Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations 59593 

(f) Costs of the verification procedure. 

The Collective shall pay the cost of the 

verification procedure, unless it is 

finally determined that there was an 

underpayment of 10% or more, in 

which case CPB shall, in addition to 

paying the amount of any 

underpayment, bear the reasonable costs 

of the verification procedure. 

§ 380.36 Verification of royalty 

distributions. 

(a) General. This section prescribes 

procedures by which any Copyright 

Owner or Performer may verify the 

royalty distributions made by the 

Collective; provided, however, that 

nothing contained in this section shall 

apply to situations where a Copyright 

Owner or Performer and the Collective 

have agreed as to proper verification 

methods. 

(b) Frequency of verification. A 

Copyright Owner or Performer may 

conduct a single audit of the Collective 

upon reasonable notice and during 

reasonable business hours, during any 

given calendar year, for any or all of the 

prior 3 calendar years, but no calendar 

year shall be subject to audit more than 

once. 

(c) Notice of intent to audit. A 

Copyright Owner or Performer must file 

with the Copyright Royalty Judges a 

notice of intent to audit the Collective, 

which shall, within 30 days of the filing 

of the notice, publish in the Federal 

Register a notice announcing such 

filing. The notification of intent to audit 

shall be served at the same time on the 

Collective. Any audit shall be 

conducted by an independent and 

Qualified Auditor identified in the 

notice, and shall be binding on all 

Copyright Owners and Performers. 

(d) Acquisition and retention of 

report. The Collective shall use 

commercially reasonable efforts to 

obtain or to provide access to any 

relevant books and records maintained 

by third parties for the purpose of the 

audit. The Copyright Owner or 

Performer requesting the verification 

procedure shall retain the report of the 

verification for a period of not less than 

3 years. 

(e) Consultation. Before rendering a 

written report to a Copyright Owner or 

Performer, except where the auditor has 

a reasonable basis to suspect fraud and 

disclosure would, in the reasonable 

opinion of the auditor, prejudice the 

investigation of such suspected fraud, 

the auditor shall review the tentative 

written findings of the audit with the 

appropriate agent or employee of the 

Collective in order to remedy any 

factual errors and clarify any issues 

relating to the audit; Provided that the 

appropriate agent or employee of the 

Collective reasonably cooperates with 

the auditor to remedy promptly any 

factual errors or clarify any issues raised 

by the audit. 

(f) Costs of the verification procedure. 

The Copyright Owner or Performer 

requesting the verification procedure 

shall pay the cost of the procedure, 

unless it is finally determined that there 

was an underpayment of 10% or more, 

in which case the Collective shall, in 

addition to paying the amount of any 

underpayment, bear the reasonable costs 

of the verification procedure. 

§ 380.37 Unclaimed funds. 

If the Collective is unable to identify 

or locate a Copyright Owner or 

Performer who is entitled to receive a 

royalty distribution under this subpart, 

the Collective shall retain the required 

payment in a segregated trust account 

for a period of 3 years from the date of 

distribution. No claim to such 

distribution shall be valid after the 

expiration of the 3-year period. After 

expiration of this period, the Collective 

may apply the unclaimed funds to offset 

any costs deductible under 17 U.S.C. 

114(g)(3). The foregoing shall apply 

notwithstanding the common law or 

statutes of any State. 

Dated: July 28, 2015. 

Suzanne M. Barnett, 

Chief Copyright Royalty Judge 

Approved by: 

James H. Billington, 

Librarian of Congress. 

[FR Doc. 2015–24504 Filed 10–1–15; 8:45 am] 

BILLING CODE 1410–72–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2015–0388; FRL–9933–30] 

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 30 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Nine 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 30 

chemical substances for an activity that 

is designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: This rule is effective on 

December 1, 2015. For purposes of 

judicial review, this rule shall be 

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

16, 2015. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before November 2, 2015 (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 November 

2, 2015, 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–2015–0388, 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 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

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

moss.kenneth@epa.gov. 


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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 

rule are subject to the export 

notification provisions of TSCA section 

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

and must comply with 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 preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/

comments.html. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, 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) 

(FRL–3658–5). 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 sections 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 30 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 

30 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). 


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• Chemical Abstracts Service (CAS) 

Registry number (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 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 8 PMN substances 

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. 

In addition, this rule includes one 

SNUR on a PMN substance that is 

subject to an ‘‘exposure-based’’ consent 

order under TSCA section 

5(e)(1)(A)(ii)(II), wherein EPA 

determined that the PMN substance is 

expected to be produced in substantial 

quantities, and that there may either be 

significant or substantial human 

exposure and/or the PMN substance 

may enter the environment in 

substantial quantities. The TSCA 

section 5(e) consent order requires 

submission of certain test data to EPA 

before the manufacturer may exceed a 

specified production volume. These 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures or exceedance of the 

production volume limit required in the 

TSCA section 5(e) consent order. 

This rule also includes SNURs on 21 

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 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 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–12–69, P–12–70, and 

P–12–520 

Chemical name: Fatty acids 

compound with cyclohexanamine 

(generic) (P–12–69 and 70) and Fatty 

acids amine salt (generic) (P–12–0520). 

CAS numbers: Claimed Confidential. 

