Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Rules and Regulations 63821 

Congressional Review Act 

This regulatory action may be 

considered a major rule under the 

Congressional Review Act, 5 U.S.C. 

801–08, because it may result in an 

annual effect on the economy of $100 

million or more. Although this 

regulatory action may constitute a major 

rule within the meaning of the 

Congressional Review Act, 5 U.S.C. 

804(2), it is not subject to the 60-day 

delay in effective date applicable to 

major rules under 5 U.S.C. 801(a)(3) 

because the Secretary finds that good 

cause exists under 5 U.S.C. 808(2) to 

make this regulatory action effective on 

January 1, 2015, consistent with the 

reasons given for the publication of this 

interim final rule. Increasing the 

copayment amount on January 1, 2015, 

might cause a significant financial 

hardship for some veterans and may 

decrease patient adherence to medical 

plans and have other unpredictable 

negative health effects. Accordingly, the 

Secretary finds that additional advance 

notice and public procedure thereon are 

impracticable, unnecessary, and 

contrary to the public interest. In 

accordance with 5 U.S.C. 801(a)(1), VA 

will submit to the Comptroller General 

and to Congress a copy of this regulatory 

action and VA’s Regulatory Impact 

Analysis (RIA). 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

one year. This interim final rule will 

have no such effect on State, local, and 

tribal governments, or on the private 

sector. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this interim final rule will not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

interim final rule will temporarily freeze 

the copayments that certain veterans are 

required to pay for prescription drugs 

furnished by VA. This rule directly 

affects individuals and will not directly 

affect small entities. Therefore, pursuant 

to 5 U.S.C. 605(b), this rulemaking is 

exempt from the initial and final 

regulatory flexibility analysis 

requirements of 5 U.S.C. 603 and 604. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance numbers and titles for the 

programs affected by this document are 

as follows: 64.005, Grants to States for 

Construction of State Home Facilities; 

64.007, Blind Rehabilitation Centers; 

64.008, Veterans Domiciliary Care; 

64.009, Veterans Medical Care Benefits; 

64.010, Veterans Nursing Home Care; 

64.011, Veterans Dental Care; 64.012, 

Veterans Prescription Service; 64.013, 

Veterans Prosthetic Appliances; 64.014, 

Veterans State Domiciliary Care; 64.015, 

Veterans State Nursing Home Care; 

64.016, Veterans State Hospital Care; 

64.018, Sharing Specialized Medical 

Resources; 64.019, Veterans 

Rehabilitation Alcohol and Drug 

Dependence; 64.022, Veterans Home 

Based Primary Care; and 64.024, VA 

Homeless Providers Grant and Per Diem 

Program. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. Jose 

D. Riojas, Chief of Staff, Department of 

Veterans Affairs, approved this 

document on September 25, 2014, for 

publication. 

List of Subjects in 38 CFR Part 17 

Administrative practice and 

procedure, Alcohol abuse, Alcoholism, 

Claims, Day care, Dental health, Drug 

abuse, Foreign relations, Government 

contracts, Grant programs-health, Grant 

programs-veterans, Health care, Health 

facilities, Health professions, Health 

records, Homeless, Medical and dental 

schools, Medical devices, Medical 

research, Mental health programs, 

Nursing homes, Philippines, Reporting 

and recordkeeping requirements, 

Scholarships and fellowships, Travel 

and transportation expenses, Veterans. 

Dated: October 22, 2014. 

William F. Russo, 

Acting Director, Office of Regulation Policy 

& Management, Office of the General Counsel, 

U.S. Department of Veterans Affairs. 

For the reasons set out in the 

preamble, VA amends 38 CFR part 17 as 

follows: 

PART 17—MEDICAL 

■ 1. The authority citation for part 17 

continues to read as follows: 

Authority: 38 U.S.C. 501(a), and as noted 

in specific sections. 

§ 17.110 [Amended] 

■ 2. Amend § 17.110 as follows: 

■ a. In paragraphs (b)(1)(i), (ii), and (iii), 

remove all references to ‘‘December 31, 

2014’’ and adding in each place 

‘‘December 31, 2015’’. 

■ b. In paragraph (b)(2) remove all 

references to ‘‘December 31, 2014’’ and 

adding in each place ‘‘December 31, 

2015’’. 

[FR Doc. 2014–25454 Filed 10–24–14; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2014–0390; FRL–9914–56] 

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 52 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 52 

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 26, 2014. For purposes of 

judicial review, this rule shall be 

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

November 10, 2014. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before November 26, 2014 (see Unit VI. 

of the SUPPLEMENTARY INFORMATION). If 

EPA receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, on one or 

more of these SNURs before November 

26, 2014, EPA will withdraw the 

relevant sections of this direct final rule 

before its effective date. 

For additional information on related 

reporting requirement dates, see Units 


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

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2014–0390, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Kenneth Moss, Chemical Control 

Division (7405 M), Office of Pollution 

Prevention and Toxics, 

Environmental Protection Agency, 

1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; 

telephone number: (202) 564–9232; 

email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, 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 submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the Agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture 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 

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 


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SNUN requirements and EPA regulatory 

procedures as submitters of PMNs under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA sections 

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 52 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 

52 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, the basis for 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 9 PMN substances 

(P–11–224, P–11–226, P–12–41, P–12– 

404, P–12–405, P–12–406, P–13–175, P– 

13–176, and P–13–239) 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. 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) consent order usually 

requires, among other things, that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL) that is 

established by EPA to provide adequate 

protection to human health. In addition 

to the actual NCEL concentration, the 

comprehensive NCELs provisions in 

TSCA section 5(e) consent orders, 

which are modeled after Occupational 

Safety and Health Administration 

(OSHA) Permissible Exposure Limits 

(PELs) provisions, include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. 

However, no comparable NCEL 

provisions currently exist in 40 CFR 

part 721, subpart B, for SNURs. 

Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 43 

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 Number P–10–235 

Chemical name: Pyridine, 4-decyl-. 

CAS number: 1815–99–2. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a fragrance component. 

Based on test data on the PMN 

substance, as well as ecological 

structure-activity relationship (SAR) 

analysis of test data on analogous 

neutral organic compounds, EPA 

predicts chronic toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 part per billion (ppb) of 

the PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early-life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 


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substance to surface water exceed 

releases from the use described in the 

PMN. For the use described in the PMN, 

environmental releases did not exceed 

the concentration of concern for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

described in the PMN, or any use of the 

substance resulting in surface water 

concentrations exceeding 1 ppb from 

manufacturing or processing waste 

stream releases, may result in 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 daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10766. 

