 through 790.99, and 799.5350(c)(2), (c)(5), (c)(7), and (c)(11)
of this proposed rule. In this proposed rule, EPA would not require the
submission of equivalence data (i.e., data demonstrating that your
chemical substance or mixture is equivalent to the chemical substance
or mixture actually being tested) as a condition for approval of your
exemption. Therefore, 40 CFR 790.82(e)(1) and 790.85 would not apply to
this proposed rule.
d. What would happen if I submitted an exemption application? EPA
believes that requiring the collection of duplicative data is
unnecessarily burdensome. As a result, if EPA has received a letter of
intent to test from another source or has received (or expects to
receive) the test data that would be required under this rule, the
Agency would conditionally approve your exemption application under 40
CFR 790.87.
The Agency would terminate conditional exemptions if a problem
occurs with the initiation, conduct, or completion of the required
testing, or with the submission of the required data to EPA. EPA may
then require you to submit a notice of intent to test or an exemption
application. See 40 CFR 790.93 and 799.5350(c)(8) of the proposed
regulatory text. In addition, the Agency would terminate a conditional
exemption if no letter of intent to test has been received by persons
required to comply with the rule. See, e.g., 40
CFR[emsp14]799.5350(c)(6) of this proposed rule. Note that the
provisions at 40 CFR 790.48(b) have been incorporated into the
regulatory text of this proposed rule; thus, persons subject to this
rule are not required to comply with 40 CFR 790.48 itself (see 40 CFR
799.5350(c)(4) through (c)(7) and 40 CFR 799.5350(d)(3) of this
proposed rule). Persons who obtain exemptions or receive automatic
conditional exemptions would nonetheless be subject to providing
reimbursement to persons who do actually conduct the testing, as
described in Unit VI.E.4.
e. What would my obligations be if I were in Tier 2? If you are in
Tier 2, you would be subject to the rule and you would be responsible
for providing reimbursement to persons in Tier 1, as described in Unit
VI.E.4. There is no difference whether you are in Tier 2A or Tier 2B as
regards reimbursement. EPA is not aware of any circumstances in which
test rule Tier 1 entities have sought reimbursement from Tier 2
entities either through private agreements or by soliciting the
involvement of the Agency under the reimbursement regulations at 40 CFR
part 791.
Concerning testing, if you are in Tier 2, you are considered to
have an automatic conditional exemption. You would not need to submit a
letter of intent to test or an exemption application unless you are
notified by EPA that you are required to do so. As previously noted,
Tier 2A manufacturers would be notified to test before Tier 2B
processors (Unit VI.E.3.ii.).
If a problem occurs with the initiation, conduct, or completion of
the required testing, or with the submission of the required data to
EPA, the Agency may require you to submit a notice of intent to test or
submit an exemption application. See 40 CFR 790.93 and 799.5350(c)(10)
of the proposed regulatory text.
In addition, you would need to submit a notice of intent to test or
an exemption application if:
No manufacturer in Tier 1 has notified EPA of its intent
to conduct testing.
EPA has published a Federal Register document directing
persons in Tier 2 to submit to EPA letters of intent to conduct testing
or exemption applications.
See 40 CFR[emsp14]799.5350(c)(4), (c)(5), (c)(6), and (c)(7) of the
proposed regulatory text. The Agency would conditionally approve an
exemption application under 40 CFR 790.87, if EPA has received a letter
of intent to test or has received (or expects to receive) the test data
required under this rule.
f. What would happen if no one submitted a letter of intent to
conduct testing? EPA anticipates that, if there were manufacturers or
processors of those chemical substances subject to the final rule, it
would receive letters of intent to conduct testing for all of the tests
specified for each mixture from one of those persons. However, in the
event it does not receive a letter of intent for one or more of the
tests required by the final rule for any of the mixtures in the final
rule within 30 days after the publication of a Federal Register
document notifying Tier 2 processors of the obligation to submit a
letter of intent to conduct testing or to apply for an exemption from
testing, EPA would notify all manufacturers and processors of the
mixture of this fact by certified letter or by publishing a Federal
Register document specifying the test(s) for which no letter of intent
has been submitted. This letter or Federal Register document would
additionally notify all manufacturers and processors that all exemption
applications concerning the test(s) have been denied, and would give
them an opportunity to take corrective action. If no one has notified
EPA of its intent to conduct the required testing of the mixture within
30 days after receipt of the certified letter or publication of the
Federal Register document, all manufacturers and processors subject to
the final rule with respect to that mixture who are not already in
violation of the final rule would be in violation of the final rule.
4. How do the reimbursement procedures work? In the past, persons
subject to test rules have independently worked out among themselves
their respective financial contributions to those persons who have
actually
[[Page 19878]]
conducted the testing. However, if persons are unable to agree
privately on reimbursement, they may take advantage of EPA's
reimbursement procedures at 40 CFR part 791, promulgated under the
authority of TSCA section 4(c). These procedures include: The
opportunity for a hearing with the American Arbitration Association;
publication by EPA of a document in the Federal Register concerning the
request for a hearing; and the appointment of a hearing officer to
propose an order for fair and equitable reimbursement. The hearing
officer may base his or her proposed order on the production volume
formula set out at 40 CFR 791.48, but is not obligated to do so. The
hearing officer's proposed order may become the Agency's final order,
which is reviewable in Federal court (40 CFR 791.60). Under this
proposed rule, for the purpose of determining fair reimbursement shares
if the hearing officer chooses to use a formula based on production
volume, the total production volume will include amounts of a mixture
produced as an impurity and amounts imported in articles.
F. What reporting requirements are proposed under this test rule?
If you were required to test, you would be required to submit a
final report for a specific test by the deadline indicated in Table 3
in Unit VI.A. as the number of months after the effective date of the
final rule; this deadline is also shown in 40 CFR[emsp14]799.5350(j) of
the proposed regulatory text.
EPA is also proposing that a robust summary of the final report for
each specific test be required to be submitted electronically in
addition to and at the same time as the final report. The term ``robust
summary'' is used to describe the technical information necessary to
adequately describe an experiment or study and includes the objectives,
methods, results, and conclusions of the full study report which can be
either an experiment or in some cases an estimation or prediction
method. Guidance for the compilation of robust summaries is described
in a document entitled ``Draft Guidance on Developing Robust
Summaries'' (Ref. 67).
G. What would I need to do if I cannot complete the testing required by
the final rule?
A person who submits a letter of intent to test under the final
rule and who subsequently anticipates difficulties in completing the
testing by the deadline set forth in the final rule may submit a
modification request to the Agency, pursuant to 40 CFR 790.55. EPA will
determine whether modification of the test schedule is appropriate, and
may first seek public comment on the modification.
H. Would there be sufficient test facilities and personnel to undertake
the testing proposed under this test rule?
EPA's most recent analysis of laboratory capacity (Ref. 68)
indicates that available test facilities and personnel would adequately
accommodate the testing proposed in this rule.
I. Might EPA seek further testing of the chemical substances in this
proposed test rule?
If EPA determines that it needs additional data regarding any of
the chemical substances included in this proposed rule, the Agency
would seek further health and/or environmental effects testing for
these mixtures. Should the Agency decide to seek such additional
testing via a test rule, EPA would initiate a separate action for that
purpose.
VII. Export Notification
A. SNUR
Any persons who export or intend to export a chemical substance
that is the subject of a proposed or final SNUR 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. Any person who
exports, or intends to export, tetraBDE, pentaBDE, hexaBDE, heptaBDE,
octaBDE, and nonaBDE became subject to those requirements with the
proposal of the SNUR in 2004 (Ref. 69). This proposed rule would not
affect the article exemption at 40 CFR 707.60(b) for notices of export
under TSCA section 12(b). Persons who export PBDEs contained in
articles would not be required to submit a notice of export respecting
such PBDEs.
B. Test Rule
Any person who exports, or intends to export, one of the mixtures
contained in this proposed test rule would be subject to the export
notification requirements in TSCA section 12(b)(1) (15 U.S.C. 2611(b))
and at 40 CFR part 707, subpart D, but only after the final rule is
promulgated and only if the mixture is contained in the final rule.
This proposed rulemaking would not affect the article exemption at 40
CFR 707.60(b) for notices of export under TSCA section 12(b). Persons
who export PBDE mixtures contained in articles would not be required to
submit a notice of export respecting such mixtures.
C. Should articles containing PBDEs be exempt from export notification
requirements?
The Agency believes that production and processing of all PBDEs,
including in articles, will have ceased in the United States by the end
of 2013 but if there are any ongoing uses they would not be subject to
a final SNUR. The purpose of the proposed SNUR is to designate new and
discontinued uses as significant new uses and to ensure that the Agency
has an opportunity to review and, if necessary, take action to restrict
or prohibit significant new uses of PBDEs, including in articles,
before they resume. The purpose of the proposed test rule is to provide
EPA with data necessary to determine the effects on health and the
environment if the manufacture and processing of commercial PBDEs and
the associated use, distribution in commerce and disposal are not
discontinued. The Agency believes that the above objectives will be
adequately met with respect to articles by making article exemptions
for SNURs and test rules inapplicable for this action. The Agency
considered including provisions in the proposed SNUR and test rule
requiring that the PBDEs contained in articles be subject to TSCA
section 12(b) export notification requirements. However, the Agency
does not believe that making exporters of PBDEs contained in articles
subject to TSCA section 12(b) export notification requirements would
significantly increase the effectiveness of this proposed rule. The
Agency is concerned that the potential burdens associated with
administration and compliance with export notification requirements for
PBDEs contained in articles could be significant. In view of the
expected costs the Agency decided that PBDEs contained in articles
should continue to be exempt from export notification requirements. The
Agency is seeking comment on the need for (and the cost of) making
PBDEs contained in articles subject to export notification
requirements.
VIII. Import Certification
A. SNUR
Persons who import a chemical substance in bulk or as part of a
mixture are subject to the TSCA section 13 (15 U.S.C. 2612) import
requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR
127.28. Such persons must certify that the shipment of the chemical
substance complies with
[[Page 19879]]
all applicable rules and orders under TSCA, including any SNUR
requirements. This rule would not affect the exemption from import
certification under TSCA section 13(b) for chemicals contained in
articles. Persons who import PBDEs contained in articles would not be
subject to import certification requirements. PBDEs imported in bulk or
as part of a mixture would continue to be subject to import
certification requirements under TSCA section 13(b), consistent with 19
CFR 12.120(b). The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. For additional guidance, please
refer to EPA's TSCA Import Compliance Checklist at http://www.epa.gov/oppt/import-export/pubs/checklist.pdf.
B. Test Rule
Section 13 of TSCA import certification requirements do not pertain
to TSCA section 4 test rules. Although importers must satisfy all
applicable requirements of TSCA section 4, compliance with those
provisions is not related to individual chemical shipments and
therefore does not affect import certification.
C. Should articles containing PBDEs be exempt from import certification
requirements?
The Agency believes that manufacture, including import, and
processing of all PBDEs, including in articles, will have ceased in the
United States by the end of 2013. The purpose of the proposed SNUR is
to designate new and discontinued uses as significant new uses and to
ensure that the Agency has an opportunity to review and, if necessary,
take action to restrict or prohibit significant new uses of PBDEs,
including in articles, before they resume. The Agency believes that the
above objective will be adequately met with respect to articles by
making the article exemption for SNURs inapplicable for this action.
The Agency does not believe that making importers of PBDEs contained in
articles subject to TSCA section 13 import certification requirements
would significantly increase the effectiveness of this proposed rule.
The Agency considered including provisions in the proposed SNUR
requiring that the PBDEs contained in articles be subject to TSCA
section 13 import certification requirements. However, the Agency is
concerned that the potential burdens associated with administration and
compliance with import certification requirements could be significant.
The Agency decided that PBDEs contained in articles should continue to
be exempt from import certification requirements. The Agency is seeking
comment on the need for (and the cost of) making PBDEs contained in
articles subject to import certification requirements.
IX. The Dates That the SNUR, Proposed Amended SNUR, and Proposed Test
Rule Requirements Apply to the Seven PBDEs and the Three Commercial
Mixtures
The SNUR that became effective on August 14, 2006, requires that
persons that intend to manufacture, including import, any of six PBDEs
(tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, and nonaBDE) for any
use after January 1, 2005, submit a SNUN to EPA at least 90 days in
advance. Processing of the PBDEs was not designated as a significant
new use because EPA believed that it was an ongoing activity at the
time of proposal. Articles were exempt from that SNUR. EPA now believes
that processing of these six PBDEs for any use and import of articles
containing them have been discontinued. These proposed amendments to
the SNUR would designate processing for any use after December 31,
2013, a significant new use. The proposed amended SNUR would also make
inapplicable the article exemption at 40 CFR 721.45(f). Therefore, a
person who intends to import or process any of the six PBDEs as part of
an article after December 31, 2013, would not be exempt from submitting
a SNUN. EPA will promulgate the amended SNUR after it has verified that
the proposed significant new uses have been discontinued. For a
discussion of applicability of the SNUR to uses begun after the
publication of this proposed rule see Unit V.C.
Any person who manufactures or processes or intends to manufacture
or process c-pentaBDE, c-octaBDE, or c-decaBDE after December 31, 2013,
would be subject to the test rule.
On December 2009, the principal manufacturers and importer of
decaBDE announced their intent to phase out their activities with
decaBDE and committed to do so by December 31, 2012 for all uses,
except military and transportation, and by December 31, 2013, for all
uses including military and transportation, with possibly an additional
6 months to sell remaining inventory of decaBDE (Refs. 9-11). The
Agency does not believe that manufacturers would need additional time
to sell remaining inventory or that processors would require any
additional time to use existing stocks, and has not proposed any
additional time in this action. EPA is seeking comment on this in Unit
XI.A.2.
With this action, EPA is also proposing to amend the 2006 PBDE SNUR
at 40 CFR 721.10000 after December 31, 2013, by designating manufacture
and processing of decaBDE for any use which is not ongoing, including
in articles, as a significant new use. Persons that intend to
manufacture or process decaBDE for a significant new use would be
required to submit a SNUN to EPA at least 90 days before commencing
such activity.
If EPA determined that any person intends to manufacture or process
c-pentaBDE c-octa BDE, or c-decaBDE for any use after December 31,
2013, EPA would promulgate the test rule and they would be subject to
the test rule requirements.
X. Economic Considerations
A. SNUR
The proposed amendment to the SNUR would require persons intending
to engage in significant new use to submit a SNUN, incurring an
estimated submission cost of $8,143 per chemical substance, plus other
costs (Ref. 70). In addition to the firms that make a SNUN submission,
the proposed amendments to the SNUR may also impact firms that do not
make a submission. By avoiding a significant new use, a firm can avoid
submission and testing costs but may incur other compliance costs. The
firm may also incur ``hidden'' costs; for example, it could forego
profitable opportunities to use the chemical substance in an
application that would be a significant new use or limit production
volume to avoid a significant new use. Costs are estimated at the firm
level and reflect the burden of a SNUR on the firms that make a
submission. The hidden costs to the firms that do not make a submission
are not quantified. EPA receives only a handful of SNUNs per year due
to SNURs. However, the number of firms affected by not making
submissions to EPA is not known; therefore, costs are not aggregated
across the affected entities.
B. Test Rule
EPA has prepared an economic assessment entitled ``Economic Impact
Analysis for the Proposed Section 4 Test Rule for c-Pentabromodiphenyl
Ether, c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether'' (Ref.
71), a copy of which has been placed in the docket for this rule. The
economic analysis evaluates the costs associated with the testing that
would be required by a final test rule. The analysis looks
[[Page 19880]]
at costs due to testing all three mixtures and to each mixture
separately. The total costs to industry of compliance, including
testing and administrative costs, for all three mixtures are estimated
under the low- and high-cost scenarios to be $9.68 million and $15.1
million, respectively. The testing cost (not including administrative
costs) to comply with the test rule requirements for c-pentaBDE or c-
octaBDE under the low- and high-cost scenarios would be $2.8 million
and $4.7 million, respectively. The testing cost (not including
administrative costs) to comply with the test rule requirements for c-
decaBDE under the low- and high-cost scenarios would be $1.8 million
and $2.5 million, respectively. (Ref. 71) These costs would only be
incurred if there were entities that manufacture or process c-pentaBDE,
c-octaBDE, or c-decaBDE, including in articles, after the effective
date of the test rule.
Currently, there are no known entities that manufacture or process
c-pentaBDE or c-octaBDE in the United States except as impurities, so
an economic impact analysis could not be done for these two chemical
substances.
