70404 Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 

DEPARTMENT OF THE TREASURY

Internal Revenue Service 

26 CFR Part 26 

[REG–145988–03] 

RIN 1545–BC60 

Predeceased Parent Rule

AGENCY: Internal Revenue Service (IRS), 

Treasury.

ACTION: Cancellation of notice of public 

hearing on proposed rulemaking. 

SUMMARY: This document provides 

notice of cancellation of a public 

hearing on proposed rulemaking 

relating to the predeceased parent rule.

DATES: The public hearing originally 

scheduled for Tuesday, December 14, 

2004, at 10 a.m. is cancelled.

FOR FURTHER INFORMATION CONTACT: Guy 

R. Traynor, Procedures and 

Administration, Publications & 

Regulations Branch, at (202) 622–3693 

(not a toll-free number).

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking and notice of 

public hearing that appeared in the 

Federal Register on Friday, September 

3, 2004 (69 FR 53862), announced that 

a public hearing was scheduled for 

December 14, 2004 at 10 a.m., in the 

auditorium of the Internal Revenue 

Service building, 1111 Constitution 

Avenue NW., Washington, DC. The 

subject of the public hearing is proposed 

regulations under section 2651 of the 

Internal Revenue Code. 

The notice of proposed rulemaking 

and notice of public hearing, instructed 

those interested in testifying at the 

public hearing to submit a request to 

speak and an outline of topics to be 

addressed by November 23, 2004. As of 

November 29, 2004, no one has 

requested to speak. Therefore, the 

public hearing scheduled for December 

14, 2004 is cancelled.

Guy R. Traynor, 

Federal Register Liaison, Publications & 

Regulations Branch, Legal Processing 

Division, Associate Chief Counsel, 

(Procedures & Administration).

[FR Doc. 04–26746 Filed 12–3–04; 8:45 am] 

BILLING CODE 4830–01–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 721

[OPPT–2004–0085; FRL–7688–1]

RIN 2070–AJ02

Certain Polybrominated 

Diphenylethers; Proposed Significant 

New Use Rule

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a significant 

new use rule (SNUR) under section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for tetrabromodiphenyl 

ether (CAS No. 40088–47–9; Benzene, 

1,1′-oxybis-, tetrabromo deriv.), 

pentabromodiphenyl ether (CAS No. 

32534–81–9; Benzene, 1,1′-oxybis-, 

pentabromo deriv.), hexabromodiphenyl 

ether (CAS No. 36483–60–0; Benzene, 

1,1′-oxybis-, hexabromo deriv.), 

heptabromodiphenyl ether (CAS No. 

68928–80–3; Benzene, 1,1′-oxybis-, 

heptabromo deriv.), octabromodiphenyl 

ether (CAS No. 32536–52–0; Benzene, 

1,1′-oxybis-, octabromo deriv.), or 

nonabromodiphenyl ether (CAS No. 

63936–56–1; Benzene, 

pentabromo(tetrabromophenoxy)-), and 

any combination of these substances 

resulting from a chemical reaction. This 

proposed rule would require 

manufacturers and importers to notify 

EPA at least 90 days before commencing 

the manufacture or import of any one or 

more of these chemical substances on or 

after January 1, 2005 for any use. EPA 

believes that this action is necessary 

because these chemical substances may 

be hazardous to human health and the 

environment. The required notice 

would provide EPA with the 

opportunity to evaluate an intended 

new use and associated activities and, if 

necessary, to prohibit or limit that 

activity before it occurs.

DATES: Comments, identified by docket 

identification (ID) number OPPT–2004–

0085, must be received on or before 

February 4, 2005.

ADDRESSES: Submit your comments, 

identified by docket (ID) number OPPT–

2004–0085, by one of the following 

methods:

• Federal eRulemaking Portal: http://

www.regulations.gov/. Follow the online instructions for submitting 

comments.

• Agency Website: http://

www.epa.gov/edocket/. EDOCKET, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments.

• E-mail: oppt.ncic@epa.gov.

• Mail: Document Control Office 

(DCO) (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, EPA East Bldg., Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

number OPPT–2004–0085. 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 Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information.

Instructions: Direct your comments to 

docket ID number OPPT–2004–0085. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available on-line at http://

www.epa.gov/edocket/, 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 EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the regulations.gov 

websites are ‘‘anonymous access’’

systems, 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 

e-mail comment directly to EPA without 

going through EDOCKET or 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public 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. For additional information 

about EPA’s public docket, visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102) 

(FRL–7181–7).

Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 70405

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket/. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the OPPT Docket, EPA Docket 

Center, EPA West, Rm. B102, 1301 

Constitution Ave., NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The EPA Docket Center 

Reading Room telephone number is 

(202) 566–1744, and the telephone 

number for the OPPT Docket, which is 

located in the EPA Docket Center, is 

(202) 566–0280.

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov.

For technical information contact:

Kenneth Moss, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (303) 312–

6700; e-mail address: 

moss.kenneth@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) one or 

more of the following polybrominated 

diphenyl ethers (PBDEs): 

tetrabromodiphenyl ether (‘‘tetraBDE’’) 

(CAS No. 40088–47–9; Benzene, 1,1′-

oxybis-, tetrabromo deriv.), 

pentabromodiphenyl ether 

(‘‘pentaBDE’’) (CAS No. 32534–81–9; 

Benzene, 1,1′-oxybis-, pentabromo 

deriv.), hexabromodiphenyl ether 

(‘‘hexaBDE’’) (CAS No. 36483–60–0; 

Benzene, 1,1′-oxybis-, hexabromo 

deriv.), heptabromodiphenyl ether 

(‘‘heptaBDE’’) (CAS No. 68928–80–3; 

Benzene, 1,1′-oxybis-, heptabromo 

deriv.), octabromodiphenyl ether 

(‘‘octaBDE’’) (CAS No. 32536–52–0; 

Benzene, 1,1′-oxybis-, octabromo 

deriv.), or nonabromodiphenyl ether 

(‘‘nonaBDE’’) (CAS No. 63936–56–1; 

Benzene, 

pentabromo(tetrabromophenoxy)-), and 

any combination of these substances 

resulting from a chemical reaction. 