PMN Number P–11–224 

Chemical name: Fluoroether 

(generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: August 5, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the PMN 

will be used as an electrolyte for 

electrical/electronic equipment. Based 

on test data on the PMN substance, EPA 

identified concerns for subchronic 

toxicity, systemic toxicity, reproductive 

effects; as well as toxicity to aquatic 

organisms at concentrations that exceed 

9 ppb of the PMN substance in surface 

waters. The Order was issued under 

TSCA section 5(e)(1)(A)(i), 

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

based on a finding that the substance 

may present an unreasonable risk of 

injury to human health and the 

environment, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance. To protect against these risks, 

the consent order requires: 

1. Submission of certain toxicity and 

fate testing prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

2. Manufacturing, processing, and use 

of the substance only as an electrolyte 

for electrical/electronic equipment as 

described in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the test data from 

certain human health, environmental 

fate, and ecotoxicity testing identified in 

the consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The company has agreed not 

to exceed the confidential production 

limit without performing a bacterial 

reverse mutation test (OPPTS Test 

Guideline 870.5100); a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395); a UV/Visible 

absorption test (Organisation for 

Economic Co-Operation and 

Development (OECD) Test Guideline 

101); and an atmospheric half-life test 

(as referenced in the Consent Order). 

EPA has also determined that the results 

of a reproduction/development toxicity 

test (OPPTS Test Guideline 870.3550); a 

fish early-life stage toxicity test (OPPTS 

Test Guideline 850.1400); a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300); and information to 

address cardiac sensitization (as 

described in the Consent Order) would 

help characterize the human health and 

ecotoxicity effects of the PMN 

substance. The consent order does not 

require submission of this pended 

testing detailed in the consent order at 

any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMNs will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10767. 

PMN Number P–11–226 

Chemical name: N-(2-hydroxyethyl) 

alkenamide (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: February 27, 2014. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a component of adhesives and 

cosmetics. Based on SAR analysis of test 

data on analogous acrylamides, EPA 

identified concerns for carcinogenicity, 

heritable mutagenicity, reproductive 

and developmental toxicity, and 

neurotoxicity from dermal and 

inhalation exposures. Consistent with 

the establishment of a Safe Drinking 

Water Act maximum contaminant level 

goal (MCLG) of zero for acrylamides, 

EPA identified concerns for nervous 

system and blood effects from general 

population drinking water exposures to 

the PMN substance. The consent order 

was issued under TSCA section 

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

finding that the uncontrolled 

manufacture, processing, distribution in 

commerce, use, and disposal of the 

PMN substance may present an 

unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

Material Safety Data Sheet (MSDS), 

within 90 days. 

2. Use of personal protective 

equipment including gloves impervious 

to the substances, when there is a 

potential dermal exposure; and a 

National Institute of Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 1,000 or 

compliance with a NCEL of 0.03 mg/m3

as an 8-hour time-weighted average 

(when there is potential inhalation 

exposure), when there is potential 

inhalation exposure. 

3. Establishment and use of a hazard 

communication program, including 

human health, environmental hazard 

precautionary statements on each label 

and the MSDS. 

4. Submission of certain testing prior 

to exceeding the confidential 

production volume limits of the PMN 

substance specified in the consent 

order. 

5. Disposal of all waste streams 

containing the PMN substance either by 

incineration (destruction and removal 

efficiency of 99.99%) or underground 

injection control (class 1 well, deep well 

injection for hazardous wastes) 

6. No use of the substances resulting 

in releases to surface water. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the test data from 

certain human health, testing identified 

in the consent order would help 

characterize possible effects of the 

substance. The company has agreed not 

to exceed the first confidential 

production limit without performing a 

90-day oral toxicity test (OPPTS Test 

Guideline 870.3100) in rodents, with a 

functional observational battery for 

neuropathology (OPPTS Test Guideline 

870.6300); a rodent oral dominant lethal 


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assay (OPPTS Test Guideline 870.5450); 

and, depending on the results of the 

rodent oral dominant lethal assay, an 

oral rodent heritable translocation test 

(OPPTS Test Guideline 870.5460) may 

be required. The company has agreed 

not to exceed the second confidential 

production limit without performing a 

2-year oral carcinogenicity test (OPPTS 

Test Guideline 870.4200) in rats and 

mice. 

CFR citation: 40 CFR 721.10768. 

PMN Number P–12–41 

Chemical name: 1- 

Octadecanaminium, N,N-dimethyl-N-[3- 

(triethoxysilyl)propyl]-, chloride (1:1), 

reaction products with ethylene glycol. 

CAS number: 1314035–96–5. 

Effective date of TSCA section 5(e) 

consent order: March 3, 2014. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the uses of 

the PMN substance will be for 

waterproofing inorganic substrates, an 

asphalt binder modifier, and 

waterproofing of soil. The consent order 

was issued under TSCA section 

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

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

the substance may present an 

unreasonable risk of injury to human 

health; and the substance may be 

produced in substantial quantities and 

there may be significant (or substantial) 

human exposure to the substance. To 

protect against these risks, the consent 

order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into an 

MSDS, within 90 days. 

2. No domestic manufacture of the 

PMN substance. 

3. Import, processing and use of the 

PMN substance only for waterproofing 

inorganic substrates, an asphalt binder 

modifier, and waterproofing of soil. 

4. Submission of certain human 

health testing prior to exceeding an 

aggregate production volume limit of 

839,000 kilograms. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

toxicity testing would help characterize 

possible health effects of the PMN 

substance. The company has agreed not 

to exceed the 839,000 kilogram 

production limit without performing a 

90-day inhalation toxicity test (OPPTS 

Test Guideline 870.3465). EPA has also 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity mitigated 

by humic acid test (OPPTS Test 

Guideline 850.1085); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (Office of Chemical Safety 

and Pollution Prevention (OCSPP) Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. The consent order 

does not require submission of this 

aquatic toxicity testing at any specified 

time or production volume. However, 

the consent order’s restrictions on 

manufacture, processing, distribution in 

commerce, use, and disposal of the 

PMN will remain in effect until the 

consent order is modified or revoked by 

EPA based on submission of that or 

other relevant information. 

CFR citation: 40 CFR 721.10769. 

PMN Numbers P–12–404, P–12–405, P– 

12–406 

Chemical names: Fluoroalkyl 

sulfonamide derivatives (generic). 

CAS numbers: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: March 14, 2014. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of the substances 

are as a chemical intermediate (P–12– 

404) and a surfactant (P–12–405 and P– 

12–406). Based on test data submitted 

on P–12–405, P–12–406, and closely 

analogous perfluorinated substances, as 

well as test data on analogous 

perfluorobutane sulfonate (PFBS), EPA 

identified concerns for liver, blood, 

kidney, developmental, and systemic 

toxicity. The consent order was issued 

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

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

based on a finding that these substances 

may present an unreasonable risk of 

injury to human health and the 

environment; and these substances may 

be produced in substantial quantities 

and may reasonably be anticipated to 

enter the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substances 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into an 

MSDS, within 90 days. 