EPA has identified six ultimate parent companies that manufacture
or import c-decaBDE in the United States. The total annualized
compliance costs for decaBDE are estimated to be, under low- and high-
cost scenarios, $264,582 and $360,218, respectively. To evaluate the
potential for an adverse economic impact of testing on manufacturers
and importers of c-decaBDE, EPA employed an initial screening approach
that estimated the impact of testing requirements as a percentage of c-
decaBDE's sale price. This measure compares annual revenues from the
sale of a mixture to the annualized compliance cost for that mixture to
assess the percentage of testing costs that can be accommodated by the
revenue stream generated by that mixture over a number of years.
Compliance costs include costs of testing and administering the
testing, as well as reporting costs. In addition, they include the
estimated cost of the TSCA section 12(b) export notification
requirements, which, under the final rule, would be required for the
first export to a particular country of a mixture subject to the rule,
estimated to range from $26.86 per notice to $85.70 per notice (Ref.
70). These export notification requirements (included in the total and
annualized cost estimates) that would be triggered by the final rule
are expected to have a negligible impact on exporters.
Annualized compliance costs divide testing expenditures into an
equivalent, constant yearly expenditure over a longer period of time.
To calculate the percent price impact, testing costs (including
laboratory and administrative expenditures) are annualized over 15
years using a 7% discount rate. These annualized testing costs are then
divided by the estimated annual revenue of the mixture to derive a
cost-to-sales ratio.
For five companies manufacturing or importing c-decaBDE, the cost-
to-sales ratios is 3% or less. One company was identified as a small
business by TSCA's employment-based definition and has a cost-to-sales
ratio greater than 3%. Mixtures for which the price impact is expected
to exceed 1% of the revenue from that chemical substance have a higher
potential for adverse economic impact. However, EPA also compared the
annualized cost of testing c-decaBDE to company revenue because, in
some cases, companies may choose to use revenue sources other than the
profits from the individual mixture to pay for testing. EPA estimates
that the costs of testing will exceed 1% of company revenue for only
one of the affected companies, i.e., the company identified as a small
business.
While processors are legally subject to this test rule if they
process c-decaBDE after December 31, 2013, processors of c-decaBDE
would be required to comply with the requirements of the rule only if
they are directed to do so by EPA as described in 40 CFR 799.5350(c)(6)
and (c)(8) of the proposed regulatory text. EPA would only require
processors to test if no subject person in Tier 1 or Tier 2A has
submitted a notice of its intent to conduct testing, or if under 40 CFR
790.93, a problem occurs with the initiation, conduct, or completion of
the required testing or the submission of the required data to EPA.
Because processors would not need to comply with the rule initially if
there are persons in Tiers 1 or 2A subject to the rule, the economic
assessment does not address processors.
The benefits resulting from this proposed test rule are discussed
qualitatively in the ``Economic Impact Analysis for the Proposed
Section 4 Test rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl
Ether, and c-Decabromodiphenyl Ether'' (Ref. 71). EPA believes the
major benefits of the test rule will be the development of hazard
information on these chemical substances and the use of this
information by the public, industry, and government.
XI. Request for Public Comment
A. Solicitation of Comments on the Proposed Amendments to the SNUR
1. EPA welcomes comments on any aspect of the proposed amendments
to the SNUR, but is especially interested in comments regarding the
possibility that manufacture and processing for some uses of decaBDE
may continue after December 31, 2013. The Agency seeks information on
such uses.
2. EPA is projecting c-decaBDE will no longer be available and that
processors will discontinue their activities by December 31, 2013.
Should EPA assume that processors will continue their activities beyond
that date? For example, should EPA assume that processors will continue
their activities for 6 months after manufacture of decaBDE ceases?
Should EPA designate processing of decaBDE after June 30, 2014, or some
other date, a significant new use?
3. EPA welcomes comments on the designation of a significant new
use of tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, and nonaBDE as
manufacture and processing for any use including in articles after
December 31, 2013.
4. EPA is proposing to make inapplicable the article exemption for
SNURs at 40 CFR 721.45(f). A person who intends to process a chemical
substance identified in that section as part of an article, other than
as an impurity, would not be exempt from submitting a SNUN. EPA
welcomes comment on this proposed course of action.
5. EPA requests comment on when to finalize the proposed amendments
to the SNUR. Should they be finalized before or after the phase-out of
decaBDE?
6. EPA requests comment on whether the proposed significant new
uses are ongoing and will still be ongoing after December 31, 2013.
B. Solicitation of Comments on the Proposed Test Rule
1. EPA is soliciting comment regarding additional information
pertaining to potential exposure of the general population, consumers,
and workers to c-pentaBDE, c-octaBDE, and c-decaBDE. Also, the Agency
solicits comment regarding additional information pertaining to
environmental releases of any of these three PBDE mixtures.
2. EPA is soliciting comments which identify existing studies that
may satisfy the data needs identified in the proposed test rule. To the
extent that data relevant to the testing specified in
[[Page 19881]]
this proposed test rule are known to exist, EPA strongly encourages the
submission of this information as comments to the proposed test rule.
Such data submitted to EPA must be in the form of full copies of
unpublished studies or full citations of published studies, and
accompanied by a robust summary (Ref. 67). To the extent that studies
proposed in this action are currently available, and the data are
judged sufficient by EPA, testing for the endpoint/mixture combination
will not be required in a final test rule.
3. EPA is soliciting comment on what test substances should be
required for pentaBDE, octaBDE, and decaBDE. EPA is proposing that the
test substances be the representative commercial forms with the percent
congener composition identified by the test sponsor(s). Instead, should
the test substances be the 99% pure pentaBDE, octaBDE, and decaBDE with
an isomer composition identified for each?
4. EPA is soliciting comment on whether a purity level of 99% or
greater can be attained for pentaBDE, octaBDE, and decaBDE.
5. EPA is soliciting comment on whether the descriptions in the
proposed regulatory text in 40 CFR 799.5350(a) of the commercial
mixtures to be tested adequately encompass the range of commercial
forms of pentaBDE, octaBDE, and decaBDE that might be produced.
6. EPA is soliciting comment on whether, for the purpose of the
testing proposed in this proposed rule, a single commercial form each
of pentaBDE, octaBDE, and decaBDE can be representative of the possible
variations of those commercial mixtures. If not, should more than one
commercial form each of pentaBDE, octaBDE, and decaBDE be tested? How
should those forms be determined?
7. EPA is soliciting comment on whether testing should be required
of tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE, and decaBDE
comparable to that proposed for c-pentaBDE, c-octaBDE, and c-decaBDE if
they are present in commercial PBDE products.
8. EPA is also soliciting comment on the proposed test guidelines,
the proposed requirement for submission of robust summaries, the
proposed deadlines to submit final reports, and the economic impact
analysis detailing the burdens and costs that would result from
complying with a final test rule.
9. The Agency invites comment on the potential use of voluntary
consensus standards in the proposed test rule, and, specifically,
invites the public to identify potentially applicable voluntary
consensus standard(s) and to explain why such voluntary consensus
standard(s) should be used here.
10. EPA is interested in receiving comments on whether the Agency
should consider establishing an alternate definition for small business
to use in the small entity impact analyses for future TSCA section 4(a)
test rules, and what size cutoff may be appropriate.
11. EPA is soliciting comment on whether, in a future rulemaking,
persons who manufacture or process c-PBDEs contained in articles as
impurities should be required to conduct testing. EPA also solicits
comment on whether persons who manufacture or process c-PBDEs as
impurities not contained in articles should be required to test.
XII. References
As indicated under ADDRESSES, a docket has been established for
this proposed rule under docket ID number EPA-HQ-OPPT-2010-1039. The
following is a listing of the documents that have been placed in the
docket. The docket includes information considered by EPA in developing
this proposed rule, including the documents listed in this unit, which
are physically located in the docket. In addition, interested parties
should consult documents that are referenced in the documents that EPA
has placed in the docket, regardless of whether these referenced
documents are physically located in the docket. For assistance in
locating documents that are referenced in documents that EPA has placed
in the docket, but that are not physically located in the docket,
please consult the appropriate technical person listed under FOR
FURTHER INFORMATION CONTACT. The docket is available for review as
specified under ADDRESSES.
A. Documents Cited in the Preamble and Available in the Docket
1. EPA. Significant New Use Rule for Certain Polybrominated
Diphenylethers. 40 CFR 721.10000.
2. EPA, 2009. Polybrominated Diphenyl Ethers (PBDEs) Action
Plan. Available online at: http://www.epa.gov/oppt/existingchemicals/pubs/pbdes_ap_2009_1230_final.pdf.
3. Zhang, S; Bursian, S.J.; Martin, P.A.; Chan, H.M.; Tomy, G.;
Palace, V.P.; Mayne, G.J.; Martin, J.W. Reproductive and
developmental toxicity of a pentabrominated diphenyl ether mixture,
DE-71, to ranch mink (Mustela vison) and hazard assessment for wild
mink in the Great Lakes region. Toxicological Sciences. 110 (1):107-
116. 2009.
4. Environment Canada. Ecological Screening Assessment Report on
Polybrominated Diphenyl Ethers (PBDEs). 2006. Available online at:
http://www.ec.gc.ca/CEPARegistry/documents/subs_list/PBDE_SAR/PBDEs_SAR_EC_June 2006_%28en%29.pdf.
5. EPA. An exposure assessment of polybrominated diphenyl
ethers. National Center for Environmental Assessment, Washington,
DC; EPA/600/R-08/086F. 2010. Available from the National Technical
Information Service, Springfield, VA, and online at: http://www.epa.gov/ncea.
6. Gobas, F.A.P.C. and Morrison, H.A. Bioconcentration and
biomagnification in the aquatic environment. In Handbook of Property
Estimation Methods for Chemicals. Environmental and Health Sciences.
pp.189-231. RS Boethling and DMackay, Eds., Lewis/CRC, Boca Raton,
FL. 2000.
7. EPA, Risk Assessment Division (RAD), OPPT. Voluntary
Children's Chemical Evaluation Program: Data Needs Decision Document
for Pentabromodiphenyl Ether and Octabromodiphenyl Ether. June 2005.
8. EPA, RAD, OPPT. Voluntary Children's Chemical Evaluation
Program: Data Needs Decision Document for Decabromodiphenyl Ether.
June 2005.
9. Albermarle Corporation. Letter from David W. Clary, Albemarle
Corp., to Lisa P. Jackson, EPA. EPA-Industry DecaBDE Phase-Out
Initiative. December 15, 2009.
10. Chemtura Corporation. Letter from Craig A. Rogerson,
Chemtura Corp., to Lisa P. Jackson, EPA. DecaBDE Phase-Out
Initiative. December 17, 2009.
11. ICL Industrial Products. Letter from Nissim Adar to Lisa P.
Jackson, EPA. Voluntary Phase-Out of DecaBDE. December 15, 2009.
12. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy.
Notice. Federal Register (58 FR 28736, May 14, 1993), pp. 28738-
28739.
13. EPA. VCCEP Web site homepage online at: http://www.epa.gov/oppt/vccep.
14. EPA, 2008a. Toxicological Review of 2, 2', 4, 4' -
Tetrabromodiphenyl Ether (BDE-47), EPA/635/R-07/005F. June 2008.
15. EPA, 2008b. Toxicological Review of 2, 2', 4 ,4',5-
Pentabromodiphenyl Ether (BDE-99), EPA/635/R-07/006F. June 2008.
16. EPA, 2008c. Toxicological Review of 2, 2', 4, 4', 5, 5'-
Hexabromodiphenyl Ether (BDE-153), EPA/635/R-07/007F. June 2008.
17. EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether
(BDE-209), EPA/635/R-07/008F. June 2008.
18. Arkoosh, M.R.; Boylen, D.; Dietrich, J.; Anulacion, B.F.;
Ylitalo, G.; Bravo, C.F.; Johnson, L.L.; Loge, F.J.; Collier, T.K.;
Disease susceptibility of salmon exposed to polybrominated diphenyl
ethers (PBDEs). Aquatic Toxicology. 98(1):51-59. 2010.
19. McKernan, M.A.; Rattner, B.A., et al. Toxicity of
Polybrominated Diphenyl Ethers (De-71) In Chicken (Gallus gallus),
Mallard (Anas platyrhynchos), and American Kestrel (Falco
sparverius) Embryos and Hatchlings. Environmental Toxicology and
Chemistry. 28(5):1007-1017. 2009.
20. Fernie, K.J.; Mayne, G.; Shutt, L.J.; Pekarick, C.; Grasman,
K.A.; Letcher, R.J.; Drouillard, K.G. Evidence of immunomodulation
in nestling American kestrels (Falco sparverius) exposed to
environmentally relevant PBDEs.
[[Page 19882]]
Environmental Pollution. 138:485-493. 2005a.
21. Fernie, K.J.; Shutt, L.J.; Mayne, G.; Hoffman, D.J.;
Letcher, R.J.; Drouillard, K.G.; Richie, I.J. Exposure to
polybrominated diphenyl ethers (PBDEs): Changes in thyroid, vitamin
A, glutathione homeostasis, and oxidative stress in American
kestrels (Falco sparverius). Toxicological Sciences. 88:375-383.
2005b.
22. Fernie, K.; Shutt, L. et al. The effects of exposure to
polybrominated diphenyl ethers on reproductive performance and
immune function in captive American Kestrels. Journal of
Ornithology. 147(5):92-92. 2006.
23. Marteinson, S. C.; Bird, D. M. et al. Multi-generational
effects of polybrominated diphenylethers exposure: Embryonic
exposure of male American kestrels (Falco sparverius) to DE-71
alters reproductive success and behaviors. Environmental Toxicology
and Chemistry. 29(8):1740-1747. 2010.
24. Fernie, K.J.; Shutt, J.L.; Letcher, R.J.; Ritchie, I.J. and
Bird, D.M. Environmentally Relevant Concentrations of DE-71 and HBCD
Alter Eggshell Thickness and Reproductive Success of American
Kestrels. Environmental Science & Technology. 43(6):2124-2130. 2009.
25. Timme-Laragy, A.R.; Levin, D.E.; Di Giulio, R.T.
Developmental and behavioral effects of embryonic exposure to the
polybrominated diphenylether mixture DE-71 in the killifish
(Fundulus heteroclitus). Chemosphere. 62:1097-1104. 2006
26. Lema, S.C.; Schultz, I.R.; Scholz, N.L.; Incardona PJ,
Swanson P. Neural defects and cardiac arrhythmia in fish larvae
following embryonic exposure to 2,2',4,4'-tetrabromodiphenyl ether
(PBDE 47). Aquatic Toxicology. 82:296-307. 2007.
27. Kuiper, R.V.; Vethaak, A.D.; Cant[oacute]n, R.F.; Anselmo,
H,; and Dubbeldam, M. Toxicity of analytically cleaned
pentabromodiphenylether after prolonged exposure in estuarine
European flounder (Platichthys flesus), and partial life-cycle
exposure in fresh water zebrafish (Danio rerio). Chemosphere.
73:195-202. 2008.
28. Nakari, T, and Huhtala, S. Comparison of toxicity of
congener-153 of PCB, PBB, and PBDE to Daphnia magna. Ecotoxicology
and Environmental Safety. 71:514-518. 2008.
29. Kimbrough, K.L.; Johnson, W.E.; Lauenstein, G.G.;
Christensen, J.D. and Apeti, D.A. An Assessment of Polybrominated
Diphenyl Ethers (PBDEs) in Sediments and Bivalves of the U.S.
Coastal Zone. NOAA Technical Memorandum NOS NCCOS 94. 2009.
30. EPA, Polybrominated Diphenyl Ethers (PBDEs) Project Plan.
March 2006. Available online at: http://www.epa.gov/oppt/pbde/pubs/proj-plan32906a.pdf (accessed Dec. 15, 2009).
31. Vonderheide AP, Mueller KE, et al. Polybrominated diphenyl
ethers: Causes for concern and knowledge gaps regarding
environmental distribution, fate and toxicity. Science of the Total
Environment. 400(1-3):425-436. 2008.
32. Environment Canada. Ecological State of the Science Report
on Decabromodiphenyl Ether (decaBDE) Bioaccumulation and
Transformation. 2010. Available online at: http://www.ec.gc.ca/lcpe-cepa/documents/substances/decabde/ess_report_decabde-eng.pdf.
33. Shaw, S.D. and Kannan, K. Polybrominated diphenyl ethers in
marine ecosystems of the American continents: Foresight from current
knowledge. Reviews on Environmental Health. 24:157-229. 2009.
34. Thuresson, K,; Bergman, A. and Jakobsson, K. Occupational
Exposure to Commercial Decabromodiphenyl Ether in Workers
Manufacturing or Handling Flame-Retarded Rubber. Environmental
Science & Technology. 39:1980-1986. 2005.
