Vol. 77 Friday, 

No. 194 October 5, 2012 

Part IV 

Environmental Protection Agency 

40 CFR Part 9 and 721 

Significant New Use Rules on Certain Chemical Substances; Final Rule 


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61118 Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2012–0277; FRL–9364–5] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

the Toxic Substances Control Act 

(TSCA) for 78 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Seven 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action requires 

persons who intend to manufacture, 

import, or process any of these 78 

chemical substances for an activity that 

is designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: This rule is effective on 

December 4, 2012. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (e.s.t.) on October 

19, 2012. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before November 5, 2012 (see Unit VI. 

of the SUPPLEMENTARY INFORMATION). 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0277, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave. NW., 

Washington, DC. ATTN: Docket ID 

Number EPA–HQ–OPPT–2012–0277. 

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– 

2012–0277. 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 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 

contained in this rule. The following list 

of North American Industrial 

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 and 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 these SNURs 

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 this rule 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 


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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? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance 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 

issue of April 24, 1990 (55 FR 17376) 

(April 24, 1990 SNUR). 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) requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture, import, or 

process the chemical substance for that 

use. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

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 sections 5(b) and 5(d)(1), the 

exemptions authorized by TSCA 

sections 5(h)(1), 5(h)(2), 5(h)(3), and 

5(h)(5), and the regulations at 40 CFR 

part 720. Once EPA receives a SNUN, 

EPA may take regulatory action under 

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

the activities for which it has received 

the SNUN. If EPA does not take action, 

EPA is required under TSCA section 

5(g) to explain in the Federal Register 

its reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 78 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

84 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) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

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

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

SNURs without TSCA section 5(e) 

consent orders). 

• 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 rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes 7 PMN substances 

(P–04–80, P–06–149, P–06–153, P–07– 


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327, P–09–48, P–09–636, and P–10–367) 

that are subject to ‘‘risk-based’’ consent 

orders under TSCA section 

5(e)(1)(A)(ii)(I) where EPA determined 

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 

Where EPA 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 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 rule also includes SNURs on 71 

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. 

PMN Number P–00–535 

Chemical name: 1-Octadecanol, 

manuf. of, distn. lights, fractionation 

heavies, distn. lights. 

CAS number: 243640–46–2. 

Basis for action: The PMN states that 

the substance will be used as a 

feedstock for esterification. Based on 

ecological structure activity relationship 

(EcoSAR) analysis of test data on 

analogous neutral organic chemicals, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 part per billion (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 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 feedstock 

for esterification 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 

early-life stage toxicity test (Office of 

Pollution Prevention and Toxics 

(OPPTS) Test Guideline 850.1400); a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300); and an algal 

toxicity test (Office for Chemical Safety 

and Pollution Prevention (OCSPP) Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10426. 

PMN Number P–01–579 

Chemical name: Acrylate ester 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a monomer. Based 

on EcoSAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 50 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 50 ppb. 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 

50 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 to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10537 

PMN Number P–02–161 

Chemical name: Phosphonium, 

tetrakis (hydroxymethyl)-, chloride 

(1:1), reaction products with 1- 

tetradecanamine and urea. 

CAS number: 359406–89–6. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a flame retardant. 

Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous cationic surfactants, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 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 


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Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 61121 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 (b)(4)(i) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 and fate 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10538. 

PMN Number P–02–653 

Chemical name: Bis[phenyl-2H-1,3- 

benzoxazine]derivative (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a resin for 

electronic laminates, adhesives, 

encapsulants, and composites. Based on 

EcoSAR analysis of test data on 

analogous neutral organic chemicals, 

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 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 

bioconcentration factor (BCF) test 

(OPPTS Test Guideline 850.1730); 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 characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10539. 

PMN Number P–02–984 

Chemical name: 1,3- 

Benzenedimethanamine, N-(2- 

phenylethyl) derivs. 

CAS number: 404362–22–7. 

Basis for action: The PMN states that 

the substance will be used as an epoxy 

curing agent. Based on EcoSAR analysis 

of test data on analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 5 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 

5 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 721.10540. 

PMN Number P–03–481 

Chemical name: 5,2,6- 

(Iminomethenimino)-1H-imidazo[4,5- 

b]pyrazine, octahydro-1,3,4,7,8,10- 

hexanitro-. 

CAS number: 135285–90–4. 

Basis for action: The PMN substance 

will be used as an explosive and 

propellant. Based on structure activity 

relationship (SAR) analysis of test data 

on analogous octahydro-1,3,5,7- 

tetranitro-1,3,5,7-tetrazocine (also called 

HMX or octogen); CAS No. 2691–41–0, 

as well as test data for hexahydro-1,3,5- 

trinitro-1,3,5-triazine (also called RDX, 

cyclonite, hexogen, or 

cyclotrimethylenetrinitramine); CAS 

No. 121–82–4, EPA identified concerns 

for neurotoxicity, including severe 

convulsions or seizures, systemic 

effects, reproductive and developmental 

effects, immunotoxicity and 

oncogenicity from exposure to the PMN 

substance. In addition, based on 

EcoSAR analysis of test data on 

analogous polynitro organic analogues, 

EPA predicts toxicity to aquatic 

organisms from the degradation product 

of the PMN substance at surface water 

concentrations that exceed 50 ppb of the 

degradation product. For the use 

described in the PMN, dermal and 

inhalation exposures are not expected, 

and releases to surface waters are not 

expected to result in surface water 

concentrations exceeding 50 ppb for the 

PMN degradation product. 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 use of the substance 

without respiratory protection, 

impervious gloves, or release to surface 

waters without chemical destruction or 

conversion may cause serious health 

effects and significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

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

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity study 

with reproductive/developmental 

toxicity screening test, including 

neurotoxicity assessment and functional 

observations (OPPTS Test Guideline 

870.3650); a combined chronic toxicity/ 

carcinogenicity test (OPPTS Test 

Guideline 870.4300); a hydroysis as a 

function of pH and temperature test 

(OPPTS Test Guideline 835.2130); and a 

ready biodegradability test (OPPTS Test 

Guideline 835.3110) would help to 

characterize the human health and 

environmental fate of the PMN 

substance. 

CFR citation: 40 CFR 721.10541. 

PMN Number P–03–624 

Chemical name: Dodecanedioic acid, 

1,12-dimethyl ester. 

CAS number: 1731–79–9. 

Basis for action: The PMN states that 

the substance will be used as a chemical 

intermediate. Based on EcoSAR analysis 

of test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

30 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 30 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, and 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 30 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 


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characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10542. 

PMN Number P–04–79 

Chemical name: Oxetane, 3-methyl-3- 

[(2,2,3,3,3-pentafluoropropoxy)methyl]-. 

CAS number: 449177–94–0. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a monomer in the 

production of reactive polymers for 

surface coatings and other polymer 

intermediates. Based on SAR analysis of 

test data on analogous oxetanes, EPA 

identified concerns for male 

reproductive toxicity, liver toxicity, and 

thyroid effects from exposure to the 

PMN substance. As described in the 

PMN, significant inhalation exposures 

are not expected and dermal exposures 

are not expected due to the use of 

protective gloves. 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 without dermal 

protection where there is a potential for 

dermal exposures 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 

combined repeated dose test with a 

reproductive/developmental toxicity 

screening (Organisation for Economic 

Co-operation and Development (OECD) 

Test Guideline 422) via gavage in rats 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10543. 

PMN Number P–04–80 

Chemical name: Oxetane, 3-methyl-3- 

[[(3,3,4,4,5,5,6,6,6- 

nonafluorohexyl)oxy]methyl]-. 

CAS number: 475678–78–5. 

Effective date of TSCA section 5(e) 

consent order: December 28, 2004. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a monomer in 

the production of reactive polymers for 

surface coating materials and other 

polymer intermediates. EPA has 

identified health and environmental 

concerns because the substance may be 

a persistent, bio-accumulative, and toxic 

(PBT) chemical, based on physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999) (FRL– 

6097–7). Also, based on SAR analysis of 

test data on analogous oxetanes, EPA 

identified concerns for male 

reproductive toxicity and systemic 

effects from exposures to the PMN 

substance. Further, based on EcoSAR 

analysis of analogous oxetanes, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

5 ppb of the PMN substance in surface 

waters. The consent order was issued 

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

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires: 

1. Use of personal protective 

equipment including dermal protection 

(where there is a potential for dermal 

exposure). 

2. Establishment and use of a hazard 

communication program. 

3. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity test 

with a reproductive/developmental 

toxicity screening test (OPPTS Test 

Guideline 870.3650 or OECD Test 

Guideline 422) in rats by gavage would 

help characterize possible human health 

effects of the PMN substance. The PMN 

submitter has agreed not to exceed the 

confidential production limit specified 

in the consent order without performing 

this test. In addition, EPA has 

determined the results of a log Kow test 

(OECD Test Guideline 117), and 

(depending upon the results of the log 

Kow test) a fish BCF test (OPPTS Test 

Guideline 850.1730); 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 

persistence, bioaccumulation, and 

environmental effects of the PMN 

substance. The consent order does not 

require submission of this additional 

recommended testing at any specified 

time or production volume. However, 

the consent 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 721.10544. 

PMN Number P–04–313 

Chemical name: Aminotriazine 

modified cresol novolec resin (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a glass epoxy 

laminate. Based on EcoSAR analysis of 

test data on analogous phenols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

10 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 10 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 10 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 BCF 

test (OPPTS Test Guideline 850.1730), 

and either an aerobic and anaerobic 

transformation in aquatic sediment 

systems test (OECD Test Guideline 308) 

or a shake flask die-away test (OPPTS 

Test Guideline 835.3170) would help to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10545. 

PMN Number P–04–340 

Chemical name: Pentenylated 

polyethylene glycol sulfate salt 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymerization 

additive. Based on EcoSAR analysis of 

test data on analogous anionic 

surfactants, 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 of the 

substance are not expected to result in 

surface water concentrations that exceed 

1 ppb. 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 


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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 to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10546. 

PMN Number P–04–587 

Chemical name: Dialkyl dimethyl 

ammonium methylcarbonate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a chemical 

intermediate. Based on EcoSAR analysis 

of test data on analogous cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 5 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 exceed 

releases from the use described in the 

PMN. For the chemical intermediate use 

described in the PMN, environmental 

releases did not exceed 5 ppb for more 

than 20 days per year. 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 other than as a 

chemical intermediate 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 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10547. 

PMN Number P–04–624 

Chemical name: Mixed alkyl 

phosphate esters alkoxylated (generic). 

CAS number: Not available. 

Basis for action: The PMN substance 

will be used as a component in a 

lubricant blend. Based on EcoSAR 

analysis of test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 40 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

40 ppb. Therefore, EPA has not 

determined that manufacturing, 

processing, and 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 40 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 to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10548. 

PMN Number P–04–635 

Chemical name: Ethane, 1,1,2,2- 

tetrafluoro-1-(2,2,2-trifluoroethoxy)-. 

CAS number: 406–78–0. 

Basis for action: The PMN states that 

the substance will be used for cleaning 

electronic components, precision 

cleaning, dewatering of electronic 

components and other parts following 

aqueous cleaning, and as a carrier/ 

lubricant coating for hard disk drives 

and other precision parts. Based on test 

data on the PMN substance, EPA 

identified concerns for neurotoxicity. 

For the industrial use described in the 

PMN, the substance is imported and no 

significant worker exposures are 

expected. Therefore, EPA has not 

determined that the proposed 

processing or use of the substance 

presents an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture, use in non-industrial 

products, or use other than as described 

in the PMN may cause serious chronic 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0277) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10549. 

PMN Number P–05–324 

Chemical name: Rare earth salt of a 

carboxylic acid (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a paint component. 

Based on SAR analysis of test data on 

analogous lanthanides, EPA identified 

concerns for developmental toxicity, 

kidney toxicity, and blood toxicity 

(specifically, anticoagulant activity). In 

addition, based on EcoSAR analysis of 

test data on analogous organic and 

inorganic salts, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 5 ppb of the 

PMN substance in surface waters. For 

the use described in the PMN, 

significant worker and general 

population exposures are not expected, 

and releases of the substance are not 

expected to result in surface water 

concentrations that exceed 5 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 other than as described in 

the PMN, or any use resulting in surface 

water concentrations exceeding 5 ppb 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

oral toxicity test (OPPTS Test Guideline 

870.1100); a bacterial reverse mutation 

test (OPPTS Test Guideline 870.5100); a 

mammalian erythrocyte micronucleus 

test (OPPTS Test Guideline 870.5395) 

via the intraperitoneal route; a repeated 

dose 28-day oral toxicity test in rodents 

(OPPTS Test Guideline 870.3050), 

including a neurotoxicity functional 

observational battery, as described in 

the neurotoxicity screening battery 

(OPPTS Test Guideline 870.6200); a 

prenatal developmental toxicity test 

(OPPTS Test Guideline 870.3700) in one 

species, via the oral route; either a 

porous pot test (OPPTS Test Guideline 

835.3220) or an aerobic sewage 

treatment simulation test (OECD Test 

Guideline 303A); 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 

human health and environmental effects 

of the PMN substance. 