2. Use of personal protective 

equipment including impervious gloves 

(when there is potential dermal 

exposure) for PMNs P–12–404 and P– 

12–406. 

3. Use of personal protective 

equipment including impervious gloves 

(when there is potential for dermal 

exposures), and either a NIOSH-certified 

respirator with an APF of at least 10 or 

compliance with a NCEL of 0.7 mg/m3

as an 8-hour time-weighted average 

(when there is potential inhalation 

exposure) for the PMN substance P–12– 

405. 

4. Establishment and use of a hazard 

communication program. 

5. Submission of certain 

environmental fate and human health 

testing prior to exceeding the 

confidential production volume limits 

of the aggregate amount of the PMN 

substances, P–12–405 and P–12–406, 

specified in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

environmental fate and toxicity testing 

would help characterize the possible 

effects of the PMN substances. The 

company has agreed not to exceed the 

first confidential production limit 

without performing a semi-continuous 

activated sludge (SCAS) test (OPPTS 

Test Guideline 835.5045) modified, on 

PMN substance P–12–406. The PMN 

submitter has also agreed not to exceed 

the second confidential production limit 

without performing a metabolism and 

pharmacokinetics test (OPPTS Test 

Guideline 870.7485) and a combined 

repeated dose toxicity test (OPPTS Test 

Guideline 870.3650) on the 

predominant degradation product 

identified in the SCAS test. EPA has 

also determined that the results of a 

combined chronic toxicity/

carcinogenicity test (OPPTS Test 

Guideline 870.4300) on PFBS would 

help characterize the human health and 

environmental effects of the PMN 

substances. The consent order does not 

require submission of this test on PFBS 

at any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMN substances will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10770. 

PMN Numbers P–13–175 and P–13–176 

Chemical names: (P–13–175) Hexane, 

1,6-diisocyanato-, homopolymer, 


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.alpha.-[1-[[[3-[[3-(dimethylamino)

propyl]amino]propyl]amino]carbonyl]- 

1,2,2,2-tetrafluoroethyl]-.omega.-

(1,1,2,2,3,3,3-heptafluoropropoxy)

poly[oxy[trifluoro(trifluoromethyl)-1,2- 

ethanediyl]]-blocked; and (P–13–176) 

Fluorinated oxirane polymer (generic). 

CAS numbers: (P–13–175) 1279108– 

20–1; and (P–13–176) Claimed 

confidential. 

Effective date of TSCA section 5(e) 

consent order: December 13, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the 

substances will be used as a coating 

additive in paper and paperboard to 

impart grease, alcohol, and solvent 

resistance (P–13–175) and an 

intermediate for use in the manufacture 

of a polymer (P–13–176). For the PMN 

substance P–13–176, where the average 

number molecular width <1,000 daltons 

is less than 0.5%, ecotoxicity concerns 

were low based on ecological SAR 

analysis of test data on analogous esters. 

However, based on potential concerns 

for perfluoro ethers, and the 

uncertainties regarding toxicity of the 

lower molecular weight portions, EPA 

predicts toxicity to aquatic organisms 

for P–13–176 if the average number 

molecular weight of <1,000 daltons is 

greater than 0.5%. The consent order 

was issued under TSCA section 

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

on a finding that the substances may 

present an unreasonable risk of injury to 

the environment. To protect against 

these risks, the consent order requires: 

1. Manufacture the PMN substance P– 

13–175 using the PMN substance P–13– 

176 as the starting raw material. 

2. Manufacture the PMN substance P– 

13–176: (a) Where the average number 

molecular weight less than 1,000 

Daltons is less than or equal to 0.5% 

and (b) for use as a chemical 

intermediate to manufacture PMN 

substance P–13–175. 

Recommended testing: EPA has 

determined that the results of either a 

zahn-wellens/EMPA test (OPPTS Test 

Guideline 835.3200) or a SCAS test 

(OPPTS Test Guideline 835.3210) 

modified; and a sediment-water 

lumbriculus toxicity test (OECD Test 

Guideline 225) using spiked sediment, 

on P–13–176, would help characterize 

the effects of the PMN substances. The 

consent order does not require 

submission of the testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMNs will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10771 (P– 

13–175) and 40 CFR 721.10772 (P–13– 

176). 

PMN Number P–13–223 

Chemical name: Methylene 

bisacetophenone derivative (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a photoinitiator for 

coatings and inks. Based on test data on 

the PMN substance, EPA identified 

concerns for reproductive and 

developmental effects from dermal and 

inhalation exposures. In addition, based 

on test data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

5 ppb of the PMN substance in surface 

waters. As described in the PMN, 

significant occupational dermal and 

inhalation exposures are not expected 

due to the use of impervious gloves and 

a NIOSH-certified respirator with an 

APF of at least 10. Further, releases to 

water are not expected to result in 

surface water concentrations that exceed 

5 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use will 

present an unreasonable risk. However, 

EPA has determined that any use of the 

substance without impervious gloves, 

where there is a potential for dermal 

exposures; any use of the substance 

without a NIOSH-certified respirator 

with an APF of at least 10, where there 

is a potential for inhalation exposures; 

or any use of the substance resulting in 

surface water concentrations exceeding 

5 ppb may result in serious health 

effects and significant adverse 

environmental effects. Based on this 

information, the PMN meets the concern 

criteria at § 721.170 (b)(3)(i) and 

(b)(4)(i). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed to facilitate solubility of the 

PMN substance in the test media. 

CFR citation: 40 CFR 721.10773. 

PMN Number P–13–239 

Chemical name: Amine adduct 

(generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: January 15, 2014. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be as a membrane 

hardener. Based on test data on the 

PMN substance, as well as ecological 

SAR analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters and 

general population exposures from 

incineration and landfill releases. The 

consent order was issued under TSCA 

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

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

the substance may present an 

unreasonable risk of injury to human 

health and the environment, may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance. To protect against these risks, 

the consent order requires: 

1. No domestic manufacture of the 

PMN substance. 

2. Import, processing and use of the 

PMN substance only as described in the 

consent order. 