35. Tokarz, J.A.; Ahn, M.Y.; Leng, J.; Filley, T.R. and Nies, L.
Reductive Debromination of Polybrominated Diphenyl Ethers in
Anaerobic Sediment and a Biomimetic System. Environmental Science &
Technology. 42:1157-1164. 2008.
36. La Guardia, M.J.; Hale, R.C.; and Harvey, E. Evidence of
Debromination of Decabromodiphenyl Ether (BDE-209) in Biota from a
Wastewater Receiving Stream. Environmental Science & Technology.
41(19):6663-6670. 2007.
37. Stapleton, H.M. Brominated flame retardants: Assessing the
decaBDE debromination in the environment. Health and Environmental
Alliance (formerly the EPHA Environmental Network (EEN)). May 2006.
38. Stapleton, H.M. and Dodder, N.G. Photodegradation of
decabromodiphenyl ether in house dust by natural sunlight.
Environmental Toxicology and Chemistry. 27:306-312. 2008
39. Wania, F. and Dugani, C.B. Assessing the long-range
transport potential of polybrominated diphenyl ethers: A comparison
of four multimedia models. Environmental Toxicology and Chemistry.
22:1252-1261. 2003.
40. ATSDR. Agency for Toxic Substances and Disease Registry.
Toxicological Profile for Polybrominated Diphenyl Ethers and
Polybrominated Biphenyls. 2004. Available online at: http://www.atsdr.cdc.gov/toxprofiles/tp68.html.
41. Allen, J.G.; McClean, M.D.; Stapleton, H.M.; and Webster,
T.F. Critical factors in assessing exposure to PBDEs via house dust.
Environment International. 34(8):1085-1091. November 2008.
42. Lorber, M. Exposure of Americans to polybrominated diphenyl
ethers. Journal of Exposure Science and Environmental Epidemiology.
18:2-19. 2008.
43. Hites, R.A. Polybrominated Diphenyl Ethers in the
Environment and in People: A Meta-Analysis of Concentrations.
Environmental Science & Technology. 38:945-956. 2004.
44. Cal/EPA PBDE Workgroup. Polybrominated Diphenyl Ethers:
Recommendations to Reduce Exposure in California. California
Environmental Protection Agency, Sacramento, California. February
2006. Available online at: http://oeha.ca.gov/pdf/PBDEWrkgrpRptFeb06.pdf.
45. Sjodin, A.; Wong, L.Y.; Jones, R.S.; Park, A.; Zhang, Y.;
Hodge, C.; Dipietro, E.; McClure, C.; Turner, W.; Needham, L.L.; and
Patterson, D.G. Serum concentrations of polybrominated diphenyl
ethers (PBDEs) and polybrominated biphenyl (PBB) in the United
States population: 2003-2004. Environmental Science & Technology.
42:1377-1384. 2008.
46. NHANES. Fourth National Report on Human Exposure to
Environmental Chemicals. Centers for Disease Control and Prevention,
Atlanta (GA). December 2009. Available online at: http://www.cdc.gov/exposurereport/faq.html.
47. Park, J.S.; Holden, A.; Chu, V.; Kim, M.; Rhee, A.; Patel,
P.; Shi, Y.; Linthicum, J.; Walton, B.J.; Mckeown, K.; Jewell, N.P.;
and Hooper, K. Time-Trends and Congener Profiles of PBDEs and PCBs
in California Peregrine Falcons (Falco peregrinus). Environmental
Science & Technology. 43(23):8744-8751. 2009.
48. Chen, D.; Mai, B.; Song, J.; Sun, Q.;, Luo, Y.; Luo, X.;
Zeng, E.Y.; and Hale, R.C. Polybrominated diphenyl ethers in birds
of prey from Northern China. Environmental Science & Technology.
41:1828-1833. 2007.
49. Voorspoels, S.; Covaci, A.; Lepom, P.; Jaspers, V.L.B.;
Neels, H.; and Schepens, P. Biomagnification of PBDEs in three small
terrestrial food chains. Environmental Science & Technology. 41:411-
416. 2007.
50. Stapleton, H.M. and Baker, J.E. Comparing polybrominated
diphenyl ether and polychlorinated biphenyl bioaccumulation in a
food web in Grand Traverse Bay, Lake Michigan. Archives of
Environmental Contamination and Toxicology. 45:227-234. 2003.
51. Gandhi, N.; Bhavsar, S.P.; Gerwurtz, S.B.; Diamond, M.L.;
Evenset, A.; Christensen, G.N.; and Gregor, D. Development of a
Multichemical Food Web Model: Application to PBDEs in Lake
Ellasj[oslash]en, Bear Island, Norway. Environmental Science &
Technology. 40(15):4714-4721. 2006.
52. Stapleton, H.M.; Alaee, M.; Letcher, R.J.; and Baker, J.E.
Debromination of the flame retardant decabromodiphenyl ether by
juvenile carp (Cyprinus carpio). Environmental Science & Technology.
38:112-119. 2004.
53. Van den Steen, E.; Covaci, A.; Jaspers, V.L.B.; Dauwe, T.;
Voorspoels. S.; Eens, M.; and Pinxten, R. Accumulation, tissue-
specific distribution and biotransformation of BDE 209 in European
starlings (Sturnus vulgaris). Environmental Pollution. 148:648-653.
2007.
54. Darnerud, P.O. Toxic effects of brominated flame retardants
in man and in wildlife. Environment International. 29:841-853. 2003.
55. Harley, K.G.; Marks, A.R.; Chevrier, J.; Bradman, A.;
Sjodin, A.; and Eskenazi, B. PBDE Concentrations in Women's Serum
and Fecundability. Environmental Health Perspectives. 118(5):699-
704. May 2010.
56. Costa, L.G.; Giordano, G.; Tagliaferri, S.; Caglieri, A.;
and Mutti, A. Polybrominated diphenyl ether (PBDE) flame retardants:
environmental contamination, human body burden and potential adverse
health effects. Acta Biomed. 79:172-183. 2008.
57. Herbstman, J.B.; Sjodin, A.; Kurzon, M.; Lederman, S.A.;
Jones, R.S.; Rauh, V.; Needham, L.L.; Tang, D.; Niedzwiecki, M.;
Wang, R.Y.; and Perera, F. Prenatal Exposure to PBDEs and
Neurodevelopment. Environmental Health Perspectives. 118(5):712-719.
May 2010.
[[Page 19883]]
58. Bromine Science and Environmental Forum. An Oral (gavage)
Developmental Neurotoxicity Test of Decabromodiphenyl Oxide in Rats.
Submitted to EPA on May 19, 2010.
59. ASTM. Standard test method for measuring the toxicity of
sediment-associated contaminants with freshwater invertebrates. ASTM
E 1706-05e1.
60. ASTM. Standard guide for collection, storage,
characterization, and manipulation of sediments for toxicological
testing and for selection of samplers used to collect benthic
invertebrates. ASTM E 1391-03.
61. ASTM. Standard guide for conducting laboratory soil toxicity
or bioaccumulation tests with the Lumbricid Earthworm Eisenia fetida
and the Enchytraeid Potworm Enchytraeus albidus. ASTM E 1676-04.
62. ASTM. Standard guide for conducting sediment toxicity tests
with Polychaetous Annelids. ASTM E 1611-00.
63. ASTM. Standard guide for conducting laboratory soil toxicity
tests with the Nematode Caenorhabditis elegans. ASTM E 2172-01.
64. ASTM. Standard test method for measuring the toxicity of
sediment-associated contaminants with estuarine and marine
invertebrates. ASTM E 1367-03.
65. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Interim Final Rule. Federal Register (50 FR 20652, May
17, 1985).
66. EPA. Toxic Substances Control Act; Data Reimbursement. Final
Rule. Federal Register (48 FR 31786, July 11, 1983).
67. EPA, OPPT. Draft Guidance on Developing Robust Summaries.
October 22, 1999. Available online at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
68. EPA, Economic and Policy Analysis Branch (EPAB), OPPT.
Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing
Program Initiatives. Washington, DC. October 28, 2010.
69. EPA. Certain Polybrominated Diphenyl Ethers; Proposed
Significant New Use Rule. Federal Register (69 FR 70404, December 6,
2004) (FRL-7688-1).
70. EPA, EPAB, OPPT. Economic Analysis of the Proposed
Significant New Use Rule for Polybrominated Diphenyl Ethers.
November 3, 2010.
71. EPA, EPAB, OPPT. Economic Impact Analysis for the Proposed
Section 4 Test Rule for c-Pentabromodiphenyl Ether, c-
Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether. October 28,
2010.
B. Documents Not Cited in the Preamble and Available in the Docket
The following documents are not cited in the preamble but are in
the docket because they are considered germane to this proposed rule.
Jones-Otazo, H.A.; Clarke, J.; Diamond, M.L.; Archbold,
J.; Ferguson, G.; Harner, T.; Richardson, S.M.; Jakeryan J.; and
Wilford, B.Y. Is House Dust the Missing Exposure Pathway for PBDEs? An
Analysis of the Urban Fate and Human Exposure to PBDEs. Environmental
Science & Technology. 39:5121-5130. 2005.
Environment Canada. Flame Retardants: A threat to the
environment? Science & the Environment Bulletin. 30:5. May/June 2002.
Available online at: http://dsp-psd.pwgsc.gc.ca/Collection/En1-28-1-2002-03E.pdf.
Chemtura. Letter from Robert Campbell to Jim Willis,
Director, Chemical Control Division (CCD), OPPT, EPA. January 6, 2006.
Arnold & Porter LLP. Letter from Lawrence Culleen to Ward
Penberthy, CCD, OPPT, EPA. June 25, 2010.
XIII. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993), this action has been
designated a ``significant regulatory action'' by the Office of
Management and Budget (OMB). Accordingly, EPA submitted this action to
OMB for review and any changes made in response to OMB recommendations
have been documented in the docket for this action.
In addition, EPA has prepared two economic analyses of the
potential impacts associated with this action. A copy of these economic
analyses, entitled ``Economic Impact Analysis for the Proposed Section
4 Test Rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether,
and c-Decabromodiphenyl Ether'' (Ref. 71) and ``Economic Analysis of
the Proposed Significant New Use Rule for Polybrominated Diphenyl
Ethers'' (Ref. 70), are available in the docket for this proposed rule
and are summarized in Unit X.
B. Paperwork Reduction Act
This proposed rule does not impose any paperwork collection
requirements that would require additional review and/or approval by
OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The
information collection requirements related to the proposed SNUR (i.e.,
the submission of a SNUN) have been approved by OMB pursuant to PRA
under OMB control number 2070-0038 (EPA ICR No. 1188). The information
collection requirements related to the proposed test rule have been
approved by OMB pursuant to the PRA under OMB control number 2070-0033
(EPA ICR No. 1139). Although the test rule information collection
activities are approved, the additional burden associated with this
test rule is not yet covered by the approved ICR until the final rule
is effective. In the context of developing a new test rule, the Agency
must determine whether the total annual burden covered by the approved
ICR needs to be amended to accommodate the burden associated with the
new test rule. If so, the Agency must submit an Information Correction
Worksheet (ICW) to OMB and obtain OMB approval of an increase in the
total approved annual burden in the OMB inventory.
The information collection activities related to export
notification under TSCA section 12(b)(1) are already approved under OMB
control number 2070-0030 (EPA ICR No. 0795). This rulemaking does not
propose any new or changes to the export notification requirements, and
is not expected to result in any substantive changes in the burden
estimates for EPA ICR No. 0795 that would require additional review
and/or approval by OMB.
Under PRA, an agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information that is subject
to approval under PRA, unless it displays a currently valid OMB control
number. The OMB control numbers for the EPA regulations codified in
chapter 40 of the CFR, after appearing in the preamble of the final
rule, are listed in 40 CFR part 9, displayed either by publication in
the Federal Register or by other appropriate means, such as on the
related collection instrument or form, if applicable. The display of
OMB control numbers in certain EPA regulations is consolidated in 40
CFR part 9.
To submit a SNUN, EPA estimates that the industry burden hours per
chemical to be 92 hours (Ref. 70). The standard chemical testing
program involves the submission of letters of intent to test (or
exemption applications), study plans, semi-annual progress reports,
test results, and administrative costs. For this proposed rule, EPA
estimates the total industry burden hours for all three mixtures to be
37,074 hours (56,717 hours) for the low (high) cost scenario. Average
industry burden hours per mixture are estimated to be 12,358 hours
(18,906 hours) in the low (high) cost scenario (Ref. 70).
The estimated burden of the information collection activities
related to export notification is estimated to average 1 burden hour
for each mixture/country combination for an initial notification and
0.5 hours for each subsequent notification (Ref. 70). In estimating the
total burden hours approved for the information collection activities
related to export notification, the Agency has included sufficient
burden hours to accommodate any
[[Page 19884]]
export notifications that may be required by the Agency's issuance of
final test rules. As such, EPA does not expect to need to request an
increase in the total burden hours approved by OMB for export
notifications.
As defined by PRA and 5 CFR 1320.3(b), ``burden'' means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to: Review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments to EPA as part of your
overall comments on this proposed action in the manner specified under
ADDRESSES. In developing the final rule, the Agency will address any
comments received regarding the information collection requirements
contained in this proposed rule.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, the Agency hereby certifies
that this proposed rule does not have a significant adverse economic
impact on a substantial number of small entities. The factual basis for
the Agency's determination is presented in the small entity impact
analysis prepared as part of the economic analyses for this proposed
rule (Refs. 70 and 71), which are summarized in Unit X., and copies of
which are available in the docket for this proposed rule. The following
is a brief summary of the factual basis for this certification.
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined in accordance with RFA as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Based on the industry profile that EPA prepared as part of the
economic analysis for this rulemaking (Ref. 71), EPA has determined
that this proposed rule is not expected to impact any small not-for-
profit organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on
small business.
Two factors are examined in EPA's small entity impact analysis
(Ref. 71) in order to characterize the potential small entity impacts
of this proposed rule on small business:
The size of the adverse economic impact (measured as the
ratio of the cost-to-sales or cost-to-revenue).
The total number of small entities that experience the
adverse economic impact.
Section 601(3) of RFA establishes as the default definition of
``small business'' the definition used in section 3 of the Small
Business Act, 15 U.S.C. 632, under which the SBA establishes small
business size standards (13 CFR 121.201). For this proposed rule, EPA
has analyzed the potential small business impacts using the size
standards established under this default definition. The SBA size
standards, which are primarily intended to determine whether a business
entity is eligible for government programs and preferences reserved for
small businesses (13 CFR 121.101), ``seek to ensure that a concern that
meets a specific size standard is not dominant in its field of
operation.'' (13 CFR 121.102(b)). See section 632(a)(1) of the Small
Business Act. In analyzing potential impacts, the RFA recognizes that
it may be appropriate at times to use an alternate definition of small
business. As such, section 601(3) of RFA provides that an agency may
establish a different definition of small business after consultation
with the SBA Office of Advocacy and after notice and an opportunity for
public comment. Even though the Agency has used the default SBA
definition of small business to conduct its analysis of potential small
business impacts for this proposed rule, EPA does not believe that the
SBA size standards are generally the best size standards to use in
assessing potential small entity impacts with regard to TSCA section
4(a) test rules.
The SBA size standard is generally based on the number of employees
an entity in a particular industrial sector may have. For example, in
the chemical manufacturing industrial sector (i.e., NAICS code 325 and
NAICS code 324110), approximately 98% of the firms would be classified
as small businesses under the default SBA definition. The SBA size
standard for 75% of this industry sector is 500 employees, and the size
standard for 23% of this industry sector is either 750; 1,000; or 1,500
employees. When assessing the potential impacts of test rules on
chemical manufacturers, EPA believes that a standard based on total
annual sales may provide a more appropriate means to judge the ability
of a chemical manufacturing firm to support chemical testing without
significant costs or burdens.
EPA is currently determining what level of annual sales would
provide the most appropriate size cutoff with regard to various
segments of the chemical industry usually impacted by TSCA section 4(a)
test rules, but has not yet reached a determination. As stated above,
therefore, the factual basis for the RFA determination for this
proposed rule is based on an analysis using the default SBA size
standards. Although EPA is not currently proposing to establish an
alternate definition for use in the analysis conducted for this
proposed rule, the analysis for this proposed rule also presents the
results of calculations using a standard based on total annual sales
(40 CFR 704.3). EPA is interested in receiving comments on whether the
Agency should consider establishing an alternate definition for small
business to use in the small entity impact analyses for future TSCA
section 4(a) test rules, and what size cutoff may be appropriate.
The SBA has developed 6 digit NAICS code-specific size standards
based on employment thresholds. These size standards range from 500 to
1,500 employees for the various 6 digit NAICS codes that are
potentially impacted (Ref. 71). For a conservative estimate of the
number of small businesses affected by this rule, the Agency chose an
employment threshold of less than 1,500 employees for all businesses
regardless of the NAIC-specific threshold to determine small business
status.