Persons who intend to import any 

chemical substance governed by a final 

SNUR are subject to the TSCA section 

13 (15 U.S.C. 2612) import certification 

requirements, and to the regulations 

codified at 19 CFR 12.118 through 

12.127 and 127.28. Those persons must 

certify that they are in compliance with 

the SNUR requirements (see TSCA 

section 13 (15 U.S.C. 2612) and 19 CFR 

12.118 through 12.127 and 127.28). The 

EPA policy in support of import 

certification appears at 40 CFR part 707, 

subpart B. In addition, any persons who 

export or intend to export a chemical 

substance that is the subject of this 

proposed rule on or after January 5, 

2005 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. Potentially 

affected entities may include, but are 

not limited to:

• Manufacturers (defined by statute to 

include importers) of PBDEs (NAICS 

325 and 324110), e.g. chemical 

manufacturing and petroleum refineries.

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions at 

40 CFR 721.5 for SNUR-related 

obligations. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 721 is available on E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

C. How Do I Submit Confidential 

Business Information?

1. Submitting CBI. Do not submit this 

information to EPA through EDOCKET, 

regulations.gov, or e-mail. 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 rulemaking 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.

II. Background

A. What Action is the Agency Taking?

This proposed rule, when finalized, 

would require persons to notify EPA at 

least 90 days before commencing the 

manufacture (including importation) of 

tetrabromodiphenyl ether (‘‘tetraBDE’’) 

(CAS No. 40088–47–9; Benzene, 1,1′-

oxybis-, tetrabromo deriv.), 

pentabromodiphenyl ether 

(‘‘pentaBDE’’) (CAS No. 32534–81–9; 

Benzene, 1,1′-oxybis-, pentabromo 

deriv.), hexabromodiphenyl ether 

(‘‘hexaBDE’’) (CAS No. 36483–60–0; 

70406 Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 

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.), or nonabromodiphenyl ether 

(‘‘nonaBDE’’) (CAS No. 63936–56–1; 

Benzene, 

pentabromo(tetrabromophenoxy)-), and 

any combination of these substances 

resulting from a chemical reaction, for 

any use on or after January 1, 2005.

B. What is the Agency’s Authority for 

Taking this Action?

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a notice to 

EPA at least 90 days before they 

manufacture, import, or process the 

chemical substance for that use (15 

U.S.C. 2604 (a)(1)(B). The mechanism 

for reporting under this requirement is 

established under 40 CFR 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear 

under subpart A of 40 CFR part 721. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear at 

40 CFR part 700. Persons subject to this 

SNUR, when finalized, would be 

required to 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 submission requirements of 

TSCA section 5(b) and 5(d)(1); the 

exemptions authorized by TSCA section 

5 (h)(1), (h)(2), (h)(3), and (h)(5); and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUR notice, EPA may 

take regulatory action under TSCA 

sections 5(e), 5(f), 6, or 7, if appropriate, 

to control the activities on which it has 

received the SNUR notice. If EPA does 

not take action, EPA is required under 

TSCA section 5(g) to explain in the 

Federal Register its reasons for not 

taking action. 

Persons who intend to export a 

chemical substance identified in a 

proposed or final SNUR are subject to 

the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. Persons 

who intend to import a chemical 

substance identified in a final SNUR are 

subject to the TSCA section 13 import 

certification requirements, which 

appear at 19 CFR 12.118 through 12.127 

and 127.28. Such persons must certify 

that they are in compliance with SNUR 

requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B.

III. Summary of the Proposed Rule 

PBDEs are members of a broader class 

of brominated chemicals used as flame 

retardants; these are called brominated 

flame retardants, or BFRs. There are 

commercial PBDE products with 

different average amounts of 

bromination: penta-, octa-, and 

decaBDE. These chemicals are major 

components of commercial products 

often used as fire retardants in furniture 

foam (pentaBDE), plastics for personal 

computers and small appliances 

(octaBDE), and plastics for TV cabinets, 

consumer electronics, wire insulation, 

and backcoatings for draperies and 

upholstery (decabromodiphenylether, or 

decaBDE). The value of these chemicals 

is their ability to slow ignition and rate 

of fire growth, and as a result increase 

available escape time in the event of a 

fire involving the above products.

Although use of these chemicals is 

intended to save lives and property, 

there have been unintended 

consequences, such as, releases to and 

accumulation in the environment. 

Environmental monitoring programs in 

Europe, Asia, North America, and the 

Arctic have detected several PBDEs in 

human breast milk, fish, aquatic birds, 

and elsewhere in the environment. The 

human health toxicological endpoints of 

concern for these chemical substances 

are liver toxicity, thyroid toxicity, and 

neurodevelopmental toxicity. More 

needs to be understood about the 

environmental fate and the exposure 

pathways that lead to PBDE presence in 

wildlife and people. The lower 

brominated PBDEs (tetraBDE, pentaBDE, 

and hexaBDE) found in the commercial 

pentaBDE and octaBDE products are the 

congeners most often detected in the 

environment and for which human 

health and environmental concerns are 

greater (see Unit IV.B. and C.). These 

factors, taken together, raise concerns 

for potential adverse effects in people 

and wildlife over time if these 

substances should continue to be 

produced, released, and built up in the 

environment.

EPA believes that the commercial 

products pentaBDE and octaBDE are 

manufactured in the United States (U.S.) 

only by Great Lakes Chemical 

Corporation. Great Lakes has committed 

to phase-out these chemicals voluntarily 

by discontinuing their manufacture by 

the end of 2004 (Ref. 1). EPA is aware 

of no ongoing production of tetra-, hexa-

, hepta- or nonaBDE except as 

components of the commercial 

pentaBDE and octaBDE commercial 

products. EPA believes that any 

manufacture or import of these 

chemicals occurring after Great Lakes’

phase-out dates would increase the 

magnitude and duration of exposure to 

these chemicals. Therefore, EPA is 

proposing to designate as a significant 

new use any manufacture or import of 

the chemical substances listed in Unit 

II.A. for any use on or after January 1, 

2005. Because decaBDE is not included 

in the voluntary phase-out and therefore 

remains in commerce after January 1, 

2005, it would not be subject to this 

proposed rule.