Effective date of TSCA section 5(e) 

consent order: February 11, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMNs states that the generic 

(non-confidential) use of the substances 

will be as a lubricity additive (P–12–69 

and P–12–70) and a chemical 

component for fuel additives (P–12– 

520). Based on structure-activity 

relationship (SAR) analysis of test data 

on analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms to 

occur at concentrations that exceed 52 

parts per billion (ppb) (P–12–69), 4 ppb 

(P–12–70) and 180 ppb (P–12–520) of 

the PMN substances in surface waters 

for greater than 20 days per year. This 

20-day criterion is derived from partial 

life cycle tests (daphnid chronic and 

fish early life stage tests) that typically 

range from 21 to 28 days in duration. 

EPA predicts toxicity to aquatic 

organisms may occur if releases of the 

substance to surface water, from uses 

other than as described in the PMNs, 

exceed releases from the use described 

in the PMNs. For the uses described in 

the PMNs, environmental releases did 

not exceed 52 ppb, 4 ppb, or 180 ppb, 

respectively, for more than 20 days per 

year. The consent order for these PMN 

substances was issued under TSCA 

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

based on a finding that the uncontrolled 

manufacture, processing, distribution in 

commerce, use and disposal may 

present an unreasonable risk to the 

environment. To protect against these 

risks, the consent order requires 

manufacturing, processing, or use of the 

substance for the specific confidential 

uses stated in the PMNs. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a fish 

early life-stage toxicity test (OPPTS Test 

Guideline 850.1400) and a daphnia 

chronic toxicity test (OPPTS 850.1300) 

would help characterize the 

environmental effects of the PMN 

substances. Testing should be done on 

P–12–69 only. The submitter has agreed 

not to exceed a confidential volume 

limit without performing this testing. 

CFR citations: CFR 721.10852 (P–12– 

69 and P–12–70) and 40 CFR 721.10856 

(P–12–520). 

PMN Number P–12–169 

Chemical name: Fluoro-modified 

acrylic copolymer (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: March 19, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the use of 

the substance will be as a substrate 

wetting and leveling agent for organic 

solvent-based paints and inks. EPA has 

concerns for potential incineration or 

other decomposition products of the 

PMN substance. These fluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substance at low temperatures. EPA has 

preliminary evidence, including data on 

some fluorinated polymers, which 

suggests that, under some conditions, 

the PMN substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic (PBT) to people, wild 

mammals, and birds. These concerns are 

based on data on analogous chemical 

substances, including perfluorooctanoic 

acid (PFOA) and other perfluorinated 

alkyls, including the presumed 

environmental degradant. The 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 the 

environment and human health, the 

substances may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 


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and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these exposures and 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. Submission of certain physical/

chemical property and environmental 

fate testing on a related PMN substance 

prior to exceeding the confidential 

production volume limits as specified in 

the consent order of the PMN substance. 

3. Recording and reporting of certain 

fluorinated impurities in the starting 

raw material and the initially isolated 

intermediates; and manufacture of the 

PMN substance not to exceed the 

maximum established impurity levels of 

certain fluorinated impurities. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

physical/chemical property and 

environmental fate testing identified in 

the TSCA 5(e) consent order would help 

characterize possible effects of the 

substance and its degradation products. 

The Order prohibits the Company from 

exceeding specified confidential 

production volumes unless the 

Company submits the information 

described in the Testing section of this 

Order in accordance with the conditions 

specified in the Testing section. Further, 

EPA has identified certain toxicity and 

environmental fate testing described in 

the Pended Testing section of the 

Preamble to the Order that would help 

characterize the possible effects of the 

PMN substance. The Order does not 

require submission of the pended 

testing 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 721.10853. 

PMN Number P–12–351 

Chemical name: Siloxanes and 

Silicones, alkyl, alky propoxy ethyl, 

methyl octyl, alkyl polyfluorooctyl 

(generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: March 19, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a coating additive. EPA has 

concerns for potential incineration or 

other decomposition products of the 

PMN substance. These fluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substance at low temperatures. EPA has 

preliminary evidence, including data on 

some fluorinated polymers, which 

suggests that, under some conditions, 

the PMN substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic (PBT) to people, wild 

mammals, and birds. These concerns are 

based on data on analogous chemical 

substances, including perfluorooctanoic 

acid (PFOA) and other perfluorinated 

alkyls, including the presumed 

environmental degradant. The 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 the 

environment and human health, the 

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 exposures and 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 

MSDS, within 90 days. 

2. Submission of certain physical/

chemical property and environmental 

fate testing on a related PMN substance 

prior to exceeding the confidential 

production volume limits as specified in 

the consent order of the PMN 

substances. 

3. Recording and reporting of certain 

fluorinated impurities in the starting 

raw material and the initially isolated 

intermediates; and manufacture of the 

PMN substances not to exceed the 

maximum established impurity levels of 

certain fluorinated impurities. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

physical/chemical property and 

environmental fate testing identified in 

the TSCA 5(e) consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The Order prohibits the 

Company from exceeding specified 

confidential production volumes unless 

the Company submits the information 

described in the Testing section of this 

Order in accordance with the conditions 

specified in the Testing section. Further, 

EPA has identified certain toxicity and 

environmental fate testing described in 

the Pended Testing section of the 

Preamble to the Order that would help 

characterize the effects of the PMN 

substances. The Order does not require 

submission of the pended testing 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 721.10854. 