For manufacturers and importers of decaBDE covered by this proposed
rule, six parent companies (ultimate corporate entity, or UCE) were
[[Page 19885]]
identified and sales and employment data were obtained for companies
where data were publicly available. Parent company sales data were used
to identify companies that qualified as a ``small business'' for
purposes of the RFA analysis. Based on the TSCA employment standard
(1,500 employees or less), one company was identified as small. This
company had cost-to-sales ratios of greater than 3% under both the low-
and high-cost scenarios. Given these results, the Agency has determined
that there is not a significant economic impact on a substantial number
of small entities as a result of this proposed rule, if finalized.
The estimated cost of the TSCA section 12(b)(1) export
notification, which, as a result of the final rule, would be required
for the first export to a particular country of a mixture subject to
the rule, is estimated to be $85.70 for the first time that an exporter
must comply with TSCA section 12(b)(1) export notification
requirements, and $26.86 for each subsequent export notification
submitted by that exporter (Ref. 70). EPA has concluded that the costs
of TSCA section 12(b)(1) export notification would have a negligible
impact on exporters of the mixtures in the final rule, regardless of
the size of the exporter.
Any comments regarding the impacts that this action may impose on
small entities, or regarding whether the Agency should consider
establishing an alternate definition of small business to be used for
analytical purposes for future test rules and what size cutoff may be
appropriate, should be submitted to the Agency in the manner specified
under ADDRESSES.
D. Unfunded Mandates Reform Act
This action does not contain any Federal mandates for State, local,
or Tribal Governments or the private sector under the provisions of
Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-
1538. EPA has determined that this regulatory action will not result in
annual expenditures of $100 million or more for State, local, and
Tribal Governments, in the aggregate, or for the private sector. For
the private sector, it is estimated that the total aggregate costs of
this proposed rule would be $15.1 million. The total annualized costs
of this proposed rule to the private sector are estimated to be $5.34
and 5.75 million using a 3% and 7% discount rate over 3 years (high
cost scenario). In addition, since EPA does not have any information to
indicate that any State, local, or Tribal Government manufactures or
processes the mixtures covered by this action such that this rule would
apply directly to State, local, or Tribal governments, EPA has
determined that this proposed rule would not significantly or uniquely
affect small governments. Accordingly, this proposed rule is not
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.
E. Executive Order 13132
Under Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999), EPA has determined that this proposed rule does not
have ``federalism implications'' because it will not have substantial
direct effects on the 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 the Executive Order. The proposed test rule would establish testing
and recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain mixtures. The proposed amendments
to the SNUR would establish notification and submission requirements
that apply to manufacturers (including importers) before certain
chemicals may be manufactured or imported. Because EPA has no
information to indicate that any State or local government manufactures
or processes the chemical substances and mixtures covered by this
action, the proposed SNUR-Test Rule does not apply directly to States
and localities and will not affect State and local governments. Thus,
Executive Order 13132 does not apply to this proposed rule.
F. Executive Order 13175
Under Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), EPA has determined that this proposed rule does not have tribal
implications because it will not have any effect on tribal governments,
on the relationship between the Federal Government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified in the Executive
Order. As indicated previously, EPA has no information to indicate that
any tribal government manufactures or processes the chemical substances
or mixtures covered by this action. Thus, Executive Order 13175 does
not apply to this proposed rule.
G. Executive Order 13045
EPA interprets Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), as applying only to those regulatory actions
that concern health or safety risks, such that the analysis required
under section 5-501 of Executive Order 13045 has the potential to
influence the regulation. This action is not subject to Executive Order
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks. Nevertheless, the information
obtained by this proposed rule could inform the Agency's decisionmaking
process regarding mixtures to which children may be disproportionately
exposed. The proposed test rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain mixtures, and would result in the
development of data about those mixture substances that can
subsequently be used to assist the Agency and others in determining
whether the mixtures in the proposed test rule present potential risks,
allowing the Agency and others to take appropriate action to
investigate and mitigate those risks. Similarly, the proposed
amendments to the SNUR would allow EPA to review available information
to identify and take action to address potential risk because it would
require manufacturers to submit notification and hazard information in
the form of a SNUN to EPA before a chemical may be manufactured or
imported.
H. Executive Order 13211
This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled ``Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy as
described in the Executive Order.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB,
[[Page 19886]]
explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
The proposed test rule involves technical standards because it
proposes to require the use of particular test methods. If the Agency
makes findings under TSCA section 4(a), EPA is required by TSCA section
4(b) to include specific standards or test methods that are to be used
for the development of the data required in the test rules issued under
TSCA section 4. For some of the testing that would be required by the
final rule, EPA is proposing the use of voluntary consensus standards
issued by ASTM International which evaluate the same type of toxicity
as the TSCA 799 test guidelines and OECD test guidelines, where
applicable. Copies of the ASTM International standards referenced in
the proposed regulatory text at 40 CFR[emsp14]799.5350 (h)(2)(i)
through (h)(2)(v) have been placed in the docket for this proposed rule
where they are available for reading, but not copying. You may obtain
copies of the ASTM International standards from the ASTM International,
100 Bar Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, or
by calling (877) 909-ASTM, or at: http://www.astm.org. In the final
rule, EPA intends to seek approval from the Director of the Federal
Register for the incorporation by reference of the ASTM International
standards used in the final rule in accordance with 5 U.S.C. 552(a) and
1 CFR part 51.
EPA is not aware of any potentially applicable voluntary consensus
standards which evaluate prenatal developmental toxicity, 2-generation
reproductive toxicity, developmental neurotoxicity, immunotoxicity, or
chronic toxicity/carcinogenicity, or screen for neurotoxicity which
could be considered in lieu of the TSCA 799 test guidelines, 40 CFR
799.9370, 799.9380, 799.9630, 799.9780, 799.9430, and 799.9620,
respectively, upon which the test standards in the proposed rule are
based.
EPA is also not aware of any potentially applicable voluntary
consensus standards which evaluate anaerobic aquatic metabolism,
biodegradation in anaerobic digester sludge, or photolytic degradation
in the indoor environment. As a result, EPA is proposing the use of
three guidelines which are published in full at 40 CFR 795.25, 795.30,
and 795.65.
The Agency invites comment on the potential use of voluntary
consensus standards in the proposed test rule, and, specifically,
invites the public to identify potentially applicable consensus
standard(s) and to explain why such standard(s) should be used here.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities that require special consideration by the Agency under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994). The Agency believes that
the information collected under this proposed rule, if finalized, will
assist EPA and others in determining the potential hazards and risks
associated with the mixtures covered by this proposed rule. Although
not directly impacting environmental justice-related concerns, this
information will enable the Agency to better protect human health and
the environment, including in low-income and minority communities.
K. Executive Order 12630
EPA has complied with Executive Order 12630, entitled ``Government
Actions and Interference with Constitutionally Protected Property
Rights (Takings)'' (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
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
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Premanufacture notification (PMN), Reporting and recordkeeping
requirements.
40 CFR Part 795
Environmental protection, Chemicals, Hazardous substances, Health,
Laboratories, Reporting and recordkeeping requirements.
40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.
Dated: March 20, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, it is proposed that 40 CFR chapter I be 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. Revise Sec. 721.10000 to read as follows:
Sec. 721.10000 Certain polybrominated diphenylethers.
(a) Chemical substances subject to significant new use reporting.
(1) The chemical substances identified as 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
chemical substances resulting from a chemical reaction are subject to
reporting under this section for the significant new uses described in
paragraph (b)(1) of this section.
(2) Decabromodiphenyl ether (decaBDE) (CAS No. 1163-19-5; benzene,
1,1'-oxybis[2,3,4,5,6-pentabromo-) is subject to reporting under this
section for the significant new uses described in paragraph (b)(2) of
this section.
(b) Significant new uses. (1) The significant new uses for chemical
substances identified in paragraph (a)(1) of this section are:
(i) Manufacture or import for any use on or after January 1, 2005.
(ii) Processing for any use after December 31, 2013.
(2) The significant new uses for the chemical identified in
paragraph (a)(2) of this section are:
(i) Manufacturing, importing, or processing for any use after
December 31, 2013.
[[Page 19887]]
(ii) [Reserved]
(c) Specific requirements. The provisions of subpart A of this part
apply to this section, except as modified by this paragraph.
(1) Revocation of certain notification exemptions. The provisions
of Sec. 721.45(f) do not apply to this section. A person who imports
or processes a chemical substance identified in this section as part of
an article is not exempt from submitting a SNUN.
(2) [Reserved]
PART 795--[AMENDED]
3. The authority citation for part 795 continues to read as
follows:
Authority: 15 U.S.C. 2603.
4. Add Sec. 795.25 to subpart B to read as follows:
Sec. 795.25 Anaerobic aquatic metabolism of decabromodiphenyl ether.
(a) Source. OCSPP Series 835--Fate, Transport and Transformation
Test Guidelines, OCSPP Test Guideline 835.4400--Anaerobic Aquatic
Metabolism.
(b) Introduction. Chemicals can enter shallow or deep surface
waters by a wide variety of routes including direct application, run-
off, groundwater seepage drainage, waste disposal, industrial or
agricultural effluent, and atmospheric deposition. This study plan
describes a laboratory test method to assess transformation of the test
substance in anaerobic aquatic sediment systems. \14\C-labeled
decabromodiphenyl ether (decaBDE) shall be used to help ensure mass
balance over time.
(c) Objectives. The objectives of the study are to:
(1) Measure the rate of transformation of the test substance,
decaBDE.
(2) Identify and quantify all detectable degradation products.
(3) Identify and quantify the transformation pathways and rate of
formation and degradation of intermediate products in the water, vapor,
and sediment phases.
(4) Measure the distribution of the test substance and degradation
products and intermediates within each phase in the test system.
(d) Experimental design. The test shall be conducted using six
sediments and their associated waters at two concentrations (one trace;
the other significantly higher), using \14\C-labeled test substance.
Sediments shall be selected to include a variety of sediment types and
shall include sediments known to contain polybrominated diphenyl ethers
(PBDEs) and polychlorinated biphenyls (PCBs).
(1) Untreated live and killed controls and test substance-dosed
biotic and abiotic systems shall be prepared for each sediment type.
Based on published studies on the biodegradation of decaBDE in
sediments, the half-life of decaBDE may be long. Tokarz (2008) reported
sediment half-lives ranging from 6 to 50 years with an average of 14
years. Therefore, it is expected that untreated control, test
substance-dosed live, and killed control systems will be incubated at
approximately 20 [deg]C for at least 36 months. However, the actual
study duration shall be dependent on the analytical results for initial
sampling periods. The total duration and interval for later samples may
be changed depending on the observed rate of degradation.
(2) Duplicate test vessels for each treatment (i.e., treated and
control) option, each test substance concentration and each sediment
shall be sacrificed at appropriate time intervals. Test substance-dosed
systems shall be used for quantification of parent material and
degradation products. Untreated controls shall be used to determine
background levels of the parent material and other PBDEs over time.
Sampling shall be performed at time zero and seven times thereafter.
Additional sample vessels may be prepared for additional analyses, if
necessary. These vessels shall be sampled at the request of the sponsor
in consultation with EPA. Additional untreated chambers shall be
prepared for use as matrix fortification samples, water-sediment
characterizations, and viability controls, as necessary.
(e) Materials and methods--(1) OCSPP test guidelines. The test
system and study conditions are selected to comply with the OCSPP
Series 835--Fate, Transport and Transformation Test Guidelines, OCSPP
Test Guideline 835.4400 (at paragraph (k)(2) of this section) with
appropriate modifications, if any, for decaBDE.
(2) Test substance. Information on the characterization of test,
control or reference substances is required by Good Laboratory Practice
(GLP) Standards and Principles. Ring-labeled, \14\C-labeled test
substance shall be used. The sponsor is responsible for providing the
test substance and verification that it has been characterized
according to GLP requirements prior to its use in the study. If
verification of GLP test substance characterization is not provided, it
shall be noted in the compliance statement of the final report. The
sponsor is responsible for all information related to the test
substance including the following descriptions of the radiolabeled form
of the test substance: Name, lot number, specific activity,
radiochemical purity, sample form, solubility in water, and storage
conditions. For the nonlabeled form of the test substance, the sponsor
is responsible for the following descriptions: Name, lot number,
purity, sample form, solubility in water, and storage conditions. The
sponsor must agree to accept any unused test substance and/or test
substance containers remaining at the end of the study.
(3) Test substance preparation and administration. A dispersal
powder of test substance shall be prepared using an inert carrier
(e.g., silica gel, quartz sand). Radiolabeled test substance shall be
placed in a round bottom flask and dissolved with an appropriate
solvent (i.e., tetrahydrofuran). The inert carrier shall be added to
the flask and the solvent shall be evaporated using a rotary evaporator
until the carrier is dry. This method of creating a dispersal powder is
an appropriate route of administration for poorly water-soluble
materials. Prior to the test, characteristics of sorption of the test
substance on various carriers shall be evaluated.
(4) Sediments and associated waters. Sediments and associated water
shall be obtained from at least six different sites known or suspected
to be contaminated with PBDEs including, but not limited to decaBDE,
and PCBs. Selection and approval of the collection sites shall be the
responsibility of the study Sponsor and must be approved by EPA.
(i) Sediments shall be collected and handled using strict anaerobic
procedures (for example see Loveley and Phillips (1986) at paragraph
(k)(1) of this section). They shall be immediately sealed under
nitrogen and transported and stored to maintain anaerobic conditions.
All collection containers shall be stored in a nitrogen atmosphere
until and during use. In addition, the containers shall be purged with
nitrogen in the field after collection. The anaerobic sediment and
associated waters shall be taken from the same location. The reduction
potential or Redox potential (Eh) of the sediment shall be measured
prior to collection and should be less than -150 millivolt (mV). The
dissolved oxygen concentration of the overlying water shall be measured
and should be less than 0.5 milligram/Liter (mg/L). The sediments and
water shall be transported to the lab under anaerobic conditions. The
sediments and associated waters may be stored at room temperature in
sealed containers for up to 7 days. If longer storage is necessary, the
sediments and associated waters
[[Page 19888]]
may be stored in sealed containers in a refrigerator for up to 4 weeks.
Prior to use, the sediment shall be settled, then separated from the
water by decanting. The settled sediment shall be wet-sieved using a 2
millimeter (mm) sieve. All handling of anaerobic sediment after
collection and prior to testing shall be performed under a constant
flow of nitrogen. At a minimum, the following properties of the
sediment shall be determined:
(A) Particle size (i.e., percentage of sand, silt, and clay).
(B) Organic carbon content.
(C) Microbial biomass.
(D) Nitrate, sulfate and iron species.
(E) Percent water.
(F) Microbial biomass (fumigation extraction method).
(G) pH.
(H) Concentration of humic material.
(I) Concentrations of electron acceptors including methane,
nitrate, nitrite, sulfate, sulfide, and iron species.
(ii) Similar characterization of the aqueous phase shall be
performed prior to the start of the test. Prior to the test, resazurin
shall be added to the water at a nominal concentration of 1 mg/L. The
water shall be sparged with nitrogen until a light pink color is
obtained and the dissolved oxygen concentration is less than 0.1 mg/L.
Redox conditions in the test vessels shall be monitored by measuring
dissolved hydrogen gas and Eh at each sampling. The test vessels shall
be stored under nitrogen or other inert atmosphere throughout the test.
(5) Test apparatus and conditions. The test vessels shall be 1-L
glass bottles sealed with butyl rubber septa and screw caps. Prior to
beginning the study, the integrity of the test vessels and caps and
their ability to maintain anaerobic conditions and prevent leakage of
hydrogen (H2) and other gas species for long periods shall
be verified. The test vessels shall be identified by project number,
test substance identity (ID), test concentration, and a unique
identifier. The test vessels shall be incubated under an atmosphere of
nitrogen at approximately 20 [deg]C in an anaerobic glove box. Test
temperatures shall be recorded each working day using a minimum/maximum
thermometer. The need for venting of the test systems shall be
evaluated prior to the start of the study. The procedure for venting
and frequency shall be added to the study protocol, if necessary, prior
to beginning the study.
(6) Preparation of the test chambers and acclimation. Test chambers
shall be prepared in an anaerobic glove box or under a constant flow of
nitrogen. Appropriate amounts of sediment and water shall be added to
each test chamber so the resulting water: Sediment volume ratio is
between approximately 1:3 and 1:4. The depth of the sediment layer
shall depend upon the characteristics of the specific sediment. As a
practical example, 200 gram (g) dry weight equivalent of sediment and
250 milliliter (mL) of associated water typically result in a sediment
layer of 6.5 centimeter (cm) and a water layer of 2.5 cm. Amounts of
sediment and water to be added may be determined prior to the
preparation of the test chambers. The sediment/water samples shall be
acclimated under the same conditions as in the test for at least 7 days
prior to the start of the test.