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CFR citation: 40 CFR 721.10550. 

PMN Number P–05–613 

Chemical name: Bisphenol S mono 

ether (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a color developer. 

Based on SAR analysis of test data on 

analogous epoxides, EPA identified 

concerns for respiratory sensitization, 

mutagenicity, oncogenicity, 

developmental toxicity, male 

reproductive toxicity, liver toxicity, and 

kidney toxicity. In addition, based on 

test data on the PMN substance and 

EcoSAR analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface water. For 

the use described in the PMN, 

occupational exposures during 

manufacture are not expected as the 

PMN substance is imported. 

Occupational exposures during 

processing and use are not expected to 

be significant due to expected use of 

appropriate personal protective 

equipment, and the substance is not 

released to surface waters during 

processing or use. Therefore, EPA has 

not determined that the proposed 

processing or use of the substance 

presents an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture, any use of the substance 

other than as described in the PMN, or 

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)(1)(i)(C), (b)(3)(ii), (b)(4)(i), and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/development toxicity 

screening test (OPPTS Test Guideline 

870.3650); a carcinogenicity test (OPPTS 

Test Guideline 870.4200); a fish earlylife stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10551. 

PMN Number P–05–774 

Chemical name: Oxirane, 2-(1- 

chlorocyclopropyl)-2-[(2- 

chlorophenyl)methyl]-. 

CAS number: 134818–68–1. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on test data on the 

PMN substance, EPA identified 

concerns for dermal sensitization. In 

addition, based on SAR analysis of test 

data on analogous epoxides and 

chlorobenzenes, EPA identified 

concerns for carcinogenicity, 

mutagenicity, systemic toxicity, 

neurotoxicity, and reproductive toxicity 

from worker exposures. Further, based 

on test data on the PMN substance and 

EcoSAR analysis of test data on 

analogous monoepoxides, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. 

For the site-limited intermediate use 

described in the PMN, significant 

worker dermal exposure is unlikely due 

to the use of impervious personal 

protective equipment and releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

2 ppb. Therefore, EPA has not 

determined that manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance without workers wearing 

impervious gloves, where there is a 

potential for dermal exposures; use of 

the substance other than as a sitelimited chemical intermediate, or any 

use of the substance resulting in surface 

water concentrations exceeding 2 ppb 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), 

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

Recommended testing: EPA has 

determined that the results of a porous 

pot test (OPPTS Test Guideline 

835.3220); a mammalian erythrocyte 

micronucleus test (OPPTS Test 

Guideline 870.5395) by the 

intraperitoneal route; a combined 

repeated dose toxicity test (OPPTS Test 

Guideline 870.3650) with the 

reproduction/development toxicity 

screening test and neurotoxicity 

endpoints; a carcinogenicity test 

(OPPTS Test Guideline 870.4200); 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 characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10552. 

PMN Number P–06–149 

Chemical name: Potassium titanium 

oxide. 

CAS number: 12673–69–7. 

Effective date of TSCA section 5(e) 

consent order: March 18, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

is as a physical characteristics modifier 

for industrial use in certain solid 

composite articles. Based on test data on 

the PMN substance and SAR analysis of 

test data on analogous respirable, poorly 

soluble particulates (subcategory 

titanium dioxide), EPA identified 

concerns for lung toxicity and fibrosis in 

workers exposed to the PMN substance 

by the inhalation route. 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 substance may present 

an unreasonable risk of injury to human 

health. To protect against this risk, the 

consent order requires: 

1. Use of personal protective 

equipment including a National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirator with 

an assigned protection factor (APF) of at 

least 10, or compliance with a NCEL of 

1.5 mg/m3 as a time weighted average 

(when there is a potential for inhalation 

exposures). 

2. Establishment and use of a hazard 

communication program. 

3. No manufacture of the PMN 

substance with a particle size less than 

100 nanometers. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA 

determined that the results of the 

following study would help characterize 

the human health effects of the PMN 

substance: A 90-day inhalation toxicity 

test with special attention to 

histopathology (inflammation and cell 

proliferation) of the lung tissues and to 

various parameters of the 

broncoalveolar lavage fluid (BALF), e.g., 

marker enzyme activities, total protein 

content, total cell count, cell 

differential, and cell viability (OPPTS 

Test Guideline 870.3465). 

CFR citation: 40 CFR 721.10553. 

PMN Number P–06–153 

Chemical name: Iso-tridecanol 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: October 13, 2006. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a reactant. 

Based on test data on the PMN 


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substance, and EcoSAR analysis of test 

data on analogous neutral organic 

compounds, EPA predicts toxicity to 

aquatic organisms at concentrations that 

exceed 8 ppb of the PMN substance in 

surface waters. Further, aquatic toxicity, 

persistence, and bioaccumulation 

potential vary depending on the 

isoindex (i.e., the average number of 

branches per alkyl unit) of the PMN 

substance. EPA has determined that as 

the isoindex increases, persistence and 

bioaccumulation values increase. At the 

isoindex value of 2.32 for the intended 

PMN substance, the substance is not 

considered a PBT chemical and aquatic 

toxicity risk is mitigated by the decrease 

in persistence. However, as the isoindex 

increases above 3, EPA estimates that 

the PMN substance will persist in the 

environment more than two months and 

EPA estimates a bioaccumulation factor 

of greater than or equal to 1000. If the 

isoindex is less than three, the PMN is 

not expected to persist. The consent 

order was issued under TSCA sections 

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

on a finding that this substance may 

present an unreasonable risk of injury to 

the environment. To protect against 

these risks, the consent order requires 

manufacture of the PMN substance 

according to the chemical composition 

section of the consent order, with no 

greater than an average of three 

branches per alkyl unit and routine 

analysis of the PMN substance to verify 

compliance with the average number of 

alkyl units restriction. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. The consent order 

does not require the submission of this 

testing at any specified time or 

production volume. However, the 

consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substances will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10554. 

PMN Number P–06–370 

Chemical name: Benzoic acid nonyl 

ester, branched and linear. 

CAS number: 670241–72–2. 

Basis for action: The PMN states that 

the substance will be used as a softener 

for polyvinyl chloride. Based on test 

data on the PMN substance, EPA 

identified concerns for developmental 

toxicity from exposure to the PMN 

substance. In addition, based on test 

data on the PMN substance and EcoSAR 

analysis of test data on analogous esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 6 ppb of the PMN substance 

in surface waters. As described in the 

PMN, dermal exposures are not 

expected due to the use of impervious 

gloves and no domestic manufacture, 

and releases of the PMN substance are 

not expected to result in surface water 

concentrations that exceed 6 ppb. 

Therefore, EPA has not determined that 

the proposed processing or use of the 

substance presents an unreasonable risk. 

EPA has determined, however, that any 

use of the substance without impervious 

gloves, where there is a potential for 

dermal exposures; any domestic 

manufacture; or any use of the 

substance resulting in surface water 

concentrations exceeding 6 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i), (b)(4)(i), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

subchronic dermal toxicity test in rats 

(OPPTS Test Guideline 870.3250) and a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10555. 

PMN Numbers P–06–450, P–06–451, 

and P–06–452 

Chemical names: (P–06–450) 

Poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-15-alkyl ethers; (P–06–451) 

Poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers; and (P–06– 

452) Poly(oxy-1,2-ethanediyl), .alpha.- 

(2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers. 

CAS numbers: (P–06–450) 675869– 

02–0; (P–06–451) 620610–66–4; and (P– 

06–452) 675869–05–3. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as wetting agents for low foam 

spray metal cleaning. Based on EcoSAR 

analysis of test data on analogous 

neutral organic chemicals, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 10 ppb of 

the PMN substances in surface waters. 

At the combined production volume 

stated in the notice, releases of the PMN 

substances are not expected to result in 

surface water concentrations that exceed 

10 ppb. 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 increase in the combined annual 

manufacture and import volume of 

45,000 kilograms (kgs) of the substances 

could result in exposures which may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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) on any of the three PMN 

substances would help characterize the 

environmental effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10556 (P– 

06–450); 40 CFR 721.10557 (P–06–451); 

and 40 CFR 721.10558 (P–06–452). 

PMN Number P–06–793 

Chemical name: Morpholine, 4-C6-12

acyl derivs. 

CAS number: 887947–29–7. 

Basis for action: The PMN states that 

the substance will be used as a pesticide 

dispersant/solvent. Based on test data 

on the PMN substance, EPA identified 

concerns for systemic effects from 

dermal exposures. As described in the 

PMN, worker dermal exposures are not 

expected due to the use of impervious 

skin protection and hazard 

communication warnings for systemic 

effects. 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 

impervious dermal protection, where 

there is a potential for dermal 

exposures, or any use of the substance 

without hazard communication 

warnings for systemic effects may cause 

serious health effects. Based on this 

information, the PMN meets the concern 

criteria at § 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that the results of 90-day 

subchronic dermal toxicity test (OPPTS 

Test Guideline 870.3250) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10559. 


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PMN Numbers P–07–143 and P–07–144 

Chemical names: Alkanoldioic 

dialkyl esters (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as lubricant 

additives. Based on EcoSAR analysis of 

test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

3 ppb of the PMN substances 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 substances to surface water 

exceed releases from the use described 

in the PMNs. For the use described in 

the PMNs, environmental releases did 

not exceed 3 ppb for more than 20 days 

per year. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances presents an unreasonable 

risk. EPA has determined, however, that 

any use of the substances other than as 

described in the PMNs may cause 

significant adverse environmental 

effects. Based on this information the 

PMN substances meet 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) would help 

characterize the environmental effects of 

the PMN substances. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10560. 

PMN Number P–07–327 

Chemical name: Substituted phenol 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: September 17, 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 antioxidant. Based on 

EcoSAR analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. The 

consent order was issued under TSCA 

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

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

that the substance may present an 

unreasonable risk of injury to the 

environment, may be produced in 

substantial quantities, and may 

reasonably be anticipated to enter the 

environment in substantial quantities. 

To protect against these risks, the 

consent order requires: 

1. Establishment and use of a hazard 

communication program. 

2. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

human health toxicity testing specified 

in the consent order would help 

characterize the human health effects of 

the substance. The PMN submitter has 

agreed not to exceed the confidential 

production volume limit without 

performing an in vitro mouse lymphoma 

assay (mammalian cell mutation test) 

(OPPTS Test Guideline 870.5300) and a 

repeated dose 28-day oral toxicity test 

(OPPTS Test Guideline 870.3050) to 

include a neurotoxicity battery (OPPTS 

Test Guideline 870.6200). 

In addition, 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 

characterize the environmental effects of 

the PMN substance. The consent order 

does not require submission of this 

aquatic toxicity testing by any specified 

time or production volume. However, 

the consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10561. 

PMN Number P–07–375 

Chemical name: Aluminum trihydrate 

and silane homopolymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance will be as a 

flame retardant. Based on test data on an 

analogous insoluble high molecular 

weight polymer, EPA identified 

concerns for lung toxicity if the PMN 

substance is inhaled. At an annual 

production volume of 100,000 kgs, 

worker exposure is limited and 

consumer exposure is 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 increase 

of the annual 100,000 kg production 

volume may result in increased 

exposure to the PMN substance which 

may cause significant adverse 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 721.10562. 

PMN Number P–07–496 

Chemical name: 2- 

Oxiranemethanamine, N-[3-(2- 

oxiranylmethoxy)phenyl]-N-(2- 

oxiranylmethyl)-. 

CAS number: 71604–74–5. 