PMN Number P–12–450 and P–12–451 

Chemical name: Partially fluorinated 

alcohol, reaction products with 

phosphorus oxide (P2O5), amine salts 

(generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: March 16, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of the substances 

will be as coating additives and surface 

active agents. EPA has concerns for 

potential incineration or other 

decomposition products of the PMN 

substances. These perfluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substances at low temperatures. EPA 

has preliminary evidence, including 

data on some fluorinated polymers, 

which suggests that, under some 

conditions, the PMN substances could 

degrade in the environment. EPA has 

concerns that these degradation 

products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic (PBT) to 

people, wild mammals, and birds. These 

concerns are based on data on analogous 

chemical substances, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated alkyls, including 

the presumed environmental degradant. 

The order was issued under TSCA 


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Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations 59597 

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 the 

environment and human health, the 

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 exposures and 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 

MSDS, within 90 days. 

2. Submission of certain physical/

chemical property and environmental 

fate testing on a related PMN substance 

prior to exceeding the confidential 

production volume limits as specified in 

the consent order of the PMN 

substances. 

3. Recording and reporting of certain 

fluorinated impurities in the starting 

raw material and the initially isolated 

intermediates; and manufacture of the 

PMN substances not to exceed the 

maximum established impurity levels of 

certain fluorinated impurities. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

physical/chemical property and 

environmental fate testing identified in 

the TSCA 5(e) consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The Order prohibits the 

Company from exceeding specified 

confidential production volumes unless 

the Company submits the information 

described in the Testing section of this 

Order in accordance with the conditions 

specified in the Testing section. Further, 

EPA has identified certain toxicity and 

environmental fate testing described in 

the Pended Testing section of the 

Preamble to the Order that would help 

characterize the effects of the PMN 

substances. The Order does not require 

submission of the pended testing 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 721.10855. 

PMN Number P–13–292 

Chemical name: Organophosphorus 

polymer (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: February 13, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an additive for polymers. 

Using available exposure information 

from the public literature (i.e., measured 

values for similar substances in house 

dust in homes), and certain assumptions 

for mouthing behavior by young 

children, EPA identified concerns for 

potential exposure to the general 

population. However, there is 

uncertainty about the risk from this 

scenario due to the absence of hazard 

data on the PMN substance itself and 

information on the ability for the PMN 

substance to migrate or leach out of 

certain consumer products. Consumer 

exposure is possible if the PMN 

migrates from these products or 

decomposes to form dust particles that 

can be inhaled or ingested. Analogous 

chemicals, including Tris(2- 

chloroethyl)phosphate (TCEP) and 

Tris(1,3-dichloro-2 propyl) phosphate 

(TDCPP), can be found in household 

dust, and are widespread in the 

environment. Assuming similar use 

patterns over time, the PMN substance 

may be expected to display similar 

exposure patterns. The order was issued 

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

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

this substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To address 

potential exposures and hazards, the 

consent order requires certain testing by 

certain confidential production volume 

limits. 

Recommended testing: EPA has 

determined that the results of certain 

physical/chemical property, toxicity, 

potential for migration from products, 

and dermal and other absorption testing 

identified in the TSCA 5(e) consent 

order would help characterize possible 

effects of the substance. The Order 

prohibits the Company from exceeding 

specified confidential production 

volumes unless the Company submits 

the information described in the Testing 

section of this Order in accordance with 

the conditions specified in the Testing 

section. 

CFR citation: 40 CFR 721.10857. 

PMN Number P–13–305 

Chemical name: Fluorinated acid 

alkylester (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: February 27, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an intermediate. EPA has 

concerns that the PMN substance will 

persist in the environment, could 

bioaccumulate, and be toxic (‘‘PBT’’) to 

humans, other mammals, and birds. 

EPA’s concerns are based on data on the 

PMN substance, and analogy to 

perfluorobutanoic acid (PFBA), PFOA, 

perfluorooctanol sulfonate (PFOS), and 

other analogs. 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 the 

environment and human health. To 

protect against these exposures and 

risks, the consent order requires: 

1. Risk notification. If 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. Use of personal protective 

equipment including impervious gloves 

and a National Institute of Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 10, when there 

is potential exposure. 

3. Establishment and use of a hazard 

communication program, including 

health hazard precautionary statements 

on each label and the MSDS. 

4. Use of the PMN substance only as 

a chemical intermediate. Any chemical 

substance manufactured using the PMN 

substance may contain residuals of the 

PMN substance at a certain maximum 

level. 

5. Recover and convert, capture 

(destroy), recycle, or reuse the substance 

at a certain overall efficiency when the 

PMN substance is used as an 

intermediate in accordance with the 

provisions. 

6. Not use the PMN substance in 

consumer products. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 


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toxicity, metabolism and 

pharmacokinetics testing described in 

the Pended Testing section of the 

Preamble to the Order would help 

characterize the human health effects of 

the PMN substance. The Order does not 

require submission of the pended 

testing 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 721.10858. 

PMN Number P–14–563 

Chemical name: Quaternary alkyl 

methyl amine ethoxylate methyl 

chloride (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a cleaner/degreaser. 

