Vol. 79 Wednesday, 

No. 131 July 9, 2014 

Part VI 

Environmental Protection Agency 

40 CFR Parts 9 and 721 

Significant New Use Rules on Certain Chemical Substances; Direct Final 

Rule 

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39268 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2014–0166; FRL–9910–01] 

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 43 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Six of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture (including 

import) or process any of these 43 

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 

September 8, 2014. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (e.s.t.) on July 23, 

2014. 

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 August 8, 2014 (see Unit VI. of 

the SUPPLEMENTARY INFORMATION). 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 August 8, 

2014, EPA will withdraw the relevant 

sections of this direct final rule before 

its effective date. 

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–2014–0166, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• 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: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division (7405 

M), Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, 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 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 a proposed or final 

SNUR, are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the Agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 39269 

EPA at least 90 days before commencing 

the manufacture 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). 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6, or 7 to control the activities 

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 43 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 

43 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 the basis for the TSCA 

non-section 5(e) SNURs (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 6 PMN substances 

(P-11-526, P-12-241, P-12-242, P-12-557, 

P-12-558, and P-13-237) 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 ‘‘TSCA section 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 

TSCA section 5(e) SNURs designate as 

a ‘‘significant new use’’ the absence of 

the protective measures required in the 

corresponding consent orders. 

This rule also includes SNURs on 36 

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 ‘‘TSCA 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 TSCA nonsection 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 Numbers P-08-512 and P-08-513 

Chemical names: (P-08-512) Alcohol 

propoxylate (generic) and (P-05-513) 

Alcohol propoxylate sulfate salt 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances are as a chemical 

intermediate (P-08-512), and for 

enhanced oil recovery applications (Pmstockstill on DSK4VPTVN1PROD with RULES4

39270 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

08-513). Based on structural activity 

relationship (SAR) analysis of the test 

data on analogous neutral organics (P08-512) and anionic surfactants (P-08- 

513), EPA predicts toxicity to aquatic 

organisms at concentrations that exceed 

1 part per billion (ppb) of P-08-512 and 

15 ppb of P-08-513 in surface waters. 

However, based on test data submitted 

on analogous chemical substances, EPA 

expects the actual risk to aquatic 

organisms in surface waters to be 

significantly mitigated following 

biological treatment at publicly owned 

treatment works or at on-site waste 

water treatment plants, injection to 

Class I or II wells, or incineration. As 

described in the PMN notices, releases 

are either injected into Class I or II 

wells, incinerated, or released to surface 

waters after biological treatment. 

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 nonindustrial use, or any release during 

manufacturing, processing, or use other 

than injection to Class I or II wells, 

incineration, or release to water 

following biological treatment and 

clarification may cause significant 

adverse environmental effects. Based on 

this information, the PMN substances 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

Modified Shake-Flask Biodegradation 

Test (Cripe, C.R., Walker, W.W., 

Pritchard, P.H., Borquin, A.W. (1987). 

Shake-Flask Test for Estimation of 

Biodegradability of Toxic Organic 

Substances in the Aquatic Environment. 

Ecotoxicology and Environmental Safety 

14:239–251) utilizing an algal toxicity 

test (Office of Chemical Safety and 

Pollution Prevention (OCSPP) Test 

Guideline 850.4500); an aquatic 

invertebrate toxicity test, freshwater 

daphnids (OPPTS Test Guideline 

850.1010); and a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) with supplemental 

analytics to identify degradation 

products, would help to characterize the 

environmental effects of the PMN 

substances. Testing is recommended to 

be conducted on P-08-513. EPA suggests 

conducting the modified shake-flask 

biodegradation test first as the results 

may impact the ecotoxicity testing 

recommendations. 

CFR citation: 40 CFR 721.10725 (P-08- 

512) and 40 CFR 721.10726 (P-08-513). 

PMN Number P-11-526 

Chemical name: Amphoteric 

fluorinated surfactant (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: August 20, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a surface active agent. Based 

on test data on the PMN substance and 

data currently available to the Agency 

on analogous perfluorooctanoic acid 

(PFOA), EPA identified concerns for 

potential incineration or other 

decomposition products or degradants 

of the PMN substance. EPA also has 

concerns that exposures to the PMN 

substance under certain conditions of 

use—particularly non-industrial, 

commercial, or consumer uses—could 

cause lung effects, based on data on 

analogous perfluorinated compounds. 

PFOA is expected to persist for years in 

the environment. Biodegradation and 

photolysis tests of analogous substances 

indicate little or no biodegradation or 

photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns 

are based on the measured presence of 

certain perfluoroalkyl compounds, 

including PFOA, in wildlife and in 

human blood samples. Toxicity studies 

on PFOA indicate developmental, 

reproductive and systemic toxicity in 

various species, as well as cancer. These 

factors taken together raise concerns for 

potential adverse chronic effects in 

humans and wildlife. 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 

these substances may present an 

unreasonable risk of injury to human 

health and the environment, these 

substances 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 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

Material Safety Data Sheet (MSDS), 

within 90 days. 

2. Manufacture of the PMN substance: 

(a) According to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting material impurities to 

EPA; and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substance as 

stated in the consent order. 

3. Use of the substance only as 

described in the consent order. 

4. Submission of certain testing prior 

to exceeding the confidential 

production volume limit of the PMN 

substance specified in the consent 

order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the test data from 

certain human health, environmental 

fate, and ecotoxicity testing identified in 

the consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The company has agreed not 

to exceed the first production limit 

without performing a Zahn-Wellens 

biodegradation test (OPPTS Test 

Guideline 835.5200) with analysis for 

degradation products as specified, and a 

hydrolysis test as a function of pH and 

temperature (OPPTS Test Guideline 

835.2130). The PMN submitter has also 

agreed not to exceed the second 

production limit without performing a 

90-day repeated dose oral toxicity study 

in rats with 1-generation reproduction 

parallel study (must include 

modifications) (OECD Test Guideline 

421 modified) and a soil biodegradation 

study (OECD Test Guideline 307). The 

company has agreed not to exceed the 

third production limit without 

performing an ultraviolet (UV) visible 

light absorption study (OPPTS Test 

Guideline 830.7050), a direct photolysis 

test, if wavelengths greater than 290 

nautical miles (nm) are absorbed in the 

previous test (OPPTS Test Guideline 

830.7050) (OPPTS Test Guideline 

835.2210), an indirect photolysis 

screening test (OPPTS Test Guideline 

835.5270), an anaerobic biodegradability 

of organic compounds in digested 

sludge test (OECD Test Guideline 311), 

and an avian reproduction test (OPPTS 

Test Guideline 850.2300) in bobwhite 

quail. Further testing details are 

available in the consent order located in 

the docket under docket EPA–HQ– 

OPPT–2014–0166. The consent order 

does not require submission of the 

additional pended testing detailed in 

the consent order at any specified time 

or production volume. However, the 

consent order’s restrictions on 

manufacture, processing, distribution in 

commerce, use, and disposal of the 

PMNs 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 721.10727. 

