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If your GAP is submitted . . . Your GAP will be handled as follows: 

(a) Before lease or grant issuance .......... You will furnish a copy of your GAP, consistency certification, and necessary data and information 

pursuant to 15 CFR part 930, subpart D, to the State’s CZM agency and BOEM at the same time. 

(b) After lease or grant issuance ............. You will submit a copy of your GAP, consistency certification, and necessary data and information 

pursuant to 15 CFR 93, subpart E to BOEM. BOEM will forward to the State CZMA agency one 

paper copy and one electronic copy of your GAP, consistency certification, and necessary data and 

information required under 15 CFR part 930, subpart E, after BOEM has determined that all information requirements for the GAP are met. 

■ 25. Revise § 585.902 paragraph (f) to 

read as follows: 

§ 585.902 What are the general 

requirements for decommissioning facilities 

authorized under my SAP, COP, or GAP? 

* * * * * 

(f) Provide BOEM with 

documentation of any coordination 

efforts you have made with the State 

CZMA agencies, and any affected States, 

local, and Tribal governments. 

PART 590—APPEAL PROCEDURES 

■ 26. The authority citation for part 590 

is revised to read as follows: 

Authority: 5 U.S.C. 301 et seq.; 31 U.S.C. 

9701; 43 U.S.C. 1334. 

■ 27. Revise § 590.4 paragraph (b)(1) to 

read as follows: 

§ 590.4 How do I file an appeal? 

* * * * * 

(b) * * * 

(1) You must pay electronically 

through the Fees for Services page on 

the BOEM Web site at http:// 

www.boem.gov, and you must include a 

copy of the Pay.gov confirmation receipt 

page with your Notice of Appeal. 

* * * * * 

[FR Doc. 2013–03992 Filed 2–22–13; 8:45 am] 

BILLING CODE 4310–MR–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2012–0727; FRL–9376–7] 

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 the Toxic 

Substances Control Act (TSCA) for 37 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). Seventeen 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 37 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 April 26, 2013. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0727, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. ATTN: Docket ID 

Number EPA–HQ–OPPT–2012–0727. 

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– 

2012–0727. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

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

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 


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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: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

in this proposed rule. The following list 

of North American Classification 

System (NAICS) codes is not intended 

to be exhaustive, but rather provides a 

guide to help readers determine whether 

this document applies to them. 

Potentially affected entities may 

include: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

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 

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 four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

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 require 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 SNUN 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. 


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• 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 37 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 37 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 TSCA non-section 

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

SNURs without TSCA section 5(e) 

consent orders). 

• 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 14 PMN 

substances whose reported chemical 

names include the term ‘‘carbon 

nanotube’’ or ‘‘carbon nanofibers.’’ 

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), multiwalled 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 TSCA 

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– 

2012–0727. 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 

proposed rule, may be claimed as CBI. 

This proposed rule includes 17 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 

orders require protective measures to 

limit exposures or otherwise mitigate 

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

PMN substances are proposed pursuant 

to § 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The section 

5(e) SNURs designate as a ‘‘significant 

new use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 

Where EPA 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 currently 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 normally 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 20 PMN substances that are 

not subject to consent orders 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 

triggered the determinations set forth 

under TSCA section 5(e). However, EPA 

does believe that certain changes from 

the use scenario described in the PMN 

could result in increased exposures, 

thereby constituting a ‘‘significant new 

use.’’ These so-called ‘‘non-section 5(e) 

SNURs’’ are promulgated pursuant to 

§ 721.170. EPA has determined that 

every activity designated as a 

‘‘significant new use’’ in all non-section 

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. 


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PMN Number P–00–835 

Chemical name: Substituted 

picolinate (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate in the manufacture of 

agricultural chemicals. Based on 

ecological structure activity relationship 

(EcoSAR) analysis of test data on 

analogous esters, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 90 parts per 

billion (ppb) of the PMN substance in 

surface waters. As described in the 

PMN, releases to surface water are not 

expected. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

90 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (Office of Chemical 

Safety and Pollution Prevention 

(OCSPP) Test Guideline 850.4500) 

would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10637. 

PMN Number P–02–167 

Chemical name: Lithium metal 

phosphate (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an electrode 

material. Based on EcoSAR analysis of 

test data on analogous inorganic 

phosphates, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases to water 

are not expected to exceed 1 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance 

presents an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10638. 

PMN Number P–02–668 

Chemical name: Siloxanes and 

Silicones, di-Me, polymers with Ph 

silsesquioxanes, hydrolyzed, reaction 

products with 2-[[3-(trimethoxysilyl)

propoxy]methyl]oxirane. 

CAS number: 478823–10–8. 