Based on submitted test data on the 

PMN substance as well as SAR analysis 

of test data on analogous cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 29 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 

29 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 that results in 

releases to surface water concentrations 

exceeding 29 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) and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR Citation: 40 CFR 721.10859. 

PMN Number P–14–756 

Chemical name: Substituted 

carboxamide (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a material for 

highly dispersive use in consumer 

products and component of a consumer 

product. Based on submitted test data 

on the PMN substance as well as SAR 

analysis of test data on analogous 

amides, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 3 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 3 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 that results in releases to 

surface water concentrations exceeding 

3 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) and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) and would help 

characterize the environmental effects of 

the PMN substance. 

CFR Citation: 40 CFR 721.10860. 

PMN Number P–14–804 

Chemical name: Phosphoric acid, 

sodium titanium (4+) salt (3:1:2). 

CAS number: 22239–24–3. 

Basis for action: The PMN states that 

the substance will be used as a 

component in anode material in sealed 

batteries. Based on SAR analysis of test 

data on analogous inorganic phosphates 

and titanium compounds, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 4 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations exceeding 

4 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 that results in 

releases to surface water concentrations 

exceeding 4 ppb may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075), an acute invertebrate 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 721.10861. 

PMN Numbers P–15–1, P–15–2, P–15–3, 

P–15–4, P–15–5, and P–15–6 

Chemical names: Oxirane, 2-methyl-, 

polymer with oxirane, monohexadecyl 

ether, phosphate (P–15–1); Oxirane, 2- 

methyl-, polymer with oxirane, 

monohexadecyl ether, phosphate, 

sodium salt (P–15–2); Oxirane, 2- 

methyl-, polymer with oxirane, 

monohexadecyl ether, phosphate, 

potassium salt (P–15–3); Oxirane, 2- 

methyl-, polymer with oxirane, 

monohexadecyl ether, phosphate, 

ammonium salt (P–15–4); Ethanol, 2- 

amino-, compd. with 2-methyloxirane 

polymer with oxirane monohexadecyl 

ether phosphate (P–15–5); and Ethanol, 

2,2′2′′,-nitrilotris-, compd. with 2- 

methyloxirane polymer with oxirane 

monohexadecyl ether phosphate (P–15– 

6). 

CAS numbers: 73361–29–2 (P–15–1); 

151688–56–1 (P–15–2); 1456802–88–2 

(P–15–3); 1456802–89–3 (P–15–4); 

1456803–12–5 (P–15–5); and 1456803– 

14–7 (P–15–6). 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as inert surfactants in 

pesticide formulations. Based on SAR 

analysis of test data on analogous 

anionic surfactant compounds, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

18 ppb in aggregate 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 

18 ppb in aggregate. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances that results in 

aggregate releases to surface waters 

exceeding 18 ppb may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test (OPPTS Test 

Guideline 850.1075), an acute 

invertebrate toxicity test (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. The recommended testing 

may be performed on any one of the 6 

PMN chemicals. 

CFR Citation: 40 CFR 721.10862. 


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PMN Number P–15–25 

Chemical name: Nitrile amine 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a site-limited 

chemical intermediate. Based on 

submitted test data on the PMN 

substance as well as SAR analysis of test 

data on analogous neutral organic 

compounds, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations exceeding 

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 that results in 

releases to 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 daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR Citation: 40 CFR 721.10863. 

PMN Number P–15–26 

Chemical name: 1,3-Propanediamine, 

N1, N1-alkyl (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a friction modifier. 

Based on submitted test data on an 

analogous substance as well as SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 32 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 

32 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 that results in 

releases to surface water concentrations 

exceeding 32 ppb may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. EPA also 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substance and mixtures 

(Organisation for Economic Cooperation and Development (OECD) 

Test Guideline 23) be consulted to 

facilitate solubility in the test media, 

because of the PMN substance’s low 

water solubility. 

CFR Citation: 40 CFR 721.10864. 

PMN Number P–15–36 

Chemical name: 2-Pyridinecarboxylic 

acid, 4,5,6-trichloro-. 

CAS number: 496849–77–5. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on SAR analysis of 

test data on analogous pyridine-alphaacids and neutral organics, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 30 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations exceeding 

30 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 that results in 

releases to surface water concentrations 

exceeding 30 ppb may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075), an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010), an algal toxicity 

test (OCSPP Test Guideline 850.4500), 

and the aerobic/anaerobic 

transformation in soil test (OECD 307) 

would help characterize the 

environmental effects of the PMN 

substance. 

CFR Citation: 40 CFR 721.10865. 

PMN Number P–15–61 

Chemical name: Imidazoliurn, 

polymer with cyclic anhydride and 

alkenoic acid, alkali salt (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a leather chemical. 

Based on SAR analysis of test data on 

analogous polyanionic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

200 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 200 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 listed in the PMN 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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110), a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR Citation: 40 CFR 721.10866. 