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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 39271 

PMN Numbers P-12-241 and P-12-242 

Chemical names: (P-12-241) 2- 

Propenoic acid, 2-methyl-, 2- 

hydroxyethyl esters, telomers with C18- 

26-alkyl acrylate, 1-dodecanethiol, N- 

(hydroxymethyl)-2-methyl-2- 

propenamide, polyfluorooctyl 

methacrylate, 2,2′-[1,2-diazenediylbis(1- 

methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated 

(generic) and (P-12-242) 2-Propenoic 

acid, 2-methyl-, C16-18 esters, telomers 

with 3-chloro-2-hydroxypropyl 

methacrylate, 1-dodecanethiol, N- 

(hydroxymethyl)-2-methyl-2- 

propenamide, polyfluorooctyl 

methacrylate, and rel- (1R,2R,4R)-1,7,7- 

trimethylbicyclo[2.2.1]hept-2-yl 

methacrylate, 2,2′-[1,2-diazenediylbis(1- 

methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated 

(generic). 

CAS numbers: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: June 5, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of these 

substances is as a water and oil 

repellant. Based on analogy to other 

perfluorinated chemicals, including 

PFOA, EPA has concerns for potential 

fluorinated incineration or other 

decomposition products of the PMN 

substances. EPA has concerns that these 

perfluorinated products may be released 

to the environment from incomplete 

incineration of the PMN substances at 

low temperatures. EPA has preliminary 

evidence that suggests that, under some 

conditions, the PMN substances could 

degrade in the environment. Based on 

data on analogous chemicals, including 

PFOA, EPA has concerns that these 

degradation products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

people, wild mammals, and birds. 

PFOA is expected to persist for years in 

the environment. Biodegradation and 

photolysis tests of analogous substances 

indicate little or no biodegradation or 

photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns 

are based on the measured presence of 

certain perfluoroalkyl compounds, 

including PFOA, in wildlife and in 

human blood samples. Toxicity studies 

on PFOA indicate developmental, 

reproductive and systemic toxicity in 

various species, as well as possible 

cancer concerns. These factors, taken 

together, raise concerns for potential 

adverse chronic effects in humans and 

wildlife. The consent order was issued 

under TSCA section 5(e)(1)(A) based on 

a finding that these substances may 

present an unreasonable risk of injury to 

human health and the environment, 

these substances 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 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substances 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

Material Safety Data Sheet (MSDS), 

within 90 days. 

2. Manufacture of the PMN 

substances: (a) According to the 

chemical composition section of the 

consent order, including analyzing and 

reporting certain starting raw material 

impurities to EPA; and (b) within the 

maximum established limits of certain 

fluorinated impurities of the PMN 

substances as stated in the consent 

order. 

3. Use of the substances only as 

described in the consent order. 

4. Submission of certain 

environmental fate and toxicity testing 

prior to exceeding the confidential 

production volume limit of the 

aggregate amount of the PMN 

substances described in P-12-241 and P12-242 specified in the consent order. 

5. The individual annual manufacture 

volume for P-12-241 and P-12-242 must 

not reach the confidential annual 

production volume specified in the 

consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the test data from 

certain human health, environmental 

fate, and ecotoxicity testing identified in 

the consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The company has agreed not 

to exceed the first production limit 

without performing a hydrolysis as a 

function of pH and temperature test 

(OPPTS Test Guideline 835.2130), a 

ready biodegradation test (OPPTS Test 

Guideline 835.3110), a UV/Visible light 

spectrum test (OPPTS Test Guideline 

830.7050), a direct photolysis test 

(OPPTS Test Guideline 835.2210) and 

an indirect photolysis screening test 

(OPPTS Test Guideline 835.5270). The 

company has also agreed not to exceed 

the second production limit without 

performing a modified semi-continuous 

activated sludge (SCAS) with analysis of 

degradation products test (OPPTS Test 

Guideline 835.5045/), an aerobic/

anaerobic transformation in soil test 

(OECD Test Guideline 307), an 

anaerobic biodegradability of organic 

compounds in digested sludge test 

(OECD Test Guideline 311), a 

phototransformation of chemicals in soil 

test, 2002, surfaces—2 soils (draft 

OECD, a simulation test—aerobic 

sewage treatment (activated sludge 

units) (OECD Test Guideline 303A), an 

aerobic and anaerobic transformation in 

aquatic sediment systems test (OECD 

Test Guideline 308), and an acute 

inhalation toxicity test (OPPTS Test 

Guideline 870.1300). Further testing 

details are available in the consent order 

located in the docket under docket 

EPA–HQ–OPPT–2014–0166. The 

consent order does not require 

submission of the pended testing 

detailed in the consent order at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMNs 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 721.10728 (P-12- 

241) and 40 CFR 721.10729 (P-12-242). 

PMN Numbers P-12-557 and P-12-558 

Chemical names: (P-12-557) Tires, 

wastes, pyrolyzed, C6-39 oil fraction 

and (P-12-58) Tires, wastes, pyrolyzed, 

C7-56 oil fraction. 

CAS numbers: (P-12-557) 1410795– 

89–9 and (P-12-558) 1410795-87-7. 

Effective date of TSCA section 5(e) 

consent order: July 22, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the 

substances will be used as naphtha used 

for high octane gas and cleaning fluids, 

kerosene used for jet fuels, distillate fuel 

oil used for off-highway diesel engines 

and power generation, and vacuum gas 

oil used for gasoline. Based on 

structure-activity relationship analysis 

of test data on analogous neutral organic 

chemicals, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 360 ppb (for 

P-12-557) and 170 ppb (for P-12-558) 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 uncontrolled manufacture, 

processing, distribution in commerce, 

use, and disposal of these substances 

may present an unreasonable risk of 

injury to the environment. To protect 

against these risks, the consent order 

requires: 

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1. Establishment and use of a hazard 

communication program, including 

human health, environmental hazard 

precautionary statements on each label 

and the MSDS. 

2. Use of the substances only as 

described in the consent order. 

3. No use of the substances resulting 

in surface water concentrations 

exceeding the concentrations of concern 

identified in the releases to water 

section of the consent order. 

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 text, 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 guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed. The 

order does not require the submission of 

these tests at any specified time or 

production volume. However, the 

order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

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 721.10730 (P-12- 

557) and 40 CFR 721.10731 (P-12-558). 

PMN Number P-13-60 

Chemical name: Neodymium, 

butadiene iso-Bu neodecanoate 

complexes. 

CAS number: 1386395–00–1. 

Basis for action: The PMN states that 

the use of the substance is as a precursor 

to polymerization catalyst. Based on 

SAR analysis of test data on analogous 

neodymium complexes, 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 

substance are not expected to result in 

surface water concentrations exceeding 

8 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 

releases to surface waters 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)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPT Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPT 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 721.10732. 

