19862 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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. 

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 (cpentaBDE), 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 cdecaBDE, 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 


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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 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 acrylonitrilebutadiene-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, coctaBDE, or c-decaBDE including in 

articles for any use after December 31, 

2013 to conduct testing of such 


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19864 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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, coctaBDE, 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 cdecaBDE will be accomplished in two 

steps. No later than December 31, 2012, 

the manufacturers and the importer of cdecaBDE 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 cdecaBDE 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 cVerDate Mar<15>2010 19:27 Mar 30, 2012 Jkt 226001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\02APP4.SGM 02APP4

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decaBDE are considered manufacturers 

of these mixtures and would be subject 

to the proposed test rule, along with 

persons who domestically manufacture 

these chemicals in bulk or as part of a 

mixture. Persons who process cpentaBDE, 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 cPBDE 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 cPBDEs, 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 cpentaBDE 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 cpentaBDE, 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: cPentaBDE, 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 cpentaBDE, 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, coctaBDE, or c-decaBDE after December 

31, 2013, EPA would promulgate the 

test rule. If a person indicated his 

intention to continue to engage in an 

activity proposed as a significant new 

use for any of these c-PBDEs, EPA 

would promulgate the proposed 

amendments to the SNUR designating 

all other uses of that PBDE as significant 

new uses. EPA would exclude the 

ongoing uses from the final SNUR. 

Therefore, a person who is 

manufacturing, importing or processing 

the c-PBDEs for an ongoing use after the 

effective date of the test rule would not 

need to submit a SNUN for that use and 

would be allowed to continue those 

activities while complying with the test 

rule. (See Unit V.C. for further 

discussion of what constitutes an 

ongoing use.) However, if EPA were to 

learn that the only persons that would 

be subject to the test rule would be 

persons that process (rather than 

manufacture) c-pentaBDE, c-octaBDE, or 

c-decaBDE as impurities contained in 

articles, EPA would not require testing 

because EPA has not determined 

whether this activity alone may present 

an unreasonable risk of injury to health 

or the environment. For example, 

persons who grind old plastic pallets 

containing decaBDE for the purpose of 

reusing the ground material in the 

fabrication of ‘‘new’’ plastic pallets 

would be considered processors of 

decaBDE as an impurity, if the decaBDE 

is unintentionally present in the 

recycled product (see Unit II.C.). If 

decaBDE is still being used as a flame 

retardant in a recycled product, it would 

have been considered to be processed. 

2. Reporting obligations if initiating 

new uses of PBDEs, including 

resumption of discontinued uses. Uses 


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not ongoing at the time of the proposal 

would be designated significant new 

uses in the final SNUR. Uses ongoing at 

the time of this proposed rule, but 

discontinued at the time the SNUR is 

finalized, would also be designated 

significant new uses. As required under 

TSCA section 5(b)(1)(A), if EPA has 

promulgated a final test rule for a 

chemical substance, any person who is 

required to submit a SNUN before 

beginning the manufacture or 

processing of that chemical substance is 

also required to submit test data under 

the final test rule for that chemical 

substance at the time that the SNUN is 

submitted. Persons who intend to begin 

(or resume) commercial manufacture, 

import, or processing of the chemical 

substance(s), including in articles, for 

such uses would have to comply with 

all applicable SNUN requirements, 

including submission of data if a test 

rule is in effect, and wait until EPA’s 

statutorily-defined time period for its 

review of the SNUN expires before 

commencing those activities. 

EPA expects that the manufacture and 

processing of the PBDEs identified in 

this proposed rule, except as impurities, 

including these PBDEs when contained 

in articles, will have been discontinued 

for most uses by the date indicated in 

the proposed amendments to the SNUR. 

