17386 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Proposed Rules 

which participated in the regional 

planning process, Connecticut will 

provide notification to the EPA 

Administrator and to those other 

State(s). Connecticut will also 

collaborate with the other State(s) 

through the regional planning process 

for the purpose of developing additional 

strategies to address any such 

deficiencies in Connecticut’s plan. 

• If Connecticut determines that its 

implementation plan is or may be 

inadequate to ensure reasonable 

progress as a result of emissions from 

sources in another country, Connecticut 

will provide notification, along with 

available information, to the EPA 

Administrator. 

• If Connecticut determines that the 

implementation plan is or may be 

inadequate to ensure reasonable 

progress as a result of emissions from 

sources within the State, Connecticut 

will revise its implementation plan to 

address the plan’s deficiencies within 

one year from this determination. 

IV. What action is EPA proposing to 

take? 

EPA is proposing approval of 

Connecticut’s November 18, 2009 SIP 

revision as meeting the applicable 

requirements of the Regional Haze Rule 

found in 40 CFR 51.308. In addition, 

EPA is proposing approval of 

Connecticut’s RCSA Section 22a–174– 

19a, ‘‘Control of sulfur dioxide 

emissions from power plants and other 

large stationary sources of air pollution’’ 

and revisions to RCSA Section 22a– 

174–22, ‘‘Control of Nitrogen Oxides 

Emissions,’’ including subdivision 22a– 

174–22(e)(3), and CGS 16a–21a, ‘‘Sulfur 

content of home heating oil and off-road 

diesel fuel. Suspension of requirements 

for emergency.’’ Furthermore, pursuant 

to CT DEEP’s request under parallel 

processing, EPA is proposing approval 

of Connecticut’s proposed RCSA 

Section 22a–174–22d, ‘‘Post-2011 

Connecticut Ozone Season NOX Budget 

Program.’’ Under this procedure, EPA 

prepared this action before the State’s 

final adoption of this regulation. 

Connecticut has already held a public 

hearing on the proposed regulation and 

received public comment. Connecticut 

may revise the regulation in response to 

comments. After Connecticut submits 

its final adopted regulation, EPA will 

review this regulation to determine 

whether it is significantly different from 

the proposed regulation. EPA will 

determine whether it is appropriate to 

approve the final rule with a description 

of any changes since the proposal, 

re-propose action based on the final 

adopted regulations, or take other 

actions as appropriate. 

RCSA 22a–174–22d is a replacement 

for RCSA 22a–174–22c, ‘‘The Clean Air 

Interstate Rule (CAIR) Nitrogen Oxides 

(NOX) Ozone Season Trading Program,’’ 

which is federally approved by EPA and 

currently being implemented in 

Connecticut. 

V. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

State choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this proposed action 

merely approves State law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by State law. For that 

reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act 

(5 U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: March 15, 2012. 

Ira W. Leighton, 

Acting Regional Administrator, EPA 

Region 1. 

[FR Doc. 2012–7216 Filed 3–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2011–0489; FRL–9341–6] 

RIN 2070–AJ88 

Significant New Use Rule for 

Hexabromocyclododecane and 

1,2,5,6,9,10-Hexabromocyclododecane 

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 two chemical 

substances: Hexabromocyclododecane 

(Chemical Abstracts Service Registry 

Number (CASRN) 25637–99–4) and 

1,2,5,6,9,10-hexabromocyclododecane 

(CASRN 3194–55–6), hereinafter 

collectively referred to as HBCD. This 

proposed rule would designate ‘‘use in 

consumer textiles, other than for use in 

motor vehicles’’ as a significant new 

use. This action would require persons 

who intend to manufacture (including 

import) or process HBCD for use in 

covered consumer textiles to notify EPA 

at least 90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if appropriate, to prohibit or 

limit that activity before it occurs. For 

this proposed rule, the general SNUR 

article exemption for persons who 


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import or process chemical substances 

as part of an article would not apply. 

DATES: Comments must be received on 

or before May 25, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0489, 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, Rm. 

6428, 1201 Constitution Ave. NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2011–0489. 

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– 

2011–0489. 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 contact: Sue 

Slotnick, National Program Chemicals 

Division, Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 566–1973; email address: 

slotnick.sue@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: TSCAHotline@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) or process 

HBCD for consumer textiles. Potentially 

affected entities may include, but are 

not limited to organizations identified 

by the following North American 

Industry Classification System (NAICS) 

codes: 

• Chemical Manufacturing (NAICS 

code 325). 

• Painting and Wall Covering 

Contractors (NAICS code 238320). 

• Textile and Fabric Finishing (except 

Broadwoven Fabric) Mills (NAICS code 

313312). 

• Curtain and Drapery Mills (NAICS 

code 314121). 

• Other Household Textile Product 

Mills (NAICS code 314129). 

• All Other Miscellaneous Textile 

Product Mills (NAICS code 314999). 

• Upholstered Household Furniture 

Manufacturing (NAICS code 337121). 

• Household Furniture (except Wood 

and Metal) Manufacturing (NAICS code 

337125). 

• Mattress Manufacturing (NAICS 

code 337910). 

• Blind and Shade Manufacturing 

(NAICS code 337920). 

• Furniture Merchant Wholesalers 

(NAICS code 423210). 

• Home Furnishing Merchant 

Wholesalers (NAICS code 423220). 

• Reupholstery and Furniture Repair 

(NAICS code 811420). 

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 in 

§ 721.5. 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. 