PMN Number P-13-237 

Chemical name: Tires, wastes, 

pyrolyzed, C5-15 condensate oil 

fraction. 

CAS number: Claimed confidential. 

Chemical substance definition: A 

complex combination of hydrocarbons 

obtained from the substance produced 

by the pyrolysis of rubber-based tires 

after removal of the carbon black 

fraction. It consists predominantly of 

hydrocarbons having carbon numbers in 

the range of C5 through C15. It boils in 

the range of approximately 36 °C to 265 

°C (97 °F to 509 °F). 

Effective date of TSCA section 5(e) 

consent order: August 8, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the use of 

the substance will be as a raw feed stock 

for refineries. Based on data for benzene 

which comprises 6% of the PMN 

substance, EPA identified concerns for 

oncogenicity, immunotoxicity, and liver 

and blood toxicity. Based on data for 

limonene, which constitutes 13% of the 

PMN substance, EPA identified 

concerns for dermal sensitization. Based 

on SAR analysis for neutral organic 

chemicals the PMN substance may be 

toxic to aquatic organisms at 

concentrations as low as 4 ppb. The 

order was issued under TSCA sections 

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

on a finding that this substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against this risk, the consent 

order requires: 

1. An 8-hour time-weighted-average 

(TWA) inhalation exposure limit of 1 

part per million (ppm) to the PMN 

substance. 

2. Use of the PMN substance only as 

a raw feed stock for refineries. 

3. No use of the substance resulting in 

surface water concentrations that exceed 

4 ppb. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of inhalation 

monitoring data, collected according to 

the EPA draft Inhalation Monitoring 

Data Collection Guidelines (located in 

the docket to this rule); 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.l010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. The order does 

not require submission of these tests at 

any specified time or production 

volume. However, the order’s 

restrictions on manufacture, 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 721.10733. 

PMN Number P-13-248 

Chemical name: Lithium salt of 

substituted imide (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an electrolyte. 

Based on test data on the PMN 

substance, and SAR analysis of test data 

on analogous lithium salts, the EPA 

identified concerns for irritation, 

possible corrosion, acute toxicity, blood 

and thyroid effects, neurotoxicity, and 

immunotoxicity from exposure to the 

PMN substance via inhalation and 

dermal exposures. As described in the 

PMN, occupational exposures are 

expected to be minimal due to the use 

of a National Institute of Occupational 

Safety and Health (NIOSH)-certified 

particulate respirator with an assigned 

protection factor (APF) of at least 10. 

Further, general population exposures 

are not expected as the PMN is not used 

in consumer products. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the PMN substance without 

a NIOSH-certified particulate respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures; 

or any use in a consumer product may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(i) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of inhalation 

monitoring data, collected according to 

the EPA draft Inhalation Monitoring 

Data Collection Guidelines (located in 

the docket to this rule) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10734. 

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PMN Number P-13-270 

Chemical name: Aromatic dibenzoate 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a catalyst component. 

Based on SAR analysis of test data on 

analogous esters, EPA predicts chronic 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. 

Based on uses 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 should there 

be any new use of the substance 

resulting in releases to surface waters 

exceeding 1 ppb significant adverse 

environmental effects could occur. 

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 

sediment-water chironomid life-cycle 

toxicity test using spiked water or 

spiked sediment (OECD Test Guideline 

233); a hydrolysis test (OECD Test 

Guideline 111); and a Zahn-Wellens 

inherent biodegradation test (OECD Test 

Guideline 302B) would help 

characterize the potential for chronic 

aquatic toxicity of the PMN substance. 

EPA also recommends that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed to 

facilitate solubility in the test media, 

because of the PMN substance’s low 

water solubility. 

CFR citation: 40 CFR 721.10735. 

PMN Number P-13-309 

Chemical name: Alcohols, C9–11- 

branched, ethoxylated propoxylated. 

CAS number: 1400790–00–2. 

Basis for action: The PMN states that 

the use of the substance will be as a 

component of a pigment dispersant 

blend for inks and coatings. Based on 

SAR analysis of test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 170 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 substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 

170 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 component 

of a pigment dispersant blend for inks 

and coatings 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 (OPPT 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 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed to 

facilitate solubility in the test media, 

because of the PMN substance’s low 

water solubility. 

CFR citation: 40 CFR 721.10736. 

PMN Number P-13-378 

Chemical name: Carboxylic 

anhydride, polymer with -hydrohydroxypoly(oxy-1,2-diethanediyl), 

compd. with 2,3,4,6,7,8,9,10- 

octahydropyrimido-[1,2-a]azepine 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance is as a 

polyurethane catalyst. Based on SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 24 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 

24 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 

releases to surface waters exceeding 24 

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); 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. 

CFR citation: 40 CFR 721.10737. 

PMN Number P-13-453 

Chemical name: Formaldehyde, 

polymer with 2,3-dimethylphenol, 2,4- 

dimethylphenol, 2,5-dimethylphenol, 

3,5-dimethylphenol, 3-ethylphenol, 4- 

ethylphenol, 3-methylphenol, 4- 

methylphenol and phenol. 

CAS number: 1415313–86–8. 

Basis for action: The PMN states that 

the substance will be used as a coating 

for electronic components. Based on 

SAR analysis of test data on analogous 

phenols, 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, 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 may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

releases to surface waters exceeding 5 

ppb may result in 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 guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed to 

facilitate solubility in the test media, 

because of the PMN substance’s low 

water solubility. 

CFR citation: 40 CFR 721.10738. 

PMN Number P-13-465 

Chemical name: Caprolactone 

homopolymer of substituted 

benzotriazole (generic). 

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CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a UV stabilizer. 

Based on SAR analysis of test data on 

analogous benzotriazoles, esters, 

phenols, and amides, 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 

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 water 

solubility test (OECD Test Guideline 

105); 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 recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed to facilitate solubility in the 

test media, due to the low water 

solubility of the PMN material. EPA 

suggests conducting the water solubility 

test first as the results may impact the 

ecotoxicity testing recommendations. 

CFR citation: 40 CFR 721.10739. 

PMN Number P-13-473 

Chemical name: Tin(2+) salt of 

alkylcarboxylic 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 catalyst. Based on 

test data on the PMN, as well as SAR 

analysis of test data on analogous tin 

compounds, the EPA identified 

potential human health concerns 

regarding eye corrosion, dermal 

sensitization, and asthma, from the 

PMN substance via dermal exposure. 

Further, based on SAR analysis of test 

data on analogous tin salts and anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 27 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 substance to 

surface water, exceed releases from the 

use and production volume described in 

the PMN. For the use and production 

volume described in the PMN, 

environmental releases did not exceed 

27 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 use of the 

substance without the use of impervious 

gloves and goggles, when there is a 

potential dermal exposure; use of the 

substance other than as described in the 

PMN; or any increase in the annual 

confidential production volume could 

result in exposures which may cause 

serious human health 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), and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that 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 

recommends filtration should be 

avoided and that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) followed to facilitate 

solubility in the test media, because of 

the PMN substance’s low water 

solubility. Repeated dose health tests 

are not recommended because of the 

PMN substance’s corrosive nature. 