(7) Characterization of water-sediment systems. The pH, total
organic carbon concentration, dissolved oxygen concentration, Eh of the
water and sediment (including microbial biomass), and other parameters/
characteristics of the water-sediment media in the test vessels shall
be measured at each sampling period noted in Table 1 of this paragraph.
The sediment and water shall be kept anaerobic with an Eh lower than -
100 mV.
Table 1--Measurements at Various Stages of the Test Procedure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage of test procedure
------------------------------------------------------------------------------------------
Parameter End
Field sampling Post-handling Start of Start of test During test of
acclimation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
Water:
Origin/source............................................ X
Temperature.............................................. X
pH....................................................... X X X X X
Total organic carbon (TOC) concentration................. X X X
Oxygen (O2) concentration................................ X X X X X
Eh (Redox potential)..................................... X X X X
Sediment:
Origin/Source............................................ X
Depth of layer........................................... X
pH....................................................... X X X X X
Particle size............................................ X
TOC...................................................... X X X X
Microbial biomass........................................ X X X
Eh....................................................... X X X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
(8) Application of the test substance. Chambers containing the
sediment/water systems shall be fortified at the start of the test with
the test substance by applying the test material to the water layer.
Methods for mixing the test material with sediment shall be evaluated
prior to the start of the test. Methods to be evaluated shall include
but are not limited to mixing by hand and the use of roller and
tumbling mixers.
(9) Preparation of abiotic systems. Test substance-dosed abiotic
controls shall be heat-sterilized (autoclaved three times at 120 [deg]C
for 60 minutes (min) on 3 consecutive days). A preliminary evaluation
of the effects of heat sterilization on the test substance shall be
conducted prior to the start of the study. If this method is found to
be unsatisfactory, irradiation shall be used to sterilize the test
systems.
(10) Sample collection. Proposed sampling intervals are day 0 and
months 3, 6, 12, 18, 24, 30, and 36. If analysis of initial sampling
results suggests more rapid degradation, the sampling interval may be
modified after consultation with EPA using procedures specified in 40
CFR 790.50. The actual sampling intervals shall be documented in the
[[Page 19889]]
study records and in the final report. Duplicate test vessels for each
treatment (i.e., treated and control) option, each test substance
concentration and each sediment shall be sacrificed at appropriate time
intervals.
(11) Headspace analysis. The headspace of the treated systems shall
be analyzed for radiolabeled mineralization products including
\14\CO2- hydrocarbons and \14\CO2 and
\14\CH4 using purge and trap methods. At each sampling time
prior to extraction of the test system, the septum shall be pierced
using a needle connected to an appropriate trap and the vessel
headspace shall be purged and trapped using a hydrocarbon trap followed
by a mineralization trapping apparatus. The headspace within each of
test chamber shall be continuously purged with a flow of nitrogen for a
minimum of 1 hour and passed through a gas collection system consisting
of a hydrocarbon trap and two sets of carbon dioxide (CO2)
traps and a combustion apparatus. The displaced gases shall initially
pass through a sorption tube containing appropriate solid phase to trap
any hydrocarbon degradation products present, then one empty bottle
followed by two more bottles, each containing approximately 100 mL of
1.5 normal (N) potassium hydroxide (KOH) (CO2 trapping
solution), followed by another empty bottle. The gas shall be combined
with a flow of oxygen and channeled through a quartz column that is
packed with cupric oxide and maintained at approximately 800 [deg]C in
a tube furnace to combust methane to CO2. Because Br may
poison the surface of the cupric oxide, a preliminary experiment shall
be run to test this, and the protocol adjusted if necessary. The gas
exiting the combustion column shall be passed through an empty bottle
followed by two additional CO2 traps.
(12) Sample processing and analysis for total radioactivity. After
purging, the overlying water shall be removed with minimal disturbance
to the sediment and assayed for total radioactivity by liquid
scintillation counting (LSC). Sediment samples shall be analyzed using
combustion followed by LSC to determine the total amount of
radioactivity associated with the sediment. Water and sediment samples
shall be extracted following aggressive methods designed to extract the
maximum amount of parent and degradation products from the sediment.
These shall be evaluated and verified and approved by EPA prior to the
start of the study. These methods shall be able to detect and quantify
parent and degradates at least as well as those reported in the
literature for PBDE analysis. The extraction method shall be robust,
for example sequential extraction by solvent washing, soxhlet
extraction, and supercritical fluid extraction, but shall not
substantially change the test substance or degradation products, or the
structure of the matrix itself. Solvent extracts and extracted solids
shall be analyzed to determine total residual radioactivity. Untreated
controls shall be extracted in the same manner as the test substance
treated systems.
(13) Characterization of extracted radioactivity. Water and
sediment extracts from the treated and untreated systems shall be
analyzed for radiolabeled test substance and degradation products using
high performance liquid chromatography (HPLC) and gas chromatography
(GC) with mass spectrometry (MS) and radiochemical detection. Methods
of analysis shall be verified prior to the start of the study and shall
be at least as sensitive and accurate as reported in the literature for
analysis of PBDEs and products.
(14) Quantification of test substance and degradation products.
Water and sediment extracts from the untreated controls and treated
systems shall be analyzed for quantification of BDE-209 (decaBDE) and
trace level lower brominated diphenyl ethers (BDEs) including but not
limited to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE-201 (octaBDE),
as well as, brominated dibenzofurans. This analysis shall be conducted
using gas chromatography/electron capture negative chemical ionization
mass spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and
quantitation (LOQ) for reasonably anticipated products shall be
determined and reported to EPA prior to starting the test. All
debromination products shall be measured in each sample, including
background and time zero samples, and both biotic systems and abiotic
(inhibited) controls.
(15) Viability controls. The assessment of the metabolic activity
of untreated sediment/water systems shall be conducted within 1 week of
each sampling interval. Duplicate incubation vessels for each sediment,
which have been incubated in parallel under the same conditions, shall
be dosed at approximately 100 milligram/kilogram (mg/kg) sediment dry
weight with a combination of radiolabeled and nonlabeled substance
suitable (i.e., glucose, benzoic acid) for viability determination. The
methods and procedures used shall be documented in the study protocol
prior to beginning the study.
(16) Treatment of results. Total mass balance of radioactivity
shall be calculated at each sampling interval. Results shall be
reported as total and percentage of added radioactivity. The behavior
of the test substance and major and minor metabolites in the whole
system as well as water, gas, and sediment compartments shall be
evaluated. Regression analysis of the percentage of test substance and
major metabolites as a function of time shall be performed and the time
for 50% degradation (DT50) and the time for 90% degradation
(DT90) of the test substance and major metabolites shall be
calculated, when possible. The ratio of BDE-209 (decaBDE) to all
detected degradation products shall be determined. All analytical
results and all raw data shall be submitted to EPA, including the mass
of each analyte at each time.
(f) Records to be maintained. Records to be submitted to EPA shall
include, but are not limited to, the following:
(1) The original signed protocol and any amendments.
(2) Identification and characterization of the test substance as
provided by sponsor.
(3) Experiment initiation and termination dates.
(4) Stock solution concentration calculations and solution
preparation.
(5) Inoculum source and pretreatment data.
(6) Results of LSC and HPLC and/or other analysis (e.g., GC or GC/
ECNI-MS).
(7) Temperature data recorded during test period.
(8) Copy of final report.
(g) Final report. A final report of the results of the study shall
be prepared and submitted to EPA. The final report shall include, but
is not limited to the following, when applicable:
(1) Name and address of facility performing the study.
(2) Dates on which the study was initiated and completed.
(3) Objectives and procedures stated in the approved protocol,
including any changes in the original protocol.
(4) Identification and characterization of the test substance as
provided by Sponsor.
(5) A summary and analysis of the data and a statement of the
conclusions drawn from the analysis.
(6) A description of the transformations and calculations performed
on the data.
(7) A description of the methods used and reference to any standard
method employed.
(8) A description of the test system.
(9) A description of the preparation of the test solutions, the
testing
[[Page 19890]]
concentrations, and the duration of the test.
(10) A description of sampling and analytical methods, including
level of detection, level of quantification, and references.
(11) A description of the test results including measured values
for individual PBDE congeners and PBDF homolog group.
(12) A description of all circumstances that may affect the quality
or integrity of the data.
(13) The name of the study director, the names of other scientists
or professionals, and the names of all supervisory personnel involved
in the study.
(14) The signed and dated reports of each of the individual
scientists or other professionals involved in the study, if applicable.
(15) The location where the raw data and final report are to be
stored.
(16) A statement prepared by the Quality Assurance Unit listing the
types of inspections, the dates that the study inspections were made
and the findings reported to the Study Director and Management.
(17) A copy of all raw data including but not limited to
chromatograms, lab notebooks and data sheets, etc.
(h) Changes to the final report. If it is necessary to make
corrections or additions to the final report after it has been
accepted, such changes shall be made in the form of an amendment issued
by the Study Director. The amendment shall clearly identify the part of
the study that is being amended and the reasons for the alteration.
Amendments shall be signed and dated by the Study Director and
Laboratory Quality Assurance Officer.
(i) Changes to the protocol. Planned changes to the protocol shall
be in the form of written amendments signed by the Study Director and
approved by the sponsor's representative and submitted to EPA using
procedures in 40 CFR 790.50. Amendments shall be considered as part of
the protocol and shall be attached to the final protocol. Any other
changes shall be in the form of written deviations signed by the Study
Director and filed with the raw data. All changes to the protocol shall
be indicated in the final report. Changes to the test standard require
prior approval from EPA using procedures in 40 CFR 790.55.
(j) Good laboratory practices. This study shall be conducted in
accordance with the Good Laboratory Practice Standards (GLPs) for EPA
and shall be consistent with the Organisation for Economic Co-operation
and Development (OECD) Principles of Good Laboratory Practice. Each
study conducted by the testing facility shall be routinely examined by
the facility's Quality Assurance Unit for compliance with GLPs,
Standard Operating Procedures (SOPs), and the specified protocol. A
statement of compliance with GLPs shall be prepared for all portions of
the study conducted by the testing facility. The sponsor is responsible
for compliance with GLPs for procedures that may be performed by other
laboratories (e.g., residue analyses). Raw data for all work performed
at the testing facility and a copy of the final report shall be filed
by project number in archives located on the facility's site or at an
alternative location to be specified in the final report.
(k) Literature cited in this section. (1) Lovley, D.R. and
Phillips, E.J.P. Organic matter mineralization with reduction of ferric
iron in anaerobic sediments. Applied and Environmental Microbiology.
51:683-689. 1986.
(2) EPA. OCSPP Series 835--Fate, Transport and Transformation Test
Guidelines. OCSPP Test Guideline 835.4400--Anaerobic Aquatic
Metabolism. EPA 712-C-08-019. October 2008.
(3) Tokarz, J.A., III; Ahn, M.Y.; Leng, J.; Filley, T.R.; and Nies,
L. Reductive debromination of polybrominated diphenyl ethers in
anaerobic-sediment and a biomimetic system. Environmental Science &
Technology. 42:1157-1164. 2008.
5. Add Sec. 795.30 to subpart B to read as follows:
Sec. 795.30 Biodegradation in anaerobic digester sludge of
decabromodiphenyl ether.
(a) Source. OCSPP Series 835--Fate, Transport and Transformation
Test Guidelines, OCSPP Test Guideline 835.3280--Simulation Test to
Assess the Primary and Ultimate Biodegradability of Chemicals
Discharged to Wastewater (see the Mineralization and Transformation in
Anaerobic Digester Sludge unit).
(b) Introduction. Anaerobic digesters are commonly used in
municipal wastewater treatment plants to stabilize various plant
sludges. The digestion process reduces the amount of solids present in
the sludge, destroys pathogenic bacteria and viruses, and removes the
biodegradable portion of the sludge. A test for biodegradation during
anaerobic sludge digestion is particularly relevant for sorbing
substances, which partition to primary and secondary sludge. This test
is useful for determining the concentration of a substance present in
the sludge leaving a treatment plant as well as demonstrating the
potential for anaerobic biodegradation. The test is characterized by
reducing conditions, a high level of anaerobic biomass, and a level of
test substance based on expected wastewater concentrations and
partitioning behavior. The test is designed to assess the extent to
which a substance can be degraded during anaerobic digestion. This
protocol describes the methods employed in determining the
biodegradability of the test substance in anaerobic digester sludge.
(c) Objectives. The objective of the study is to assess the
potential for mineralization and transformation of decabromodiphenyl
ether (decaBDE) in anaerobic digester sludge, and the quantity and
identity of degradants (if present).
(d) Experimental design. The test shall be conducted using digester
sludge from six different sources. Untreated control and test
substance-dosed systems shall be prepared for each sludge source.
Additionally, an abiotic control shall be prepared. The test substance
treatment systems shall be dosed at two concentrations with \14\C-
labeled test substance or a combination of radiolabeled and nonlabeled
forms of the test substance. A very low concentration is used to
establish environmentally relevant transformation kinetics; whereas a
higher concentration is required to quantify product formation. The
test systems shall be incubated at approximately 35 [deg]C for
approximately 10 months; e.g., approximately 300 days. Studies using
anaerobic digester sludge normally involve incubating sludge for 60
days, which is about twice the normal residence time of sludge in
anaerobic digesters. The extended length of this study is based on a
half-life of the test substance in sludge without added primers of
1,400 days as reported by Gerecke et al. at paragraphs (k)(1) and
(k)(2) of this section, and the general recommendation that test
duration be at least 20% of the anticipated half-life.
(1) Based on the length of the study, bench-scale anaerobic reactor
systems with semi-continuous feeding shall be used. A system consists
of a 5 liter (L) glass reactor containing an anaerobic digester sludge
mixture incubated at 35 [deg]C and gas collection bladder. On a weekly
basis, supernatant shall be removed from the reactor and replaced with
an anoxic mixture of settled activated sludge solids (secondary sludge)
and fresh anaerobic digester sludge solids.
(2) Test substance-dosed systems shall be used for quantification
of parent
[[Page 19891]]
material and degradation products. Untreated controls shall be used to
determine background levels of the parent material and other
polybrominated diphenyl ethers. Sampling shall be performed at time
zero and seven times thereafter.
(e) Materials and methods. The test system and study conditions are
selected to comply with OCSPP Test Guideline 835.3280 at paragraph
(k)(3) of this section.
(1) Test substance. Information on the characterization of test,
control or reference substances is required by Good Laboratory Practice
Standards (GLPs) and principles. The sponsor is responsible for
providing verification that the test substance has been characterized
according to GLP requirements prior to its use in the study. If
verification of GLP test substance characterization is not provided, it
shall be noted in the compliance statement of the final report. The
sponsor is responsible for all information related to the test
substance. Following are descriptions of the radiolabeled form of the
test substance: Name, lot number, specific activity, radiochemical
purity, radiolabel position, identities and percentages of all
brominated diphenylethers, sample form, solubility in water, and
storage conditions. Following are descriptions of the nonlabeled form
of the test substance: Name, lot number, purity, identities and
percentages of all brominated diphenyl ethers, sample form, solubility
in water, and storage conditions. The sponsor must agree to accept any
unused test substance and/or test substance containers remaining at the
end of the study.
(2) Test substance preparation and administration. A dispersal
powder of test substance shall be prepared using an inert carrier
(e.g., silica gel, quartz sand). A combination of radiolabeled and
nonlabeled test substance shall be placed in a round bottom flask and
dissolved with an appropriate solvent (i.e., tetrahydrofuran). The
inert carrier shall be added to the flask and the solvent shall be
evaporated using a rotary evaporator until the sediment is dry. This
method of creating a dispersal powder is an appropriate route of
administration for poorly water-soluble materials. Prior to the test,
the adsorption characteristics of the test substance on various
carriers shall be evaluated.
(3) Test inoculum. Anaerobic digester sludge shall be obtained from
at least six different sites. Selection of the collection sites shall
be the responsibility of the study Sponsor, with review and final
approval by the EPA. All collection containers shall be purged with
nitrogen and immediately sealed prior to use. In addition, purging the
containers with nitrogen in the field after collection shall be
performed if possible. Sludge shall be screened using a 2 millimeter
(mm) mesh screen to remove debris and may be held for up to 7 days
prior to the start of the test. The total solids level of the digester
sludge shall be measured and should be in the range of 4-6% (40,000-
60,000 (milligrams (mg)/L). On the day the test is to start, the
inoculum shall be diluted with mineral salts solution to an initial
solids level of approximately 25,000 mg/L. If the solids concentration
is too low, the solids can be allowed to settle, the supernatant
decanted, and the sludge resuspended in mineral salts solution. A final
solids level and pH shall then be determined. All handling of anaerobic
sludge after collection and prior to testing shall be performed under a
constant flow of nitrogen or in an anaerobic glove box.