Basis for action: The PMN substance 

will be used as a preparation of preimpregnated cloth/fiber tapes for 

aerospace composite articles. Based on 

SAR analysis of test data on analogous 

epoxides, EPA identified concerns for 

oncogenicity, mutagenicity, 

developmental toxicity, reproductive 

toxicity, and liver toxicity from 

exposure to the PMN substance. As 

described in the PMN, worker dermal 

exposure to the PMN substance will be 

minimal due to the use of impervious 

gloves, and no significant inhalation 

exposure is 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 without the use 

of impervious gloves, where there is 

potential for dermal exposure, or any 

use of the substance other than as a 

preparation of pre-impregnated cloth/ 

fiber tapes for aerospace composite 

articles may cause 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 

subchronic dermal toxicity test in rats 

(OPPTS Test Guideline 870.3250) and a 

dermal carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10563. 

PMN Number P–08–39 

Chemical name: Mixed amino diaryl 

sulfone isomers (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a hardening agent. 

Based on SAR analysis of test data on 

analogous dianilines, EPA identified 


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concerns for immunotoxicity, 

oncogenicity, blood effects, liver effects, 

and hypersensitivity from exposures to 

the PMN substance. In addition, based 

on EcoSAR analysis of analogous 

dianilines, EPA predicts toxicity to 

aquatic organisms at concentrations that 

exceed 8 ppb of the PMN substance in 

surface waters. For the non-consumer 

use described in the PMN, significant 

worker exposures are not expected as 

the PMN is used in liquid form, and 

releases of the substance to surface 

waters are not expected. 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 in consumer 

products, any use of the substance in 

the form of a powder, or any use of the 

substance resulting in surface water 

concentrations exceeding 8 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a rat acute 

oral retinopathy screening test; a 

pigmented rat 90-day subchronic 

toxicity test (OPPTS Test Guidelines 

870.3100 or 870.3465) by either the oral 

or inhalation route, including 

histopathological examination of the 

eyes (by both light and electron 

microscopy) and reproductive organs; 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 human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10564. 

PMN Number P–08–263 

Chemical name: Ethanol, 2,2′-[[3-[(2- 

hydroxyethyl)amino]propyl]imino]bis-, 

N-(hydrogenated tallow alkyl) derivs. 

CAS number: 90367–25–2. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a raw material to 

manufacture a surfactant blend. Based 

on EcoSAR analysis of test data on 

analogous aliphatic amines, 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 of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 1 ppb. 

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). 

Recommended testing: EPA has 

determined that the results of a 

simulation test—aerobic sewage 

treatment: activated sludge units 

(OPPTS Test Guideline 835.3240); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity mitigated 

by humic acid (OPPTS Test Guideline 

850.1085); 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 721.10565. 

PMN Number P–08–292 

Chemical name: 1-Propanamine, N- 

(1-methylethyl) -,3- (C12-15-alkyloxy) 

derivs. 

CAS number: 944835–56–7. 

Basis for action: The PMN states that 

the substance will be used as a lubricant 

additive intermediate. Based on EcoSAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

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 

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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 721.10566. 

PMN Number P–08–300 

Chemical name: Amidoamine salt 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a laundry product 

additive. Based on EcoSAR analysis of 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the substance in 

surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that 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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 721.10567. 

PMN Number P–08–464 

Chemical name: Diethanolamine salt 

of polymeric acid (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a pigment 

dispersant in latex paints. Based on 

EcoSAR analysis of test data on 

analogous inorganic phosphates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 ppb of the substance in surface waters. 

As described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

4 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 4 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 

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 721.10568. 

PMN Number P–08–471 

Chemical name: Tricyclic quaternary 

amine salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on EcoSAR analysis 

of test data on analogous cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 100 ppb of 

the 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 

presents an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 100 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 721.10569. 

PMN Number P–08–537 

Chemical name: Cyclic amine 

reaction product with acetophenone and 

formaldehyde acid salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an acid inhibitor. 

Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 8 ppb of the PMN substance 

in surface waters. As described in the 

PMN, releases of the PMN substance are 

not expected to result in surface water 

concentrations that exceed 8 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 8 ppb may 

cause significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of fish earlylife 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 characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10570. 

PMN Number P–08–611 

Chemical name: 1,3-Benzenediol, 

polymer with 1,1′- 

methylenebis[isocyanatobenzene]. 

CAS number: 1008753–84–1. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a rubber additive. 

Based on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for dermal and respiratory 

sensitization and for pulmonary toxicity 

to workers exposed to free isocyanates. 

Also, based on EcoSAR analysis of test 

data on analogous esters and phenols, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. For the use scenarios 

described in the PMN, which were 

supported by product composition tests 

and simulated use condition tests, 

significant worker exposure is not 

expected, and 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 use of the substance other 

than as described in the PMN 

(manufacture with all isocyanate groups 

reacted within the polymer), or any use 

of the substance resulting in surface 

water concentrations exceeding 1 ppb 

could result in exposures which may 

cause serious health effects or 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a dermal 

sensitization test (OPPTS Test Guideline 

870.2600); a 90-day subchronic 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); 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 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10571. 

PMN Number P–08–680 

Chemical name: Benzamide, N-[[4- 

[(cyclopropylamino)carbonyl]phenyl]

sulfonyl]-2-methoxy-. 

CAS number: 221667–31–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adjuvant for 

agricultural products. Based on test data 

on the PMN substance, EPA identified 

concerns for urinary tract toxicity from 

exposure to the PMN substance. As 

described in the PMN, worker dermal 

and inhalation exposures will be 

minimal due to the use of impervious 

gloves, a NIOSH-certified respirator 

with an APF of at least 10, and 

establishment of a hazard 

communication program. 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 impervious gloves, where there 

is a potential for dermal exposures; any 

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

least 10, where there is a potential for 

inhalation exposures; or without 

establishing the hazard communication 

program may result in serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that inhalation monitoring 

data would help characterize the health 

effects of the PMN substance. EPA’s 

draft Inhalation Monitoring Data 

Collection Guidelines are available in 

the docket for this rule under docket ID 

number EPA–HQ–OPPT–2012–0277. 

CFR citation: 40 CFR 721.10572. 

PMN Number P–08–737 

Chemical name: Magnesium 

hydroxide surface treated with 

substituted alkoxy silanes (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a flame 

retardant. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 


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lung toxicity and immunotoxicity if the 

PMN substance is inhaled. For the use 

described in the PMN, and at the annual 

100,000 kg production volume stated in 

the PMN, worker inhalation exposure 

will be minimal due to adequate 

personal protective equipment. 

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 increase 

of the annual 100,000 kg production 

volume, or use without workers wearing 

a NIOSH-certified respirator with an 

APF of at least 10, or use without an 

appropriate hazard communication 

program may result in serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60-day 

holding period would help characterize 

the health effects of the PMN substance. 

CFR citation: 40 CFR 721.10573. 

PMN Number P–09–48 

Chemical name: Alkylcarboxy 

polyester acrylate reaction products 

with mixed metal oxides (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: August 31, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a film coating additive. Based 

on particle size data on the PMN 

substance, and SAR analysis of test data 

on analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

inflammation of the lungs, lung fibrosis 

and lung cancer, as well as internal 

organ effects. In addition, based on 

EcoSAR analysis of test data on 

analogous acrylate substances, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

55 ppb of the PMN substance in surface 

waters. The consent order was issued 

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

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

this substance may present an 

unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of impervious gloves (when 

there is a potential for dermal exposure). 

2. Establishment and use of a hazard 

communication program. 

3. No manufacturing, processing, or 

use of the PMN substance in nonenclosed processes when the PMN 

substance is in the powder form. 

4. No use involving an application 

method that generates a vapor, mist, 

aerosol, or a dust. 

5. Transport of the PMN substance to 

processors using only reusable tote 

tanks cleaned not more than once per 

year. 

6. Use of the PMN substance only for 

the confidential use specified in the 

consent order. 

7. Disposal of the PMN substance, any 

waste streams from manufacture of the 

PMN substance, and any waste streams 

from processing of the PMN substance 

only by incineration in a Resource 

Conservation and Recovery Act (RCRA)- 

approved hazardous waste incinerator. 

8. Waste streams from use of the PMN 

substance must either be disposed of by 

incineration in a RCRA-approved 

hazardous waste incinerator, or be 

recycled via polymer reclamation. 

9. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates 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 in rats with a 

post-exposure observation period of up 

to 60 days, including bronchoalveolar 

lavage fluid analysis (OPPTS Test 

Guideline 870.3465 or OECD Test 

Guideline 413); determination of 

incineration removal efficiency, full 

dissolution test using transformed PMN 

substance following incineration (OECD 

ENV/JM/MONO(2001)); and particle 

size distribution, aspect ratio, and 

crystalline structure of transformed 

PMN substance following incineration 

(OPPTS Test Guideline 830.7520) would 

help characterize the human health 

effects, environmental fate, and physical 

chemical properties of the PMN 

substance. The consent order does not 

require submission of this testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10574. 

PMN Number P–09–480 

Chemical name: 1-Propanone, 1,1′- 

(oxydi-4,1-phenylene)bis[2-hydroxy-2- 

methyl-. 

CAS number: 71868–15–0. 

Basis for action: The PMN states that 

the use of the substance will be used as 

a co-photoinitiator for ultra-violet (UV)- 

curable pigmented inks, co-photo 

initiator for photoresists, optical fibers 

and printed plates, and cophotoinitiator for UV-curable coatings 

and a co-photoinitiator for UV-curable 

adhesives and other coatings. Based on 

test data on the PMN substance, EPA 

identified concerns for reproductive 

toxicity effects from exposure to the 

PMN substance. In addition, based on 

test data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

14 ppb of the PMN substance in surface 

waters. For the use described in the 

PMN, worker exposure will be minimal 

due to the use of a NIOSH-certified 

respirator with an APF of at least 50, 

adequate hazard communication, and 

no domestic manufacture of the PMN 

substance, and environmental effects 

will be minimal as releases of the 

substance to surface waters are not 

expected. Therefore, EPA has not 

determined that the proposed 

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 50, 

where there is potential inhalation 

exposure; any domestic manufacture; 

without adequate hazard 

communication; or any use of the 

substance resulting in surface water 

concentrations exceeding 14 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(i) and (b)(4)(i). 

Recommended testing: EPA has 

determined that the results of a twogeneration reproductive toxicity (OECD 

Test Guideline 416); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10575. 

PMN Number P–09–486 

Chemical name: Polyalkenyl, N,N′- 

bistriazole (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non confidential) use of the 

substance will be as a lubricant 

additive. Based on EcoSAR analysis of 

analogous polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

140 ppb of the PMN substance in 

surface waters for greater than 20 days 


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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 exceed releases from the 

use described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 140 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 described in the PMN 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 daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10576. 

PMN Number P–09–636 

Chemical name: Benzenamine, 5-(1,1- 

dimethylethyl)-2-[(2-ethylhexyl)thio]-,4- 

methylbenzenesulfonate (1:1). 

CAS number: 852360–51–1. 

Effective date of TSCA section 5(e) 

consent order: June 4, 2010. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a chemical 

intermediate. EPA has identified health 

and environmental concerns because 

the substance may be a PBT chemical, 

based on physical/chemical properties 

of the PMN substance, as described in 

the New Chemical Program’s PBT 

category. EPA estimates that the PMN 

substance will persist in the 

environment more than two months and 

estimates a bioaccumulation factor of 

greater than or equal to 5,000. Also, 

based on test data on the PMN 

substance and SAR analysis for anilines, 

EPA predict toxicity to aquatic 

organisms at concentrations that exceed 

1 ppb and developmental toxicity to 

workers from exposures during uses 

other than as a site-limited chemical 

intermediate. The consent order was 

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

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

that this substance may present an 

unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Establishment and use of a hazard 

communication program. 

2. Use of the PMN substance only as 

a site-limited intermediate. 

3. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of human 

health, aquatic toxicity, and 

environmental fate testing would help 

characterize the effects of the PMN 

substance. The PMN submitter has 

agreed not to exceed the first production 

volume limit of 15,000 kgs prior to 

submitting testing to determine the log 

Kow value (by either the liquid 

chromatography test (OPPTS Test 

Guideline 830.7575) or the generator 

column method (OPPTS Test Guideline 

830.7560)); and the ready 

biodegradability test (OPPTS Test 

Guideline 835.3110) by any of six 

methods described in the consent order: 

Depending on the results of the first tier 

testing, the PMN submitter has agreed 

not to exceed the second production 

volume limit of 170,000 kgs prior to 

submitting testing to determine 

biodegradation and bioaccumulation 

potential. Further, depending upon the 

results of the second tier testing, the 

PMN submitter has agreed not to exceed 

the third production volume limit of 

496,000 kgs prior to submitting: a 

combined repeated dose toxicity test 

with a reproductive/developmental 

toxicity screening test (OECD Test 

Guideline 422) in rats; a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395) via the 

intraperitoneal route; a sediment/water 

microcosm biodegradation test (OPPTS 

Test Guideline 835.3180); fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300). 