CFR citation: 40 CFR 721.10740. 

PMN Number P-13-563 

Chemical name: Propylene glycol, 

alpha isocyanate, omega silane 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate for polyurethane polymers. 

Based on SAR analysis of analogous 

diisocyanates, EPA identified concerns 

for oncogenicity, mutagenicity, 

respiratory and dermal sensitization and 

lung and mucous membrane irritation 

from exposure to the PMN substance via 

inhalation and dermal exposures. For 

the use described in the PMN, EPA does 

not expect significant occupational or 

consumer exposure. 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 10, where there 

is a potential for inhalation exposures; 

any use other than as an intermediate; 

or any use of the substance in consumer 

products, may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(1)(i)(C) and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600); a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465); 

and a carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10741. 

PMN Numbers P-13-617, P-13-618, and 

P-13-619 

Chemical names: (P-13-617) Aromatic 

dicarboxylic acid polymer with 

alkanediol, alkyl alkyl-2-alkenoate,1,4- 

dialkyl aromatic dicarboxylate, 

alkanedioic acid, alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2- 

alkenoate, aromatic diisocyanate, alkyl 

2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (generic), (P-13-618) 

Alkanedioic acid, polymer with alkyl 2- 

alkyl-2-alkenoate, alkanedioic acid, 

alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1 2-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, 

aromatic diisocyanate, alkyl 2-alkyl-2- 

alkenoate and 2-alkyl-2-alkenoic acid 

(generic); and (P-13-619) Alkanedioic 

acid, polymer with alkyl alkylalkenoate, alkanedioic acid, alkanediol, 

.alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1,2-alkanediyl)], 

aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substances will be as an adhesive. Based 

on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for respiratory sensitization. 

For the use described in the PMN, EPA 

does not expect significant occupational 

or consumer inhalation exposure as the 

substances are not applied using a 

method that generates a vapor, mist, or 

aerosol, nor are they used in a consumer 

product. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

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substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances without a 

NIOSH-certified particulate respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures; 

any use in consumer products; or any 

use of the substances 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)(3)(ii). 

Recommended testing: EPA has 

determined that the results of 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 721.10742 (P-13- 

617); 40 CFR 721.10743 (P-03-618) and 

40 CFR 721.10744 (P-13-619). 

PMN Number P-13-722 

Chemical name: Alkoxylated 

quaternary alkyl ammonium 

fluoroalkylsulfonimide (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymer additive. 

Based on SAR analysis of test data on 

analogous cationic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

9 ppb of the PMN substance in surface 

waters. For the use described in the 

PMN, environmental releases are not 

expected to result in surface water 

concentrations that exceed 9 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 9 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, freshwater daphnids (OPPTS 

Test Guideline 850.1010); and an algal 

toxicity test (OPPTS Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed to facilitate solubility in the 

test media, due to the low water 

solubility of the PMN material. 

CFR citation: 40 CFR 721.10745. 

PMN Number P-13-753 

Chemical name: Isocyanate 

terminated urethane polymer (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive and 

sealant. Based on SAR analysis of test 

data on analogous isocyanates, EPA 

identified concerns for respiratory and 

dermal sensitization to workers from 

exposure to the PMN substance. In 

addition, based on test data submitted 

under the TSCA section 8(e) program, 

the Agency identified concern for 

mutagenicity. For the uses described in 

the PMN, significant occupational 

dermal and inhalation exposures are not 

expected. Further, general population 

exposures are not expected as the PMN 

is not used in consumer products. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

particulate respirator with an APF of at 

least 10, where there is a potential for 

inhalation exposure, or any use in 

consumer products may cause serious 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10746. 

PMN Number P-13-773 

Chemical name: 4-Pyrimidianamine, 

2,5 dimethoxy-. 

CAS number: 6960–17–4. 

Basis for action: The PMN states that 

the substance will be used as an 

herbicide intermediate. Based on test 

data of the PMN substance, as well as 

SAR analysis of test data on analogous 

aromatic amines, EPA identified 

concerns for mutagenicity, oncogenicity, 

and developmental toxicity to workers 

exposed to the PMN substance. Further, 

based on SAR analysis of test data on 

analogous anilines, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 7 ppb of 

the PMN substance in surface water. As 

described in the PMN, EPA does not 

expect significant occupational 

exposures and releases of the PMN 

substance are not expected to result in 

surface water concentrations that exceed 

7 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 without a 

NIOSH-certified respirator with an APF 

of at least 10, where there is potential 

inhalation exposure; any use without 

impervious gloves, where there is 

potential for dermal exposure; or any 

use other than as an herbicide 

intermediate may cause serious health 

and environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(1)(i)(B), (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 test 

(OECD Test Guideline 422), with the 

reproduction/development toxicity 

screening test; a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465); and an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) would 

help characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10747. 

PMN Numbers P-13-796, P-13-797, P-13- 

798, P-13-799, and P-13-800 

Chemical names: (P-13-796, P-13-797, 

and P-13-798) Dicarbomonocyclesubstituted 

carbomonocycledicarboxamide 

(generic); (P-13-799) 

Dicarboheterocycle-substituted 

carbomonocycledicarboxamide 

(generic); and (P-13-800) 

Tricarbomonocycle-substituted 

carbomonocycletricarboxamide 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substances are as additives for polymer 

manufacturing. Based on SAR analysis 

of test data on analogous amides, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 ppb (for P-13-796 and P-13-797); 14 

ppb (for P-13-798); 1 ppb (for P-13-799); 

and 2 ppb (for P-13-800) of the PMN 

substance in surface waters. For the use 

described in the PMNs, releases of the 

substances are not expected to result in 

surface water concentrations that exceed 

the respective concentrations for 

concern. 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 resulting in releases 

to surface waters exceeding the 

respective concentrations of concern 

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may result in significant adverse 

environmental effects. Based on this 

information, the PMN substances meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OECD Test 

Guideline 301); 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 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed to 

facilitate solubility in the test media, 

because of the PMN substance’s low 

water solubility. EPA suggests 

conducting the biodegradation test first 

as the results may impact the 

ecotoxicity testing recommendations. 

CFR citation: 40 CFR 721.10748 (P-13- 

796, P-13-797, and P-13-798); 40 CFR 

721.10749 (P-13-799); and 40 CFR 

721.10750 (P-13-800). 

PMN Number P-13-810, P-13-811, P-13- 

812, P-13-813, P-13-814, and P-13-815 

Chemical names: Cycloalkylamino 

oleyl alkylamide acid salts (generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of 

these substances are as inhibitors for oil 

field applications. Based on SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts chronic 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substances in surface waters. 