Basis for action: The PMN substance 

will be used as a binder for silicone 

coatings. Based on structure activity 

relationship (SAR) analysis of test data 

on analogous epoxides and 

alkoxysilanes, EPA identified concerns 

for mutagenicity, oncogenicity, 

reproductive toxicity, developmental 

toxicity, lung toxicity, and sensitization 

from dermal and inhalation exposures 

to the PMN substance. For the use 

described in the PMN, significant 

occupational dermal and inhalation 

exposures are not expected due to the 

use of impervious gloves and a National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirator with 

an assigned protection factor (APF) of at 

least 10, and consumer exposures are 

not expected as the substance is not 

used in consumer products. Therefore, 

EPA has not determined that 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that use of the substance 

without impervious gloves where there 

is a potential for dermal exposure; any 

use of the substance without a NIOSHcertified respirator with an APF of at 

least 10; or any use of the substance in 

consumer products may result in 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

(b)(1)(i)(C) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465), with attention to 

the pathology of the reproductive 

organs, and a carcinogenicity test 

(OPPTS Test Guideline 870.4200) would 

help to characterize the human health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10639. 

PMN Number P–03–135 

Chemical name: 1,2- 

Cyclohexanedicarboxylic acid, 1-(2- 

ethylhexyl) 2-(2-methylpropyl) ester. 

CAS number: 252958–29–5. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a compressor 

lubricant. Based on EcoSAR analysis of 

test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. As described in the PMN, the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. There are two 

other chemical substances identified in 

the PMN that are already on the TSCA 

Inventory. The SNUR does not apply to 

those chemical substances. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help to characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10640. 

PMN Number P–03–255 

Chemical name: Phenol and 

vinyltoluene based hydrocarbon resin 

(generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a diluent for 

coatings. Based on EcoSAR analysis of 

test data on analogous neutral organics, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, releases to water are not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 


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Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help to characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10641. 

PMN Numbers P–03–762 and P–03–763 

Chemical name: Modified 

polyisocyanates (generic). 

CAS number: Claimed as confidential. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as hardeners. Based on SAR analysis 

of test data on analogous isocyanates, 

EPA has identified concerns for 

sensitization and irritation from dermal 

and inhalation exposure to the PMN 

substances. For the use described in the 

PMN, significant occupational 

inhalation and dermal exposures are not 

expected due to no domestic 

manufacture, use of impervious gloves, 

and no use of the substances involving 

an application method that generates a 

vapor, mist, or aerosol. Further, 

consumer exposures are not expected as 

the substance is not used in consumer 

products. Therefore, EPA has not 

determined that the proposed 

processing or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any domestic 

manufacture of the substances; any use 

of the substances without impervious 

gloves where there is a potential for 

dermal exposures; any use of the 

substance in consumer products; or any 

use of the substances involving an 

application method that generates a 

vapor, mist, or aerosol may result in 

serious health effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10642. 

PMN Number P–04–640 

Chemical name: Diisocyanate 

terminated polycarbodiimide (generic). 

CAS number: Claimed as confidential. 

Effective date of TSCA section 5(e) 

consent order: February 1, 2006. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a crosslinking agent for 

solvent-based inks; a monomer for 

polymerization; and a water scavenger 

for producing anhydrous polymers. The 

PMN did not identify consumer uses for 

the PMN substance. Based on SAR 

analysis of test data on structurally 

similar diisocyanates, EPA identified 

concerns for dermal sensitization, 

respiratory sensitization, and 

pulmonary toxicity from exposure to the 

PMN substance by the inhalation and 

dermal routes. The order was issued 

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

5(e)(1)(A)(ii)(I) of TSCA based on a 

finding that this substance may present 

an unreasonable risk of injury to human 

health. To protect against these risks, 

the order requires: 

1. Use of personal protective 

equipment including impervious gloves 

(when there is potential dermal 

exposure) and either a NIOSH-certified 

respirator with an APF of at least 2,000, 

or compliance with a NCEL of 0.05 mg/ 

m3 as an 8-hour time-weighted average 

(when there is potential inhalation 

exposure). 

2. Establishment and use of a hazard 

communication program. The SNUR 

would designate as a ‘‘significant new 

use’’ the absence of these protective 

measures and consumer use of the PMN 

substance. 

Recommended testing: EPA has 

determined that data from worker 

exposure to the PMN substance (such as 

inhalation monitoring data generated 

according to the NCELs section of the 

consent order) or a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. The order does not require 

submission of the testing at any 

specified time or production volume. 

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 721.10643. 

PMN Number P–07–553 

Chemical name: Reaction product of 

aluminum hydroxide and modified 

alkoxysilane (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the substance will be used as a flame 

retardant. Based on SAR analysis of test 

data on analogous respirable, poorly 

soluble particulates, EPA identified 

concerns for lung toxicity from 

inhalation exposures to the PMN 

substance. At an annual production 

volume of 100,000 kilograms (kgs), 

significant occupational inhalation 

exposures are not expected due to the 

use of a NIOSH-certified respirator with 

an APF of at least 10. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified respirator with an APF 

of at least 10, where there is a potential 

for inhalation exposure; or any increase 

of the annual 100,000 kg production 

volume may result in increased 

exposure to the PMN substance, which 

may cause serious human 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) with a 60-day 

holding period would help characterize 

the health effects of the PMN substance. 