PMN Number P–15–98 

Chemical name: 

Hydrochlorofluorocarbon (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an intermediate in 

the production of a hydrofluorocarbon 

(HFC). Based on SAR analysis of test 

data on analogous neutral organics, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

99 ppb of the PMN substance in surface 

waters. Further, based on test data on 

analogous organohalogen compounds, 

there were health concerns regarding 

anesthesia at high inhalation doses from 

exposure to the PMN substance via 

dermal and inhalation exposure. As 

described in the PMN, exposure is 

expected to be minimal due to use of 

adequate dermal and respiratory 


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personal protection equipment and 

releases of the substance are not 

expected to result in surface water 

concentrations exceeding 99 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 that results in releases to 

surface waters exceeding 99 ppb, or any 

use without the use of NIOSH-certified 

organic vapor cartridge respirator with 

an assigned protection factor of at least 

25, or any use other than as a chemical 

intermediate may result in serious 

human health or significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a an acute 

inhalation toxicity test (OPPTS Test 

Guideline 870.1300), fish acute toxicity 

test (OPPTS Test Guideline 850.1075), 

an aquatic invertebrate acute toxicity 

test (OPPTS Test Guideline 850.1010), 

and 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 721.10867. 

PMN Number P–15–136 

Chemical name: Alkylalkenoic acid 

copolymer (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an encapsulating 

polymer. Based on test data on 

analogous high molecular weight 

polymers, EPA identified concerns for 

lung toxicity. As described in the PMN, 

EPA does not expect significant worker 

inhalation exposure due to no domestic 

manufacture, and the substance is not 

manufactured, processed, or used in the 

form of a powder. 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 domestic manufacture of the 

substance or any import, processing, or 

use of the substance in the form of a 

powder 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 with a 60-day 

holding period (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR Citation: 40 CFR 721.10868. 

PMN Number P–15–141 

Chemical name: D-Glucitol, 

alkylamino-N-acyl derivs. (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a 

surfactant in cleaning products and 

liquid soaps. Based on test data on the 

PMN substance, as well as SAR analysis 

of test data on analogous nonionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 14 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 

14 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 

14 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) and a ready 

biodegradability test (OECD Test 

Guideline 301) would help characterize 

the environmental effects of the PMN 

substance. 

CFR Citation: 40 CFR 721.10869. 

PMN Number P–15–150 

Chemical name: 

Cyclohexanedicarboxylic acid, dialkyl 

ester (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adjuvant used in 

reaction processes. Based on SAR 

analysis of test data on analogous esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 10 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

10 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

10 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate 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 721.10870. 

PMN Number P–15–221 

Chemical name: Isocyanate 

prepolymer (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as ingredient in an 

industrial adhesive. Based on SAR 

analysis of test data on analogous 

diisocyanates, EPA identified concerns 

for irritation and sensitization to the 

skin and lungs. As described in the 

PMN, EPA does not expect significant 

occupational dermal or inhalation 

exposure due to use of adequate 

personal protective equipment and 

consumer exposures are not expected as 

the PMN substance is not used in 

consumer products. 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 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day subchronic 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR Citation: 40 CFR 721.10871. 

PMN Number P–15–242 

Chemical name: Heteropolycyclic, 

polymer with alkanedioic acid, dialkenoate (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a coating resin. 

Based on test data on analogous 

acrylates, EPA identified concerns for 

oncogenicity, developmental toxicity, 

liver and kidney toxicity, sensitization, 


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irritation, and acute toxicity. Further, 

based on SAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 120 ppb of 

the PMN substance in surface waters. As 

described in the PMN, occupational 

exposures are expected to be minimal 

due to the use of impervious gloves, 

goggles, and NIOSH-certified particulate 

respirators with an APF of at least 10. 

Further, releases of the substance are 

not expected to result in surface water 

concentrations exceeding 120 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 of the 

substance without use of impervious 

gloves and goggles, when there is a 

potential dermal exposure; 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; or any use of the 

substance that results in releases to 

surface waters exceeding 120 ppb may 

result in significant adverse health and 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

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

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/developmental 

toxicity screening test (OPPTS 

870.3650); 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 721.10872. 

PMN Number P–15–247 

Chemical name: Methylene 

diisocyanate polymer with diols and 

triols (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an industrial 

adhesive. Based on SAR analysis of test 

data on analogous diisocyanates, EPA 

identified concerns for respiratory and 

dermal sensitization and lung and 

mucous membrane irritation based on 

the isocyanate moiety As described in 

the PMN, EPA does not expect 

significant occupational dermal or 

inhalation exposure due to use of 

adequate personal protective equipment 

and consumer exposures are not 

expected as the PMN substance is not 

used in consumer products. 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 

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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day subchronic 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR Citation: 40 CFR 721.10873. 

PMN Number P–15–278 

Chemical name: Polymer of 

isophorone diisocyanate and amineterminated propoxylatedpolyol 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a crosslinker. Based 

on analogous diisocyanates, EPA 

identified concerns for potential dermal 

and respiratory sensitization from 

dermal and inhalation exposures, and 

for pulmonary toxicity from inhalation 

exposure, to the PMN substance when 

the average molecular weight is below 

2500 daltons and any molecular weight 

species is below 1000 daltons. EPA does 

not expect significant exposures from 

the form of the PMN substance as 

described in the PMN. Therefore, EPA 

has not determined that the proposed 

manufacture of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any 

manufacture of the PMN substance with 

an average molecular weight of below 

2500 daltons and any molecular weight 

species below 1000 daltons may cause 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day subchronic 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR Citation: 40 CFR 721.10874. 