As described in the PMNs, releases of 

the substances are not expected to result 

in surface water concentrations 

exceeding 1 ppb of the aggregate of 

these PMN substances. 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 

use of the substances resulting in 

releases to surface waters exceeding 1 

ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substances meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a water 

solubility: Column elution method; 

shake flask method test (OPPTS Test 

Guideline 830.7840) or a water 

solubility: Generator column method 

test (OPPTS Test Guideline 830.7860); a 

determination of the partition 

coefficient (n-octanol/water) by shake 

flask method (OPPTS Test Guideline 

830.7550), generator column method 

(OPPTS Test Guideline 830.7560), or 

estimation by liquid chromatography 

(OPPTS Test Guideline 830.7570); and 

log Koc determination by adsorptiondesorption using a batch equilibrium 

method (OECD Test Guideline 106) in 

representative salt water conditions 

would help characterize the 

environmental effects of the PMN 

substances. Based on the results of these 

studies, EPA would recommend either 

of the following as additional testing: 

(A) Fish acute toxicity test, freshwater 

and marine (OPPTS Test Guideline 

850.1075); a mysid acute toxicity test 

(OPPTS Test Guideline 850.1350); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) or; 

(B) the whole sediment acute toxicity 

test, invertebrates, marine (OPPTS Test 

Guideline 850.1740). 

CFR citation: 40 CFR 721.10751. 

PMN Numbers P-13-816, P-13-817, P-13- 

818, P-13-819, P-13-820, and P-13-821 

Chemical names: Cycloalkylamino 

cocoalkyl alkylamide acid salts 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of 

these substances is as inhibitors for oil 

field applications. Based on SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts chronic 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substances in surface waters. 

As described in the PMNs, releases of 

the substances are not expected to result 

in surface water concentrations 

exceeding 1 ppb of the aggregate of 

these PMN substances. 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 

use of the substances resulting in 

releases to surface waters exceeding 1 

ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substances meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a water 

solubility: Column elution method; 

shake flask method test (OPPTS Test 

Guideline 830.7840) or a water 

solubility: Generator column method 

test (OPPTS Test Guideline 830.7860); a 

determination of the partition 

coefficient (n-octanol/water) by shake 

flask method (OPPTS Test Guideline 

830.7550), generator column method 

(OPPTS Test Guideline 830.7560), or 

estimation by liquid chromatography 

(OPPTS Test Guideline 830.7570); and 

log Koc determination by adsorptiondesorption using a batch equilibrium 

method (OECD Test Guideline 106) in 

representative salt water conditions 

would help characterize the 

environmental effects of the PMN 

substances. Based on the results of these 

studies, EPA would recommend either 

of the following as additional testing: 

(A) Fish acute toxicity test, freshwater 

and marine (OPPTS Test Guideline 

850.1075); a mysid acute toxicity test 

(OPPTS Test Guideline 850.1350); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) or; 

(B) the whole sediment acute toxicity 

test, invertebrates, marine (OPPTS Test 

Guideline 850.1740). 

CFR citation: 40 CFR 721.10752. 

PMN Number P-13-839 

Chemical name: Methanamine, N,Ndimethyl-, reaction products with 

alkylamine-epichlorohydrin polymer, 

chlorides (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an ingredient of 

pre-coat solution. Based on the test data 

submitted with this PMN as well as the 

structural activity relationships analysis 

for analogous polycationic polymers, 

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 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 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)(i) and (ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a fish acute 

toxicity mitigated by humic acid 

(OPPTS Test Guideline 850.1085); 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 recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed to facilitate solubility in the 

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test media, because of the PMN 

substance’s low water solubility. 

CFR citation: 40 CFR 721.10753. 

PMN Number P-13-882 

Chemical name: Mixture of alkylated 

benzene, brominated (generic) and 

alkylated benzene, dibrominated 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance will be as a feed 

for a bromine recovery unit. Based on 

analogous chemical substances that 

contain bromine and alkylation 

potential of the PMN substance, EPA 

identified concerns for neurotoxicity, 

liver and kidney toxicities, 

mutagenicity, and oncogenicity, as well 

as concerns for developmental toxicity 

and dermal sensitization to workers 

exposed to the PMN substance. The 

Agency also identified the potential for 

human health risk due to the possible 

formation of dioxins. Further, based on 

test data on analogous benzyl halides, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 5 ppb of the PMN substance 

in surface water. For the use described 

in the PMN, EPA does not expect 

significant occupational inhalation or 

dermal exposures; significant general 

population inhalation or drinking water 

exposures; or releases of the PMN 

substance that result in surface water 

concentrations that exceed 5 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 use other 

than for use other than as feed for a 

bromine recovery unit may cause 

serious health and significant 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(1)(i)(D), (b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); 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 721.10754. 

PMN Number: P-14-42 

Chemical name: Substituted 

perfluoroether (generic). 

CAS Number: Claimed confidential. 

Basis for Action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a surfactant for 

laboratory use fluid. Based on SAR 

analysis of test data on analogous high 

molecular weight polymers, EPA 

identified concerns for lung toxicity if 

respirable droplets of the PMN 

substance are inhaled. Further, based on 

analogy to perfluorooctanoic acid 

(PFOA) and perfluorooctane sulfonate 

(PFOS), EPA identified concerns for 

liver toxicity, acute toxicity, 

developmental and reproductive 

toxicity, and cancer, for the PMN 

substance, when the mean moles of each 

perfluoro propylene (PPO) unit is less 

than 5. The low molecular weight 

species have been identified as having 

the potential to be persistent, 

bioaccumulative, and toxic (PBT) 

chemicals. EPA does not have 

comparable toxicity information on the 

low molecular weight fraction of the 

PMN substance and unreacted starting 

material. EPA has concerns that this 

PMN substance will persist in the 

environment. In addition, the perfluoro 

degradation products could persist, 

bioaccumulate, and be toxic to people, 

wild mammals, and birds. EPA’s 

concerns are based on analogy to other 

perfluoro chemicals, including PFOA 

and PFOS, which are both currently 

under review by EPA for PBT concerns. 

PFOA and PFOS are expected to persist 

for years in the environment. 

Biodegradation and photolysis tests of 

analogous substances indicate little or 

no biodegradation or photolysis of 

perfluoroalkyl compounds. 

Bioaccumulation concerns are based on 

the measured presence of certain 

perfluoroalkyl compounds, including 

PFOA, in wildlife and in human blood 

samples. In addition, EPA expects the 

PMN substance and the perfluoro 

degradation products to be highly 

persistent, and the low molecular 

weight fraction is expected to be mobile 

and bioaccumulate in the environment. 

No ecotoxicological concerns were 

raised for the PMN substance itself. 