CFR citation: 40 CFR 721.10644. 

PMN Number P–08–392 

Chemical name: Multi-walled carbon 

nanotube (generic) (P–08–392). 

CAS number: Claimed as confidential. 

Effective date of TSCA section 5(e) 

consent order: November 14, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an antistatic, reinforcement 

additive. Based on test data on the PMN 

substance, and SAR analysis of test data 

on structurally similar respirable, poorly 

soluble particulates, EPA identified 

concerns for pulmonary toxicity, 

fibrosis, carcinogenicity, mutagenicity, 

and immunotoxicity. The order was 

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

5(e)(1)(A)(ii)(I) of TSCA, based on a 

finding that the PMN substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the order: 

1. Requires use of personal protective 

equipment including impervious gloves 

and protective clothing (when there is a 

potential dermal exposure) and a 

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

N100 filters with an APF of at least 50 

(when there is potential inhalation 

exposure). 

2. Prohibits manufacture of the PMN 

substance in the United States. 

3. Restricts processing and use of the 

PMN substance to those uses specified 

in the consent order. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 


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Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465 or Organisation for 

Economic Co-operation and 

Development (OECD) Test Guideline 

413) in rats with a post exposure 

observation period of up to 3 months, 

including bronchoalveolar lavage fluid 

(BALF) analysis and certain material 

characterization data, would help 

characterize possible effects of the 

substance. In the consent order, the 

PMN submitter has agreed to perform 

these tests within 18 months of 

commencing non-exempt commercial 

manufacture. 

CFR citation: 40 CFR 721.10645. 

PMN Number P–09–257 

Chemical name: Multi-walled carbon 

nanotube (generic) (P–09–257). 

CAS number: Claimed as confidential. 

Effective date of TSCA section 5(e) 

consent order: August 11, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) uses of the substance 

will be as an electric conductive filler to 

replace conventional material such as 

carbon black or carbon fiber in matrixes 

such as polymer resin for conductive 

applications, and an additive for 

elastomers, polymers, and resins to 

enhance mechanical properties. Based 

on SAR analysis of test data on 

analogous respirable, poorly soluble 

particulates and other CNTs, EPA 

identified concerns for pulmonary 

toxicity, fibrosis, carcinogenicity, 

mutagenicity, and immunotoxicity. 

Further, available data suggests that 

pulmonary deposition of some 

nanoparticles, including CNTs, may 

induce cardiovascular toxicity if 

inhaled. Although there are no 

environmental toxicity studies on CNTs 

available, EPA expects that some 

fraction of the CNTs, if released into the 

environment, will eventually be 

suspended in water. There have been 

sublethal effects observed for single 

walled CNTs in rainbow trout at levels 

as low as 100 ppb. The order was issued 

under section 5(e)(1)(A)(i) and 

(e)(1)(A)(ii)(I) of TSCA based on a 

finding that this substance may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the order: 

1. Requires use of personal protective 

equipment including impervious gloves 

and protective clothing (when there is a 

potential dermal exposure) and a 

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

N100 filters with an APF of at least 50 

(when there is potential inhalation 

exposure). 

2. Prohibits manufacture of the PMN 

substance in the United States. 

3. Restricts processing and use of the 

PMN substance to those uses specified 

in the consent order. 

4. Prohibits release to water during 

processing and use. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

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) in rats with a post 

exposure observation period of up to 3 

months (including BALF analysis, a 

determination of cardiovascular toxicity 

(clinically-based blood/plasma protein 

analyses), and histopathology of the 

heart) and development of data on 

certain physical/chemical properties 

would help characterize possible effects 

of the substance. In the consent order, 

the PMN submitter has agreed not to 

exceed a specified production volume/ 

time limit (whichever comes first) 

without performing the 90-day test on 

the PMN substance. In addition, in the 

consent order, the PMN submitter 

agreed to provide the physical/chemical 

properties data within a specified time 

limit. 

CFR citation: 40 CFR 721.10646. 

PMN Numbers P–10–115, P–10–116, P– 

10–117, P–10–118, P–10–119, P–10–120, 

P–10–121, P–10–122, P–10–123, P–10– 

124, P–10–125, and P–10–126 

Chemical name: Multi-walled carbon 

nanofibers (generic). 

CAS number: Claimed as confidential. 

Effective date of TSCA section 5(e) 

consent order: May 9, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the uses of 

the substances will be as electrical and 

thermal conductivity additives, 

mechanical reinforcement additives, 

energy storage additives, and chemical 

intermediates. Based on SAR analysis of 

test data on analogous respirable, poorly 

soluble particulates and other CNTs, 

EPA identified concerns for pulmonary 

toxicity, fibrosis, carcinogenicity, 

mutagenicity, and immunotoxicity. 