Given that, based on information 

available to EPA, no companies other 

than Great Lakes Chemical Corporation 

are currently manufacturing or 

importing the commercial pentaBDE or 

octaBDE products, or the PBDE 

congeners that comprise these products, 

and given the negative commercial and 

regulatory environment associated with 

these chemicals, EPA believes it is 

unlikely that companies would incur 

the costs associated with establishing 

new manufacturing capacity for these 

chemicals in order to enter this market. 

This proposed rule, when finalized, 

would require persons who intend to 

manufacture or import the chemical 

substances listed in Unit II.A. to submit 

a SNUN at least 90 days before 

commencing the manufacture or 

importation of any of these chemicals 

for any use on or after January 1, 2005. 

The required notice would provide EPA 

with the opportunity to evaluate the 

intended use, and, if necessary, to 

prohibit or limit that use before it 

occurs. In the event that the phase-out 

of these chemicals does not progress as 

described in this proposed rule, EPA 

may pursue additional regulatory action 

as appropriate under TSCA sections 4, 

6, and 8.

IV. Overview of PBDEs 

See Unit XI. for selected primary 

references for the information 

summarized in this unit. For a more 

complete treatment of PBDEs and 

comprehensive lists of relevant articles, 

see the risk assessments developed 

under EPA’s Voluntary Children’s 

Chemical Evaluation Program (VCCEP) 

Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 70407

and the reports from the VCCEP Peer 

Consultation meetings held for these 

chemicals (Refs. 2–7), in addition to the 

overview articles (Refs. 8 and 9).

A. Defining the PBDEs Subject to this 

Proposed SNUR

The chemical substances that are 

subject to this proposed rule are listed 

on the TSCA Inventory. Each individual 

chemical substance is actually a 

reaction product of diphenyl ether with 

a brominating agent. The different 

products, each having different numbers 

of bromines depending on reaction 

stoichiometry, are a normal distribution 

of possible polybrominated diphenyl 

ethers. For example, the commercially 

available ‘‘pentaBDE’’ product, sold 

under the single CAS No. (32534–81–9), 

is predominantly an almost equal 

mixture of tetraBDE and pentaBDE 

congeners, along with smaller amounts 

of the higher brominated congeners. It is 

a reaction product combination of 

aromatic brominated compounds in 

which 4–6 hydrogen atoms in the 

diphenyl oxide structure are replaced by 

bromine atoms (Refs. 2 and 10). The 

‘‘octaBDE’’ product (CAS No. 32536–

52–0) consists predominantly of 

heptaBDE and octaBDE congeners with 

small amounts of hexa- and nonaBDE. It 

is a reaction product combination of 

aromatic brominated compounds in 

which 6–9 hydrogen atoms in the 

diphenyl oxide structure are replaced by 

bromine atoms (Refs. 3 and 10). In order 

to insure that the PBDEs listed in Unit 

II.A. would be subject to review before 

manufacture or import for commercial 

purposes, this proposed rule would 

require the reporting for any 

manufacture or importation of these 

chemical substances.

B. Health and Environmental Effects

Existing health hazard information on 

the subject chemical substances is 

incomplete (Ref. 8). The currently 

available toxicity test data indicate the 

potential for adverse effects in humans, 

especially for lower brominated 

congeners (Refs. 8 and 9). The major 

findings from subchronic and chronic 

pentaBDE toxicity studies in rodents are 

induction of hepatic enzymes and 

effects on thyroid homeostasis. The 

effects on thyroid homeostasis have 

raised concerns for the potential for 

developmental neurotoxicity (Ref. 5). 

The toxicity database for octaBDE is 

similar to that of pentaBDE, but less 

complete (Ref. 6).

With regards to environmental 

hazards of the subject chemical 

substances, the European Union (EU) 

risk assessment for pentaBDE concludes 

for aquatic and terrestrial ecosystems 

that there is a need for specific measures 

to limit risks. This conclusion is 

reached because of ‘‘concerns for effects 

on the local aquatic (sediment) and 

terrestrial environment as a 

consequence of exposure arising from 

polyurethane foam production [and] 

concerns for secondary poisoning to the 

environmental spheres mentioned in 

Unit IV.B. both locally and regionally as 

a consequence of exposure arising from 

production and/or use of polyurethane 

foams.’’ (Ref. 11). For octaBDE, the EU 

concluded that there is a risk of 

‘‘secondary poisoning via the 

earthworm route for the 

hexabromodiphenyl ether component in 

the commercial octabromodiphenyl 

ether product from the use in polymer 

applications.’’ There was a need 

identified for further monitoring to 

determine whether findings in top 

predators (including birds’ eggs) is a 

widespread or localized phenomenon, 

and for avian reproduction tests (Ref. 

12).

C. Exposure and Environmental Fate 

Data

Current information suggests strongly 

that PBDEs as a class are persistent and 

may bioaccumulate. Environmental 

monitoring programs in Europe, Asia, 

North America, and the Arctic have 

detected many PBDE congeners in 

human blood and breast milk, fish, 

aquatic birds, and elsewhere in the 

environment (Refs. 9, 13, 14, 15, 16, 17, 

and 18). This widespread presence, 

combined with persistence, 

bioaccumulative potential, and toxicity 

from low level exposures, raises 

concerns for potential adverse effects to 

people and wildlife over time should 

the chemical substances that are subject 

to this proposed rule continue to be 

produced, released, and accumulated in 

the environment. 

Of the congeners found in the 

commercial products, tetraBDE, 

pentaBDE, and hexaBDE are the PBDEs 

most frequently detected in wildlife and 

humans (Refs. 8 and 9). The octanolwater partition coefficient, which is an 

important property in determining the 

environmental fate of hydrophobic 

organic chemicals, particularly in biota, 

has been measured for a number of 

PBDEs, and shown to be in the range of 

optimum bioaccumulation potential 

(Ref. 19). With the present data, the 

Agency can only speculate on 

environmental transport and 

partitioning of PBDEs in general and 

specifically regarding the chemical 

substances that are subject to this 

proposed rule. While the exact 

mechanisms or pathways by which the 

various PBDE congeners end up in the 

environment and humans are not 

known yet, they could include direct 

releases from manufacturing or 

processing of the chemicals into 

products like plastics or textiles, aging 

and wear of these consumer products 

(Ref. 20), photolytic breakdown of 

higher brominated congeners (Ref. 21), 

and direct exposure during use or via 

indoor air or house dust (Refs. 22 and 

23), as well as bioaccumulation up the 

food chain (Ref. 24). The small amount 

of environmental information on 

octaBDE shows it does not readily 

degrade, although an exception is in 

fish, where there is evidence that 

octaBDE could have the potential to be 

metabolized to pentaBDE (Ref. 25).