EPA intends to promulgate amendments 

to the SNUR designating manufacturing 

and processing for any use which is not 

ongoing (including uses first arising 

after April 2, 2012 and uses 

discontinued since April 2, 2012) as a 

significant new use. The proposed 

SNUR would not apply to any ongoing 

uses identified at the point of 

finalization (i.e., uses arising before 

April 2, 2012 and which have not been 

discontinued as of the date of 

finalization). All other uses, including 

discontinued uses, would be designated 

as significant new uses. EPA recognizes 

that certain portions of the proposed 

significant new use may be still ongoing 

as of April 2, 2012, and will verify 

whether they have been discontinued 

(i.e., whether they are indeed ongoing) 

before issuing a final SNUR that 

incorporates them. 

G. What is the Agency’s authority for 

taking this action? 

1. SNURs. Section 5(a)(2) of TSCA (15 

U.S.C. 2604(a)(2)) authorizes EPA to 

determine that a use of a chemical 

substance is a ‘‘significant new use.’’ 

EPA must make this determination by 

rule after considering all relevant 

factors, including those listed in TSCA 

section 5(a)(2). Once EPA determines 

that a use of a chemical substance is a 

significant new use, TSCA section 

5(a)(1)(B) requires persons to submit a 

SNUN to EPA at least 90 days before 

they manufacture or process the 

chemical substance for that use (15 

U.S.C. 2604(a)(1)(B)). For purposes of 

TSCA section 5, the terms 

‘‘manufacture’’ and ‘‘process’’ mean 

manufacturing or processing for 

commercial purposes. 

2. Test rule. Section 2(b)(1) of TSCA 

(15 U.S.C. 2601(b)(1)) states that it is the 

policy of the United States that 

‘‘adequate data should be developed 

with respect to the effect of chemical 

substances and mixtures on health and 

the environment and that the 

development of such data should be the 

responsibility of those who manufacture 

[which is defined by statute to include 

import] and those who process such 

chemical substances and mixtures[.]’’ 

To implement this policy, TSCA section 

4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) 

provides that EPA shall require by a rule 

published in the Federal Register 

manufacturers or processors or both of 

chemical substances and mixtures 

conduct testing, if the EPA 

Administrator makes the findings under 

either or both TSCA section 4(a)(1)(A) 

(an ‘‘A’’ finding) and/or TSCA section 

4(a)(1)(B) (a ‘‘B’’ finding) in a final rule. 

Under TSCA section 4(a)(1)(A), the EPA 

Administrator must find that: 

(i) the manufacture, distribution in 

commerce, processing, use, or disposal of a 

chemical substance or mixture, or that any 

combination of such activities, may present 

an unreasonable risk of injury to health or the 

environment, 

(ii) there are insufficient data and 

experience upon which the effects of such 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture or any combination of such 

activities on health or the environment can 

reasonably be determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to 

develop such data[.] 

Under TSCA section 4(a)(1)(B), the EPA 

Administrator must find that: 

(i) a chemical substance or mixture is or 

will be produced in substantial quantities, 

and (I) it enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities or (II) there is or may 

be significant or substantial human exposure 

to such substance or mixture, (ii) there are 

insufficient data and experience upon which 

the effects of the manufacture, distribution in 

commerce, processing, use, or disposal of 

such substance or mixture or of any 

combination of such activities on health or 

the environment can reasonably be 

determined or predicted, and (iii) testing of 

such substance or mixture with respect to 

such effects is necessary to develop such 

data. 

Under TSCA section 4(a)(2), if the 

EPA Administrator finds that, in the 

case of a mixture, the effects which the 

mixture’s manufacture, distribution in 

commerce, processing, use, or disposal 

or any combination of such activities 

may have on health or the environment 

may not be reasonably and more 

efficiently determined or predicted by 

testing the chemical substances which 

comprise the mixture; the EPA 

Administrator shall by rule require that 

testing be conducted on such mixture. 

The purpose of the testing would be 

to develop data with respect to the 

health and environmental effects for 

which there is an insufficiency of data 

and experience, and which are relevant 

to a determination that the manufacture, 

distribution in commerce, processing, 

use, or disposal of the chemical 

substance or mixture, or that any 

combination of such activities, does or 

does not present an unreasonable risk of 

injury to health or the environment. 