Further, available data suggests that 

pulmonary deposition of some 

nanoparticles, including CNTs may 

induce cardiovascular toxicity if 

inhaled. Although there are no 

environmental toxicity studies on CNTs 

available, EPA expects that some 

fraction of the CNTs, if released into the 

environment, will eventually be 

suspended in water. There have been 

sub-lethal effects observed for single 

walled CNTs in rainbow trout at levels 

as low as 100 ppb. The order was issued 

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

5(e)(1)(A)(ii)(I) of TSCA based on a 

finding that these substances may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against this risk, the order: 

1. Requires use of personal protective 

equipment including impervious gloves 

and protective clothing (when there is a 

potential dermal exposure) and a 

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

N100 filters with an APF of at least 50 

(when there is potential inhalation 

exposure). 

2. Restricts use of the PMN substances 

to use only as electrical and thermal 

conductivity additives, mechanical 

reinforcement additives, energy storage 

additives, and chemical intermediates 

as specified in the consent order. 

3. Restricts processing and use of the 

PMN substances to industrial settings. 

4. Prohibits release of the PMN 

substances into the waters of the United 

States during processing and use 

activities. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the results of certain 

physical/chemical properties data, 

workplace exposure monitoring and 

characterization testing, and a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465 or OECD Test 

Guideline 413) in rats would help 

characterize the human health effects of 

the PMN substances. The PMN 

submitter agreed to provide the 

physical/chemical properties data for 

the PMN substances within one year 

after submitting the notice of 

commencement. The consent order 

contains two additional production 

volume limits. The PMN submitter 

agreed not to exceed the first production 

volume limit without submitting 

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, such as 

handling, tearing and cutting the PMN 

substances. The PMN submitter has also 

agreed not to exceed the second 

production volume limit without 

performing two 90-day inhalation 

toxicity tests, with a post-exposure 

observation period of up to 3 months, 

BALF analysis, aggregation/ 

agglomeration state, shape, size/size 

particle distribution and surface 

properties of materials as administered, 

aggregation/agglomeration state, shape, 

size/size particle distribution and 

surface properties of materials of the 


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delivered materials after administration, 

determination of cardiovascular 

toxicity, heart histopathology, and data 

on pulmonary deposition. One 90-day 

inhalation toxicity test will be 

conducted from a representative PMN 

substance in the group P–10–115, P–10– 

116, P–10–117, P–10–118, P–10–119, 

and the other 90-day inhalation toxicity 

test will be conducted from a 

representative PMN substance in the 

group P–10–120, P–10–121, P–10–122, 

P–10–123, P–10–124, P–10–125, and P– 

10–126. 

CFR citation: 40 CFR 721.10647. 

PMN Numbers P–10–545 and P–10–546 

Chemical name: Modified lithium 

iron phosphates (generic). 

CAS number: Claimed as confidential. 

Effective date of TSCA section 5(e) 

consent order: December 10, 2010. 

Basis for TSCA section 5(e) consent 

order: The consolidated PMN states that 

the generic (non-confidential) use of the 

substances will be as battery electrode 

components, contained use. Based on 

test data on analogous respirable, poorly 

soluble particulates, there is potential 

risk for adverse lung effects including 

cancer, lung fibrosis, lung inflammation 

and systemic effects, including 

immunotoxicity. EPA has identified 

concerns for these health effects from 

exposures to the PMN substances. Based 

on EcoSAR analysis of test data on 

analogous phosphates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. 

The order was issued under sections 

5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA 

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. Restricts manufacturing, 

processing, and use of the substances to 

a fully-enclosed and automated process, 

including all loading and unloading 

activities. 

2. Restricts use of the PMN substances 

to use only as specified in the consent 

order. 

3. Prohibits release of the PMN 

substances into the waters of the United 

States during processing and use 

activities. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) in rats with a postexposure observation period of up to 3 

months, including BALF analysis; an 

algal toxicity test (OCSPP Test 

Guideline 850.5400); and physical/ 

chemical properties testing for: Water 

solubility (OECD Test Guideline 105); 

surface chemistry, particle size 

distribution of the PMN substances, 

dustiness test (European Standard 

15051); and particle size distribution, 

aggregation state, and porosity would 

help characterize the human health and 

environmental effects of the PMN 

substances. The PMN submitter has 

agreed not to exceed the confidential 

production volume in the consent order 

without performing the 90-day 

inhalation toxicity test and the physical/ 

chemical properties tests. 

CFR citation: 40 CFR 721.10648. 

PMN Number P–11–115 

Chemical name: MDI modified 

polyalkylene glycol adipate polyester 

(generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive. Based 

on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for respiratory and dermal 

sensitization. For the use described in 

the PMN, significant occupational 

dermal and inhalation exposures are not 

expected due to the use of a NIOSHcertified respirator with an APF of at 

least 10, and consumer exposures are 

not expected as the substance is not 

used in consumer products. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

without a NIOSH-certified respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures, 

or any use of the substance in consumer 

products 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10649. 