In addition, chemical importers are 

subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28 (the corresponding EPA policy 

appears at 40 CFR part 707, subpart B). 

Chemical importers must certify that 

shipments of chemical substances 

comply with all applicable rules and 

orders under TSCA, including SNURs. 

In addition, 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 § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
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1As of August 16, 2011, the Inventory Update 

Rule (IUR) was renamed ‘‘Chemical Data Reporting 

rule (CDR).’’ See the TSCA Inventory Update 

Reporting Modifications; Chemical Data Reporting 

final rule in the Federal Register issue of August 

16, 2011 (76 FR 50816) (FRL–8872–9). 

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. 

II. Background 

A. What action is the agency taking? 

EPA is proposing a SNUR for HBCD 

which would require persons to notify 

EPA at least 90 days before commencing 

the manufacture (including import) or 

processing of HBCD for use in consumer 

textiles other than for use in motor 

vehicles. EPA is considering future 

regulatory action on additional uses of 

HBCD. 

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: 

• 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, and 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance.’’ 

In addition to these factors 

enumerated in TSCA section 5(a)(2), the 

statute authorizes EPA to consider any 

other relevant factors. 

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 significant new use 

notice (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)). As described in 

Unit II.C., the general SNUR provisions 

are found at 40 CFR part 721, subpart 

A. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

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. Additional provisions 

appear at § 721.1(c) which describe how 

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 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 SNUN, 

the Agency 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, the Agency is required under 

TSCA section 5(g) to explain in the 

Federal Register its reasons for not 

taking action. 

EPA proposes that a person who 

imports or processes HBCD as part of an 

article for use in consumer textiles 

(except for use in motor vehicles) would 

not be exempt from submitting a SNUN. 

(See rationale at Unit VI.C.) For this 

reason, § 721.45(f), which exempts 

persons importing or processing a 

chemical substance as part of an article, 

would not apply to this proposed 

SNUR. 

Persons who export or intend to 

export a chemical substance(s) 

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 import chemical 

substances are subject to the TSCA 

section 13 import certification 

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(s) 

comply with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. 

III. Overview of HBCD 

A. What chemicals are included in the 

proposed SNUR? 

This proposed SNUR would apply to 

two chemical substances: 

Hexabromocyclododecane (CASRN 

25637–99–4) and 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194–55–6). Hexabromocyclododecane 

is manufactured by adding bromine to 

technical grade 1,5,9-cyclododecatriene 

to make a chemical substance where the 

positions of the six bromine atoms are 

not specified on the cyclododecane ring, 

corresponding to CASRN 25637–99–4. 

The specific 1,2,5,6,9,10- 

hexabromocyclododecane isomer 

(CASRN 3194–55–6) is the major 

component of CASRN 25637–99–4. 

Throughout this proposed rule, the term 

‘‘HBCD’’ represents both chemical 

substances, unless a specific CASRN is 

also noted. 

B. What is the production volume of 

HBCD? 

The Inventory Update Rule (IUR) 1

submissions to EPA reported annual 

U.S. import/production volumes of 10– 

50 million pounds (lb) in both 2002 and 

2006 for CASRN 3194–55–6 (EPA, 

2006). IUR submissions to EPA reported 

annual U.S. import/production volumes 

of 10,000 to 500,000 lb in 2002 for 

CASRN 25637–99–4; no import/ 

production was reported in 2006 (EPA, 

2006). 


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C. What are the uses of HBCD? 

Based on information gathered from 

research, industry, and government, 

EPA believes that HBCD is not used in 

consumer textiles other than for use in 

motor vehicles. The major use of HBCD 

is in polystyrene foam insulation boards 

used in construction. It is also used to 

a minor extent in high-impact 

polystyrene in electronic products and 

in textile coatings in carpets, vehicles, 

furniture, and upholstery, such as 

draperies (Posner, 2006). In the IUR 

data, one manufacturer/importer of 

HBCD (CASRN 3194–55–6) reported the 

use of the chemical substance under the 

NAICS code for textile and fabric 

finishing mills (EPA, 2006). For this use, 

1% of the total production volume of 

the chemical substance was in 

consumer and commercial products. 

However, the reporting does not 

distinguish between commercial and 

consumer use (EPA, 2006). 

Information available to EPA 

indicates that the use of HBCD in 

textiles is as a backcoating to function 

as a flame retardant. EPA conducted 

preliminary research to determine 

whether HBCD was used in textile 

applications for end products sold to 

consumers. In 2010, an HBCD expert 

with the Consumer Product Safety 

Commission (CPSC) expressed to EPA 

his understanding that HBCD is used 

only in non-consumer textiles such as 

firefighters’ suits (CPSC, 2010). In 2011, 

EPA requested information from current 

and former manufacturers of HBCD. The 

responses indicate that only one 

manufacturer sells HBCD for textile 

uses. The company does not know 

whether the end use of any of those 

textiles is a consumer article. (ACC, 

2011). Additionally, a representative of 

the furniture manufacturing company 

Herman Miller told EPA that HBCD is 

not in their products (Herman Miller, 

2011). EPA also received information 

from a group of textile formulators that 

the end uses of HBCD-containing 

textiles are for military, institutional, 

and aviation uses only (EPP, 2011). EPA 

solicits comment on whether any of 

these uses could be considered 

consumer textile uses. (See definition of 

‘‘consumer textile’’ at § 721.10281 in the 

regulatory language of this proposed 

rule). 