However, there is high concern for 

possible environmental effects to 

mammals and wild birds from the 

perfluoro degradation products of the 

PMN substance. As stated previously, 

the analog PFOA is persistent in the 

environment; has a long bioretention 

time in various species; has been 

detected in a number of species of 

wildlife, including marine mammals; 

and is considered toxic to mammalian 

and other species. The toxicological 

properties and presence of PFOA in the 

environment continue to be 

investigated. For the use described in 

the PMN, EPA does not expect 

occupational, general population, or 

environmental exposures to the PMN 

substance. Therefore, EPA has not 

determined that the proposed 

manufacture, 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, or any 

manufacture of the PMN substance 

where the mean number of moles of 

each perfluoro propylene oxide unit is 

less than 5, may result in serious health 

effects or significant adverse 

environmental effects. Based on this 

information, the PMN meets the concern 

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

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

Recommended Testing: EPA has 

determined that the results of the 

following testing on the presumed 

perfluoro degradation products of the 

PMN substance would be necessary to 

evaluate the potential human health 

effects of the PMN substance: a repeated 

dose metabolism and pharmacokinetics 

test (OPPTS Test Guideline 870.7485) in 

rats and mice; a 1-generation 

reproduction study (OECD Test 

Guideline 421), modified; a 90-day oral 

toxicity test (OPPTS Test Guideline 

870.3100) in rats; a combined chronic 

toxicity/carcinogenicity test (OPPTS 

Test Guideline 870.4300 or OECD Test 

Guideline 453) in rats; and an avian 

reproduction test (OPPTS Test 

Guideline 850.2300 or OECD Test 

Guideline 206). EPA recommends that 

the Company conduct the 

pharmacokinetics testing first to confirm 

species acceptability and to provide a 

reliable half-life for this substance. 

Further, EPA has determined that the 

results of the following physical/

chemical properties and fate and 

transport tests on the PMN substance 

would be necessary to evaluate the 

environmental fate and transport: A UV 

visible light absorption test (OPPTS Test 

Guideline 830.7050); a hydrolysis as a 

function of pH test (OPPTS Test 

Guideline 835.2130); a semi-continuous 

activated sludge (‘‘SCAS’’) test (OPPTS 

Test Guideline 835.5045, OPPTS Test 

Guideline 835.3210, or OECD Test 

Guideline 302A) modified for analysis 

for perfluoro degradation products; an 

aerobic transformation in soil test 

(OECD Test Guideline 307); an aerobic 

and anaerobic transformations test 

(OECD Test Guideline 308) in aquatic 

sediment systems; a direct photolysis 

test (OPPTS Test Guideline 835.2210); 

an indirect photolysis screening test 

(OPPTS Test Guideline 835.5270); 

phototransformation of chemicals on 

soil surfaces (Draft OECD Test Guideline 

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39278 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

January 2002) using 2 soils, a simulation 

test-aerobic sewage treatment (OECD 

Test Guideline 303A) activated sludge 

units; and an anaerobic biodegradability 

test (OECD Test Guideline 311) on 

organic compounds in digested sludge. 

CFR Citation: 40 CFR 721.10764. 

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 6 of the 43 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 VI.). 

In the other 36 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 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 or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to regulate 

prospective manufacturers 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 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 September 8, 2014 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

August 8, 2014. 

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 

August 8, 2014, 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. 

This rule establishes SNURs for a 

number of 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 the Significant 

New Use Designation 

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. 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 person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. However, 

TSCA section 5(e) consent orders have 

been issued for 6 of the 43 chemical 

substances, and the PMN submitters are 

prohibited by the TSCA section 5(e) 

consent orders from undertaking 

activities which would be designated as 

significant new uses. The identities of 

39 of the 43 chemical substances subject 

to this rule have been claimed as 

confidential and EPA has received no 

post-PMN bona fide submissions (per 40 

CFR 720.25 and § 721.11). Based on this, 

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. 

Therefore, EPA designates July 9, 

2014 as the cutoff date for determining 

whether the new use is ongoing. Persons 

who begin commercial manufacture or 

processing of the chemical substances 

for a significant new use identified as of 

that date would have to cease any such 

activity upon the effective date of the 

final rule. To resume their activities, 

these persons would have to first 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990, for a more detailed discussion of 

the cutoff date for ongoing uses. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for TSCA nonsection 5(e) SNURs. Descriptions of tests 

are provided for informational purposes. 

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EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several 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 study 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 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 

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 § 721.1725(b)(1). 

Under these procedures a 

manufacturer or processor may request 

EPA to determine whether a proposed 

use would be a significant new use 

under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture 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 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 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 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E-PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers 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– 

2014–0166. 

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, or 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. 

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39280 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

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 

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) 

In addition, since this action does not 

involve any technical standards, 

NTTAA section 12(d) (15 U.S.C. 272 

note), does not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

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: June 27, 2014. 

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 sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

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§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10725 2070–0012 

721.10726 2070–0012 

721.10727 2070–0012 

721.10728 2070–0012 

721.10729 2070–0012 

721.10730 2070–0012 

721.10731 2070–0012 

721.10732 2070–0012 

721.10733 2070–0012 

721.10734 2070–0012 

721.10735 2070–0012 

721.10736 2070–0012 

721.10737 2070–0012 

721.10738 2070–0012 

721.10739 2070–0012 

721.10740 2070–0012 

721.10741 2070–0012 

721.10742 2070–0012 

721.10743 2070–0012 

721.10744 2070–0012 

721.10745 2070–0012 

721.10746 2070–0012 

721.10747 2070–0012 

721.10748 2070–0012 

721.10749 2070–0012 

721.10750 2070–0012 

721.10751 2070–0012 

721.10752 2070–0012 

721.10753 2070–0012 

721.10754 2070–0012 

721.10764 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 § 721.10725 to subpart E to 

read as follows: 

§ 721.10725 Alcohol propoxylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alcohol propoxylate (PMN 

P-08-512) 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(l) 

(ii) Disposal. Requirements as 

specified in § 721.85(a)(1), (a)(3) (Class I 

or II wells), (b)(1), (b)(3) (Class I or II 

wells), (c)(1), and (c)(3) (Class I or II 

wells). 

(iii) Release to water. Requirements as 

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

and (c)(2)(ii). 

(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 in 

§ 721.125(a), (b), (c), (i), (j), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10726 to subpart E to 

read as follows: 

§ 721.10726 Alcohol propoxylate sulfate 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alcohol propoxylate 

sulfate salt (PMN P-08-513) 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(l) 

(ii) Disposal. Requirements as 

specified in § 721.85(a)(1), (a)(3) (Class I 

or II wells), (b)(1), (b)(3) (Class I or II 

wells), (c)(1), and (c)(3) (Class I or II 

wells). 

(iii) Release to water. Requirements as 

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

and (c)(2)(ii). 