PMN Number P–11–155 

Chemical name: Polyether substituted 

anthraquinone derivative (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be used as a colorant for 

cleaners and detergents. Based on 

EcoSAR analysis of test data on 

analogous aromatic amines and 

nonionic dyes, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, environmental releases did not 

exceed 1 ppb for more than 20 days per 

year. 

Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as a colorant 

for cleaners and detergents may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) and an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10650. 

PMN Number P–11–290 

Chemical name: Carbide derived 

nanocarbon (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a sensor element in 

an electrochemical sensor. Based on 

SAR analysis of test data on respirable, 

poorly soluble particulates, EPA 

identified concerns for pulmonary 

toxicity, fibrosis, carcinogenicity, 

mutagenicity, and immunotoxicity if the 

substances were manufactured by a 

method other than described in the 

PMN. Further, available data suggests 

that pulmonary deposition of some 

carbon-based nanoparticles, may induce 

cardiovascular toxicity if inhaled. EPA 

identified concerns for lung toxicity to 

workers from inhalation exposures to 

the PMN substance. For the 

manufacture method described in the 

PMN, significant dermal and inhalation 

exposures are not expected. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 


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unreasonable risk. EPA has determined, 

however, that manufacture of the 

substance by a method other than as 

described in the PMN 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 inhalation monitoring 

data collected during the manufacturing 

process according to the EPA draft 

Inhalation Monitoring Data Collection 

Guidelines (located in the docket under 

docket ID number EPA–HQ–OPPT– 

2012–0727) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10651. 

PMN Numbers P–11–309, P–11–311, P– 

11–312, P–11–313, and P–11–314 

Chemical names: (P–11–309) 

Hexanedioic acid, polymer with 

polyether polyol, 1,1′-methylenebis[4- 

isocyanatobenzene] and 

dihydroxydialkyl ether (generic); (P–11– 

311) Hexanedioic acid, polymer with 

.alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether and dialkanol ether (generic); (P– 

11–312) Hexanedioic acid, polymer 

with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′- 

methylenebis[isocyanatobenzene], 

dihydroxydialkyl ether and dialkanol 

ether (generic); (P–11–313) Hexanedioic 

acid, polymer with .alpha.-hydro- 

.omega.-hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether, reaction products with 

dialkylcarbinol (generic); and (P–11– 

314) Hexanedioic acid, polymer with 

.alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether reaction products with 

dialkylcarbinol (generic). 

CAS numbers: Claimed as 

confidential. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as industrial 

adhesives. Based on SAR analysis of test 

data on analogous isocyanates, EPA 

identified concerns for sensitization 

from dermal and inhalation exposure to 

the PMN substances. For the use 

described in the PMNs, significant 

occupational dermal and inhalation 

exposures are not expected due to the 

use of a NIOSH-certified respirator with 

an APF of at least 10, and consumer 

exposures are not expected. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substances 

without a NIOSH-certified respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures, 

or any use of the substances in 

consumer products may cause serious 

health effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10652 (P– 

11–309); 40 CFR 721.10653 (P–11–311); 

40 CFR 721.10654 (P–11–312); 40 CFR 

721.10655 (P–11–313); and 40 CFR 

721.10656 (P–11–314). 

PMN Number P–12–73 

Chemical name: Castor oil, polymer 

with hydrogenated vegetable oil, 1,1′- 

methylenebis[isocyanatobenzene] and 

isocyanate (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an industrial adhesive. 

Based on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for sensitization. For the use 

described in the PMN, significant 

occupational dermal and inhalation 

exposures are not expected due to the 

use of a NIOSH-certified respirator with 

an APF of at least 10, and consumer 

exposures are not expected as the 

substance is not used in consumer 

products. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified respirator with an APF 

of at least 10, where there is a potential 

for inhalation exposures, or any use of 

the substances in consumer products 

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 skin 

sensitization (OPPTS Test Guideline 

870.2600) and a 90-day subchronic 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) in rodents would 

help characterize the human health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10657. 

PMN Number P–12–133 

Chemical name: 2-Oxepanone, 

polymer with 1,6-diisocyanatohexane, 

2,2′′dimethyl-1;3-propanediol and 2,2′- 

oxybis[ethanol]. 

CAS number: 1313708–90–5. 

Basis for action: The PMN states that 

the substance will be used as a coating 

for wind craft wings. Based on SAR 

analysis of test data on structurally 

similar chemicals submitted under 

TSCA section 8(e), EPA identified 

concerns for oncogenicity and 

mutagenicity. Additionally, based on 

the isocyanate moiety, the Agency 

identified concerns for sensitization. For 

the use described in the PMN, 

significant occupational inhalation 

exposures are not expected due to the 

use of a NIOSH-certified respirator with 

an APF of at least 10, and consumer 

exposures are not expected as the 

substance is not used in consumer 

products. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified respirator with an APF 

of at least 10, where there is a potential 

for inhalation exposures, or any use of 

the substance in consumer products 

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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity study (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10658. 

