Document ID: EPA-HQ-OPPT-2010-1039-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use and Test Rules: Certain Polybrominated Diphenylethers
Posted Date: 2012-04-02T04:00Z

[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Proposed Rules]
[Pages 19862-19899]
From the Federal Register Online via the Government Printing 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: bowser.john@epa.gov.
    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: roman.catherine@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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

[[Page 19864]]

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-

[[Page 19865]]

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

[[Page 19866]]

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