CFR citation: 40 CFR 721.10577. 

PMN Number P–10–231 

Chemical name: Unsaturated 

polyester imide (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance will be as 

electrical insulating varnish for motors, 

generators and transformers. Based on 

EcoSAR analysis of aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 52 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 52 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. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10578. 

PMN Number P–10–367 

Chemical name: Carbon black derived 

from the pyrolysis of rubber tire shreds 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 16, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as carbon black for general 

industrial use. Based on test data on 

carbon black and SAR analysis of test 

data on analogous respirable, poorly 

soluble particulates, EPA identified 

concerns for immunotoxicity, 

pulmonary toxicity, and 

carcinogenicity. In addition, based on 

aquatic toxicity data on carbon black, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1,000 ppb of the PMN 

substance in surface waters. The 

consent order was issued under TSCA 

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

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health and the 

environment. To protect against these 

risks, the consent order requires: 

1. Manufacture of the PMN substance 

using only the process described in the 

PMN. 

2. Manufacturing, processing, or use 

of the PMN substance in compliance 

with the Occupational Safety and 

Health Administration (OSHA) 

Permissible Exposure Limit (PEL) for 

carbon black of 3.5 mg/m3. 

3. Manufacture of the PMN substance 

to meet the NIOSH recommended time 

weighted average (TWA) for 

polyaromatic hydrocarbons (PAH) in 

carbon black of 0.1 mg/m3 as described 

in the NIOSH Pocket Guide to Chemical 


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Hazards Appendix C (see http:// 

www.cdc.gov/niosh/npg/ 

nengapdza.html). 

4. Submission of data demonstrating 

compliance with the NIOSH TWA for 

PAH as described in the testing section 

of the consent order. 

5. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

human health testing would help 

characterize the human health effects of 

the PMN substance. The PMN submitter 

has agreed not to exceed the 

confidential production volume 

specified in the consent order prior to 

performing a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465) 

with (1) a post-exposure observation 

period of up to 3 months; (2) 

bronchoalveolar lavage fluid (BALF) 

analysis, aggregate/agglomeration state, 

shape, size/size particle distribution and 

surface properties of materials as 

administered; (3) aggregation/ 

agglomeration state, shape, size/size 

particle distribution; and surface 

properties of materials of the delivered 

materials after administration; and (4) 

determination of cardiovascular 

toxicity, heart histopathology, and data 

on pulmonary deposition. Further, the 

PMN submitter must submit additional 

worker exposure monitoring data to 

determine whether worker exposures 

exceed the NIOSH REL for PAH. In 

addition, EPA has determined that the 

results of a 2-year carcinogenicity test 

(OPPTS Test Guideline 870.4300) would 

help characterize the human health 

effects of the PMN substance. The 

consent order does not require 

submission of this test at any specified 

time or production volume. However, 

the consent order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10579. 

PMN Number P–10–452 

Chemical name: Poly[oxy(methyl-1,2- 

ethanediyl)], alpha, alpha’-[1,4-c

yclohexanediylbis(methylene)]bis

[omega-(2-aminomethylethoxy)-. 

CAS number: 1220986–58–2. 

Basis for action: The PMN states that 

the use for this substance will be as an 

epoxy curing agent. Based on EcoSAR 

on analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

98 ppb of the PMN substance in surface 

waters. As described in the PMN notice, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 98 ppb. 

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 98 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 porous 

pot test (OPPTS Test Guideline 

835.3220); 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 721.10580. 

PMN Numbers P–10–524 and P–10–525 

Chemical names: Brominated 

polyurethane prepolymers of methylene 

diphenyl diisocyanate (MDI) (generic). 

CAS numbers: Not available. 

Basis for action: The consolidated 

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

be as components of polyurethane 

coatings for non-consumer use. Based 

on test data on analogous isocyanates, 

EPA identified concerns for dermal 

sensitization, respiratory sensitization, 

and irritation. For the non-consumer use 

described in the PMNs, worker 

inhalation exposures will be minimal 

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 substances may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substances without a NIOSHcertified respirator with an APF of at 

least 10, where there is a potential of 

inhalation exposures, or any consumer 

use of the substances may result in 

human exposures which 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 dermal 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS 870.3465) in 

rodents would help characterize the 

human health effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10581. 

PMN Number P–10–571 

Chemical name: Quaternary 

ammonium compound (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an inhibitor for oil 

field applications. Based on EcoSAR on 

analogous cationic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

47 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 47 ppb. 

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 47 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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 and fate effects of the 

PMN substance. EPA also recommends 

that the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10582. 

PMN Number P–10–588 

Chemical name: Benzenamine, 4,4’- 

[1,3-phenylenebis(1- 

methylethylidene)]bis-. 

CAS number: 2687–27–6. 

Basis for action: The PMN states that 

the use will be as a precursor to a 

polyimide resin. Based on SAR analysis 

of test data on analogous aromatic 

amines, EPA identified concerns for 

chronic organ effects, developmental 

toxicity and reproductive toxicity from 

exposures to the PMN substance. In 

addition, based on EcoSAR analysis of 

test data on analogous aromatic amines, 

EPA predicts toxicity to aquatic 

organisms at concentrations that exceed 


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1 ppb of the PMN substance in surface 

waters. As described in the PMN, 

inhalation exposures are expected to be 

minimal due to the use of a NIOSHcertified particulate respirator with an 

APF of at least 1,000 and releases to 

surface waters 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 without a NIOSH-certified 

particulate respirator with an APF of at 

least 1,000, where there is potential for 

inhalation exposures, or any use of the 

substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a log Kow 

test (OPPTS Test Guideline 830.7550, 

830.7560 or 830.7570; or OECD Test 

Guideline 123); a ready biodegradability 

test (OPPTS Test Guideline 835.3110); 

and a combined repeated dose toxicity 

with the reproduction/development 

toxicity screening test (OPPTS Test 

Guideline 835.3650) would help 

characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10583. 

PMN Number P–11–29 

Chemical name: Cyclopentene, 

1,3,3,4,4,5,5-heptafluoro-. 

CAS number: 1892–03–1. 

Basis for action: The PMN states that 

the substance will be used as a dry 

etching agent for production of 

semiconductors. Based on test data on 

the PMN substance and SAR analysis of 

test data on analogous halogenated 

hydrocarbons, EPA identified concerns 

for chronic toxicity from exposure to the 

PMN substance. In addition, based on 

EcoSAR analysis of analogous neutral 

organic compounds, 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 exceed 

releases from the use described in the 

PMN. Significant exposures are not 

expected at a production volume of less 

than 10,000 kg per year. In addition, 

there is no consumer use or domestic 

manufacture for the PMN substance. 

Further, for the use described in the 

PMN, environmental releases did not 

exceed 2 ppb for more than 20 days per 

year. Therefore, EPA has not determined 

that the proposed processing or use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that any domestic 

manufacture; any use of the substance 

other than as a dry etching agent for 

production of semiconductors; any use 

in a consumer product; or exceedance of 

the annual import limit of 10,000 kg per 

year could change exposure potential 

and may cause serious health effects 

and significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i), (b)(3)(ii), 

(b)(4)(i), and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

repeated dose inhalation test (OPPTS 

Test Guideline 870.3465); a fish earlylife stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10584. 

PMN Numbers P–11–43 and P–11–44 

Chemical names: (P–11–43) 

Disiloxane, 1-butyl-1,1,3,3-tetramethyland (P–11–44) Disiloxane, 1,3-dibutyl1,1,3,3-tetramethyl-. 

CAS numbers: (P–11–43) 121263–51– 

2 and (P–11–44) 4619–08–3. 

Basis for action: The PMN states that 

the use of the substances will be as 

reducing agents for organic substrates 

and as chemical intermediates. Based on 

EcoSAR analysis of test data on 

analogous neutral organic compounds, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN 

substances in surface waters. As 

described in the PMNs, the substances 

are not released to surface waters. 

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 resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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 characterize the environmental 

effects of the PMN substances. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citations: 40 CFR 721.10585 (P– 

11–43) and 40 CFR 721.18586 (P–11– 

44). 

PMN Number P–11–81 

Chemical name: 1H-Pyrazole, 3,4- 

dimethyl-. 

CAS number: 2820–37–3. 

Basis for action: The PMN states that 

the use of the substance will be as an 

intermediate. Based on EcoSAR analysis 

of test data on analogous pyrazoles, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

19 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 

19 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: either a 

ready biodegradability test (OPPTS Test 

Guideline 835.3110) or a porous pot test 

(OPPTS Test Guideline 835.3220); 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 and fate 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10587. 

PMN Number P–11–98 

Chemical name: Phenol, 2-[1-[[3-(1Himidazol-1-yl)propyl]imino]ethyl]-. 

CAS number: 1253404–90–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use will 

be as an epoxy catalyst. Based on 

EcoSAR analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 


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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. 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 ready 

biodegradability test (OPPTS Test 

Guidelines 835.3110); a hydrolysis as a 

function of pH test (OPPTS Test 

Guideline 835.2110); an aerobic 

treatment simulation test (OECD Test 

Guideline 303A); a fish acute toxicity 

test, freshwater and marine (OPPTS Test 

Guidelines 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 and fate effects of the 

PMN substance. EPA also recommends 

that the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10588. 

PMN Numbers P–11–106 and P–11–107 

Chemical names: (P–11–106) 

Unsaturated fatty acids, amides with 

polyethylenepolyamine (generic) and 

(P–11–107) Fatty acids, amides with 

triethylentetramine (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

substances will be used as a surfactant 

in asphalt emulsion (P–11–106) and an 

anti-stripping agent in asphalt (P–11– 

107). Based on EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN 

substances in surface waters. As 

described in the PMN, the substances 

are not released to surface waters. 

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 resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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 substances. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citations: 40 CFR 721.10589 (P– 

11–106) and 40 CFR 721.10590 (P–11– 

107). 

PMN Number P–11–110 

Chemical name: Tertiary ammonium 

compound (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an inhibitor for oil 

field applications. Based on EcoSAR 

analysis of test data on analogous 

aliphatic amines, 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. 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 test, freshwater and 

marine (OPPTS Test Guideline 

850.1400); a daphnid chronic toxicity 

test (OPPTS Test Guideline 850.1300); 

and a mysid chronic toxicity test 

(OPPTS Test Guideline 850.1350) in salt 

water would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10591. 

PMN Number P–11–130 

Chemical name: 1-Butanol, 4-amino-. 

CAS number: 13325–10–5. 

Basis for action: The PMN states that 

the PMN substance will be used as an 

intermediate. Based on SAR analysis of 

test data on analogous aliphatic amines, 

EPA identified concerns for 

neurotoxicity, liver toxicity, and kidney 

toxicity from exposures to the PMN 

substance. For the intermediate use 

described in the PMN, significant 

worker exposures 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, use of the 

substance other than as an intermediate 

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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); an acute oral 

toxicity test (OPPTS Test Guideline 

870.1100); a repeated dose 28-day oral 

toxicity in rodents (OPPTS Test 

Guideline 870.3050) including a 

neurotoxicity functional observational 

battery, as described in the 

neurotoxicity screening battery (OPPTS 

Test Guideline 870.6200); a bacterial 

reverse mutation test (OPPTS Test 

Guideline 870.5100); and a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395) via the 

intraperitoneal route would help 

characterize the human health and fate 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10592. 

PMN Number P–11–162 

Chemical name: 5- 

Isobenzofurancarboxylic acid, 1,3- 

dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo2-propen-1-yl)oxy]ethyl ester. 

CAS number: 70293–55–9. 

Basis for action: The PMN states that 

the substance will be uses as an 

adhesive monomer. Based on EcoSAR 

analysis of test data on analogous esters 

and methacrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

20 ppb. 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 

20 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 


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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. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10593. 

PMN Number P–11–173 

Chemical name: Hexanedioic acid, 

polymer with 2,2-dimethyl-1,3- 

propanediol, 1,6-hexanediol, hydrazine, 

3-hydroxy-2-(hydroxymethyl)-2- 

methylpropanoic acid, 5-isocyanato-1- 

(isocyanatomethyl)-1,3,3- 

trimethylcyclohexane and 1,1’-[(1- 

methylethylidene)bis(4,1- 

phenyleneoxy)]bis[2-propanol], iso-Bu 

alc.-blocked, compds. with 

triethylamine. 