PMN Number P–12–143 

Chemical name: Poly(oxy-1,4- 

butanediyl), -hydro—hydroxy-, polymer 

with alkyldiisocyanates (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a crosslinking resin. 

Based on SAR analysis of test data on 

analogous isocyanates, EPA identified 

concerns for sensitization from dermal 

and respiratory exposures to the PMN 

substance. For the use described in the 

PMN, significant occupational dermal 

and inhalation exposures are not 

expected due to the use of a NIOSHcertified respirator with an APF of at 

least 10, and consumer exposures are 

not expected as the substance is not 

used in consumer products. Therefore, 


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EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

without a NIOSH-certified respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures, 

or any use of the substance in consumer 

products 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10659. 

PMN Number P–12–274 

Chemical name: Aliphatic 

diisocyanate adduct with substituted 

amino alkyl silane (generic). 

CAS number: Claimed as confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive. Based 

on SAR analysis of test data on 

analogous isocyanates, EPA identified 

concern for sensitization from dermal 

and inhalation exposure to the PMN 

substance. Additionally, liquid and 

vapor contact with the eye can cause 

moderate to severe irritation. For the use 

described in the PMN, significant 

occupational dermal and inhalation 

exposures are not expected due to the 

use of a NIOSH-certified respirator with 

an APF of at least 10, and consumer 

exposures are not expected as the 

substance is not used in consumer 

products. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified respirator with an APF 

of at least 10, where there is a potential 

for inhalation exposures; or any use of 

the substance in consumer products 

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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10660. 

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 17 of the 37 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 20 cases, where the uses 

are 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 

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 Chemical Substance Inventory 

(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 April 26, 2013 

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 17 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 SNUR, 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 any extensions, expires. 

EPA has promulgated provisions to 

allow persons to comply with these 

proposed SNURs before the effective 

date. If a person meets the conditions of 

advance compliance under § 721.45(h), 

the person would be considered exempt 

from the requirements of the SNUR. 


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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. The two exceptions are: 

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 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 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(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 OCSPP 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 Source OECD 

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

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this 

proposed rule, EPA has established 

production volume limits 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 limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Listings of the tests 

specified in the TSCA section 5(e) 

consent orders are included in Unit IV. 

The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture, import, or 

processing. 

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 tests specified in 

Unit IV. 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 notification requirements and 

EPA regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E–PMN software is 

available electronically 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–2012–0727. 

XI. 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 (PRA) 

According to 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 

this proposed rule, if the SNUR is 

subsequently issued as a final rule. 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 


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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 (RFA) 

On February 18, 2012, EPA certified 

pursuant to RFA section 605(b) (5 U.S.C. 

601 et seq.), that promulgation of these 

SNURS would not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this proposed 

rule. 

This proposed rule is within the 

scope of the February 18, 2012 

certification. Based on the Economic 

Analysis discussed in Unit X. and EPA’s 

experience promulgating SNURs 

(discussed in the certification), EPA 

believes that the following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

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 UMRA sections 202, 203, 204, or 205 

(2 U.S.C. 1501 et seq.). 

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). 

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 action 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 (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

NTTAA 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: February 15, 2013. 

Maria J. Doa, 

Director, Chemical Control Division, 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 § 721.10637 to subpart E to 

read as follows: 

§ 721.10637 Substituted picolinate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted picolinate 

(PMN P–00–835) 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) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=90). 

(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 (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 

section. 

■ 3. Add § 721.10638 to subpart E to 

read as follows: 

§ 721.10638 Lithium metal phosphate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as lithium metal phosphate 

(PMN P–02–167) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 


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(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=1). 

(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 (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 

section. 

■ 4. Add § 721.10639 to subpart E to 

read as follows: 

§ 721.10639 Siloxanes and Silicones, diMe, polymers with Ph silsesquioxanes, 

hydrolyzed, reaction products with 2-[[3-(

trimethoxysilyl)propoxy]methyl]oxirane. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

siloxanes and silicones, di-Me, 

polymers with Ph silsesquioxanes, 

hydrolyzed, reaction products with 2- 

[[3-(trimethoxysilyl)propoxy]methyl

]oxirane (PMN P–02–668; CAS No. 

478823–10–8) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63 (a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 10 meet the requirements of 

§ 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; and 

(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(o). 

(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. 

■ 5. Add § 721.10640 to subpart E to 

read as follows: 

§ 721.10640 11,2-Cyclohexanedicarboxylic 

acid, 1-(2-ethylhexyl) 2-(2-methylpropyl) 

ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-cyclohexanedicarboxylic acid, 1-(2- 

ethylhexyl) 2-(2-methylpropyl) ester 

(PMN P–03–135; CAS Nos. 252958–29– 

5) 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) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=1). 

(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 (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 

section. 