EPA found that a small amount of 

HBCD is used in floor mats, headliners, 

and possibly other interior fabrics in 

motor vehicles made in the United 

States, including passenger vehicles. 

The automotive industry plans to phase 

out these uses in 2015. This phase-out 

is consistent with the addition of HBCD 

to the Annex XIV List of Substances 

Subject to Authorisation under the 

European Union’s Registration, 

Evaluation, Authorisation and 

Restriction of Chemical Substances 

(REACH) regulations (REACH, 2011). 

See http://echa.europa.eu/reach_en.asp. 

The REACH regulations are expected to 

effectively ban the use of HBCD by 

major U.S. automotive companies 

unless authorized for use in the 

European Union (EU) after July 21, 

2015. The companies are not likely to 

manufacture a different set of products 

for sale in the EU and for sale in the 

United States. Because the use of HBCD 

in textiles in motor vehicles is currently 

ongoing, that use is not included in this 

proposed rule. 

Based on the sum of available 

information, EPA believes HBCD is not 

used in consumer textiles other than 

those used in motor vehicles. The 

Agency also believes HBCD could 

potentially be used in the future in 

consumer textiles in the United States 

because the chemical substance: 

1. Is used in non-consumer textile 

applications in the United States 

including institutional, military, and 

aviation uses. 

2. Is used in textiles in motor vehicles 

in the United States. 

3. Has been used in residential 

consumer textile applications. 

See more information on uses of 

HBCD in EPA’s ‘‘Economic Analysis of 

the Proposed Significant New Use Rule 

for Hexabromocyclododecane (HBCD)’’ 

(EPA, 2011). 

D. What are the potential health and 

environmental effects of HBCD? 

1. Human health effects. Repeated 

exposure of HBCD to rats showed 

disturbances in thyroid hormone system 

and effects on the thyroid in males and 

females (Chengelis, 2001). A study by 

Eriksson, et al. (2006), concluded that 

neonatal exposure of HBCD to mice 

affected spontaneous motor behavior, 

learning and memory processes in adult 

mice. However, this study was not 

conducted according to established 

Organization for Economic Cooperation 

and Development (OECD) Test 

Guidelines. 

In a recently conducted, more robust, 

2-generation reproductive toxicity study 

in rats conducted according to 

established OECD test guidelines, HBCD 

showed treatment-related reproductive 

effect (a significant decrease in the 

number of primordial follicles in the F1 

females) (Ema, et al., 2008). Although 

this decrease in ovarian follicles did not 

affect any reproductive parameters in 

this study, this effect is suggestive of 

potential reproductive toxicity. 

Developmental effects were observed 

including delays in eye opening in the 

second (F2) generation and transient 

changes in learning and memory in F1 

males, but exposure did not cause any 

changes in spontaneous behavior. In 

addition, there was high and dosedependent pup mortality during 

lactation (Ema, et al., 2008). 

2. Environmental effects. Laboratory 

studies have shown that HBCD is 

capable of producing adverse effects in 

a variety of organisms including algae, 

fish, invertebrates, and soil-dwelling 

organisms at environmentally relevant 

concentrations. HBCD is toxic to algae 

and acutely toxic to fish embryos 

(Desjardins, et al., 2004 and Deng, et al., 

2009). A number of sub-lethal effects 

(e.g., altered thyroid status, protein 

metabolism, oxidative stress, 

reproductive activity) have also been 

observed in fish (Palace, et al., 2008; 

Kling et al., 2009; Zhang, et al., 2008; 

and Ronisz, et al., 2004). One study 

reported a reduced number and size of 

daphnid offspring in first and second 

generations (Drottar, 1998). Thyroid 

hormone-dependent developmental 

effects were observed in tadpoles 

(Xenopus laevis) exposed to HBCD 

(Schriks, et al., 2006). HBCD has been 

reported to reduce egg production and 

lower biomass in soil dwelling 

organisms (Lumbriculus variegatus) 

(Oetken, et al., 2001). HBCD 

administered to chicken (Gallus 

domesticus) embryonic hepatocytes in 

vitro resulted in significant alterations 

in expression of genes (mRNA) 

associated with liver and thyroid 

function (Crump, et al., 2008). Thinner 

egg shells were measured in American 

kestrels exposed to a combination of 

polybrominated diphenyl ethers 

(PBDEs) and HBCD (Fernie, et al., 2009). 

E. What are the potential sources and 

routes of exposure to HBCD? 

Because HBCD is not chemically 

bound to its substrate (the protected 

textile material), there is potential for 

HBCD to be released at any point in the 

lifecycle. There is potential for release 

when the HBCD is initially 

manufactured, when it is being 

formulated into the material that is 

commonly used in textile back coatings, 

as well as when it is being combined 

with the textile material to which it is 

added. In addition, HBCD can be 

released during the service life of the 

textile material containing it, including 

release into water used to wash the 

treated textiles or into the air via dust 

particulates. Workers and the general 

population can be exposed to HBCD 

through direct contact as it migrates 

across land, in air, and in water by 

diffusion or environmental transport. 