3. Submission of certain toxicity and 

fate testing prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

toxicity testing would help characterize 

possible health effects of the PMN 

substance. The company has agreed not 

to exceed the confidential production 

limit specified in the consent order 

without performing an in vitro 

mammalian chromosome aberration test 

(OECD Test Guideline 473); an in vitro 

mammalian cell gene mutation test 

(OECD Test Guideline 476) by the 

hypoxanthine-guanine phosphoribosyl 

transferase (HPRT) path; and a 

combined repeated dose toxicity study 

with reproduction/developmental 

toxicity screening (OPPTS Test 

Guideline 870.3670 or OECD Test 

Guideline 422). EPA has also 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish early-life stage toxicity 

test (OPPTS Test Guideline 850.1400); 


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and a daphnid chronic toxicity test 

(OPPTS Test Guideline 850.1300) would 

help characterize the environmental 

effects of the PMN substance. The 

consent order does not require 

submission of this testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10774. 

PMN Number P–13–495 

Chemical name: Metal hydroxide, 

treated with alkenyl alkoxy silane 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance will be as a 

filler in fire resistant silicone rubber 

blends. Based on SAR analysis of test 

data on analogous respirable poorly 

soluble particulates, EPA identified 

human health concerns for lung toxicity 

and oncogenicity from exposure to the 

PMN substance via inhalation. As 

described in the PMN, occupational 

inhalation exposures are not expected as 

the substance is not handled 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 use of the substance in the form of 

a powder may result in serious health 

effects. Based on this information, the 

PMN substance meets the concern 

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

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60-day 

holding period would help characterize 

the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10775. 

PMN Number P–13–793 

Chemical name: Functionalized 

carbon nanotubes (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a thin film 

for electronic device applications. Based 

on SAR analysis of test data on 

analogous carbon nanotubes and other 

respirable poorly soluble particulates, 

EPA identified potential lung effects, 

developmental toxicity, and dermal 

toxicity from exposure to the PMN 

substance via inhalation, dermal, and 

oral routes. Further, EPA predicts 

toxicity to aquatic organisms via 

releases of the PMN substance to surface 

water. As described in the PMN, EPA 

does not expect significant occupational 

exposures due to the use of impervious 

gloves, where there is potential for 

dermal exposure, and because the PMN 

is used in liquid form and is not spray 

applied. Further, EPA does not expect 

environmental releases during the use 

identified in the PMN submission. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk human 

health or the environment. EPA has 

determined, however, that any use of 

the substance without the use of 

impervious gloves, where there is a 

potential for dermal exposure; 

manufacturing the PMN substance for 

use other than as a thin film for 

electronic device applications; 

manufacturing, processing, or using the 

PMN substance in a form other than a 

liquid; use of the PMN substance 

involving an application method that 

generates a mist, vapor, or aerosol; or 

any release of the PMN substance into 

surface waters may cause serious health 

effects or significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria in § 721.170 

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

Recommended testing: EPA has 

determined that the results of an oral 

and inhalation pharmacokinetic test 

(OPPTS Test Guideline 870.7485); a 90- 

day inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); an algal toxicity test (OCSPP 

Test Guideline 850.4500); and a surface 

charge by electrophoresis by either the 

(ASTM Test Guideline E2865–12) or 

measuring the zeta potential of 

nanoparticles (Nanotechnology 

Characterization Library (NCL) Method 

PCC–2) (located in the Docket under 

Docket ID number EPA–HQ–OPPT– 

2014–0390); would help characterize 

the human health and environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10776. 

PMN Numbers P–13–945 and P–13–946 

Chemical names: (P–13–945) 2,4- 

Hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester; and (P– 

13–946) 2,4,Hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester (2E,4E)-. 

CAS numbers: (P–13–945) 3090–13–9 

and (P–13–946) 163802–53–7. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as industrial 

thermoplastic additives. Based on test 

data on the PMN substances, as well as 

SAR analysis of test data on analogous 

alkoxysilanes, EPA identified concerns 

for respiratory irritation and chronic 

lung toxicity from inhalation exposures. 

Further, based on test data on the PMN 

substances, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 58 ppb of the 

substances in surface waters. As 

described in the PMNs, inhalation 

exposures are not expected, and releases 

to surface waters are not expected to 

result in surface water concentrations 

that exceed 58 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. However, EPA has determined that 

any use of the substances involving an 

application method that generates a 

vapor, mist, or aerosol; or any use of the 

substances resulting in surface water 

concentrations exceeding 58 ppb may 

result in serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

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

and (b)(4)(i). 

Recommended testing: EPA has 

determined that the results of a 90-day 

toxicity test in rodents (OPPTS Test 

Guideline 870.3100) via the inhalation 

route; a hydrolysis test (OPPTS Test 

Guideline 835.2120); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) on PMN substance 

P–13–946 would help characterize the 

human health and environmental effects 

of the PMN substances. 

CFR citation: 40 CFR 721.10777 (P– 

13–945) and 40 CFR 721.10778 (P–13– 

946). 

PMN Number P–14–28 

Chemical name: Substituted alkene, 

reaction products with 

isophoronediamine (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance will be as a sitelimited intermediate for coating resin 

manufacture. Based on SAR analysis of 

test data on analogous organonitriles 

and cyanides, EPA identified human 

health concerns for acute oral toxicity 

and developmental toxicity from 

exposure to the PMN substance via 

inhalation. Further, based on ecological 

SAR analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 49 ppb of the 

PMN substance in surface waters. As 

described in the PMN, occupational 


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exposures are expected to be minimal as 

the substance is used as a site-limited 

intermediate by an application method 

that does not generate a dust, mist, 

vapor, or aerosol. In addition, releases of 

the substance are not expected to result 

in surface water concentrations that 

exceed 49 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 other than as 

a site-limited intermediate; any use of 

the substance involving an application 

method that generates a dust, vapor, 

mist, or aerosol; or any use of the 

substance resulting in surface water 

concentrations exceeding 49 ppb 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 prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700) in rats; a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); a fish 

acute toxicity mitigated by humic acid 

(OPPTS Test Guideline 850.1085); an 

aquatic invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10779. 

PMN Number P–14–72 

Chemical name: Propaneperoxoic 

acid, 2,2-dimethyl-, 1,1,3,3- 

tetramethylbutyl ester. 

CAS number: 22288–41–1. 

Basis for action: The PMN states that 

the use of the substance will be as a 

polymerization initiator for the 

production of polyvinyl chloride (PVC) 

and polyethylene resin. Based on test 

data on the PMN substance, as well as 

ecological SAR analysis of test data on 

analogous peroxy esters, 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 that exceed 

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 resulting in 

surface waters concentrations exceeding 

3 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OECD Test 

Guideline 301C) with product-specific 

chemical analytics to validate the 

degradation products (including 

intermediate products) and the rates of 

degradation (including intermediate 

degradation rates); and a hydrolysis as 

a function of pH and temperature test 

(OPPTS Test Guideline 835.2130) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10780. 