■ 6. Add § 721.10641 to subpart E to 

read as follows: 

§ 721.10641 Phenol and vinyltoluene 

based hydrocarbon resin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phenol and vinyltoluene 

based hydrocarbon resin (PMN P–03– 

255) 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) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=1). 

(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 (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 

section. 

■ 7. Add § 721.10642 to subpart E to 

read as follows: 

§ 721.10642 Modified polyisocyanates 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as modified polyisocyanates 

(PMNs P–03–762 and P–03–763) are 

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), (b) (concentration 

set at 0.1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (o), and (y)(l). 

(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 these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.10643 to subpart E to 

read as follows: 

§ 721.10643 Diisocyanate terminated 

polycarbodiimide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diisocyanate terminated 

polycarbodiimide (PMN P–04–640) is 

subject to reporting under this section 

for the significant new uses described in 

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


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requirements of this rule do not apply 

to quantities of the PMN substance that 

have been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(3), (a)(4), and (a)(6)(ii). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63 (a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 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 2,000 meets the minimum 

requirements § 721.63(a)(4). As an 

alternative to the respiratory 

requirements listed here, 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 0.05 mg/ 

m3. 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. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), 

(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) 

(use respiratory protection or maintain 

airborne concentrations at or below an 

8-hour time-weighted average of 0.05 

mg/m3), (g)(2)(v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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) through (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. 

■ 9. Add § 721.10644 to subpart E to 

read as follows: 

§ 721.10644 Reaction product of aluminum 

hydroxide and modified alkoxysilane 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as reaction product of 

aluminum hydroxide and modified 

alkoxysilane (PMN P–07–553) 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)(4), (a)(6)(i), (b) (concentrations set at 

0.1 percent), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(s) (100,000 

kilograms). 

(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), 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. 

■ 10. Add § 721.10645 to subpart E to 

read as follows: 

§ 721.10645 Multi-walled carbon nanotube 

(generic) (P–08–392). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotube (PMN P–08–392) 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 completely reacted (cured); 

incorporated or embedded into a 

polymer matrix that itself has been 

completely 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), 

and (a)(6) (particulate, including solids 

or liquid droplets). When determining 

which persons are reasonably likely to 

be exposed as required for § 721.63 

(a)(1) and (a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. A National 

Institute for Occupational Safety and 

Health (NIOSH)-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 filters with an assigned 

protection factor (APF) of at least 50 

meet the minimum requirements of 

§ 721.63(a)(4). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

(within 18 months of commencing nonexempt commercial manufacture). 

(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 


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of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 11. Add § 721.10646 to subpart E to 

read as follows: 

§ 721.10646 Multi-walled carbon nanotube 

(generic) (P–09–257). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotube (PMN P–09–257) 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 completely reacted (cured); 

incorporated or embedded into a 

polymer matrix that itself has been 

completely reacted (cured); embedded 

in a permanent solid polymer form that 

is not intended to undergo further 

processing except for mechanical 

processing; or incorporated into an 

article as defined at 40 CFR 720.3(c). 

(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 (a)(6) (particulate, including solids 

or liquid droplets). When determining 

which persons are reasonably likely to 

be exposed as required for § 721.63 

(a)(1) and (a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. A National 

Institute for Occupational Safety and 

Health (NIOSH)-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 filters with an assigned 

protection factor (APF) of at least 50 

meets the minimum requirements of 

§ 721.63(a)(4). 

(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 (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 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 12. Add § 721.10647 to subpart E to 

read as follows: 

§ 721.10647 Multi-walled carbon 

nanofibers (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanofibers (PMNs P–10–115, P–10–116, 

P–10–117, P–10–118, P–10–119, P–10– 

120, P–10–121, P–10–122, P–10–123, P– 

10–124, P–10–125, and P–10–126) 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); incorporated or embedded into 

a polymer matrix that itself has been 

reacted (cured); embedded into a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing; or incorporated into an 

article as defined at 40 CFR 720.3(c). 

(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 (a)(6)(i). When determining which 

persons are reasonably likely to be 

exposed as required for § 721.63 (a)(1) 

and (a)(4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. A 

National Institute for Occupational 

Safety and Health (NIOSH)-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 filters 

with an assigned protection factor (APF) 

of at least 50 meets the minimum 

requirements of § 721.63(a)(4). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (electrical and 

thermal conductivity additive in 

encapsulated thermoplastics, 

thermosets, elastomers, glass, metals, 

and ceramics; mechanical reinforcement 

additive in encapsulated thermoplastics, 

thermosets, elastomers, glass, metals, 

and ceramics; energy storage additive; 

or chemical intermediate), (l) 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 these substances. 

(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 paragraph 

(a)(2)(ii) of this section. 

■ 13. Add § 721.10648 to subpart E to 

read as follows: 

§ 721.10648 Modified lithium iron 

phosphates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as modified lithium iron 

phosphates (PMNs P–10–545 and P–10– 

546) 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 in a permanent solid polymer 

form that is not intended to undergo 

further processing, except mechanical. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (a), (b), (c), (k), and 

(q). 