D. Use Information

The chemical substances subject to 

this proposed rule, listed in Unit II.A., 

are the commercial products pentaBDE 

and octaBDE, and other PBDE congeners 

that comprise these products and are 

separately listed on the TSCA Inventory. 

PentaBDE (often formulated with 

nonhalogenated organophosphates) has 

been widely used in formulations for 

flexible polyurethane foams used in 

upholstered products ranging from 

home furniture to seats in airplanes and 

automobiles. OctaBDE has been 

primarily used as an additive to a type 

of plastic known as acrylonitrilebutadiene-styrene (ABS), used in 

housings for office and medical 

electronics, the interior and exterior 

trim of automobiles, telephone 

handsets, and other products. It is also 

incorporated into resins (polyamide and 

polybutylene terephthalate) in the 

manufacture of electrical connectors 

and components and automotive 

interior parts.

World-wide demand for pentaBDE 

and octaBDE in 2001 was estimated to 

be 7,500,000 and 3,790,000 kilograms 

(kg), respectively; demand for these 

chemicals in the Americas was 

7,100,000 kg for pentaBDE and 

1,500,000 kg for octaBDE (Ref. 26). On 

November 3, 2003, Great Lakes 

Chemical Corporation, the only U.S. 

manufacturer of pentaBDE and octaBDE, 

announced a voluntary phase-out of 

both those commercial products by the 

end of 2004. According to the 

information currently available to EPA, 

Great Lakes is the sole U.S. 

manufacturer of commercial pentaBDE 

and octaBDE and EPA also understands 

that currently there is no import of these 

commercial products into the U.S. 

Furthermore, based on available 

information, none of the other PBDE 

congeners subject to this proposed rule 

are currently manufactured or imported 

into the U.S.

70408 Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 

V. Objectives and Rationale of the Rule

As summarized in Unit IV., EPA has 

concerns regarding the environmental 

fate and the exposure pathways that 

lead to PBDE presence in wildlife and 

people, and the persistence, 

bioaccumulation, and toxicity (PBT) 

potential of pentaBDE and octaBDE. 

Great Lakes Chemical Corporation, the 

sole manufacturer of these chemicals in 

the U.S., has chosen voluntarily to 

discontinue their manufacture for all 

uses by December 31, 2004. With Great 

Lakes Chemical Corporation’s exit from 

the market, EPA believes that all U.S. 

manufacture and import of these 

chemicals likely will cease. However, 

EPA is concerned that manufacture or 

import could be reinitiated in the future, 

and wants the opportunity to evaluate 

and control, if appropriate, exposures 

associated with those activities. Based 

on the current situation, including 

substantial production volume, number 

of uses, potential for widespread release 

and exposure, as well as the PBT nature 

of the chemical substances, any new 

manufacture or import after January 1, 

2005 is expected to significantly 

increase exposures after manufacture 

and import are discontinued, over that 

which could otherwise exist. The notice 

that would be required by this proposed 

SNUR would provide EPA with the 

opportunity to evaluate activities 

associated with a significant new use as 

proposed herein and an opportunity to 

protect against unreasonable risks, if 

any, from exposure to the substances.

Based on these considerations, EPA 

wants to achieve the following 

objectives with regard to the significant 

new uses that are designated in this 

proposed rule. EPA wants to ensure 

that: 

1. EPA would receive notice of any 

person’s intent to manufacture or import 

the chemical substances subject to this 

proposed rule for a designated 

significant new use before that activity 

begins. 

2. EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or importing these 

chemical substances for a significant 

new use.

3. EPA would be able to regulate 

prospective manufacturers and 

importers of these chemical substances 

before a significant new use occurs, 

provided such regulation is warranted 

pursuant to TSCA sections 5(e), 5(f), 6 

or 7. 

VI. Significant New Use Determination

In making a determination that a use 

of a chemical substance is a significant 

new use, the Agency must consider all 

relevant factors, including those listed 

in section 5(a)(2) of TSCA. Those factors 

are: 

• The projected volume of 

manufacturing and processing of the 

chemical substance.

• The extent to which the use 

changes the type or form of exposure to 

human beings or the environment to a 

chemical substance.

• The extent to which the use 

changes the magnitude and duration of 

exposure to human beings or the 

environment to a chemical substance.

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance.

Given that no companies other than 

Great Lakes Chemical Corporation are 

currently manufacturing or importing 

commercial pentaBDE or octaBDE in the 

U.S., the negative commercial and 

regulatory environment associated with 

these chemicals (including the EU ban 

on marketing and use of pentaBDE and 

octaBDE (Ref. 27) and similar 

restrictions enacted by certain States in 

the U.S. (Ref. 28)), and the expectation 

that viable substitutes will be available 

including those being considered in the 

Design for Environment Furniture 

Flame Retardancy Partnership (Ref. 29), 

EPA believes it is unlikely that 

companies would incur the costs 

associated with establishing new 

manufacturing capacity for these 

chemicals in order to enter this market. 

With Great Lakes Chemical 

Corporation’s exit from the market, EPA 

believes that all U.S. manufacture and 

import of these chemicals likely will 

cease and that any new manufacture or 

import, for any use, subsequent to Great 

Lakes Chemical Corporation’s December 

31, 2004 phase-out date would result in 

a significant increase in the magnitude 

and duration of exposures to humans 

and the environment over that which 

would otherwise exist. Based on these 

considerations, EPA has determined 

that any manufacture or import of the 

chemical substances listed in Unit II.A. 

for any use on or after January 1, 2005 

is a significant new use.

VII. Alternatives/Other Options 

Considered

Before proposing this SNUR, EPA 

considered the following alternative 

regulatory actions for the chemical 

substances that are the subject of this 

proposed rule.