PMN Numbers P–14–89, P–14–90, P–14– 

91, and P–14–92 

Chemical names: Fatty acid amide 

hydrochlorides (generic). 

CAS numbers: Claimed confidential. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as surfactants for use in asphalt 

emulsions. Based on ecological SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed the following 

values of the PMN substances in surface 

waters: 

PMN No. 

Concentration of 

concern 

(ppb) 

P–14–89, P–14–92 ....... 110 

P–14–90 ....................... 240 

P–14–91 ....................... 53 

For the use described in the PMNs, 

releases of the substances are not 

expected to result in surface water 

concentrations that exceed these values. 

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 substances resulting in surface water 

concentrations exceeding the 

aforementioned concentrations of 

concern 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, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substances. EPA also 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures (OECD 

Test Guideline 23) be followed. 

CFR citation: 40 CFR 721.10781. 

PMN Numbers P–14–158, P–14–159, P– 

14–161, P–14–162, and P–14–163 

Chemical names: Fatty acid amides 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as chemical intermediates and 

additives for flotation products. Based 

on ecological SAR analysis of test data 

on analogous amides and aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed the following values of the 

PMN substances in surface waters: 

PMN No. 

Concentration of 

concern 

(ppb) 

P–14–158, P–14–159, 

P–14–161, P–14–163 1 

P–14–162 ..................... 140 

For the use described in the PMNs, 

releases of the substances are not 

expected to result in surface water 

concentrations that exceed these values. 

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 substances resulting in surface water 

concentrations exceeding the 

aforementioned concentrations of 

concern 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 (1) a water 

solubility: Column elution method; 

shake flask method test (OPPTS Test 

Guideline 830.7840) or a water 

solubility generator column method test 

(OPPTS Test Guideline 830.7860); and 

(2) a determination of the partition 

coefficient (n-octanol/water) by shake 

flask method (OPPTS Test Guideline 

830.7550), or generator column method 

(OPPTS Test Guideline 830.7560), or 

estimation by liquid chromatography 

(OPPTS Test Guideline 830.7570) would 

help characterize the physical/chemical 

properties of the PMN substances. 

Depending upon the results of these 

data, 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 


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Guideline 850.4500) may be 

recommended to help characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10782. 

PMN Numbers P–14–173, P–14–175, P– 

14–176, P–14–177, P–14–178, P–14–179, 

P–14–180, P–14–181, P–14–182, P–14– 

183, P–14–184, P–14–185, P–14–186, P– 

14–187, P–14–188, P–14–190, P–14–191, 

P–14–192 and P–14–193 

Chemical names: Fatty acid amide 

acetates (generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the substances will be used as flotation 

additives for use in mineral processing. 

Based on ecological SAR analysis of test 

data on analogous amides and aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed the following values of the 

PMN substances in surface waters: 

PMN No. 

Concentration 

of concern 

(ppb) 

P–14–173, P–14–175, P– 

14–178, P–14–179, P– 

14–181, P–14–183, P– 

14–184, P–14–192, P– 

14–193 ............................ 1 

P–14–176, P–14–180, P– 

14–185, P–14–186, P– 

14–187, P–14–190 .......... 2 

P–14–177, P–14–188 ......... 3 

P–14–191 ........................... 4 

P–14–182 ........................... 140 

For the use described in the PMNs, 

releases of the substances are not 

expected to result in surface water 

concentrations that exceed these values. 

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 substances resulting in surface water 

concentrations exceeding the 

aforementioned concentrations of 

concern 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, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) on P–14–184, and 

any one of the remaining PMN 

substances, would help characterize the 

environmental effects of the PMN 

substances. Further, EPA determined 

that the results of a fish acute toxicity 

mitigated by humic acid test (OPPTS 

Test Guideline 850.1085) on PMN P– 

14–184 would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10783. 

PMN Numbers P–14–216, P–14–217, P– 

14–218, and P–14–231 

Chemical names: (P–14–216, P–14– 

217, and P–14–218) Mixed butyltin 

mercaptoester sulfides (generic) and (P– 

14–231) Mixed methyltin mercaptoester 

sulfides (generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the substances will be used as 

stabilizers in polyvinyl chloride. Based 

on the physical-chemical properties of 

the PMN substances and their 

anticipated degradation products, as 

well as SAR analysis of test data on 

analogous organotin compounds, EPA 

identified concerns for immunotoxicity, 

neurotoxicity, developmental and 

reproductive toxicity, asthma and skin 

sensitization from dermal and 

inhalation exposures to the PMN 

substances, and toxicity to aquatic 

organisms at concentrations that exceed 

0.5 ppb of the PMN substances in 

surface waters. For the use described in 

the PMNs (including waste handling 

and hazard communication), EPA does 

not expect significant occupational or 

general population exposures, nor 

significant releases to the aquatic 

environment due to 

1. Use of impervious gloves, where 

there is a potential for dermal 

exposures. 

2. Maintaining workplace airborne 

concentrations of the PMN substances 

not to exceed the OSHA PEL for 

organotins of 0.1 micrograms/m3 by 

percent tin (% Sn). 

3. Labeling transport containers and 

providing hazard communication. 

4. Use of the substance only as 

described in the PMN. and 

5. Releases of any waste stream into 

the waters of the United States not to 

exceed 0.5 ppb. 

Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without dermal 

protection, where there is a potential for 

dermal exposures; any use of the PMN 

substances without maintaining 

workplace airborne concentrations 

exceeding the OSHA PEL of 0.1 

micrograms/m3 by percent tin; use of 

the substance without container labeling 

and appropriate hazard communication; 

or any use of the substances other than 

as stabilizers in polyvinyl chloride at 

concentrations not to exceed 2%, or any 

use of the substance resulting in releases 

to surface waters exceeding 

concentrations of 0.5 ppb of the PMN 

substances may result in serious health 

effects and significant adverse 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(3)(ii), (b)(3)(iii), (b)(4)(ii), 

and (b)(4)(iv). 

Recommended testing: EPA has 

determined that the results of the 

following testing on either P–14–216, P– 

14–217, or P–14–218; and P–14–231 

would help characterize the human 

health and environmental effects of the 

PMN substances: A 90-day toxicity test 

(OPPTS Test Guideline 870.3100) in 

rats, by the oral route, with special 

attention to lymphoid organs (thymus, 

spleen, peripheral lymph nodes) and 

bone marrow; a neurotoxicity test 

(OPPTS Test Guideline 870.6200) to 

include motor activity, functional 

observational battery, and 

neuropathology with special attention to 

lesions in the hippocampus; 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); 

an aerobic ready biodegradability test 

(OECD Test Guideline 301); a fish early 

life stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300). In addition, 

Further, EPA had determined that a 

leaching from PVC pipe study on PMN 

substances P–14–216, P–14–217, or P– 

14–218 (or model dibutyltin 

mercaptoester sulfide); and a leaching 

from PVC pipe study on PMN substance 

P–14–231 (or model dimethyltin 

mercaptoester sulfide) would be helpful 

in characterizing the PMN substances. 