The extent to which such activities 

may affect health or the environment is 

dependent in part upon the human and 

environmental exposures to the 

chemical substance or mixture 

occasioned by those activities. As an 

example, TSCA section 4(b)(2)(A) 

specifically addresses testing for 

persistence of a substance. Testing to 

identify where and in what 

concentrations a chemical substance or 

mixture may become present in the 

environment contributes to an 

understanding of human and 

environmental exposures resulting from 

those activities. 

Once the EPA Administrator has 

made the relevant findings under TSCA 

section 4(a), EPA may require any 

health or environmental effects testing 

for which data are insufficient and 

which are necessary to develop the data. 

EPA need not limit the scope of testing 

required to the factual basis for the 

TSCA section 4(a)(1)(A)(i) or 

4(a)(1)(B)(i) finding as long as EPA also 

finds that there are insufficient data and 

experience upon which the effects of the 

manufacture, distribution in commerce, 

processing, use, or disposal of such 

substance or mixture or of any 

combination of such activities on health 

or the environment can reasonably be 

determined or predicted, and that 

testing is necessary to develop such 

data. This approach is explained in 

more detail in EPA’s TSCA section 

4(a)(1)(B) Final Statement of Policy (B 

Policy) published in the Federal 

Register issue of May 14, 1993 (Ref. 12). 

In this proposed test rule, based on a 

preliminary ‘‘A’’ finding, EPA would 

use its authority under TSCA section 

4(a) to require the development of data 

‘‘which are relevant to a determination 

that the manufacture, processing, 


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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, coctaBDE, 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). 

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, coctaBDE, and c-decaBDE; each 

commercial product is a mixture of 

PBDE congeners (see Table 2 of this 

unit). 


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TABLE 1—PBDE HOMOLOG GROUPS

Common 

name Chemical abstracts (CA) index name 

Chemical 

abstracts service registry number 

(CASRN) 

Number of 

bromine (Br) 

atoms 

TetraBDE ...... Benzene, 1,1′-oxybis-, tetrabromo deriv. ......................................................................... 40088–47–9 4 

PentaBDE ..... Benzene, 1,1′-oxybis-, pentabromo deriv ......................................................................... 32534–81–9 5 

HexaBDE ...... Benzene, 1,1′-oxybis-, hexabromo deriv .......................................................................... 36483–60–0 6 

HeptaBDE ..... Benzene, 1,1′-oxybis-, heptabromo deriv ......................................................................... 68928–80–3 7 

OctaBDE ....... Benzene, 1,1′-oxybis-, octabromo deriv ........................................................................... 32536–52–0 8 

NonaBDE ...... Benzene, 1,1′-oxybis-, 1,2,3,4,5- pentabromo-6- (tetrabromophenoxy)- ......................... 63936–56–1 9 

DecaBDE ...... Benzene, 1,1′-oxybis [2,3,4,5,6- pentabromo- ................................................................. 1163–19–5 10 

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 cdecaBDE 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 cPBDEs 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 cPBDEs. 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 coctaBDE 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 cpentaBDE 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 cdecaBDE 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 peerreviewed 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, industrysponsored screening level risk 

assessments for c-pentaBDE, c-octaBDE, 

and c-decaBDE were developed to 


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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 cpentaBDE were observed in the 

following studies: 

• Repeated-dose toxicity studies for cpentaBDE 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 coctaBDE, 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 cdecaBDE 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 cpentaBDE 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 


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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 nondetectable 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-observedadverse-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, 


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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 cdecaBDE 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 cdecaBDE. 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 cpentaBDE, 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, coctaBDE, and c-decaBDE, coupled with 

the evidence of human and/or 

environmental hazard of c-pentaBDE, coctaBDE, 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, coctaBDE, 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 cpentaBDE, 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 cpentaBDE, 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, coctaBDE, 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 


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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 cpentaBDE, 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 


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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 cpentaBDE, 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 ePMN 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 

Proposed test Test guideline 

Test proposed for: Deadline for 

submitting final 

report (number 

of months 

after the 

effective date 

in proposed 40 

CFR 

799.5350(k)) 

c-penta 

BDE c-octa BDE c-deca BDE 

Toxicity to freshwater invertebrates of 

sediment-associated contaminants.