(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 in 

§ 721.125(a), (b), (c), (i), (j), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.10727 to subpart E to 

read as follows: 

§ 721.10727 Amphoteric fluorinated 

surfactant (generic). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified 

generically as amphoteric fluorinated 

surfactant (PMN P-11-526) 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. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), (h), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.10728 to subpart E to 

read as follows: 

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§ 721.10728 2-Propenoic acid, 2-methyl-, 2- 

hydroxyethyl esters, telomers with C18–26- 

alkyl acrylate, 1-dodecanethiol, N- 

(hydroxymethyl)-2-methyl-2-propenamide, 

polyfluorooctyl methacrylate, 2,2′-[1,2- 

diazenediylbis(1-methylethylidene)]bis[4,5- 

dihydro-1H-imidazole]hydrochloride (1:2)- 

initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl-, 2-hydroxyethyl esters, telomers 

with C18-26-alkyl acrylate, 1- 

dodecanethiol, N-(hydroxymethyl)-2- 

methyl-2-propenamide, polyfluorooctyl 

methacrylate, 2,2′-[1,2-diazenediylbis(1- 

methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated 

(PMN P-12-241) 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. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (q), and (t). 

(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), (h), and (i) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.10729 to subpart E to 

read as follows: 

§ 721.10729 2-Propenoic acid, 2-methyl-, 

C16-18 esters, telomers with 3-chloro-2- 

hydroxypropyl methacrylate, 1- 

dodecanethiol, N-(hydroxymethyl)-2-methyl2-propenamide, polyfluorooctyl 

methacrylate, and rel- (1R,2R,4R)-1,7,7- 

trimethylbicyclo[2.2.1]hept-2-yl 

methacrylate, 2,2′-[1,2-diazenediylbis(1- 

methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl-, C16-18 esters, telomers with 3- 

chloro-2-hydroxypropyl methacrylate, 

1-dodecanethiol, N-(hydroxymethyl)-2- 

methyl-2-propenamide, polyfluorooctyl 

methacrylate, and rel-(1R,2R,4R)-1,7,7- 

trimethylbicyclo[2.2.1]hept-2-yl 

methacrylate, 2,2′-[1,2-diazenediylbis(1- 

methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated 

(PMN P-12-242) 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. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (q), and (t). 

(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), (h), and (i) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 9. Add § 721.10730 to subpart E to 

read as follows: 

§ 721.10730 Tires, wastes, pyrolyzed, C6- 

39 oil fraction. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

tires, wastes, pyrolyzed, C6-39 oil 

fraction (P-12-557; CAS No. 1410795– 

89–9) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the chemical 

substance that has been blended into 

finished petroleum products or sent to 

a petroleum refinery for use as a 

chemical intermediate. 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), (f), 

(g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). 

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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(iii) Release to water. Requirements as 

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

(c)(4) (N=360). 

(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 and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

(a)(1) of this section. 

■ 10. Add § 721.10731 to subpart E to 

read as follows: 

§ 721.10731 Tires, wastes, pyrolyzed, C7- 

56 oil fraction. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

tires, wastes, pyrolyzed, C7–56 oil 

fraction (P-12-558; CAS No. 1410795– 

87–7) 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 chemical 

substance that has been blended into 

finished petroleum products or sent to 

a petroleum refinery for use as a 

chemical intermediate. 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), (f), 

(g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(iii) Release to water. Requirements as 

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

(c)(4) (N=170). 

(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 and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

(a)(1) of this section. 

■ 11. Add § 721.10732 to subpart E to 

read as follows: 

§ 721.10732 Neodymium, butadiene iso-Bu 

neodecanoate complexes. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

neodymium, butadiene iso-Bu 

neodecanoate complexes (PMN P-13-60; 

CAS No. 1386395–00–1) 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) Releases 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), (i), and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.10733 to subpart E to 

read as follows: 

§ 721.10733 Tires, wastes, pyrolyzed, C5- 

15 condensate oil fraction. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

tires, wastes, pyrolyzed, C5-15 

condensate oil fraction (PMN P-13-237; 

chemical substance definition: A 

complex combination of hydrocarbons 

obtained from the substance produced 

by the pyrolysis of rubber-based tires 

after removal of the carbon black 

fraction. It consists predominantly of 

hydrocarbons having carbon numbers in 

the range of C5 through C15. It boils in 

the range of approximately 36 °C to 265 

°C (97 °F to 509 °F).) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substances that 

have been blended into finished 

petroleum products or sent to a 

petroleum refinery for use as a chemical 

intermediate, or stored as described in 

the Distribution section of the order. 

(2) The significant new uses are: 

(i) Protection in the workplace. The 

significant new use is any exposure 

exceeding an 8 hour time weighted 

average (TWA) exposure limit of 1 part 

per million (ppm). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use other than as a raw 

feedstock for refineries. 

(iii) Release to water. Requirements as 

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

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

(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), (k), and records 

documenting that exposures do not 

exceed an 8 hour time weighted average 

(TWA) exposure limit of 1 part per 

million are applicable to manufacturers 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

■ 13. Add § 721.10734 to subpart E to 

read as follows: 

§ 721.10734 Lithium salt of substituted 

imide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as lithium salt of substituted 

imide (PMN P-13-248) 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 1.0 percent) and 

(c). When determining which persons 

are reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

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(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10735 to subpart E to 

read as follows: 

§ 721.10735 Aromatic dibenzoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic dibenzoate 

(PMN P-13-270) 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) Releases 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10736 to subpart E to 

read as follows: 

§ 721.10736 Alcohols, C9-11-branched, 

ethoxylated propoxylated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alcohols, C9–11-branched, ethoxylated 

propoxylated (PMN P-13-309; CAS No. 

1400790–00–2) 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. A significant new 

use is any use other than as a 

component of a pigment dispersant 

blend for inks and coatings. 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10737 to subpart E to 

read as follows: 

§ 721.10737 Carboxylic anhydride, 

polymer with -hydro—hydroxypoly(oxy-1,2- 

diethanediyl), compd. with 2,3,4,6,7,8,9,10- 

octahydropyrimido-[1,2-a]azepine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carboxylic anhydride, 

polymer with -hydro— 

hydroxypoly(oxy-1,2-diethanediyl), 

compd. with 2,3,4,6,7,8,9,10- 

octahydropyrimido-[1,2-a]azepine (PMN 

P-13-378) 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) Releases to water. Requirements as 

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

(c)(4) (N=24). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10738 to subpart E to 

read as follows: 

§ 721.10738 Formaldehyde, polymer with 

2,3-dimethylphenol, 2,4-dimethylphenol, 

2,5-dimethylphenol, 3,5-dimethylphenol, 3- 

ethylphenol, 4-ethylphenol, 3-methylphenol, 

4-methylphenol and phenol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

formaldehyde, polymer with 2,3- 

dimethylphenol, 2,4-dimethylphenol, 

2,5-dimethylphenol, 3,5- 

dimethylphenol, 3-ethylphenol, 4- 

ethylphenol, 3-methylphenol, 4- 

methylphenol and phenol (PMN P-13- 

453; CAS No. 1415313–86–8) 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=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), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10739 to subpart E to 

read as follows: 

§ 721.10739 Caprolactone homopolymer of 

substituted benzotriazole (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as caprolactone 

homopolymer of substituted 

benzotriazole (PMN P-13-465) 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 19. Add § 721.10740 to subpart E to 

read as follows: 

§ 721.10740 Tin(2+) salt of alkylcarboxylic 

acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tin(2+) salt of 

alkylcarboxylic acid (PMN P-13-473) 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: 

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(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) and (s). 