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 9 of the 30 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 21 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 section 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 


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

existingchemicals/pubs/tscainventory/

index.html. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

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

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

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

of this rule is December 1, 2015 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before November 2, 

2015. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

November 2, 2015, 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 9 of the 30 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 

22 of the 30 chemical substances subject 

to this rule have been claimed as 

confidential and EPA has received no 

post-PMN bona fide submissions (per 

§§ 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 October 2, 

2015 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 non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or 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 


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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 40 CFR 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– 

2015–0388. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action 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 action. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act (5 U.S.C. 

553(b)(3)(B)) to amend this table 

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this action. 

This action 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 

action. As such, EPA has determined 


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that this action 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 action does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This action 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 action. 

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). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: September 21, 2015. 

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: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR Citation OMB Control 

No. 

40 CFR Citation OMB Control 

No. 

*****

Significant New Uses of Chemical 

Substances 

*****

721.10852 ............................. 2070–0012 

721.10853 ............................. 2070–0012 

721.10854 ............................. 2070–0012 

721.10855 ............................. 2070–0012 

721.10856 ............................. 2070–0012 

721.10857 ............................. 2070–0012 

721.10858 ............................. 2070–0012 

721.10859 ............................. 2070–0012 

721.10860 ............................. 2070–0012 

721.10861 ............................. 2070–0012 

721.10862 ............................. 2070–0012 

721.10863 ............................. 2070–0012 

721.10864 ............................. 2070–0012 

721.10865 ............................. 2070–0012 

721.10866 ............................. 2070–0012 

721.10867 ............................. 2070–0012 

721.10868 ............................. 2070–0012 

721.10869 ............................. 2070–0012 

721.10870 ............................. 2070–0012 

721.10871 ............................. 2070–0012 

721.10872 ............................. 2070–0012 

721.10873 ............................. 2070–0012 

721.10874 ............................. 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 § 721.10852 to subpart E to 

read as follows: 

§ 721.10852 Fatty acids compound with 

cyclohexanamine (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acids compound 

with cyclohexanamine (PMNs P–12–69 

and P–12–70) are subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(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 


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§ 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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 5. Add § 721.10853 to subpart E to 

read as follows: 

§ 721.10853 Fluoro-modified acrylic 

copolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluoro-modified acrylic 

copolymer (PMN P–12–169) 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 the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the 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 the substance, the 

employer becomes aware that the 

substances 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 the 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), and (i) 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 this section. 

■ 6. Add § 721.10854 to subpart E to 

read as follows: 

§ 721.10854 Siloxanes and Silicones, alkyl, 

alky propoxy ethyl, methyl octyl, alkyl 

polyfluorooctyl (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as siloxanes and silicones, 

alkyl, alky propoxy ethyl, methyl octyl, 

alkyl polyfluorooctyl (PMN P–12–351) 

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 the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the 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 the substance, the 

employer becomes aware that the 

substances 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 the 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), and (i) 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 this section. 

■ 7. Add § 721.10855 to subpart E to 

read as follows: 

§ 721.10855 Partially fluorinated alcohol, 

reaction products with phosphorus oxide 

(P2O5) amine salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as partially fluorinated 

alcohol, reaction products with 

phosphorus oxide (P2O5), amine salts 

(PMNs P–12–450 and P–12–451) 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) Hazard communication program. A 

significant new use of the substances is 

any manner or method of manufacture 

or processing associated with any use of 

the substances 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 the substances, the 

employer becomes aware that the 

substances 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 the substance(s) are not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance(s) are 

reintroduced into the workplace. 


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(B) The employer must ensure that 

persons who will receive the PMN 

substance(s) from the employer, or who 

have received the PMN substance(s) 

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), and (i) 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)(2)(ii) of this section. 

■ 8. Add § 721.10856 to subpart E to 

read as follows: 

§ 721.10856 Fatty acids amine salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids amine salt 

(PMN P–12–520) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 9. Add § 721.10857 to subpart E to 

read as follows: 

§ 721.10857 Organophosphorus polymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as organophosphorus 

polymer (PMN P–13–292) 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(q). 

(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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 10. Add § 721.10858 to subpart E to 

read as follows: 

§ 721.10858 Fluorinated acid alkylester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorinated acid alkylester 

(PMN P–13–305) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(a)(6)(ii), (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): Any 

NIOSH-certified air-purifying full 

facepiece respirator equipped with 

N100 (if oil aerosols absent), R100, or 

P100 filters. 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e), 

(f)(concentration set at 1.0 percent), 

(g)(1)(The PMN substance may cause 

central nervous system depression, liver 

effects, endocrine effects), (g)(2), and 

(g)(5). In addition a significant new use 

of the substances is any manner or 

method of manufacture or processing 

associated with any use of the 

substances 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 the substances, the 

employer becomes aware that the 

substances 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 the substance(s) are not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance(s) are 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance(s) from the employer, or who 

have received the PMN substance(s) 

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. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (g) and (o). It is a 

significant new use for any chemical 

substance manufactured using the PMN 

substance to contain residuals of the 

PMN substance above the level 

specified in the consent order. It is a 

significant new use to recover and 

convert, capture (destroy), recycle, or 

reuse the PMN substance below the 

overall efficiency specified in the 

consent order, when the PMN substance 

is used as an intermediate. 

