Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81447 

(a), (b), (c), (d), (e) (concentration set at 

1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), 

(g)(2)(iv) (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.5 mg/m3), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (f), (g), (h), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

3. Add § 721.10231 to subpart E to 

read as follows: 

§ 721.10231 Rutile, tin zinc, sodium-doped. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

rutile, tin zinc, sodium-doped (PMN P– 

06–37; CAS No. 389623–07–8) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been incorporated into a polymer, 

glass, dispersion, cementitious matrix, 

or a similar incorporation. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(5), (a)(6)(i), (b) (concentration 

set at 1.0 percent), and (c). The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10 

meet the minimum requirements for 

§ 721.63(a)(5): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

(C) NIOSH-certified powered airpurifying respirator equipped with a 

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

(1) As an alternative to the respiratory 

requirements listed in paragraph 

(a)(2)(i), a manufacturer, importer, or 

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for these substances. 

The NCEL is 1.5 mg/m3 as an 8-hour 

time-weighted-average for both 

chemical substances combined. Persons 

who wish to pursue NCELs as an 

alternative to the § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will receive NCELs 

provisions comparable to those 

contained in the corresponding section 

5(e) consent order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (e) (concentration set at 

1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), 

(g)(2)(iv) (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.5 mg/m3), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (f), (g), (h), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–33255 Filed 12–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2010–0279; FRL–9326–2] 

RIN 2070–AB27 

Proposed Significant New Use Rules 

on Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under section 

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

Act (TSCA) for 17 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Fifteen 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action would 

require persons who intend to 

manufacture, import, or process any of 

these 17 chemical substances for an 

activity that is designated as a 

significant new use by this proposed 

rule 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 necessary, to prohibit or limit 

that activity before it occurs. 

DATES: Comments must be received on 

or before January 27, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0279, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

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–2010–0279. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2010–0279. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

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81448 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

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: 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: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA–Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA– 

Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this proposed rule. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 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 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. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. 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. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to a final SNUR 

must certify their compliance with the 

SNUR requirements. 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 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 

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? 

These proposed SNURs would, when 

finalized, require persons to notify EPA 

at least 90 days before commencing the 

manufacture, import, or processing of 

the specific chemical substances 

identified in the PMNs for any activity 

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designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

of April 24, 1990 (55 FR 17376). Consult 

that preamble for further information on 

the objectives, rationale, and procedures 

for SNURs and on the basis for 

significant new use designations, 

including provisions for developing test 

data. 

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 TSCA section 5(a)(2) 

factors, listed in Unit III. of this 

document. Once EPA determines that a 

use of a chemical substance is a 

significant new use, TSCA section 

5(a)(1)(B) and 40 CFR part 721 requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture, import, or 

process the chemical substance for that 

use. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 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. 

According to § 721.1(c), persons 

subject to these SNURs must comply 

with the same notice requirements and 

EPA regulatory procedures as submitters 

of 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, 

EPA may take regulatory action under 

TSCA section 5(e), 5(f), 6, or 7 to control 

the activities for which it has received 

the SNUN. If EPA does not take action, 

EPA is required under TSCA section 

5(g) to explain in the Federal Register 

its reasons for not taking action. 

III. Significant New Use Determination 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 17 chemical 

substances that are the subject of these 

proposed SNURs, EPA considered 

relevant information about the toxicity 

of the chemical substances, likely 

human exposures and environmental 

releases associated with possible uses, 

taking into consideration the four 

bulleted TSCA section 5(a)(2) factors 

listed in this unit. 

IV. Substances Subject to this Proposed 

Rule 

EPA is proposing to establish 

significant new use and recordkeeping 

requirements for 17 chemical substances 

in 40 CFR part 721, subpart E. In this 

unit, EPA provides the following 

information for each chemical 

substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

number (if assigned for non-confidential 

chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for non-section 5(e) 

SNURs, the basis for the SNUR (i.e., 

SNURs without TSCA section 5(e) 

consent orders). 

• Toxicity concerns. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this proposed 

rule. 

This proposed rule includes 7 PMN 

substances whose reported chemical 

names include the term ‘‘carbon 

nanotube’’ or ‘‘CNT’’. Because of a lack 

of established nomenclature for carbon 

nanotubes, the TSCA Inventory names 

for carbon nanotubes are currently in 

generic form, e.g., carbon nanotube 

(CNT), multi-walled carbon nanotube 

(MWCNT), double-walled carbon 

nanotube (DWCNT), or single-walled 

carbon nanotube (SWCNT). EPA uses 

the specific structural characteristics 

provided by the PMN submitter to more 

specifically characterize the Inventory 

listing for an individual CNT. All 

submitters of new chemical notices for 

CNTs have claimed those specific 

structural characteristics as CBI. EPA is 

publishing the generic chemical name 

along with the PMN number to identify 

that a distinct chemical substance was 

the subject of the PMN without 

revealing the confidential chemical 

identity of the PMN substance. 

Confidentiality claims preclude a more 

detailed description of the identity of 

these CNTs. If an intended 

manufacturer, importer, or processor of 

CNTs is unsure of whether its CNTs are 

subject to this proposed SNUR or any 

other SNUR, the company can either 

contact EPA or obtain a written 

determination from EPA pursuant to the 

bona fide procedures at § 721.11. EPA is 

using the specific structural 

characteristics, for all CNTs submitted 

as new chemical substances under 

TSCA, to help develop standard 

nomenclature for placing these chemical 

substances on the TSCA Inventory. EPA 

has compiled a generic list of those 

structural characteristics entitled 

‘‘Material Characterization of Carbon 

Nanotubes for Molecular Identity (MI) 

Determination & Nomenclature.’’ A 

copy of this list is available in the 

docket for these proposed SNURs under 

docket ID number EPA–HQ–OPPT– 

2010–0279. If EPA develops a more 

specific generic chemical name for these 

materials, that name will be made 

publicly available. 

The regulatory text section of this 

proposed rule specifies the activities 

designated as significant new uses. 

Certain new uses, including exceeding 

production volume limits (i.e., limits on 

manufacture and importation volume) 

and other uses designated in this rule, 

may be claimed as CBI. 