CFR citation: 40 CFR 721.10784 (P– 

14–216, P–14–217, and P–14–218) and 

40 CFR 721.10785 (P–14–231). 

PMN Number P–14–234 

Chemical name: Trisubsituted 

ethoxylated carbomonocycle (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a dispersant. Based on 

test data on the PMN substance, as well 

as ecological SAR analysis of test data 

on analogous nonionic surfactants, EPA 

predicts toxicity to aquatic organisms 


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may occur at concentrations that exceed 

24 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 24 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 24 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10786. 

PMN Number P–14–270 

Chemical name: Multi-functional 

novolac type epoxy resin (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a 

monomer for polyamides and as an 

ingredient to produce metamethylene 

1,5 diisocyanate. Based on ecological 

SAR analysis of test data on analogous 

polyepoxides, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 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 721.10787. 

PMN Number P–14–357 

Chemical name: Alkanedioic acids, 

polymer with substituted propanediol, 

alkanediols, polyethylene glycol and 

MDI (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance will be with 

lamination of plastic sheets and textiles. 

Based on SAR analysis of test data on 

analogous diisocyanates, EPA identified 

concerns for irritation to the eye, skin, 

and mucous membranes; and dermal 

and respiratory sensitization. As 

described in the PMN, EPA does not 

expect significant occupational 

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

least 10, where there is a potential for 

inhalation exposures; and the substance 

is applied by a method that does not 

generate a vapor, mist, or aerosol. 

Further, consumer inhalation exposures 

are not expected as the PMN is not 

being used in consumer products. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

organic vapor respirator with an APF of 

at least 10, where there is a potential for 

inhalation exposure; any use in 

consumer products; or any use of the 

substance involving an application 

method that generates a vapor, mist, or 

aerosol may cause serious health effects. 

Based on this information, the PMN 

substances meet the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10788. 

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 52 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 43 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture or 

process a listed chemical substance for 

the described significant new use before 

that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to regulate 

prospective manufacturers or processors 

of a listed chemical substance before the 

described significant new use of that 

chemical substance occurs, provided 

that regulation is warranted pursuant to 

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

• EPA will ensure that all 

manufacturers and processors of the 

same chemical substance that is subject 

to a TSCA section 5(e) consent order are 

subject to similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Chemical Substance Inventory 

(TSCA Inventory). Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

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

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

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

of this rule is December 26, 2014 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

November 26, 2014. 

If EPA receives written adverse or 

critical comments, or notice of intent to 


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submit adverse or critical comments, on 

one or more of these SNURs before 

November 26, 2014, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of the Significant 

New Use Designation 

To establish a significant new use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. In cases where 

EPA has not received a notice of 

commencement (NOC) and the chemical 

substance has not been added to the 

TSCA Inventory, no person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. However, 

TSCA section 5(e) consent orders have 

been issued for 9 of the 52 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 

46 of the 52 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 27, 

2014 as the cutoff date for determining 

whether the new use is ongoing. Persons 

who begin commercial manufacture or 

processing of the chemical substances 

for a significant new use identified as of 

that date would have to cease any such 

activity upon the effective date of the 

final rule. To resume their activities, 

these persons would have to first 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990 for a more detailed discussion of 

the cutoff date for ongoing uses. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

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

are provided for informational purposes. 

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. ASTM 

International standards are available at 

http://www.astm.org/Standard/ 

index.shtml. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study before 

reaching the specified production limit. 

Listings of the tests specified in the 

TSCA section 5(e) consent orders are 

included in Unit IV. The SNURs contain 

the same production volume limits as 

the TSCA section 5(e) consent orders. 

Exceeding these production limits is 

defined as a significant new use. 

Persons who intend to exceed the 

production limit must notify the Agency 

by submitting a SNUN at least 90 days 

in advance of commencement of nonexempt commercial manufacture or 

processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at 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 


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under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture or process the chemical 

substance, EPA will tell the person 

whether the use identified in the bona 

fide submission would be a significant 

new use under the rule. Since most of 

the chemical identities of the chemical 

substances subject to these SNURs are 

also CBI, manufacturers and processors 

can combine the bona fide submission 

under the procedure in § 721.1725(b)(1) 

with that under § 721.11 into a single 

step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture or 

process the chemical substance so long 

as the significant new use trigger is not 

met. In the case of a production volume 

trigger, this means that the aggregate 

annual production volume does not 

exceed that identified in the bona fide 

submission to EPA. Because of 

confidentiality concerns, EPA does not 

typically disclose the actual production 

volume that constitutes the use trigger. 

Thus, if the person later intends to 

exceed that volume, a new bona fide 

submission would be necessary to 

determine whether that higher volume 

would be a significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notification requirements and 

EPA regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and 721.25. E–PMN software is 

available electronically at http:// 

www.epa.gov/opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances subject to 

this rule. EPA’s complete economic 

analysis is available in the docket under 

docket ID number EPA–HQ–OPPT– 

2014–0390. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

B. Paperwork Reduction Act (PRA) 

According to PRA (44 U.S.C. 3501 et 

seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this rule. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act (5 U.S.C. 

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

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is available 

in the docket for this rule. 

This rule is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

rule. As such, EPA has determined that 

this rule does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of UMRA sections 202, 

203, 204, or 205 (2 U.S.C. 1501 et seq.). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 


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Executive Order 13132, entitled 

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

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

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

note), does not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIV. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: October 9, 2014. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10766 ............................. 2070–0012 

721.10767 ............................. 2070–0012 

721.10768 ............................. 2070–0012 

721.10769 ............................. 2070–0012 

721.10770 ............................. 2070–0012 

721.10771 ............................. 2070–0012 

721.10772 ............................. 2070–0012 

721.10773 ............................. 2070–0012 

721.10774 ............................. 2070–0012 

721.10775 ............................. 2070–0012 

721.10776 ............................. 2070–0012 

721.10777 ............................. 2070–0012 

40 CFR citation OMB control 

No. 