1. Promulgate a TSCA section 8(a) 

reporting rule. Under a TSCA section 

8(a) rule, EPA could generally require 

any person to report information to the 

Agency when they intend to 

manufacture, import or process the 

chemical substances listed in Unit II.A. 

However, the use of TSCA section 8(a) 

rather than the SNUR authority, would 

not provide the opportunity for EPA to 

review human and environmental 

hazards and exposures associated with 

the new uses of these substances and, if 

necessary, to take immediate regulatory 

action under TSCA section 5(e) or 

section 5(f) to prohibit or limit the 

activity before it begins. In addition, 

EPA may not receive important 

information from small businesses, 

because those firms generally are 

exempt from TSCA section 8(a) 

reporting requirements. In view of 

EPA’s concerns about the chemical 

substances and its interest in having the 

opportunity to review these substances 

and regulate them as appropriate, 

pending the development of exposure 

and/or hazard information should a 

significant new use be initiated, the 

Agency believes that a TSCA section 

8(a) rule for certain PBDEs would not 

meet all of EPA’s regulatory objectives.

2. Regulate the chemical substances 

subject to this proposed rule under 

TSCA section 6. EPA must regulate 

under TSCA section 6 if there is a 

reasonable basis to conclude that the 

manufacture, import, processing, 

distribution in commerce, use, or 

disposal of a chemical substance or 

mixture ‘‘presents or will present’’ an 

unreasonable risk of injury to human 

health or the environment. Based on 

EPA’s findings that after December 31, 

2004 there would be no manufacture or 

import of the chemical substances 

subject to this proposed rule, EPA 

concluded that risk management action 

under TSCA section 6 is not necessary 

at this time. This proposed SNUR would 

allow the Agency to address the 

potential risks associated with any 

intended significant new use of these 

chemical substances.

3. Require persons that import certain 

PBDEs as part of articles to comply with 

the requirements of this proposed 

SNUR. 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 part 721 is not generally 

subject to the notification requirements 

of § 721.25 for that substance, if the 

person imports or processes the 

substance as part of an article. See 40 

CFR 721.45(f). EPA considered requiring 

persons that import (processors are not 

covered by this proposed SNUR) the 

PBDEs subject to this proposed rule as 

part of articles to comply with the 

requirements of this proposed SNUR, 

due to concerns that exempting articles 

would render the SNUR less effective 

Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 70409

because of the possibility that 

upholstered products or plasticscontaining articles treated with these 

PBDEs could be imported. The current 

import status of articles treated with 

PBDEs, i.e., whether or not import of 

these articles is presently ongoing, is not 

known at this time. However, given the 

negative commercial and regulatory 

environment associated with these 

chemicals (including the EU ban on 

marketing and use of pentaBDE and 

octaBDE, the EU ban on placing on the 

market articles containing these 

substances (Ref. 27)), similar restrictions 

enacted by certain states in the U.S. 

(Ref. 28), and the expectation that viable 

substitutes will be available, EPA 

believes it would be unlikely that these 

chemical substances will be imported as 

part of articles. Based on this belief, and 

the resultant low likelihood of exposure 

to pentaBDE and octaBDE imported as 

part of an article, EPA is not proposing 

to amend the general SNUR exemption 

provisions for the purpose of this 

proposed SNUR. EPA is specifically 

seeking comments on the issue of 

whether persons that import the 

chemical substances listed in Unit II.A. 

as part of articles should be subject to 

the reporting requirements of this 

proposed SNUR.

VIII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule

As discussed in the Federal Register

of April 24, 1990 (55 FR 17376), EPA 

believes that the intent of section 

5(a)(1)(B) of TSCA is best served by 

designating a use as a significant new 

use as of the proposal date of the SNUR, 

rather than as of the effective date of the 

final rule. If uses begun after publication 

of the proposed SNUR were considered 

to be ongoing, rather than new, it would 

be difficult for EPA to establish 

notification requirements, because any 

person could defeat the SNUR by 

initiating the proposed significant new 

use before the proposed rule became 

final, and then argue that the use was 

ongoing as of the effective date of the 

final rule.

Any person who, after publication of 

this proposed SNUR, begins commercial 

manufacture or import of the chemical 

substances listed in Unit II.A. must stop 

such activity before the effective date of 

the final rule. Persons who cease those 

activities will have to meet all SNUR 

notice requirements and wait until the 

end of the notice review period, 

including all extensions, before 

engaging in any activities designated as 

significant new uses. If, however, 

persons who begin commercial 

manufacture or import of the chemical 

substances listed in Unit II.A. between 

the proposal and the effective date of 

the final SNUR meet the conditions of 

advance compliance as codified at 40 

CFR 721.45(h), those persons would be 

considered to have met the 

requirements of the final SNUR for 

those activities.

IX. Test Data and Other Information

EPA recognizes that section 5 of 

TSCA does not require the development 

of any particular test data before 

submission of a SNUN. Persons are 

required only to submit test data in their 

possession or control and to describe 

any other data known to or reasonably 

ascertainable by them (15 U.S.C. 

2604(d); 40 CFR 721.25).

However, in view of the potential 

health or environmental risks posed by 

any manufacture or importation of the 

chemical substances listed in Unit II.A., 

EPA would recommend in the final rule 

that potential SNUN submitters include 

data that would permit a reasoned 

evaluation of risks posed by these 

chemical substances during their 

manufacture, processing, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN 

for these substances, and, for 

commercial pentaBDE and octaBDE, to 

take advantage of the data needs 

assessments as reviewed under the 

Agency’s VCCEP (see VCCEP Peer 

Consultation meeting reports - Refs. 5 

and 6 - and any forthcoming Agency 

decision under the VCCEP process). As 

part of this optional pre-notice 

consultation, EPA would discuss 

specific data it believes are necessary to 

evaluate a significant new use. EPA also 

encourages SNUN submitters to provide 

all available information that is relevant 

to assessing the potential for 

environmental or consumer exposure, as 

well as information on risks posed by 

these substances compared to risks 

posed by possible substitutes. A SNUN 

submitted without sufficient data to 

reasonably evaluate risks posed by a 

significant new use of the chemical 

substances listed in Unit II.A. may 

increase the likelihood that EPA will 

take action under TSCA section 5(e) to 

prohibit or limit activities associated 

with these chemicals.