This proposed rule includes 15 PMN 

substances for which EPA determined, 

pursuant to TSCA section 5(e), that 

uncontrolled manufacture, import, 

processing, distribution in commerce, 

use, and disposal may present an 

unreasonable risk of injury to human 

health or the environment. Accordingly, 

these substances are subject to ‘‘riskbased’’ consent orders under TSCA 

section 5(e)(1)(A)(ii)(I). Those consent 

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81450 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

orders require protective measures to 

limit exposures or otherwise mitigate 

the potential unreasonable risk. The socalled ‘‘5(e) SNURs’’ on these PMN 

substances are proposed pursuant to 

§ 14;721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 

Where EPA has determined that the 

PMN substance may present an 

unreasonable risk of injury to human 

health via inhalation exposure, the 

underlying TSCA section 5(e) consent 

order usually requires, among other 

things, that potentially exposed 

employees wear specified respirators 

unless actual measurements of the 

workplace air show that air-borne 

concentrations of the PMN substance 

are below a New Chemical Exposure 

Limit (NCEL) that is established by EPA 

to provide adequate protection to 

human health. In addition to the actual 

NCEL concentration, the comprehensive 

NCELs provisions in TSCA section 5(e) 

consent orders, which are modeled after 

Occupational Safety and Health 

Administration (OSHA) Permissible 

Exposure Limits (PELs) provisions, 

include requirements addressing 

performance criteria for sampling and 

analytical methods, periodic 

monitoring, respiratory protection, and 

recordkeeping. However, no comparable 

NCEL provisions exist in 40 CFR part 

721, subpart B, for SNURs. Therefore, 

for these cases, the individual SNURs in 

40 CFR part 721, subpart E, will state 

that persons subject to the SNUR who 

wish to pursue NCELs as an alternative 

to the § 721.63 respirator requirements 

may request to do so under § 721.30. 

EPA expects that persons whose 

§ 721.30 requests to use the NCELs 

approach for SNURs are approved by 

EPA will be required to comply with 

NCELs provisions that are comparable 

to those contained in the corresponding 

TSCA section 5(e) consent order for the 

same chemical substance. 

This proposed rule also includes 

SNURs on 2 PMN substances that are 

not subject to a consent order under 

TSCA section 5(e). In these cases, for a 

variety of reasons, EPA did not find that 

the use scenario described in the PMN 

met the criteria set forth under TSCA 

section 5(e). However, EPA does believe 

that certain changes from the use 

scenario described in these PMNs could 

result in increased exposures, and 

therefore should be designated a 

significant new use. These so-called 

‘‘non-5(e) SNURs’’ are being proposed 

pursuant to § 721.170. EPA has 

determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

stipulated in § 721.170(c)(2), i.e., these 

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–04–244 

Chemical name: Ethane, 2-bromo-1, 

1-difluoro-. 

CAS number: 359–07–9. 

Effective date of the TSCA section 5(e) 

consent order: February 16, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that the 

substance will be used as a chemical 

intermediate for an herbicide. The order 

was issued under TSCA sections 

5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based 

on a finding that this substance may 

present an unreasonable risk of injury to 

human health. To protect against this 

risk, the consent order: (1) Requires use 

of personal protective equipment 

including impervious gloves and a 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

supplied-air respirator operated in 

pressure demand or other positive 

pressure mode and equipped with a 

tight-fitting full facepiece with an 

assigned protection factor (APF) of at 

least 75, or compliance with a NCEL of 

0.5 mg/m3 as an 8-hour time-weighted 

average; (2) requires establishment of a 

hazard communication program; (3) 

prohibits use of the PMN substance 

other than as a chemical intermediate 

for an herbicide; and (4) requires 

corresponding recordkeeping. The 

proposed SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data 

on analogous structurally similar alkyl 

halides, EPA identified health concerns 

for systemic toxicity, developmental 

toxicity, reproductive toxicity, and 

cancer in workers exposed to the PMN 

substance by the inhalation route. 

Recommended testing: EPA has 

determined that a carcinogenicity test 

(OPPTS Test Guideline 870.4200) in rats 

by the inhalation route would help 

characterize the human health effects of 

the PMN substance. The PMN submitter 

has agreed not to exceed a particular 

production volume limit without 

performing this test. 

CFR citation: 40 CFR 721.10265. 

PMN Numbers P–08–733 and P–08–734 

Chemical names: Multi-walled carbon 

nanotubes (generic) (P–08–733 and 

P–08–734). 

CAS numbers: Not available. 

Effective date of the TSCA section 5(e) 

consent order: July 26, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMNs state that the 

generic (non-confidential) uses of the 

substances will be as: Reinforcement for 

composites, conductive additive for 

composites, and conductive additive for 

batteries. The order was issued under 

TSCA sections 5(e)(1)(A)(i) and 

5(e)(1)(A)(ii)(I) based on a finding that 

these substances may present an 

unreasonable risk of injury to human 

health or the environment. To protect 

against these risks, the consent order: (1) 

Requires use of personal protective 

equipment including gloves and 

chemical protective clothing, and a 

NIOSH-certified air-purifying, tightfitting full-face respirator equipped with 

N–100, P–100, or R–100 filter with an 

APF of at least 50; (2) prohibits the 

domestic manufacture of the PMN 

substances; (3) restricts use of the PMN 

substances to those uses specified in the 

consent order; prohibits the release of 

the PMN substances into the waters of 

the United States; and (4) requires 

corresponding recordkeeping. The 

proposed SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data 

for analogous chemicals, including 

other carbon nanotubes, there are 

concerns for pulmonary toxicity, 

fibrosis, carcinogenicity, mutagenicity, 

and immunotoxicity of the PMN 

substances. Based on test data on 

respirable, poorly soluble particulates, 

EPA has concerns for lung effects. There 

are also data suggesting that pulmonary 

deposition of some nanoscale materials, 

including carbon nanotubes in the 

agglomerated form, may induce 

cardiovascular toxicity when these 

nanoscale materials are inhaled. The 

major health concerns are for potential 

pulmonary toxicity, fibrosis, and cancer 

to workers exposed via inhalation. 

Sublethal effects have been noted for 

some carbon nanoscale substances in 

fish at levels as low as 100 parts per 

billion (ppb). Further, studies need to be 

conducted before EPA can determine a 

concentration of concern. Such studies 

must measure actual concentrations of 

carbon nanotubes and control for the 

effects of contaminants, solvents, and 

physical factors such as blockage of gills 

or intestines. 

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Recommended testing: EPA has 

determined that the following tests 

would help characterize possible effects 

of the substances. The PMN submitter 

has agreed not to exceed a specified 

production limit without performing 

these tests on one of the PMN 

substances: A 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465 or 

Organisation for Economic Co-operation 

and Development (OECD) Test 

Guideline 413) with a post-exposure 

observation period of up to 3 months, 

bronchoalveolar lavage fluid (BALF) 

analysis, a determination of 

cardiovascular toxicity (clinically-based 

blood/plasma protein analyses), and 

histopathology of the heart and certain 

material characterization data. 

CFR citation: 40 CFR 721.10266. 

PMN Numbers P–09–54, P–09–55, P–09– 

56, and P–09–57 

Chemical names: (P–09–54) 

[5,6]Fullerene-C60-Ih; (P–09–55) 

[5,6]Fullerene-C70-D5h(6); (P–09–56) 

[5,6]Fullerene-C84-D2; and (P–09–57) 

[5,6]Fullerene-C84-D2d. 