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2The definition at 40 CFR 85.1703 is: ‘‘a vehicle 

which is self-propelled and capable of transporting 

a person or persons or any material or any 

permanently or temporarily affixed apparatus shall 

be deemed a motor vehicle, unless any one or more 

of the criteria set forth below are met, in which case 

the vehicle shall be deemed not a motor vehicle and 

excluded from the operation of the [Clean Air] Act: 

(1) The vehicle cannot exceed a maximum speed 

of 25 miles per hour over level, paved surfaces; or 

(2) The vehicle lacks features customarily 

associated with safe and practical street or highway 

use, such features including, but not being limited 

to, a reverse gear (except in the case of 

motorcycles), a differential, or safety features 

required by state and/or federal law; or 

(3) The vehicle exhibits features which render its 

use on a street or highway unsafe, impractical, or 

highly unlikely, such features including, but not 

being limited to, tracked road contact means, an 

inordinate size, or features ordinarily associated 

with military combat or tactical vehicles such as 

armor and/or weaponry.’’ 

40 CFR 85.1703 is available online at: http:// 

www.gpo.gov/fdsys/pkg/CFR–2000-title40-vol12/ 

xml/CFR–2000-title40-vol12-sec85–1703.xml. 

Other opportunities for release can 

occur at the end of the lifecycle of the 

consumer articles when they are 

transported as waste and disposed of, 

although incineration at high 

temperatures destroys the HBCD 

(Posner, 2006). 

Evidence strongly suggests there is 

potential for exposure to the general 

population from HBCD in the 

environment and also from products 

and dust in the home and workplace. 

HBCD is found world-wide in the 

environment and wildlife. Human 

exposure is evidenced from its presence 

in breast milk, adipose tissue, and blood 

(Covaci, et al., 2006). The chemical 

substance bioaccumulates and 

biomagnifies in food chains. The 

frequent detection of HBCD over a large 

geographic area, with increasing 

exposure in remote locations such as the 

Arctic, where no demonstrable local 

sources exist that can account for these 

exposures, suggest that HBCD is 

persistent and undergoes long-range 

transport (UNEP, 2007). 

To the extent HBCD is present in 

household applications (e.g., building 

foam, furniture upholstery, carpeting), 

children could be exposed, especially 

given children’s increased exposure via 

dust and the hand-to-mouth ingestion 

pathway. In vitro experiments 

conducted to demonstrate leaching of 

HBCD from textiles showed that the 

presence of simulated biological fluids 

(sweat, saliva) and fruit juices enhances 

the leaching of HBCD from back-coated 

samples (Ghanem, 2009). Children’s 

exposure to HBCD from mouthing of 

textiles and from ingestion of dust has 

been estimated (EC, 2008). 

HBCD has been measured in air and 

sediment in Scandinavian countries, 

North America and Asia (Covaci, et al., 

2006 and Arnot, et al., 2009). HBCD has 

also been measured in marine and arctic 

mammals, freshwater and marine fish, 

aquatic invertebrates, birds and bird 

eggs, and one plant species (Covaci, et 

al., 2006 and Arnot, et al., 2009). HBCD 

has been detected in Arctic air in 

northern Scandinavia and in Arctic 

birds and bird eggs, Arctic fish, ringed 

seals and polar bears (UNEP, 2009). It 

has been detected in freshwater, marine, 

and avian organisms, and in upper 

trophic-level mammals (polar bears and 

seals). 

For more information on HBCD 

concerning its physical-chemical 

properties, fate, releases, and human 

and environmental exposure, see EPA’s 

‘‘Hexabromocyclododecane (HBCD) 

Action Plan’’ dated August 18, 2010 

(HBCD Action Plan, 2010). 

IV. Summary of Proposed Rule 

EPA is proposing to designate as a 

significant new use any use of HBCD in 

consumer textiles other than for use in 

motor vehicles. EPA believes the only 

current use of HBCD for consumer 

textiles is in motor vehicles. Thus any 

use of HBCD in consumer textiles (other 

than for textiles in motor vehicles) 

would be a significant new use. A 

proposed definition of ‘‘consumer 

textile’’ can be found at § 721.10281 of 

the regulatory text of this proposed rule. 

The proposed definition of ‘‘motor 

vehicle’’ refers to 40 CFR 85.1703.2

This proposed rule would add a 

section to 40 CFR part 721 to require 

persons who intend to manufacture 

(including import) or process HBCD for 

an activity preliminarily designated as a 

significant new use by this action to 

notify EPA at least 90 days before 

commencing that activity. The required 

notification would provide EPA with 

the opportunity to evaluate the intended 

use and, if appropriate, to prohibit or 

limit that activity before it occurs. For 

this proposed rule, the general SNUR 

exemption for persons that import or 

process chemical substances as part of 

an article at § 721.45(f) would not apply. 

(See discussion at Unit VI.C.) 

V. Significant New Use Determination 

A. Rationale 

As summarized in Unit III.D. and E., 

EPA has concerns regarding the 

potential exposure to and human health 

and environmental effects of HBCD. 

EPA believes that HBCD could be 

manufactured or processed for 

consumer textiles other than for use in 

motor vehicles in the future. 

Accordingly, EPA wants the 

opportunity to evaluate and control, 

where appropriate, activities associated 

with that use, if such manufacturing or 

processing were to be commenced in the 

future. The required notification 

provided by a SNUN would provide 

EPA with the opportunity to evaluate 

activities associated with the significant 

new use and an opportunity to protect 

against unreasonable risks, if any, from 

exposure to HBCD. 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), EPA’s decision to propose a 

SNUR for a particular chemical use 

need not be based on an extensive 

evaluation of the hazard, exposure, or 

potential risk associated with that use. 