CAS number: 1138156–39–4. 

Basis for action: The PMN states that 

the generic (non-confidential) use for 

the substance will be as a coating for 

wooden floors. Based on EcoSAR 

analysis of test data on analogous 

amphoteric polymers, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 150 ppb 

for the PMN substance in surface 

waters. As described in the PMN, 

releases of the substance to surface 

waters are not expected to result in 

surface water concentrations that exceed 

150 ppb, due to pretreatment by 

primary, secondary, and tertiary waste 

treatment, or treatment in a lined, selfcontained solar evaporation pond. 

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 150 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. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10594. 

PMN Number P–11–230 

Chemical name: Octadecen-1- 

aminium, N-ethyl-N,N-dimethy-, ethyl 

sulfate (1:1). 

CAS number: 1256282–88–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an antistatic agent 

for acrylic yarn. Based on EcoSAR 

analysis of test data on cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 4 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 4 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) in clean dilution water; a fish 

acute toxicity test mitigated by humic 

acid (OPPTS Test Guideline 850.1085); 

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. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10595. 

PMN Number P–11–234 

Chemical name: Oligomeric phenolic 

ether (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on EcoSAR analysis 

of test data on analogous neutral organic 

chemicals, 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 and result in substantial human 

exposure via drinking water or fish 

ingestion. 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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); an acute toxicity 

test (OPPTS Test Guideline 870.1000); a 

mammalian erythrocyte micronucleus 

test (OPPTS Test Guideline 870.5395); a 

repeated dose 28-day oral toxicity test in 

rodents (OPPTS Test Guideline 

870.3050); a bacterial reverse mutation 

test (OPPTS Test Guideline 870.5100); a 

fish BCF test (OPPTS Test Guideline 

850.1730); 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 characterize the 

human health and environmental effects 

of the PMN substance. EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10596. 

PMN Number P–11–252 

Chemical name: Benzeneacetonitrile, 

alkoxy-[[(alkylsulfonyl)oxy]imino]- 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a photographic 

chemical. Based on EcoSAR analysis of 

test data on analogous vinyl/allyl 

nitriles, 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. 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 characterize the environmental 

effects of the PMN substance. EPA also 


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recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10597. 

PMN Numbers P–11–270, P–11–271, P– 

11–272, P–11–273, and P–11–274 

Chemical names: (P–11–270) Lead 

strontium titanium zirconium oxide; (P– 

11–271) Calcium cobalt lead titanium 

tungsten oxide; (P–11–272) Calcium 

cobalt lead strontium titanium tungsten 

oxide; (P–11–273) Lanthanum lead 

titanium zirconium oxide; and (P–11– 

274) Lead niobium titanium zirconium 

oxide. 

CAS numbers: (P–11–270) 61461–40– 

3; (P–11–271) 1262279–31–1; (P–11– 

272) 1262279–30–0; (P–11–273) 

1227908–26–0; and (P–11–274) 56572– 

83–9. 

Basis for action: The PMNs state that 

the substances will be used as 

piezoelectric ceramics for active and 

passive underwater acoustic systems. 

Based on test data on lead and SAR 

analysis of test data on analogous 

respirable, poorly soluble particulates, 

EPA identified concerns for 

neurobehavioral and other neurological 

effects, cerebrovascular disease, high 

blood pressure, renal effects, cardiac 

effects, lung effects, neurological effects, 

hematological effects, reproductive 

toxicity, and immunotoxicity. In 

addition, based on EcoSAR analysis of 

test data on analogous inorganic lead 

compounds, EPA expects toxicity to 

aquatic organisms to occur at 

concentrations that exceed an aggregate 

of 8 ppb of the PMN substances in 

surface waters. For the uses described in 

the PMNs, worker inhalation exposures 

are expected to be minimal due to use 

of a NIOSH-certified respirator with an 

APF of at least 50, and releases of the 

PMN substances are not expected to 

result in an aggregate surface water 

concentration that exceeds 8 ppb. 

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 the use of a 

NIOSH-certified respirator with an APF 

of at least 50, where there is a potential 

for inhalation exposures; any use of the 

substances other than as piezoelectric 

ceramics for active and passive 

underwater acoustic systems; or any use 

of the substances resulting in an 

aggregate surface water concentration 

exceeding 8 ppb may cause serious 

health effects and significant adverse 

environmental effects. Based on this 

information the PMN substances meet 

the concern criteria at § 721.170 (b)(3)(i) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0277) would help 

characterize the human health effects of 

the PMN substances. 

CFR citations: 40 CFR 721.10598 (P– 

11–270); 40 CFR 721.10599 (P–11–271); 

40 CFR 721.10600 (P–11–272); 40 CFR 

721.10601 (P–11–273); and 40 CFR 

721.10602 (P–11–274). 

PMN Number P–11–280 

Chemical name: Epoxy modified 

alkyd resin, partially neutralized 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a coating resin. 

Based on EcoSAR analysis of test data 

on analogous 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, 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. 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 an algal 

toxicity test (OCSPP Test Guideline 

850.4500) without adding phosphate 

would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed. 

CFR citation: 40 CFR 721.10603. 

PMN Number P–11–447 

Chemical name: Polyetherdiamine 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a gas 

treatment chemical for the removal of 

hydrogen sulfide from natural gas. 

Based on EcoSAR analysis of test data 

on analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 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 

4 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 721.10604. 

PMN Numbers P–11–485, P–11–486, P– 

11–488, and P–11–489 

Chemical names: (P–11–485) 

Polyoxyalkylene ether, polymer with 

aliphatic diisocyanate, homopolymer, 

alkanol-blocked (generic); (P–11–486) 

Alkyl substituted alkanediol polymer 

with aliphatic and alicyclic 

diisocyanates (generic); (P–11–488) 

Aliphatic diisocyanate, homopolymer, 

alkanol-blocked (generic); and (P–11– 

489) Aliphatic diisocyanate polymer 

with alkanediol and alkylglycol 

(generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as hardeners for 

industrial coatings. Based on test data 

on analogous diisocyanates (including 

TSCA section 8(e) data on polymeric 

MDI), EPA identified concerns for 

oncogenicity. Also, based on test data 

on the PMN substances, the Agency 

identified concerns for lung and mucous 

membranes irritation as well as 

sensitization to workers from exposures 

to the PMN substances. For the uses and 

at the production volumes stated in the 

PMN, worker inhalation exposures will 

be minimal due to use of a NIOSHcertified respirator with an APF of at 

least 10, and there are no consumer 

exposures. 

Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of these substances 

may present an unreasonable risk. EPA 

has determined, however, that any use 

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

least 10, where there is a potential for 


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inhalation exposures; any substantial 

increase of the annual manufacturing 

and importation volume of 10,000 kgs; 

or any use of the substances in 

consumer products may cause serious 

health effects. Based on this 

information, the PMN substances meets 

the concern criteria at § 721.170 

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

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) on PMNs P–11– 

485, P–11–486, and either P–11–488 or 

P–1l–489, would help characterize the 

human health effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10605 (P– 

11–485); 40 CFR 721.10606 (P–11–486); 

40 CFR 721.10607 (P–11–488); and 40 

CFR 721.105608 (P–11–489). 

PMN Number P–11–548 

Chemical name: Imidodicarbonic 

diamide, N,N’-dibutyl-N’,2-bis[4-[(4- 

isocyanatophenyl)methyl]phenyl]-. 

CAS number: 1254743–03–7. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymer 

crosslinking agent. Based on SAR 

analysis of test data on analogous 

diisocyanates, EPA identified concerns 

for oncogenicity, sensitization, lung 

irritation, and mucous membrane 

irritation from exposure to the PMN 

substance. For the non-consumer use 

described in the PMN, inhalation 

exposures are not expected as the 

substance is not applied by a method 

that generates a vapor, mist, or aerosol. 

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 in consumer products; or 

any use of the substance involving an 

application method that generates a 

vapor, mist, or aerosol may cause 

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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) in rats would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10609. 

PMN Numbers P–11–635 and P–11–636 

Chemical names: Toluene 

diisocyanate, polymers with 

polyalkylene glycol (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as reactants for the 

production of polyurethane elastomers. 

Based on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for oncogenicity, irritation to 

lungs and mucous membranes, and 

sensitization to workers from exposure 

to the PMN substances. For the uses 

described in the PMNs significant 

worker exposure is unlikely because 

there are no applications generating a 

vapor, mist or aerosol, and there are no 

consumer exposures. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of 

these substances may present an 

unreasonable risk. EPA has determined, 

however, that use of any of the 

substances in consumer products; or 

any use of the substance involving an 

application method that generates a 

vapor, mist, or aerosol may cause 

serious health effects. Based on this 

information, the PMN substances meet 

the concern criteria at § 721.170 

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

Recommended testing: EPA has 

determined that the results of a dermal 

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 721.10610. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 7 of the 78 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 SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160 (see 

Unit II.). 

In the other 71 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 issuing 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 rule: 

• EPA will 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 will 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 will 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 will 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. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

§ 721.160(c)(3) and § 721.170(d)(4). In 

accordance with § 721.160(c)(3)(ii) and 

§ 721.170(d)(4)(i)(B), the effective date 

of this rule is December 4, 2012 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before November 5, 

2012. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

November 5, 2012, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 


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This rule establishes SNURs for 78 

chemical substances. Any person who 

submits adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments, must identify the 

chemical substance and the new use to 

which it applies. EPA will not withdraw 

a SNUR for a chemical substance not 

identified in the comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule, October 5, 2012. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

7 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. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 40 of the 78 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

has received a limited number of postPMN bona fide submissions (per 

§§ 720.25 and 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the Federal Register 

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

has decided that the intent of TSCA 

section 5(a)(1)(B) is best served by 

designating a use as a significant new 

use as of the date of publication of this 

direct final rule rather than as of the 

effective date of the rule. If uses begun 

after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notification requirements because a 

person could defeat the SNUR by 

initiating the significant new use before 

the rule became effective, and then 

argue that the use was ongoing before 

the effective date of the rule. Thus, 

persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through this SNUR will have to cease 

any such activity before the effective 

date of this rule. To resume their 

activities, these persons would have to 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. 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 

§ 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-section 

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.’’ or for 

guidelines that are not currently 

available on the Web site, EPA has 

placed a copy of that guideline in the 

public docket. The OECD test guidelines 

are available from the OECD Bookshop 

at http://www.oecdbookshop.org or 

Source OECD at http:// 

www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for 7 of the chemical substances 

regulated under this 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. Under recent 

TSCA section 5(e) consent orders, each 

PMN submitter is required to submit 

each test at least 14 weeks (earlier TSCA 

section 5(e) consent orders required 

submissions at least 12 weeks) before 

reaching the specified production limit. 

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 nonexempt commercial manufacture, 

import, or processing. 

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. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 


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under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at 40 CFR 721.1725(b)(1). 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

would not be a significant new use, i.e., 

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. 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 

§ 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 §§ 721.25 and 

720.40. E-PMN software is available 

electronically at http://www.epa.gov/ 

opptintr/newchems. 

XI. 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 rule. EPA’s complete 

economic analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0277. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes 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 is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this 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 does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does 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 rule. 

This rule is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. 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 will be impacted by this 

rule. As such, EPA has determined that 

this rule does not impose any 


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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 will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this 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) 

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). 

XIV. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: September 24, 2012. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, add the following entries 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR 

citation 

OMB 

Control No. 