CAS numbers: (P–09–54) 99685–96–8; 

(P–09–55) 115383–22–7; (P–09–56) 

145809–19–4; and (P–09–57) 145809– 

20–7. 

Effective date of the TSCA section 5(e) 

consent order: August 16, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that uses 

of the substances will be as: An 

intermediate compound for use in 

producing downstream products that 

will in turn be used in organic 

electronic devices and an additive to 

improve mechanical properties or 

conductivity; a compound used to 

improve the mechanical properties of 

rubbers, plastics, and lubricants; and a 

compound for use as an additive to 

increase the conductivity of materials. 

The order was issued under TSCA 

sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) 

based on a finding that these substances 

may present an unreasonable risk of 

injury to human health. To protect 

against this risk, the consent order: (1) 

Requires use of personal protective 

equipment including gloves and 

protective clothing impervious to the 

chemical substances and a NIOSHcertified full-face respirator with N–100 

cartridges; (2) restricts use of the PMN 

substances to those uses specified in the 

consent order; (3) prohibits release of 

the PMN substances into the waters of 

the United States; and (4) requires 

corresponding recordkeeping. The 

proposed SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data 

on poorly soluble particulates, 

including some carbon-based nanosized chemicals, and test data 

correlating lung irritation to particle 

size, EPA has concerns for lung effects 

from inhalation exposure. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize possible effects 

of the substances. The PMN submitter 

has agreed not to exceed a particular 

production limit without performing 

these tests on all of the PMN substances: 

Dry particle size distribution by count 

for each PMN substance in a form which 

has the highest content of particles 

smaller than 10 microns as 

manufactured, processed, or used in the 

workplace at sites controlled by the 

PMN submitter (the method shall be 

scanning transmission electron 

microscopy, using a dry particle 

counting method, with a resolution of 

less than 1 nanometer and with no 

counting after dispersion in a solution 

and evaporating solvent) and dustiness 

(EN 15051 method). 

EPA has determined that the results of 

the following tests would help 

characterize the human health effects of 

the PMN substance. The order does not 

require the submission of the following 

information at any specified time or 

production volume: 90-day inhalation 

toxicity (OPPTS Test Guideline 

870.3465 or OECD Test Guideline 413); 

dispersion and solubility in fresh water 

without the use of dispersants or 

solvents (Refs. 1 and 2). However, the 

order’s restrictions on manufacture, 

import, processing, distribution in 

commerce, use, and disposal of the 

PMN substance will remain in effect 

until the order is modified or revoked 

by EPA based on submission of that or 

other relevant information. 

CFR citations: 40 CFR 721.10267 (P– 

09–54); 40 CFR 721.10268 (P–09–55); 40 

CFR 721.10269 (P–09–56); and 40 CFR 

721.10270 (P–09–57). 

PMN Numbers P–09–142, P–09–143, 

P–09–144, and P–09–416 

Chemical names: (P–09–142 and 

Chemical A in P–09–416) 3′-Hcyclopropa[1,9][5,6]fullerene-C60-Ih-3′- 

butanoic acid, 3′-phenyl-, methyl ester; 

(P–09–143 and Chemical B in P–09– 

416) 3′H-cyclopropa[8,25][5,6]fullereneC70-D5h(6)-3′-butanoic acid, 

3′-phenyl-, methyl ester; and (P–09–144 

and Chemical C in P–09–416) 3′Hcyclopropa[7,22][5,6]fullerene-C70- 

D5h(6)-3′-butanoic acid, 3′-phenyl-, 

methyl ester. 

CAS numbers: (P–09–142 and 

Chemical A in P–09–416) 160848–22–6; 

(P–09–143 and Chemical B in P–09– 

416) 609771–63–3; and (P–09–144 and 

Chemical C in P–09–416) 1051371–21– 

1. 

Effective date of the TSCA section 5(e) 

consent orders: (P–09–142, P–09–143, 

and P–09–144) November 1, 2010 and 

(P–09–416) October 28, 2010. 

Basis for the TSCA section 5(e) 

consent orders: The PMNs state that the 

uses of the substances will be: As a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage, or other 

characteristics of the device, and a 

compound that improves the 

mechanical properties of lubricants and 

plastics (P–09–142, P–09–143, and 

P–09–144), and as acceptor molecules in 

a polymer coating in an encapsulated 

organic photovoltaic electronic device 

(P–09–416). The orders were issued 

under TSCA sections 5(e)(1)(A)(i) and 

5(e)(1)(A)(ii)(I) based on a finding that 

these substances may present an 

unreasonable risk of injury to human 

health. To protect against these risks, 

the consent orders: (1) Require the use 

of personal protective equipment 

including impervious gloves and 

chemical protective clothing and use of 

a NIOSH-certified air-purifying tightfitting full-face respirator equipped with 

N–100 cartridges; (2) restrict use of the 

PMN substances to those uses specified 

in their respective consent orders; (3) 

prohibit release of the PMN substances 

into the waters of the United States; and 

(4) require corresponding 

recordkeeping. The proposed SNUR 

would designate as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Toxicity concern: Based on test data 

on poorly soluble particulates, 

including some carbon-based nanosized chemicals, and test data 

correlating lung irritation to particle 

size, EPA has concerns for lung effects 

from inhalation exposure. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize the human 

health effects of the PMN substances. 

The consent orders each contain two 

production limits. The PMN submitters 

have agreed not to exceed their first 

production limits without performing a 

90-day inhalation toxicity study (OPPTS 

Test Guideline 870.3465 or OECD Test 

Guideline 413) in rats with a post 

exposure observation period of up to 3 

months, including a BALF analysis, a 

determination of cardiovascular toxicity 

(clinically-based blood/plasma protein 

analyses), and histopathology of the 

heart and certain material 

characterization data on the test 

material which can be any one of these 

PMN substances. The PMN submitters 

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have also agreed not to exceed the 

second production limits without 

providing certain physical-chemical 

properties on each of the PMN 

substances. 

The consent order for P–09–416 does 

not require the submission of the 

following information at any specified 

time or production volume: Dispersion 

and solubility in fresh water without the 

use of dispersants or solvents (Refs. 1 

and 2) and daphnid chronic toxicity test 

(OPPTS Test Guideline 850.1300). 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citations: 40 CFR 721.10271 (P– 

09–142 and Chemical A in P–09–416); 

40 CFR 721.10272 (P–09–143 and 

Chemical B in P–09–416); and 40 CFR 

721.10273 (P–09–144 and Chemical C in 

P–09–416). 

PMN Number P–09–188 

Chemical name: Multi-walled carbon 

nanotubes (generic) (P–09–188). 

CAS number: Not available. 