(ii) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), and 

(a)(3). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

(a)(1) of this section. 

■ 20. Add § 721.10741 to subpart E to 

read as follows: 

§ 721.10741 Polyalkylene glycol, alpha 

isocyanate, omega silane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyalkylene glycol, alpha 

isocyanate, omega silane (PMN P-13- 

563) 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)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10742 to subpart E to 

read as follows: 

§ 721.10742 Aromatic dicarboxylic acid 

polymer with alkanediol, alkyl alkyl-2- 

alkenoate, 1,4-dialkyl aromatic 

dicarboxylate, alkanedioic acid, alkanedioic 

acid. alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, aromatic 

diisocyanate, alkyl 2-alkyl-2-alkenoate and 

2-alkyl-2-alkenoic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic dicarboxylic 

acid polymer with alkanediol, alkyl 

alkyl-2-alkenoate,1,4-dialkyl aromatic 

dicarboxylate, alkanedioic acid, 

alkanedioic acid. alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2- 

alkenoate, aromatic diisocyanate, alkyl 

2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (PMN P-13-617) 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)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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 (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10743 to subpart E to 

read as follows: 

§ 721.10743 Alkanedioic acid, polymer 

with alkyl 2-alkyl-2-alkenoate, alkanedioic 

acid, alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1 2-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, aromatic 

diisocyanate, alkyl 2-alkyl-2-alkenoate and 

2-alkyl-2-alkenoic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acid, polymer 

with alkyl 2-alkyl-2-alkenoate, 

alkanedioic acid, alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkyl-1 

2-alkanediyl)], hydroxyalkyl 2-alkyl-2- 

alkenoate, aromatic diisocyanate, alkyl 

2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (PMN P-13-618) 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)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

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specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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 (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 23. Add § 721.10744 to subpart E to 

read as follows: 

§ 721.10744 Alkanedioic acid, polymer 

with alkyl alkyl-alkenoate, alkanedioic acid, 

alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1,2-alkanediyl)], 

aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acid, polymer 

with alkyl alkyl-alkenoate, alkanedioic 

acid, alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1,2-alkanediyl)], 

aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid 

(PMN P-13-619) 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)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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 (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10745 to subpart E to 

read as follows: 

§ 721.10745 Alkoxylated quaternary alkyl 

ammonium fluoroalkylsulfonimide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkoxylated quaternary 

alkyl ammonium 

fluoroalkylsulfonimide (PMN P-13-722) 

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=9). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.10746 to subpart E to 

read as follows: 

§ 721.10746 Isocyanate terminated 

urethane polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as isocyanate terminated 

urethane polymer (PMN P-13-753) 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)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10747 to subpart E to 

read as follows: 

§ 721.10747 4-Pyrimidianamine, 2,5 

dimethoxy-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

4-pyrimidianamine, 2,5 dimethoxy- 

(PMN P-13-773; CAS No. 6960–17–4) 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), 

(a)(6)(ii), (a)(6)(v), (b) (concentration set 

at 0.1 percent) and (c). When 

determining which persons are 

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reasonably likely to be exposed as 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 10 meet the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters; 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet; 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use other than as an herbicide 

intermediate. 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 27. Add § 721.10748 to subpart E to 

read as follows: 

§ 721.10748 Dicarbomonocyclesubstituted carbomonocycledicarboxamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as dicarbomonocyclesubstituted 

carbomonocycledicarboxamide (PMNs 

P-13-796, P-13-797, and P-13-798) 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) Release to water. Requirements as 

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

(c)(4) (N=4 for P-13-796 and P-13-797; 

and N=14 for P-13-798). 

(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 and 

processors of this substance, 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

■ 28. Add § 721.10749 to subpart E to 

read as follows: 

§ 721.10749 Dicarboheterocyclesubstituted carbomonocycledicarboxamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as dicarboheterocyclesubstituted 

carbomonocycledicarboxamide (PMN P13-799) 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 and 

processors of this substance, 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

■ 29. Add § 721.10750 to subpart E to 

read as follows: 

§ 721.10750 Tricarbomonocyclesubstituted carbomonocycletricarboxamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tricarbomonocyclesubstituted 

carbomonocycletricarboxamide (PMN P13-800) 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 and 

processors of this substance, 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

■ 30. Add § 721.10751 to subpart E to 

read as follows: 

§ 721.10751 Cycloalkylamino oleyl 

alkylamide acid salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as cycloalkylamino oleyl 

alkylamide acid salts (PMNs P-13-810, 

P-13-811, P-13-812, P-13-813, P-13-814, 

and P-13-815) 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) Release to water. Requirements as 

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

(c)(4) (N=1, for the aggregate of the PMN 

substances P-13-810, P-13-811, P-13- 

812, P-13-813, P-13-814, and P-13-815). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 31. Add § 721.10752 to subpart E to 

read as follows: 

§ 721.10752 Cycloalkylamino cocoalkyl 

alkylamide acid salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as cycloalkylamino 

cocoalkyl alkylamide acid salts (PMNs 

P-13-816, P-13-817, P-13-818, P-13-819, 

P-13-820, and P-13-821) 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) Release to water. Requirements as 

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

(c)(4) (N=1, for the aggregate of the PMN 

substances P-13-816, P-13-817, P-13- 

818, P-13-819, P-13-820, and P-13-821). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

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39288 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.10753 to subpart E to 

read as follows: 

§ 721.10753 Methanamine, N,N-dimethyl-, 

reaction products with alkylamineepichlorohydrin polymer, chlorides 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methanamine, N,Ndimethyl-, reaction products with 

alkylamine-epichlorohydrin polymer, 

chlorides (PMN P-13-839) 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 33. Add § 721.10754 to subpart E to 

read as follows: 

§ 721.10754 Mixture of alkylated benzene, 

brominated (generic) and alkylated 

benzene, dibrominated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mixture of alkylated 

benzene, brominated and alkylated 

benzene, dibrominated (PMN P-13-882) 

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. A significant new 

use is any use other than as feed for a 

bromine recovery unit. 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 34. Add § 721.10764 to subpart E to 

read as follows: 

§ 721.10764 Substituted perfluoroether 

(generic) 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted perfluoroether 

(PMN P-14-42) 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. A significant new 

use of this substance is: (1) Use of the 

substance for any application other than 

the confidential use identified in the 

Premanufacture Notice (PMN) or (2) 

Manufacture of the PMN substance 

where the mean number of moles of 

each perfluoro propylene oxide (‘‘PPO’’) 

unit is less than 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 (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.180 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

[FR Doc. 2014–15774 Filed 7–8–14; 8:45 am] 

BILLING CODE 6560–50–P 

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