X. Economic Considerations

EPA has evaluated the potential costs 

of establishing a SNUR for the chemical 

substances listed in Unit II.A. These 

potential costs are related to the 

submission of SNUNs, the export 

notification requirements of TSCA 

section 12(b) and the development of 

test data. If the firm undertakes testing 

to support the submission of a SNUN, 

costs could range from roughly $339,000 

to over $1.4 million per chemical, but 

could be substantially lower if not all 

recommended tests are performed. EPA 

notes that, with the possible exception 

of export notification requirements, the 

costs of submission of SNUNs will not 

be incurred by any company unless that 

company decides to pursue a significant 

new use as defined in this SNUR. The 

Agency’s economic analysis is available 

in the public docket for this proposed 

rule (Ref. 30).

A. SNUNs 

The Agency has analyzed the 

potential costs of compliance with the 

proposed SNUR (Ref. 30). EPA’s 

complete economic analysis is available 

in the public docket. The Agency has 

estimated the average cost of 

compliance with the SNUR per 

chemical (e.g., cost of submitting a 

SNUN) to be $6,956 based on 105 

burden hours or a total cost of $13,912 

or 210 hours for both chemicals. These 

estimates do not include the costs of 

testing or submission of other 

information to permit a reasoned 

evaluation of potential risks (see Unit 

IX.).

B. Export Notification

As noted in Unit II.C. of this 

document, persons who intend to export 

a chemical substance identified in a 

proposed or final SNUR are subject to 

the export notification provisions of 

TSCA section 12(b) (15 U.S.C. 2611(b)). 

These provisions require that, for 

chemicals subject to a proposed or final 

SNUR, a company notify EPA of the first 

shipment to a particular country in a 

calendar year of an affected chemical 

substance. EPA estimated that the onetime cost of preparing and submitting an 

export notification to be $89.29. The 

total costs of export notification will 

vary per chemical, depending on the 

number of required notifications (i.e., 

number of countries to which the 

chemical is exported).

EPA is unable to estimate the total 

number of TSCA section 12(b) 

notifications that will be received as a 

result of this proposed SNUR, or the 

total number of companies that will file 

these notices. However, EPA expects 

that the total cost of complying with the 

export notification provisions of TSCA 

section 12(b) will be limited based on 

historical experience with TSCA section 

12(b) notifications and the fact that no 

companies have currently been 

identified that currently market any of 

the chemical substances that are the 

subject of this proposed rule 

commercially. If companies were to 

70410 Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 

manufacture for export only any of the 

chemical substances covered by this 

proposed SNUR, such companies would 

incur the minimal costs associated with 

export notification despite the fact they 

would not be subject to the SNUR 

notification requirements. See TSCA 

section 12(a) and 40 CFR 721.45(g). EPA 

is not aware of any companies in this 

situation.

XI. References

These references have been placed in 

the public docket that was established 

under docket ID number OPPTS–2004–

0085 for this rulemaking.

1. Noonan, Anne P. Phase-Out Plan 

for Pentabromodiphenyl-oxide and 

Octabromodiphenyl-oxide Products. 

Great Lakes Chemical Corporation. West 

Lafayette, IN. April 8, 2004.

2. Voluntary Children’s Chemical 

Evaluation Program (VCCEP) Tier 1 

Assessment of the Potential Health 

Risks to Children Associated with 

Exposure to Commercial for 

Pentabromodiphenyl ether (CAS No. 

32534–81–9), April 21, 2003; Great 

Lakes Chemical Corporation.

3. Voluntary Children’s Chemical 

Evaluation Program (VCCEP) Tier 1 

Assessment of the Potential Health 

Risks to Children Associated with 

Exposure to Commercial for 

Octabromodiphenyl ether (CAS No. 

32536–52–0), April 21, 2003; Great 

Lakes Chemical Corporation.

4. Voluntary Children’s Chemical 

Evaluation Program (VCCEP) Data 

Summary, Decabromodiphenyl ether 

(CAS No. 1163–19–5), December 17, 

2002; American Chemistry Council’s 

Brominated Flame Retardant Industry 

Panel.

5. Report of the Peer Consultation 

Meeting (June 3 and 4, 2003) on 

Pentabromodiphenyl ether; Great Lakes 

Chemical Corporation for the Voluntary 

Children’s Chemical Evaluation 

Program (VCCEP); January 22, 2004.

6. Report of the Peer Consultation 

Meeting (June 3 and 4, 2003) on 

Octabromodiphenyl ether; Great Lakes 

Chemical Corporation for the Voluntary 

Children’s Chemical Evaluation 

Program (VCCEP); January 22, 2004.

7. Report of the Peer Consultation 

Meeting (April 2 and 3, 2003) on 

Decabromodiphenyl ether; American 

Chemistry Council’s Brominated Flame 

Retardant Industry Panel for the 

Voluntary Children’s Chemical 

Evaluation Program (VCCEP); 

September 30, 2003.

8. Birnbaum, LS and DF Staskal. 2004. 

Brominated Flame Retardants: Cause for 

Concern?; Environmental Health 

Perspectives 112:9–17. 

9. CA de Wit; An overview of 

brominated flame retardants in the 

environment. 2002. Chemosphere 46: 

583–624.

10. National Toxicology Program 

Nomination Background Document: 

Technical Pentabromodiphenyl Ether, 

Technical Octabromodiphenyl Ether, 

2,2′,4,4′-Tetrabromodiphenyl Ether, 

2,2′,4,4′,5-Pentabromodiphenyl Ether, 

2,2′,4,4′,5,5′-Hexabromodiphenyl Ether; 

Review of Toxicological Literature. 

March 2001. Prepared for National 

Institute of Environmental Health 

Sciences.

11. Risk-Assessment Report Vol. 05, 

August 2000 on: diphenyl ether, 

pentabromo derivative, CAS No.: 

32534–81–9, EINECS #: 251–084–2. 

Publication: EUR 19730 EN. See http:/

/ecb.jrc.it/existing-chemicals/, 

‘‘penta_bdereport015.’’