Rather, the Agency’s action is based on 

EPA’s determination that if the use 

begins or resumes, it may present a risk 

that EPA should evaluate before the 

manufacturing or processing for that use 

begins. Since the new use does not 

currently exist, deferring a detailed 

consideration of potential risks or 

hazards related to that use is an effective 

use of resources. If a person decides to 

begin manufacturing or processing the 

chemical for the new use, the SNUN to 

EPA allows EPA to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use. 

B. Objectives 

Based on the considerations in Unit 

V.A., EPA has the following objectives 

with regard to the significant new use 

that is preliminarily designated in this 

proposed rule: 

1. EPA would receive notification of 

any person’s intent to manufacture 

(including import) or process HBCD for 

the described significant new use before 

that activity begins. 

2. EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the SNUN submitter 

begins manufacturing or processing of 

HBCD for the described significant new 

use. 

3. EPA would be able to regulate 

prospective manufacturers or processors 

of HBCD before the described significant 

new use of the chemical substance(s) 

occur, provided that regulation is 

warranted pursuant to TSCA sections 

5(e), 5(f), 6, or 7. 

C. Relevant Factors Considered for This 

Proposed SNUR 

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 those listed at TSCA section 

5(a)(2) (see list at Unit II.B.). EPA has 

preliminarily determined that 

manufacturing or processing of HBCD 

for use in consumer textiles other than 


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for use in motor vehicles is a significant 

new use. This determination is based 

primarily on the following factor listed 

at TSCA section 5(a)(2): ‘‘The extent to 

which a use increases the magnitude 

and duration of exposure of human 

beings or the environment to a chemical 

substance.’’ The latest information 

available to EPA indicates that the only 

ongoing use of HBCD in consumer 

textiles is for use in motor vehicles. 

Initiation of new uses of HBCD in 

consumer textiles could increase the 

magnitude and duration of exposure to 

the general population from HBCD in 

the environment and from products and 

dust in the home and workplace. 

Workers could be exposed to HBCD at 

facilities of all types involved in the 

lifecycle of the products, as described in 

greater detail in Unit III.E. Releases to 

the environment are expected to occur 

during the service life of the textiles 

containing HBCD. Such increase in 

releases could contribute additional 

HBCD to the atmosphere, long-range 

transport, and greater concentrations in 

water, which could be detrimental to 

overall environmental and human 

health. Thus, EPA believes that 

initiating the use of HBCD in consumer 

textiles other than for use in motor 

vehicles would increase the magnitude 

and duration of exposure to humans and 

the environment over that which would 

otherwise exist. 

D. Request for Comment 

EPA welcomes comment on all 

aspects of this proposed rule, including: 

1. The basis for the significant new 

use determination presented for this 

proposed rule. 

2. Information about any ongoing 

manufacture, import, or processing of 

HBCD for use in consumer textiles. 

VI. Alternative Regulatory Approaches 

Before proposing this SNUR, EPA 

considered the following alternative 

regulatory actions: 

A. 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 for a specific use or any use. 

However, for HBCD in consumer 

textiles, 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 use in consumer textiles and, if 

necessary, take immediate follow-up 

regulatory action under TSCA sections 

5(e) or 5(f) to prohibit or limit the 

activity before it begins, if warranted. In 

addition, EPA might not receive 

important information from small 

businesses, because such firms generally 

are exempt from TSCA section 8(a) 

reporting requirements. In view of 

health and environmental concerns 

related to HBCD, if used for the 

proposed significant new use, EPA 

believes that a TSCA section 8(a) rule 

for these chemical substances would not 

meet EPA’s regulatory objectives. 

B. Regulate HBCD in Consumer Textiles 

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)). EPA concluded that risk 

management action under TSCA section 

6 is not necessary at this time because 

EPA: 

1. Believes HBCD is not being used in 

consumer textiles in the United States, 

other than for use in motor vehicles. 

2. Has not determined as of this date 

that use of HBCD in motor vehicles 

presents unreasonable risk. 

3. Expects the use in motor vehicles 

to end within a few years. This 

proposed SNUR would allow the 

Agency to address the potential risks 

associated with the proposed significant 

new use. 

C. Allow the Exemption for Persons Who 

Import or Process HBCD as Part of 

Articles That Would Be Subject to the 

Proposed SNUR 

Under the SNUR exemption provision 

at § 721.45(f), a person who imports or 

processes a chemical substance covered 

by a SNUR identified in 40 CFR part 

721, subpart E, as part of an article is 

not generally subject to the notification 

requirements of § 721.25 for that 

chemical substance. However, EPA is 

concerned that exempting HBCD as part 

of articles would render the SNUR less 

effective because of the possibility that 

consumer textile articles containing 

HBCD, the primary concern of EPA 

associated with this proposed rule, 

could be imported or processed for uses 

subject to this proposed SNUR without 

the submission of a SNUN. This 

proposed rule would not include the 

exemption at § 721.45(f). 