40 CFR 

citation 

OMB 

Control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10426 ............................. 2070–0012 

721.10537 ............................. 2070–0012 

721.10538 ............................. 2070–0012 

721.10539 ............................. 2070–0012 

721.10540 ............................. 2070–0012 

721.10541 ............................. 2070–0012 

721.10542 ............................. 2070–0012 

721.10543 ............................. 2070–0012 

721.10544 ............................. 2070–0012 

721.10545 ............................. 2070–0012 

721.10546 ............................. 2070–0012 

721.10547 ............................. 2070–0012 

721.10548 ............................. 2070–0012 

721.10549 ............................. 2070–0012 

721.10550 ............................. 2070–0012 

721.10551 ............................. 2070–0012 

721.10552 ............................. 2070–0012 

721.10553 ............................. 2070–0012 

721.10554 ............................. 2070–0012 

721.10555 ............................. 2070–0012 

721.10556 ............................. 2070–0012 

721.10557 ............................. 2070–0012 

721.10558 ............................. 2070–0012 

721.10559 ............................. 2070–0012 

721.10560 ............................. 2070–0012 

721.10561 ............................. 2070–0012 

721.10562 ............................. 2070–0012 

721.10563 ............................. 2070–0012 

721.10564 ............................. 2070–0012 

721.10565 ............................. 2070–0012 

721.10566 ............................. 2070–0012 

721.10567 ............................. 2070–0012 

721.10568 ............................. 2070–0012 

721.10569 ............................. 2070–0012 

721.10570 ............................. 2070–0012 

721.10571 ............................. 2070–0012 

721.10572 ............................. 2070–0012 

721.10573 ............................. 2070–0012 

721.10574 ............................. 2070–0012 

721.10575 ............................. 2070–0012 

721.10576 ............................. 2070–0012 

721.10577 ............................. 2070–0012 

721.10578 ............................. 2070–0012 

721.10579 ............................. 2070–0012 

721.10580 ............................. 2070–0012 

721.10581 ............................. 2070–0012 

721.10582 ............................. 2070–0012 

721.10583 ............................. 2070–0012 

721.10584 ............................. 2070–0012 

721.10585 ............................. 2070–0012 

721.10586 ............................. 2070–0012 

721.10587 ............................. 2070–0012 

721.10588 ............................. 2070–0012 

721.10589 ............................. 2070–0012 

721.10590 ............................. 2070–0012 

721.10591 ............................. 2070–0012 

721.10592 ............................. 2070–0012 

721.10593 ............................. 2070–0012 

721.10594 ............................. 2070–0012 

721.10595 ............................. 2070–0012 

721.10596 ............................. 2070–0012 

721.10597 ............................. 2070–0012 

721.10598 ............................. 2070–0012 

721.10599 ............................. 2070–0012 

721.10600 ............................. 2070–0012 


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40 CFR 

citation 

OMB 

Control No. 

721.10601 ............................. 2070–0012 

721.10602 ............................. 2070–0012 

721.10603 ............................. 2070–0012 

721.10604 ............................. 2070–0012 

721.10605 ............................. 2070–0012 

721.10606 ............................. 2070–0012 

721.10607 ............................. 2070–0012 

721.10608 ............................. 2070–0012 

721.10609 ............................. 2070–0012 

721.10610 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10426 to subpart E to 

read as follows: 

§ 721.10426 1-Octadecanol, manuf. of, 

distn. lights, fractionation heavies, distn. 

lights. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-octadecanol, manuf. of, distn. lights, 

fractionation heavies, distn. lights (PMN 

P–00–535; CAS No. 243640–46–2) 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)(feedstock for 

esterification). 

(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. 

■ 5. Add § 721.10537 to subpart E to 

read as follows: 

§ 721.10537 Acrylate ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylate ester (PMN P–01– 

579) 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=50). 

(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 § 721.10538 to subpart E to 

read as follows: 

§ 721.10538 Phosphonium, tetrakis 

(hydroxymethyl)-, chloride (1:1), reaction 

products with 1-tetradecanamine and urea. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonium, tetrakis(hydro 

xymethyl)-, chloride (1:1), reaction 

products with 1-tetradecanamine and 

urea (PMN P–02–161; CAS No. 359406– 

89–6) 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 = 2). 

(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 § 721.10539 to subpart E to 

read as follows: 

§ 721.10539 Bis[phenyl-2H-1,3- 

benzoxazine]derivative (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as bis[phenyl-2H-1,3- 

benzoxazine]derivative (PMN P–02– 

653) 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. 

■ 8. Add § 721.10540 to subpart E to 

read as follows: 

§ 721.10540 1,3-Benzenedimethanamine, 

N-(2-phenylethyl) derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-benzenedimethanamine, N-(2- 

phenylethyl) derivs. (PMN P–02–984; 

CAS No. 404362–22–7) 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=5). 

(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. 

■ 9. Add § 721.10541 to subpart E to 

read as follows: 

§ 721.10541 5,2,6-(Iminomethenimino)-1Himidazo[4,5-b]pyrazine, octahydro1,3,4,7,8,10-hexanitro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

5,2,6-(iminomethenimino)-1Himidazo[4,5-b]pyrazine, octahydro1,3,4,7,8,10-hexanitro- (PMN P–03–481; 

CAS No. 135285–90–4) 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), 

(b)(concentration set at 0.1 percent), and 

(c). The following respirator meets the 

requirements of § 721.63(a)(4): a 


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National Institute for Occupational 

Safety and Health (NIOSH)-certified air 

purifying respirator with a particulate 

P100 vapor cartridge or canister. 

(ii) Release to water. Requirements as 

specified in § 721.90 (a)(2)(v), (b)(2)(v), 

and (c)(2)(v). 

(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 (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. 

■ 10. Add § 721.10542 to subpart E to 

read as follows: 

§ 721.10542 Dodecanedioic acid, 1,12- 

dimethyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

dodecanedioic acid, 1,12-dimethyl ester 

(PMN P–03–624; CAS No. 1731–79–9) 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=30). 

(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. 

■ 11. Add § 721.10543 to subpart E to 

read as follows: 

§ 721.10543 Oxetane, 3-methyl-3- 

[(2,2,3,3,3-pentafluoropropoxy)methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxetane, 3-methyl-3-[(2,2,3,3,3- 

pentafluoropropoxy)methyl]- (PMN P– 

04–79; CAS No. 449177–94–0) 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), (b)(concentration 

set at 0.1 percent), and (c). 

(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) through (e) 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. 

■ 12. Add § 721.10544 to subpart E to 

read as follows: 

§ 721.10544 Oxetane, 3-methyl-3- 

[[(3,3,4,4,5,5,6,6,6- 

nonafluorohexyl)oxy]methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6- 

nonafluorohexyl)oxy]methyl]- (PMN P– 

04–80; CAS No. 475678–78–5) 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 after it has 

been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), 

(b)(concentration set at 0.1 percent), and 

(c). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

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

(g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), 

(g)(4)(ii), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (f), (g), (h), (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 (a)(2)(iii) of 

this section. 

■ 13. Add § 721.10545 to subpart E to 

read as follows: 

§ 721.10545 Aminotriazine modified cresol 

novolec resin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aminotriazine modified 

cresol novolec resin (PMN P–04–313) 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) Release to water. Requirements as 

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

(c)(4) (N = 10). 

(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. 

■ 14. Add § 721.10546 to subpart E to 

read as follows: 

§ 721.10546 Pentenylated polyethylene 

glycol sulfate salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as pentenylated 

polyethylene glycol sulfate salt (PMN P– 

04–340) 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. 

■ 15. Add § 721.10547 to subpart E to 

read as follows: 

§ 721.10547 Dialkyl dimethyl ammonium 

methylcarbonate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as dialkyl dimethyl 


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ammonium methylcarbonate (PMN P– 

04–587) 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(g). 

(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 § 721.10548 to subpart E to 

read as follows: 

§ 721.10548 Mixed alkyl phosphate esters 

alkoxylated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mixed alkyl phosphate 

esters alkoxylated (PMN P–04–624) 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 = 40). 

(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. 

■ 17. Add § 721.10549 to subpart E to 

read as follows: 

§ 721.10549 Ethane, 1,1,2,2-tetrafluoro-1- 

(2,2,2-trifluoroethoxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethane, 1,1,2,2-tetrafluoro-1-(2,2,2- 

trifluoroethoxy)- (PMN P–04–635; CAS 

No. 406–78–0) 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 (f), (j)(cleaning 

electronic components; precision 

cleaning; dewatering of electronic 

components and other parts following 

aqueous cleaning; and carrier/lubricant 

coating for hard disk drives and other 

precision parts), and (l). 

(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. 

■ 18. Add § 721.10550 to subpart E to 

read as follows: 

§ 721.10550 Rare earth salt of a carboxylic 

acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as rare earth salt of a 

carboxylic acid (PMN P–05–324) 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). 

(ii) Release to water. Requirements as 

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

(c)(4) (N = 5). 

(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 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 (a)(2)(i) of 

this section. 

■ 19. Add § 721.10551 to subpart E to 

read as follows: 

§ 721.10551 Bisphenol S mono ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as bisphenol S mono ether 

(PMN P–05–613) 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 (f) and (j). 

(ii) Release to water. Requirements as 

specified in § 721.90 (b)(4) and (c)(4) 

(N=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 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 (a)(2)(i) of 

this section. 

■ 20. Add § 721.10552 to subpart E to 

read as follows: 

§ 721.10552 Oxirane, 2-(1- 

chlorocyclopropyl)-2-[(2- 

chlorophenyl)methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane, 2-(1-chlorocyclopropyl)-2-[(2- 

chlorophenyl)methyl]- (PMN P–05–774; 

CAS No. 134818–68–1) 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), (b)(concentration 

set at 0.1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h). 

(iii) Release to water. Requirements as 

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

(c)(4) (N=2). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (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. 

■ 21. Add § 721.10553 to subpart E to 

read as follows: 


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§ 721.10553 Potassium titanium oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

potassium titanium oxide (PMN P–06– 

149; CAS No. 12673–69–7) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4) and (a)(6)(i). 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. 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

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

(1) As an alternative to the respiratory 

requirements listed 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 1.5 mg/ 

m3. Persons who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under 40 CFR 721.30. Persons 

whose § 721.30 requests to use the 

NCELs approach are approved by EPA 

will receive NCELs provisions 

comparable to those contained in the 

corresponding section 5(e) consent 

order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (f), (g)(1)(ii), (g)(2)(ii), 

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

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.5 mg/m3), 

and (a)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k)(manufacture of 

the substance with a particle size of at 

least 100 nanometers). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10554 to subpart E to 

read as follows: 

§ 721.10554 Iso-tridecanol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as iso-tridecanol (PMN P– 

06–153) 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(k) (manufacture of 

the PMN substance with no greater than 

an average of three branches per alkyl 

unit, and routine analysis of 

representative samples for compliance 

with the chemical composition section 

of the consent order). 

(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. 

■ 23. Add § 721.10555 to subpart E to 

read as follows: 

§ 721.10555 Benzoic acid nonyl ester, 

branched and linear. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzoic acid nonyl ester, branched and 

linear (PMN P–06–370; CAS No. 

670241–72–2) 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), (b)(concentration 

set at 0.1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(iii) Release to water. Requirements as 

specified in § 721.90 (b)(4) and (c)(4) 

(N=6). 

(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. 

■ 24. Add § 721.10556 to subpart E to 

read as follows: 

§ 721.10556 Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-15-alkyl ethers. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-15-alkyl ethers (PMN P–06– 

450; CAS No. 675869–02–0) 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(s)(45,000 

kilograms cumulative production 

volume of: Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) 

-.omega.-hydroxy-,C12-15-alkyl ethers 

(PMN P–06–450; CAS No. 675869–02– 

00); Poly(oxy-1,2-ethanediyl), .alpha.- 

(2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers (PMN P–06– 

451; CAS No. 620610–66–4); and 

Poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers (PMN P–06– 

452; CAS No. 675869–05–3)). 

(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. 


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■ 25. Add § 721.10557 to subpart E to 

read as follows: 

§ 721.10557 Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers (PMN P–06– 

451; CAS No. 620610–66–4) 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(s)(45,000 

kilograms cumulative production 

volume of: Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) 

-.omega.-hydroxy-,C12-15-alkyl ethers 

(PMN P–06–450; CAS No. 675869–02– 

00); Poly(oxy-1,2-ethanediyl), .alpha.- 

(2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers (PMN P–06– 

451; CAS No. 620610–66–4); and 

Poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers (PMN P–06– 

452; CAS No. 675869–05–3)). 

(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. 

■ 26. Add § 721.10558 to subpart E to 

read as follows: 

§ 721.10558 Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers (PMN P–06– 

452; CAS No. 675869–05–3) 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(s)(45,000 

kilograms cumulative production 

volume of: Poly(oxy-1,2-ethanediyl), 

.alpha.- (2-methyl-2-propen-1-yl) 

-.omega.-hydroxy-,C12-15-alkyl ethers 

(PMN P–06–450; CAS No. 675869–02– 

00); Poly(oxy-1,2-ethanediyl), .alpha.- 

(2-methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C10-16-alkyl ethers (PMN P–06– 

451; CAS No. 620610–66–4); and 

Poly(oxy-1,2-ethanediyl), .alpha.- (2- 

methyl-2-propen-1-yl) -.omega.- 

hydroxy-,C12-16-alkyl ethers (PMN P–06– 

452; CAS No. 675869–05–3)). 