12. Risk-Assessment Report Vol. 16, 

2003 on: diphenyl ether, octabromo 

derivativeCAS No.: 32536–52–0, 

EINECS #: 251–087–9. Publication: EUR 

20403 EN. See http://ecb.jrc.it/existingchemicals/, ‘‘octareport014.’’

13. Rayne S, MG Ikonomou. 2002. 

Reconstructing source polybrominated 

diphenyl ether congener patterns from 

semipermeable membrane devices in 

the Fraser River, British Columbia, 

Canada: Comparison to commercial 

mixtures. Environ. Toxicol. Chem. 

21:2292–2300.

14. Rice CP, Chernyak SM, Begnoche 

L, Quintal R, Hickey J. 2002. 

Comparisons of PBDE composition and 

concentration in fish collected from the 

Detroit River, MI and Des Plaines River, 

IL. Chemosphere 49:731–737.

15. Lindberg P, Sellstrom U, Haggberg 

L, deWit CA. 2004. Higher brominated 

diphenyl ethers and 

hexabromocyclododecane found in eggs 

of peregrine falcons (Falco peregrinus) 

breeding in Sweden. Environ. Sci. 

Technol. 38:93–96. 

16. Hale RC, M Alaee, JB ManchesterNeesvig, HM Stapleton, MG Ikonomou. 

2003. Polybrominated diphenyl ether 

flame retardants in the North American 

environment. Environment International 

29:771–779.

17. Hites RA. 2004. Polybrominated 

diphenyl ethers in the environment and 

in people: a meta-analysis of 

concentrations. Environ. Science 

Technol. 38 (4): 945–956.

18. Law RJ, M Alaee, CR Allchin, JP 

Boon, M Lebeuf, P Lepom, GA Stern. 

2003. Levels and trends of 

polybrominated diphenylethers and 

other brominated flame retardants in 

wildlife. Environment International 29: 

757–770.

19. Braekevelt E, SA Tittlemier, GT 

Tomy. 2003. Direct measurement of 

octanol-water partition coefficients of 

some environmentally relevant 

brominated diphenyl ether congeners. 

Chemosphere 51:563–567.

20. Hale, RC, MJ La Guardia, E 

Harvey, TM Mainor. 2002. Potential role 

of fire retardant-treated polyurethane 

foam as a source of brominated 

diphenyl ethers to the US environment. 

Chemosphere 46:729–735.

21. Soderstrom, G, U Sellstro ̈m, C de 

Wit, M Tysklind. 2004. Photolytic 

debromination of 

decabromodiphenylether (deBDE). 

Environ. Science Technol. 38 (1): 127–

132.

22. Rudel RA, DE Camann, JD 

Spengler, LR Korn, JG Brody. 2003. 

Phthalates, alkylphenols, pesticides, 

polybrominated diphenyl ethers, and 

other endocrine-disrupting compounds 

in indoor air and dust. Environ. Science 

Technol. 37 (20): 4543–4553.

23. Butt CM, ML Diamond, J Truong, 

MG Ikonomou, AFH ter Schure. 2004. 

Spatial distribution of polybrominated 

diphenyl ethers in southern Ontario as 

measured in indoor and outdoor 

window organic films. Environ. Science 

Technol. 38 (3):724–731.

24. Tomy GT, VP Palace, T 

Halldorson, E Braekevelt, R Danell, K 

Wautier, B Evans, L Brinkworth, AT 

Fisk. 2004. Bioaccumulation, 

biotransformation, and biochemical 

effects of brominated diphenyl ethers in 

juvenile lake trout (Salvelinus 

namaycush). Environ. Science Technol. 

38(5): 1496–1504.

25. Stapleton, H.M, R.J. Letcher, and 

J.E. Baker. 2004. Debromination of 

polybrominated diphenyl Ether 

Congeners BDE99 and BDE183 in the 

intestinal tract of the common carp 

(Cyprinus carpio). Environmental 

Science and Technology, 38(4): 1054–

1061.

26. http://www.bsef-site.com/docs/

BFR_vols_2001.doc. Major Brominated 

Flame Retardants Volume Estimates, 

Total Market Demand by Region in 

2001. 21 January 2003.

27. European Union. Directive 2003/

11/EC of the European Parliament and 

of the Council of 6 February 2003 

amending for the 24th time Council 

Directive 76/769/EEC relating to 

restrictions on the marketing and use of 

certain dangerous substances and 

preparations (pentabromodiphenyl 

ether, octabromodiphenyl ether).

28. California Bill AB 302, bill text. 

‘‘An act to add Chapter 10 (commencing 

with Section 108920) to Part 3 of 

Division 104 of the Health and Safety 

Code, relating to toxic substances.’’

Signed by the California Governor on 

August 9, 2003.

Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 70411

29. Design for the Environment 

Program, USEPA. September 2004. 

Environmentally Preferable Approaches 

for Achieving Fire Furniture Safety 

Standards.

30. Lehman, T., USEPA. June 18, 

2004. Economic Analysis for Certain 

Polybrominated Diphenylethers; 

Proposed Significant New Use Rule.

XII. Statutory and Executive Order 

Reviews

A. Executive Order 12866: Regulatory 

Planning and Review

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

the Office of Management and Budget 

(OMB) has determined that proposed or 

final SNURs are not a ‘‘significant 

regulatory action’’ subject to review by 

OMB, because they do not meet the 

criteria in section 3(f) of the Executive 

Order.

B. Paperwork Reduction Act

According to the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable.

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to the PRA under OMB control 

number 2070–0038 (EPA ICR No. 

1188.07). This action does not impose 

any burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN.

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of this 

proposed SNUR will not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The rationale supporting this 

conclusion is as follows. A SNUR 

applies to any person (including small 

or large entities) who intends to engage 

in any activity described in the rule as 

a ‘‘significant new use.’’ By definition of 

the word ‘‘new,’’ and based on all 

information currently available to EPA, 

it appears that no small or large entities 

will be engaged in such activity on or 

after January 1, 2005. Since a SNUR 

only requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN, no economic 

impact will even occur until someone 

decides to engage in those activities. 

Although some small entities may 

decide to conduct such activities in the 

future, EPA cannot presently determine 

how many, if any, there may be. 