ASTM International (ASTM) E 1706– 

05e1 and ASTM E 1391–03 1.

X X X 12 

Laboratory soil toxicity and bioaccumulation tests with the lumbricid earthworm 

Eisenia fetida and the enchytraeid 

potworm Enchytraeus albidu.

ASTM E 1676–04 and ASTM E 1391– 

03 2.

X X X 12 

Toxicity to polychaetous annilids of sediment-associated contaminants.ASTM E 1611–00 and ASTM E 1391– 

03 1.

X X X 12 

Laboratory soil toxicity to nematode 

Caenorhabditis elegans.

ASTM E 2172–01 and ASTM E 1391– 

03 2.

X X X 12 

Toxicity to estuarine and marine invertebrates of sediment-associated contaminants.ASTM E 1367–03, ASTM E 1676–04 3

and ASTM E 1391–03 1.

X X X 12 

Prenatal developmental toxicity in rabbits.40 CFR 799.9370 .................................. X X X 12 

2-Generation reproductive toxicity with 

satellite group for body burden determinations.

40 CFR 799.9380 .................................. X X X 29 

Immunotoxicity ........................................ 40 CFR 799.9780 .................................. X X X 12 

Neurotoxicity screening battery, acute 

and subchronic.

40 CFR 799.9620 .................................. X X X 21 


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19874 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

TABLE 3—PROPOSED TESTING AND REPORTING REQUIREMENTS FOR C-PENTABDE, C-OCTABDE, AND C-DECABDE— 

Continued 

Proposed test Test guideline 

Test proposed for: Deadline for 

submitting final 

report (number 

of months 

after the 

effective date 

in proposed 40 

CFR 

799.5350(k)) 

c-penta 

BDE c-octa BDE c-deca BDE 

Developmental neurotoxicity ................... 40 CFR 799.9630 .................................. X X 4X 21 

Chronic toxicity/carcinogenicity ............... 40 CFR 799.9430 .................................. X X .................... 60 

Anaerobic aquatic metabolism ................ 40 CFR 795.25 (modified OCSPP 

835.4400 5).

.................... .................... X 60 

Biodegradation in Anaerobic Digester 

Sludge.

40 CFR 795.30 (modified OCSPP 

835.3280 5).

.................... .................... X 24 

Photolytic degradation in the indoor environment.40 CFR 795.65 ...................................... .................... .................... X 24 

1ASTM 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. 2ASTM E 1391–03 provides general guidance. 

3ASTM E 1676–04 provides guidance for collecting laboratory soil. 

4A 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 cdecaBDE. 5Office 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 sedimentassociated 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 


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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 decaBDEcontaining 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 cpentaBDE, 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 


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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 required to comply) Tier 2 (persons not initially required to comply) 

Persons who manufacture (as defined at TSCA 

section 3(7)), or intend to manufacture, a test 

rule mixture and who are not listed under Tier 

2. Importers of articles containing 

polybrominated diphenyl ethers (PBDEs) are 

manufacturers.

A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a 

test rule mixture solely as one or more of the following: 

—As a byproduct (as defined at 40 CFR 791.3(c)); 

—As an impurity (as defined at 40 CFR 790.3); 

—As a naturally occurring chemical 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 nonisolated 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, coctaBDE, 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 


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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 nonisolated 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 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 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 


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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 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 


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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 cdecaBDE 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 cpentaBDE 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, cOctabromodiphenyl Ether, and cDecabromodiphenyl 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 


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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 highcost 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 cdecaBDE, 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 lowand 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 cdecaBDE’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 costto-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, cOctabromodiphenyl Ether, and cDecabromodiphenyl 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 


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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 cdecaBDE 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 cPBDEs 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 PhaseOut 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. 