(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. 

■ 27. Add § 721.10559 to subpart E to 

read as follows: 

§ 721.10559 Morpholine, 4–C6-12 acyl 

derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

morpholine, 4–C6-12 acyl derivs. (PMN 

P–06–793; CAS No. 887947–29–7) 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), (b)(concentration 

set at 0.1 percent), and (c). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

0.1 percent), (f), (g)(1)(systemic effects), 

(g)(2)(i), and (g)(2)(v). 

(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 (h) 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. 

■ 28. Add § 721.10560 to subpart E to 

read as follows: 

§ 721.10560 Alkanoldioic dialkyl esters 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkanoldioic dialkyl esters 

(PMNs P–07–143 and P–07–144) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(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 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 (a)(2)(i) of 

this section. 

■ 29. Add § 721.10561 to subpart E to 

read as follows: 

§ 721.10561 Substituted phenol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted phenol (PMN 

P–07–327) 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) Hazard communication program. 

Requirements as specified as § 721.72 

(a), (b), (c), (f), (g)(3)(i), (g)(3)(ii), 

(g)(4)(iii), and (g)(5). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified as § 721.80(q). 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (f), (g), (h), (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 (a)(2)(ii) of 

this section. 

■ 30. Add § 721.10562 to subpart E to 

read as follows: 


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§ 721.10562 Aluminum trihydrate and 

silane homopolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aluminum trihydrate and 

silane homopolymer (PMN P–07–375) 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(s)(100,000 

kilograms). 

(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. 

■ 31. Add § 721.10563 to subpart E to 

read as follows: 

§ 721.10563 2-Oxiranemethanamine, N-[3- 

(2-oxiranylmethoxy)phenyl]-N-(2- 

oxiranylmethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-oxiranemethanamine, N-[3-(2- 

oxiranylmethoxy)phenyl]-N-(2- 

oxiranylmethyl)- (PMN P–07–496; CAS 

No. 71604–74–5) 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)(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(j)(preparation of 

pre-impregnated cloth/fiber tapes for 

aerospace composite articles). 

(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. 

■ 32. Add § 721.10564 to subpart E to 

read as follows: 

§ 721.10564 Mixed amino diaryl sulfone 

isomers (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mixed amino diaryl 

sulfone isomers (PMN P–08–39) 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 (o), (v)(1), (w)(1), 

and (x)(1). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=8). 

(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 this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 33. Add § 721.10565 to subpart E to 

read as follows: 

§ 721.10565 Ethanol, 2,2′-[[3-[(2- 

hydroxyethyl)amino]propyl]imino]bis-, N- 

(hydrogenated tallow alkyl) derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethanol, 2,2′-[[3-[(2- 

hydroxyethyl)amino]propyl]imino]bis-, 

N-(hydrogenated tallow alkyl) derivs. 

(PMN P–08–263; CAS No. 90367–25–2) 

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. 

■ 34. Add § 721.10566 to subpart E to 

read as follows: 

§ 721.10566 1-Propanamine, N-(1- 

methylethyl) -,3-(C12-15-alkyloxy) derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propanamine, N-(1-methylethyl)-,3- 

(C12-15-alkyloxy) derivs (PMN P–08–292; 

CAS No. 944835–56–7) 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. 

■ 35. Add § 721.10567 to subpart E to 

read as follows: 

§ 721.10567 Amidoamine salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amidoamine salt (PMN P– 

08–300) 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. 

■ 36. Add § 721.10568 to subpart E to 

read as follows: 

§ 721.10568 Diethanolamine salt of 

polymeric acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diethanolamine salt of 

polymeric acid (PMN P–08–464) is 


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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=4). 

(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. 

■ 37. Add § 721.10569 to subpart E to 

read as follows: 

§ 721.10569 Tricyclic quaternary amine 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tricyclic quaternary amine 

salt (PMN P–08–471) 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=100). 

(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. 

■ 38. Add § 721.10570 to subpart E to 

read as follows: 

§ 721.10570 Cyclic amine reaction product 

with acetophenone and formaldehyde acid 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as cyclic amine reaction 

product with acetophenone and 

formaldehyde acid salt (PMN P–08–537) 

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=8). 

(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. 

■ 39. Add § 721.10571 to subpart E to 

read as follows: 

§ 721.10571 1,3-Benzenediol, polymer with 

1,1’-methylenebis[isocyanatobenzene]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-benzenediol, polymer with 1,1’- 

methylenebis[isocyanatobenzene] (PMN 

P–08–611; CAS No. 1008753–84–1) 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 

with all isocyanate groups reacted 

within the polymer). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=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 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 (a)(2)(i) of 

this section. 

■ 40. Add § 721.10572 to subpart E to 

read as follows: 

§ 721.10572 Benzamide, N-[[4- 

[(cyclopropylamino)carbonyl]phenyl]

sulfonyl]-2-methoxy-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzamide, N-[[4-[(cyclopropyl

amino)carbonyl]phenyl]sulfonyl]-2-

methoxy- (PMN P–08–680; CAS No. 

221667–31–8) 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)(i), 

(b)(concentration set at 0.1 percent), and 

(c). 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. 

(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) Hazard communication program. 

Requirements as specified in § 721.72 

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

0.1 percent), (f), (g)(1)(iv), (g)(2)(iv), and 

(g)(2)(v). 

(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 (h) 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. 

■ 41. Add § 721.10573 to subpart E to 

read as follows: 

§ 721.10573 Magnesium hydroxide surface 

treated with substituted alkoxysilanes 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as magnesium hydroxide 

surface treated with substituted 

alkoxysilanes (PMN P–08–737) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(6)(i), (b)(concentration set at 

0.1 percent), and (c). 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. 

(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) Hazard communication program. 

Requirements as specified in § 72l.72(a), 

(b), (c), (d), (e)(concentration set at 0.1 

percent), (f), (g)(l)(ii), (g)(l)(viii), and 

(g)(2)(iv). 

(iii) 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), (f), (g), (h), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 42. Add § 721.10574 to subpart E to 

read as follows: 

§ 721.10574 Alkylcarboxy polyester 

acrylate reaction products with mixed metal 

oxides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylcarboxy polyester 

acrylate reaction products with mixed 

metal oxides (PMN P–09–48) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), and (a)(3). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(v), 

(g)(4)(i), (g)(4)(iii), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified § 721.80 (a) (if used in the 

form of a powder), (b) (if manufactured 

in the form of a powder), (c) (if 

processed in the form of a powder), (k) 

(transport to processors using only 

reusable tote tanks cleaned not more 

than once per year), (y)(1), and (y)(2). 

(iv) Disposal. Requirements as 

specified in § 721.85 (a)(1), (b)(1), (c)(1), 

and (d)(recycling of use waste stream 

via polymer reclamation as an 

alternative to incineration). (All 

incineration shall be via Resource 

Conservation and Recovery Act (RCRA) 

approved hazardous waste 

incineration). 

(v) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a) through (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 (a)(2)(iii) of 

this section. 

■ 43. Add § 721.10575 to subpart E to 

read as follows: 

§ 721.10575 1-Propanone, 1,1’-(oxydi-4,1- 

phenylene)bis[2-hydroxy-2-methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propanone, 1,1’-(oxydi-4,1- 

phenylene)bis[2-hydroxy-2-methyl- 

(PMN P–09–480; CAS No. 71868–15–0) 

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) (concentration set at 

0.1 percent), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 satisfy 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. 

(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) Hazard communication program. 

Requirements as specified in § 72l.72(a), 

(b), (c), (d), (e) (concentration set at 0.1 

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

(g)(2)(iv), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(iv) Release to water. Requirements as 

specified in § 721.90 (b)(4) and (c)(4) 

(N=14). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (f), (g), (h), (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. 

■ 44. Add § 721.10576 to subpart E to 

read as follows: 

§ 721.10576 Polyalkenyl, N,N’-bistriazole 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyalkenyl, N,N’- 

bistriazole (PMN P–09–486) 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). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 


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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 (a)(2)(i) of 

this section. 

■ 45. Add § 721.10577 to subpart E to 

read as follows: 

§ 721.10577 Benzenamine, 5-(1,1- 

dimethylethyl)-2-[(2-ethylhexyl)thio]-,4- 

methylbenzenesulfonate (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenamine, 5-(1,1-dimethylethyl)-2- 

[(2-ethylhexyl)thio]-,4- 

methylbenzenesulfonate (1:1) (PMN P– 

09–636; CAS No. 852360–51–1) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (f), (g)(1)(ix), (g)(2)(ii), 

(g)(2)(iii), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), 

and (g)(5). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (h) and (p)(15,000 

kilograms, 170,000 kilograms, and 

496,000 kilograms). 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (f), (g), (h), (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. 

■ 46. Add § 721.10578 to subpart E to 

read as follows: 

§ 721.10578 Unsaturated polyester imide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as unsaturated polyester 

imide (PMN P–10–231) 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 = 52). 

(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. 

■ 47. Add § 721.10579 to subpart E to 

read as follows: 

§ 721.10579 Carbon black derived from the 

pyrolysis of rubber tire shreds (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon black derived from 

the pyrolysis of rubber tire shreds (PMN 

P–10–367) 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 (k)(Manufacture of 

the PMN substance using only the 

process described in PMN; 

manufacturing, processing, or use of the 

PMN substance in compliance with the 

Occupational Safety and Health 

Administration (OSHA) Permissible 

Exposure Limit (PEL) for carbon black of 

3.5 mg/m3; and manufacture of the PMN 

substance to meet the NIOSH 

recommended time weighted average 

(TWA) for polyaromatic hydrocarbons 

(PAH) in carbon black of 0.1 mg/m3); 

and (q). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (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 (a)(2)(i) of 

this section. 

■ 48. Add § 721.10580 to subpart E to 

read as follows: 

§ 721.10580 Poly[oxy(methyl-1,2- 

ethanediyl)], alpha, alpha′-[1,4- 

cyclohexanediylbis(methylene)]bis[omega- 

(2-aminomethylethoxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly[oxy(methyl-1,2-ethanediyl)], alpha, 

alpha′-[1,4-cyclohexanediylbis

(methylene)]bis[omega-(2-amino

methylethoxy)- (PMN P–10–452; CAS 

No. 1220986–58–2) 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 = 98). 

(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. 

■ 49. Add § 721.10581 to subpart E to 

read as follows: 

§ 721.10581 Brominated polyurethane 

prepolymers of methylene diphenyl 

diisocyanate (MDI) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as brominated polyurethane 

prepolymers of methylene diphenyl 

diisocyanate (MDI) (PMNs P–10–524 

and P–10–525) 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)(4), (a)(6)(i), (a)(6)(ii), 

(b)(concentration set at 0.1 percent), and 

(c). 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): 


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(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. 

(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 these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 50. Add § 721.10582 to subpart E to 

read as follows: 

§ 721.10582 Quaternary ammonium 

compound (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as quaternary ammonium 

compound (PMN P–10–571) 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 = 47). 

(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. 

■ 51. Add § 721.10583 to subpart E to 

read as follows: 

§ 721.10583 Benzenamine, 4,4′-[1,3- 

phenylenebis(1-methylethylidene)]bis-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenamine, 4,4′-[1,3-phenylenebis(1- 

methylethylidene)]bis- (PMN P–10–588; 

CAS No. 2687–27–6) 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), 

(b)(concentration set at 0.1 percent), and 

(c). The following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 1,000 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. 

(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) Release to water. Requirements as 

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

(c)(4) (N = 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), 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. 

■ 52. Add § 721.10584 to subpart E to 

read as follows: 

§ 721.10584 Cyclopentene, 1,3,3,4,4,5,5- 

heptafluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cyclopentene, 1,3,3,4,4,5,5-heptafluoro- 

(PMN P–11–29; CAS No. 1892–03–1) 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 (f), (j)(dry etching 

agent for production of 

semiconductors), (o), and (s) (10,000 

kilograms). 

(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. 

■ 53. Add § 721.10585 to subpart E to 

read as follows: 

§ 721.10585 Disiloxane, 1-butyl-1,1,3,3- 

tetramethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

disiloxane, 1-butyl-1,1,3,3-tetramethyl- 

(PMN P–11–43; CAS No. 121263–51–2) 

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. 