721.10778 ............................. 2070–0012 

721.10779 ............................. 2070–0012 

721.10780 ............................. 2070–0012 

721.10781 ............................. 2070–0012 

721.10782 ............................. 2070–0012 

721.10783 ............................. 2070–0012 

721.10784 ............................. 2070–0012 

721.10785 ............................. 2070–0012 

721.10786 ............................. 2070–0012 

721.10787 ............................. 2070–0012 

721.10788 ............................. 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 § 721.10766 to subpart E to 

read as follows: 

§ 721.10766 Pyridine, 4-decyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

pyridine, 4-decyl- (PMN P–10–235; CAS 

No. 1815–99–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) Release to water. Requirements as 

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

(N=1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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. 

■ 5. Add § 721.10767 to subpart E to 

read as follows: 

§ 721.10767 Fluoroether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 


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generically as fluoroether (PMN P–11– 

224) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any manufacturing, 

processing, or use other than as an 

electrolyte for electrical/electronic 

equipment) 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 (b). 

(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. 

■ 6. Add § 721.10768 to subpart E to 

read as follows: 

§ 721.10768 N-(2-hydroxyethyl) alkenamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as N-(2-hydroxyethyl) 

alkenamide (PMN P–11–226) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(a)(6)(ii), (a)(6)(vi), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(A) The following gloves have been 

demonstrated to meet the requirements 

of § 721.63(a)(3): North Silver Shield 

Gloves, Ansell Barrier Gloves, North 

Butyl Gloves, Ansell Chemi Pro Gloves, 

Ansell Neoprene Gloves, Ansell So-Vex, 

and Ansell Canners. 

(B) The following National Institute 

for Occupational Safety and Health 

(NIOSH)-certified respirators with an 

Assigned Protection Factor (APF) of at 

least 1,000 meet the requirements of 

§ 721.63(a)(4): 

(1) 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. 

(2) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(3) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(C) As an alternative to the respiratory 

requirements listed here, a manufacturer 

or processor may choose to follow the 

New Chemical Exposure Limit (NCEL) 

provisions listed in the section TSCA 

5(e) consent order for this substance. 

The NCEL is 0.03 mg/m3 as an 8-hour 

time weighted average verified by actual 

monitoring data. 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e), (f), (g)(1)(i), 

(g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), 

(g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), 

and (g)(2)(iv) (use respiratory protection, 

or maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 0.03 mg/m3), 

(g)(2)(v), (g)(3), and (g)(4). A significant 

new use of this substance is any manner 

or method of manufacture or processing 

associated with any use of this 

substance without providing risk 

notification as follows under 

§ 721.72(c): 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1) (destruction 

and removal efficiency of 99.99%), 

(a)(3) (underground injection control 

(class 1 well, deep well injection 

hazardous waste)), (b)(1) (destruction 

and removal efficiency of 99.99%), 

(b)(3) (underground injection control 

(class 1 well, deep well injection 

hazardous waste)), (c)(1) (destruction 

and removal efficiency of 99.99%), 

(c)(3) (underground injection control 

(class 1 well, deep well injection 

hazardous waste)). 

(v) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (k) are applicable 

to manufacturers and processors of 

these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.10769 to subpart E to 

read as follows: 

§ 721.10769 1-Octadecanaminium, N,Ndimethyl-N-[3-(triethoxysilyl)propyl]-, 

chloride (1:1), reaction products with 

ethylene glycol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-octadecanaminium, N,N-dimethyl-N- 

[3-(triethoxysilyl)propyl]-, chloride 

(1:1), reaction products with ethylene 

glycol (PMN P–12–41; CAS No. 

1314035–96–5) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 


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(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (a significant 

new use is import, processing and use 

of the PMN substance other than for 

waterproofing inorganic substrates, an 

asphalt binder modifier, and 

waterproofing of soil), and (q) (839,000 

kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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. 

■ 8. Add § 721.10770 to subpart E to 

read as follows: 

§ 721.10770 Fluoroalkyl sulfonamide 

derivatives (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fluoroalkyl sulfonamide 

derivatives (PMN P–12–404, P–12–405, 

and P–12–406) 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 for P–12– 

404 and P–12–406 are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1), 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. 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (e), (f), (g)(1) (The 

PMN substances may: Cause serious eye 

damage; and suspected of damaging 

fertility or the unborn child), and (g)(2) 

(When using these substances: Wear 

eye/face protection; avoid breathing 

dust/fume/gas/mist/vapors/spray; and 

wear protective gloves). A significant 

new use of these substances is any 

manner or method of manufacture or 

processing associated with any use of 

these substances without providing risk 

notification as follows under 

§ 721.72(c): 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for these substances, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If these substances are not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substances are 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substances from the employer, or who 

have received the PMN substances 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(k) and (q). 

(3) The significant new uses for P–12– 

405 are: 

(i) Protection in the workplace. (A) 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(a)(6)(v), (a)(6)(vi), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (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): 

(1) 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. 

(2) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(3) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(B) As an alternative to the respiratory 

requirements listed here, a manufacturer 

or processor may choose to follow the 

New Chemical Exposure Limit (NCEL) 

provisions listed in the section TSCA 

5(e) consent order for these substances. 

The NCEL is 0.7 mg/m3 as an 8-hour 

time weighted average verified by actual 

monitoring data. 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (e), (f), (g)(1) (The 

PMN substance may: Cause serious eye 

damage; and suspected of damaging 

fertility or the unborn child), and (g)(2) 

(When using this substance: Wear eye/ 

face protection; avoid breathing dust/

fume/gas/mist/vapors/spray; use 

respiratory protection, or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.70 mg/m3; and wear protective 

gloves). A significant new use of this 

substance is any manner or method of 

manufacture or processing associated 

with any use of this substance without 

providing risk notification as follows 

under § 721.72(c): 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a) through (i) are applicable to 


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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)(iii) and (a)(3)(iii) of this section. 

■ 9. Add § 721.10771 to subpart E to 

read as follows: 

§ 721.10771 Hexane, 1,6-diisocyanato-, 

homopolymer, .alpha.-[1-[[[3-[[3-

(dimethylamino)propyl]amino]propyl]

amino]carbonyl]-1,2,2,2-tetrafluoroethyl]- 

.omega.-(1,1,2,2,3,3,3-heptafluoro

propoxy)poly[oxy[trifluoro(trifluoromethyl)- 

1,2-ethanediyl]]-blocked. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

hexane, 1,6-diisocyanato-, 

homopolymer, .alpha.-[1-[[[3-[[3- 

(dimethylamino)propyl]amino]

propyl]amino]carbonyl]-1,2,2,2- 

tetrafluoroethyl]-.omega.-(1,1,2,2,3,3,3- 

heptafluoropropoxy)poly[oxy[trifluoro

(trifluoromethyl)-1,2-ethanediyl]]- 

blocked (PMN P–13–175; CAS No. 

1279108–20–1) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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)(ii) of this section. 