VII. 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 

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 this 

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 notification 

requirements, because a person could 

defeat the SNUR by initiating the 

proposed significant new use before the 

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) 

(including manufacturing or processing 

the chemical substance(s) as part of an 

article) for a use that would be regulated 

through this proposed rule, if finalized, 

would have to cease any such activity 

before the effective date of the rule if 

and when finalized. To resume their 

activities, these persons would have to 

comply with all applicable SNUR 

notification requirements and wait until 

the notification review period, 

including all extensions, expires. EPA 

has promulgated provisions 

(§ 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 § 721.45(h), that person 

would be considered to have met the 

requirements of the final SNUR for 

those activities. If persons who begin 

commercial manufacture, import, or 

processing of the chemical substance 

between publication of the proposed 

rule and the effective date of the final 

SNUR do not meet the conditions of 

advance compliance, they must cease 

that activity before the effective date of 

the final rule. To resume their activities, 

these persons would have to comply 

with all applicable SNUN requirements 

and wait until the notification review 

period, including all extensions, 

expires. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require the development of any 

particular test data before submission of 

a SNUN. There are two exceptions: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 


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2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a TSCA section 4 

test rule or a TSCA section 5(b)(4) 

listing covering the chemical substance, 

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 (TSCA 

section 5(d); 40 CFR 720.50 and 40 CFR 

721.25). However, 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, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN. 

As part of this optional pre-SNUN 

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: 

• Human exposure and 

environmental releases that may result 

from the significant new use of the 

chemical substance. 

• Potential benefits of the chemical 

substance. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notification 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 

Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and 40 CFR 721.25. The e-PMN software 

is available electronically at http:// 

www.epa.gov/opptintr/newchems. 

X. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of HBCD 

in consumer textiles. The evaluation is 

in the ‘‘Economic Analysis of the 

Proposed Significant New Use Rule for 

Hexabromocyclododecane (HBCD)’’ 

(EPA, 2011). It is briefly summarized 

here and is available in the docket for 

this proposed rule. 

Because there appears to be no use of 

HBCD in consumer textiles in the 

United States at the current time, other 

than for use in motor vehicles, EPA 

expects very few, if any, entities would 

submit a SNUN. As a result, the 

economic impact of this rule is 

anticipated to be either zero or very low. 

In the event that a SNUN is 

submitted, costs are estimated at 

approximately $8,300 per SNUN 

submission for large businesses and 

$5,900 for small businesses, and include 

the cost to prepare and submit the 

SNUN and the payment of a user fee. 

Businesses that submit a SNUN would 

be subject to either a $2,500 user fee 

required by 40 CFR 700.45(b)(2)(iii), or, 

if they are a small business with annual 

sales of less than $40 million when 

combined with those of the parent 

company (if any), a reduced user fee of 

$100 (40 CFR 700.45(b)(1)). In its 

evaluation of this proposed rule, EPA 

also considered the potential costs a 

company might incur by avoiding or 

delaying the significant new use in the 

future, but these costs have not been 

quantified. 

XI. References 

The following documents are 

specifically referenced in the preamble 

for this proposed rule. In addition to 

these documents, other materials may 

be available in the docket established 

for this proposed rule under docket ID 

number EPA–HQ–OPPT–2011–0489, 

which you can access through http:// 

www.regulations.gov. Those interested 

in the information considered by EPA in 

developing this proposed rule, should 

also consult documents that are 

referenced in the documents that EPA 

has placed in the docket, regardless of 

whether the other documents are 

physically located in the docket. 

1. EPA. 2006. Inventory Update Reporting 

(IUR): Non-Confidential 2006 TSCA 

Inventory Update Rule (IUR) Records. 

Available online at: http://cfpub.epa.gov/ 

iursearch (accessed March 8, 2012). 

2. Posner. 2006. Survey and technical 

assessment of alternatives to TBBPA and 

HBCDD. Kemi Report. January 2006. 

3. CPSC. 2010. Personal communication 

with Dr. Michael Babich, Chemist, United 

States Consumer Product Safety Commission 

(CPSC). March 16, 2010. 

4. ACC. 2011. Personal communication 

with Jackson Morrill, Director of Chemical 

Products of the American Chemistry Council 

(ACC). February 16, 2011. 

5. Herman Miller. 2011. Personal 

communication with Gabe Wing of Herman 

Miller, Inc. March 30, 2011. 

6. EPP. 2011. Personal communication 

with John Friddle, President of Eagle 

Performance Products. March 3, 2011. 

7. REACH. 2011. Available online at: 

http://echa.europa.eu/reach_en.asp. 

8. EPA. 2011. Economic Analysis of the 

Proposed Significant New Use Rule for 

Hexabromocyclododecane (HBCD). 

Washington, DC. OPPT/Environmental 

Economics and Technology Division (EETD)/ 

Economic and Policy Analysis Branch 

(EPAB). February 6, 2012. 

9. Chengelis. 2001. An oral (gavage) 90 day 

toxicity study of HBCD in rats. Study No. 

WIL–186012. WIL Research Laboratories, Inc. 

Ashland, Ohio, USA. 

10. Eriksson, et al. 2006. Impaired 

behaviour, learning and memory, in adult 

mice neonatally exposed to 

hexabromocyclododecane (HBCDD). 

Environmental Toxicology and 

Pharmacology. May 2006. 21(3), pp. 317–322. 

11. Ema, M., et al. 2008. Two-generation 

reproductive toxicity study of the flame 

retardant hexabromcyclododecane in rats. 

Reproductive Toxicology. April 2008. 25(3), 

pp. 335–351. 

12. Desjardins, et al. 2004. 

Hexabromocyclododecane (HBCD): A 72- 

hour toxicity test with the marine diatom 

(Skeletonema costatum). Final Report. 

Wildlife International, Ltd. Easton, Maryland, 

USA. pp. 66. 

13. Deng, et al. 2009. 

Hexabromocyclododecane-induced 

developmental toxicity and apoptosis in 

zebrafish embryos. Aquatic Toxicology. June 

2009. 93(1), pp. 29–36. 