Effective date of the TSCA section 5(e) 

consent order: December 14, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an electric 

conductive filler to replace conventional 

material such as carbon black or carbon 

fiber in matrices such as polymer resin 

for conductive applications. The order 

was issued under TSCA sections 

5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based 

on a finding that this substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the consent 

order: (1) Requires use of personal 

protective equipment including gloves 

and chemical protective clothing 

impervious to the PMN substance, and 

a NIOSH-certified air-purifying, tightfitting full-face respirator equipped with 

N–100, P–100, or R–100 filter with an 

APF of at least 50; (2) prohibits 

domestic manufacture in the United 

States; (3) restricts use of the PMN 

substance to those uses specified in the 

consent order; (4) prohibits the 

manufacture, processing, or use of the 

PMN substance for commercial or 

consumer products, or in a consumer 

product; prohibits release of the PMN 

substance into the waters of the United 

States; and (5) requires corresponding 

recordkeeping. The proposed SNUR 

would designate as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Toxicity concern: Based on test data 

for analogous chemicals including other 

carbon nanotubes there are concerns for 

pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity of the PMN substance. 

Based on test data on respirable, poorly 

soluble particulates, EPA has concerns 

for lung effects. There are also data 

suggesting that pulmonary deposition of 

some nanoscale materials, including 

carbon nanotubes in the agglomerated 

form, may induce cardiovascular 

toxicity when these nanoscale materials 

are inhaled. The major health concerns 

are for potential pulmonary toxicity, 

fibrosis, and cancer to workers exposed 

via inhalation. Sublethal effects have 

been noted for some carbon nanoscale 

substances in fish at levels as low as 100 

ppb. Further studies need to be 

conducted before EPA can determine a 

concentration of concern. Such studies 

must measure actual concentrations of 

carbon nanotubes and control for the 

effects of contaminants, solvents, and 

physical factors such as blockage of gills 

or intestines. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize possible effects 

of the PMN substance. The PMN 

submitter has agreed not to exceed two 

production volume limits specified in 

the order without performing these 

tests: A 90-day inhalation toxicity test 

(OPPTS Test Guideline 870.3465 or 

OECD Test Guideline 413) with a postexposure observation period of up to 3 

months, a BALF analysis, determination 

of cardiovascular toxicity, heart 

histopathology, data on pulmonary 

deposition, and certain material 

characterization and physical-chemical 

properties on the test material(s). 

The order does not require the 

submission at any specified time or 

production volume of the following 

exposure data on representative forms of 

the PMN substance: Release of the PMN 

substance after landfill disposal (EPA 

Method 1320), release of the PMN 

substance during burning (American 

Society for Testing and Materials 

International (ASTM) E1354–09), 

release of the PMN substance after 

exposure to sunlight (ASTM D2565–99 

(2008)), and release of the PMN 

substance during shipping and use. 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. The company may propose 

alternative methods, guidelines, or 

representative sets subject to EPA’s 

approval. 

CFR citation: 40 CFR 721.10274. 

PMN Number P–09–417 

Chemical name: Multi-walled carbon 

nanotubes (generic) (P–09–417). 

CAS number: Not available. 

Effective date of the TSCA section 5(e) 

consent order: March 23, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that the 

use of the substance will be as a plastics 

additive to improve electrical, thermal, 

and/or mechanical properties. The order 

was issued under TSCA sections 

5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based 

on a finding that this substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the consent 

order: (1) Requires use of personal 

protective equipment including gloves 

and protective clothing impervious to 

the chemical substance and NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter with an APF of 50; 

(2) prohibits the domestic manufacture 

of the PMN substance; (3) restricts use 

of the PMN substance to the uses 

specified in the consent order; (4) 

prohibits use of the PMN substance in 

commercial or consumer products; (5) 

prohibits release of the PMN substance 

into the waters of the United States 

during processing and use activities; 

and (6) requires corresponding 

recordkeeping. The proposed SNUR 

would designate as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Toxicity concern: Based on test data 

for analogous chemicals including other 

carbon nanotubes there are concerns for 

pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity of the PMN substance. 

Based on test data on the PMN 

substance and respirable, poorly soluble 

particulates, EPA has concerns for lung 

effects. There are also data suggesting 

that pulmonary deposition of some 

nanoscale materials, including carbon 

nanotubes in the agglomerated form, 

may induce cardiovascular toxicity 

when these nanoscale materials are 

inhaled. The major health concerns are 

for potential pulmonary toxicity, 

fibrosis, and cancer to workers exposed 

via inhalation. Sublethal effects have 

been noted for some carbon nanoscale 

substances in fish at levels as low as 100 

ppb. Further studies need to be 

conducted before EPA can determine a 

concentration of concern. Such studies 

must measure actual concentrations of 

carbon nanotubes and control for the 

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effects of contaminants, solvents, and 

physical factors such as blockage of gills 

or intestines. 

Recommended testing: EPA has 

determined that the following test 

would help characterize the possible 

effects of the PMN substance. The PMN 

submitter has agreed not to exceed the 

production limit without providing 

certain physical/chemical properties 

test data. The order does not require the 

submission of the following information 

at any specified time or production 

volume: The results of a combined 

chronic toxicity/carcinogenicity testing 

of respirable fibrous particles test 

(OPPTS Test Guideline 870.8355). 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10275. 

PMN Numbers P–10–39 and P–10–40 

Chemical names: Multi-walled carbon 

nanotubes (generic) (P–10–39) and 

single-walled and multi-walled carbon 

nanotubes (generic) (P–10–40). 

CAS numbers: (P–10–39) Not 

available and (P–10–40) not available. 

Effective date of the TSCA section 5(e) 

consent order: August 30, 2010. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that the 

generic (non-confidential) use of the 

substances will be as composite 

structures for defense, electronic, and 

aerospace applications. The order was 

issued under TSCA sections 5(e)(1)(A)(i) 

and 5(e)(1)(A)(ii)(I) based on a finding 

that these substances may present an 

unreasonable risk of injury to human 

health or the environment. To protect 

against these risks, the consent order: 

(1) Requires use of personal protective 

equipment including gloves and 

protective clothing impervious to the 

chemical substances, and a NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, 

P–100, or R–100 filter with an APF of 

at least 50; (2) restricts use of the PMN 

substances to the uses specified in the 

consent order; (3) prohibits 

manufacture, processing, or use of the 

PMN substance for commercial or 

consumer products; (4) prohibits release 

of the PMN substances into the waters 

of the United States; and (5) requires 

corresponding recordkeeping. The 

proposed SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data 

for analogous chemicals including other 

carbon nanotubes there are concerns for 

pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity of the PMN substances. 