(b) Specific requirements. The 

provisions of subpart A of this part 


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apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 11. Add § 721.10859 to subpart E to 

read as follows: 

§ 721.10859 Quaternary alkyl methyl amine 

ethoxylate methyl chloride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as quaternary alkyl methyl 

amine ethoxylate methyl chloride (PMN 

P–14–563) 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) Release to water. Requirements as 

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

(c)(4) (N=29). 

(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. 

■ 12. Add § 721.10860 to subpart E to 

read as follows: 

§ 721.10860 Substituted carboxamide 

(generic). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified 

generically as substituted carboxamide 

(PMN P–14–756) 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=3). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (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. 

■ 13. Add § 721.10861 to subpart E to 

read as follows: 

§ 721.10861 Phosphoric acid, sodium 

titanium (4+) salt (3:1:2). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified as 

phosphoric acid, sodium titanium (4+) 

salt (3:1:2) (PMN P–14–804; CAS No. 

22239–24–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10862 to subpart E to 

read as follows: 

§ 721.10862 Oxirane, 2-methyl-, polymer 

with oxirane, monohexadecyl ether, 

phosphate; Oxirane, 2-methyl-, polymer 

with oxirane, monohexadecyl ether, 

phosphate, sodium salt; Oxirane, 2-methyl- 

, polymer with oxirane, monohexadecyl 

ether, phosphate, potassium salt; Oxirane, 

2-methyl-, polymer with oxirane, 

monohexadecyl ether, phosphate, 

ammonium salt; Ethanol, 2-amino-, compd. 

with 2-methyloxirane polymer with oxirane 

monohexadecyl ether phosphate; and 

Ethanol, 2,2′2′′,-nitrilotris-, compd. with 2- 

methyloxirane polymer with oxirane 

monohexadecyl ether phosphate. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as oxirane, 2-methyl-, polymer with 

oxirane, monohexadecyl ether, 

phosphate (P–15–1; CAS No. 73361–29– 

2); oxirane, 2-methyl-, polymer with 

oxirane, monohexadecyl ether, 

phosphate, sodium salt (P–15–2; CAS 

No. 151688–56–1); oxirane, 2-methyl-, 

polymer with oxirane, monohexadecyl 

ether, phosphate, potassium salt (P–15– 

3; CAS No. 1456802–88–2); oxirane, 2- 

methyl-, polymer with oxirane, 

monohexadecyl ether, phosphate, 

ammonium salt (P–15–4; CAS No. 

1456802–89–3); ethanol, 2-amino-, 

compd. with 2-methyloxirane polymer 

with oxirane monohexadecyl ether 

phosphate (P–15–5; CAS No, 1456803– 

12–5); and ethanol, 2,2′′2′′,-nitrilotris-, 

compd. with 2-methyloxirane polymer 

with oxirane monohexadecyl ether 

phosphate (PMN P–15–6; CAS No. 

1456803–14–7) 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=18 in aggregate). 

(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 § 721.10863 to subpart E to 

read as follows: 

§ 721.10863 Nitrile amine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as nitrile amine (PMN P–15– 

25) 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. 

■ 16. Add § 721.10864 to subpart E to 

read as follows: 


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§ 721.10864 1,3-propanediamine, N1, N1- 

alkyl (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 1,3-propanediamine, N1, 

N1-alkyl (PMN P–15–26) 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=32). 

(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 § 721.10865 to subpart E to 

read as follows: 

§ 721.10865 2-Pyridinecarboxylic acid, 

4,5,6-trichloro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-pyridinecarboxylic acid, 4,5,6- 

trichloro- (PMN P–15–36; CAS No. 

496849–77–5) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=30). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10866 to subpart E to 

read as follows: 

§ 721.10866 Imidazoliurn, polymer with 

cyclic anhydride and alkenoic acid, alkali 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as imidazoliurn, polymer 

with cyclic anhydride and alkenoic 

acid, alkali salt (PMN P–15–61) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

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. 

(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. 

■ 19. Add § 721.10867 to subpart E to 

read as follows: 

§ 721.10867 Hydrochlorofluorocarbon 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hydrochlorofluorocarbon. 

(PMN P–15–98) 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 § 40 CFR 

721.63 (a)(4), (a)(6)(i), (a)(6)(ii), 

(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 25 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. 

(ii) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (g). 

(iii) Release to water. Requirements as 

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

(c)(4) (N=99). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

to manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10868 to subpart E to 

read as follows: 

§ 721.10868 Alkylalkenoic acid copolymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylalkenoic acid 

copolymer (PMN P–15–136) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (v)(1), (w)(1), 

and (x)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c) and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10869 to subpart E to 

read as follows: 

§ 721.10869 D-Glucitol, alkylamino-N-acyl 

derivs. (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as D-glucitol, alkylamino-Nacyl derivs. (PMN P–15–141) 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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Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations 59609 

(i) Release to water. Requirements as 

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

(c)(4) (N=14). 

(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. 

■ 22. Add § 721.10870 to subpart E to 

read as follows: 

§ 721.10870 Cyclohexanedicarboxylic 

acid, dialkyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as cyclohexanedicarboxylic 

acid, dialkyl ester (PMN P–15–150) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 23. Add § 721.10871 to subpart E to 

read as follows: 

§ 721.10871 Isocyanate prepolymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as isocyanate prepolymer 

(PMN P–15–221) 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), 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, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10872 to subpart E to 

read as follows: 

§ 721.10872 Heteropolycyclic, polymer 

with alkanedioic acid, di-alkenoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as heteropolycyclic, polymer 

with alkanedioic acid, di-alkenoate 

(PMN P–15–242) 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) Protection in the workplace. 