14. Palace, et al. 2008. Biotransformation 

enzymes and thyroid axis disruption in 

juvenile rainbow trout (Oncorhynchus 

mykiss) exposed to hexabromocyclododecane 

diastereoisomers. Environmental Science and 

Technology. February 2008. 42(6), pp. 1967– 

1972. 

15. Kling, et al. 2009. Proteomic studies in 

zebrafish liver cells exposed to the 

brominated flame retardants HBCD and 

TBBPA. Ecotoxicology and Environmental 

Safety. November 2009. 72, pp. 985–1993. 

16. Zhang, et al. 2008. Induction of hepatic 

enzymes and oxidative stress in Chinese rare 

minnow (Gobiocypris rarus) exposed to 

waterborne hexabromocyclododecane 

(HBCD). Aquatic Toxicology. January 2008. 

86(1), pp. 4–11. 

17. Ronisz, et al. 2004. Sublethal effects of 

the flame retardants 

hexabromocyclododecane (HBCDD), and 

tetrabromobisphenol A (TBBPA), on hepatic 

enzymes and other biomarkers in juvenile 

rainbow trout and feral eelpout. Aquatic 

Toxicology. August 2004. 69(3), pp. 229–245. 

18. Drottar, et al. 1998. 

Hexabromocyclododecane (HBCD): A flowthrough life-cycle toxicity test with the 

cladoceran (Daphnia magna). Final Report. 

439A–108, Wildlife International, Ltd. 

Easton, Maryland, USA. 1998. pp. 78. 

19. Schriks, et al. 2006. Disruption of 

thyroid hormone-mediated Xenopus laevis 

tadpole tail tip regression by 

hexabromocyclododecane (HBCD) and 


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2,2’,3,3’,4,4’,5,5’, 6-nona brominated 

diphenyl ether (BDE206). Chemosphere. 

December 2006. 65(10), pp. 1904–1908. 

20. Oetken, et al. 2001. Validation of the 

preliminary EU-concept of assessing the 

impact of chemicals to organisms in 

sediment by using selected substances. UBA– 

FB 299 67 411, Institute of Hydrobiology, 

Dresden University of Technology, Dresden, 

Germany. 2001. pp. 97. 

21. Crump, et al. 2008. Effects of 

hexabromocyclododecane and 

polybrominated diphenyl ethers on mRNA 

expression in chicken (Gallus domesticus) 

hepatocytes. Toxicological Sciences. 

December 2008. 106(2), pp. 479–487. 

22. Fernie, et al. 2009. Environmentally 

relevant concentrations of DE–71 and HBCD 

alter eggshell thickness and reproductive 

success of American kestrels. Environmental 

Science and Technology. March 2009. 43(6), 

pp. 2124–30. 

23. Covaci, et al. 2006. 

Hexabromocyclododecanes (HBCDs) in the 

Environment and Humans: A Review. 

Environmental Science and Technology. May 

2006. 40(12), pp. 3679–3688. 

24. UNEP. 2007. Stockholm Convention on 

Persistent Organic Pollutants. Persistent 

Organic Pollutants Review Committee, Third 

meeting, Geneva. pp. 19–23, November 2007, 

Item 7 of the provisional agenda, 

Presentation on environmental transport and 

modeling. The OECD screening tool for 

overall persistence and long-range transport 

potential. UNEP/POPS/POPRC.3/INF/7. 

25. Ghanem, R. 2009. Kinetics of Thermal 

and Photolytic Segregation of 

Hexabromocyclododecane in Backcoated 

Textile Samples. Jordan Journal of 

Chemistry. April 2009. 4(2), pp. 171–181. 

26. EC. 2008. European Commission (EC). 

Risk Assessment: Hexabromocyclododecane 

CAS–No.: 25637–99–4 EINECS–No.: 247– 

148–4, Final Report. Office for Official 

Publications of the European Communities: 

Luxembourg. May 2008. 

27. Arnot, et al. 2009. An evaluation of 

hexabromocyclododecane (HBCD) for 

Persistent Organic Pollutant (POP) properties 

and the potential for adverse effects in the 

environment. Submitted to European 

Brominated Flame Retardant Industry Panel 

(EBFRIP). May 2009. 

28. UNEP. 2009. Stockholm Convention on 

Persistent Organic Pollutants. Summary of 

the proposal for the listing of 

hexabromocyclododecane (HBCDD) in Annex 

A to the Convention. July 2009. 

29. HBCD Action Plan. 2010. EPA’s 

Hexabromocyclododecane (HBCD) Action 

Plan. August 2010. Available online at http:// 

www.epa.gov/oppt/existingchemicals/pubs/ 

actionplans/hbcd.html (accessed March 8, 

2012). 

XII. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

Under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

this action has been designated a 

‘‘significant regulatory action.’’ 

Accordingly, EPA submitted this action 

to the Office of Management and Budget 

(OMB) for review under Executive 

Orders 12866 and 13563, entitled 

‘‘Improving Regulation and Regulatory 

Review’’ (76 FR 3821, January 21, 2011), 

and any changes made in response to 

OMB recommendations have been 

documented in the docket for this action 

as required by section 6(a)(3)(E) of the 

Executive Order. 

EPA has prepared an economic 

analysis of this action, entitled 

‘‘Economic Analysis of the Proposed 

Significant New Use Rule for 

Hexabromocyclododecane (HBCD)’’ 

(EPA, 2011). A copy of the document is 

available in the docket for this proposed 

rule and is summarized in Unit X. 