(4) Mineral salts solution. A mineral salts solution shall be
prepared using high quality water. All chemicals used in the
preparation of the solution shall be reagent grade or better, if
available. The solution shall be autoclaved for 30 min and allowed to
cool overnight in an anaerobic chamber or under an anaerobic
atmosphere. The solution shall contain the following constituents per L
of high quality water, as set forth in Table 1 of this paragraph:
Table 1--Constituents of High Quality Water
------------------------------------------------------------------------
Chemical constituent Gram/liter
------------------------------------------------------------------------
Anhydrous potassium dihydrogen phosphate (KH2PO4)......... 0.27
Disodium hydrogen phosphate dodecahydrate 1.12
(Na2HPO4[middot]12H2O)...................................
Ammonium chloride (NH4Cl)................................. 0.53
Calcium chloride dihydrate (CaCl2[middot]2H2O)............ 0.075
Magnesium chloride hexahydrate (MgCl2[middot]6H2O)........ 0.10
Iron (II) chloride tetrahydrate (FeCl2[middot]4H2O)....... 0.02
------------------------------------------------------------------------
(5) Digester sludge feed. The source guideline for this study,
OCSPP Test Guideline 835.3280, has no provision for feeding. However,
due to the length of the study, periodic feeding is needed. The
anaerobic digester sludge shall be fed an anoxic mixture of settled
activated sludge solids (secondary sludge) and fresh anaerobic digester
sludge solids. Activated sludge shall be collected from a sewage
treatment plant receiving waste from predominantly domestic sources.
The sludge shall be sieved using a 2 mm mesh screen to remove debris,
then dewatered using filtration. A feed solution shall be prepared at a
sludge solids concentration of approximately 50 gram (g)/L using
mineral salts solution. The feed solution shall be stored under
nitrogen and refrigerated. In addition, freshly prepared solutions
should be stored for at least 1 week prior to use.
(6) Test apparatus and conditions. The test reactors shall be 5-L
glass bottles and shall be identified by project number, test substance
ID, test concentration, and unique identifier. The reactors shall be
sealed with black rubber stoppers with stopcock ports and connections
used for the addition of feed sludge, sample removal and gas collection
bag. The test reactors shall be incubated at 35 3 [deg]C
and in the dark. Reactor contents shall be mixed for at least 10 min.
every day using a magnetic stirrer and test temperatures shall be
measured each working day using a min/max thermometer.
(7) Preparation of the test reactors. Working under a constant flow
of nitrogen, 1.5 L of anaerobic digester sludge (4-6% solids), mineral
salts solution to achieve an initial solids level of approximately
25,000 mg/L, and test substance dispersal powder shall be combined in
the reactor. The headspace in the reactor shall be purged with
nitrogen, then the reactor sealed and transferred to the incubator.
(8) Reactor maintenance. The contents of the reactors (anaerobic
sludge and mineral salts solution at a solids level of approx. 25,000
mg/L) shall be fed on a weekly basis. Prior to mixing, approximately 75
milliliter (mL) of supernatant shall be removed from the reactor and
replaced with an equal volume of digester sludge feed solution.
[[Page 19892]]
The solids added in this way are expected to be approximately
equivalent to 10% of the total digester solids reasonably expected to
be present. The amount of digester sludge feed solution added may be
adjusted based on the observed level of gas production. The activity of
the supernatant removed shall be measured using liquid scintillation
counting (LSC).
(9) Abiotic control. An abiotic control shall be included.
Biological activity is inhibited in the abiotic control, which is used
for estimating mineralization by difference, establishing extraction
efficiency and recovery of the test substance, and quantifying other
loss processes such as hydrolysis, oxidation, volatilization or
sorption to test apparatus. The preparation of the abiotic system is
typically performed using a combination of chemical and heat
sterilization. A proven approach is to add mercuric chloride (1 g/L) to
the sludge, which is then autoclaved for at least 90 min. Typically the
volume of medium is less than or equal to half the volume of the
container being autoclaved (e.g., 500 ml sludge in a 1-L container).
After cooling, the pH of the abiotic system should be measured and
adjusted to match that of the biologically active system. Alternative
approaches to deactivate the system can also be used.
(10) Sample collection schedule. Proposed sampling times are day 0
and months 1, 2, 4, 6, 8, 9, and 10, but the actual sampling times
shall be documented in the study records and in the final report. The
timing of the sampling may be altered at the discretion of the Study
Director, and more frequent sampling may be conducted. Based on the
analytical method that is selected, the minimum change in the initial
concentration of the test substance that can be detected shall be
estimated, then applied to help determine the sampling schedule and
assess the need for additional samples. As an example, if the minimum
reliably detectable change is 5% relative to the starting
concentration, and if this has already occurred at the first suggested
sampling time (1 month), then measurements should be made monthly up to
10 months. The solids concentration of sludge shall be measured at each
sampling interval.
(11) Evolved gas and headspace analysis. The evolved gas and
headspace of the treated systems shall be analyzed for radiolabeled
mineralization products (\14\CO2 and \14\CH4). At
intervals throughout the study, evolved gases shall be analyzed by
passing the contents of the gas collection bags through the
mineralization apparatus described in this paragraph. Reactor headspace
analysis shall be performed at the end of the study. The headspace
gases within the reactor shall be continuously purged with a flow of
nitrogen for a minimum of 2 hours and passed through a gas collection
system consisting of two sets of carbon dioxide (CO2) traps
and a combustion apparatus. The displaced gases shall initially pass
through one empty bottle followed by two bottles each containing
approximately 100 mL of 1.5 normal (N) potassium hydroxide (KOH)
(CO2 trapping solution) followed by another empty bottle.
The gas shall be combined with a flow of oxygen and channeled through a
quartz column that is packed with cupric oxide and maintained at
approximately 800 [deg]C in a tube furnace to combust methane to
CO2. The gas exiting the combustion column shall be passed
through an empty bottle followed by two additional CO2
traps.
(12) Sample processing and analysis for total radioactivity. (i)
Treated digester sludge samples shall be analyzed using a combination
of LSC and combustion followed by LSC to determine the total amount of
radioactivity associated with the sludge. At each sampling interval,
replicate (minimum 3) one mL aliquots of well mixed digester sludge
shall be placed into microcentrifuge tubes and centrifuged at 10,000 x
g for 15 min. The activity associated with the supernatant shall be
measured by LSC. Solids shall be analyzed using combustion followed by
LSC to determine the total amount of radioactivity associated with the
sludge solids.
(ii) Digester sludge shall be extracted following methods evaluated
and verified prior to the start of the study. These methods shall be
able to detect and quantify parent and degradates at least as well as
those reported in the literature for polybrominated diphenyl ether
(PBDE) analysis. The extraction method shall be robust, for example
sequential extraction by solvent washing, soxhlet extraction and
supercritical fluid extraction, but shall not substantially change the
test substance or degradation products, or the structure of the matrix
itself. Solvent extracts and extracted solids shall be analyzed to
determine total radioactivity. Untreated controls shall be extracted in
the same manner as the test substance-treated systems, but will not be
analyzed for radioactivity.
(13) Characterization of extracted radioactivity. Digester sludge
extracts from the treated systems shall be analyzed for radiolabeled
test substance and degradation products using high performance liquid
chromatography with radiochemical detection. Methods of analysis shall
be verified prior to the start of the study.
(14) Quantification of test substance and degradation products. (i)
Digester sludge extracts from the untreated control, abiotic control
and treated systems shall be analyzed for quantification of BDE-209
(decaBDE) and trace level lower brominated diphenyl ethers (BDE)
including but not limited to BDE-202 (octaBDE), BDE-197 (octaBDE), and
BDE-201 (octaBDE), as well as brominated dibenzofurans. (ii) Methods
for analysis shall be evaluated and verified prior to the start of the
study and shall reference available best practice techniques for the
type of analyte. This analysis shall be conducted using gas
chromatography/electron capture negative chemical ionization mass
spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and
quantitation (LOQ) for reasonably anticipated products shall be
determined and reported to EPA prior to starting the test.
(iii) All debromination products shall be measured in each sample,
including background and time zero samples, and both biotic systems and
abiotic (inhibited) controls.
(15) Treatment of results. Total mass balance of radioactivity
shall be calculated at each sampling interval. Results shall be
reported as a percentage of added radioactivity. Regression analysis of
the percentage of test substance and major metabolites as a function of
time shall be performed and the time for 50% degradation
(DT50) and the time for 90% degradation (DT90) of
the test substance and major metabolites shall be calculated, when
appropriate. The ratio of BDE-197 (octaBDE) to BDE-201 (octaBDE) shall
be determined, if present.
(f) Records to be maintained. Records to be maintained shall
include, but are not limited to, the following:
(1) The original signed protocol and any amendments.
(2) Identification and characterization of the test substance as
provided by sponsor.
(3) Experiment initiation and termination dates.
(4) Stock solution concentration calculations and solution
preparation.
(5) Inoculum source and pretreatment data.
(6) Results of LSC and/or other (e.g., GC/ECNI-MS) analyses.
(7) Temperature data recorded during test period.
(8) Copy of final report.
(g) Final report. A final report of the results of the study shall
be prepared by
[[Page 19893]]
the testing facility. The final report shall include, but is not
limited to the following, when applicable:
(1) Name and address of facility performing the study.
(2) Dates on which the study was initiated and completed.
(3) Objectives and procedures stated in the approved protocol,
including any changes in the original protocol.
(4) Identification and characterization of the test substance as
provided by Sponsor.
(5) A summary and analysis of the data and a statement of the
conclusions drawn from the analysis.
(6) A description of the transformations and calculations performed
on the data.
(7) A description of the methods used and reference to any standard
method employed.
(8) A description of the test system.
(9) A description of the preparation of the test solutions, the
testing concentrations, and the duration of the test.
(10) A description of sampling and analytical methods, including
level of detection, level of quantification, and references.
(11) A description of the test results including measured values
for individual PBDE congeners and polybrominated dioxin/furan (PBDF)
homolog group.
(12) A description of all circumstances that may affect the quality
or integrity of the data.
(13) The name of the study director, the names of other scientists
or professionals, and the names of all supervisory personnel involved
in the study.
(14) The signed and dated reports of each of the individual
scientists or other professionals involved in the study, if applicable.
(15) The location where the raw data and final report are to be
stored.
(16) A statement prepared by the Quality Assurance Unit listing the
types of inspections, the dates that the study inspections were made
and the findings reported to the Study Director and Management.
(17) A copy of all raw data including but not limited to
chromatograms, lab notebooks, and data sheets etc.
(h) Changes to the final report. If it is necessary to make
corrections or additions to the final report after it has been
accepted, such changes shall be made in the form of an amendment issued
by the Study Director. The amendment shall clearly identify the part of
the study that is being amended and the reasons for the alteration.
Amendments shall be signed and dated by the Study Director and
Laboratory Quality Assurance Officer.
(i) Changes to the protocol. Planned changes to the protocol shall
be in the form of written amendments signed by the Study Director and
approved by the sponsor's representative and submitted to EPA using
procedures in 40 CFR 790.50. Amendments shall be considered as part of
the protocol and shall be attached to the final protocol. Any other
changes shall be in the form of written deviations signed by the Study
Director and filed with the raw data. All changes to the protocol shall
be indicated in the final report. Changes to the test standard require
prior approval from EPA using procedures in 40 CFR 790.55.
(j) Good laboratory practices. This study shall be conducted in
accordance with GLPs for EPA and shall be consistent with the
Organisation for Economic Co-operation and Development (OECD)
Principles of Good Laboratory Practice. Each study conducted by the
testing facility shall be routinely examined by the facility's Quality
Assurance Unit for compliance with GLPs Standard Operating Procedures
(SOP), and the specified protocol. A statement of compliance with GLPs
shall be prepared for all portions of the study conducted by the
testing facility. The sponsor is responsible for compliance with GLPs
for procedures that may be performed by other laboratories (e.g.,
residue analyses). Raw data for all work performed at the testing
facility and a copy of the final report shall be filed by project
number in archives located on the facility's site or at an alternative
location to be specified in the final report.
(k) Literature cited in this section. (1) Gerecke, A.C.; Hartmann,
P.C.; Heeb, N.V.; Kohler, H-P.E.; Giger, W.; Schmid, P.; Zennegg, M.;
and Kohler, M. Anaerobic degradation of decabromodiphenyl ether.
Environmental Science & Technology. 39:1078-1083. 2005.
(2) Gerecke, A.C.; Giger, W.; Hartmann, P.C.; Heeb, N.V.; Kohler,
H-P.E.; Schmid, P.; Zennegg, M.; and Kohler, M. Anaerobic degradation
of brominated flame retardants in sewage sludge. Chemosphere. 64:311-
317. 2006.
(3) EPA. OCSPP Series 835--Fate, Transport and Transformation Test
Guidelines. OCSPP Test Guideline 835.3280--Simulation Test to Assess
Primary and Ultimate Biodegradability of Chemicals Discharged to
Wastewater (see the Mineralization and Transformation in Anaerobic
Digester Sludge unit). 2008.
6. Add Sec. 795.65 to subpart B to read as follows:
Sec. 795.65 Photolytic degradation in the indoor environment of
decabromodiphenyl ether.
(a) Source. EPA, based on a method in an article entitled
``Photodegradation of Decabromodiphenyl Ether in House Dust by Natural
Sunlight'' by Stapleton and Dodder reported in Environmental Toxicology
and Chemistry. 27:306-312. 2008.
(b) Introduction. Recent studies have found elevated levels of
polybrominated diphenylethers (PBDEs) in indoor air and house dust,
suggesting the presence of indoor sources. It has also been observed
that photolytic degradation of BDE-209 (decabromodiphenyl ether
(decaBDE)) can take place in house dust when exposed to sunlight,
forming debrominated products. It is not well understood, however, how
PBDEs are transferred from the sources to indoor media (e.g., house
dust) and whether photolytic degradation can occur under indoor
lighting conditions. Most Americans spend over 85% of their time
indoors. Elderly and young children tend to stay indoors even longer.
Therefore, understanding indoor exposure is a key to exposure
assessment and risk reduction. This guideline describes test methods to
characterize potential sources of these emerging contaminants in the
indoor environment.
(c) PBDE off-gassing and photolytic degradation--(1) Objectives.
The objectives of this first part of the investigation are to
determine:
(i) If PBDEs can migrate out of plastics/fabrics by volatilization.
(ii) Determine if photolytic degradation can take place on the
surfaces of plastics and fabrics and quantify these processes.
(2) Experimental design. Accelerated aging tests shall be conducted
in an environmental chamber. PBDE off-gassing will be determined by
taking integrated air samples and potential photolytic degradation by
taking wipe samples on the surface of test specimens. The chamber
system must meet the following criteria:
(i) It has uniform ultraviolet A (UV-A) light irradiation sources.
(ii) The light intensity is no less than 5 Watts per square meter
(W/m\2\) incident to the test specimen.
(iii) The chamber has a constant air flow to allow air sampling.
(iv) The moisture content in the air flow is no less than 10 gram/
meter cubed (g/m\3\) (i.e., 50% relative humidity at 23 [deg]C).
(v) The light source shall be operated according to ASTM G 151-09,
Standard
[[Page 19894]]
Practice for Exposing Nonmetallic Materials in Accelerated Test Devices
that Use Laboratory Light Sources.
(vi) Window-filtered sunlight shall be simulated according to ASTM
D 4459-06, Standard Practice for Xenon-Arc Exposure of Plastics
Intended for Indoor Applications. ASTM D 4459-06 is intended to
simulate the effects produced by exposure to solar irradiation through
glass. A chamber system conforming to ASTM D 4459-06 can provide
spectral irradiance of approximately 0.3 W/m\2\/nanometer (nm) at 340
nm (i.e., peak emission) when operated in the continuous light-on mode
without water spray. This light source satisfies the light intensity
requirement of 5 W/m\2\ as specified in paragraph (c)(2)(ii) of this
section.
(3) Materials and methods--(i) Test specimens. (A) The test
specimens shall include BDE-209-containing high impact polystyrene
(HIPS) coupons and commercial fabric swatches. HIPS coupons shall be
prepared using typical commercial extrusion and injection molding
conditions for the manufacture of HIPS television cabinet backs. High
purity (99% or greater) BDE-209 shall be used in making the coupons.