Based on test data on respirable, poorly 

soluble particulates, EPA has concerns 

for lung effects. There are also data 

suggesting that pulmonary deposition of 

some nanoscale materials, including 

carbon nanotubes in the agglomerated 

form, may induce cardiovascular 

toxicity when these nanoscale materials 

are inhaled. The major health concerns 

are for potential pulmonary toxicity, 

fibrosis, and cancer to workers exposed 

via inhalation. Sublethal effects have 

been noted for some carbon nanoscale 

substances in fish at levels as low as 100 

ppb. Further studies need to be 

conducted before EPA can determine a 

concentration of concern. Such studies 

must measure actual concentrations of 

carbon nanotubes and control for the 

effects of contaminants, solvents, and 

physical factors such as blockage of gills 

or intestines. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize the possible 

effects of the PMN substances. The 

consent order contains three production 

limits. The PMN submitter has agreed 

not to exceed the first production limit 

without submitting certain material 

characterization data on both 

substances. The PMN submitter has 

agreed not to exceed the second 

production limit without performing 

workplace exposure monitoring and 

characterization testing (including 

byproducts) as well as quantification 

and characterization of substances that 

may be released during exposures 

typical during the use phase. The PMN 

submitter has also agreed not to exceed 

the third production limit without 

performing a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465 or 

OECD Test Guideline 413) with a postexposure observation period of up to 3 

months, a BALF analysis, determination 

of cardiovascular toxicity, heart 

histopathology, data on pulmonary 

deposition, and certain material 

characterization and physical-chemical 

properties on either or both of the 

substances that workers may be exposed 

to. 

CFR citations: 40 CFR 721.10276 (P– 

10–39) and 40 CFR 721.10277 (P–10– 

40). 

PMN Number P–10–224 

Chemical name: 4,4′-Bipyridinium, 1- 

(phosphonoalkyl)-1′-substituted-, salt 

with anion (1:2) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a constituent in ink 

formulation. Based on test data on a salt 

of the anion of the PMN substance and 

analogous respirable poorly soluble 

particulates, EPA identified concerns for 

toxicity concerns to the liver and lung 

and neurotoxicity to workers exposed to 

the PMN substance. For the uses 

described in the PMN, significant 

worker exposure is unlikely, as dermal 

and inhalation exposure will be 

minimal due to adequate personal 

protective equipment and no domestic 

manufacture. Therefore, EPA has not 

determined that the proposed 

manufacturing method, processing 

method, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the PMN substance: (1) Without the use 

of impervious gloves where there is 

potential for dermal exposure, (2) 

without the use of a NIOSH-certified 

respirator with an APF of at least 10 

where there is potential inhalation 

exposure, (3) involving domestic 

manufacture, (4) other than as described 

in the PMN, (5) where the annual 

manufacture and importation volume 

exceeds 1,000 kilograms, or (6) in the 

form of a powder or a solid may cause 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465 or OECD Test 

Guideline 413) would help characterize 

the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10278. 

PMN Number P–10–246 

Chemical name: Multi-walled carbon 

nanotubes (generic) (P–10–246). 

CAS number: Not available. 

Effective date of the TSCA section 5(e) 

consent order: April 4, 2011. 

Basis for the TSCA section 5(e) 

consent order: The PMN states that the 

use of the substance will be as a 

conductivity additive to resins, rubber, 

and battery electrodes. The order was 

issued under TSCA sections 5(e)(1)(A)(i) 

and 5(e)(1)(A)(ii)(I) based on a finding 

that this substance may present an 

unreasonable risk of injury to human 

health or the environment. To protect 

against these risks, the order: (1) 

Requires use of personal protective 

equipment including gloves and 

protective clothing impervious to the 

chemical substance, and at minimum, a 

NIOSH-certified air-purifying, tightfitting full-face respirator equipped with 

N–100, P–100, or R–100 cartridges or 

power air purifying particulate 

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respirator with an APF of at least 50; (2) 

prohibits the domestic manufacture of 

the PMN substance; (3) restricts use of 

the PMN substance to the uses specified 

in the consent order; (4) prohibits 

release of the PMN substance into the 

waters of the United States during 

processing and use activities; and (5) 

requires corresponding recordkeeping. 

The proposed SNUR would designate as 

a ‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data 

for analogous chemicals including other 

carbon nanotubes there are concerns for 

pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity of the PMN substances. 

Based on test data on respirable, poorly 

soluble particulates, EPA has concerns 

for lung effects. There are also data 

suggesting that pulmonary deposition of 

some nanoscale materials, including 

carbon nanotubes in the agglomerated 

form, may induce cardiovascular 

toxicity when these nanoscale materials 

are inhaled. The major health concerns 

are for potential pulmonary toxicity, 

fibrosis, and cancer to workers exposed 

via inhalation. Sublethal effects have 

been noted for some carbon nanoscale 

substances in fish at levels as low as 100 

ppb. Further studies need to be 

conducted before EPA can determine a 

concentration of concern. Such studies 

must measure actual concentrations of 

carbon nanotubes and control for the 

effects of contaminants, solvents, and 

physical factors such as blockage of gills 

or intestines. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

possible effects of the PMN substance. 

The PMN submitter has agreed not to 

exceed a specified production time limit 

before performing these tests on the 

PMN substance: A 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465 or OECD Test Guideline 413) 

in rats with a post exposure observation 

period of up to 3 months, including a 

BALF analysis, a determination of 

cardiovascular toxicity (clinically-based 

blood/plasma protein analyses), and 

histopathology of the heart and certain 

material characterization data. 

CFR citation: 40 CFR 721.10279. 

PMN Number P–10–476 

Chemical name: Benzene, ethenyl-, 

polymer with 1,3-butadiene. 

CAS number: 1195978–93–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymer additive. 

Based on analogous high molecular 

weight polymers, EPA identified 

concerns for potential lung overload 

from exposure to the PMN substance via 

inhalation. Specifically, EPA predicts 

potential toxicity to consumers and the 

general population from inhalation of 

respirable particles of 10 microns or less 

of the PMN substance where the average 

number molecular weight is greater than 

10,000 daltons. Further, based on the 

physical/chemical properties of the 

PMN substance, EPA has concluded, if 

the PMN substance were manufactured 

where the average number molecular 

weight is less than 1,000 daltons, the 

PMN substance may be considered 

persistent, bio-accumulative, and toxic 

(PBT), as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999) (FRL– 

6097–7). EPA estimates, if the PMN 

substance were manufactured where the 

average number molecular weight is less 

than 1,000 daltons, that the PMN 

substance will persist in the 

environment more than six months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. For the 

manufacturing method, processing 

method, and use described in the PMN, 

significant inhalation exposures are 

unlikely, and the PMN is not considered 

to be a PBT. Accordingly, EPA has not 

determined that the proposed 

manufacturing method, processing 

method, or use of the substance as 

described in the PMN notice may 

present an unreasonable risk. EPA has 

determined, however, that any 

manufacturing method, processing 

method, or use of the PMN substance 

where greater than 5 percent of the 

particles are in the respirable range of 

10 microns or less and the average 

number molecular weight is greater than 

10,000 daltons may cause serious health 

effects. EPA has also determined that 

any manufacturing method, processing 

method, or use of the PMN substance 

where the average number molecular 

weight is less than 1,000 daltons may 

cause significant adverse environmental 

effects and may be characterized as a 

potential PBT substance. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the 

following testing would help 

characterize the possible human health 

effects and potential PBT attributes of 

the PMN substance: A 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465 or OECD Test Guideline 413) 

with a 60-day holding period (for the 

PMN substance where greater than 5 

percent is in the respirable range of 10 

microns or less and the average number 

molecular weight is greater than 10,000 

daltons) and the tiered testing described 

in the New Chemicals Program’s PBT 

Category (64 FR 60194; November 4, 

1999) (FRL–6097–7) (for the PMN 

substance where the average number 

molecular weight is less than 1,000 

daltons). Test reports should include 

protocols approved by EPA, certificate 

of analysis for the test substance, raw 

data, and results. 