However, EPA’s experience to date is 

that, in response to the promulgation of 

over 1,000 SNURs, the Agency receives 

on average only 10 notices per year. Of 

those SNUNs submitted, none appear to 

be from small entities in response to any 

SNUR. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit X.), are minimal regardless of 

the size of the firm. Therefore, EPA 

believes that the potential economic 

impact of complying with this SNUR are 

not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published on June 2, 1997 (62 FR 29684) 

(FRL–5597–1), the Agency presented it’s 

general determination that proposed 

and final SNURs are not expected to 

have a significant economic impact on 

a substantial number of small entities, 

which was provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration.

D. Unfunded Mandates Reform Act

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

rulemaking. As such, EPA has 

determined that this regulatory action 

does not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any affect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4).

E. Executive Order 13132: Federalism

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999).

F. Executive Order 13175: Consultation 

and Coordination with Indian Tribal 

Governments

This proposed rule does not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This does not 

significantly or uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000), do not apply 

to this proposed rule.

G. Executive Order 13045: Protection of 

Children from Environmental Health 

Risks and Safety Risks

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

Although the chemicals that are 

addressed in this significant new use 

rule might present such risks to 

children, significant new use rules are 

administrative actions that require 

chemical manufacturers to submit a 

significant new use notice to EPA before 

a chemical may be manufactured or 

imported. Therefore, this action does 

not in and of itself affect children’s 

health.

H. Executive Order 13211: Actions that 

Significantly Affect Energy Supply, 

Distribution, or Use

This proposed rule is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

70412 Federal Register / Vol. 69, No. 233 / Monday, December 6, 2004 / Proposed Rules 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use.

I. National Technology Transfer 

Advancement Act

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note), does not 

apply to this action.

J. Executive Order 12898: Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994).

K. Executive Order 12630: 

Governmental Actions and Interference 

with Constitutionally Protected Property 

Rights (Takings)

EPA has complied with Executive 

Order 12630, entitled Governmental 

Actions and Interference with 

Constitutionally Protected Property 

Rights (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: Civil Justice 

Reform

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 in 40 CFR Part 721

Environmental protection, Chemicals, 

Hazardous substances, Premanufacture 

notification, Reporting and 

recordkeeping requirements.

Dated: November 30, 2004. 

Charles M. Auer, 

Director, Office of Pollution Prevention and 

Toxics.

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows:

PART 721—[AMENDED]

1. The authority citation for part 721 

would continue to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 

2625(c).

2. By adding new § 721.10000 to 

subpart E to read as follows:

§ 721.10000 Certain polybrominated 

diphenylethers.

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as tetrabromodiphenyl ether (CAS No. 

40088–47–9; Benzene, 1,1′-oxybis-, 

tetrabromo deriv.), pentabromodiphenyl 

ether (CAS No. 32534–81–9; Benzene, 

1,1′-oxybis-, pentabromo deriv.), 

hexabromodiphenyl ether (CAS No. 

36483–60–0; Benzene, 1,1′-oxybis-, 

hexabromo deriv.), heptabromodiphenyl 

ether (CAS No. 68928–80–3; Benzene, 

1,1′-oxybis-, heptabromo deriv.), 

octabromodiphenyl ether (CAS No. 

32536–52–0; Benzene, 1,1′-oxybis-, 

octabromo deriv.), and 

nonabromodiphenyl ether (CAS No. 

63936–56–1; Benzene, 

pentabromo(tetrabromophenoxy)-), and 

any combination of these substances 

resulting from a chemical reaction are 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section.

(2) The significant new use is 

manufacture or import for any use on or 

after January 1, 2005.

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph.

(1) Persons who must report. Section 

721.5 applies to this section except for 

section 721.5(a)(2). A person who 

intends to manufacture or import for 

commercial purposes the substances 

identified in paragraph (a)(1) of this 

section and intends to distribute the 

substance in commerce must submit a 

significant new use notice.

(2) [Reserved]

[FR Doc. 04–26731 Filed 12–1–04; 2:54 pm]

BILLING CODE 6560–50–S

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

50 CFR Part 17

RIN 1018–AT65

Endangered and Threatened Wildlife 

and Plants; Establishment of an 

Additional Manatee Protection Area in 

Lee County, FL

AGENCY: Fish and Wildlife Service, 

Interior.

ACTION: Proposed rule; notice of public 

hearing and reopening of public 

comment period. 

SUMMARY: We, the Fish and Wildlife 

Service (Service), provide notice that 

the public comment period for the 

proposed rule to establish the Pine 

Island-Estero Bay Manatee Refuge in Lee 

County, Florida, is reopened to allow all 

interested parties to submit written 

comments on the proposed rule. We are 

reopening the public comment period to 

accommodate those individuals and 

communities that are continuing to 

recover from the effects of both 

Hurricane Charley and Hurricane 

Frances. Comments previously 

submitted during the initial comment 

period need not be resubmitted as they 

will be incorporated into the public 

record and will be fully considered in 

the final determination on the proposal.

DATES: The original comment period 

closed on October 5, 2004. The 

comment period is hereby reopened 

until February 2, 2005. Comments from 

all interested parties must be received 

by the closing date. Any comments 

received after the closing date may not 

be considered in the final decision on 

this proposal. Furthermore, the public 

hearing that was originally scheduled 

for Wednesday, September 8, 2004, has 

been rescheduled for Wednesday, 

January 12, 2005, from 6:30 p.m. to 9:30 

p.m. in Fort Myers, Florida. See 

additional information on the public 

comment process in the SUPPLEMENTARY

INFORMATION section.

ADDRESSES: A formal public hearing 

will be held on Wednesday, January 12, 

2005, from 6:30 p.m. to 9:30 p.m. at the 

Harborside Convention Hall, 1375 

Monroe Street, Fort Myers, Florida. 

If you wish to comment, you may 

submit your comments by any one of 

several methods: 

1. You may submit written comments 

and information by mail to the Field 

Supervisor, South Florida Field Office, 

U.S. Fish and Wildlife Service, Attn: 

Proposed Manatee Refuge, 1339 20th 

Street, Vero Beach, Florida 32960.