The high purity will assist in detection of any lower brominated
diphenyl ethers (BDEs) formed as degradants. The coupons shall be
manufactured using high impact polystyrene resin, BDE-209 (12% by
weight (wt)), antimony oxide (4% by wt), and the typical additives of
television cabinet backs (UV inhibitors, antioxidants, colorants,
etc.). A total of 36 coupons shall be prepared for tests listed in
Table 1 of paragraph (c)(3)(ii) of this section. Each coupon shall have
an area of at least 100 centimeter squared (cm\2\) (one-side).
(B) Fabric swatches shall be obtained from a commercial source,
depending on availability, or manufactured using 99+% BDE-209 as the
flame retardant. A total of 36 swatches shall be prepared for tests
listed in Table 1 of paragraph (c)(3)(ii) in this section. Each swatch
shall have an area of at least 100 cm\2\ (one-side).
(ii) Test matrix. A total of six tests listed in Table 1 of this
paragraph shall be conducted.
Table 1--Test Matrix for Polybrominated Diphenylether (PBDE) Off-Gassing and Photolytic Degradation
----------------------------------------------------------------------------------------------------------------
Durations
Test No. Material Ultraviolet (UV) light (hours)
----------------------------------------------------------------------------------------------------------------
1.................................... High Impact Polystyrene on..................... 300, 600, 900
(HIPS) coupons.
2.................................... HIPS coupons................. on..................... 300, 600, 900
3.................................... HIPS coupons................. off.................... 300, 600, 900
4.................................... Fabric swatches.............. on..................... 300, 600, 900
5.................................... Fabric swatches.............. on..................... 300, 600, 900
6.................................... Fabric swatches.............. off.................... 300, 600, 900
----------------------------------------------------------------------------------------------------------------
(iii) Test procedure. (A) Prepare 12 identical coupons (or
swatches) for an aging test.
(B) Put aside 3 coupons (or swatches) for taking wipe samples.
These wipe samples represent no-exposure conditions. To take a wipe
sample of fabric, use the California roller method per Ross, et al.
(1991) in paragraph (j)(5) of this section.
(C) Clean the chamber by wiping the interior surfaces with ethanol-
soaked paper towel.
(D) Take two wipe samples for chamber walls (100 cm\2\ area each).
(E) Place three passive air samplers (PUF disks) on supporting
cradle about half chamber height and away from inlet air.
(F) Place the remaining 9 coupons (or swatches) on chamber floor or
rack, depending on the type of chamber used.
(G) Close chamber door and, for light-on tests, turn on the UV
light, and start the test.
(H) At 300 elapsed hours, turn off the UV light and then open the
chamber door.
(I) Remove three coupons (or swatches) from the chamber for taking
wipe samples.
(J) Remove one PUF disk for determination of time-integrated air
concentrations of BDE-209, lower PBDE congeners, and polybrominated
dibenzofurans (PBDFs).
(K) Close chamber door and turn on the UV light.
(L) At 600 elapsed hours, turn off the UV light and then open the
chamber door.
(M) Remove three coupons (or swatches) from the chamber for taking
wipe samples.
(N) Remove one PUF disk for determination of time-integrated air
concentrations of BDE-209, lower PBDE congeners, and PBDFs.
(O) Close chamber door and turn on the UV light.
(P) At 900 elapsed hours, turn off the UV light and then open the
chamber door.
(Q) Remove the last three coupons (or swatches) from the chamber
for taking wipe samples.
(R) Remove one PUF disk for determination of time-integrated air
concentrations of BDE-209, lower PBDE congeners, and PBDFs.
(S) Take two wipe samples for chamber walls (100 cm\2\ area each).
(iv) Sampling and analytical methods--(A) Surface sampling for HIPS
coupons. ASTM D 6661-10, Standard Practice for Field Collection of
Organic Compounds from Surfaces Using Wipe Sampling, or an equivalent
method, shall be used for surface sampling on HIPS coupons. The wipe
samples shall be extracted (Stapleton et al. (2008) in paragraph (j)(6)
of this section) and then analyzed for BDE-209, lower PBDE congeners,
and PBDFs.
(B) Surface sampling for fabric swatches. A modified ASTM D 6661-10
method, as described in this paragraph, shall be used for surface
sampling on fabric swatches. Modified procedure: Use 10 x 10 cm\2\
heavy filter paper instead of cotton gauze pad; place the fabric swatch
on pre-cleaned flat surface; place the solvent-wetted filter paper on
the fabric swatch; place a 10 x 10 cm\2\ stainless steel (or aluminum)
plate on the paper filter; add additional weights on the plate such
that the total weight is 2 pounds (lb); wait for 5 minutes; remove
plate and weights; extract the paper filter.
(C) Air sampling. Time-integrated air samples shall be collected by
using passive air samplers (PUF disks; see Harrad, et al, 2006 (in
paragraph (j)(4) of this section) and references therein).
(D) Analytical method. High sensitivity is a key factor in
selecting the analytical method. A method based on chromatography/mass
spectrometry in electron capture negative ionization mode (GC/MS-ECNI)
shall be used. The analytes shall include BDEs and PBDFs as listed in
Bezares-Cruz et al. 2004 in paragraph (j)(2) of this section; Stapleton
and Dodder 2008 in paragraph (j)(7) of this section; and Geller et al.
2006 in paragraph (j)(3) of this section.
[[Page 19895]]
(d) Accelerated aging tests for HIPS coupons and fabric swatches
with house dust--(1) Objectives. The objectives of this, second part of
the investigation are to determine:
(i) If PBDEs or PBDF can migrate from plastics/fabrics to settled
house dust by direct partitioning.
(ii) If the particle-bound PBDEs are subject to photolytic
degradation and quantify these processes.
(2) Experimental design. (i) HIPS coupons and used TV cabinets
shall be subjected to accelerated aging in a test chamber in the
presence of standard house dust, National Institute of Standards
Technology, Standard Reference Material 2583 (NIST SRM 2583), free of
BDE-209. The requirements for the test chamber are the same as
described in paragraph (c)(2) of this section, unless indicated
otherwise. This investigation shall be performed as described in
paragraph (c) of this section with the exception of the addition of
pre-cleaned house dust to the surface of the HIPS coupons and fabric
swatches. Accelerated aging under simulated sunlight and fluorescent
lighting, exposure durations, and sample collections shall be identical
to those described in paragraph (c) of this section, with the addition
of collection and analysis of the added house dust. This experiment
requires that the coupons are sufficiently large (500 cm\2\ or larger)
that there is enough house dust for sampling while the dust layer is
not too thick.
(ii) The house dust can be deposited on test specimens by using a
separate dust deposition chamber or spiked manually on test specimens
(Ashley et al., 2007 in paragraph (j)(1) of this section). The test
samples and dust shall then be exposed to accelerated aging for 300,
600, and 900 hours, the dust collected by vacuum, and analyzed for
content of BDE-209, lower BDEs, and PBDFs.
(3) Materials and methods--(i) Test specimens. (A) HIPS coupons and
used TV cabinets shall be used in this investigation. The procedure for
preparing HIPS coupons described in paragraph (c)(3)(i)(A) of this
section shall be followed except that the size of the coupon shall be
at least 500 cm\2\, such that an adequate amount of house dust can be
spiked on the surface without forming a thick layer of dust. The target
dust load is between 0.5 and 1 milligram (mg)/cm\2\ coupon.
(B) Two used TV sets shall be vacuumed and the dust analyzed for
PBDEs and PBDFs with the methods described by Takigami, et al. (2008)
in paragraph (j)(9) of this section. Samples of the backcover shall be
analyzed by Fourier transform infrared spectroscopy (FT-IR) to identify
the plastic and the flame retardant. Ground samples shall be prepared
for determination of PBDE and PBDF content.
(ii) Test matrix. A total of seven tests listed in Table 2 of this
paragraph shall be conducted.
Table 2--Test Matrix for PBDE Migration From Source to House Dust and Photolytic Degradation
----------------------------------------------------------------------------------------------------------------
Test No. Material Ultraviolet (UV) light Durations (hours)
----------------------------------------------------------------------------------------------------------------
1.................................... High impact polystyrene Off.................... 300, 600, 900
(HIPS) coupons.
2.................................... HIPS coupons................. Off.................... 300, 600, 900
3.................................... HIPS coupons................. On..................... 300, 600, 900
4.................................... TV cabinet 1a................ Off.................... 600
5.................................... TV cabinet 1b................ On..................... 600
6.................................... TV cabinet 2a................ Off.................... 600
7.................................... TV cabinet 2b................ On..................... 600
----------------------------------------------------------------------------------------------------------------
(iii) Test procedure for HIPS coupons. (A) Prepare HIPS coupons.
(B) Determine PBDE content in test specimens by preparing and
analyzing ground samples.
(C) Evenly spike approximately 0.25 to 0.5 gram (g) NIST standard
house dust, SRM 2583, on each of the six HIPS coupons. This can be done
either manually (Ashley et al. 2007 in paragraph (j)(1) of this
section) or in a particle deposition chamber. The targeted dust load is
between 0.5 and 1 mg/cm\2\ coupon.
(D) Clean the test chamber by wiping the interior surfaces with
ethanol-soaked paper towel.
(E) Take two wipe samples from chamber walls (100 cm\2\ area each);
the PBDE and PBDF content shall be below the method detection limit.
(F) Open the chamber door, place six coupons on chamber floor (or
rack), and close the door.
(G) Set the chamber temperature at 55 [deg]C and air change rate
between 0.3 to 0.5 air changes per hour, or the lowest air change flow
the chamber system allows.
(H) Close chamber door and start the test.
(I) At 300 elapsed hours, remove 2 coupons for dust sampling,
restart chamber.
(J) Repeat the above step at 600 and 900 elapsed hours.
(iv) Test procedure for used TV cabinets. (A) Open the TV set and
collect settled dust from the interior surfaces (see Takigami et al.
(2008) in paragraph (j)(9) of this section).
(B) Determine the PBDE and PBDF content in the settled dust.
(C) Clean the backcover by soft cloth and air jet; do not clean it
with solvents.
(D) Determine PBDE and PBDF content in test specimen by preparing
and analyzing ground samples.
(E) Divide the backcover evenly into two pieces (designated a and b
in Table 2 of paragraph (d)(3)(ii) of this section), one for test with
light and the other without light.
(F) For each half, cut flat areas into rectangular panels for
testing; the total area of the flat panels shall be no less than 1,000
cm\2\.
(G) Evenly spike NIST standard house dust, SRM 2583, on the
interior side of the backcover panels for a targeted dust load between
0.5 to 1 mg/cm\2\.
(H) Clean the test chamber by wiping the interior surfaces with
ethanol-soaked paper towel.
(I) Take two wipe samples from chamber walls (100 cm\2\ area each);
the PBDE and PBDF content shall be below the method detection limit.
(J) Open the chamber door, place the half backcover with NIST
standard house dust, SRM 2583, on chamber floor (or rack).
(K) Set the chamber temperature at 55 [deg]C and air change rate
between 0.3 to 0.5 air changes per hour, or the lowest air change flow
the chamber system allows.
(L) Close chamber door and start test.
(M) At 600 elapsed hours, remove the backcover panels from chamber,
collect and extract dust samples.
(v) Sampling and analytical methods. Dust samples shall be
collected by micro-vacuuming (Ashley et al. (2007) in paragraph (j)(1)
of this section or ASTM D 7144-05a (2011)). The method described by
Stapleton and Dodder
[[Page 19896]]
(2008) in paragraph (j)(7) of this section shall be used to determine
the PBDE content in dust samples. Wipe and air sampling methods are
described in paragraph (c)(3)(iv) of this section.
(e) Records to be maintained. Records to be submitted to EPA shall
include, but are not limited to, the following:
(1) The original signed protocol and any amendments.
(2) Identification and characterization of the test substance as
provided by Sponsor.
(3) Experiment initiation and termination dates.
(4) Stock solution concentration calculations and solution
preparation, if applicable.
(5) Results of liquid scintillation counter (LSC) and high
performance liquid chromatography (HPLC) and/or other analysis (e.g.,
gas chromatography (GC) or GC/ECNI-MS).
(6) Data on temperature, air flow and inlet air moisture content.
(7) Copy of final report.
(f) Final report. A final report of the results of the study shall
be prepared and submitted to EPA. The final report shall include, but
is not limited to the following, when applicable:
(1) Name and address of facility performing the study.
(2) Dates on which the study was initiated and completed.
(3) Objectives and procedures stated in the approved protocol,
including any changes in the original protocol.
(4) Identification and characterization of the test substance as
provided by sponsor.
(5) A summary and analysis of the data and a statement of the
conclusions drawn from the analysis.
(6) A description of the transformations and calculations performed
on the data.
(7) A description of the methods used and reference to any standard
method employed.
(8) A description of the test system and test chamber(s), including
chamber type, dimensions and light source; and spectral irradiance
inside the chamber if applicable.
(9) A description of the preparation of the test solutions, the
testing concentrations, and the duration of the test.
(10) A description of sampling and analytical methods, including
level of detection, level of quantification, and references.
(11) A description of test specimens and test matrix.
(12) A description of the test results including measured values
for individual PBDE congeners and PBDF homolog group for each matrix,
exposure condition, and exposure duration.
(13) A description of all circumstances that may affect the quality
or integrity of the data.
(14) The name of the study director, the names of other scientists
or professionals, and the names of all supervisory personnel involved
in the study.
(15) The signed and dated reports of each of the individual
scientists or other professionals involved in the study, if applicable.
(16) The location where the raw data and final report are to be
stored.
(17) A statement prepared by the Quality Assurance Unit listing the
types of inspections, the dates that the study inspections were made
and the findings reported to the Study Director and Management.
(18) A copy of all raw data including but not limited to
chromatograms, lab notebooks and data sheets, etc.
(g) Changes to the final report. If it is necessary to make
corrections or additions to the final report after it has been
accepted, such changes shall be made in the form of an amendment issued
by the Study Director. The amendment shall clearly identify the part of
the study that is being amended and the reasons for the alteration.
Amendments shall be signed and dated by the Study Director and
Laboratory Quality Assurance Officer.
(h) Changes to the protocol. Planned changes to the protocol shall
be in the form of written amendments signed by the Study Director and
approved by the sponsor's representative and submitted to EPA using
procedures in 40 CFR 790.50. Amendments shall be considered as part of
the protocol and shall be attached to the final protocol. Any other
changes shall be in the form of written deviations signed by the Study
Director and filed with the raw data. All changes to the protocol shall
be indicated in the final report. Changes to the test standard require
prior approval from EPA using procedures in 40 CFR 790.55.
(i) Good laboratory practices. This study shall be conducted in
accordance with Good Laboratory Practice Standards (GLPs) for EPA and
shall be consistent with Organisation for Economic Co-operation and
Development (OECD) Principles of Good Laboratory Practice. Each study
conducted by the testing facility shall be routinely examined by the
facility's quality assurance unit for compliance with GLPs, Standard
Operating Procedures (SOP), and the specified protocol. A statement of
compliance with GLPs shall be prepared for all portions of the study
conducted by the testing facility. The sponsor is responsible for
compliance with GLPs for procedures that may be performed by other
laboratories (e.g., residue analyses). Raw data for all work performed
at the testing facility and a copy of the final report shall be filed
by project number in archives located on the facility's site or at an
alternative location to be specified in the final report.
(j) Literature cited in this section. (1) Ashley, K.; Applegate,
G.T.; Wise, T.J.; Fernback, J.E.; and Goldcamp, M.J. Evaluation of a
standardized micro-vacuum sampling method for collection of surface
dust. Journal of Occupational and Environmental Hygiene. 4:215-223.
2007.
(2) Bezares-Cruz, J.; Jafvert, C.T.; and Hua, I. Solar
photodecomposition of decabromodiphenyl ether: products and quantum
yield. Environmental Science & Technology. 38:4149-4156. 2004.
(3) Geller, A.M.; Kr[uuml]ger, H.U.; Palm, W.U.; and Zetsch, C.
Identification of polybrominated dibenzofurans from photolysis of
decabromodiphenyl ether by UV spectroscopy. Abstract from DIOXIN 2006,
Oslo, Norway. August 21-24, 2006.
(4) Harrad, S.; Hazrati, S.; and Ibarra, C. Concentrations of
polychlorinated biphenyls in indoor air and polybrominated diphenyl
ethers in indoor air and dust in Birmingham, United Kingdom:
implications for human exposure. Environmental Science & Technology.
40:4633-4638. 2006.
(5) Ross, J.; Fong, H.; Thongsinthusak, T.; Margetich, S.; and
Krieger, R. Measuring potential dermal transfer of surface pesticide
residue generated from indoor fogger use: using the CDFA roller method
interim report II. Chemosphere. 22:975-984. 1991.