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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.; Canto ́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_decabdeeng.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 FlameRetarded 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<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. 


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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, cOctabromodiphenyl Ether, and cDecabromodiphenyl 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 cPentabromodiphenyl Ether, cOctabromodiphenyl Ether, and cDecabromodiphenyl 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 


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19884 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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 


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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 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, 


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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 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 § 721.10000 to read as 

follows: 

§ 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. 


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(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 

§ 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 § 795.25 to subpart B to read 

as follows: 

§ 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. 14C-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 14C-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 °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, 

14C-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 


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19888 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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 °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 watersediment 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

Parameter 

Stage of test procedure 

Field sampling Post-handling Start of acclimation Start of test During test End of 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 °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 


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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 

14CO2- hydrocarbons and 14CO2 and 14CH4 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 °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 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
19890 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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 § 795.30 to subpart B to read 

as follows: 

§ 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 14Clabeled 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 °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 

°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 


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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 (Na2HPO4·12H2O) ...................................................................................................... 1 .12 

Ammonium chloride (NH4Cl) ................................................................................................................................................................. 0 .53 

Calcium chloride dihydrate (CaCl2·2H2O) ............................................................................................................................................. 0 .075 

Magnesium chloride hexahydrate (MgCl2·6H2O) .................................................................................................................................. 0 .10 

Iron (II) chloride tetrahydrate (FeCl2·4H2O) ........................................................................................................................................... 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 °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. 


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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 (14CO2 and 14CH4). 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 °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 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 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 § 795.65 to subpart B to read 

as follows: 

§ 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 offgassing 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/m2) 

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/m3) (i.e., 50% relative 

humidity at 23 °C). 

(v) The light source shall be operated 

according to ASTM G 151–09, Standard 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
19894 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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/m2/nanometer 

(nm) at 340 nm (i.e., peak emission) 

when operated in the continuous lighton mode without water spray. This light 

source satisfies the light intensity 

requirement of 5 W/m2 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 (cm2) (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 cm2

(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

Test No. Material Ultraviolet 

(UV) light 

Durations 

(hours) 

1 ................................ High Impact Polystyrene (HIPS) coupons ...................................................................... on .............. 300, 600, 900 

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 cm2 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 lighton 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 cm2 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 × 10 cm2 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 

× 10 cm2 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. 


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(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 cm2 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 cm2, 

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)/cm2 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 (HIPS) coupons ....................................................................... Off ............. 300, 600, 900 

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/cm2 coupon. 

(D) Clean the test chamber by wiping 

the interior surfaces with ethanolsoaked paper towel. 

(E) Take two wipe samples from 

chamber walls (100 cm2 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 

°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 cm2. 

(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/cm2. 

(H) Clean the test chamber by wiping 

the interior surfaces with ethanolsoaked paper towel. 

(I) Take two wipe samples from 

chamber walls (100 cm2 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 

°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 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
19896 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

(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 microvacuum 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.; Kru ̈ 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-tomouth 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. 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 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 § 799.5350 to subpart D to read 

as follows: 

§ 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 cdecaBDE 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 cdecaBDE for export from the United 

States. For this section, importers of 

articles containing c-pentaBDE, coctaBDE, 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 at TSCA section 3(7)), or intend to manufacture, 

a test rule mixture and who are not listed under Tier 2. Importers of articles containing PBDEs are considered manufacturers.

A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a test rule mixture 

solely as one or more of the following: 

—As a byproduct (as defined at 40 CFR 791.3(c)); 

—As an impurity (as defined at 40 CFR 790.3); 

—As a naturally occurring chemical 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 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 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS4
19898 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 

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 § 790.45; § 790.48; paragraph (a)(2) 

and paragraph (b) of § 790.80; paragraph 

(e)(1) of § 790.82; and § 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 


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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Proposed Rules 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 cpentaBDE 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 sedimentassociated 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 sedimentassociated 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, coctaBDE, 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 


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