CFR citation: 40 CFR 721.10280. 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these proposed SNURs, EPA 

concluded that for 15 of the 17 chemical 

substances, regulation was warranted 

under TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

or environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The proposed 

SNUR provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are being 

proposed pursuant to § 721.160. 

In the other 2 cases, where the uses 

were not regulated under a TSCA 

section 5(e) consent order, EPA 

determined that one or more of the 

criteria of concern established at 

§ 721.170 were met, as discussed in 

Unit IV. 

B. Objectives 

EPA is proposing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this proposed rule: 

• EPA would receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA would be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

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regulation is warranted pursuant to 

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

• EPA would ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

Internet at http://www.epa.gov/opptintr/ 

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Notice and Comment Procedures 

EPA is issuing these SNURs by notice 

and comment procedure, as described in 

§ 721.170(d)(4). In accordance with 

§ 721.170(d)(4)(ii)(A), persons are being 

given the opportunity to submit 

comments on or before January 27, 2012 

on whether EPA should establish 

notification requirements. 

VII. Applicability of Proposed Rule to 

Uses Occurring Before Effective Date of 

the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this proposed rule have 

undergone premanufacture review. 

TSCA section 5(e) consent orders have 

been issued for 15 chemical substances 

and the PMN submitters are prohibited 

by the TSCA section 5(e) consent orders 

from undertaking activities which EPA 

is designating as significant new uses. 

EPA is soliciting comments on whether 

any of the uses proposed as significant 

new uses are ongoing. 

As discussed in the Federal Register 

of April 24, 1990, 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 

notice requirements because a person 

could defeat the SNUR by initiating the 

significant new use before the rule 

became final, and then argue that the 

use was ongoing before the effective 

date of the final rule. Thus, persons who 

begin commercial manufacture, import, 

or processing of the chemical substances 

that would be regulated through these 

proposed SNURs will 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 notice requirements 

and wait until the notice review period, 

including all extensions, expires. 

EPA has promulgated provisions to 

allow persons to comply with these 

proposed SNURs before the effective 

date. If a person were to meet the 

conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing 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)). 

2. Development of test data may also 

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 (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In the TSCA section 5(e) consent 

orders for 15 of the chemical substances 

regulated under this proposed rule, EPA 

has established restrictions in view of 

the lack of data on the potential health 

and environmental risks that may be 

posed by the significant new uses or 

increased exposure to the chemical 

substances. These restrictions will not 

be removed until EPA determines that 

the unrestricted use will not present an 

unreasonable risk of injury or result in 

significant or substantial exposure or 

environmental release. This 

determination is usually made based on 

the results of the required or 

recommended toxicity tests. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists tests required or recommended in 

each of the section 5(e) consent orders 

underlying the proposed 5(e) SNURs, 

and lists tests recommended for the 

substances subject to the proposed non5(e) SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OPPTS Test 

Guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. The 

American Society for Testing and 

Materials International (ASTM) 

standards are available at http:// 

www.astm.org/Standard/index.shtml. 

To access the European standard, EN 

15051 method, issued by The European 

Committee for Standardization (CEN), 

please go to http://www.cen.eu/cen/ 

products. To access EPA Method 1320, 

please go to http://www.epa.gov/osw/ 

hazard/testmethods/sw846/pdfs/ 

1320.pdf. 

When physical/chemical properties of 

test material and/or material 

characterization tests are recommended 

for nanoscale substances that are the 

subject of this proposed rule, you 

should take into consideration the 

characterizations identified in the 

Guidance Manual for the Testing of 

Manufactured Nanomaterials: OECD’s 

Sponsorship Programme, which is 

available at http://www.oecd.org/ 

officialdocuments/displaydocumentpdf/ 

?cote=env/jm/mono(2009)20/ 

rev&doclanguage=en. 

The recommended testing specified in 

Unit IV. of this document may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, submitting a SNUN 

without any test data may increase the 

likelihood that EPA will take action 

under TSCA section 5(e), particularly if 

satisfactory test results have not been 

obtained from a prior PMN or SNUN 

submitter. EPA recommends that 

potential SNUN submitters contact EPA 

early enough so that they will be able 

to conduct the appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• 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 notice requirements and EPA 

regulatory procedures as persons 

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submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 

§ 720.50. SNUNs must be submitted to 

EPA on EPA Form No. 7710–25 in 

accordance with the procedures set 

forth in § 721.25 and § 720.40. Forms 

and information are available on-line at 

http://www.epa.gov/opptintr/newchems. 

X. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this proposed rule. EPA’s 

complete Economic Analysis is 

available in the docket under docket ID 

number EPA–HQ–OPPT–2010–0279. 

XI. References 

The following is a listing of the 

documents that have been placed in the 

proposed rule phase of the docket under 

docket ID number EPA–HQ–OPPT– 

2010–0279, which is available for 

inspection as specified under 

ADDRESSES. 

1. Cheng, X., Kan, A.T., and Tomson, 

M.B. Napthalene Adsorption and 

Desorption from Aqueous C60 Fullerene. 

Journal of Chemical & Engineering Data. 

2004, 49 (3), 675–683. 

2. Brant, J., Lecoanet, H., Hotze, M., 

and Wiesner, M. Comparison of 

Electrokinetic properties of Colloidal 

Fullerenes (n-C60) Formed Using Two 

Procedures. Environmental Science & 

Technology 2005, 39 (17), 6343–6351. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would establish 

SNURs for several new chemical 

substances that were the subject of 

PMNs, and, in some cases, TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

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

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 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. EPA would amend the table 

in 40 CFR part 9 to list the OMB 

approval number for the information 

collection requirements contained in 

these proposed SNURs, if the SNURs are 

subsequently issued as final rules. This 

listing of the OMB control numbers and 

their subsequent codification in the CFR 

satisfies the display requirements of 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

cause’’ under section 553(b)(3)(B) of the 

Administrative Procedure Act, 5 U.S.C. 