(6) Stapleton, H.M.; Kelly, S.M.; Allen, J.G.; McClean, M.D.; and
Webster, T.F. Measurement of polybrominated diphenyl ethers on hand
wipes: estimating exposure from hand-to-mouth contact. Environmental
Science & Technology. 42:3329-3334. 2008.
(7) Stapleton, H.M. and Dodder, N.G. Photodegradation of
decabromodiphenyl ether in house dust by natural sunlight.
Environmental Toxicology and Chemistry. 27:306-312. 2008.
(8) Strandberg, B.; Dodder, N.G.; Basu, I.; and Hites, R.A.
Concentrations and spatial variations of polybrominated diphenyl ethers
and other organohalogen compounds in Great Lakes air. Environmental
Science & Technology. 35:1078-1083. 2001.
[[Page 19897]]
(9) Takigami, H.; Suzuki, G.; Hirai, Y.; and Sakai, S. Transfer of
brominated flame retardants from components into dust inside television
cabinets. Chemosphere. 73:161-169. 2008.
PART 799--[AMENDED]
7. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
8. Add Sec. 799.5350 to subpart D to read as follows:
Sec. 799.5350 Certain polybrominated diphenylethers.
(a) What mixtures will be tested under this section? The chemical
mixtures that must be tested under this section are three
representative commercial forms of pentabromodiphenyl ether (pentaBDE),
octabromodiphenyl ether (octaBDE), and decabromodiphenyl ether
(decaBDE). The test sponsor(s) must identify the percentage of each of
the seven polybrominated diphenylether (PBDE) congeners present in each
of the representative commercial mixtures that will be tested.
(1) Commercial pentabromodiphenyl ether (c-pentaBDE), whose
predominant components are tetrabromodiphenyl ether (tetraBDE) (CASRN
40088-47-9; benzene, 1,1'-oxybis-, tetrabromo deriv.), pentaBDE (CASRN
32534-81-9; benzene, 1,1'-oxybis-, pentabromo deriv.), and
hexabromodiphenyl ether (hexaBDE) (CASRN 36483-60-0; benzene, 1,1'-
oxybis-, hexabromo deriv.),
(2) Commercial octabromodiphenyl ether (c-octaBDE), whose
predominant components are heptabromodiphenyl ether (heptaBDE) (CASRN
68928-80-3; benzene, 1,1'-oxybis-, heptabromo deriv.), octaBDE (CAS No.
32536-52-0; benzene, 1,1'-oxybis-, octabromo deriv.), and
nonabromodiphenyl ether (CASRN 63936-56-1; benzene, pentabromo
(tetrabromophenoxy)-).
(3) Commercial decabromodiphenyl ether (c-decaBDE), whose component
with the highest percent composition is decaBDE (CASRN 1163-19-5;
benzene, 1,1'-oxybis [2,3,4,5,6-pentabromo-), aka BDE-209.
(b) Am I subject to this section? (1) If you manufacture (including
import) or process c-pentaBDE, c-octaBDE, or c-decaBDE for any use
including in articles at any time after December 31, 2013, until the
end of the test data reimbursement period as defined in 40 CFR
791.3(h), you are subject to this section with respect to that mixture.
You are also subject to this section if you manufacture (including
import) or process c-pentaBDE, c-octaBDE, or c-decaBDE for export from
the United States. For this section, importers of articles containing
c-pentaBDE, c-octaBDE, or c-decaBDE are considered manufacturers and
are subject to this section.
(2) If you do not know or cannot reasonably ascertain that you
manufacture or process a mixture listed in paragraph (a) of this
section during the time period described in paragraph (b)(1) of this
section (based on all information in your possession or control, as
well as all information that a reasonable person similarly situated
might be expected to possess, control, or know, or could obtain without
unreasonable burden), you are not subject to this section with respect
to that mixture.
(c) If I am subject to this section, when must I comply with it?
(1)(i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
Table 1--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
----------------------------------------------------------------------------------------------------------------
Tier 1 (persons initially required
to comply) Tier 2 (persons not initially required to comply)
----------------------------------------------------------------------------------------------------------------
Persons who manufacture (as defined A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to
at TSCA section 3(7)), or intend to manufacture a test rule mixture solely as one or more of the following:
manufacture, a test rule mixture --As a byproduct (as defined at 40 CFR 791.3(c));
and who are not listed under Tier --As an impurity (as defined at 40 CFR 790.3);
2. Importers of articles containing --As a naturally occurring chemical substance (as defined at 40 CFR
PBDEs are considered manufacturers. 710.4(b));
--As a non-isolated intermediate (as defined at 40 CFR 704.3);
--As a component of a Class 2 substance (as described at 40 CFR
720.45(a)(1)(i));
--In amounts of less than 500 kg (1,100 pounds (lb)) annually (as
described at 40 CFR 790.42(a)(4)); or
--In small quantities solely for research and development (R and D) (as
described at 40 CFR 790.42(a)(5)).
B. Persons who process (as defined at TSCA section 3(10)) or intend to
process a test rule mixture, including in articles (see 40 CFR
790.42(a)(2)).
----------------------------------------------------------------------------------------------------------------
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the
list of persons in Tier 2, that is those persons specified in 40 CFR
790.42(a)(2), (a)(4), and (a)(5), who, while legally subject to this
section, must comply with the requirements of this section only if
directed to do so by EPA under the circumstances set forth in
paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this section.
(2) If you are in Tier 1 with respect to a mixture listed in
paragraph (a) of this section, you must, for each test required under
this section for that mixture, either submit to EPA a letter of intent
to test or apply to EPA for an exemption from testing. The letter of
intent to test or the exemption application must be received by EPA no
later than 30 days after the effective date in paragraph (k) of this
section.
(3) If you are in Tier 2 with respect to a mixture listed in
paragraph (a) of this section, you are considered to have an automatic
conditional exemption and you will be required to comply with this
section with regard to that mixture only if directed to do so by EPA
under paragraphs (c)(5), (c)(7), or (c)(10) of this section.
(4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more
[[Page 19898]]
of the tests required by this section on any mixture listed in
paragraph (a) of this section within 30 days after the effective date
in paragraph (k) of this section, EPA will publish a Federal Register
document that would specify the test(s) and the mixture(s) for which no
letter of intent has been submitted and notify manufacturers in Tier 2A
of their obligation to submit a letter of intent to test or to apply
for an exemption from testing.
(5) If you are in Tier 2A (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in
paragraph (a) of this section, and if you manufacture, or intend to
manufacture, this chemical substance after the effective date in
paragraph (k) of this section, or within 30 days after publication of
the Federal Register document described in paragraph (c)(4) of this
section, you must, for each test specified for that chemical substance
in the document described in paragraph (c)(4) of this section, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than 30 days after
publication of the Federal Register document described in paragraph
(c)(4) of this section.
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
intent to conduct one or more of the tests required by this section on
any chemical substance listed in paragraph (a) of this section within
30 days after the publication of the Federal Register document
described in paragraph (c)(4) of this section, EPA will publish another
Federal Register document that would specify the test(s) and the
chemical substance(s) for which no letter of intent has been submitted,
and notify processors in Tier 2B of their obligation to submit a letter
of intent to test or to apply for an exemption from testing.
(7) If you are in Tier 2B (as specified in Table 1 in paragraph (c)
of this section) with respect to a mixture listed in paragraph (a) of
this section, and if you process, or intend to process, this mixture
after the effective date in paragraph (k) of this section, or within 30
days after publication of the Federal Register document described in
paragraph (c)(6) of this section, you must, for each test specified for
that mixture in the Federal Register document described in paragraph
(c)(6) of this section, either submit to EPA a letter of intent to test
or apply to EPA for an exemption from testing. The letter of intent to
test or the exemption application must be received by EPA no later than
30 days after publication of the Federal Register document described in
paragraph (c)(6) of this section.
(8) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the mixtures listed in paragraph (a) of this section within 30 days
after the publication of the Federal Register document described in
paragraph (c)(6) of this section, EPA will notify all manufacturers and
processors of those mixtures of this fact by certified letter or by
publishing a Federal Register document specifying the test(s) for which
no letter of intent has been submitted. This letter or Federal Register
document will additionally notify all manufacturers and processors that
all exemption applications concerning the test(s) have been denied, and
will give the manufacturers and processors of the mixture(s) an
opportunity to take corrective action.
(9) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the mixtures listed in paragraph (a) of this section within 30 days
after receipt of the certified letter or publication of the Federal
Register document described in paragraph (c)(8) of this section, all
manufacturers and processors subject to this section with respect to
that mixture who are not already in violation of this section will be
in violation of this section.
(10) If a problem occurs with the initiation, conduct, or
completion of the required testing or the submission of the required
data with respect to a mixture listed in paragraph (a) of this section,
under the procedures in 40 CFR 790.93 and 790.97, EPA may initiate
termination proceedings for all testing exemptions with respect to that
mixture and may notify persons in Tier 1 and Tier 2 that they are
required to submit letters of intent to test or exemption applications
within a specified period of time.
(11) If you are required to comply with this section, but your
manufacture or processing of, or intent to manufacture or process, a
mixture listed in paragraph (a) of this section begins after the
applicable compliance date referred to in paragraphs (c)(2), (c)(5), or
(c)(7) of this section, you must either submit a letter of intent to
test or apply to EPA for an exemption. The letter of intent to test or
the exemption application must be received by EPA no later than the day
you begin manufacture or processing.
(d) What must I do to comply with this section? (1) To comply with
this section you must either submit to EPA a letter of intent to test,
or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter
of intent to test, you must conduct the testing specified in paragraphs
(h) and (i) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule
requirements in 40 CFR part 790, as modified by this section, including
the submission of letters of intent to test or exemption applications,
the submission of study plans prior to testing, the conduct of testing,
and the submission of data; 40 CFR part 792--Good Laboratory Practice
Standards; and this section. The following provisions of 40 CFR part
790 do not apply to this section: Paragraphs (a), (d), (e), and (f) of
Sec. 790.45; Sec. 790.48; paragraph (a)(2) and paragraph (b) of Sec.
790.80; paragraph (e)(1) of Sec. 790.82; and Sec. 790.85.
(e) If I do not comply with this section, when will I be considered
in violation of it? You will be considered in violation of this section
as of 1 day after the date by which you are required to comply with
this section.
(f) How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more mixtures included in this section, any
person may request a hearing as described in 40 CFR part 791. In the
determination of fair reimbursement shares under this section, if the
hearing officer chooses to use a formula based on production volume,
the total production volume amount will include amounts of a mixture
manufactured and processed as impurities and amounts imported in
articles.
(g) Who must comply with the export notification requirements? Any
person who exports, or intends to export, a mixture listed in paragraph
(a) of this section is subject to 40 CFR part 707, subpart D, except
when the mixture is in articles.
(h) How must I conduct my testing of c-pentaBDE and c-octaBDE? The
tests that are required for c-pentaBDE and c-octaBDE and the test
methods that must be followed are listed in paragraphs (h)(1) through
(11) of this section. All tests must be conducted in accordance with
the requirements described in 40 CFR part 792--Good Laboratory Practice
Standards.
(1) Toxicity to freshwater invertebrates of sediment-associated
contaminants conducted in accordance
[[Page 19899]]
with ASTM E 1706-05e1 and following the guidance of ASTM E 1391-03.
(2) Laboratory soil toxicity and bioaccumulation tests with the
lumbricid earthworm Eisenia fetida and the enchytraeid potworm
Enchytraeus albidu conducted in accordance with ASTM E 1676-04 and
following general guidance in ASTM E 1391-03.
(3) Toxicity to polychaetous annilids of sediment-associated
contaminants conducted in accordance with ASTM E 1611-00 and following
the guidance of ASTM E 1391-03.
(4) Laboratory soil toxicity to nematode Caenorhabditis elegans
conducted in accordance with ASTM E 2172-01 and following guidance for
collecting laboratory soil in ASTM E 1676-04, and following general
guidance in ASTM E 1391-03.
(5) Toxicity to estuarine and marine invertebrates of sediment-
associated contaminants conducted in accordance with ASTM E 1367-03 and
following the guidance of ASTM E 1391-03.
(6) Prenatal developmental toxicity in rabbits conducted in
accordance with 40 CFR 799.9370.
(7) 2-Generation reproductive toxicity with a satellite group for
body burden determinations conducted in accordance with 40 CFR
799.9380.
(8) Immunotoxicity conducted in accordance with 40 CFR 799.9780.
(9) Neurotoxicity screening battery, acute and subchronic,
conducted in accordance with 40 CFR 799.9620.
(10) Developmental neurotoxicity conducted in accordance with 40
CFR 799.9630.
(11) Chronic toxicity/carcinogenicity conducted in accordance with
40 CFR 799.9430.
(i) How must I conduct my testing of c-decaBDE? The tests that are
required for c-decaBDE and the test methods that must be followed are
listed in paragraphs (i)(1) through (4) of this section. The use of the
term ``test substance'' in the guidelines listed in paragraphs (i)(2)
through (4) of this section, should be understood to mean c-decaBDE or
test mixture where appropriate. All tests must be conducted in
accordance with the requirements described in 40 CFR part 792--Good
Laboratory Practice Standards.
(1) The tests and test methods listed in paragraphs (h)(1) through
(10) of this section.
(2) Anaerobic aquatic metabolism conducted in accordance with 40
CFR 795.25.
(3) Biodegradation in anaerobic digester sludge conducted in
accordance with 40 CFR 795.30.
(4) Photolytic degradation of decaBDE in the indoor environment in
accordance with 40 CFR 795.65.
(j) Reporting requirements. For c-pentaBDE and c-octaBDE or c-
decaBDE a final report for each specific test for each subject mixture
must be received by EPA by the number of months designated for that
test in this paragraph after December 31, 2013, unless an extension is
granted in writing pursuant to 40 CFR 790.55. A robust summary of the
final report for each specific test shall be submitted electronically
in addition to and at the same time as the final report. The term
``robust summary'' is used to describe the technical information
necessary to adequately describe an experiment or study and includes
the objectives, methods, results, and conclusions of the full study
report which can be either an experiment or in some cases an estimation
or prediction method. Guidance for the compilation of robust summaries
is described in a document entitled ``Draft Guidance on Developing
Robust Summaries'' which is available online at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
(1) The final report on toxicity to freshwater invertebrates of
sediment-associated contaminants shall be received by EPA by (12 months
after the effective date in paragraph (k) of this section).
(2) The final report on laboratory soil toxicity and
bioaccumulation tests with the lumbricid earthworm Eisenia fetida and
the enchytraeid potworm Enchytraeus albidu shall be received by EPA by
(12 months after the effective date in paragraph (k) of this section).
(3) The final report on toxicity to polychaetous annilids of
sediment-associated contaminants shall be received by EPA by (12 months
after the effective date in paragraph (k) of this section).
(4) The final report on toxicity to nematode Caenorhabditis elegans
of sediment-associated contaminants shall be received by EPA by (12
months after the effective date in paragraph (k) of this section).
(5) The final report on toxicity to estuarine and marine
invertebrates of sediment-associated contaminants shall be received by
EPA by (12 months after the effective date in paragraph (k) of this
section).
(6) The final report on prenatal developmental toxicity in rabbits
shall be received by EPA by (12 months after the effective date in
paragraph (k) of this section).
(7) The final report on 2-generation reproductive toxicity with a
satellite group for body burden shall be received by EPA by (29 months
after the effective date in paragraph (k) of this section).
(8) The final report on immunotoxicity shall be received by EPA by
(12 months after the effective date in paragraph (k) of this section).
(9) The final report on the neurotoxicity screening battery, acute
and subchronic, shall be received by EPA by (21 months after the
effective date in paragraph (k) of this section).
(10) The final report on developmental neurotoxicity shall be
received by EPA by (21 months after the effective date in paragraph (k)
of this section).
(11) The final report for the chronic toxicity/carcinogenicity test
shall be received by EPA by (60 months after the effective date in
paragraph (k) of this section).
(12) The final report for anaerobic aquatic metabolism shall be
received by EPA by (60 months after the effective date in paragraph (k)
of this section).
(13) The final report for biodegradation in anaerobic digester
sludge shall be received by EPA by (24 months after the effective date
in paragraph (k) of this section).
(14) The final report for photolytic degradation of c-decaBDE in
the indoor environment shall be received by EPA by (24 months after the
effective date in paragraph (k) of this section).
(k) Effective date. This section is effective after December 31,
2013, for manufacturers (including importers) and processors of c-
pentaBDE, c-octaBDE, and c-decaBDE for any use, including in articles.
[FR Doc. 2012-7195 Filed 3-30-12; 8:45 am]
BILLING CODE 6560-50-P