■ 10. Add § 721.10772 to subpart E to 

read as follows: 

§ 721.10772 Fluorinated oxirane polymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorinated oxirane 

polymer (PMN P–13–176) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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)(ii) of this section. 

■ 11. Add § 721.10773 to subpart E to 

read as follows: 

§ 721.10773 Methylene bisacetophenone 

derivative (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methylene 

bisacetophenone derivative (PMN P–13– 

223) 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), and (a)(4). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(A) 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): 

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

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 


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specific) cartridges in combination with 

HEPA filters. 

(2) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(3) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(B) [Reserved] 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), 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 § 721.10774 to subpart E to 

read as follows: 

§ 721.10774 Amine adduct (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amine adduct (PMN P– 

13–239) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (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 (b). 

(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. 

■ 13. Add § 721.10775 to subpart E to 

read as follows: 

§ 721.10775 Metal hydroxide, treated with 

alkenyl alkoxy silane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as metal hydroxide, treated 

with alkenyl alkoxy silane (PMN P–13– 

495) 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(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 (b). 

(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. 

■ 14. Add § 721.10776 to subpart E to 

read as follows: 

§ 721.10776 Functionalized carbon 

nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as functionalized carbon 

nanotubes (PMN P–13–793) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), and (a)(3). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1), 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. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (a significant 

new use is use other than as a thin film 

for electronic device applications), 

(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), 

and (y)(1). 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (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. 

■ 15. Add § 721.10777 to subpart E to 

read as follows: 

§ 721.10777 2,4-Hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2,4-hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester (PMN P– 

13–945; CAS No. 3090–13–9) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(1). 

(ii) Release to water. Requirements as 

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

(c)(4) (N = 58). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10778 to subpart E to 

read as follows: 

§ 721.10778 2,4,Hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester (2E,4E)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2,4,hexadienoic acid, 3- 

(trimethoxysilyl)propyl ester (2E,4E)- 

(PMN P–13–946; CAS No. 163802–53–7) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(1). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=58). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 


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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10779 to subpart E to 

read as follows: 

§ 721.10779 Substituted alkene, reaction 

products with isophoronediamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted alkene, 

reaction products with 

isophoronediamine (PMN P–14–28) 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(h), (y)(1), and 

(y)(2). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=49). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10780 to subpart E to 

read as follows: 

§ 721.10780 Propaneperoxoic acid, 2,2- 

dimethyl-, 1,1,3,3-tetramethylbutyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

propaneperoxoic acid, 2,2-dimethyl-, 

1,1,3,3-tetramethylbutyl ester (PMN P– 

14–72; CAS No. 22288–41–1) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 19. Add § 721.10781 to subpart E to 

read as follows: 

§ 721.10781 Fatty acid amide 

hydrochlorides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amide 

hydrochlorides (PMNs P–14–89, P–14– 

90, P–14–91 and P–14–92) 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) (where N=110 for PMNs P–14–89 

and P–14–92; N=240 for PMN P–14–90; 

N=53 for PMN P–14–91). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10782 to subpart E to 

read as follows: 

§ 721.10782 Fatty acid amides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amides (PMN 

P–14–158, P–14–159, P–14–161, P–14– 

162, and P–14–163) 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) (where N=1 for PMNs P–14–158, 

P–14–159, P–14–161, and P–14–163; 

N=140 for PMN P–14–162). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10783 to subpart E to 

read as follows: 

§ 721.10783 Fatty acid amide acetates 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amide acetates 

(PMNs P–14–173, P–14–175, P–14–176, 

P–14–177, P–14–178, P–14–179, P–14– 

180, P–14–181, P–14–182, P–14–183, P– 

14–184, P–14–185, P–14–186, P–14– 

187, P–14–188, P–14–190, P–14–191, P– 

14–192 and P–14–193) 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) (where N = concentration of 

concern as follows): 

PMN No. 

Concentration 

of concern 

(ppb) 

P–14–173, P–14–175, P– 

14–178, P–14–179, P– 

14–181, P–14–183, P– 

14–184, P–14–192, P– 

14–193 ............................ 1 

P–14–176, P–14–180, P– 

14–185, P–14–186, P– 

14–187, P–14–190 .......... 2 

P–14–177, P–14–188 ......... 3 

P–14–191 ........................... 4 

P–14–182 ........................... 140 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10784 to subpart E to 

read as follows: 

§ 721.10784 Mixed butyltin mercaptoester 

sulfides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as mixed butyltin 

mercaptoester sulfides (PMNs P–14– 

216, P–14–217, and P–14–218) are 

subject to reporting under this section 

for the significant new uses described in 


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

requirements of this section do not 

apply to quantities of the PMN 

substances after they have been 

completely reacted (cured) or 

permanently entrained into a solid 

polyvinyl chloride matrix. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iv), 

(a)(3), (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)(1) 

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. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0 

percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), 

(g)(1)(iv), (g)(1)(v), (g)(1)(viii), (g)(1)(ix), 

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

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

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use other than as a stabilizer 

in polyvinyl chloride (PVC) at a 

concentration of no greater than 2 

percent. 

(iv) Release to water. Requirements as 

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

(c)(4) (N=0.5). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 23. Add § 721.10785 to subpart E to 

read as follows: 

§ 721.10785 Mixed methyltin 

mercaptoester sulfides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mixed methyltin 

mercaptoester sulfides (PMN P–14–231) 

is subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after it has been completely 

reacted (cured) or permanently 

entrained into a solid polyvinyl chloride 

matrix. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iv), 

(a)(3), (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)(1), 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. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0 

percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), 

(g)(1)(iv), (g)(1)(v), (g)(1)(viii), (g)(1)(ix), 

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

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

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use other than as a stabilizer 

in polyvinyl chloride at a concentration 

of no greater than 2 percent. 

(iv) Release to water. Requirements as 

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

(c)(4) (N=0.5). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 24. Add § 721.10786 to subpart E to 

read as follows: 

§ 721.10786 Trisubsituted ethoxylated 

carbomonocycle (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trisubsituted ethoxylated 

carbomonocycle (PMN P–14–234) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.10787 to subpart E to 

read as follows: 

§ 721.10787 Multi-functional novolac type 

epoxy resin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-functional novolac 

type epoxy resin (PMN P–14–270) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) 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 (b). 

(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. 

■ 26. Add § 721.10788 to subpart E to 

read as follows: 

§ 721.10788 Alkanedioic acids, polymer 

with substituted propanediol, alkanediols, 

and polyethylene glycol and MDI (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acids, 

polymer with substituted propanediol, 

alkanediols, and polyethylene glycol 

and MDI (PMN P–14–357) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 


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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 face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2014–24916 Filed 10–24–14; 8:45 am] 

BILLING CODE 6560–50–P 


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