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 PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for certain EPA 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 PRA under OMB control 

number 2070–0038 (EPA ICR No. 1188). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average 97 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 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. Small Entity Impacts 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

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

certifies that promulgation of this SNUR 

would not have a significant adverse 

economic impact on a substantial 

number of small entities. The rationale 

supporting this conclusion is as follows. 

Under RFA, small entities include 

small businesses, small organizations, 

and small governmental jurisdictions. 

Small entity is defined in accordance 

with section 601 of RFA as: A small 

business as defined by the Small 

Business Administration’s (SBA) 

regulations at 13 CFR 121.201; 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; and a 

small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. For purposes of 

assessing the impacts of this proposed 

rule on small entities, EPA has 

determined that this proposed rule is 

not expected to impact any small notfor-profit organizations or small 

governmental jurisdictions. As such, the 

Agency estimated potential impacts on 

small business. 

A SNUR applies to any person 

(including small or large entities) who 

intends to manufacture, import, or 

process a chemical substance for a use 

the EPA has designated as a ‘‘significant 

new use.’’ By definition of the word 

‘‘new,’’ and based on information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activity. Since this 

proposed SNUR would require a person 

who intends to engage in such activity 

in the future to first notify EPA by 

submitting a SNUN, no economic 

impact will occur unless someone files 

a SNUN to pursue a significant new use 

in the future or forgoes profits by 

avoiding or delaying the significant new 

use. 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 

SNURs covering over 1,000 chemical 

substances, the Agency receives only a 

handful of SNUNs per year. For 

example, the number of SNUNs was 

four in Federal fiscal year 2005, eight in 

FY2006, six in FY2007, eight in FY2008, 

and seven in FY2009. During this 5-year 

period, three small entities submitted a 

SNUN. Therefore, EPA believes that the 

potential economic impact of complying 

with a SNUR is not expected to be 

significant or adversely impact a 

substantial number of small entities. In 

a SNUR that published as a final rule on 

August 8, 1997 (62 FR 42690) (FRL– 

5735–4), the Agency presented its 

general determination that proposed 


tkelley on DSK3SPTVN1PROD with PROPOSALS
17394 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Proposed Rules 

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 

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 reason to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this regulatory action 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

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

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1531–1538). 

E. Federalism 

This action would not have 

federalism implications because it is not 

expected to 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. Indian Tribal Governments 

This action would not have tribal 

implications as specified in Executive 

Order 13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000). This action is not expected to 

have substantial direct effects on Indian 

Tribes, would not significantly or 

uniquely affect the communities of 

Indian Tribal governments, and would 

not involve or impose any requirements 

that affect Indian Tribes. Thus, 

Executive Order 13175 does not apply 

to this action. 

G. Protection of Children 

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. 

H. Effect on Energy Supply, Distribution, 

or Use 

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 this action is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

I. Technical Standards 

Because this action would not involve 

any technical standards, section 12(d) of 

the National Technology Transfer and 

Advancement Act of 1995 (NTTAA) (15 

U.S.C. 272 note), does not apply to this 

action. 

J. Environmental Justice 

This action would 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). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: March 20, 2012. 

Wendy C. Hamnett, 

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 

continues to read as follows: 

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

2625(c). 

2. Add § 721.10281 to subpart E to 

read as follows: 

§ 721.10281 Hexabromocyclododecane 

and 1,2,5,6,9,10-hexabromocyclododecane. 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as hexabromocyclododecane (CASRN 

25637–99–4) and 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194–55–6) are subject to reporting 

under this section for the significant 

new use described in paragraph (a)(2) of 

this section. 

(2) The significant new use is use in 

consumer textiles, other than for use in 

motor vehicles. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Definitions. The definitions in 

§ 721.3 apply to this section. In 

addition, the following definitions 

apply: 

Consumer textile means any cloth, 

fabric, or other item produced during 

the milling process (including spinning, 

weaving, knitting, felting, or finishing), 

consisting in whole or in part as a 

product that is sold to or made available 

to a private individual who uses the 

product in or around a permanent or 

temporary household or residence, 

during recreation, or for any personal 

use or enjoyment. Consumer textiles 

include, but are not limited to, 

upholstered household furniture, 

mattresses, and draperies. 

Motor vehicle has the meaning found 

at 40 CFR 85.1703. 

(2) Revocation of article exemption. 

The provisions of § 721.45(f) do not 

apply to this section. A person who 

imports or processes the chemical 

substances identified in paragraph (a)(1) 

of this section as part of an article for 

the significant new use described in 

paragraph (a)(2) of this section must 

submit a significant new use notice 

(SNUN). 

[FR Doc. 2012–7207 Filed 3–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Part 173 

[Docket No. PHMSA–2010–0201 (HM–254)] 

RIN 2137–AE62 

Hazardous Materials: Approval and 

Communication Requirements for the 

Safe Transportation of Air Bag 

Inflators, Air Bag Modules, and SeatBelt Pretensioners 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: In this NPRM, PHMSA is 

proposing to revise the Hazardous 

Materials Regulations applicable to air 

bag inflators, air bag modules, and seatbelt pretensioners. The proposed 

changes would incorporate the 

provisions of two special permits into 

the regulations. In addition, PHMSA 

proposes to revise the current approval 

and documentation requirements for a 

material appropriately classified as a 


tkelley on DSK3SPTVN1PROD with PROPOSALS