Requirements as specified in 

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

(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)(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. 

(ii) Release to water. Requirements as 

specified 721.90 (a)(4), (b)(4), and (c)(4) 

(N=120). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.10873 to subpart E to 

read as follows: 

§ 721.10873 Methylene diisocyanate 

polymer with diols and triols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methylene diisocyanate 

polymer with diols and triols (PMN P– 

15–247) 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), 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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59610 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations 

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, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10874 to subpart E to 

read as follows: 

§ 721.10874 Polymer of isophorone 

diisocyanate and amine-terminated 

propoxylatedpolyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polymer of isophorone 

diisocyanate and amine-terminated 

propoxylatedpolyol (PMN P–15–278) 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. The significant 

new use is manufacture of the substance 

where the average molecular weight is 

below 2500 daltons and where any 

molecular weight species is below 1000 

daltons. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c) and (i) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2015–24846 Filed 10–1–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2015–0246; FRL–9931–19– 

Region 9] 

Revisions to the California State 

Implementation Plan, Butte County Air 

Quality Management District, Feather 

River Air Quality Management District, 

and San Luis Obispo County Air 

Pollution Control District; Correcting 

Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correcting 

amendment. 

SUMMARY: On June 11, 2015, the 

Environmental Protection Agency (EPA) 

published a final rule in the Federal 

Register approving a revision to the 

Butte County Air Quality Management 

District (BCAQMD) portion of the 

California State Implementation Plan 

(SIP). In that rulemaking, the EPA 

indicated that final approval of the 

revision would supersede certain older 

rules in the California SIP but failed to 

include regulatory text to that effect. 

This document adds appropriate 

regulatory text to correct that omission, 

clarifying the specific regulations that 

were superseded and that are no longer 

part of the applicable California SIP, 

and adds a line of text identifying the 

affected air quality district that was 

missing in the original action. 

DATES: This action is effective on 

October 2, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Gong, EPA Region IX, (415) 972– 

3073, gong.kevin@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

action corrects inadvertent errors in a 

rulemaking related to BCAQMD’s SIPapproved definitions. On June 11, 2015 

(80 FR 33195), the EPA published a 

direct final rulemaking action approving 

revisions to various sections of the 

California State Implementation Plan 

(SIP). This action contained regulatory 

text amendments to 40 CFR part 52, 

subpart F. The amendments, which 

incorporated material by reference into 

section 52.220, Identification of plan, 

paragraph (c)(457), omitted regulatory 

language that addressed the replacement 

of Butte County Air Pollution Control 

District (BCAPCD) Rule 101—‘‘Title’’ 

and parts of BCAPCD Rule 102— 

‘‘Definitions’’ with BCAQMD Rule 

101—‘‘Definitions’’ as described in 

Footnote 1 of 80 FR 33195. This action 

adds regulatory text to clarify the rules 

or portions of rules that were 

superseded in the Butte County AQMD 

portion of the California SIP by our June 

11, 2015 direct final action. 

The EPA has determined that this 

action falls under the ‘‘good cause’’ 

exemption in section 553(b)(3)(B) of the 

Administrative Procedures Act (APA) 

which, upon finding ‘‘good cause,’’ 

authorizes agencies to dispense with 

public participation where public notice 

and comment procedures are 

impracticable, unnecessary, or contrary 

to the public interest. Public notice and 

comment for this action is unnecessary 

because this action correcting 

inadvertent regulatory text errors 

included in the EPA’s June 11, 2015 

final rule is consistent with the 

substantive revision to the California 

SIP as described in the preamble of said 

action concerning definitions for the 

BCAQMD portion of the California SIP. 

In addition, the EPA can identify no 

particular reason why the public would 

be interested in having the opportunity 

to comment on the correction prior to 

this action being finalized, since this 

correction action does not change the 

EPA’s analysis or overall action related 

to the approval of BCAQMD’s revisions 

to their definitions into the California 

SIP. 

The EPA also finds that there is good 

cause under APA section 553(d)(3) for 

this correction to become effective on 

the date of publication of this action. 

Section 553(d)(3) of the APA allows an 

effective date of less than 30 days after 

publication ‘‘as otherwise provided by 

the agency for good cause found and 

published with the rule.’’ 5 U.S.C. 

553(d)(3). The purpose of the 30-day 

waiting period prescribed in APA 

section 553(d)(3) is to give affected 

parties a reasonable time to adjust their 

behaviour and prepare before the final 

rule takes effect. This rule, however, 

does not create any new regulatory 

requirements such that affected parties 

would need time to prepare before the 

rule takes effect. Rather, this action 

merely corrects inadvertent errors for 

the regulatory text of the EPA’s prior 

rulemaking for the California SIP. For 

these reasons, the EPA finds good cause 

under APA section 553(d)(3) for this 

correction to become effective on the 

date of publication of this action. 

Need for Correction 

As published, the final regulations 

omitted amendatory language that 

addressed the replacement of BCAQMD 

Rule 101. 

Statutory and Executive Order Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 


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