■ 54. Add § 721.10586 to subpart E to 

read as follows: 

§ 721.10586 Disiloxane, 1,3-dibutyl-1,1,3,3- 

tetramethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

disiloxane, 1,3-dibutyl-1,1,3,3- 

tetramethyl- (PMN P–11–44; CAS No. 

4619–08–3) is subject to reporting under 


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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. 

■ 55. Add § 721.10587 to subpart E to 

read as follows: 

§ 721.10587 1H-Pyrazole, 3,4-dimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1H-pyrazole, 3,4-dimethyl- (PMN P–11– 

81; CAS No. 2820–37–3) 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 = 19). 

(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. 

■ 56. Add § 721.10588 to subpart E to 

read as follows: 

§ 721.10588 Phenol, 2-[1-[[3-(1H-imidazol1-yl)propyl]imino]ethyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-[1-[[3-(1H-imidazol-1- 

yl)propyl]imino]ethyl]- (PMN P–11–98; 

CAS No. 1253404–90–8) 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) 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. 

■ 57. Add § 721.10589 to subpart E to 

read as follows: 

§ 721.10589 Unsaturated fatty acids, 

amides with polyethylenepolyamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as unsaturated fatty acids, 

amides with polyethylenepolyamine 

(PMN P–11–106) 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. 

■ 58. Add § 721.10590 to subpart E to 

read as follows: 

§ 721.10590 Fatty acids, amides with 

triethylentetramine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, amides with 

triethylentetramine (PMN P–11–107) 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. 

■ 59. Add § 721.10591 to subpart E to 

read as follows: 

§ 721.10591 Tertiary ammonium 

compound (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tertiary ammonium 

compound (PMN P–11–110) 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. 

■ 60. Add § 721.10592 to subpart E to 

read as follows: 

§ 721.10592 1-Butanol, 4-amino-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-butanol, 4-amino- (PMN P–11–130; 

CAS No. 13325–10–5) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(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. 


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■ 61. Add § 721.10593 to subpart E to 

read as follows: 

§ 721.10593 5-Isobenzofurancarboxylic 

acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1- 

oxo-2-propen-1-yl)oxy]ethyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

5-isobenzofurancarboxylic acid, 1,3- 

dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo2-propen-1-yl)oxy]ethyl ester (PMN P– 

11–162; CAS No. 70293–55–9) 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=20). 

(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. 

■ 62. Add § 721.10594 to subpart E to 

read as follows: 

§ 721.10594 Hexanedioic acid, polymer 

with 2,2-dimethyl-1,3-propanediol, 1,6- 

hexanediol, hydrazine, 3-hydroxy-2- 

(hydroxymethyl)-2-methylpropanoic acid, 5- 

isocyanato-1-(isocyanatomethyl)-1,3,3- 

trimethylcyclohexane and 1,1′-[(1- 

methylethylidene)bis(4,1- 

phenyleneoxy)]bis[2-propanol], iso-Bu alc.- 

blocked, compds. with triethylamine. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

hexanedioic acid, polymer with 2,2- 

dimethyl-1,3-propanediol, 1,6- 

hexanediol, hydrazine, 3-hydroxy-2- 

(hydroxymethyl)-2-methylpropanoic 

acid, 5-isocyanato-1-(isocyanatomethyl)- 

1,3,3-trimethylcyclohexane and 1,1′-[(1- 

methylethylidene)bis(4,1- 

phenyleneoxy)]bis[2-propanol], iso-Bu 

alc.-blocked, compds. with 

triethylamine (PMN P–11–173; CAS No. 

1138156–39–4) 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=150) (Where primary, 

secondary, and tertiary waste treatment 

will occur, or treatment in a lined, selfcontained solar evaporation pond where 

ultraviolet light will degrade the 

substance, the number of kilograms per 

day per site is calculated after 

wastewater treatment). 

(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. 

■ 63. Add § 721.10595 to subpart E to 

read as follows: 

§ 721.10595 Octadecen-1-aminium, Nethyl-N,N-dimethy-, ethyl sulfate (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

octadecen-1-aminium, N-ethyl-N,Ndimethy-, ethyl sulfate (1:1) (PMN P– 

11–230; CAS No. 1256282–88–8) 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) Release to water. Requirements as 

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

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

(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. 

■ 64. Add § 721.10596 to subpart E to 

read as follows: 

§ 721.10596 Oligomeric phenolic ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oligomeric phenolic ether 

(PMN P–11–234) 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. 

■ 65. Add § 721.10597 to subpart E to 

read as follows: 

§ 721.10597 Benzeneacetonitrile, alkoxy- 

[[(alkylsulfonyl)oxy]imino]- (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzeneacetonitrile, 

alkoxy-[[(alkylsulfonyl)oxy]imino]- 

(PMN P–11–252) 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. 

■ 66. Add § 721.10598 to subpart E to 

read as follows: 

§ 721.10598 Lead strontium titanium 

zirconium oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3) 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), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

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. 


pmangrum on DSK3VPTVN1PROD with RULES4
61152 Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 

(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. 

(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(j) (piezoelectric 

ceramics for active and passive 

underwater acoustic systems). 

(iii) Release to water. Requirements as 

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

(c)(4) (Where N=8, and 8 is an aggregate 

of releases for the following substances: 

Lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3); Calcium cobalt lead titanium 

tungsten oxide (PMN P–11–271; CAS 

No. 1262279–31–1); Calcium cobalt lead 

strontium titanium tungsten oxide 

(PMN P–11–272; CAS No. 1262279–30– 

0); Lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0); and Lead niobium 

titanium zirconium oxide (PMN P–11– 

274; CAS No. 56572–83–9)). 

(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), (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. 

■ 67. Add § 721.10599 to subpart E to 

read as follows: 

§ 721.10599 Calcium cobalt lead titanium 

tungsten oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

calcium cobalt lead titanium tungsten 

oxide (PMN P–11–271; CAS No. 

1262279–31–1) 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), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

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. 

(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(j) (piezoelectric 

ceramics for active and passive 

underwater acoustic systems). 

(iii) Release to water. Requirements as 

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

(c)(4) (Where N=8, and 8 is an aggregate 

of releases for the following substances: 

Lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3); Calcium cobalt lead titanium 

tungsten oxide (PMN P–11–271; CAS 

No. 1262279–31–1); Calcium cobalt lead 

strontium titanium tungsten oxide 

(PMN P–11–272; CAS No. 1262279–30– 

0); Lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0); and Lead niobium 

titanium zirconium oxide (PMN P–11– 

274; CAS No. 56572–83–9)). 

(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), (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. 

■ 68. Add § 721.10600 to subpart E to 

read as follows: 

§ 721.10600 Calcium cobalt lead strontium 

titanium tungsten oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

calcium cobalt lead strontium titanium 

tungsten oxide (PMN P–11–272; CAS 

No. 1262279–30–0) 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), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

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. 

(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(j) (piezoelectric 

ceramics for active and passive 

underwater acoustic systems). 

(iii) Release to water. Requirements as 

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

(c)(4) (Where N=8, and 8 is an aggregate 

of releases for the following substances: 

Lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3); Calcium cobalt lead titanium 

tungsten oxide (PMN P–11–271; CAS 

No. 1262279–31–1); Calcium cobalt lead 

strontium titanium tungsten oxide 

(PMN P–11–272; CAS No. 1262279–30– 

0); Lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0); and Lead niobium 

titanium zirconium oxide (PMN P–11– 

274; CAS No. 56572–83–9)). 

(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), (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. 


pmangrum on DSK3VPTVN1PROD with RULES4
Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 61153 

■ 69. Add § 721.10601 to subpart E to 

read as follows: 

§ 721.10601 Lanthanum lead titanium 

zirconium oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0) 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), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

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. 

(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(j) (piezoelectric 

ceramics for active and passive 

underwater acoustic systems). 

(iii) Release to water. Requirements as 

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

(c)(4) (Where N=8, and 8 is an aggregate 

of releases for the following substances: 

Lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3); Calcium cobalt lead titanium 

tungsten oxide (PMN P–11–271; CAS 

No. 1262279–31–1); Calcium cobalt lead 

strontium titanium tungsten oxide 

(PMN P–11–272; CAS No. 1262279–30– 

0); Lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0); and Lead niobium 

titanium zirconium oxide (PMN P–11– 

274; CAS No. 56572–83–9)). 

(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), (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. 

■ 70. Add § 721.10602 to subpart E to 

read as follows: 

§ 721.10602 Lead niobium titanium 

zirconium oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lead niobium titanium zirconium oxide 

(PMN P–11–274; CAS No. 56572–83–9) 

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), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

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. 

(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(j) (piezoelectric 

ceramics for active and passive 

underwater acoustic systems). 

(iii) Release to water. Requirements as 

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

(c)(4) (Where N=8, and 8 is an aggregate 

of releases for the following substances: 

Lead strontium titanium zirconium 

oxide (PMN P–11–270; CAS No. 61461– 

40–3); Calcium cobalt lead titanium 

tungsten oxide (PMN P–11–271; CAS 

No. 1262279–31–1); Calcium cobalt lead 

strontium titanium tungsten oxide 

(PMN P–11–272; CAS No. 1262279–30– 

0); Lanthanum lead titanium zirconium 

oxide (PMN P–11–273; CAS No. 

1227908–26–0); and Lead niobium 

titanium zirconium oxide (PMN P–11– 

274; CAS No. 56572–83–9)). 

(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), (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. 

■ 71. Add § 721.10603 to subpart E to 

read as follows: 

§ 721.10603 Epoxy modified alkyd resin, 

partially neutralized (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as epoxy modified alkyd 

resin, partially neutralized (PMN P–11– 

280) 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. 

■ 72. Add § 721.10604 to subpart E to 

read as follows: 

§ 721.10604 Polyetherdiamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyetherdiamine (PMN 

P–11–447) 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=4). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 


pmangrum on DSK3VPTVN1PROD with RULES4
61154 Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 

(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. 

■ 73. Add § 721.10605 to subpart E to 

read as follows: 

§ 721.10605 Polyoxyalkylene ether, 

polymer with aliphatic diisocyanate, 

homopolymer, alkanol-blocked (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyoxyalkylene ether, 

polymer with aliphatic diisocyanate, 

homopolymer, alkanol-blocked (PMN 

P–11–485) 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), (b) 

(concentration set at 0.1 percent), and 

(c). 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. 

(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) and (s) (10,000 

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. 

■ 74. Add § 721.10606 to subpart E to 

read as follows: 

§ 721.10606 Alkyl substituted alkanediol 

polymer with aliphatic and alicyclic 

diisocyanates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl substituted 

alkanediol polymer with aliphatic and 

alicyclic diisocyanates (PMN P–11–486) 

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), (b) 

(concentration set at 0.1 percent), and 

(c). 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. 

(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) and (s) (10,000 

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. 

■ 75. Add § 721.10607 to subpart E to 

read as follows: 

§ 721.10607 Aliphatic diisocyanate, 

homopolymer, alkanol-blocked (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic diisocyanate, 

homopolymer, alkanol-blocked (PMN 

P–11–488) 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), (b) 

(concentration set at 0.1 percent), and 

(c). 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. 

(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) and (s) (10,000 

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. 

■ 76. Add § 721.10608 to subpart E to 

read as follows: 


pmangrum on DSK3VPTVN1PROD with RULES4
Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations 61155 

§ 721.10608 Aliphatic diisocyanate 

polymer with alkanediol and alkylglycol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic diisocyanate 

polymer with alkanediol and alkylglycol 

(PMN P–11–489) 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), (b) 

(concentration set at 0.1 percent), and 

(c). 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. 

(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) and (s) (10,000 

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. 

■ 77. Add § 721.10609 to subpart E to 

read as follows: 

§ 721.10609 Imidodicarbonic diamide, 

N,N′-dibutyl-N′,2-bis[4-[(4- 

isocyanatophenyl)methyl]phenyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

imidodicarbonic diamide, N,N′-dibutylN′,2-bis[4-[(4- 

isocyanatophenyl)methyl]phenyl]-(PMN 

P–11–548; CAS No. 1254743–03–7) 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 (o) and (y)(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 (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. 

■ 78. Add § 721.10610 to subpart E to 

read as follows: 

§ 721.10610 Toluene diisocyanate, 

polymers with polyalkylene glycol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as toluene diisocyanate, 

polymers with polyalkylene glycol 

(PMNs P–11–635 and P–11–636) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (o) and (y)(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 (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. 

[FR Doc. 2012–23993 Filed 10–4–12; 8:45 am] 

BILLING CODE P 


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