553(b)(3)(B), to amend this table without 

further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action would 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 these 

SNURs would not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The rationale supporting this 

conclusion is discussed in this unit. The 

requirement to submit a SNUN applies 

to any person (including small or large 

entities) who intends to engage in any 

activity described in the proposed rule 

as a ‘‘significant new use.’’ Because 

these uses are ‘‘new,’’ based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activities. A 

SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. Although some 

small entities may decide to pursue a 

significant new use 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 chemicals, the Agency 

receives only a handful of notices per 

year. For example, the number of 

SNUNs was four in Federal fiscal year 

(FY) 2005, eight in FY 2006, six in FY 

2007, eight in FY 2008, and seven in FY 

2009. During this 5-year period, three 

small entities submitted a SNUN. In 

addition, the estimated reporting cost 

for submission of a SNUN (see Unit X.) 

is minimal regardless of the size of the 

firm. Therefore, the potential economic 

impacts of complying with these SNURs 

would not be expected to be significant 

or adversely impact a substantial 

number of small entities. In a SNUR that 

published in the Federal Register of 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that 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 would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

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) (Pub. L. 104–4). 

E. Executive Order 13132 

This action would 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). 

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F. Executive Order 13175 

This proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would not significantly nor 

uniquely affect the communities of 

Indian Tribal governments, nor would 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 9, 2000), do not apply 

to this proposed rule. 

G. Executive Order 13045 

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. Executive Order 13211 

This proposed rule is not subject to 

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 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

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 

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). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 19, 2011. 

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 § 721.10265 to subpart E to 

read as follows: 

§ 721.10265 Ethane, 2-bromo-1, 

1-difluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethane, 2-bromo-1, 1-difluoro-(PMN P– 

04–244; CAS No. 359–07–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 0.1 

percent), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 75 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified 

supplied-air respirator operated in 

pressure demand or other positive 

pressure mode and equipped with a 

tight-fitting full facepiece. 

(A) As an alternative to the respiratory 

requirements listed in paragraph 

(a)(2)(i), a manufacturer, importer, or 

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for this substance. 

The NCEL is 0.5 mg/m3 as an 8-hour 

time-weighted average. Persons who 

wish to pursue NCELs as an alternative 

to the § 721.63 respirator requirements 

may request to do so under § 721.30. 

Persons whose § 721.30 requests to use 

the NCELs approach are approved by 

EPA will receive NCELs provisions 

comparable to those contained in the 

corresponding section 5(e) consent 

order. 

(B) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (e) (concentration set at 

0.1 percent), (f), (g)(1)(iv), (g)(1)(vi), 

(g)(1)(vii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), 

(g)(2)(iv) (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 0.5 mg/m3), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (chemical 

intermediate for a herbicide), and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (f), (g), (h), and (i) 

are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

3. Add § 721.10266 to subpart E to 

read as follows: 

§ 721.10266 Multi-walled carbon 

nanotubes (generic) (P–08–733 and P–08– 

734). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as multi-walled carbon 

nanotubes (PMNs P–08–733 and P–08– 

734) are subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the PMN 

substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that has been reacted (cured); or 

embedded, encapsulated or 

incorporated by the polymer binder into 

a permanent solid matrix (does not 

include slurries) that is not intended to 

undergo further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 50 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (k), and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

4. Add § 721.10267 to subpart E to 

read as follows: 

§ 721.10267 [5,6]Fullerene-C60-Ih. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]fullerene-C60-Ih (PMN P–09–54; 

CAS No. 99685–96–8) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

5. Add § 721.10268 to subpart E to 

read as follows: 

§ 721.10268 [5,6]Fullerene-C70-D5h(6). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]fullerene-C70-D5h(6) (PMN P–09– 

55; CAS No. 115383–22–7) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 50 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

6. Add § 721.10269 to subpart E to 

read as follows: 

§ 721.10269 [5,6]Fullerene-C84–D2. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]fullerene-C84-D2 (PMN P–09–56; 

CAS No. 145809–19–4) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

7. Add § 721.10270 to subpart E to 

read as follows: 

§ 721.10270 [5,6]Fullerene-C84-D2d. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]fullerene-C84-D2d (PMN P–09–57; 

CAS No. 145809–20–7) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

8. Add § 721.10271 to subpart E to 

read as follows: 

§ 721.10271 3′Hcyclopropa[1,9][5,6]Fullerene-C60-Ih-3′- 

butanoic acid, 3′-phenyl-, methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3′H-cyclopropa[1,9][5-6]Fullerene-C60– 

Ih-3′-butanoic acid, 3′-phenyl-, methyl 

ester, (PMNs P–09–142 and Chemical A 

in P–09–416; CAS No. 160848–22–6) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substances 

after they have been completely reacted 

(cured); embedded or incorporated into 

a polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage, or other 

characteristics of the device and a 

compound that improves the 

mechanical properties of lubricants and 

plastics; or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

9. Add § 721.10272 to subpart E to 

read as follows: 

§ 721.10272 3′Hcyclopropa[8,25][5,6]Fullerene-C70-D5h(6)- 

3′-butanoic acid, 3′-phenyl-, methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as 3′H-cyclopropa[8,25][5-6]FullereneC70-D5h(6)-3′-butanoic acid, 3′-phenyl-, 

methyl ester (PMNs P–09–143 and 

Chemical B in P–09–416; CAS No. 

609771–63–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

rule do not apply to quantities of the 

PMN substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that itself has been reacted (cured); or 

embedded in a permanent solid polymer 

form that is not intended to undergo 

further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage or other 

characteristics of the device and a 

compound that improves the 

mechanical properties of lubricants and 

plastics; or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

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(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

10. Add § 721.10273 to subpart E to 

read as follows: 

§ 721.10273 3′H-cyclopropa[7,22][5- 

6]Fullerene-C70–D5h(6)-3′-butanoic acid, 3′- 

phenyl-, methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as 3′H-cyclopropa[7,22][5,6]FullereneC70–D5h(6)-3′-butanoic acid, 3′- 

phenyl-, methyl ester (P–09–144 and 

Chemical C in P–09–416, CAS No. 

1051371–21–1) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

rule do not apply to quantities of the 

PMN substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that itself has been reacted (cured); or 

embedded in a permanent solid polymer 

form that is not intended to undergo 

further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage or other 

characteristics of the device and a 

compound that improves the 

mechanical properties of lubricants and 

plastics; or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

11. Add § 721.10274 to subpart E to 

read as follows: 

§ 721.10274 Multi-walled carbon 

nanotubes (generic) (P–09–188). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–09–188) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form with a 

concentration of the PMN substance 

equal to or below 30 percent that is not 

intended to undergo further processing 

except for mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), and (c). The following National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirator 

meets the minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), (m), (o), and 

(q). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

12. Add § 721.10275 to subpart E to 

read as follows: 

§ 721.10275 Multi-walled carbon 

nanotubes (generic) (P–09–417). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–09–417) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 50 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (k) (plastics 

additive to improve electrical, thermal, 

and/or mechanical properties), (m), and 

(o). 