(ii) 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), (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 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

■ 14. Add § 721.10649 to subpart E to 

read as follows: 

§ 721.10649 MDI modified polyalkylene 

glycol adipate polyester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as MDI modified 

polyalkylene glycol adipate polyester 

(PMN P–11–115) is subject to reporting 

under this section for the significant 


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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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63 (a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 15. Add § 721.10650 to subpart E to 

read as follows: 

§ 721.10650 Polyether substituted 

anthraquinone derivative (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyether substituted 

anthraquinone derivative (PMN P–11– 

155) 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) (colorant for 

cleaners and detergents). 

(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. 

■ 16. Add § 721.10651 to subpart E to 

read as follows: 

§ 721.10651 Carbide derived nanocarbon 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbide derived 

nanocarbon (PMN P–11–290) 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 of 

the substance by the method described 

in the premanufacture notice). 

(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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

■ 17. Add § 721.10652 to subpart E to 

read as follows: 

§ 721.10652 Hexanedioic acid, polymer 

with polyether polyol, 1,1′-methylenebis[4- 

isocyanatobenzene] and dihydroxydialkyl 

ether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hexanedioic acid, 

polymer with polyether polyol, 1,1′- 

methylenebis[4-isocyanatobenzene] and 

dihydroxydialkyl ether (PMN P–11–309) 

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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 18. Add § 721.10653 to subpart E to 

read as follows: 


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§ 721.10653 Hexanedioic acid, polymer 

with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl ether 

and dialkanol ether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hexanedioic acid, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1′-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether and dialkanol ether (PMN P–11– 

311) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 19. Add § 721.10654 to subpart E to 

read as follows: 

§ 721.10654 Hexanedioic acid, polymer 

with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1’- 

methylenebis[isocyanatobenzene], 

dihydroxydialkyl ether and dialkanol ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hexanedioic acid, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1’- 

methylenebis[isocyanatobenzene], 

dihydroxydialkyl ether and dialkanol 

ether (PMN P–11–312) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63 (a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 20. Add § 721.10655 to subpart E to 

read as follows: 

§ 721.10655 Hexanedioic acid, polymer 

with .alpha.-hydro-.omega.-hydroxypoly

[oxy(methyl-1,2-ethanediyl)],1,1’- 

methylenebis[4-isocyanatobenzene], 

dihydroxydialkyl ether, reaction products 

with dialkylcarbinol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hexanedioic acid, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1’-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether, reaction products with 

dialkylcarbinol (PMN P–11–313) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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 


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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; and 

(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(o). 

(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), 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. 

■ 21. Add § 721.10656 to subpart E to 

read as follows: 

§ 721.10656 Hexanedioic acid, polymer 

with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1’-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl ether 

reaction products with dialkylcarbinol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hexanedioic acid, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(methyl-1,2- 

ethanediyl)],1,1’-methylenebis[4- 

isocyanatobenzene], dihydroxydialkyl 

ether reaction products with 

dialkylcarbinol (PMN P–11–314) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 22. Add § 721.10657 to subpart E to 

read as follows: 

§ 721.10657 Castor oil, polymer with 

hydrogenated vegetable oil, 1,1’- 

methylenebis[isocyanatobenzene] and 

isocyanate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as castor oil, polymer with 

hydrogenated vegetable oil, 1,1’- 

methylenebis[isocyanatobenzene] and 

isocyanate (PMN P–12–73) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 23. Add § 721.10658 to subpart E to 

read as follows: 

§ 721.10658 2-Oxepanone, polymer with 

1,6-diisocyanatohexane, 2,2-dimethyl-1,3- 

propanediol and 2,2’-oxybis[ethanol]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-oxepanone, polymer with 1,6- 

diisocyimatohexane, 2,2-dimethyl-1,3- 

propanediol and 2,2’-oxybis[ethanol] 

(PMN P–12–133; CAS No. 1313708–90– 

5) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 


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and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 24. Add § 721.10659 to subpart E to 

read as follows: 

§ 721.10659 Poly(oxy-1,4-butanediyl), 

-hydro—hydroxy-, polymer with 

alkyldiisocyanates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as poly(oxy-1,4-butanediyl), 

-hydro—hydroxy-, polymer with 

alkyldiisocyanates (PMN P–12–143) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 

■ 25. Add § 721.10660 to subpart E to 

read as follows: 

§ 721.10660 Aliphatic diisocyanate adduct 

with substituted amino alkyl silane 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic diisocyanate 

adduct with substituted amino alkyl 

silane (PMN P–12–274) 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)(4), (a)(6)(i), (a)(6)(ii), 

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

percent), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 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; and 

(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(o). 

(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), 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. 2013–04298 Filed 2–22–13; 8:45 am] 

BILLING CODE 6560–50–P 


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