(iii) Release to water. Requirements as 

specified in § 721.90 (b)(1) and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

13. Add § 721.10276 to subpart E to 

read as follows: 

§ 721.10276 Multi-walled carbon 

nanotubes (generic) (P–10–39). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–10–39) is subject to 

reporting under this section for the 

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significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer, metal, glass, 

or ceramic form that is not intended to 

undergo further processing except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

and (c). The following National Institute 

for Occupational Safety and Health 

(NIOSH)-certified respirators with an 

approved protection factor (APF) of at 

least 50 meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (m), (o), and (p) 

(120,000 kilograms of the aggregate of 

this chemical substance and the 

substance in § 721.10277 for P–10–40). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, 

importers, and processors of these 

substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

14. Add § 721.10277 to subpart E to 

read as follows: 

§ 721.10277 Single-walled and multi-walled 

carbon nanotubes (generic) (P–10–40). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as single-walled and multiwalled carbon nanotubes (PMN P–10– 

40) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the PMN 

substance after it has been completely 

reacted (cured); embedded or 

incorporated into a polymer matrix that 

itself has been reacted (cured); or 

embedded in a permanent solid 

polymer, metal, glass, or ceramic form 

that is not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), and (c). The following National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirators 

with an assigned protection factor (APF) 

of at least 50 meet the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, 

P–100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (m), (o), and (p) 

(120,000 kilograms of the aggregate of 

this chemical substance and the 

substance in § 721.10276 for P–10–39). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, 

importers, and processors of these 

substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

15. Add § 721.10278 to subpart E to 

read as follows: 

§ 721.10278 4,4′-Bipyridinium, 1- 

(phosphonoalkyl)-1′-substituted-, salt with 

anion (1:2) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 4,4′-bipyridinium, 1- 

(phosphonoalkyl)-1′-substituted-, salt 

with anion (1:2) (PMN P–10–224) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(3) (applicable to 

gloves only), (a)(4), (a)(6), (b) 

(concentration set at 1.0 percent), and 

(c). The following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10– 

25 meet the minimum requirements for 

§ 721.63(a)(4): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

(C) NIOSH-certified powered airpurifying respirator equipped with a 

loose- fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (j), (s) (1,000 

kilograms), (v)(1), and (v)(2). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

16. Add § 721.10279 to subpart E to 

read as follows: 

§ 721.10279 Multi-walled carbon 

nanotubes (generic) (P–10–246). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–10–246) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 50 meet the minimum 

requirements for § 721.63(a)(4): 

(A) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

(B) NIOSH-certified powered airpurifying respirator equipped with a 

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

or 

(C) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (conductivity 

additive to resins, rubber, and to battery 

electrodes), and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(b)(1) and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

17. Add § 721.10280 to subpart E to 

read as follows: 

§ 721.10280 Benzene, ethenyl-, polymer 

with 1,3-butadiene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzene, ethenyl-, polymer with 1,3- 

butadiene (PMN P–10–476; CAS No. 

1195978–93–8) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (manufacture by 

the method where the average number 

molecular weight is in the range of 

1,000 to 10,000 daltons or where less 

than 5 percent of the particles are in the 

respirable range of 10 microns or less 

and the average number molecular 

weight is greater than or equal to 10,000 

daltons). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–33261 Filed 12–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Chapter I 

[GC Docket No. 11–199; DA 11–2002] 

Preliminary Plan for Retrospective 

Analysis of Existing Rules 

AGENCY: Federal Communications 

Commission. 

ACTION: Notice of availability. 

SUMMARY: This document seeks 

comment on the Commission’s 

preliminary plan for retrospective 

analysis of existing rules. The 

Commission prepared this preliminary 

plan consistent with the President’s 

Executive Order 13579 encouraging 

independent agencies to engage in such 

retrospective review in order to identify 

unnecessary or unduly burdensome 

regulations that may be hindering job 

creation and economic development. 

The Commission seeks input from the 

public on all aspects of its preliminary 

plan. 

DATES: Comments may be filed on or 

before February 8, 2012, and reply 

comments may be filed on or before 

February 22, 2012. 

ADDRESSES: You may submit comments, 

identified by GC Docket No. 11–199, by 

any of the following methods: 

fi Federal Communications 

Commission’s Web Site: http://fjallfoss.

fcc.gov/ecfs2/. Follow the instructions 

for submitting comments. 

fi Mail: See the SUPPLEMENTARY

INFORMATION section of this document. 

fi People with Disabilities: Contact 

the FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov 

or phone: (202) 418–0530 or TTY: (202) 

418–0432. 

For detailed instructions for 

submitting comments and additional 

information, see the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding this 

proceeding, contact Jennifer Tatel, 

Office of General Counsel, (202) 418– 

1700. 

SUPPLEMENTARY INFORMATION: This is a 

summary of a Public Notice released by 

the Office of General Counsel on 

December 8, 2011. The full text of this 

document is available for public 

inspection and copying during regular 

business hours in the Commission’s 

Reference Information Center, Portals II, 

445 12th Street SW., Room CY–A257, 

Washington, DC 20554. The complete 

text of this document also may be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc., 

Portals II, 445 12th Street SW., Room 

CY–B402, Washington, DC 20554, 

telephone (202) 488–5300, facsimile 

(202) 488–5563 or via email FCC@BCPI

WEB.com. The full text may also be 

downloaded at http://www.fcc.gov. 

Pursuant to §§ 1.415 and 1.419 of the 

Commission’s rules, 47 CFR 1.415, 

1.419, interested parties may file 

comments and reply comments on or 

before the dates indicated on the first 

page of this document. Comments may 

be filed using the Commission’s 

Electronic Comment Filing System 

(ECFS). See Electronic Filing of 

Documents in Rulemaking Proceedings, 

63 FR 24121 (1998). 

fi Electronic Filers: Comments may 

be filed electronically using the Internet 

by accessing the ECFS: http://fjallfoss.

fcc.gov/ecfs2/. 

fi Paper Filers: Parties who choose to 

file by paper must file an original and 

one copy of each filing. If more than one 

docket or rulemaking number appears in 

the caption of this proceeding, filers 

must submit two additional copies for 

each additional docket or rulemaking 

number. 

Filings can be sent by hand or 

messenger delivery, by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

fi All hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th St. SW., Room TW–A325, 

Washington, DC 20554. The filing hours 

are 8 a.m. to 7 p.m. All hand deliveries 

must be held together with rubber bands 

or fasteners. Any envelopes and boxes 

mstockstill on DSK4VPTVN1PROD with PROPOSALS